[Federal Register: July 25, 1996 (Rules and Regulations)]
[Page 38906-38956]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy96-21]
 
[[pp. 38906-38956]] Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems

[[Continued from page 38905]]

[[Page 38906]]

dogs, and humans. Cysts in humans are most common in the subcutaneous 
tissues, eye and the brain.
    Foods associated with illness include: raw or undercooked pork.
    Toxoplasma gondii is a protozoan parasite that encysts in the 
tissues of a variety of mammalian hosts including pigs. Human infection 
may result in ``flu like'' symptoms in adults, late term abortions in 
pregnant women or serious congenial infections in children.
    Foods associated with illness include: raw or undercooked pork.
    Balantidium coli is a protozoal organism.
    Foods associated with illness include: raw, undercooked pork (fecal 
contamination)

Cryptosporidium spp.

    Foods associated with illness include: inadequately treated water, 
raw or undercooked veal or beef.

Chemical Hazards

    While biological hazards are of great concern because contaminated 
foods can cause widespread illness outbreaks, chemical hazards may also 
cause foodborne illnesses, although generally affecting fewer people.
    Chemical hazards can originate from four general sources:
    (1) Agriculture chemicals: pesticides, herbicides, animal drugs, 
fertilizers, etc.
    (2) Plant chemicals: cleaners, sanitizers, oils, lubricants, 
paints, pesticides, etc.
    (3) Naturally-occurring toxicants: products of plant, animal, or 
microbial metabolisms such as aflatoxins, etc.
    (4) Food chemicals: preservatives, acids, food additives, sulfiting 
agents, processing aids, etc.
    (5) Environmental contaminants: lead, cadmium, mercury, arsenic, 
PCBs.
    For many years the Food Safety and Inspection Service has conducted 
a National Residue Program to monitor the occurrence of residues from 
hazardous chemicals in meat and poultry products. Under a HACCP regime, 
frontline responsibility for control of residues from animal drugs or 
environmental contaminants will move from the government to the 
industry, although the agency will continue to verify that these 
controls and preventive measures are effective. Companies that 
slaughter livestock and poultry will probably find the FSIS National 
Residue Program Plan to be a useful document. The plan contains lists 
of compounds that might leave residues in the tissues of animals or 
birds, and provides some information on their relative risk through the 
rankings in the Compound Evaluation System. It provides information on 
which compounds FSIS has included in its annual testing program. It 
also provides information on the methods that are used to test for the 
compounds. Another FSIS document, the Domestic Residue Data Book, 
presents the results of FSIS testing. These data can help a HACCP team 
understand the overall hazard presented by various residues, although 
each company should gather information about the residue control 
performance of its own suppliers.
    Another useful reference about hazardous chemicals is the FSIS List 
of Proprietary Substances and Nonfood Compounds. This publication lists 
substances used in the preparation of product and nonfood compounds 
used in the plant environment that have been authorized by FSIS.
    Table 2 identifies some additional sources of chemical hazards. 
References listed in Section VIII can be used by the HACCP team in 
evaluating the potential chemical hazards associated with their product 
or process.

                                                           Table 2.--Types of Chemical Hazards                                                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
              Location                                                                      Hazard                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
Raw Materials.......................  Pesticides, antibiotics, hormones, toxins, fertilizers, fungicides, heavy metals, PCBs.                           
                                      Color additives, inks, indirect additives, packaging materials.                                                   
Processing..........................  Direct food additives--preservatives (nitrite), flavor enhancers, color additives.                                
                                      Indirect food additives--boiler water additives, peeling aids, defoaming agents.                                  
Building and Equipment Maintenance..  Lubricants, paints, coatings.                                                                                     
Sanitation..........................  Pesticides, cleaners, sanitizers.                                                                                 
Storage and Shipping................  All types of chemicals, cross contamination.                                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------

Physical Hazards

    Physical hazards include a variety of materials referred to as 
extraneous materials or foreign particles or objects. A physical hazard 
can be defined as any physical material not normally found in a food 
that can cause illness or injury to a person consuming the product.
    Physical hazards in finished products can arise from several 
sources, such as contaminated raw materials, poorly designed or 
maintained facilities and equipment, faulty procedures during 
processing, and improper employee training and practices. Table 3 
identifies some common physical hazards and their causes or sources.

                                                           Table 3.--Types of Physical Hazards                                                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
               Hazard                                                                   Source or cause                                                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glass...............................  Bottles, jars, light fixtures, utensils, gauge covers, thermometers.                                              
Metal...............................  Nuts, bolts, screws, steel wool, wire, meat hooks.                                                                
Stones..............................  Raw materials.                                                                                                    
Plastics............................  Packaging materials, raw materials.                                                                               
Bone................................  Raw material, improper plant processing.                                                                          
Bullet/BB Shot/Needles..............  Animals shot in field, hypodermic needles used for infections.                                                    
Jewelry.............................  Pens/pencils, buttons, careless employee practices.                                                               
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 38907]]



Section II

Controls and Critical Limits for Biological, Chemical, and Physical 
Hazards
    When all significant biological, chemical, and physical hazards are 
identified along with their points of occurrence, the next task is to 
identify measures to prevent the hazards from compromising the safety 
of the finished product.
    Preventive measures or controls can be defined as physical, 
chemical, or other factors that can be used to remove or limit an 
identified hazard. When considering preventive measures or controls, a 
limit must be established--this is the criterion that must be met to 
ensure safety. For example, proper heat treatment will control some 
pathogenic bacteria, and it is thus crucial to know what time/
temperature combinations constitute proper heat treatment for various 
products; these time/temperature combinations are the critical limits. 
Another example of a preventive measure for a biological hazard is the 
chlorination of poultry chiller water to prevent cross contamination of 
carcasses with Salmonella.
    With identified physical hazards, the most common preventive 
measures may be visual examinations of product or the use of a metal 
detector. Chemical hazards associated with raw materials may be 
controlled through detailed product specifications, letters of 
guarantee, or purchase specifications.
    Tables 4, 5, and 6 identify preventive measures that may be 
considered by the HACCP team. Table 7 gives some examples of regulatory 
limits.

    Table 4.--Examples of Preventive Measures for Biological Hazards    
------------------------------------------------------------------------
                Pathogen                  Preventive measure or control 
------------------------------------------------------------------------
Bacillus cereus........................  Proper holding and cooling     
                                          temperatures of foods; thermal
                                          processing of shelf-stable    
                                          canned food.                  
Campylobacter jejuni...................  Proper pasteurization or       
                                          cooking; avoiding cross-      
                                          contamination of utensils,    
                                          equipment; freezing;          
                                          atmospheric packaging.        
Clostridium botulinum..................  Thermal processing of shelf-   
                                          stable canned food; addition  
                                          of nitrite and salt to cured  
                                          processed meats; refrigeration
                                          of perishable vacuum packaged 
                                          meats; acidification below pH 
                                          4.6; reduction of moisture    
                                          below water activity of 0.93. 
Clostridium perfringens................  Proper holding and cooling     
                                          temperatures of foods; proper 
                                          cooking times and             
                                          temperatures; adequate cooking
                                          and avoidance of cross-       
                                          contamination by unsanitary   
                                          equipment or infected food    
                                          handlers.                     
Listeria monocytogenes.................  Proper heat treatments; rigid  
                                          environmental sanitation      
                                          program; separation of raw and
                                          ready-to-eat production areas 
                                          and product.                  
Salmonella spp.........................  Proper heat treatment;         
                                          separation of raw and cooked  
                                          product; proper employee      
                                          hygiene; fermentation         
                                          controls; decreased water     
                                          activity; withdrawing feed    
                                          from animals before slaughter;
                                          avoiding exterior of hide from
                                          contacting carcass during     
                                          skinning; antimicrobial       
                                          rinses; scalding procedures;  
                                          disinfecting knives.          
Staphylococcus aureus..................  Employee hygiene; proper       
                                          fermentation and pH control;  
                                          proper heat treatment and post-
                                          process product handling      
                                          practices; reduced water      
                                          activity.                     
Yersinia enterocolitica................  Proper refrigeration; heat     
                                          treatments; control of salt   
                                          and acidity; prevention of    
                                          cross-contamination.          
------------------------------------------------------------------------


     Table 5.--Examples of Preventive Measures for Chemical Hazards     
------------------------------------------------------------------------
                 Hazard                         Preventive measure      
------------------------------------------------------------------------
Naturally-Occurring Substances.........  Supplier warranty or guarantee;
                                          verification program to test  
                                          each supplier's compliance    
                                          with the warranty or          
                                          guarantee.                    
Added Hazardous Chemicals..............  Detailed specifications for    
                                          each raw material and         
                                          ingredient; warranty or letter
                                          of guarantee from the         
                                          supplier; visiting suppliers; 
                                          requirement that supplier     
                                          operates with a HACCP plan;   
                                          testing program to verify that
                                          carcasses do not have         
                                          residues.                     
In-Process Chemicals...................  Identify and list all direct   
                                          and indirect food additives   
                                          and color additives; check    
                                          that each chemical is         
                                          approved; check that each     
                                          chemical is properly used;    
                                          record the use of any         
                                          restricted ingredients.       
------------------------------------------------------------------------


     Table 6.--Examples of Preventive Measures for Physical Hazards     
------------------------------------------------------------------------
                 Hazard                         Preventive measure      
------------------------------------------------------------------------
Foreign objects in raw materials.......  Supplier's HACCP plan; use of  
                                          specifications, letters of    
                                          guarantee; vendor inspections 
                                          and certification; in-line    
                                          magnets; screens, traps, and  
                                          filters; in-house inspections 
                                          of raw materials.             
Foreign objects in packaging materials,  Supplier's HACCP plan; use of  
 cleaning compounds, etc.                 specifications, letters of    
                                          guarantee; vendor inspections 
                                          and certification; in-house   
                                          inspections of materials.     
Foreign objects introduced by            In-line metal detectors; visual
 processing operations or employee        product examinations; proper  
 practices.                               maintenance of equipment;     
                                          frequent equipment            
                                          inspections.                  
------------------------------------------------------------------------


[[Page 38908]]



              Table 7.--Some Examples of Regulatory Limits              
------------------------------------------------------------------------
                                                              Regulatory
              Hazard                   Regulatory limit        citation 
------------------------------------------------------------------------
biological: Microbial growth due   All poultry must be       Sec.  381.6
 to temperature abuse-Poultry       chilled immediately                6
 Chilling.                          after processing to a               
                                    temperature of 40                   
                                    deg.F or less.                      
chemical: Excess chemicals         Chemicals used are        Sec.  318.7
 contact product.                   approved for the                    
                                    intended use and at                 
                                    appropriate amounts.                
chemical: Chemical hazard from     Edible products must be   Sec.  317.2
 packaging materials.               packaged in container              4
                                    that will not                       
                                    adulterate product or               
                                    be injurious to health.             
                                    Packaging materials                 
                                    must be covered by a                
                                    letter of guaranty.                 
biological: Trichinae in pork....  Products containing pork  Sec.  318.1
                                    muscle tissue must be              0
                                    effectively heated,                 
                                    refrigerated, or cured              
                                    to destroy any possible             
                                    live trichinae.                     
biological: Pathogens in ready to  For destruction of        Sec.  318.1
 eat products.                      pathogens that may                 7
                                    survive a dry heat                  
                                    process. One of the                 
                                    time/temperature                    
                                    combinations for cooked             
                                    beef, roast beef, and               
                                    cooked corned beef;                 
                                    e.g., 143  deg.F\61.7               
                                    deg.C minimum                       
                                    temperature at minimum              
                                    time of 6 minutes.                  
physical: Extraneous material      Sampled carcasses         Sec.  381.7
 found on post chill examination    observed for                       6
 of poultry carcasses.              conformance with post               
                                    chill criteria,                     
                                    including unidentified              
                                    foreign material.                   
------------------------------------------------------------------------

Section III

Table 8.--Red Meat (Beef) Slaughter Hazards and Controls Use of 
Information
    This section contains examples of common process steps in beef 
slaughter. With each processing step, shown in the first column, you 
will find an ``X'' in the next three columns to tell you if there is a 
Biological hazard in column 2, a Chemical hazard in column 3, or a 
Physical hazard in column 4. Column 5 describes the hazard(s), and the 
last column lists some relevant controls or preventive measures. This 
table should be used in conjunction with the process flow diagram 
developed by your HACCP team for your plant's beef slaughter process.

                                       Table 8.--Red Meat Slaughter: Beef                                       
----------------------------------------------------------------------------------------------------------------
                                                       Description of biological,                               
 Red meat slaughter-beef: examples of                     chemical, or physical        Controls or preventive   
           processing steps             B    C    P      hazards for the process              measures          
                                                                  steps                                         
----------------------------------------------------------------------------------------------------------------
Receiving & Holding..................        X        --Residues present in edible  --Residue certification     
                                                       tissues above tolerances.     presented for live         
                                                                                     animal(s).                 
Skinning.............................   X             --Micro contamination of      --Skinning procedures are   
                                                       carcass surface due to        accomplished without hair  
                                                       contaminated outside hide     or visible fecal           
                                                       surface--contamination of     contamination of the       
                                                       carcass from floor--cross-    carcass.--Careful employee 
                                                       contamination.                practices.--Udder and      
                                                                                     puzzle removal are         
                                                                                     accomplished without       
                                                                                     contamination of edible    
                                                                                     product.                   
Evisceration.........................   X             --cross-contamination from    --Esophagus is tied to      
                                                       broken viscera.               prevent escape of stomach  
                                                                                     contents--Bung is dropped  
                                                                                     with sanitized knife and   
                                                                                     bagged to prevent escape of
                                                                                     feces--Viscera are removed 
                                                                                     intact.                    
Final Wash...........................   X             --growth of pathogens         --Final wash: Temperature:  
                                                       through insufficient wash.    90-100 deg.F Pressure: 345-
                                                                                     2070 kpa (50-300 psi)--    
                                                                                     Steam Pasteurization:      
                                                                                     Temperature: 195 deg.F or  
                                                                                     greater at surface Dwell   
                                                                                     time: 5-15 seconds in      
                                                                                     cabinet.                   
Chilling.............................   X             --growth of pathogens.......  --Surface temperature <ls-  
                                                                                     thn-eq>40 deg.F as soon as 
                                                                                     possible--Carcasses spaced 
                                                                                     a minimum of 1 inch apart. 
Receiving-Packaging Materials and Non        X        --contamination from          Letters of guarantee on file
 Beef Supplies.                                        deletious chemicals present   for all packaging materials/
                                                       in the packaging materials.   non-poultry supplies used  
                                                                                     by the establishment.      
Storage-Non Beef Supplies............             X   --contamination of stored     Examine to ensure no visible
                                                       packing materials/supplies    foreign material on/in non-
                                                       from foreign material.        poultry supplies or        
                                                                                     packaging materials.       
----------------------------------------------------------------------------------------------------------------

Section IV

Table 9.--Poultry Slaughter Hazards and Controls
Use of Information
    This section contains examples of common process steps in poultry 
slaughter. With each processing step, shown in the first column, you 
will find an ``X'' in the next three columns to tell you if there is a 
Biological hazard in column 2, a Chemical hazard in column 3, or a 
Physical hazard in column 4. Column 5 describes the hazard(s), and the 
last column lists some relevant controls or preventive measures. This 
table should be used in conjunction with the process flow diagram 
developed by your HACCP team for your plant's poultry slaughter 
process.

[[Page 38909]]



                                           Table 9.--Poultry Slaughter                                          
----------------------------------------------------------------------------------------------------------------
                                                       Description of biological,                               
    Poultry slaughter: examples of                        chemical, or physical        Controls or preventive   
           processing steps             B    C    P      hazards for the process              measures          
                                                                  steps                                         
----------------------------------------------------------------------------------------------------------------
Scalding.............................   X             --contamination from          --Fresh water input to      
                                                       scalding medium.              achieve a minimum of 1     
                                                                                     quart per bird             
                                                                                    --Temperature of the scald  
                                                                                     water maintained at        
                                                                                     appropriate levels (e.g.,  
                                                                                     <gr-thn-eq>126 deg.F)      
                                                                                    --Maintain counterflow      
                                                                                     scalding unit function     
                                                                                    --Post scald wash has       
                                                                                     sufficient pressure and    
                                                                                     volume to cover carcass    
                                                                                     with fresh (potable) water 
                                                                                     spray                      
                                                                                    --Overflow volumes are at   
                                                                                     required amounts           
Offline Procedures...................   X             --cross contamination from    Follow approved offline     
                                                       intestinal contents/exudate.  plant procedures for       
                                                                                     handling airsacculitis     
                                                                                     salvage and reprocessing   
                                                                                     for contamination (e.g., an
                                                                                     airsac salvage program that
                                                                                     transfers the carcasses to 
                                                                                     another station where the  
                                                                                     thigh, drumstick, wing tip,
                                                                                     and first wing section are 
                                                                                     salvaged and washed with   
                                                                                     chlorinated water).        
Final Wash...........................   X             --growth of pathogens.......  --A final water wash with   
                                                                                     appropriate levels of      
                                                                                     chlorinated water (e.g. 20-
                                                                                     50 ppm residual chlorine in
                                                                                     the water).                
                                                                                    --Sufficient water volume   
                                                                                     and pressure for equipment 
                                                                                     operation and sufficient   
                                                                                     dwell time in the final    
                                                                                     washer to remove visible   
                                                                                     contamination on internal  
                                                                                     and external surfaces of   
                                                                                     the carcass.               
Chilling-Carcass.....................   X             --growth of pathogens.......  Deep breast muscle          
                                                                                     temperature of carcass is  
                                                                                     <ls-thn-eq> 40 deg.F within
                                                                                     the specified time from    
                                                                                     slaughter for the class of 
                                                                                     poultry.                   
                                                                                    --Maintain an adequate      
                                                                                     chlorine level in the      
                                                                                     overflow water of in-line  
                                                                                     immersion chillers (e.g.,  
                                                                                     20-50 ppm residual chlorine
                                                                                     in the incoming water).    
                                                                                    --Maintain proper water flow
                                                                                     rates (input/overflow) for 
                                                                                     continuous chillers per    
                                                                                     USDA requirements (not less
                                                                                     than \1/2\ gallon of fresh 
                                                                                     water per frying chicken   
                                                                                     with continuous overflow). 
                                                  X   --contamination from foreign  Product entering (prechill) 
                                                       material.                     and exiting (postchill) the
                                                                                     chiller system meets the   
                                                                                     criteria for defects per   
                                                                                     USDA requirements (e.g. the
                                                                                     limits are not exceed for  
                                                                                     the number and size of     
                                                                                     extraneous materials found 
                                                                                     during the postchill       
                                                                                     examination-9 CFR Sec.     
                                                                                     381.76).                   
Chilling-Giblet/Neck.................   X             --growth of pathogens.......  --Temperature and fresh     
                                                                                     water input sufficient to  
                                                                                     meet USDA requirements for 
                                                                                     giblets and necks.         
                                                                                    --Chlorination of giblet    
                                                                                     chiller water at           
                                                                                     appropriate levels for     
                                                                                     giblets and necks [e.g.,   
                                                                                     giblets must be chilled to 
                                                                                     40 deg.F within 2 hours    
                                                                                     from removal from other    
                                                                                     viscera/fresh water intake 
                                                                                     not less than 1 gallon per 
                                                                                     40 frying chickens         
                                                                                     processed-9 CFR Sec.       
                                                                                     381.66 (c)(5)].            
                                                  X   --contamination from foreign  --Visually free of hazardous
                                                       material.                     foreign material.          
                                                                                    --Defects on poultry giblet 
                                                                                     and necks meet USDA        
                                                                                     requirements (e.g., each   
                                                                                     carcass must be observed   
                                                                                     for conformance against pre
                                                                                     and post chill criteria,   
                                                                                     including unidentified     
                                                                                     foreign materials-MPI      
                                                                                     Regulations 381.76).       

[[Page 38910]]

                                                                                                                
Cut-Up/Boning/Packaging/ Labeling....   X             --growth of pathogens.......  Temperature of product does 
                                                                                     not exceed 55 deg.F during 
                                                                                     further or second          
                                                                                     processing.                
                                                                                    --Movement of product       
                                                                                     through these areas and    
                                                                                     into the cooler is timely  
                                                                                     and efficient.             
                                                                                    --A mid-shift cleanup of the
                                                                                     area(s) is performed if the
                                                                                     room temperature is not    
                                                                                     maintained at or below 50  
                                                                                     deg.F.                     
                                                                                    --Packaging/labeling        
                                                                                     materials that come into   
                                                                                     direct contact with product
                                                                                     are intact.                
Receiving-Packaging Materials and Non        X        --contamination from          Letters of guarantee are on 
 Poultry Supplies.                                     deleterious chemicals         file for all packaging     
                                                       present in the packaging      materials/non-poultry      
                                                       materials.                    supplies used by the       
                                                                                     establishment.             
Storage-Non Poultry Supplies.........             X   --contamination of stored     Examine to ensure no visible
                                                       packing materials/supplies    foreign material on/in non-
                                                       from foreign material.        poultry supplies or        
                                                                                     packaging materials.       
----------------------------------------------------------------------------------------------------------------



Section V

Table 10.--Red Meat (Swine) Slaughter Hazards and Controls
Use of Information
    This section contains examples of common process steps in swine 
slaughter. With each processing step, shown in the first column, you 
will find an ``X'' in the next three columns to tell you if there is a 
Biological hazard in column 2, a Chemical hazard in column 3, or a 
Physical hazard in column 4. Column 5 describes the hazard(s), and the 
last column lists some relevant controls or preventive measures. This 
table should be used in conjunction with the process flow diagram 
developed by your HACCP team for your plant's swine slaughter process.

                                      Table 10.--Red Meat Slaughter: Swine                                      
----------------------------------------------------------------------------------------------------------------
                                                       Description of biological,                               
Red meat slaughter-swine: Examples of                     chemical, or physical        Controls or preventive   
           processing steps             B    C    P      hazards for the process              measures          
                                                                  steps                                         
----------------------------------------------------------------------------------------------------------------
Scalding.............................   X         X   --contamination from          Plant time/temperature      
                                                       scalding medium.              limits for scalding (e.g., 
                                                                                     although it may vary with  
                                                                                     facilities, a temperature  
                                                                                     of 138 to 140 deg.F is     
                                                                                     usually satisfactory).     
                                                                                    --Carcasses should remain in
                                                                                     scalding tanks long enough 
                                                                                     to loosen hair (excessive  
                                                                                     time or temperature results
                                                                                     in carcass cooking).       
                                             X   ...  --contamination with          --USDA-FDA approved chemical
                                                       chemicals..                   concentration not to exceed
                                                                                     manufacturer's             
                                                                                     recommendations.           
Dehairing............................   X   ...  ...  --contamination and growth    --Time/temperature          
                                                       of microorganisms due to      determined by plant-       
                                                       breaking of the skin from     specific testing results to
                                                       overexposure to the           remove visible hair to an  
                                                       dehairer.                     acceptable level without   
                                                                                     breaking skin.             
Evisceration.........................   X   ...  ...  --cross contamination from    --Remove all viscera intact.
                                                       equipment/utensils.          --Contaminated equipment    
                                                      --contamination from           will be clean and sanitized
                                                       stomach, intestines, and/or   before being used again.   
                                                       bladder contents.            --Training program for all  
                                                      --contamination from           employees, to include      
                                                       employee handling.            personal hygiene, product  
                                                                                     handling procedures, and   
                                                                                     sanitary dressing          
                                                                                     procedures.                
Trimming.............................   X   ...  ...  Stick wound has not been      Remove all visible stick-   
                                                       removed..                     wound related defects.     
Chilling.............................   X   ...  ...  --growth of pathogens.......  --Cool surface temperature  
                                                                                     to 40 deg. as soon as      
                                                                                     possible.                  
Receiving-Packaging Materials and Non  ...   X   ...  --contamination from          Letters of guarantee are on 
 Swine Supplies.                                       deleterious chemicals         file for all packaging     
                                                       present in the packaging      materials/non-poultry      
                                                       materials.                    supplies used by the       
                                                                                     establishment.             
Storage-Non Swine Supplies...........  ...        X   --contamination of stored     Examine to ensure no visible
                                                       packing materials/supplies    foreign material on/in non-
                                                       from foreign material.        poultry supplies or        
                                                                                     packaging materials.       
----------------------------------------------------------------------------------------------------------------


[[Page 38911]]



Section VI

Table 11.--Ingredient Hazards and Ingredient-Related Hazards
Use of Information
    This section contains an alphabetical list of ingredients commonly 
used in making meat and poultry products. For each entry you will find 
the name of the ingredient in the first column, and an ``X'' in the 
next three columns to tell you if there is a Biological hazard in 
column 2, Chemical hazard in column 3, or Physical hazard in column 4. 
Column 5 describes the hazard(s), and the last column lists some 
relevant controls or preventive measures. This table should be used in 
conjunction with the list of ingredients developed by your HACCP team 
for the products produced by the process under consideration.
    The HACCP team may find that a particular ingredient does not 
present the hazard identified in these tables. The presence or absence 
of a hazard can be influenced by the ingredient source and company. 
Also, Ingredient Specifications, provided by the supplier to the 
establishment, may give details on the material/ingredient being sold, 
including statements that the materials/ingredients are food grade and 
are free of harmful components. For example, the ingredient 
specifications for dried legumes might state that there will be fewer 
than 5 small rocks or stones per 10 pound bag and that no harmful 
pesticides were used in the growing process.

                                          Table 11.--Ingredient Hazards                                         
----------------------------------------------------------------------------------------------------------------
                                                       Description of biological,                               
        Examples of ingredient          B    C    P   chemical, or physical hazard     Controls or preventive   
                                                           for the ingredient                 measures          
----------------------------------------------------------------------------------------------------------------
Acidifiers...........................  ...   X   ...  --toxicological effects if    --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Anticoagulants.......................  ...   X   ...  --toxicological effect if     --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Antifoaming agents...................  ...   X   ...  --toxicological effect if     --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/ provider
                                                                                     ingredient specifications. 
Antioxidants.........................  ...   X   ...  --toxicological effect if     --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Batter/Breading......................   X   ...   X   --growth of pathogens due to  --Temperature controls for  
                                                       improper storage and          use                        
                                                       handling.                    --Ingredient specification  
                                                      --foreign material             sheet identifying the      
                                                                                     required parameters the    
                                                                                     ingredient must meet.      
                                                                                    --Where applicable,         
                                                                                     ingredients must be        
                                                                                     pathogen-free.             
Beef (fresh, frozen).................   X   ...  ...  --growth of pathogens due to  --Product temperature must  
                                                       improper storage and          be 40 degrees F or less at 
                                                       handling.                     receiving.                 
                                                                                    --Product must meet         
                                                                                     establishment purchase     
                                                                                     specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Binders/Extenders....................  ...   X    X   --foreign material..........  --Ingredients purchased     
                                                                                     under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/ provider
                                                                                     ingredient specifications. 
Bleaching agents.....................  ...   X   ...  --toxicological effect if     --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/ provider
                                                                                     ingredient specifications. 
Blood................................   X   ...  ...  --growth of pathogens from    --Ingredient specification  
                                                       improper handling and         sheet identifying the      
                                                       storage.                      required parameters the    
                                                                                     ingredient must meet.      
                                                                                     --Where applicable,        
                                                                                     ingredients must be        
                                                                                     pathogen-free.             
                                                                                     --Meet appropriate temp.   
Boneless beef........................   X   ...   X   --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                       --foreign particle            --Product must meet        
                                                       contamination, e.g., metal    establishment purchase     
                                                       fragments or bone.            specifications.            
                                                                                     --Product must be produced 
                                                                                     under a HACCP plan.        
                                                                                     --Visual examination of    
                                                                                     product for foreign        
                                                                                     materials.                 

[[Page 38912]]

                                                                                                                
Cooked beef..........................   X   ...   X   --growth of pathogens due to  --Receiving temperature of  
                                                       improper handling and         product must be frozen or  
                                                       storage.                      refrigerated at 40 degrees 
                                                       --foreign particle            F or below.                
                                                       contamination, e.g., metal    --Product must be received 
                                                       fragments or bone particles   from an approved supplier  
                                                       in boneless beef.             who produces the product   
                                                                                     under a HACCP plan.        
                                                                                     --Visual examination of    
                                                                                     product for foreign        
                                                                                     materials upon receipt.    
Cooked poultry.......................   X   ...   X   --growth of pathogens due to  --Receiving temperature of  
                                                       improper handling and         product must be frozen or  
                                                       storage.                      refrigerated at 40 degrees 
                                                       --foreign particle            F or below.                
                                                       contamination, e.g., bone     --Product must be received 
                                                       particles in boneless         from an approved supplier  
                                                       poultry.                      who produces the product   
                                                                                     under a HACCP plan.        
                                                                                     --Product must be          
                                                                                     organoleptically acceptable
                                                                                     at receipt.                
Cooked pork..........................   X   ...   X   --growth of pathogens due to  --Receiving temperature of  
                                                       improper handling and         product must be frozen or  
                                                       storage.                      refrigerated at 40 degrees 
                                                       --foreign particle            F or below.                
                                                       contamination, e.g., bone     --Product must be received 
                                                       particles in boneless pork.   from an approved supplier  
                                                                                     who produces the product   
                                                                                     under a HACCP plan.        
                                                                                     --Product must be          
                                                                                     organoleptically acceptable
                                                                                     at receipt.                
Coloring agents (natural)............  ...   X   ...  --Toxicological effect if     --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                     --Ingredients purchased    
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Coloring agents (artificial).........  ...   X   ...  --Toxicological effect if     --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Curing agents........................  ...   X   ...  --Toxico logical effect if    --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Curing accelerators..................  ...   X   ...  ---toxicological effect if    --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Dairy products.......................   X   ...   X   --growth of pathogens due to  --Temperature control.      
                                                       improper handling and        --Ingredient specification  
                                                       storage.                      sheet identifying the      
                                                       --foreign material            required parameters the    
                                                                                     ingredient must meet.      
                                                                                    --Where applicable,         
                                                                                     ingredients must be        
                                                                                     pathogen-free.             
Eggs or egg products.................   X   ...   X   --growth of pathogens due to  --Temperature control.      
                                                       improper handling and        --Ingredient specification  
                                                       storage.                      sheet identifying the      
                                                      --foreign particle             required parameters the    
                                                       contamination, e.g., shell    ingredient must meet.      
                                                       particles in broken eggs.    --Where applicable,         
                                                                                     ingredients must be        
                                                                                     pathogen-free.             
Emulsifying agents...................  ...   X   ...  --toxicological effects if    --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Flavoring agents.....................  ...   X   ...  --toxicological effects if    --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Fruits...............................  ...   X    X   --contamination from          --Ingredient specification  
                                                       agricultural chemicals.       sheet identifying the      
                                                      --foreign material             required parameters the    
                                                                                     ingredient must meet.      
Honey................................   X   ...   X   --contamination from          --Ingredient specification  
                                                       inherent microorganisms.      sheet identifying the      
                                                      --foreign particle             required parameters the    
                                                       contamination, e.g., dirt,    ingredient must meet.      
                                                       insect parts.                                            
Legumes (dry)........................  ...  ...   X   --foreign particle            --Ingredient specification  
                                                       contamination, e.g., rocks.   sheet identifying the      
                                                                                     required parameters the    
                                                                                     ingredient must meet.      

[[Page 38913]]

                                                                                                                
Mechanically deboned product.........   X   ...   X   --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                      --foreign particle            --Product must meet         
                                                       contamination, e.g., bone     establishment purchase     
                                                       particles.                    specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Mold inhibitors......................  ...   X   ...  --toxicological effect if     --Ingredient specification  
                                                       improper amounts used.        sheet identifying the      
                                                                                     required parameters the    
                                                                                     ingredient must meet.      
Mushrooms............................   X    X    X   --contamination from          --Ingredient specification  
                                                       inherent microorganisms.      sheet identifying the      
                                                      --contamination from           required parameters the    
                                                       agricultural chemicals.       ingredient must meet.      
                                                      --foreign material            --Where applicable,         
                                                                                     ingredients must be        
                                                                                     pathogen-free.             
Nuts.................................   X    X    X   --contamination from          --Ingredient specification  
                                                       inherent microorganisms.      sheet identifying the      
                                                      --contamination from           required parameters the    
                                                       agricultural chemicals.       ingredient must meet.      
                                                      --foreign particle                                        
                                                       contamination, e.g., broken                              
                                                       shells.                                                  
Packaging materials..................  ...  ...   X   --toxicological effects.....  --Use only FDA approved     
                                                                                     packaging materials.       
                                                                                    -- Each lot of packaging    
                                                                                     material must be           
                                                                                     accompanied by a Letter of 
                                                                                     Guarantee in which the     
                                                                                     manufacturer attests to    
                                                                                     compliance with FDA        
                                                                                     requirements.              
Phosphates...........................  ...   X   ...  --toxicological effect if     --Ingredients purchased     
                                                       limits are exceeded.          under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Poultry (fresh, frozen)..............   X   ...  ...  --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                                                    --Product must meet         
                                                                                     establishment purchase     
                                                                                     specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Pork (fresh, frozen).................   X   ...  ...  --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                                                    --Product must meet         
                                                                                     establishment purchase     
                                                                                     specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Proteolytic enzymes--Aspergillus       ...  ...  ...  --toxicological effects if    --Ingredients purchased     
 oryzae, Aspergillus, Flavusoryzae                     limits exceeded.              under a Letter of          
 group, Bromelin, Ficin, Papain.                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Partially defatted products..........   X   ...   X   --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                      --foreign particle            --Product must meet         
                                                       contamination, e.g., metal,   establishment purchase     
                                                       plastic.                      specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Seafood (fresh, frozen)..............   X    X   ...  --growth of pathogens due to  --Product temperature must  
                                                       improper handling and         be 40 degrees F or less at 
                                                       storage.                      receiving.                 
                                                      --environmental               --Product must meet         
                                                       contamination.                establishment purchase     
                                                                                     specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Spices/herbs--Sterilized,               X   ...  ...  --contamination from          --Ingredient specification  
 Unsterilized.                                         microorganisms inherent to    sheet identifying the      
                                                       the ingredient.               required parameters the    
                                                      --contamination from           ingredient must meet.      
                                                       agricultural chemicals.                                  
                                                      --foreign material                                        
Sweeteners--Saccharin, Citric acid,    ...  ...  ...  --toxicological effects if    --Ingredients purchased     
 Malic acid, Monoisopropyl citrate,                    limits exceeded.              under a Letter of          
 Phosphoric acid, Monoglyceride                                                      Guarantee.                 
 citrate.                                                                           --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 

[[Page 38914]]

                                                                                                                
Tenderizing agents...................  ...   X   ...  --toxicological effects if    --Ingredients purchased     
                                                       limits exceeded.              under a Letter of          
                                                                                     Guarantee.                 
                                                                                    --Ingredients purchased     
                                                                                     based on producer/provider 
                                                                                     ingredient specifications. 
Variety meats........................   X   ...  ...  --growth of pathogens due to  --Product temperature must  
                                                       improper handling, storage,   be 40 degrees F or less at 
                                                       or cleaning.                  receiving.                 
                                                                                    --Product must meet         
                                                                                     establishment purchase     
                                                                                     specifications.            
                                                                                    --Product must be produced  
                                                                                     under a HACCP plan.        
Vegetables...........................   X    X    X   --growth of pathogens due to  --Ingredient specification  
                                                       improper handling and         sheet identifying the      
                                                       storage.                      required parameters the    
                                                      --contamination from           ingredient must meet.      
                                                       agricultural chemicals.                                  
                                                      --foreign material                                        
----------------------------------------------------------------------------------------------------------------



Section VII

Table 12.--Processing Hazards and Controls
Use of Information
    This section contains a list of processing hazards and controls 
commonly used in making meat and poultry products. They are listed in 
alphabetical order. For each processing step, shown in the 1st column, 
you will find an ``X'' in the next three columns to tell you if there 
is a Biological hazard in column 2, Chemical hazard in column 3, or 
Physical hazard in column 4. Column 5 describes the hazard(s), and the 
last column lists some relevant controls or preventive measures. This 
table should be used in conjunction with the process flow diagram 
developed by your HACCP team for the products produced during the 
process under consideration.

                                       Table 12.--Processing Step Hazards                                       
----------------------------------------------------------------------------------------------------------------
                                                       Description of biological,                               
                                                          chemical, or physical        Controls or preventive   
           Processing steps             B    C    P      hazards for the process              measures          
                                                                  steps                                         
----------------------------------------------------------------------------------------------------------------
Acidifying (also see Pickling,          X   ...  ...  --survival of pathogens due   --Shelf-stable non-heat     
 Brining).                                             to final pH>4.6.              treated acidified product  
                                                                                     must obtain a pH of 4.6 or 
                                                                                     lower.                     
Aging (Meats)........................   X   ...  ...  --growth/survival of          --The temperature of the    
                                                       pathogens from                aging room will not exceed 
                                                       inappropriate storage         40 degrees Fahrenheit.     
                                                       temperatures and humidity    --Product temperature does  
                                                       (inadequate product water     not exceed 40 degrees      
                                                       activity (a<INF>w)).               Fahrenheit throughout the  
                                                      --growth of pathogens due to   aging process.             
                                                       rise in the pH due to        --The aging process will not
                                                       development of surface        exceed seven days.         
                                                       molds.                                                   
Boning...............................   X   ...  ...  --contamination by pathogens  --Careful employee practices
                                                       in product accumulations      to make sure that there is 
                                                       (e.g., cutting boards,        no contamination of the    
                                                       conveyor belts, utensils      product.                   
                                                       and other equipment).        --Equipment and utensils are
                                                      --cross-contamination of       washed and sanitized       
                                                       product by equipment/         immediately when           
                                                       utensils contaminated with    contaminated and each time 
                                                       pathogens when cutting        the employee leaves the    
                                                       through a non-apparent        working station.           
                                                       lesion (e.g., abscesses).    --All hot water sanitizers  
                                                                                     are maintained at 180      
                                                                                     degrees Fahrenheit.        
                                                                                    --Processing room           
                                                                                     temperature is maintained  
                                                                                     at 50 degrees Fahrenheit,  
                                                                                     or a midshift cleanup is   
                                                                                     performed within five hours
                                                                                     after operations begin.    
                                                      --contamination from bones,   --A boneless beef re-       
                                                       cartilage/extraneous          inspection procedure will  
                                                       material.                     be established using       
                                                                                     specifications outlined by 
                                                                                     FSIS.                      
Cooling..............................   X   ...  ...  --growth of pathogens due to  Cooked product will be      
                                                       improper temperatures.        cooled according to        
                                                      --germination of spore-        established procedures.    
                                                       forming pathogens due to                                 
                                                       slow chilling (e.g., C.                                  
                                                       perfringens).                                            
Cooking..............................   X   ...  ...  --survival of pathogens due   --Time/Temperature          
                                                       to improper procedures.       combinations are adequate  
                                                                                     to destroy the pathogens of
                                                                                     concern.                   

[[Page 38915]]

                                                                                                                
Drying (Meat)........................   X   ...  ...  --bacterial growth due to     --A water activity will be  
                                                       inadequate control over       specified that in          
                                                       time, temperature and         conjunction with other     
                                                       humidity.                     barriers will inhibit      
                                                                                     growth of pathogenic       
                                                                                     microorganisms (e.g., for  
                                                                                     shelf stable sausage A<INF>w of 
                                                                                     0.91 and a pH of 4.6).     
Filling..............................   X   ...  ...  --recontamination by          --Product will be protected 
                                                       pathogens in product          from contamination during  
                                                       accumulations.                the filling process, and   
                                                      --growth of pathogens due to   product temperature/ time  
                                                       temperature abuse.            will be maintained at or   
                                                                                     below the maximum          
                                                                                     determined to inhibit      
                                                                                     growth of pathogenic       
                                                                                     microorganisms.            
                                       ...   X   ...  --contamination from          --No lubricants or other    
                                                       lubricants.                   chemical contaminants will 
                                                                                     be allowed in or on the    
                                                                                     product.                   
Formulation..........................   X   ...  ...  --contamination by employee   --Careful employee practices
                                                       handling.                     used at all times to make  
                                                      --incorrect formulation        sure that there is no      
                                                      --contamination through        contamination of product.  
                                                       damaged packages.            --Ingredient packages will  
                                                                                     be clean and intact.       
                                                                                    --Ingredients will be added 
                                                                                     to product according to    
                                                                                     requirements outlined 9CR  
                                                                                     Sec.  318.7.               
                                       ...   X   ...  --excessive addition of       --Restricted ingredients    
                                                       restricted ingredients/       will be added to product   
                                                       additives could be toxic to   according to requirements  
                                                       the consumer.                 outlined in the 9CFR Sec.  
                                                                                     317.8.                     
Freezing (Meats).....................   X   ...  ...  --survival of parasites due   --Rapid cooling and         
                                                       to improper time/             freezing.                  
                                                       temperature application.                                 
                                                      --growth of pathogens due to                              
                                                       temperature abuse.                                       
Grinding.............................   X   ...  ...  --contamination by employee   --Careful employee practices
                                                       handling.                     to make sure that there is 
                                                      --recontamination by           no contamination of        
                                                       pathogens in product          product.                   
                                                       accumulations.                --Product will not be      
                                                                                     allowed to accumulate at   
                                                                                     the end of the grinder.    
                                                                                    --The temperature of the    
                                                                                     grinding room will be      
                                                                                     maintained at 50 degrees   
                                                                                     Fahrenheit.                
Grinding.............................  ...   X   ...  --contamination from          --Food grade lubricants will
                                                       lubricants.                   be used on areas of the    
                                                                                     machinery where a potential
                                                                                     for product contamination  
                                                                                     exists.                    
                                       ...  ...   X   --contamination from          --All boneless product will 
                                                       extraneous material.          be re-inspected before     
                                                                                     being loaded into the      
                                                                                     grinder.                   
Handling and Inspecting of Empty        X    X    X   --recontamination through     --Packaging materials and   
 Containers and Packaging Materials.                   damaged or soiled             empty containers will be   
                                                       containers/packaging          protected from             
                                                       material.                     contamination during their 
                                                                                     storage and handling.      
                                                                                    --No materials or containers
                                                                                     that appear to be          
                                                                                     contaminated with hazardous
                                                                                     foreign material will be   
                                                                                     used.                      
Mechanical Separating................   X   ...  ...  --growth of pathogens.......  --Product holding and       
                                                                                     cooling requirements       
                                                                                     outlined in 9CFR 318.18    
                                                                                     will be followed.          
                                                  X   --contamination from bone,    --The finished product will 
                                                       cartilage fragments.          meet the standards outlined
                                                      --contamination from           in 9CFR 319.5 for bone     
                                                       extraneous material.          particles and calcium.     
Packaging (also see Modified            X    X    X   --contamination from          --Closure and/or machine    
 Atmosphere Packaging, Vacuum                          packaging material.           specifications sufficient  
 Packaging Seaming, Sealing).                         --contamination through        to ensure adequate barrier 
                                                       damaged containers.           formation.                 
                                       ...  ...   X   ............................  --No detectable foreign     
                                                                                     material will be allowed in
                                                                                     or on the product or       
                                                                                     immediate product          
                                                                                     containers.                
Peeling..............................   X   ...  ...  --contamination by pathogens  --Careful employee practices
                                                       in product accumulations.     to make sure that there is 
                                                      --contamination from           no contamination of        
                                                       employee handling.            product.                   
                                                                                    --Product will not be       
                                                                                     allowed to accumulate in/on
                                                                                     peeling equipment.         
                                       ...  ...   X   --contamination from harmful  --Peeling equipment will be 
                                                       extraneous material.          maintained in a proper     
                                                                                     operating condition. No    
                                                                                     foreign material in the    
                                                                                     finished product.          

[[Page 38916]]

                                                                                                                
Receiving............................   X   ...  ...  --contamination through       --Product must be received  
                                                       damaged containers.           in sound containers and at 
                                                      --growth of pathogens due to   temperatures appropriate   
                                                       inappropriate storage         for the type of product.   
                                                       conditions (temperature,                                 
                                                       humidity).                                               
                                                      --growth of pathogens due to                              
                                                       temperature abuse.                                       
                                                      --contamination from                                      
                                                       receiving equipment (pumps,                              
                                                       hoses).                                                  
                                       ...   X   ...  --cross-contamination from    --Product must be received  
                                                       non-food chemicals.           in sound containers and be 
                                                                                     accompanied by a letter of 
                                                                                     guarantee from the supplier
                                                                                     if such letter is not on   
                                                                                     file.                      
                                       ...   X   ...  --contamination from          --Product must be received  
                                                       hazardous extraneous          in sound containers and be 
                                                       material (wood, nails from    accompanied by a letter of 
                                                       pallets, plastic pieces).     guarantee from the supplier
                                                                                     if such letter is not on   
                                                                                     file.                      
Retorting............................   X   ...  ...  --inadequate application of   --A thermal process specific
                                                       scheduled process.            to the product, container  
                                                                                     type and size, and         
                                                                                     retorting system must be in
                                                                                     use. The initial product   
                                                                                     temperature and any        
                                                                                     critical factors specified 
                                                                                     for the thermal process    
                                                                                     must also be controlled.   
                                                                                     Specified retort come up   
                                                                                     procedures will be         
                                                                                     followed.                  
Reworking............................   X   ...  ...  --contamination by employee   --Careful employee practices
                                                       handling.                     to make sure that there is 
                                                      --contamination by pathogens   no contamination of        
                                                       in product accumulations.     product.                   
                                                                                    --Room temperature of       
                                                                                     storage coolers will not   
                                                                                     exceed 40 degrees          
                                                                                     Fahrenheit.                
                                       ...  ...   X   --contamination foreign       --Careful employee practices
                                                       material.                     to make sure that there is 
                                                                                     no contamination of        
                                                                                     product.                   
Shipping.............................   X   ...  ...  --growth due to improper      --Product will not be       
                                                       temperatures.                 shipped unless it is 40    
                                                                                     degrees Fahrenheit or less.
                                                                                    --Product will not be loaded
                                                                                     into transport vehicles if 
                                                                                     the trailer temperature    
                                                                                     exceeds 40 degrees         
                                                                                     Fahrenheit.                
                                       ...  ...   X   --contamination from          --All product packages will 
                                                       hazardous extraneous          be intact before shipping. 
                                                       material through damaged     --All transport vehicles    
                                                       packages.                     will be cleaned after each 
                                                                                     use and before loading of  
                                                                                     product.                   
Thawing..............................   X   ...  ...  --growth of pathogens due to  --Thawing Room temperature  
                                                       improper temperatures.        will not exceed 50 degrees 
                                                                                     Fahrenheit.                
----------------------------------------------------------------------------------------------------------------



Section VIII

REFERENCES

Hazard Analysis Critical Control Point Systems

Agriculture Canada. Food Safety Enhancement Program--Implementation 
Manual. Nepean, Ontario, Canada.
HACCP: The Hazard Analysis and Critical Control Point System in the 
Meat and Poultry Industry. 1994. American Meat Institute Foundation. 
Washington, D.C.
International Commission on Microbiological Specification for Foods. 
1989. ``Microorganisms in Foods 4. Application of hazard analysis 
and critical control point (HACCP) system to ensure microbiological 
safety and quality.'' Blackwell Scientific Publications, Boston.
National Advisory Committee on Microbiological Criteria for Foods 
(NACMCF).
March 20, 1992--Hazard Analysis and Critical Control Point System.
Int. J. Food Micr. 16: 1-23.
National Advisory Committee on Microbiological Criteria for Foods
(NACMCF). June 1993--Report on Generic HACCP for Raw Beef. Food
Micr. 10: 449-488.
Pierson, M.D. and Corlett, D.A., Jr. ed. 1992. ``HACCP/Principles 
and Applications.'' Van Nostrand Reinhold.
Stevenson, K.E. ed. 1993. ``HACCP-Establishing Hazard Analysis 
Critical Control Point Programs.'' A Workshop Manual. The Food 
Processors Institute. Washington, D.C.
Tompkin, R.B. 1990. The Use of HACCP in the Production of Meat and 
Poultry Products. J. of Food Protect. 53(9): 795-803.
Tompkin, R.B. 1995. The use of HACCP for producing and distributing 
processed meat and poultry products. In Advances in Meat Research. 
Volume 10. Hazard Analysis Critical Control Point (HACCP) in Meat, 
Poultry and Seafoods. Chapman & Hall (In Press).

Foodborne Illnesses

Bean, N.H. and Griffin, P.M. 1990. Foodborne disease outbreaks in 
the United States, 1973-1987: Pathogens, vehicles, and trends. J. 
Food Protect. 53: 804-817.
Bean, N.H. and Griffin, P.M. 1990. Foodborne disease outbreaks, 5-
year summary, 1983-1987. J. Food Protect. 53: 711.
Council for Agricultural Science and Technology. ``Risks Associated 
with Foodborne Pathogens.'' February 1993.

[[Page 38917]]

Oblinger, J.L., ed. 1988. Bacteria Associated with Foodborne 
Illnesses, A Scientific Status Summary by the Institute of Food 
Technologists Expert Panel on Food Safety and Nutrition. Food 
Technol. 42(4).
Padhye, N.V.; Doyle, M.P. 1992. E. Coli O157:H7 Epidemiology, 
pathogenesis, and methods for detection in food. J. Food Prot. 
55:55-565.
Schuchat, A., Swaminathan, B. and Broome, C.V. 1991. Epidemiology of 
human listeriosis. Clin. Microbiol. Rev. 4: 169-183.
Tauxe, R.V., ``Epidemiology of Camplyobacter jejuni infections in 
the United States and other Industrialized Nations,'' In Nachamkin, 
Blaser, Tompkins, ed. Camplyobacter jejuni: Current Status and 
Future Trends, 1994, chapter 2, pages 9-19.
Tauxe, R.V., Hargett-Bean, N., Patton, C.M. and Wachsmuth, I.K. 
1988. Campylobacter isolates in the United States, 1982-1986. In, 
CDC Surveillance Summaries, June 1988. MMWR 37 (No. SS-2) : 1-13.
Todd, E. 1990. Epidemiology of Foodborne Illness: North America. The 
Lancet 336:788.

Microbiological, Chemical, and Physical Hazards

Corlett, D.A., Jr. and R.F. Steir. 1991. Risk assessment within the 
HACCP system. Food Control 2:71-72.
Environmental Protection Agency. 1992. Tolerances for Pesticides in 
Foods. Title 40, Code of Federal Regulations, Part 185. U.S. 
Government Printing Office, Washington, DC.
FDA. 1989. The Food Defect Action Levels. FDA/CFSAN. Washington, DC.
FDA. 1994. Fish and Fishery Products Hazards and Control Guide--Get 
Hooked on Seafood Safety. Office of Seafood, Washington, DC.
HACCP: The Hazard Analysis and Critical Control Point System in the 
Meat and Poultry Industry. 1994. American Meat Institute Foundation, 
Washington, DC.
International Commission on Microbiological Specification for Foods. 
1989. ``Microorganisms in Foods 4. Application of hazard analysis 
and critical control point (HACCP) system to ensure microbiological 
safety and quality.'' Blackwell Scientific Publications, Boston.
Pierson, M.D. and Corlett, D.A., Jr. ed. 1992. ``HACCP/Principles 
and Applications.'' Van Nostrand Reinhold.
Stevenson, K.E. ed. 1993. ``HACCP-Establishing Hazard Analysis 
Critical Control Point Programs.'' A Workshop Manual. The Food 
Processors Institute. Washington, DC.
USDA, 1994. Domestic Residue Data Book: 1993. USDA, FSIS, 
Washington, DC.
USDA, 1994. List of Propriety Substances and Nonfood Compounds 
Authorized for Use under USDA Inspection and Grading Programs. USDA, 
FSIS, Washington, DC.
USDA, 1995. National Residue Program Plan: 1995. USDA, FSIS, 
Washington, DC.

Internet Home Pages

Agriculture Canada/http://aceis.agr.ca
Food Law Sites/http://www.fsci.umn.edu/FoodLaw/foodlaw.html
HACCP95/http://www.cvm.uiuc.edu/announcements/haccp95/haccp95.html
Center for Disease Control/http://fftp.cdc.gov/pub/mmwr/MMWRweekly
Material Safety Data Sheets/http://listeria.nwfsc.noaa.gov/msds.html
U.S. Food and Drug Administration/http://vm.cfsan.fda.gov/list.html 
Bad Bug Book
U.S. Department of Agriculture/http://www.usda.gov

Appendix E--FSIS Sample Collection Guidelines and Procedure for 
Isolation and Identification of Salmonella from Raw Meat and Poultry 
Products

Introduction

    This sampling protocol has been prepared to support the Pathogen 
Reduction/HACCP Regulation. FSIS will be conducting a Salmonella 
testing program in support of this regulation. The regulation does not 
require establishments to conduct their own testing for Salmonella. 
However, for those who choose to conduct their own Salmonella testing 
program, the protocol outlined in this document provides detailed 
instruction for sample collection and analysis that are the same as 
those used in the FSIS Salmonella testing program for raw meat and 
poultry products.
    This protocol incorporates the use of a non-destructive sampling 
technique for sample collection of raw beef and swine carcasses. These 
techniques have been evaluated by the Agricultural Research Service and 
have been designed to give comparable results to the FSIS Nationwide 
Microbiological Baseline Data Collection Programs' excised tissue 
samples. We are continuing to improve the sponging techniques and 
welcome comments. This technique will be closely monitored during the 
first year of prevalence phase Salmonella testing. Carcass sampling for 
broiler and turkey carcasses remain the nondestructive whole bird rinse 
which was used in the Baseline Programs. Ground product sampling 
involves collecting approximately \1/2\ pound of the product.
    The analytical methods section of this protocol details the 
cultural procedures currently in use by FSIS/USDA for the examination 
of raw meat and poultry products for Salmonella. Any screening method 
under consideration for Salmonella testing must meet or exceed the 
following performance characteristics: sensitivity = <gr-thn-eq>97%, 
specificity <gr-thn-eq>96%, false-negative rate = 3%, false-positive 
rate <ls-thn-eq>4%.

Guidelines for Sample Collectors/Microbiologists

Pre-Sampling Preparation
    Prior to collecting samples, the individual designated for sample 
collection should compile a written establishment-specific sample 
collection protocol for microbiological analysis. This protocol should 
include a check list for tasks to be performed prior to sample 
collection, materials needed for sample collection, random selection 
procedures, where the samples will be analyzed (on-site versus off-
site), and other information that will aid the sample collector. 
Sampling supplies, such as sterile gloves, sterile sampling solutions, 
hand soap, sanitizing solution, etc., as well as specific materials 
needed for sampling different carcass types (i.e., specimen sponges in 
bags, if sampling cattle or swine carcasses), will need to be 
assembled.
    For cattle and hog carcass sampling, a template will be needed to 
mark off the area to sample (Figure 1). The template can be made of 
metal or aluminum foil, brown paper, etc. From a sheet larger than the 
area to be sampled, cut out a 10 cm (3.94 inches) x 10 cm square for 
sampling cattle or a 6 cm x 10 cm rectangle for swine carcass sampling. 
If a reusable metal template is used, it will need to be sanitized with 
an approved sanitizing solution (e.g. hypochlorite (bleach) solution or 
alcohol). However, the template needs to be dry before placing it on 
the carcass. Aluminum foil or paper templates can be used once and 
discarded. The foil for the template should be stored in a manner to 
prevent contamination. Since the area enclosed by the template will be 
sampled, take care not to touch this area with anything other than the 
sampling sponge. Using dirty or contaminated material may lead to 
erroneous results. If an autoclave is available, paper or aluminum foil 
templates can be wrapped in autoclavable paper and sterilized.
    The sterile sampling solution, Buffered Peptone Water (BPW), can be 
stored at room temperature. However, at least one day prior to sample 
collection, check solutions for absence of cloudiness and/or turbidity 
and place the number of containers of sampling solution (BPW) that will 
be needed for the next day's sampling in the refrigerator. DO NOT use 
solutions that are cloudy, turbid, or contain particulate matter.
    To obtain the most accurate results, samples should be analyzed as 
soon after collection as possible. However, if samples must be 
transported to an off-site laboratory, the samples need to be

[[Page 38918]]

maintained at refrigeration temperatures until transport, then shipped 
refrigerated via an overnight delivery service to the laboratory 
performing the analysis. Samples analyzed off-site must be picked up by 
the overnight courier the SAME calendar day the sample is collected. 
The sample must arrive at the laboratory no later than the day after 
the sample is collected. Samples shipped to an outside laboratory must 
be analyzed no later than the day after collection. The following 
section gives information on shipping containers and transporting 
samples to off-site facilities.

Shipping Containers and Coolant Packs

    It is important that samples fit easily into the shipping so that 
the sample bags do not break.
    Correct use of the refrigerant gel-ice packs and proper packing of 
the shipping container are necessary so that samples arrive at the 
laboratory at an acceptable temperature. Frozen samples or samples 
which are too warm are not considered valid and must not be analyzed. 
Some bacteria may be damaged by temperatures that are too cold. 
Temperatures that are too warm can allow bacteria to reproduce. 
Maintaining samples at improper temperatures may cause inaccurate 
sample results.
    The sample should be kept refrigerated, NOT FROZEN, in the shipping 
container prior to pickup by the courier. The shipping container, 
itself, should not be used as a refrigerator. However, multiple samples 
(if needed) for that day may be stored in the open shipping container 
in the cooler or refrigerator.
Random Selection of Carcasses or Ground Product for Sampling
    Samples are to be taken randomly. There are different methods of 
selecting the specific carcass for sampling that could be used but all 
require the use of random numbers. Methods could include: using random 
number tables, drawing cards, using calculator- or computer-generated 
random numbers, etc. When selecting the random numbers, use the 
method(s) currently in use at the establishment for other sampling 
programs, if other programs are currently underway.
    The carcass or ground product for sampling must be selected at 
random from all eligible carcasses. If multiple lines exist, randomly 
select the line for sample collection for that interval. Repeat the 
random selection process for the next sampling interval. Each line 
should have an equal chance of being selected at each sampling 
interval.

Cattle Carcass Selection

    The half-carcasses eligible for sampling should be selected from 
those in the cooler 12 or more hours after slaughter. Both the 
``leading'' and ``trailing'' sides of a carcass should have an equal 
chance of being selected. NOTE: If more than one shift is operating at 
the plant, the sample can be taken on any shift, provided the following 
requirements are met:
    Selection of TIME: Determine the times that carcasses chilled for 
12 or more hours will be on hand. Then randomly select a time for 
collecting samples. If samples are shipped off-site, then take into 
account that the delivery service may have limitations on pickup times.
    Selection of COOLER SITE: Select a safe and accessible site in the 
cooler for random selection of the half-carcass. This site may be 
located at the transfer chain, grading chain, or a rail that contains 
carcasses that have been chilled 12 hours or more.
    Selection of HALF-CARCASS: At the random time selected, identify a 
half-carcass (selected by your random number method) from the 
predetermined point along the chain (selected cooler site) and then 
count back five (5) half-carcasses and select the next half-carcass 
(carcass) for sampling. The reason for counting back five half-
carcasses is to avoid any possible bias during selection.

Swine Carcass Selection

    The carcasses eligible for sampling should be selected from those 
in the cooler 12 or more hours after slaughter. Every carcass should 
have an equal chance of being selected.

    Note: If more than one shift is operating at the plant, the 
sample can be taken on any shift, provided the following 
requirements are met:

    Selection of TIME: Determine the times that carcasses chilled for 
12 or more hours will be on hand. Then randomly select a time for 
collecting samples. If samples are shipped off-site, then take into 
account that the delivery service may have limitations on pickup times.
    Selection of COOLER SITE: Select a safe and accessible site in the 
cooler for random selection of the carcass. This site may be located at 
the transfer chain, or a rail that contains carcasses that have been 
chilled 12 hours or more. If there are multiple sites of the same kind, 
select one at random.
    Selection of CARCASS: At the random time selected, identify a 
carcass (selected by your random number method) from the predetermined 
point along the chain and then count back five (5) carcasses and select 
the next carcass for sampling. The reason for counting back five 
carcasses is to avoid any possible bias during selection.

Poultry Carcass Selection

    The poultry carcasses will be selected at random after chilling, at 
the end of the drip line or last readily accessible point prior to 
packing/cut-up. A WHOLE carcass is required, that is, one that has not 
been trimmed.

    Note: If more than one shift is operating at the plant, the 
sample can be taken on any shift, provided the following 
requirements are met:

    Selection of TIME: Determine the times that chilled carcasses will 
be on hand, then randomly select a time for collecting samples. If 
samples are shipped off-site, then take into account that the delivery 
service may have limitations on pickup times.
    Selection of CHILLER: If more than one chiller system is in 
operation at the time of sample collection, the chill tank from which 
the sample is selected must be randomly selected.
    Selection of POULTRY CARCASS: At the random time, identify a 
carcass (selected by your random number method) from the predetermined 
point, and then count back five (5) carcasses and select the next 
carcass for sampling. Exception: If the fifth carcass is not a WHOLE 
(untrimmed) bird, count back an additional five carcasses for sample 
selection. Remember: Each carcass must have an equal chance of being 
selected. The reason for counting back five carcasses is to avoid any 
possible bias during selection.

Raw Ground Product Selection (Beef, Pork, Chicken, Turkey)

    Raw ground product samples will be randomly selected and collected 
after the grinding process and, if possible before any addition of 
spices or seasonings, but prior to final packaging.

    Note: If more than one shift is operating at the plant, the 
sample can be taken on any shift, provided the following 
requirements are met:

    Selection of TIME: Determine the times that raw ground product will 
be produced, then randomly select a time for collecting samples. Take 
into account that the overnight delivery service may have limitations 
on pickup times, for determining sample collection time.
    Selection of GRINDER: If more than one grinder is in operation at 
the time of sample collection, the grinder from which the sample is 
selected must be randomly selected.

[[Page 38919]]

Aseptic Techniques/Sampling
    Extraneous organisms from the environment, hands, clothing, sample 
containers, sampling devices, etc., may lead to erroneous analytical 
results. Stringent requirements for microbiological analysis are 
necessary, therefore, use of aseptic sampling techniques and clean 
sanitized equipment and supplies are of utmost importance. The 
following information gives general techniques for aseptic techniques 
that are routinely used during sample collection for microbiological 
analysis.
    There should be an area designated for preparing samples, etc. A 
stainless steel, wheeled cart or table would be useful during sampling. 
A small tote or caddy could be could be easily transported to the 
location of sampling and used for carrying supplies, supporting sample 
bags when adding sterile solutions to sample bags, etc.
    Sterile gloves should be used for collecting samples. The only 
items which may contact the external surface of the glove are the 
exposed sample being collected and/or the sterile sample utensil 
(specimen sponge). Keep in mind that the outside surfaces of the sample 
container are not sterile. Do not handle the inside surface of the 
sterile sample containers. Do not touch anything else. The following 
procedure for putting on sterile gloves can be followed when collecting 
samples:
    (a) Peel open the package of sterile gloves from the top without 
contaminating (touching, breathing on, contacting, etc.) the exterior 
of the gloves.
    (b) Remove a glove by grasping it from the wrist-side opening inner 
surface which is folded. Avoid any contact with the outer surface of 
the glove. Insert the washed and sanitized hand into the glove, taking 
care not to puncture the glove or touch the outside surface of the 
glove.
    (c) Next, follow the same procedure for the hand you will use to 
physically handle the sample, using care not to contaminate the outer 
surface of the glove.
    (d) If at any time you are concerned that a glove may be 
contaminated, discard it and begin again with Step (a) above.
Preparation for Sample Collection
    Prior to collecting samples, review steps for sample collection, 
random selection procedure, etc.
    At least one or more days prior to sample collection, check 
sampling solution (BPW) for cloudiness/turbidity and refrigerate if not 
cloudy or turbid. If shipping samples to off-site facility, place 
coolant packs in freezer then pre-chill open shipping in cooler/
refrigerator.
    On the day of sampling, gather all sample collection bags, sterile 
gloves, sanitizer, hand soap, sterile solutions for sampling, and 
specific materials listed under the Materials section of the sample 
collection section for the type of carcass to be sampled.
    Label the sample bags before starting sampling procedure. Use 
permanent ink. If you are using paper labels, it is important that the 
label be applied to the bag at normal room temperature; it will not 
stick if applied in the cooler.
    Outer clothing (frocks, gloves, head gear, etc.) worn in other 
areas of the plant should be removed before entering the sampling area 
or preparing to collect samples. Replace outer clothing removed earlier 
with clean garments (i.e. laboratory coat) that have not been directly 
exposed to areas of the plant outside of the sampling area.
    Sanitize the sample work area surfaces by wiping with a clean 
disposable cloth or paper towel dipped in a freshly prepared 500 ppm 
sodium hypochlorite solution (0.05% sodium hypochlorite) or other 
approved sanitizer which provides an equivalent available chlorine 
concentration. The sample work area surfaces must be free of standing 
liquid before sample supplies and/or product containers are placed on 
them.
    Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include 
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands 
using disposable paper towels.
Specific Sample Collection Procedures
Raw Ground Product

Materials

    1. 2 sterile ziplock-type or stomacher bags or equivalent.
    2. Sterile gloves.
    3. Plastic cable-tie-wrap or thick rubber band for securing bag.

Collection

    Ensure that all supplies are on hand and readily available. Use the 
predetermined random selection procedure to select sample. Samples of 
raw ground product will be collected after the grinding process, and, 
if possible, before the addition of any spices or seasonings, but prior 
to final packaging.
    1. Put on sterile gloves.
    2. Aseptically collect approximately \1/2\ pound of ground product, 
if possible, before the addition of any spices or seasonings, but just 
prior to final packaging. (Sample will be about the size of an orange.) 
Use the sterile sampling bag, taking care not to contaminate the inside 
of the bag with your gloved hand.
    3. Close the bag tightly by twisting the top and securing it with 
the plastic cable-tie-wrap or rubber band or securely closing the 
ziplock-type bag.
    4. Place bagged sample inside a second bag and close the outer bag 
tightly.
    5. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation for analysis.
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow the procedure in the Sample Shipment section.
Cattle Surface Sample Collection Procedure

Materials

1. Sterile specimen sponge in sterile Whirl-Pak<Register> bag or 
equivalent
2. 10 ml sterile Buffered Peptone Water (BPW)
3. Sterile ziplock-type or stomacher bag
4. Template for a 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies

Collection

    A sterile, moistened sampling sponge (which usually come pre-
packaged in a sterile bag) will be used to sample all three sites on 
the swine carcass (ham, belly, and jowls--see Figure 3). It is 
important to swab the sampling areas in the order of least to most 
contaminated to avoid spreading any contamination on the carcass. 
Therefore, swab sampling areas in the sequence indicated in this 
protocol. Use predetermined random selection procedures for selecting 
carcass to be sampled. Remember: samples will be collected from 
carcasses in the cooler 12 hours or more after slaughter. 
Nondestructive surface sampling will be conducted as follows:
    1. Ensure that all bags have been pre-labeled and all supplies are 
on hand, including the sampling template. (An assistant may be helpful 
during the sampling process.)
    2. Position the wheeled ladder, sampling platform, or step ladder 
near the carcass so the rump sample area (Figure 2) is within easy 
reach from the ladder.
    3. IF a reusable template is used, have the assistant immerse the 
sampling

[[Page 38920]]

template in a sanitizing solution for at least 1-2 minutes. Just prior 
to taking the first sample on the carcass, have the assistant put on a 
pair of gloves (taking care not to contaminate the outer surface of the 
glove with fingers) and retrieve the sampling template from the 
sanitizing solution. Shake excess solution from utensil, then protect 
the portion of the template that will contact the carcass from 
contamination.
    4. Locate the flank, rump, and brisket sampling sites using 
illustrations and directions in Figure 2 (cattle carcass sampling 
locations).
    5. To hydrate the sponge, open the sponge bag. Remove cap from 
sterile BPW bottle, being careful not to touch the bottle opening. 
Carefully pour the contents of the sterile BPW bottle (10 ml) into the 
sponge bag to moisten the sponge.
    6. Close the top of the bag. Use hand pressure from the outside of 
the bag and carefully massage the sponge until it is FULLY HYDRATED 
(moistened).
    7. With the bag still closed, carefully push the moistened sponge 
to the upper portion of the bag orienting one narrow end of the sponge 
up toward the opening of the bag. Do NOT open the bag or touch the 
sponge with your fingers.
    8. Open the bag containing the sponge, being careful not to touch 
the inner surface of the bag with your fingers. The wire closure at the 
top of the bag should keep the bag open. Set bag aside.
    9. Put on sterile gloves.
    10. Carefully remove the moistened sponge from the bag with your 
sampling hand. Take care to avoid touching the surfaces of the sampling 
sponge.
    11. With the other hand, retrieve the template by the outer edge 
taking care to avoid contaminating the inner edges of the sampling area 
of the template.
    12. Locate the flank sampling area (Figure 2) and place template 
over this
    location.
    13. Hold the template in place with one gloved hand. Take care not 
to contaminate the enclosed sampling area with your hands.
    14. With the other hand, wipe the sponge over the entire enclosed 
area (10 cm x 10 cm) for the sample for a total of approximately 10 
times in the vertical and 10 times in the horizontal directions. The 
pressure for swabbing would be as if you were removing dried blood from 
the carcass. However, the pressure should not be too hard as to crumble 
or destroy the sponge. (Note: The template may need to be ``rolled'' 
from side to side during swabbing since the surface of the carcass is 
not flat. This ensures that the 100 cm\2\ area is enclosed while 
swabbing.)
    15. Repeat steps 13-15 for the brisket area, using the SAME side or 
surface of the sponge used to swab the flank sampling area.
    16. After swabbing the brisket area, transfer the template to the 
same hand holding the sponge. Do not contaminate the inner edges of the 
sampling area of the template.
    17. Climb the ladder or platform, holding onto the handrail with 
the hand NOT used to perform swabbing. Once at a convenient and safe 
height for sampling the rump, transfer template back to ``climbing'' 
hand (hand used to hold onto the rail while climbing the ladder), 
taking care not to contaminate the inner edges of the sampling area of 
the template. Avoid contaminating your sampling hand.
    18. Repeat steps 13-15 for the rump area, using the ``clean'' 
surface or side (the side that was NOT previously used to swab the 
flank/brisket areas).
    19. After swabbing the rump area, carefully place the sponge back 
in the sample bag, taking care not to touch the outside of the sponge 
to the outside of the sample bag.
    20. While holding the handrail, climb down from the ladder.
    21. Expel excess air and fold the top edge of the bag containing 
the sponge 3 or 4 times to close. Secure the bag by folding the 
attached wire tie back against the bag.
    22. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation (ANALYTICAL METHODS section)
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow procedure in the Sample Shipment section.
Swine Surface Sample Collection Procedure

Materials

1. Sterile specimen sponge in sterile Whirl-Pak<Register> bag or 
equivalent
2. 10 ml sterile Buffered Peptone Water (BPW)
3. Sterile Ziplock-type or stomacher bag
4. Template for a 100 cm<SUP>2 sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. A 
sterile, moistened sampling sponge (which usually come pre-packaged in 
a sterile bag) will be used to sample all three sites on the swine 
carcass (ham, belly, and jowls--see Figure 3). It is important to swab 
the sampling areas in the order of least to most contaminated to avoid 
spreading any contamination on the carcass. Therefore, swab sampling 
areas in the sequence indicated in this protocol. Use predetermined 
random selection procedures for selecting carcass to be sampled. 
Remember: samples will be collected from carcasses in the cooler 12 
hours or more after slaughter.
    Nondestructive surface sampling will be conducted as follows:
    1. Ensure that all supplies are on hand. (An assistant may be 
helpful during the sampling process.)
    2. Position the wheeled ladder, sampling platform, or step ladder 
near the carcass so the ham sample area (Figure 3) is within easy reach 
from the ladder.
    3. Immerse the sampling template in a sanitizing solution for at 
least 1-2 minutes. Just prior to swabbing the first sampling site on 
the carcass (step 1), retrieve the sampling template from the 
hypochlorite sanitizing solution. Shake excess solution from utensil, 
then protect the portion of the template (especially the inner edges of 
the sampling area) that will contact the carcass from contamination.
    4. Locate the ``belly'', ham, and jowl sampling sites using 
illustrations and directions in Figure 3 (swine carcass sampling 
locations).
    5. Open the sponge bag by holding the bag at one corner by the wire 
closure (which is usually colored yellow) then tear off the clear, 
perforated strip at the top of the bag. (Do not remove or tear off the 
wire closures). Next, pull apart the two small white tabs on either 
side of the bag to open the mouth of the bag.
    6. Remove cap from sterile BPW tube, being careful not to touch the 
bottle opening. Carefully pour the entire contents of the BPW bottle 
(10 ml) into the sponge bag to moisten the sponge.
    7. Close the top of the bag by pressing the wire closures together. 
Use hand pressure from the outside of the bag and carefully massage the 
sponge until it is FULLY HYDRATED (moistened).
    8. With the bag still closed, carefully push the moistened sponge 
to the upper portion of the bag positioning one narrow end of the 
sponge up toward the opening of the bag. The whole sponge should still 
be inside the bag.
    9. Open the top of the bag containing the sponge, being careful not 
to touch the inner surface of the bag with your fingers. The wire 
closure at the top of

[[Page 38921]]

the bag should keep the bag open. Set bag aside.
    10. Put on a pair of sterile gloves.
    11. Carefully remove the moistened sponge from the bag with your 
sampling hand. Take care not to touch the surfaces of the sampling 
sponge intended for sampling with sterile glove.
    12. With the other hand, retrieve the template by the outer edge, 
taking care not to contaminate the inner edges of the sampling area of 
the template.
    13. Locate the ``belly'' sampling area (Figure 2) and place the 
template over this location.
    14. Hold the template in place with one gloved hand (Remember, only 
the sponge should touch the sampling area. Take care not to contaminate 
this area with your hands).
    15. With the other hand, wipe the sponge over the entire enclosed 
area (10 cm  x  10 cm) for the sample for a total of approximately 10 
times in the vertical and 10 times in the horizontal directions. The 
pressure for swabbing would be as if you were removing dried blood from 
the carcass. However, the pressure should not be too hard as to crumble 
or destroy the sponge. (Note: The template may need to be ``rolled'' 
from side to side during swabbing since the surface of the carcass is 
not flat. This ensures that the 100 cm<SUP>2 area is enclosed while 
swabbing.)
    16. After swabbing the ``belly'' area, transfer the template to the 
same hand that is holding the sponge. Do not contaminate the inner 
edges of the sampling area of the template.
    17. Climb the ladder or platform, holding onto the handrail with 
the hand not used for sampling. Once at a convenient and safe height 
for sampling the ham, transfer template back to the ``climbing'' hand 
(hand used to hold onto the rail while climbing the ladder), taking 
care not to contaminate the inner edges of the template. Avoid 
contaminating your sampling hand.
    18. Repeat steps 13-15 for the ham sampling area, using the SAME 
surface of the sponge used to swab the ``belly'' area.
    19. After swabbing the ham area, carefully place the template back 
to the same hand that is holding the sponge. Do not contaminate the 
inner edges of the sampling area of the template.
    20. While holding the handrail with the hand not used for sampling, 
climb down from the ladder.
    21. Transfer the template back to the ``climbing'' hand (hand used 
to hold onto the rail while descending the ladder), taking care not to 
contaminate the inner edges of the template.
    22. Repeat steps 13-15 for the the jowl area, using the ``clean'' 
surface or side (the side that was NOT previously used to swab the 
``belly''/ham areas).
    23. After swabbing the jowl area, carefully place the sponge back 
into the sponge bag. Do not touch the surface of the sponge to the 
outside of the sponge bag.
    24. Press wire closures on the sponge bag together, expel the 
excess air, then fold over the top of the bag 3 or 4 times. Close the 
bag with attached wire by bending the wire tie back against the bag to 
secure it.
    25. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation (ANALYTICAL METHODS section).
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow procedure in the Sample Shipment section.
Whole Chicken Carcass Rinse Sampling Procedure

Materials

1. 2 Sterile 3500 ml stomacher-type bags or equivalent
2. 400 ml sterile Buffered Peptone Water (BPW)
3. Plastic cable-tie wraps or thick rubber bands or equivalent
4. Sterile gloves

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Ensure 
all sampling supplies are present and have been properly labeled. Use 
predetermined random selection procedure to select a carcass. Birds 
will be collected after the chiller, at the end of the drip line as 
follows:
    1. Gather all supplies for sampling. An assistant may be helpful 
during the sampling process when pouring the rinse solution (BPW) into 
the bag containing the carcass.
    2. Put on sterile gloves. Open a stomacher-type 3500 bag without 
touching the sterile interior of the bag. Rubbing the top edges between 
the thumb and forefinger will cause the opening to gap for easy 
opening.
    3. With one hand, push up through the bottom of the sampling bag to 
form a `glove' over one hand with which to grab the bird, while using 
your other hand to pull the bag back over the hand that will grab the 
bird. This should be done aseptically without touching the exposed 
interior of the bag.
    4. Using the hand with the bag reversed over it, pick up the bird 
by the legs (hocks) through the stomacher bag. (The bag functions as a 
``glove'' for grabbing the bird's legs.) Take care not to contaminate 
the exposed interior of the bag. Allow any excess fluid to drain before 
reversing the bag back over the bird. (Alternately, have an assistant 
hold open the bag. Using your gloved hand, pick up the bird by the 
legs, allow any fluid to drain, and place the bird vent side up into 
the sampling bag.)
    5. Rest the bottom of the bag on a flat surface. While still 
holding the top of the bag slightly open, add the 400 ml of sterile BPW 
to the sterile plastic bag. (Alternately, with the aid of an assistant 
holding the bag open, add the 400 ml of sterile BPW to the bag, pouring 
the solution into the carcass cavity.)
    6. Close the bag and while securely holding the bag, rinse bird 
inside and out using a rocking motion for 30 shakes (approximately one 
minute). This is done by holding the bird through the bottom of the bag 
with one hand and the closed top of the bag with the other hand. Hold 
the bird securely and rock it in an arcing motion, alternating the 
weight of the bird from one hand to the other (motion like drawing an 
invisible rainbow or arch), assuring that all surfaces (interior and 
exterior of the carcass) are rinsed.
    7. Put the bird in the bag on a flat surface. Open the bag.
    8. With a gloved hand, remove the carcass from the bag. Since the 
carcass was rinsed with a sterile solution, it should be returned to 
the chill tank. Be sure not to touch the interior of the bag with your 
gloved hand.
    9. Twist the top of the bag several times (about 4 or 5 turns). 
Fold the twisted portion of the bag to form a loop. Secure the twisted 
loop with the supplied plastic tie-wrap. The tie-wrap should be very 
tight so that the rinse fluid will not spill out. Place the sample bag 
into another bag and secure the opening of the outer bag. [Alternately, 
at least 30 ml of the rinse fluid can be poured into a sterile, leak-
proof sampling container and the container then can be placed in a 
sampling bag for transport to the lab. NOTE: It is important to send at 
least the minimum volume of rinse fluid, since 30 ml of rinse fluid 
will be used for sample analysis. The solution remaining after 
decanting the 30 ml can be poured down the drain]
    10. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation for the selected method of analysis.
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow the procedure in the Sample Shipment section.

[[Page 38922]]

Turkey Carcass Rinse Sampling Procedure

Materials

    1. 1 large sterile 3500 ml stomacher-type or ziplock-type bags or 
equivalent, at least 8''  x  24''
    2. 600 ml sterile, Buffered Peptone Water (BPW)
    3. Plastic cable-tie wraps or thick rubber bands or equivalent
    4. Sterile gloves

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Ensure 
that all supplies are on hand, labeled, and readily available. An 
assistant will be needed to hold the bag for collecting the bird. Use 
the predetermined random selection procedure to select the turkey 
carcass to be sampled. The randomly selected birds will be collected 
after the chiller, at the end of the drip line as follows:
    1. Have an assistant open the large stomacher-type bag (18''  x  
24''). (Rubbing the top edges of the stomacher-type bag between the 
thumb and index finger will cause the opening to gap.) The assistant 
should be ready to receive the turkey carcass.
    2. Put on sterile gloves.
    3. Remove the selected turkey from the drip line by grasping it by 
the legs and allowing any fluid to drain from the cavity.
    4. Place the turkey carcass, vent side up, into a sterile 
Stomacher-type 3500 bag (or equivalent). Large turkeys should be placed 
in a plain, clear polypropylene autoclave bag (ca. 24''  x  30-36''). 
Only the carcass should come in contact with the inside of the bag.
    5. While still supporting the carcass with one hand on the bottom 
of the bag, have the assistant open the bag with the other hand. 
Alternately, the assistant can rest the bottom of the bag on a 
sanitized table and while still supporting the carcass, open the bag 
with the other hand.
    6. Add the 600 ml of sterile BPW to the sterile plastic bag, 
pouring the solution into the carcass cavity of the BPW over the 
exterior of the carcass. Close the bag.
    7. Manipulate the loose neck skin on the carcass through the bag 
and position it over the neck bone area to act as a cushion and prevent 
puncturing of the bag. The assistant will need to support the carcass 
with one hand on the bottom of the bag. Close bag.
    8. Squeeze air from the bag and close top. Take the bag from the 
assistant. Close the bag and while securely holding the bag, rinse bird 
inside and out using a rocking motion for 30 shakes (approximately one 
minute). This is done by holding the carcass through the bag with one 
hand and the closed top of the bag with the other hand. Holding the 
bird securely with both hands, rock in an arcing motion alternating the 
weight of the bird from one hand to the other (motion like drawing an 
invisible rainbow or arch), assuring that all surfaces (interior and 
exterior of the carcass) are rinsed.
    9. Hand the bag back to the assistant.
    10. With a gloved hand, remove the carcass from the bag first 
letting any excess fluid drain back into the bag. Since the carcass was 
rinsed with a sterile solution, it should returned to the chill tank. 
Be sure not to touch the interior of the bag with your gloved hand.
    11. Expel excess air, taking care not to expel any rinse fluid. 
Twist the top of the bag several times (about 4 or 5 turns). Fold the 
twisted portion of the bag to form a loop. Secure the twisted loop with 
the supplied plastic tie-wrap. The tie-wrap should be very tight so 
that the rinse fluid will not spill out.
    12. Place the sample bag into another bag and secure the opening of 
the outer bag. [Alternately, no less than 30 ml of the rinse fluid can 
be poured into a sterile, leak-proof sampling container and placed in a 
sampling bag for transport to the lab. Thirty ml of rinse fluid will be 
used for sample analysis. The solution remaining after decanting the 30 
ml can be poured down the drain]
    13. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation for the selected method of analysis. (See 
Analytical Methods section.)
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow the procedure in the Sample Shipment section.
Sample Shipment
    It is recommended that samples be analyzed on-site (not in the 
plant itself, but in a suitable laboratory). Those samples analyzed on-
site must be analyzed as soon after collection as possible. If no on-
site facilities are available, the samples must be shipped the same 
calendar day as collected, to an outside laboratory. The samples must 
be analyzed the day after collection.
    1. Prechill shipping container by placing the open shipping 
container in the refrigerator at least the day before sampling.
    2. Place the appropriately-labeled double-bagged sample in the 
prechilled shipper in an upright position to prevent spillage. 
Newspaper may be used for cushioning the sample and holding it in the 
upright position. Ensure that the sample is maintained at refrigeration 
temperature to prevent multiplication of any microorganisms present and 
to provide the most accurate results.
    3. Place a corrugated cardboard pad on top of the sample. Next, 
place the frozen gel pack(s) on top of the corrugated pad to prevent 
direct contact of frozen gel packs with the sample. Use sufficient 
frozen coolant to keep the sample refrigerated during shipment to the 
designated laboratory. Insert a foam plug and press it down to minimize 
shipper head space.
    4. Ship sample (via overnight delivery or courier) to the assigned 
laboratory.

Analytical Methods

Equipment, Reagents, and Media Equipment
1. Sterile scalpels, scissors, forceps, knives, spatulas, spoons, ruler 
or template, pipettes, petri dishes, test tubes
2. Sterile Stomacher 3500 bags (or equivalent) or plain, clear 
polypropylene autoclave bags (ca. 24''  x  30-36'')
3. Incubator, 36 <plus-minus> 1 deg.C
4. Incubator/Water bath, 42 <plus-minus> 0.5 deg.C
5. A mechanical homogenization device. A Stomacher, used with sterile 
plastic bags, is acceptable. Some laboratories prefer to use a sterile 
Osterizer-type blender with sterilized cutting assemblies and adapters 
for use with sterile Mason jars.
6. Water bath, 48-50 deg.C
7. Glass slides, glass plate marked off in one-inch squares or 
agglutination ring slides
8. Balance, 2000 gram capacity, sensitivity of 0.1 gram
9. Inoculating needles and loops
10. Vortex mixer
11. Sterile sampling sponge and sponge bag
Reagents
1. Iodine solution for TT broth (Hajna)
2. Buffered Peptone Water (BPW) diluent
3. Methyl red reagent
4. O'Meara's V-P reagent, modified
5. Kovac's reagent
6. Ferric chloride, 10% aqueous solution
7. Sterile mineral oil
8. Saline, 0.85%
9. Saline, 0.85% with 0.6% formalin
10. Salmonella polyvalent O antiserum
11. Salmonella polyvalent H antiserum
12. Salmonella individual O grouping sera for groups A-I

[[Page 38923]]

Media
1. Buffered peptone water (BPW)
2. Tetrathionate broth (TT-Hajna)
3. Rappaport-Vassiliadis (RV) broth (4)--Merck Chemical Co., Cat. #7700 
or equivalent
4. Brilliant green sulfa agar (BGS; contains 0.1% sodium sulfapyridine)
5. Double modified lysine iron agar (DMLIA; 2)
6. Triple sugar iron agar (TSI)
7. Lysine iron agar (LIA)
8. MR-VP Medium
9. Tryptone broth
10. Simmons citrate agar
11. Phenol red tartrate agar
12. Motility Medium
13. Christensen's urea agar
14. Carbohydrate fermentation media with Andrade's indicator
15. Decarboxylase test media (Moeller)
16. Malonate broth
17. KCN broth
18. Phenylalanine agar
19. Nutrient gelatin
20. Trypticase soy broth
21. Tryptose broth
Analytical Procedures
Sample Preparation for Analysis
    The diverse nature of the samples which may require analysis (e.g., 
ground product versus a poultry carcass rinse sample) requires separate 
preparation procedures for each sample type.

Raw Ground Product Sample Preparation

    a. Use a sterile spoon or spatula to take portions of product from 
several areas of the sample to prepare a 25 g composite sample in a 
sterile plastic stomacher-type bag or blender jar. Use of a stomacher 
filter bag may facilitate pipetting after pre-enrichment.
    b. Add 225 ml BPW. Homogenize for two minutes in a Stomacher or 
blender.

Beef or Pork Carcass Sponge Sample Preparation

    a. Add 50 ml of BPW to the sample bag containing the sponge to 
bring the total volume to 50 ml. Mix well.

Whole Chicken Carcass Rinse-Fluid Sample Preparation

    a. Remove 30 ml of carcass-rinse fluid and place it in a sterile 
plastic bag or other sterile container.
    b. Add 30 ml of BPW to the sample. Mix well.

Turkey Carcass Rinse-Fluid Sample Preparation

    a. Remove 30 ml of carcass-rinse fluid and place it in a sterile 
plastic bag or other sterile container.
    b. Add 30 ml of BPW to the sample. Mix well.
Detection Procedure
    Sample/BPW suspensions prepared as directed in Sample preparation 
for analysis section (above) are the starting point for this step in 
the protocol. From this point on, sample suspensions of various types 
(e.g., whole bird rinse sample vs. raw ground product) can be treated 
in the same manner.

    Note: If using a screening test, follow manufacturer's 
instruction for enrichment procedures. If an alternate enrichment 
scheme is to be used, verification of the effectiveness of this 
alternate enrichment protocol with the screening test should be 
received from the manufacturer of the screening test or by in-
laboratory testing.

    1. Incubate sample/BPW suspension at 36 <plus-minus> 1 deg.C for 
20-24 hours.
    2. a. Transfer 0.5 ml of the BPW sample pre-enrichment culture into 
10 ml TT broth.
    b. Transfer 0.1 ml of the BPW sample pre-enrichment culture into 10 
ml RV broth.
    3. a. Incubate the TT enrichment culture at 42 <plus-minus> 
0.5 deg.C for 22-24 hours.
    b. Incubate the RV enrichment culture at 42 <plus-minus> 0.5 deg.C 
for 22-24 hours.
    4. Streak each enrichment culture onto both DMLIA and BGS agar 
plates. Do not subdivide plates for streaking multiple samples; streak 
the entire agar plate with a single sample enrichment.
    5. Incubate plates at 36 <plus-minus> 1 deg.C.
    6. Examine plates after 22-24 hours of incubation. Reincubate 
negative plates and reexamine them the following day.
    7. Select and confirm suspect colonies as described in the sections 
for Isolation procedure through Biochemical testing procedures (below).
Isolation Procedure
    1. Pick typical well-isolated colonies.
    a. BGS. Select colonies that are pink and opaque with a smooth 
appearance and an entire edge surrounded by a red color in the medium. 
On very crowded plates, look for colonies that appear tan against a 
green background.
    b. DMLIA. Select purple colonies with or without black centers. 
Since salmonellae typically decarboxylate lysine and ferment neither 
lactose nor sucrose, the color of the medium reverts to purple.
    2. Select three suspect colonies from each plate. Pick only from 
the surface and center of the colony. Avoid touching the agar because 
these selective media may suppress growth of organisms which are viable 
but not visible; such ``sleeper'' organisms can be picked up from the 
agar surface and carried forward onto media used for confirmation 
tests. If a plate is crowded and there are no well-isolated colonies 
available, restreak from this plate directly onto fresh selective agar 
plates.
Initial Isolate Screening Procedure
    1. Inoculate TSI and LIA slants consecutively with a single pick 
from a colony by stabbing the butts and streaking the slants in one 
operation. If screw-cap tubes are used, the caps must be loosened 
before incubation. Incubate at 36 <plus-minus> 1 deg.C for 
24<plus-minus>2 hours.
    2. Examine TSI and LIA slants as sets. Note the colors of butts and 
slants, blackening of the media and presence of gas as indicated by gas 
pockets or cracking of the agar. Note also the appearance of the growth 
on the slants along the line of streak. Discard sets that show 
``swarming'' from the original site of inoculation. Discard sets that 
show a reddish slant in LIA. Isolates giving typical Salmonella spp. 
reactions should be confirmed by serological tests. Examine isolates 
which are suggestive, but not typical of Salmonella spp. by a 
combination of biochemical and serological procedures. Confirm by 
biochemical tests ONLY those isolates that appear typical of 
salmonellae, but do not react serologically. Refer to the following 
chart for assistance in making these determinations.

--------------------------------------------------------------------------------------------------------------------------------------------------------
              Triple sugar iron agar                       Lysine iron agar                   Polyvalent sera                                           
----------------------------------------------------------------------------------------------------------------------            Disposition           
      Butt            Slant             H <INF>2S             Butt             H<INF>2S               O                H                                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
Y..............               R                +                P                +                +                +   Salmonella spp.                  
Y..............               R                +                P                +                +                -   B. & M. T.                       
Y..............               R                -                P                -   ...............  ...............  B. & M. T.                       
Y..............               R                -                Y                -                +                +   B. & M. T.\1\                    
Y..............               R                -                Y                -                -   ...............  Discard.                         
Y..............               R                +                Y     <plus-minus>   ...............  ...............  Discard.                         
Y..............               Y                -              Y/P                -   ...............  ...............  Discard.                         

[[Page 38924]]

                                                                                                                                                        
Y..............               Y                +                P                +   ...............  ...............  B. & M. T.\2\                    
NC.............               NC  ...............  ...............  ...............  ...............  ...............  Discard.                         
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Y = Yellow; R = Red; P = Purple; B. & M. T. = Biochemical and motility tests; NC = No change in color from uninoculated medium.                        
\1\ Salmonella choleraesuis (rarely found in swine in U.S.).                                                                                            
\2\ Salmonella arizonae.                                                                                                                                


Serological Tests
    All isolates giving TSI and LIA reactions which could be considered 
suggestive of Salmonella should be tested serologically. If the TSI and 
LIA reactions, together with the serological reactions, are indicative 
of Salmonella, confirmation may cease at this point. If, however, 
atypical TSI or LIA results and/or negative serological tests are 
encountered, biochemical testing is mandatory (see Biochemical testing 
procedure, below).
1. O Agglutination Tests
    At a minimum, isolates should be tested with polyvalent O antiserum 
reactive with serogroups A through I. Following a positive reaction 
with polyvalent O antiserum, it is necessary to type the isolate using 
individual Salmonella antisera for O groups A through I. Testing for O 
groups A through I should encompass the majority of the Salmonella 
serotypes commonly recovered from meat and poultry products. 
Occasionally, however, an isolate which is typical of Salmonella 
(biochemically and Poly H serologically) but non-reactive with antisera 
to groups A through I will be recovered; such an isolate should be 
reported as ``Salmonella non A-I'' or ``Salmonella O group beyond I''.
    Follow the manufacturer's instructions enclosed with the antisera. 
Use growth from either the TSI or LIA slant. Test the isolate first 
using polyvalent O antiserum. Do not read agglutination tests with a 
hand lens. If there is agglutination with the saline control alone 
(autoagglutination), identify such an isolate by biochemical reactions. 
If the saline control does not agglutinate and the polyvalent serum 
does, identify the individual O group using the individual Salmonella O 
grouping antisera for groups A through I. Record positive results and 
proceed to H agglutination tests.
2. H Agglutination Tests
    Inoculate Trypticase soy broth or Tryptose broth. Incubate at 36 
<plus-minus> 1  deg.C overnight or until growth has an approximate 
density of three on McFarland's scale. Add an equal amount of saline 
containing 0.6% formalin and let set one hour. Remove one ml to each of 
two 13  x  100 mm test tubes. To one of the tubes, add Salmonella 
polyvalent H serum in an amount indicated by the serum titer or 
according to the manufacturer's instructions. The other tube serves as 
an autoagglutination control. Incubate both tubes at 48-50  deg.C in a 
water bath for up to one hour. Record presence or absence of 
agglutination. Alternatively, any other poly H agglutination test may 
be used as long as it gives results equivalent to the conventional tube 
agglutination procedure described above.
Biochemical Testing Procedures
    Biochemical confirmation is only necessary with those isolates 
giving atypical TSI or LIA results and/or negative serological tests. 
Do the minimum number of tests needed to establish that an isolate can 
be discarded or that it is a member of the genus Salmonella. Exhaustive 
testing of any isolate from a sample that has already yielded a 
typical, easily identifiable Salmonella is unnecessary.
    If further testing is necessary, inoculate the following media 
first: Tryptone broth, MR-VP medium, Simmons citrate agar, 
Christensen's urea agar, motility test medium, phenol red tartrate 
agar, and glucose, lactose, sucrose, salicin and dulcitol fermentation 
broths. Incubate at 36 <plus-minus> 1  deg.C and record reactions the 
following day. Test Tryptone broth with Kovac's reagent for indole 
production in 24 hours and, if negative, again in 48 hours. Do not 
perform the MR-VP test until 48 hours have elapsed. If results are 
ambiguous, repeat MR test after five days of incubation. Hold negative 
carbohydrate fermentation tests for 14 days.
    Refer to ``Edwards and Ewing's Identification of 
Enterobacteriaceae'', 4th Edition (3), for biochemical reactions of 
Enterobacteriaceae and for fermentation media and test procedures.
    Discard all isolates that give positive urea or VP reactions. 
Discard any isolate that has the following combination of 
characteristics: produces gas in glucose, produces indole but not 
H<INF>2S, is MR positive, VP negative and citrate negative; such 
organisms are E. coli regardless of ability to ferment lactose in 48 
hours.
    Inoculate additional biochemical tests as necessary to eliminate 
other Enterobacteriaceae. Refer to Edwards and Ewing for details. 
Eliminate Providencia spp. by a positive phenylalanine reaction. 
Eliminate Hafnia alvei on the basis of the following biochemical 
pattern: indole negative; MR negative, and VP and citrate positive 
based on four days of incubation at 25  deg.C; fermentation of 
arabinose and rhamnose; failure to ferment adonitol, inositol, 
sorbitol, and raffinose.
    Alternatively, any other biochemical test system may be used as 
long as it gives results equivalent to the conventional tests.
Quality Control Procedures
    It is recommended that a minimum of three method controls be 
analyzed whenever meat or poultry products are being examined for the 
presence of salmonellae. These controls should include a S. typhimurium 
(H<INF>2S positive), S. senftenberg (H<INF>2S negative), and an 
uninoculated media control. The inoculum level for the positive 
controls should approximate 30-300 CFU per container of enrichment 
medium. Inoculate positive controls at the end of each day's run. 
Incubate the three controls along with the samples, and analyze them in 
the same manner as the samples. Confirm at least one isolate recovered 
from each positive control sample.
Storage of Isolates
    Do not store isolates on TSI agar because this tends to cause 
roughness of O antigens. For short-term (2-3 months) storage, inoculate 
a nutrient agar slant, incubate at 36 <plus-minus> 1  deg.C overnight, 
and then store at 4-8  deg.C.
    For long-term storage of isolates, subculture Salmonella isolates 
by stabbing nutrient agar (0.75% agar). Incubate at 36 <plus-minus> 1 
deg.C overnight, and then seal with hot paraffin-soaked corks. 
Household wax is better than embedding paraffin because it stays 
relatively soft at room temperature making the corks easy to remove. 
Store isolates in the dark at room

[[Page 38925]]

temperature. Such isolates will remain viable for several years.
    Store ``working'' Salmonella stock cultures on nutrient agar 
slants. Transfer stocks monthly, incubate overnight at 36 <plus-minus> 
1  deg.C, and then store them at 4-8  deg.C.

References

    1. AOAC International. 1995. Official Methods of Analysis of 
AOAC International. P.A. Cunniff, ed. 16th Edition. Gaithersburg, 
MD.
    2. Bailey, J. S., J. Y. Chiu, N.A. Cox, and R.W. Johnston. 1988. 
Improved selective procedure for detection of salmonellae from 
poultry and sausage products. J. Food Protect. 51(5):391-396.
    3. Ewing, W. H. 1986. ``Edwards and Ewing's Identification of 
Enterobacteriaceae'', 4th Edition. Elsevier Science Publishing Co., 
Inc., New York, NY.
    4. Vassiliadis, P. 1983. The Rappaport-Vassiliadis (RV) 
enrichment medium for the isolation of salmonellas: An overview. J. 
Appl. Bacteriol. 54:69-76.

BILLING CODE 3410-DM-P

[[Page 38926]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.018



[[Page 38927]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.019



[[Page 38928]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.020



BILLING CODE 3410-DM-C

[[Page 38929]]

Appendix F--Guidelines for Escherichia coli Testing for Process Control 
Verification in Cattle and Swine Slaughter Establishments

Introduction

    Under the Pathogen Reduction/HACCP Regulation, all slaughter 
establishments will be required to test carcasses for generic E. coli 
as a tool to verify process control. This document outlines the 
sampling and microbial testing that should be followed to meet this 
requirement. It also gives guidance to interpreting your results. This 
document is a supplement to the Regulation, but not a substitute for 
it. Further in-depth details of the program may be found in the 
Regulation. Please provide these guidelines to your company 
microbiologist or testing laboratory in order to help you meet the 
regulatory requirements for generic E. coli testing.

Guidelines for Sample Collectors/Microbiologists

Background
    This sampling protocol has been prepared to support the Pathogen 
Reduction/HACCP Regulation. This protocol incorporates the use of a 
nondestructive sampling technique for sample collection from raw beef 
and swine carcasses. These techniques have been evaluated by the 
Agricultural Research Service and have been designed to give comparable 
results to the FSIS Nationwide Microbiological Baseline Data Collection 
Programs' excised tissue samples. We are continuing to improve the 
sponging techniques and welcome comments. This technique will also be 
used in the FSIS Salmonella testing programs and will be closely 
monitored during the first year of prevalence phase testing.
    Carcasses within the same establishment and in different 
establishments must be sampled and analyzed in the same manner if the 
results are to provide a useful measure of process control across the 
nation. It is imperative that all like establishments adhere to the 
same sampling and analysis requirements detailed here, without 
deviation. These sampling and analytical procedures may be directly 
written into your establishment's individual HACCP plan.
    Cattle and swine carcasses must be sampled at the end of the 
slaughter process in the cooler. These sample collection locations are 
the same as those in the FSIS baseline studies, making samples taken 
here comparable to the nationwide baseline performance criteria.
Pre-sampling Preparation
    Sample collection will be carried out by the individual designated 
in the establishment's written protocol for microbiological sampling. 
This protocol should include a check list of tasks to be performed 
prior to sample collection, materials needed for sample collection, 
random selection procedures, where the samples will be analyzed (on-
site versus off-site), and other information that will aid the sample 
collector. As stated previously, this guideline can be a part of the 
plant's sample collection guidelines, but plant specific details and 
procedures will need to be included. Sampling supplies, such as sterile 
gloves, sterile sampling solutions, hand soap, sanitizing solution, 
etc., as well as specific materials needed for sampling different 
carcass types (i.e., specimen sponges in bags and template for sampling 
cattle or swine carcasses), will need to be assembled prior to 
beginning sample collection.
    For cattle and swine carcass sampling, a template will be needed to 
mark off the area to sample. The template can be made of metal or 
aluminum foil, brown paper, flexible plastic, etc. Some disposable 
templates may come sterilized and individually prepackaged. To make a 
reusable template, cut out a 10 centimeters (cm) x 10 cm (3.94 inches x 
3.94 inches) square from a sheet larger than the area to be sampled. 
(See Figure 1). If a reusable template is used, it will need to be 
sanitized with an approved sanitizing solution [e.g., hypochlorite 
(bleach) solution or alcohol]. However, the template needs to be dry 
before placing it on the carcass. Aluminum foil or paper templates can 
be used once and discarded. The foil for the template should be stored 
in a manner to prevent contamination. Since the area enclosed by the 
template will be sampled, take care not to touch this area with 
anything other than the sampling sponge. Using dirty or contaminated 
material may lead to erroneous results. If an autoclave is available, 
paper or aluminum foil templates can be wrapped in autoclavable paper 
and sterilized.
    Sterile sampling solutions, Butterfield's phosphate diluent (BPD), 
can be stored at room temperature. However, at least on the day prior 
to sample collection, check solutions for cloudiness. DO NOT use 
solutions that are cloudy, turbid or contain particulate matter. Place 
the number of containers of sampling solution (BPD) that will be needed 
for the next day's sampling in the refrigerator.
    To obtain the most accurate results, samples should be analyzed as 
soon after collection as possible. However, if samples must be 
transported to an off-site laboratory, the samples need to be 
maintained at refrigeration temperatures until transport, then shipped 
refrigerated via an overnight delivery service to the laboratory 
performing the analysis. Samples analyzed off-site must be picked up by 
the overnight courier the SAME calendar day the sample is collected. 
The sample must arrive at the laboratory the day after the sample is 
collected. Samples shipped to an outside laboratory must be analyzed no 
later than the day after collection. The following section gives 
information on shipping containers and transporting samples to off-site 
facilities.

Shipping Containers and Coolant Packs

    It is important that samples fit easily into the shipping 
containers so that the sample bags do not break. Correct use of the 
refrigerant gel-ice packs and proper packing of the shipping container 
are necessary so that samples arrive at the laboratory at an acceptable 
temperature. Frozen samples or samples which are too warm are not 
considered valid and must not be analyzed. Some bacteria may be damaged 
by temperatures that are too cold, while temperatures that are too warm 
can allow bacteria to reproduce. Maintaining samples at improper 
temperatures may cause inaccurate sample results. The sample should be 
kept refrigerated, NOT FROZEN, in the shipping container prior to 
pickup by the courier service. The shipping container, itself, should 
not be used as a refrigerator. However, multiple samples (if needed) 
for that day may be stored in the open shipping container in the cooler 
or refrigerator.
Sampling frequency
    Sampling frequency for E. coli testing is determined by production 
volume. The required minimum testing frequencies for all but very low 
production volume establishments are shown in Table 1 by slaughter 
species.

                 Table 1.--E. coli Testing Frequencies <SUP>a                
------------------------------------------------------------------------
                                                                        
Cattle....................................  1 test per 300 carcasses.   
Swine.....................................  1 test per 1,000 carcasses. 
------------------------------------------------------------------------
<SUP>a Note: These testing frequencies do not apply to very low volume       
  establishments. See Table 2.                                          

Very Low Volume Establishments

    Some establishments may be classified as very low volume 
establishments. The maximum yearly

[[Page 38930]]

slaughter volumes for very low volume establishments are described in 
Table 2.

Table 2.--Maximum Yearly Livestock Slaughter Volumes for Very Low Volume
                             Establishments                             
------------------------------------------------------------------------
                                           Criteria (yearly slaughter   
           Slaughter species                         volume)            
------------------------------------------------------------------------
Cattle................................  Not more than 6,000 head.       
Swine.................................  Not more than 20,000 head.      
Cattle and Swine......................  Not more than 20,000 total, with
                                         not more than 6,000 cattle.    
------------------------------------------------------------------------

    Establishments with very low volumes are to sample the predominant 
species at an initial rate of once per week until at least 13 test 
results have been obtained. Once the initial criteria have been met for 
very low volume establishments (see APPLYING PERFORMANCE CRITERIA TO 
TEST RESULTS), the establishment will repeat the same sampling regime 
once per year, in the 3 month period of June through August, or 
whenever a change is made in the slaughter process or personnel.
Random Selection of Carcasses
    Samples are to be taken randomly at the required frequency (See 
section on Sampling Frequency). For example, given the frequency of 
testing for cattle is 1 (one) test per every 300 cattle slaughtered, 
then if a plant slaughters 150 head of cattle an hour, 1 (one) sample 
will be taken every 2 hours.
    Different methods of selecting the specific carcass for sampling 
could be used, but all require the use of random numbers. Methods could 
include: using random number tables, using calculator- or computer-
generated random numbers, drawing cards, etc. When selecting the random 
numbers, use the method(s) currently in use at the establishment for 
other sampling programs, if other programs are currently underway.
    The carcass for sampling must be selected at random from all 
eligible carcasses. If multiple lines exist, randomly select the line 
for sample collection for that interval. Repeat the random selection 
process for the next sampling interval. Each line should have an equal 
chance of being selected at each sampling interval.

Cattle Carcass Selection

    The half-carcasses eligible for sampling should be selected from 
those in the cooler 12 or more hours after slaughter. Both the 
``leading'' and ``trailing'' sides of a carcass should have an equal 
chance of being selected within the designated time frame (based on the 
sampling frequency for the plant). NOTE: If more than one shift is 
operating at the plant, the sample can be taken on any shift, provided 
the following requirements are met:
    Selection of TIME: Select the time, based on the appropriate 
sampling frequency, for collecting the sample.
    Selection of COOLER SITE: Select a safe and accessible site in the 
cooler for random selection of the half-carcass. This site may be 
located at the transfer chain, grading chain, or a rail that contains 
carcasses that have been chilled 12 hours or more. If there are 
multiple sites of the same kind, select one at random.
    Selection of HALF-CARCASS: Based on the sampling frequency for the 
plant, identify a half-carcass (selected by your random number method) 
from the predetermined point along the chain (cooler site) and then 
count back five (5) half-carcasses and select the next half-carcass 
(carcass) for sampling. The reason for counting back five half-
carcasses is to avoid any possible bias during selection. (See Sampling 
Frequency section to determine the rate of sampling.)

Swine Carcass Selection

    The carcasses eligible for sampling should be selected from those 
in the cooler 12 or more hours after slaughter. Every carcass should 
have an equal chance of being selected within the designated time frame 
(based on the sampling frequency for the plant). NOTE: If more than one 
shift is operating at the plant, the sample can be taken on any shift, 
provided the following requirements are met:
    Selection of TIME: Select the time, based on the appropriate 
sampling frequency, for collecting the sample.
    Selection of COOLER SITE: Select a safe and accessible site in the 
cooler for random selection of the carcass. This site may be located at 
the transfer chain, grading chain, or a rail that contains carcasses 
that have been chilled 12 hours or more. If there are multiple sites of 
the same kind, select one at random.
    Selection of CARCASS: Based on the sampling frequency for the 
plant, identify a whole carcass from the predetermined point along the 
chain and then count back five (5) carcasses and select the next 
carcass for sampling. The reason for counting back five carcasses is to 
avoid any possible bias during selection. (See Sampling Frequency 
section to determine the rate of sampling.)
Aseptic Techniques/Sampling
    Extraneous organisms from the environment, hands, clothing, sample 
containers, sampling devices, etc., may lead to erroneous analytical 
results. More stringent requirements for microbiological analysis are 
necessary, therefore, use of aseptic sampling techniques and clean, 
sanitized equipment and supplies are of utmost importance.
    There should be an area designated for preparing sampling supplies, 
etc. A stainless steel, wheeled cart or table would be useful during 
sampling. A small tote or caddy could be moved to the location of 
sampling and could be used for carrying supplies, supporting sample 
bags when adding sterile solutions to sample bags, etc.
    Sterile gloves should be used for collecting samples. The only 
items which may contact the external surface of the glove are the 
exposed sample being collected and/or the sterile sample utensil 
(specimen sponge). Keep in mind that the outside surfaces of the sample 
container are not sterile. Do not handle the inside surface of the 
sterile sample containers. Do not touch anything else. The following 
procedure for putting on sterile gloves can be followed when collecting 
samples:
    (a) Peel open the package of sterile gloves from the top without 
contaminating (touching, breathing on, contacting, etc.) the exterior 
of the gloves.
    (b) Remove a glove by holding it from the wrist-side opening inner 
surface. Avoid any contact with the outer surface of the glove. Insert 
the washed and sanitized hand into the glove, taking care not to 
puncture the glove.
    (c) Taking care not to contaminate the exterior surface of the 
glove, repeat the above step for the hand you will use to physically 
handle the sample.
    (d) If at any time you are concerned that a glove may be
Preparation for Sample Collection
    Prior to collecting samples, review appropriate sampling steps, 
random selection procedures, and other information that will aid in 
sample collection.
    On the day prior to sample collection, after checking for 
cloudiness/turbidity, place the number of BPD containers that will be 
needed for the next day's sampling in the refrigerator/cooler. If 
samples are to be shipped to an off-site facility, pre-chill shipping 
container and refrigerator packs.
    On the day of sampling, gather all sample collection bags, sterile 
gloves, sanitizer, hand soap, sterile solutions for

[[Page 38931]]

sampling, and specific materials listed under the Materials section of 
the sample collection section for the type of carcass to be sampled. 
Ensure that all sampling supplies are on hand and readily available 
before beginning sample collection.
    Label the sample bags before starting the sampling procedure. Use 
permanent ink. If you are using paper labels, it is important that the 
label be applied to the bag at normal room temperature; it will not 
stick if applied in the cooler.
    Outer clothing (frocks, gloves, head gear, etc.) worn in other 
areas of the plant should be removed before entering the sampling area 
or preparing to collect samples. Replace outer clothing removed earlier 
with clean garments (i.e., laboratory coat) that have not been directly 
exposed to areas of the plant outside of the sampling area.
    Sanitize the sample work area surfaces by wiping with a clean 
disposable cloth or paper towel dipped in a freshly prepared 500 ppm 
(parts per million) sodium hypochlorite solution (0.05% sodium 
hypochlorite) or other approved sanitizer which provides an equivalent 
available chlorine concentration. The sample work area surfaces must be 
free of standing liquid before sample supplies and/or product 
containers are placed on them.
    Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include 
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands 
using disposable paper towels.
Specific Sample Collection Procedures
Cattle Sample Collection Procedure

Materials

1. Sterile specimen sponge in sterile Whirl-pack<Register>-type bag or 
equivalent
2. 25 ml sterile Butterfield's phosphate diluent (BPD)
3. Sterile ziplock-type or stomacher bag
4. Template for 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Use 
predetermined random selection procedures for selecting the half-
carcass to be sampled. Remember, samples will be collected from half-
carcasses in the cooler 12 hours or more after slaughter.
    A sampling sponge (which usually comes dehydrated and prepackaged 
in a sterile bag) will be used to sample all three sites on the carcass 
(flank, brisket, and rump--see Figure 2). It is important to swab the 
areas in the order of least to most contamination in order to avoid 
spreading any contamination.
    Therefore, swab the areas in the sequence indicated in this 
sampling protocol. Nondestructive surface sampling will be conducted as 
follows:
    1. Ensure that all bags have been pre-labeled and all supplies are 
on hand, including the sampling template. (An assistant may be helpful 
during the sampling process.)
    2. IF a reusable template is used, immerse the sampling template in 
an approved sanitizing solution for at least 1-2 minutes. Just prior to 
swabbing the first sample site on the carcass (step 13), retrieve the 
sampling template from the sanitizing solution. Shake excess solution 
from the utensil, then protect the portion of the template that will 
contact the carcass from contamination.
    3. Locate the flank, brisket, and rump sampling sites using 
illustrations and directions in Figure 2 (cattle carcass sampling 
locations).
    4. Position the wheeled ladder, sampling platform, or step ladder 
near the carcass so the rump sample area (Figure 2) is within easy 
reach from the ladder.
    5. While holding the sponge bag at the top corner by the wire 
closure, tear off the clear, perforated strip at the top of the bag.
    6. Remove the cap from sterile BPD bottle, being careful not to 
touch the bottle opening.
    7. Carefully pour about half the contents of the sterile BPD bottle 
(approximately 10 ml) into the sponge bag to moisten the sponge.
    8. Close the top of the bag by pressing the wire closures together. 
Use hand pressure from the outside of the bag and carefully massage the 
sponge until it is FULLY HYDRATED (moistened).
    9. With the bag still closed, carefully push the moistened sponge 
to the upper portion of the bag orienting one narrow end of the sponge 
up toward the opening of the bag. Do NOT open the bag or touch the 
sponge with your fingers. While holding the bag, gently squeeze any 
excess fluid from the sponge using hand pressure from the outside. The 
whole sponge should still be in the bag.
    10. Open the bag containing the sponge, being careful not to touch 
the inner surface of the bag with your fingers. The wire closure at the 
top of the bag should keep the bag open. Set bag aside.
    11. Put on a pair of sterile gloves.
    12. Carefully remove the moistened sponge from the bag with the 
thumb and fingers (index and middle) of your sampling hand.
    13. With the other hand, retrieve the template by the outer edge, 
taking care not to contaminate the inner edges of the sampling area of 
the template.
    14. Locate the flank sampling area (Figure 2). Place the template 
over this location.
    15. Hold the template in place with one gloved hand (Remember, only 
the sponge should touch the sampling area. Take care not to contaminate 
this area with your hands)
    16. With the other hand, wipe the sponge over the enclosed sampling 
area (10 cm x 10 cm) for a total of approximately 10 times in the 
vertical and 10 times in the horizontal directions. The pressure for 
swabbing would be as if you were removing dried blood from the carcass. 
However, the pressure should not be too hard as to crumble or destroy 
the sponge. (Note: The template may need to be ``rolled'' from side to 
side during swabbing since the surface of the carcass is not flat. This 
ensures that the 100 cm\2\ area is enclosed while swabbing.)
    17. Repeat steps 14-16 for the brisket area, using the SAME side or 
surface of the sponge used to swab the flank area.
    18. After swabbing the brisket area, transfer the template to the 
same hand holding the sponge. Do not contaminate the sponge or inner 
edges of the sampling area of the template.
    19. Climb the ladder or platform, holding onto the handrail with 
the hand used to hold the template. Once at a convenient and safe 
height for sampling the rump, transfer template back to ``climbing'' 
hand (hand used to hold onto the rail while climbing the ladder), 
taking care not to contaminate the inner edges of the template.
    20. Repeat steps 14-16 for the rump area, using the ``clean'' 
surface or side (the side that was NOT previously used to swab the 
flank/brisket areas) of the sponge.
    21. After swabbing the rump area, carefully place the sponge back 
in the sponge sample bag, taking care not to touch the sponge to the 
outside of the sample bag.
    22. While holding the handrail, climb down from the ladder.
    23. Add the additional BPD (about 15 ml) to the sample bag to bring 
the total volume to approximately 25 ml.
    24. Expel excess air from the bag containing the sponge and fold 
down the top edge of the bag 3 or 4 times to close. Secure the bag by 
folding the attached wire tie back against the bag.

[[Page 38932]]

Place closed sponge bag into second bag and close the second bag 
securely.
    25. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation (ANALYTICAL METHODS section)
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow procedure in the Sample Shipment section.
    Swine surface sample collection procedure:

Materials

1. Sterile specimen sponge in sterile Whirl-Pak<Register>-type bag or 
equivalent
2. 25 ml sterile Butterfield's phosphate diluent (BPD)
3. Sterile ziplock-type or stomacher-type bag
4. Template for a 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Use 
predetermined random selection procedures for selecting carcass to be 
sampled. Remember: samples will be collected from carcasses in the 
cooler 12 hours or more after slaughter. A sampling sponge (which 
usually comes dehydrated and prepackaged in a sterile bag) will be used 
to sample all three sites on the swine carcass (belly, ham, and jowl--
see Figure 3). It is important to swab the areas in the order of least 
to most contamination in order to avoid spreading any contamination. 
Therefore, swab the areas in the sequence indicated in this sampling 
protocol. Nondestructive surface sampling will be conducted as follows:
    1. Ensure that all supplies are on hand. (An assistant may be 
helpful during the sampling process.)
    2. If a reusable template is used, immerse the sampling template in 
a sanitizing solution for at least 1-2 minutes. Just prior to swabbing 
the first sample site on the swine carcass (step 12), retrieve the 
sampling template from the sanitizing solution. Shake excess solution 
from the utensil, then protect the portion of the template that will 
contact the carcass from contamination.
    3. Locate the belly, ham, and jowl sampling sites using 
illustrations and directions in Figure 3 (swine carcass sampling 
locations).
    4. Position the wheeled ladder, sampling platform, or step ladder 
near the carcass so the ham sample area (Figure 3) is within easy reach 
from the ladder.
    5. Hold the sponge bag at the top corner by the wire closure, then 
tear off the clear perforated strip at the top of the bag. Open the 
bag.
    6. Remove the cap from sterile BPD bottle, being careful not to 
touch the bottle opening. Do not contaminate the lid.
    7. Carefully pour about half of the contents of the sterile BPD 
bottle (10 ml) into the sponge bag to moisten the sponge. Put the lid 
back on the BPD bottle.
    8. Close the top of the bag by pressing the wire closures together. 
Use hand pressure from the outside of the bag and carefully massage the 
sponge until it is FULLY HYDRATED (moistened).
    9. With the bag still closed, carefully push the moistened sponge 
to the upper portion of the bag orienting one narrow end of the sponge 
up toward the opening of the bag. Do NOT open the bag or touch the 
sponge with your fingers. While holding the bag, gently squeeze any 
excess fluid from the sponge using hand pressure from outside. The 
whole sponge should still be inside the bag.
    10. Open the bag containing the sponge, being careful not to touch 
the inner surface of the bag with your fingers. The wire closure at the 
top of the bag should keep the bag open.
    11. Put on a pair of sterile gloves.
    12. Carefully remove the moistened sponge from the bag with the 
thumb and fingers (index and middle) of your sampling hand.
    13. With the other hand, retrieve the template by the outer edge, 
taking care not to contaminate the inner edges of the sampling area of 
the template.
    14. Locate the belly sampling area (Figure 2). Place the template 
over this location.
    15. Hold the template in place with one gloved hand. Remember, only 
the sponge should touch the sampling area. Take care not to contaminate 
this area with your hands.
    16. With the other hand, wipe the sponge over the enclosed sampling 
area (10 cm  x  10 cm) for a total of approximately 10 times in the 
vertical and 10 times in the horizontal directions. The pressure for 
swabbing would be as if you were removing dried blood from the carcass. 
However, the pressure should not be too hard as to crumble or destroy 
the sponge.

    Note: The template may need to be ``rolled'' from side to side 
during swabbing since the surface of the carcass is not flat. This 
ensures that the 100 cm<SUP>2 area is enclosed while swabbing.

    17. After swabbing the belly area, transfer the template to the 
same hand that is holding the sponge. Do not contaminate the sponge or 
the inner edges of the sampling area of the template.
    18. Climb the ladder or platform, holding onto the handrail with 
the hand used to hold the sampling template in place. Once at a 
convenient and safe height for sampling the ham, transfer template back 
to the ``climbing'' hand (hand used to hold onto the rail while 
climbing the ladder), taking care not to contaminate the sponge or the 
inner edges of the template.
    19. Repeat steps 14-16 for the ham sampling area, using the SAME 
surface of the sponge used to swab the belly area.
    20. After swabbing the ham area, carefully place the template back 
to the same hand that is holding the sponge. Do not contaminate the 
sponge or the inner edges of the sampling area of the template.
    21. While holding the handrail, climb down from the ladder.
    22. Transfer the template back to the ``climbing'' hand (hand used 
to hold onto the rail while descending the ladder), taking care not to 
contaminate the sponge or the inner edges of the template.
    23. Repeat steps 14-16 for the jowl area, using the ``clean'' 
surface or side (the side that was not previously used to swab the 
belly/ham areas).
    24. After swabbing the jowl area, carefully place the sponge back 
into the sponge bag. Do not touch the surface of the sponge to the 
outside of the sponge bag.
    25. Add the additional BPD (about 15 ml) to the bag to bring the 
total volume to approximately 25 ml.
    26. Press wire closures of the sponge bag together, expel excess 
air, then fold down the top edge of the bag 3 or 4 times. Secure the 
bag by folding the attached wire tie back against the bag. Place the 
closed sponge bag into the second bag and close the second bag 
securely.
    27. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation (ANALYTICAL METHODS section).
    (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow procedure in the Sample Shipment section.
Sample Shipment
    Samples analyzed on-site must be analyzed as soon after collection 
as possible. If no on-site facilities are available, the samples must 
be shipped the same calendar day as collected, to

[[Page 38933]]

an outside laboratory. The samples must be analyzed no later than the 
day after collection.
    1. Prechill shipping container by placing the open shipping 
container in the refrigerator at least the day before sampling.
    2. Place the appropriately-labeled, double-bagged sample(s) in the 
prechilled shipping container in an upright position to prevent 
spillage. Newspaper may be used for cushioning the sample and holding 
it in the upright position. If more than one sample is collected during 
the day, take steps to ensure that samples are maintained at 
refrigeration temperature. Refrigeration temperatures help limit 
multiplication of any microorganisms present which ensures the most 
accurate results.
    3. Place a corrugated cardboard pad on top of samples. This 
corrugated cardboard pad prevents direct contact of frozen gel packs 
with the samples. Next place the frozen gel pack(s) on top of the 
corrugated pad. Use sufficient frozen coolant to keep the sample 
refrigerated during shipment to the designated laboratory. Insert foam 
plug and press it down to minimize shipper head space.
    4. Ship samples (via overnight delivery or courier) to the assigned 
laboratory.
Analytical Methods
    Samples must be analyzed using one of the E. coli (Biotype I) 
quantitation methods found in the Official Methods of Analysis of the 
Association of Official Analytical Chemists (AOAC), International, 16th 
edition, or by any method which is validated by a scientific body in 
collaborative trials against the three tube Most Probable Number (MPN) 
method and agreeing with the 95% upper and lower confidence limits of 
the appropriate MPN index.
Suggested Quantitation Schemes
    If a generic one ml plating technique is used for E. coli 
quantitation for cattle or swine carcass sponging sample analysis, the 
plate count would be divided by 12 to equal the count per cm\2\. To 
cover the marginal and unacceptable range for E. coli levels (described 
in later section), the undiluted sample extract, a 1:10, a 1:100, a 
1:1,000 and a 1:10,000 dilution should be plated, preferably in 
duplicate. Higher or lower dilutions may need to be plated based on the 
specific product.
    If a hydrophobic grid membrane filtration method were used, the 
only difference would be filtration of one ml of the undiluted sample 
extract, 1:10, 1:100, 1:1,000 and 1:10,000 dilutions.
    Additional dilutions of the original extract may need to be used if 
a three tube MPN protocol is used. The three highest dilutions that 
were positive for E. coli are used to calculate the MPN. MPN values 
from the appropriate MPN Table represent the count per ml of original 
extract and therefore must be divided by 12 to obtain the count per 
cm\2\ of carcass surface area.
Record Keeping
    Each test result must by recorded in terms of colony forming units 
per square centimeter (cfu/cm\2\). A process control table or chart can 
be used to record the results and facilitate evaluation. Results should 
be recorded in the order of sample collection and include information 
useful for determining appropriate corrective actions when problems 
occur. The information needed for each sample includes date and time of 
sample collection, and, if more than one slaughter line exists, the 
slaughter line from which the sample was collected. These records are 
to be maintained at the establishment for twelve months and must be 
made available to Inspection Program employees on request. Inspection 
personnel review results over time, to verify effective and consistent 
process control.
    For E. coli testing to be the most useful for verifying process 
control, timeliness is important and the record should be updated with 
the receipt of each new result. Detailed records should also be kept of 
any corrective actions taken if process control deviations are detected 
through microbiological testing.

Applying Performance Criteria to Test Results

Categorizing Test Results
    E. coli test levels have been separated into 3 categories for the 
purpose of process control verification: acceptable, marginal, and 
unacceptable. (In the Pathogen Reduction/HACCP Regulation, the upper 
limits for the acceptable and marginal ranges were denoted by m and M.) 
These categories are described by slaughter species in Table 3.

             Table 3.--Values for Marginal and Unacceptable Results for E. Coli Performance Criteria            
----------------------------------------------------------------------------------------------------------------
           Slaughter class                 Acceptable range          Marginal range         Unacceptable range  
----------------------------------------------------------------------------------------------------------------
Cattle...............................  Negative*..............  Positive but not above   Above 100 cfu/cm\2\.   
                                                                 100 cfu/cm\2\.                                 
Swine................................  10 cfu/cm\2\...........  Above 10 cfu/cm\2\ but   Above 10,000 cfu/cm\2\.
                                                                 not above 10,000 cfu/                          
                                                                 cm\2\.                                         
----------------------------------------------------------------------------------------------------------------
* It should be noted that negative here is defined by the sensitivity of the sampling and test method used in   
  the Baseline survey (5 cfu/cm\2\ carcass surface area).                                                       

    To illustrate the use of Table 3, consider a steer/heifer slaughter 
establishment. E. coli test results for this establishment will be 
acceptable if negative, marginal if positive but not above 100 cfu/
cm\2\, and unacceptable if above 100 cfu/cm\2\.
Verification Criteria
    The verification criteria are applied to test results in the order 
that samples are collected. The criteria consist of limits on 
occurrences of marginal and unacceptable results.
    As each new test result is obtained, the verification criteria are 
applied anew to evaluate the status of process control with respect to 
fecal contamination.
    1. An unacceptable result should trigger immediate action to review 
process controls, discover the cause if possible, and prevent 
recurrence.
    2. A total of more than three marginal or unacceptable results in 
the last 13 consecutive results also signals a need to review process 
controls.
    This way of looking at the number of marginal and unacceptable 
results is described as a ``moving window'' approach in the regulation. 
With this approach, results are accumulated until 13 have been accrued. 
After this, only the most recent 13 results--those in the ``moving 
window''--are considered.
    An example of a record of results for Steer/Heifer testing is shown 
(in table form) below for an establishment performing two tests per 
day.

[[Page 38934]]



----------------------------------------------------------------------------------------------------------------
                                                                                     Number                     
                       Time      Test result         Result           Result       marginal or                  
 Test #     Date    collected    (cfu/cm\2\)     unacceptable?      marginal?     unacceptable     Pass/fail?   
                                                                                   in last 13                   
----------------------------------------------------------------------------------------------------------------
1......     10-07      08:50   10.............  No.............  Yes............           1    Pass            
2......  .........     14:00   Negative.......  No.............  No.............           1    Pass            
3......     10-08      07:10   50.............  No.............  Yes............           2    Pass            
4......  .........     13:00   Negative.......  No.............  No.............           2    Pass            
5......     10-09      10:00   Negative.......  No.............  No.............           2    Pass            
6......  .........     12:20   Negative.......  No.............  No.............           2    Pass            
7......     10-10      09:20   80.............  No.............  Yes............           3    Pass            
8......  .........     13:30   Negative.......  No.............  No.............           3    Pass            
9......     10-11      10:50   Negative.......  No.............  No.............           3    Pass            
10.....  .........     14:50   Negative.......  No.............  No.............           3    Pass            
11.....     10-14      08:40   50.............  No.............  Yes............           4    Fail            
12.....  .........     12:00   Nonegative.....  No.............  No.............           4    Fail            
13.....     10-15      09:30   Negative.......  No.............  No.............           4    Fail            
14.....  .........     15:20   Negative.......  No.............  No.............           3    Pass            
15.....     10-16      07:30   Negative.......  No.............  No.............           3    Pass            
16.....  .........     11:40   Negative.......  No.............  No.............           2    Pass            
17.....     10-17      10:20   120............  Yes............  No.............           3    Fail            
----------------------------------------------------------------------------------------------------------------

    The following observations can be made on this example:
    1. As of 10-14 at 08:40, there are four marginal or unacceptable 
results in the last 11 results, which exceeds the limit of 3 in 13 
consecutive tests.
    2. The limit of 3 in 13 also is exceeded for the next two tests, 
but since no new marginal or unacceptable result has occurred, these 
failures should not be treated as evidence of a new problem. The log or 
documentation of corrective action taken for the first failure should 
be adequate to verify that the deviation or problem was addressed.
    3. On 10-15 at 15:20 the number of marginal or unacceptable results 
in the last 13 tests goes down to 3 because the marginal result for 10-
07 at 08:50 is dropped and replaced by an acceptable result as the 13-
test window moves ahead 1 test.
    4. The result for 10-17 at 10:20 exceeds 100 and is unacceptable.
    Figure 4 shows the same results as the above example but the 
results are displayed in chart form. The numbers along the horizontal 
axis of the graph (x-axis), refers to the test number in the chart 
above. The information for each test result, such as the time and date 
the sample was collected could also be recorded on the chart.

BILLING CODE 3410-DM-P

[[Page 38935]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.021



[[Page 38936]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.022



[[Page 38937]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.023



[[Page 38938]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.024



BILLING CODE 3410-DM-C

[[Page 38939]]

Appendix G--Guidelines for Escherichia coli Testing for Process Control 
Verification in Poultry Slaughter Establishments

Introduction

    Under the Pathogen Reduction/HACCP Regulation, all poultry 
slaughter establishments will be required to test carcasses for generic 
E. coli as a tool to verify process control. This document outlines the 
sampling and microbial testing that should be followed to meet this 
requirement. It also gives guidance to interpreting your results. This 
document is a supplement to the Regulation, but not a substitute for 
it. Further in-depth details of the program may be found in the 
Regulation. Please provide these guidelines to your company 
microbiologist or testing laboratory in order to help you meet the 
regulatory requirements for generic E. coli testing.

Guidelines for Sample Collectors/Microbiologists

Background
    This sampling protocol has been prepared to support the Pathogen 
Reduction/HACCP Regulation. Carcass sampling for broiler and turkey 
carcasses remain the nondestructive whole bird rinse which was used in 
the FSIS Nationwide Microbiological Baseline Data Collection Programs.
    Carcasses within the same establishment and in different 
establishments must be sampled and analyzed in the same manner if the 
results are to provide a useful measure of process control across the 
nation. It is imperative that all like establishments adhere to the 
same sampling and analysis requirements detailed here, without 
deviation. These sampling and analytical procedures may be directly 
written into your establishment's individual HACCP plan.
    Poultry carcasses must be sampled after the chill tank at the end 
of the drip line or last readily accessible point prior to packing/cut-
up. This sample collection location is the same as that in the FSIS 
baseline studies, making samples taken here comparable to the 
nationwide baseline performance criteria.
Pre-sampling Preparation
    Sample collection will be carried out by the individual designated 
in the establishment's written protocol for microbiological sampling. 
The protocol should include a check list of tasks to be performed prior 
to sample collection, materials needed for sample collection, random 
selection procedures, where the samples will be analyzed (on-site 
versus off-site), and other information that will aid the sample 
collector. As stated previously, this guideline can be a part of the 
plant's sample collection guidelines, but plant specific details and 
procedures will need to be included. Sampling supplies, such as sterile 
gloves, sterile sampling solutions, hand soap, sanitizing solution, 
etc., need to be assembled prior to beginning sample collection.
    Sterile sampling solutions, Butterfield's phosphate diluent (BPD), 
can be stored at room temperature. However, at least on the day prior 
to sample collection, check solutions for cloudiness (DO NOT use 
solutions that are cloudy, turbid or contain particulate matter) and 
place the number of containers of sampling solution (BPD) that will be 
needed for the next day's sampling in the refrigerator.
    To obtain the most accurate results, samples should be analyzed as 
soon after collection as possible. However, if samples must be 
transported to an off-site laboratory, the samples need to be 
maintained at refrigeration temperatures until transport, then shipped 
refrigerated via an overnight delivery service to the laboratory 
performing the analysis. Samples analyzed off-site must be picked up by 
the overnight courier the SAME calendar day the sample is collected. 
The sample must arrive at the laboratory no later than the day after 
the sample is collected. Samples shipped to an outside laboratory must 
be analyzed no later than the day after collection. The following 
section gives information on shipping containers and transporting 
samples to off-site facilities.

Shipping Containers and Coolant Packs

    It is important that samples fit easily into the shipping 
containers so that the sample bags do not break.
    Correct use of the refrigerant gel-ice packs and proper packing of 
the shipping container are necessary so that samples arrive at the 
laboratory at an acceptable temperature. Frozen samples or samples 
which are too warm are not considered valid and must not be analyzed. 
Some bacteria may be damaged by temperatures that are too cold, while 
temperatures that are too warm can allow bacteria to reproduce. 
Maintaining samples at improper temperatures may cause inaccurate 
sample results.
    The sample should be kept refrigerated, NOT FROZEN, in the shipping 
container prior to pickup by the courier service. The shipping 
container, itself, should not be used as a refrigerator. However, 
multiple samples (if needed) for that day may be stored in the open 
shipping container in the cooler or refrigerator.
Sampling Frequency
    Sampling frequency for E. coli testing is determined by production 
volume. The required minimum testing frequencies for all but very low 
production volume establishments are shown in Table 1 by slaughter 
species.

                 Table 1.--E. coli Testing Frequencies <SUP>a                
------------------------------------------------------------------------
                                                                        
------------------------------------------------------------------------
Chickens............................  1 test per 22,000                 
                                      carcasses.                        
Turkeys.............................  1 test per 3,000                  
                                      carcasses.                        
------------------------------------------------------------------------
<SUP>a Note: These testing frequencies do not apply to very low volume       
  establishments. See Table 2.                                          

Very Low Volume Establishments

    Some establishments may be classified as very low volume 
establishments based on their annual production volume. The maximum 
yearly slaughter volumes for very low volume establishments are 
described in Table 2.

 Table 2.--Maximum Yearly Poultry Slaughter Volumes for Very Low Volume 
                             Establishments                             
------------------------------------------------------------------------
                                             Criteria (yearly slaughter 
             Slaughter species                         volume)          
------------------------------------------------------------------------
Chickens..................................  Not more than 440,000 birds.
Turkeys...................................  Not more than 60,000 birds. 
Chickens and turkeys......................  Not more than 440,000 total,
                                             with not more than 60,000  
                                             turkeys.                   
------------------------------------------------------------------------

    Establishments with very low volumes are to sample the predominant 
species once per week, initially, until at least 13 test results have 
been obtained.
    Once the initial criteria have been met for very low volume 
establishments (see APPLYING PERFORMANCE CRITERIA TO TEST RESULTS), the 
establishment will repeat the same sampling regime once per year, in 
the 3 month period of June through August, or whenever a change is made 
in the slaughter process or personnel.
Random Selection of Carcasses
    Samples are to be taken randomly at the required frequency (See 
section on Sampling Frequency). For example, given the frequency of 
testing for turkeys is 1 (one) test per every 3,000 turkeys 
slaughtered, then if a plant slaughters 1,500 turkeys an hour, 1 (one) 
sample will be taken every 2 hours.
    Different methods of selecting the specific carcass for sampling 
could be used, but all require the use of random

[[Page 38940]]

numbers. Methods could include: using random number tables, using 
calculator- or computer-generated random numbers, drawing cards, etc. 
When selecting the random numbers, use the method(s) currently in use 
at the establishment for other sampling programs, if other programs are 
currently underway.
    The carcass for sampling must be selected at random from all 
eligible carcasses. If multiple lines exist, randomly select the line 
for sample collection for that interval. Repeat the random selection 
process for the next sampling interval. Each line should have an equal 
chance of being selected at each sampling interval.

Poultry Carcass Selection

    The poultry carcasses will be selected at random after chilling, at 
the end of the drip line or last readily accessible point prior to 
packing/cut-up. A WHOLE carcass is required, that is, one that has not 
been trimmed.

    Note: If more than one shift is operating at the plant, the 
sample can be taken on any shift, provided the following 
requirements are met:
    Selection of TIME: Select the time, based on the appropriate 
sampling frequency, for collecting the sample.
    Selection of CHILLER: If more than one chiller system is in 
operation at the time of sample collection, the chill tank from 
which the sample is selected must be randomly selected.
    Selection of POULTRY CARCASS: Based on the frequency of sampling 
for your establishment, identify a carcass (selected by your random 
number method) from the predetermined point, and then count back 
five (5) carcasses and select the next carcass for sampling. 
Exception: If the fifth carcass is not a WHOLE (untrimmed) bird, 
count back an additional five carcasses for sample selection. Each 
carcass must have an equal chance of being selected. The reason for 
counting back five carcasses is to avoid any possible bias during 
selection.
Aseptic Techniques/Sampling
    Extraneous organisms from the environment, hands, clothing, sample 
containers, sampling devices, etc., may lead to erroneous analytical 
results. Stringent requirements for microbiological analysis are 
necessary, therefore, use of aseptic sampling techniques and clean 
sanitized equipment and supplies are of utmost importance.
    There should be an area designated for preparing sampling supplies, 
etc. A stainless steel, wheeled cart or table would be useful during 
sampling. A small tote or caddy could be easily moved to the location 
of sampling and could be used for carrying supplies, supporting sample 
bags when adding sterile solutions to sample bags, etc.
    Sterile gloves should be used for collecting samples. The only item 
which may contact the external surface of the glove is the exposed 
sample being collected. Keep in mind that the outside surfaces of the 
sample container are not sterile. Do not handle the inside surface of 
the sterile sample containers. Do not touch anything else. The 
following procedure for putting on sterile gloves can be followed when 
collecting samples:
    (a) Peel open the package of sterile gloves from the top without 
contaminating (touching, breathing on, contacting, etc.) the exterior 
of the gloves.
    (b) Remove a glove by holding it from the wrist-side opening inner 
surface. Avoid any contact with the outer surface of the glove. Insert 
the washed and sanitized hand into the glove, taking care not to 
puncture the glove.
    (c) Next, taking care not to contaminate the outer surface of the 
glove, repeat the step above for the hand you will use to physically 
handle the sample.
    (d) If at any time you are concerned that a glove may be 
contaminated, discard it and begin again with Step (a) above.
Preparation for Sample Collection
    Prior to collecting samples, review appropriate sampling steps, 
random selection procedures, and other information that will aid in 
sample collection.
    On the day prior to sample collection, after checking for 
cloudiness/turbidity, place the number of Butterfield's phosphate 
diluent (BPD) containers that will be needed for the next day's 
sampling in the refrigerator/cooler. If samples will be shipped to an 
off-site facility, pre-chill shipping container and refrigerator packs 
(follow manufacturer's directions for gel-packs).
    On the day of sampling, gather all sample collection bags, sterile 
gloves, sanitizer, hand soap, sterile solutions for sampling (BPD), and 
specific materials listed under the Materials section of the sample 
collection section for the type of carcass to be sampled. Ensure that 
all sampling supplies are on hand and readily available before 
beginning sample collection.
    Label the sample bags before starting the sampling procedure. Use 
permanent ink. If you are using paper labels, it is important that the 
label be applied to the bag at normal room temperature; it will not 
stick if applied in the cooler.
    Outer clothing (frocks, gloves, head gear, etc.) worn in other 
areas of the plant should be removed before entering the sampling area 
or preparing to collect samples. Replace outer clothing removed earlier 
with clean garments (i.e., laboratory coat) that have not been directly 
exposed to areas of the plant outside of the sampling area.
    Sanitize the sample work area surfaces by wiping with a clean 
disposable cloth or paper towel dipped in a freshly prepared 500 ppm 
sodium hypochlorite solution (0.05% sodium hypochlorite) or other 
approved sanitizer which provides an equivalent available chlorine 
concentration. The sample work area surfaces must be free of standing 
liquid before sample supplies and/or product containers are placed on 
them.
    Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include 
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands 
using disposable paper towels.
Specific Sample Collection Procedures
Chicken Carcass Rinse Sampling Procedure

Materials

    1. 2 Sterile 3500 milliliter (ml) stomacher-type or ziplock-type 
bags or equivalent. (The bag must be sterile and should be large enough 
to hold the carcass while rinsing.)
    2. 400 ml sterile, Butterfield's phosphate diluent (BPD).
    3. Plastic tie wraps or equivalent (if needed to secure the bag).
    4. Sterile gloves.
    5. Optional--(See alternate sampling--step 10)--Sterile leak-proof 
container.

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Use the 
predetermined random selection procedure to select the carcass to 
sample. The randomly selected bird will be collected after the chiller, 
at the end of the drip line as follows:
    1. Ensure all sampling supplies are present and have been properly 
labeled. An assistant may be helpful during sampling.
    2. Open a large stomacher-type bag without touching the sterile 
interior of the bag. (Rubbing the top edges of the bag between the 
thumb and forefinger will cause the opening to gap for easy opening.)
    3. Put on sterile gloves.
    4. With one hand, push up through the bottom of the sampling bag to 
form

[[Page 38941]]

a ``glove'' over one hand with which to grab the bird, while using your 
other hand to pull the bag back over the hand that will grab the bird. 
This should be done aseptically without touching the exposed interior 
of the bag.
    5. Using the hand with the bag reversed over it, pick up the bird 
by the legs (hocks) through the stomacher bag. (The bag functions as a 
`glove' for grabbing the bird's legs.) Take care not to contaminate the 
exposed interior of the bag. Allow any excess fluid to drain before 
reversing the bag back over the bird. (Alternately, have an assistant 
hold open the bag. Using your gloved hand, pick up the bird by the 
legs, allow any fluid to drain, and place the bird in the sampling 
bag.)
    6. Rest the bottom of the bag on a flat surface. While still 
holding the top of the bag slightly open, add the sterile BPD (400 ml) 
to the bag containing the carcass, pouring the solution over the 
carcass.

(Alternately, with the aid of an assistant holding the bag open, add 
the sterile BPD (400 ml) to the bag containing the carcass, pouring the 
solution over the carcass.)
    7. Expel most of the air from the bag, then close the top of the 
bag. While securely holding the bag, rinse the bird inside and out 
using a rocking motion for 30 shakes (approximately one minute). This 
is done by holding the bird through the bottom of the bag with one hand 
and the closed top of the bag with the other hand. Hold the bird 
securely and rock it in an arcing motion, alternating the weight of the 
bird from one hand to the other (motion like drawing an invisible 
rainbow or arch), assuring that all surfaces (interior and exterior of 
the carcass) are rinsed.
    8. Rest the bag with the bird on a flat surface and, while still 
supporting the bird, open the bag.
    9. With a gloved hand, remove the carcass from the bag. Since the 
carcass was rinsed with a sterile solution, it can be returned to the 
chill tank. Be sure not to touch the interior of the bag with your 
gloved hand.
    10. Secure the top of the bag so that the rinse fluid will not 
spill out or become contaminated.

(Alternately, at least 30 milliliters of rinse fluid can be poured into 
a sterile leak-proof container to be sent to the lab for analysis.)
    11. Place the sample bag (or leak-proof container) into another bag 
and secure the opening of the outer bag.
    12. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation for the selected method of analysis.
     (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow the procedure in the Sample Shipment section.
Turkey Carcass Rinse Sampling Procedure

Materials

    1. 2 Sterile 3500 ml stomacher-type or ziplock-type bags or 
equivalent. (The bag must be sterile and should be large enough to hold 
the carcass while rinsing, the bags FSIS will be using for the 
Salmonella sampling program measure approximately 18''  x  24''. Large 
turkeys should be placed in a plain, clear polypropylene autoclave bag 
, about 24''  x  30'' to 36'').
    2. 600 ml sterile, Butterfield's phosphate diluent (BPD)
    3. Plastic tie wraps or thick rubber bands or equivalent, if needed 
to secure sample bag
    4. Sterile gloves
    5. Optional--sterile, leak-proof container (see step 12 Alternate 
procedure)

Collection

    Read the sections under Pre-sampling Preparation and Preparation 
for Sample Collection before beginning the sampling procedure. Use a 
predetermined random selection procedure to select the carcass to be 
sampled. The randomly selected bird will be collected after the 
chiller, at the end of the drip line as follows:
    1. Ensure that all supplies are on hand and readily available. An 
assistant will be needed to hold the bag for collecting the bird.
    2. Have an assistant open the large sterile stomacher-type bag 
(designated for rinsing the carcass) and be ready to receive the turkey 
carcass. (Rubbing the top edges of the bag between the thumb and index 
finger will cause the opening to gap open).

(Alternately: If no assistant is available, place the closed large 
sampling bag into a bucket or pail (e.g., use the bag to ``line'' a 
bucket like a trash-can liner), then open the bag. The bucket will be 
used as a holder or stand to support the bag. Do not contaminate the 
inner surfaces of the sampling bag.)
    3. Put on sterile gloves.
    4. Remove the selected turkey from the drip line by grasping it by 
the legs and allowing any fluid to drain from the cavity.
    5. Place the turkey carcass, vent side up, into a sterile sampling 
bag. Only the carcass should come in contact with the inside of the 
bag.
    6. Manipulate the loose neck skin on the carcass through the bag 
and position it over the neck bone area to act as a cushion and prevent 
puncturing of the bag. The assistant will need to support the carcass 
with one hand on the bottom of the bag.
    7. While still supporting the bottom of the bag, have the assistant 
open the bag with the other hand. Alternately, rest the bottom of the 
bag on a pre-sanitized surface (i.e. a table), and while still 
supporting the carcass in the bag, open the bag with the other hand.
    8. Add the sterile BPD (600 ml) to the bag containing the carcass, 
pouring the diluent over the carcass.
    9. Take the bag from the assistant and expel excess air from the 
bag and close the top. While securely holding the bag, rinse the bird 
inside and out using a rocking motion for 30 shakes (approximately one 
minute). This is done by holding the carcass through the bag with one 
hand and the closed top of the bag with the other hand. Holding the 
bird securely with both hands, rock in an arcing motion alternating the 
weight of the bird from one hand to the other (motion like drawing an 
invisible rainbow or arch), assuring that all surfaces (interior and 
exterior of the carcass) are rinsed.
    10. Hand the bag back to the assistant.
    11. With a gloved hand, remove the carcass from the bag letting 
excess fluid drain back into the bag. Since the carcass was rinsed with 
a sterile solution, it can be returned to the chill tank. Be sure not 
to touch the interior of the bag with your gloved hand.
    12. Expel excess air, taking care not to expel any rinse fluid. 
Secure the top of the bag so that the rinse fluid will not spill out or 
become contaminated.

(Alternately, at least 30 milliliters of rinse fluid can be poured into 
a sterile, leak-proof container and sent to the lab for analysis.)
    13. Place the sample bag (or container) into another bag and secure 
the opening of the outer bag.
    14. (a) If samples are to be analyzed at an ON-SITE LABORATORY, 
begin sample preparation for the selected method of analysis. (See 
Analytical Methods section.)
     (b) If samples are to be analyzed at an OUTSIDE (OFF-SITE) 
LABORATORY, follow the procedure in the Sample Shipment section.
Sample Shipment
    Samples analyzed on-site must be analyzed as soon after collection 
as possible. If no on-site facilities are available, the samples must 
be shipped the same calendar day as collected, to an outside 
laboratory. The samples must be analyzed no later than the day after 
collection.

[[Page 38942]]

    1. Prechill shipping container by placing the open shipping 
container in the refrigerator at least the day before sampling.
    2. Place the appropriately-labeled, double-bagged sample in the 
prechilled shipping container in an upright position to prevent 
spillage. Newspaper may be used for cushioning the sample and holding 
it in the upright position. Ensure that samples are maintained at 
refrigeration temperature. Refrigeration temperatures limit 
multiplication of any microorganisms present.
    3. Place a corrugated cardboard pad on top of samples. The 
corrugated pad prevents direct contact of frozen gel packs with the 
samples. Next, place the frozen gel pack(s) on top of the corrugated 
pad. Use sufficient frozen coolant to keep the sample refrigerated 
during shipment to the designated laboratory. Insert foam plug and 
press it down to minimize shipper head space.
    4. Ship samples (via overnight delivery or courier) to the assigned 
laboratory.
Analytical Methods
    Samples must be analyzed using one of the E. coli (Biotype I) 
quantitation methods found in the Official Methods of Analysis of the 
Association of Official Analytical Chemists (AOAC), International, 16th 
edition, or by any method which is validated by a scientific body in 
collaborative trials against the three tube Most Probable Number (MPN) 
method and agreeing with the 95% upper and lower confidence limits of 
the appropriate MPN index.
Suggested Quantitation Schemes
    For poultry rinse fluid samples, if a generic one ml plating 
technique is used for E. coli quantitation, the plate count would not 
have to be divided to get the count per ml of rinse fluid. To cover the 
marginal and unacceptable range for E. coli levels (described in later 
section), the undiluted extract (optional), a 1:10, a 1:100, a 1:1,000 
and a 1:10,000 dilution should be plated, preferably in duplicate. 
Higher or lower dilutions may need to be plated based on the specific 
product.
    If a hydrophobic grid membrane filtration method were used, the 
only difference would be filtration of one ml of the undiluted extract 
(optional), 1:10, 1:100, 1:1,000 and 1:10,000 dilutions.
    Additional dilutions of the original extract may need to be used if 
a three tube MPN protocol is used. The three highest dilutions that 
were positive for E. coli are used to calculate the MPN.
Record Keeping
    Results of each test must by recorded, in terms of colony forming 
units per milliliter rinse fluid (cfu/ml) for chicken and turkeys. A 
process control table or chart can be used to record the results and 
facilitate evaluation. Results should be recorded in the order of 
sample collection and include information useful for determining 
appropriate corrective actions when problems occur. The information 
needed for each sample includes date and time of sample collection, 
and, if more than one slaughter line exists, the slaughter line from 
which the sample was collected. These records are to be maintained at 
the establishment for twelve months and must be made available to 
Inspection Program employees on request. Inspection personnel review 
results over time, to verify effective and consistent process control.
    For E. coli testing to be the most useful for verifying process 
control, timeliness is important and the record should be updated with 
the receipt of each new result. Detailed records should also be kept of 
any corrective actions taken if process control deviations are detected 
through microbiological testing.

Applying Performance Criteria to Test Results

Categorizing Test Results
    E. coli test levels have been separated into 3 categories for the 
purpose of process control verification: acceptable, marginal, and 
unacceptable. (In the Pathogen Reduction/HACCP Regulation, the upper 
limits for the acceptable and marginal ranges were denoted by m and M.) 
These categories are described by slaughter species in Table 3.

                                 Table 3.--Values for Marginal and Unacceptable Results for E. coli Performance Criteria                                
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Slaughter class                           Acceptable range                       Marginal range                   Unacceptable range        
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chicken...............................  100 cfu/ml or less.........................  Over 100 cfu/ml but not over    Above 1,000 cfu/ml.                
                                                                                      1,000 cfu/ml.                                                     
Turkey................................  NA *.......................................  NA *..........................  NA *.                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The FSIS Baseline study has not been completed for this slaughter class. Levels will be set upon completion of this baseline.                         

    To illustrate the use of Table 3, consider a chicken slaughter 
establishment. E. coli test results for this establishment will be 
acceptable if not above 100 cfu/ml, marginal if above 100 cfu/ml but 
not above 1,000 cfu/ml, and unacceptable if above 1,000 cfu/ml.
Verification Criteria
    The verification criteria are applied to test results in the order 
that samples are collected. The criteria consist of limits on 
occurrences of marginal and unacceptable results.
    As each new test result is obtained, the verification criteria are 
applied anew to evaluate the status of process control with respect to 
fecal contamination.
    1. An unacceptable result should trigger immediate action to review 
process controls, discover the cause if possible, and prevent 
recurrence.
    2. A total of more than three marginal or unacceptable results in 
the last 13 consecutive results also signals a need to review process 
controls.
    This way of looking at the number of marginal and unacceptable 
results is described as a ``moving window'' approach in the regulation. 
With this approach, results are accumulated until 13 have been accrued. 
After this, only the most recent 13 results--those in the ``moving 
window''--are considered.
    An example of a record of results for Chicken testing is shown (in 
table form) below for an establishment performing two tests per day.

[[Page 38943]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                          Number                        
                                                      Time     Test result                                              marginal or                     
              Test No.                   Date      collected     (cfu/ml)   Result unacceptable?    Result marginal?   unacceptable       Pass/Fail?    
                                                                                                                        in last 13                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
1..................................        10-07        08:50          120  No..................  Yes................             1  Pass.              
2..................................  ...........        14:00           10  No..................  No.................             1  Pass.              
3..................................        10-08        07:10          150  No..................  Yes................             2  Pass.              
4..................................  ...........        13:00           50  No..................  No.................             2  Pass.              
5..................................        10-09        10:00        (\1\)  No..................  No.................             2  Pass.              
6..................................  ...........        12:20           10  No..................  No.................             2  Pass.              
7..................................        10-10        09:20          800  No..................  Yes................             3  Pass.              
8..................................  ...........        13:30           10  No..................  No.................             3  Pass.              
9..................................        10-11        10:50           10  No..................  No.................             3  Pass.              
10.................................  ...........        14:50           10  No..................  No.................             3  Pass.              
11.................................        10-14        08:40          500  No..................  Yes................             4  Fail.              
12.................................  ...........        12:00           30  No..................  No.................             4  Fail.              
13.................................        10-15        09:30           10  No..................  No.................             4  Fail.              
14.................................  ...........        15:20           10  No..................  No.................             3  Pass.              
15.................................        10-16        07:30           10  No..................  No.................             3  Pass.              
16.................................  ...........        11:40           10  No..................  No.................             3  Pass.              
17.................................        10-17        10:20        1,200  Yes.................  No.................             3  Fail.              
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Negative.                                                                                                                                           

    The following observations can be made on this example:
    1. As of 10-14 at 08:40, there are four marginal or unacceptable 
results in the last 11 results, which exceeds the limit of 3 in 13 
consecutive tests.
    2. The limit of 3 in 13 also is exceeded for the next two tests, 
but since no new marginal or unacceptable result has occurred, these 
failures should not be treated as evidence of a new problem. The log or 
documentation of corrective action taken for the first failure should 
be adequate to verify that the deviation or problem, if any, was 
addressed.
    3. On 10-15 at 15:20 the number of marginal or unacceptable results 
in the last 13 tests goes down to 3 because the marginal result for 10-
07 at 08:50 is dropped replaced by an acceptable result as the 13-test 
window moves ahead 1 test.
    4. The result for 10-17 at 10:20 exceeds 1,000 and is unacceptable.
    The Figure 1 shows the same results as above displayed in chart 
form. The numbers along the horizontal axis of the graph (x-axis) refer 
to the test number in the chart above. The information for each test 
result, such as the time and date the sample was collected could also 
be recorded on the chart.

BILLING CODE 3410-DM-P

[[Page 38944]]

[GRAPHIC] [TIFF OMITTED] TR25JY96.025



BILLING CODE 3410-DM-C

[[Page 38945]]

    Note: The following Supplement will not appear in the Code of 
Federal Regulations.

    Supplement--Final Regulatory Impact Assessment for Docket No. 93-
016F, ``Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems.''

Table of Contents

I. Introduction
    A. Purpose
    B. Methodology
    C. Summary Comparison of Costs and Benefits--Proposal to Final
II. Regulatory Alternatives
    A. Market Failure
    B. General Regulatory Approaches
    C. Need For Improved Process Control
    D. Regulatory Alternatives for Process Control
    1. Mandatory HACCP
    2. Alternatives to Mandatory HACCP
    E. Comments on Analysis of Regulatory Alternatives
III. Summary of Impacts
    A. Introduction
    B. Net Benefit Analysis
    C. Impact on ``Smaller'' Businesses
    D. Effect on Retail Price
    E. Impact on International Trade
    F. Impact on Agency Costs
    G. Impact on State Programs
    H. Consumer Welfare Analysis
IV. Analysis of Public Health Benefits
    A. Introduction
    B. FSIS Risk Assessment
    C. Risk Assessment Framework
    D. FSIS Data Initiatives
    E. ARS Food Safety Research Program
    F. Analysis of Comments on Public Health Benefits
    1. Incidence of Foodborne Illness
    2. Cost of Foodborne Illness
    3. Percentage of Foodborne Illness and Cost of Foodborne Illness 
Attributable to Meat and Poultry
    4. Pathogens Addressed by the Rule
    5. Effectiveness of the Rule in Reducing Pathogens
    6. Estimated Reduction in Cost of Foodborne Illness
    G. Summary
V. Cost Analysis
    A. Introduction
    B. Methodology for Cost Analysis
    C. Regulatory Flexibility
    D. Final Cost Estimates
    1. Sanitation Standard Operating Procedures
    2. Costs of Meeting Pathogen Reduction and Microbial Sampling
    3. HACCP Programs--Plan Development and Annual Reassessment 
Costs
    4. HACCP Programs--Recordkeeping Costs
    5. HACCP Programs--Training Costs
    6. HACCP Programs--Impact on Total Quality Control/Overtime 
Issues
    E. Summary of Costs for Low Volume Producers

Appendix A to Final Regulatory Impact Assessment

I. Introduction

A. Purpose

    In docket No. 93-016F, the Food Safety and Inspection Service 
(FSIS) is promulgating new regulations that require an estimated 9,079 
inspected meat and poultry establishments to adopt a Hazard Analysis 
and Critical Control Points (HACCP) processing control system covering 
all production operations within 3\1/2\ years of final rule 
publication. The regulation also requires that all 9,079 establishments 
adopt and implement standard operating procedures (SOP's) for 
sanitation and establishes, for the first time, food safety performance 
standards for microorganisms on raw meat and poultry products. This 
final rule establishes pathogen reduction performance standards for 
Salmonella that are established using the current pathogen prevalence 
as determined by the national baseline studies. These standards are not 
directed at judging whether specific lots of a product are adulterated 
under the law. Rather, compliance with the standards will be determined 
by a statistical evaluation of the prevalence of bacteria in each 
establishment's products. FSIS will implement sampling programs to 
determine compliance with the Salmonella standard. The rule does not 
require inspected establishments to test for Salmonella. The pathogen 
reduction performance standards apply to 2,682 slaughter establishments 
and another estimated 2,840 establishments that produce raw ground 
product but do not have slaughter operations.
    The final rule also requires that all slaughter establishments test 
for generic E. coli to verify process control for fecal contamination 
during slaughter and sanitary dressing. Results will be measured 
against performance criteria established from the national baseline 
surveys. Under this final rule, the 2,682 inspected slaughter 
establishments will be required to verify by microbial testing that 
they are controlling their slaughter and sanitary dressing processes in 
accordance with the performance criteria. The rule establishes testing 
frequencies based on production levels, but does not establish the 
performance criteria as enforceable regulatory standards. As the 
preamble points out, the criteria will be flexible and subject to 
change as FSIS and the industry gain experience with them and 
accumulate more data on establishment performance. The criteria are 
intended specifically to provide an initial basis upon which slaughter 
establishments and FSIS can begin to use microbial testing to evaluate 
the adequacy of establishment controls for slaughter and sanitary 
dressing procedures.
    The objective of this regulation is to reduce the risk of foodborne 
illness from meat and poultry. The focus is on reducing and eventually 
minimizing the risk from the following four pathogens:
    <bullet> Campylobacter jejuni/coli.
    <bullet> Escherichia coli O157:H7.
    <bullet> Listeria monocytogenes.
    <bullet> Salmonella.
    This document is the final Regulatory Impact Analysis (RIA) 
prepared in compliance with the provisions of Executive Order 12866 and 
analyses requirements of the Regulatory Flexibility Act (P.L. 96-354) 
and the Unfunded Mandates Reform Act (P.L. 104-4). The purpose of this 
final RIA is to evaluate alternatives to and costs and benefits 
associated with a mandatory HACCP-based regulatory program for all meat 
and poultry establishments under inspection.

B. Methodology

    The methodology used to develop cost estimates for this final RIA 
is relatively straightforward. The costs estimates are based on data 
for average wages, the cost of specific processing equipment or the 
cost of conducting specific laboratory analyses.
    The benefits analysis is less straightforward. The analysis has 
defined regulatory effectiveness as the percentage of pathogens 
eliminated at the manufacturing stage. The benefits analysis concludes 
that there is insufficient knowledge to predict with certainty the 
effectiveness of the proposed rule. Without specific predictions of 
effectiveness, FSIS has calculated projected health benefits for a 
range of effectiveness levels.
    The link between regulatory effectiveness and health benefits is 
the assumption that a reduction in pathogens leads to a proportional 
reduction in foodborne illness. FSIS has presented the proportional 
reduction calculation as a mathematical expression that facilitates the 
calculation of a quantified benefit estimate for the purposes of this 
final RIA. FSIS has not viewed proportional reduction as a risk model 
that would have important underlying assumptions that merit discussion 
or explanation. For a mathematical expression to be a risk model, it 
must have some basis or credence in the scientific community. That is 
not the case here. FSIS has acknowledged that very little is known 
about the relationship between pathogen levels at the manufacturing

[[Page 38946]]

stage and dose, i.e., the level of pathogens consumed.
    There are many factors that play important roles in the actual link 
between pathogen levels at the manufacturing stage and frequency of 
foodborne illness. First, the effectiveness definition of ``percentage 
of pathogens reduced'' can refer to the percentage of packages that 
contain pathogens or the level of pathogens within packages. The 
pathogens-to-illness relationship is further complicated because cross-
contamination in kitchens is believed to play a major role. It can not 
be assumed that a reduction in the number of pathogens present in a 
package of meat or poultry will prevent a cross-contamination related 
illness. On the other hand, given that the number of consumed pathogens 
necessary to cause illness (threshold) can be different for every 
possible pathogen or individual combination, a reduction in pathogen 
levels at the time of packaging may prevent illness for many cross-
contamination scenarios.
    These types of unknowns illustrate why the relationship between 
pathogen levels and foodborne illness levels remains unknown. As stated 
above, without a known relationship, FSIS has used the proportional 
reduction assumption to provide a quantified estimate, recognizing that 
the real relationship is probably different for each pathogen and 
category of meat and poultry product.
    Risk minimization as the objective of this rule means the 
elimination of most foodborne illness caused by the contamination of 
meat and poultry products in inspected establishments by any of the 
four pathogens listed above. The reduction in pathogens needed to do 
this is unknown and would vary for individual pathogens and products.
    This final RIA includes a discussion of the status of risk 
assessment for foodborne pathogens that responds to the new 
Departmental guidelines for preparing risk assessments contained in 
Departmental Regulation 1521-1, December 21, 1995. Although the 
statutory requirements for risk analysis included in the Federal Crop 
Insurance Reform and Department of Agriculture Reorganization Act of 
1994 (P.L. 103-354) do not apply to this final rule, there were public 
comments on the need for additional risk assessment or risk analysis. 
This final RIA includes the Agency's response to those comments.
    On February 3, 1995, FSIS published a preliminary RIA as part of 
the proposed Pathogen Reduction HACCP rule (60 F.R. 6871). The 
preliminary RIA announced the availability of a detailed supplemental 
cost analysis, titled ``Costs of Controlling Pathogenic Organisms on 
Meat and Poultry,'' which was available from the FSIS Docket Clerk 
during the comment period. This final RIA will refer to the analysis 
published with the proposed rule and the supplemental cost analysis 
collectively as the ``preliminary analysis.''
    During the public comment period the Department conducted a number 
of public hearings, technical conferences and information briefings. On 
May 22, 1995, the Agency conducted a special hearing in Kansas City 
dealing with the impacts of the proposed rule on small businesses. In 
July 1995, FSIS conducted a survey of the State inspection programs to 
collect additional information to assess the impact on State 
establishments.
    This final RIA is based on the preliminary RIA, the supplemental 
cost analysis, all written public comments, the records from public 
hearings including the meeting on small business impacts, the survey of 
State programs, and any new information or data that have become 
available during the comment period. The analysis also refers 
specifically to cost estimates developed by the Research Triangle 
Institute (RTI) during personal interviews with nine establishments 
that previously participated in the FSIS HACCP Pilot Program. The RTI 
report, HACCP Pilot Program Cost Findings, August 31, 1994, which was 
referred to in both written and public hearing comments were developed 
under contract to FSIS in 1994.

C. Summary Comparison of Costs and Benefits--Proposal to Final

    FSIS estimated that the proposed rule would have 20-year industry 
costs of $2.2 billion. Those costs are presented in Table 1, organized 
by the regulatory components identified in the proposal.
    The estimated costs for the final rule are also presented in Table 
1. For some of the regulatory components, it is easy to track the costs 
from the proposal to the final rule. For example, the costs for 
Sanitation SOP's remain essentially the same. The reduction from $175.9 
to $171.9 million reflects the change in implementation period from 90 
days to six months.
    The costs for developing and implementing HACCP plans are also 
directly comparable. The estimated cost has increased for the HACCP 
component of plan development. FSIS has increased its estimate for this 
cost after reviewing the public comments and assessing the overall 
impact on plan development costs of the decisions to eliminate the 
requirements for implementing time/temperature and antimicrobial 
treatment requirements prior to HACCP implementation. In the 
preliminary analysis, the cost for developing HACCP plans was reduced 
because of the experience that establishments would have gained in 
developing their plans for implementing time/temperature and 
antimicrobial treatment requirements.

                                Table 1.--Comparison of Costs--Proposal to Final                                
                                  [$ Millions--Present Value of 20-year Costs]                                  
----------------------------------------------------------------------------------------------------------------
     Regulatory component                         Proposal                                   Final              
----------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's..........  175.9<SUP>a........................................  171.9                            
II. Time/Temperature           45.5..........................................  0.0                              
 Requirements.                                                                                                  
III. Antimicrobial Treatments  51.7..........................................  0.0                              
IV. Micro Testing............  1,396.3<SUP>b......................................  174.1                            
V.                                                                                                              
    Compliance with            Not Separately Estimated<SUP>c.....................  55.5-243.5                       
     Salmonella standards.                                                                                      
    Compliance with generic    Not Applicable................................  Not Separately Estimated         
     E. coli criteria.                                                                                          
VI. HACCP:                                                                                                      
    Plan Development.........  35.7..........................................  54.8                             
    Annual Plan Reassessment.  0.0...........................................  8.9                              
    Recordkeeping (Recording,  456.4.........................................  440.5<SUP>d                           
     Reviewing and Storing                                                                                      
     Data).                                                                                                     
    Initial Training.........  24.2..........................................  22.7<SUP>d                            
    Recurring Training.......  0.0...........................................  22.1<SUP>e                            
VII. Additional Overtime.....  20.9..........................................  17.5<SUP>d                            
                              ----------------------------------------------------------------------------------

[[Page 38947]]

                                                                                                                
      Subtotal--Industry       2,206.6.......................................  968.0-1,156.0                    
       Costs.                                                                                                   
VIII. FSIS Costs.............  28.6<SUP>f.........................................  56.5                             
                              ----------------------------------------------------------------------------------
      Total..................  2,235.2.......................................  1,024.5-1,212.5                  
----------------------------------------------------------------------------------------------------------------
<SUP>a The preliminary analysis included a higher cost estimate for sanitation SOP's ($267.8 million) that resulted  
  because of a programming error. The cost estimate of $175.9 million is based on an effective date of 90 days  
  after publication.                                                                                            
<SUP>b The preliminary analysis was based on the premise that microbial testing would be expanded to cover all meat  
  and poultry processing after HACCP implementation. The proposed rule only required sampling for carcasses and 
  raw ground product. Thus, the cost estimate of $1,396.3 million was higher than the actual cost of the        
  proposed sampling requirements.                                                                               
<SUP>c The preliminary analysis accounted for some of the cost of complying with the new standards under the         
  regulatory components of micro testing, antimicrobial treatments, and time and temperature requirements.      
<SUP>d These costs are slightly different from the proposal because of changes in the implementation schedule.       
<SUP>e FSIS added costs for recurring training based on the review of public comments.                               
<SUP>f Based on current estimates for the cost of training, inspector upgrades, and $0.5 million for annual HACCP    
  verification testing.                                                                                         


    Table 1 shows that FSIS has added two categories of HACCP costs 
that were not included in the preliminary cost analysis. A cost for 
recurring annual HACCP training was added in response to comments that 
there would be recurring costs because of employee turnover. FSIS also 
added a minimal cost for annual reassessment of HACCP plans, although 
the Agency believes that reassessment will be negligible for 
establishments successfully operating under a HACCP plan.
    Table 1 shows that the proposed requirements for time and 
temperature specifications and antimicrobial treatments have not been 
included in the final rule. The preliminary analysis treated these 
items as interim costs that were incurred prior to HACCP 
implementation. For the time and temperature requirements, the 
preliminary analysis identified both one-time capital equipment costs 
and recurring recordkeeping costs. The time and temperature 
recordkeeping costs were assumed to become part of the HACCP 
recordkeeping costs. The recurring costs for antimicrobials were 
assumed to end with HACCP implementation. The preliminary analysis 
indicated that at the time of HACCP implementation, the slaughter 
establishments would make a decision on whether to continue the 
antimicrobial treatments and employ other methods to reduce the 
microbial load on carcasses. The preliminary analysis did not, however, 
include a cost component for either continuing the antimicrobial 
treatments or adding alternative pathogen reduction methods.
    Under the micro testing component, the final rule requires that all 
2,682 slaughter establishments implement microbial sampling programs 
using generic E. coli. The 20-year cost of this requirement is $174.1 
million. After HACCP implementation including validation that the E. 
coli performance criteria are being met, establishments may use 
alternate testing programs unless FSIS specifically objects. In 
addition, in the period prior to mandatory HACCP, FSIS will consider 
exemptions on a case-by-case basis for establishments that are 
currently using an alternative E. coli sampling frequency if the 
establishment can provide data demonstrating the adequacy of its 
existing program. The cost estimate of $174.1 million assumes that all 
slaughter establishments continue to test at the frequencies outlined 
in the final rule.
    Up to this point, all the costs discussed have been predictable in 
the sense that they refer to a specific requirement directing all 
establishments or a specific category of establishments to take a well-
defined action. FSIS has developed point estimates for all predictable 
costs. In contrast, the pathogen reduction performance standards for 
Salmonella do not prescribe a set of actions that establishments must 
take. Because the standards are set using the national prevalence 
estimates from the baseline studies, the Agency is also not able to 
predict how many establishments are already meeting the standards or 
how many will have to modify their current operations to comply.
    The cost analysis in Section V recognizes that the performance 
standards create a set of potential costs for 5,522 establishments, 
2,682 slaughter establishments and another estimated 2,840 
establishments that produce raw ground product but do not have 
slaughter operations. The analysis estimates potential costs by 
developing two scenarios that lead to a range of possible costs 
depending on how the different industry sectors will respond to the new 
standards and depending on how many establishments will need to modify 
their production processes in order to comply.
    Reducing pathogens for slaughter establishments involves either 
modifying the incoming animals or birds, improving the dressing 
procedures so as to reduce contamination during procedures such as hide 
removal and evisceration, or using interventions such as antimicrobial 
treatments to kill or remove the pathogens following contamination. For 
many establishments, the process of implementing HACCP programs may, by 
itself, improve the dressing procedures sufficiently to meet the new 
standards. Other establishments may have to choose between slowing 
production lines, modifying some attribute of their incoming live 
animals or birds, or adding post-dressing interventions such as the new 
steam vacuum process or antimicrobial rinses.
    The 2,840 raw ground processing operations will have to control 
their incoming ingredients either by conducting their own testing or by 
requiring that suppliers meet purchase specifications. The cost 
analysis also recognizes that even though the rule does not require the 
2,682 slaughter establishments to test for Salmonella, some 
establishments may conduct their own Salmonella testing programs to 
avoid failing a series of tests conducted by the Agency. Thus, it can 
be argued that the Agency's intent to implement establishment specific 
testing for Salmonella is indirectly requiring the industry to 
routinely monitor their Salmonella levels to assure they will be in 
compliance.
    As shown in Table 1, the two scenarios developed in the cost 
analysis lead to a range in cost estimates of $55.5 to $243.5 million 
to comply with the new pathogen reduction standards. Some of these 
costs are contained in the

[[Page 38948]]

Table 1 proposal costs of $51.7 for antimicrobial treatments and the 
$1,396.3 for micro testing that included the cost of having 5,522 
establishments conduct daily Salmonella testing for each species 
slaughtered and each variety of raw ground product produced.
    The two cost scenarios were developed to illustrate potential costs 
for compliance with standards established using the current pathogen 
prevalence as determined by the national baseline studies. These 
standards move the Agency's regulatory program in the direction of 
meeting the food safety objective of minimizing the risk of foodborne 
illness from pathogens that contaminate meat and poultry products. The 
Agency has stated its intent to establish tighter standards over time. 
The Agency recognizes that future tighter standards could impose a new 
set of compliance costs. To illustrate, where the use of hot water 
rinses may be adequate to assure compliance with the Salmonella 
standards as established for this rule, such rinses may not be adequate 
to assure compliance with future standards. Any change in the standards 
will, however, be implemented through additional rulemaking. At that 
time the Agency will have extensive data on the distribution of 
pathogens by establishment and better data on the cost and 
effectiveness of different interventions. These data enhancements will 
allow for improved cost analysis of future standard setting activities. 
Inspected establishments need to consider the Agency's overall food 
safety objectives when making decisions on capital investments designed 
to assure compliance with the food safety standards established by this 
rulemaking.
    The cost analysis in Section V also recognizes that the performance 
criteria for generic E. coli create a set of potential costs for 2,682 
slaughter establishments. A line for these costs is shown in Table 1 
along with the entry that these costs were not separately quantified.
    As discussed in Section V, the anticipated actions to comply with 
the generic E. coli criteria are the same as the anticipated actions to 
comply with the standards for Salmonella. FSIS has concluded that if 
the low cost scenario for Salmonella compliance proves to be more 
accurate, then the Agency would expect to see some compliance costs for 
the generic E. coli performance criteria. If the high cost scenario is 
correct, then the compliance actions taken to assure compliance with 
the Salmonella standards should also assure compliance with the generic 
E. coli criteria.
    Finally, Table 1 includes a cost of $17.5 million associated with 
additional overtime charges for inspection. While it is recognized that 
final decisions on the future of the Agency's Total Quality Control 
(TQC) program have not been made, this analysis includes a conservative 
impact assumption that the existing TQC regulations will be withdrawn.
    Both the preliminary and final analysis identify a maximum 
potential 20-year public health benefit from $7.13 to $26.59 billion 
that is tied to eliminating establishment-related contamination from 
four pathogens on meat and poultry. The contamination from these four 
pathogens at the manufacturing stage leads to an estimated annual cost 
of foodborne illness ranging from $0.99 billion to $3.69 billion. The 
maximum 20-year benefit results from eliminating this annual cost of 
foodborne illness beginning in the fifth year after publication. 
Although there is reason to believe significant benefits will be 
generated during the first four years, for analytical purposes FSIS 
used the conservative estimate that benefits do not begin until all 
establishments have HACCP systems in place and pathogen reduction 
standards for Salmonella apply to all establishments that slaughter or 
produce raw ground product.
    There are two principle reasons why benefits will begin to accrue 
before the fifth year. First, the HACCP requirements and Salmonella 
standards apply to large establishments at 18 months and small 
establishments at 30 months. The large slaughter establishments account 
for over 74 percent of total carcass weight. Second, the generic E. 
coli testing requirements are effective six months after publication. 
The generic E. coli results will provide both establishment management 
and inspection program personnel a tool by which to assess 
establishments' control over slaughter and sanitary dressing 
procedures. Although the generic E. coli criteria are not being 
established as regulatory standards, FSIS believes their use will lead 
to improved control over slaughter and sanitary dressing procedures 
which will, in turn, lead to reductions in fecal contamination and 
corresponding reductions in contamination by enteric pathogens. Rather 
than attempt to estimate the benefits associated with reduced 
contamination resulting from use of generic E. coli testing, this 
analysis has assumed public health benefits begin in the fifth year. By 
that time all establishments have had an opportunity to adjust their E. 
coli sampling programs based on their HACCP programs.
    The low and high estimates for potential benefits are due to the 
current uncertainty in estimates for incidence of foodborne illness and 
death. If the low potential benefit estimate is correct, the analysis 
shows that the new HACCP-based program must reduce pathogens by 15 to 
17 percent for benefits to outweigh projected costs. If the high 
estimate is the correct estimate, the new program needs to reduce 
pathogens by only 4 to 5 percent to generate net societal benefits.
    As discussed in Section III, there are other benefits to this rule 
that have not been quantified. Examples include increased public 
protection from physical hazards and the increased production 
efficiency that accompanies improved process control.
    In the preliminary analysis FSIS took the position that quantified 
pathogen reduction benefits were related to the overall proposed HACCP-
based regulatory program and that there was no way to distribute 
benefits among the five different components that made up the proposed 
rule. Under the proposed rule it was essentially impossible to 
determine the proportion of pathogen reduction benefits that could be 
attributable to the proposed pathogen reduction standards versus the 
proposed antimicrobial treatments or time-temperature requirements or 
the proposed mandatory HACCP programs. Given the revised structure of 
the final rule, this analysis attributes pathogen reduction benefits to 
the requirements that all establishments implement HACCP systems and 
that if those systems are implemented in slaughter establishments or 
establishments shipping raw ground product, they must have critical 
limits set to assure compliance with the new pathogen reduction 
standards for Salmonella. However, as discussed above, FSIS believes 
that pathogen reduction benefits will begin to occur when 
establishments start using the generic E. coli results to assess their 
control over slaughter and sanitary dressing procedures.
    FSIS believes that the Sanitation SOP's component of this final 
rule has significant benefits in terms of increased productivity for 
inspection resources. The HACCP component also has productivity 
benefits in addition to public health benefits. One of the reasons FSIS 
has not yet achieved a program that can focus appropriate resources on 
the risks of microbial pathogens is that in recent years

[[Page 38949]]

national budget problems have provided limited increases in Agency 
resources compared to the increase in its responsibilities generated by 
industry growth, the Federal takeover of more State programs, and new 
food production technologies and products. For most of its history, the 
inspection program was able to obtain additional resources when it took 
on new responsibilities. Now FSIS is faced with taking on new 
responsibilities with the same resources.
    The final rule is a necessary component of an FSIS management 
strategy that will raise the productivity of current resources so that 
the program can maintain all its consumer protection objectives. 
Raising productivity requires raising outputs, reducing inputs or any 
combination of the two that gets more done for less. Productivity can 
be increased in today's inspection program by: (1) focusing resource 
use on the basis of risk, giving the highest priority to safety 
objectives; (2) clarifying the respective responsibilities of 
government and industry to assure the best use of government resources; 
and (3) designing new methods of inspection that are more efficient 
than existing inspection but which maintain or improve consumer 
protection.
    The Sanitation SOP's and HACCP requirements are designed to 
accomplish objectives in all three of the above areas. With SOP's FSIS 
can monitor sanitation plans with fewer resources than it takes to 
conduct comprehensive sanitation reviews. The benefit of the SOP's is, 
therefore, the capacity to reallocate inspection resources to other 
activities where the payoff in terms of reducing the risk of foodborne 
illness may be greater. With SOP's there is less likelihood that 
establishments will be able to substitute the inspector's sanitation 
review for their own sanitation program. Similarly, with HACCP there is 
less likelihood that firms can use inspection as a substitute for their 
own control programs. In both cases productivity is enhanced by 
clarifying responsibilities. The benefits associated with increased 
productivity are difficult to quantify because the precise reallocation 
of inspection resources is not yet clear.
    Finally, with the implementation of this rule, FSIS intends to 
introduce new methods of inspection that are more efficient than those 
currently in place. As noted above, more efficient methods is the third 
way in which productivity can be increased in the inspection system.

II. Regulatory Alternatives

A. Market Failure

    Consumers make choices about the food they purchase based upon 
factors such as price, appearance, convenience, texture, smell, and 
perceived quality. In an ideal world, people would be able to make 
these decisions with full information about product attributes and 
choose those foods which maximize their satisfaction. In the real 
world, however, information deficits about food safety complicate 
consumer buying decisions.
    Since all raw meat and poultry products contain microorganisms that 
may include pathogens, raw food unavoidably entails some risk of 
pathogen exposure and foodborne illness to consumers. However, the 
presence and level of this risk cannot be determined by a consumer, 
since pathogens are not visible to the naked eye. Although they may 
detect unwholesomeness from obvious indications such as unpleasant odor 
or discoloration caused by spoilage microorganisms, consumers cannot 
assume products are safe in the absence of spoilage. They simply have 
no clear-cut way to determine whether the food they buy is safe to 
handle and eat.
    When foodborne illness does occur, consumers often cannot correlate 
the symptoms they experience with a specific food because some 
pathogens do not cause illness until several days, weeks or even months 
after exposure. Thus, food safety attributes are often not apparent to 
consumers either before purchase or immediately after consumption of 
the food. This information deficit also applies to wholesalers and 
retailers who generally use the same sensory tests--sight and smell--to 
determine whether a food is safe to sell or serve.
    The societal impact of this food safety information deficit is a 
lack of accountability for foodborne illnesses caused by preventable 
pathogenic microorganisms. Consumers often cannot trace a transitory 
illness to any particular food or even be certain it was caused by 
food. Thus, food retailers and restaurateurs are generally not held 
accountable by their customers for selling pathogen-contaminated 
products and they, in turn, do not hold their wholesale suppliers 
accountable.
    This lack of information applies equally to small businesses. Some 
small businesses have argued for exemption from the rule because they 
sell most of their product to family, friends and neighbors, but they 
are overlooking the fact that perhaps the majority of foodborne illness 
victims may believe they had some type of flu virus or other illness 
and have no idea that their illness was foodborne and, if they do, they 
have no idea as to the source. Without feedback, (i.e., without a 
connection of product to illness), there is no market where buyers and 
sellers have sufficient information upon which to judge purchase 
decisions. Without feedback there is insufficient incentive to make 
substantial improvements in process control.
    This lack of marketplace accountability for foodborne illness means 
that meat and poultry producers and processors have little incentive to 
incur extra costs for more than minimal pathogen controls. The 
widespread lack of information about pathogen sources means that 
businesses at every level from farm to final sale can market unsafe 
products and not suffer legal consequences or a reduced demand for 
their product. An additional complication is that raw product is often 
fungible at early stages of the marketing chain. For example, beef from 
several slaughterhouses may be combined in a batch of hamburger 
delivered to a fast food chain. Painstaking investigation by public 
health officials in cases of widespread disease often fails to identity 
foodborne illness causes; in half the outbreaks the etiology is 
unknown.
    Most markets in industrialized economies operate without close 
regulation of production processes in spite of consumers having limited 
technical or scientific knowledge about goods in commerce. Branded 
products and producer reputations often substitute for technical or 
scientific information and result in repeat purchases. Thus, brand 
names and product reputations become valuable capital for producers.
    In the U.S. food industry, nationally recognized brand names have 
historically provided significant motivation for manufacturers to 
ensure safe products. In recent years, more and more raw meat and 
poultry have come to be marketed under brand names. Nevertheless, not 
even all brand name producers produce their products under the best 
available safety controls. Further, a significant part of meat and 
poultry, particularly raw products, are not brand name products and are 
not produced under conditions that assure the lowest practical risk of 
pathogens.
    The failure of meat and poultry industry manufacturers to produce 
products with the lowest risk of pathogens and other hazards cannot be 
attributed to a lack of knowledge or appropriate technologies. The 
science and technology required to significantly

[[Page 38950]]

reduce meat and poultry pathogens and other hazards is well 
established, readily available and commercially practical.
    Explanations for why a large portion of the meat and poultry 
industry has not taken full advantage of available science and 
technology to effectively control manufacturing processes include the 
following:
    1. Meat and poultry processing businesses are relatively easy to 
enter; there are no training or certification requirements for 
establishment operators. Consequently, the level of scientific and 
technical knowledge of management in many establishments is minimal.
    2. The industry is very competitive and largely composed of small 
and medium-sized firms that have limited capital and small profits.
    3. Management in many of these establishments has little incentive 
to make capital improvements for product safety because results from 
that investment are not distinguishable by customers and therefore 
yield no income.
    In spite of these barriers, many industry establishments do produce 
meat or poultry products using process controls that assure the lowest 
practical risk of pathogens and other hazards.
    FSIS has concluded that the lack of consumer information about meat 
and poultry product safety and the absence of adequate incentives for 
industry to provide more than minimal levels of processing safety 
represents a market failure requiring Federal regulatory intervention 
to protect public health.

B. General Regulatory Approaches

    The problem of microbial pathogens in meat and poultry has become 
increasingly apparent. Documented cases of foodborne illness each year, 
some of which have resulted in death, represent a public health risk 
that FSIS judges to be unacceptable. Within existing authorities there 
are four broad regulatory approaches the Department could use to 
address this unacceptable public health risk.
    <bullet> Market Incentives.
    <bullet> Information and Education.
    <bullet> Voluntary Industry Standards.
    <bullet> Government Standards.
    The final rule represents the fourth approach.
    The above discussion on market failure summarizes why FSIS has 
concluded that the market will not address the public health risk 
resulting from microbial pathogens in meat and poultry.
    The role and effectiveness of consumer and food service worker 
education in assuring food safety was raised in public comments. For 
example, comments suggested that since most foodborne illness involves 
temperature abuse or consumer/food handler mishandling, consumer 
education offers the most cost-effective approach. FSIS sees a clear 
role for education and agrees that education is essential for assuring 
food safety. However, experience has shown that education alone has 
limited effectiveness in reducing foodborne illness. The effectiveness 
of education for food safety, and, indeed, for improving diets and 
other food related behavior, has not been demonstrated. FSIS views 
education as a valuable adjunct to other regulatory approaches, but it 
has no evidence that a major increase in education expenditures will 
produce the behaviors required to reduce foodborne illness.
    A voluntary industry standard would call for the formation of a 
standards setting group, such as the American National Standards 
Institute (ANSI) to develop and publish a voluntary standard. 
Compliance with such a voluntary standard would be determined by third-
party testing and certification. For example, Underwriter's Laboratory 
(UL) tests and certifies electronic components for industry-wide 
standards. FSIS has not seen any evidence that the industry is prepared 
to undertake, or even desires a voluntary standards approach. This is 
understandable. Because the principles underlying the safe production 
of meat and poultry are the same regardless of who administers the 
standards, an industry administered system is likely to be more 
expensive and less effective than a government one. The lack of power 
to mandate participation reduces the value of standard setting to 
participants, since foodborne illness episodes attributable to non-
participants tend to raise suspicion of all similar products. Further, 
the industry would be called upon to pay the enforcement cost which 
under the present rule would be paid by the government.
    For these reasons, the Department concludes that mandatory process 
control regulations offer the best approach for addressing this 
unacceptable public health risk.

C. Need For Improved Process Control

    FSIS has determined that effective process control is needed 
throughout the meat and poultry industry in order to minimize pathogen 
contamination and control other health hazards. Accordingly, a 
regulatory strategy has been formulated to mandate process control 
improvements to achieve immediate reductions and an eventual 
minimization of the risk of meat and poultry pathogens, chemical, and 
physical hazards in the nation's food supply. This strategy is 
supported by consumers, scientists, and the majority of meat and 
poultry industry processors who already recognize the benefits of good 
process control.
    Process control is a proactive strategy that all segments of 
industry can undertake to anticipate manufacturing problems in advance 
and prevent unsafe foods from being produced. In practice, process 
control is a systematic means to:
    <bullet> Identify and control production hazards.
    <bullet> Determine control points in the processing system.
    <bullet> Establish standard measures for each control point.
    <bullet> Set procedures for establishment workers to monitor 
requirements.
    <bullet> Provide clear instructions for appropriate corrective 
actions when a control point goes out of control.
    <bullet> Establish record-keeping to document control point 
measurements.
    <bullet> Provide procedures for verification tests to ensure that 
the system continues to operate as planned.
    The process control strategy summarized in this paper is founded on 
three principles:
    1. USDA regulatory policy should be focused on providing a solution 
to meat and poultry biological, chemical, and physical hazards that 
present the highest public health risks.
    2. It is essential that the Nation's food safety system address 
pathogenic microorganisms which present the greatest foodborne risk to 
human health.
    3. These pathogens and resulting risks of foodborne illness can be 
largely avoided by uniform meat and poultry industry efforts to attain 
and maintain more effective methods of control during the manufacturing 
process.
    The focus of this strategy is explicitly on prevention; it is 
designed to prevent the production of defective product as opposed to 
more costly and less effective detect-and-condemn methods.
    Process control is not a substitute for inspection any more than 
inspection could be a substitute for process control. This distinction 
is important because Federal inspection was never intended to be--and 
cannot be--the front-line control for food safety in meat and poultry 
processing establishments. Safety controls must be built into the 
manufacturing process and be administered continuously by industry. The 
objective of inspection in a process control environment is to assure 
that those controls are present, adequate, and properly used.

[[Page 38951]]

    To summarize, the process control regulatory strategy promulgated 
by this rule will among its other well established attributes, correct 
two important deficiencies in the nation's current food safety effort. 
It will: (1) provide industry the tools and incentive to reduce meat 
and poultry pathogens as a means to improve food safety, and (2) help 
focus Federal inspection on the highest product, process and 
establishment risks, and, at the same time, clarify that the industry 
is responsible for producing safe meat and poultry, while the 
Government's role is oversight.
Factors Considered in Evaluating a Process Control Strategy
    The process control regulatory strategy was evaluated using five 
factors for effectiveness. A processing control program is effective if 
it:
    1. Controls production safety hazards.
    2. Reduces foodborne illness.
    3. Makes inspection more effective.
    4. Increases consumer confidence.
    5. Provides the opportunity for increased productivity.
    The following sections discuss these five effectiveness factors 
that have been applied to evaluate process control alternatives.
Controls Production Safety Hazards
    Process control is a system for identifying food hazards and 
reducing or eliminating the risks they present. In operation, control 
points are established in a food production line where potential health 
hazards exist; management of these points has proven to be effective in 
reducing the probability that unsafe product will be produced. Ongoing 
records of each process control will enable establishment managers and 
quality control personnel to spot trends that could lead to problems 
and devise a strategy that prevents them before they occur.
    Detection by end product testing is not a viable alternative to 
process control because it only sorts good product from bad and does 
not address the root cause of unacceptable foods. Additionally, keeping 
``bad'' foods out of commerce through sorting end product is possible 
only when tests and standards for sampling are well established and it 
is practical only where the ``test'' is not expensive because sorting 
requires a huge number of samples for reliability.
Reduces Foodborne Illness
    As industry improves its control over the safety aspects of meat 
and poultry production, foodborne illness will begin to decline. This 
is the principal non-negotiable goal for both USDA and industry.
    The precise occurrence of human health problems attributed to 
pathogenic microorganisms or other potential foodborne hazards, such as 
chemical contaminants, animal drug residues, pesticides, extraneous 
materials, or other physical contaminants is not known. Foodborne 
illness is nevertheless recognized by both domestic and international 
scientists as a significant public health problem and there is wide 
agreement that pathogenic microorganisms are the major cause of food-
related disease. The estimated annual (not discounted) cost of 
foodborne illness attributable to meat and poultry products from the 
four pathogens that are the focus of this regulation is from $1.1 to 
$4.1 billion. FSIS estimates that 90 percent of this annual cost, $0.99 
to $3.69 billion, is attributable to contamination that occurs in 
establishments.
Makes Inspection More Effective
    Currently, the FSIS inspectors in meat and poultry establishments 
that are not assigned to slaughter line positions perform selected 
inspection tasks that generate independent data about an 
establishment's production processes and environment. This activity 
produces ``snapshots'' of establishment operations at a particular 
moment. In contrast, process control generates records of establishment 
performance over time. These records and periodic verification 
inspections will enable FSIS inspectors to see how an establishment 
operates at all times, i.e., whether and where processing problems have 
occurred, and how problems were addressed.
    The availability of more and better processing data will establish 
trends that set benchmarks from which deviations can be more quickly 
and accurately assessed. USDA inspectors will be trained to spot these 
deviations and take action when needed to ensure establishments bring a 
faulty process back into control. This type of Federal oversight is 
substantially more effective than a regulatory program that merely 
detects and condemns faulty end products. In the words of the National 
Advisory Committee on Microbiological Criteria for Foods, 
``Controlling, monitoring, and verifying processing systems are more 
effective than relying upon end-product testing to assure a safe 
product.''
Increases Consumer Confidence
    The number of foodborne illness outbreaks and incidents 
attributable to pathogens in meat or poultry raise questions about 
whether Federal inspection is as effective as it should be. Highly 
visible public controversies about meat and poultry inspection indicate 
an erosion of public confidence in the safety of meat and poultry 
products. There are growing demands that USDA improve its regulation of 
pathogens. The process control regulatory strategy described in this 
paper is USDA's response to those demands.
    Many outbreaks of foodborne illness have been determined to be 
caused by mishandling of meat and poultry products after federally 
inspected processing. USDA believes that additional efforts to reduce 
pathogens during manufacturing will reduce these risks as well. This 
coupled with the improved retail regulatory controls from state 
adoption and enforcement of the Food Code should reduce this cause of 
illness. The Food Code is an FDA publication, a reference that provides 
guidance to retail outlets such as restaurants and grocery stores and 
institutions such as nursing homes on how to prepare food to prevent 
foodborne illness. State and local regulatory bodies use the FDA Food 
Code as a model to help develop or update their food safety rules and 
to be consistent with national food regulatory policy.
    A significant portion of the meat and poultry industry do not take 
advantage of readily available methods to control their manufacturing 
processes. The Department has concluded that further regulation will 
bring industry standards up to what can practically be achieved in the 
manufacture of meat and poultry products through current scientific 
knowledge and available process control techniques. Raising the safety 
floor through regulations that mandate better process control will 
demonstrate to the public that USDA and industry are making a concerted 
effort to reduce the risk of foodborne illness from meat and poultry.
    The economic benefits of increased consumer confidence can be 
conceptually realized as the amount consumers would be willing to pay 
for safer food. This ``willingness to pay'' reflects consumer desires 
to avoid foodborne illness and the expected medical and other costs 
associated with it. However, the data are not available to make 
quantitative estimates of this benefit.
Provides the Opportunity for Increased Productivity
    Better process control is a sound and rational investment in the 
future of our

[[Page 38952]]

nation's meat and poultry industry. USDA's process control strategy 
will educate industry management about the need and methodology for 
development of a consistent, preventive, problem-solving approach to 
safety hazards, which can be expanded to other business objectives such 
as product quality and production efficiency. There is considerable 
evidence of how process control has improved worldwide industrial 
productivity in the past 40 years. This proposal will extend process 
control principles to parts of the meat and poultry industry that have 
not formerly used them.
    Some important non-safety benefits that will accrue from industry 
use of better process control methods are:
    <bullet> First, better production controls will result in more 
efficient processing operations overall with fewer product defects. 
Fewer defects mean less reworking, waste and give-away, resulting in 
increased yields and more profit opportunities.
    <bullet> Second, better controls will significantly reduce the risk 
to processors that product with food safety defects will slip into 
commerce. Expensive and embarrassing product recalls can be, for the 
most part, avoided or greatly reduced with proper process controls.
    <bullet> Third, better control of pathogens will impact all 
microorganisms, including those responsible for decomposition, 
resulting in quality improvement and longer shelf life for products.
    <bullet> Fourth, better production controls improve establishment 
employee productivity which improves profit opportunities.

D. Regulatory Alternatives for Process Control

1. Mandatory HACCP
    Considering the five effectiveness criteria of process control 
discussed above, the most effective means for generating the benefits 
reflected in these criteria is a mandatory HACCP regulatory program. 
This alternative clearly meets all five criteria described above. In 
fact, a mandatory HACCP program was judged to be the only option that 
will effect adequate processing improvements in all establishments 
throughout the industry. Only through mandatory HACCP can pathogen 
risks be minimized to the fullest extent possible; thereby 
significantly reducing foodborne illness, improving effectiveness of 
inspection, increasing consumer confidence, and ensuring a more viable 
industry. No other alternative accomplishes as much in these five areas 
as mandatory HACCP.
    HACCP is a process control strategy that has been scientifically 
proven effective in food manufacturing establishments. HACCP is widely 
recognized by scientific authorities such as the National Academy of 
Sciences and international organizations such as the Codex 
Alimentarius. It is used today by a number of establishments in the 
food industry to produce consistently safe products. This approach has 
been supported for years by numerous groups that have studied USDA meat 
and poultry regulatory activities.
    In 1983 FSIS asked the National Academy of Sciences (NAS) to 
evaluate the scientific basis of its inspection system and recommend a 
modernization agenda. The resulting report, ``Meat and Poultry 
Inspection, The Scientific Basis of the Nation's Program,'' National 
Academy Press, 1985 was the first comprehensive evaluation of a 
scientific basis for inspection. The 1985 NAS report provided a 
blueprint for change: it recommended that FSIS focus on pathogenic 
microorganisms and require that all official establishments operate 
under a HACCP system to control pathogens and other safety hazards.
    After urging (NAS Recommendations, Page 4) the intensification of 
``current efforts to control and eliminate contamination with micro-
organisms that cause disease in humans,'' NAS encouraged (Page 135) 
USDA to ``move as vigorously as possible in the application of the 
HACCP concept to each and every step in establishment operations, in 
all types of enterprises involved in the production, processing, and 
storage of meat and poultry products.''
    The General Accounting Office (GAO) has also identified needed 
improvements in USDA's present inspection system. In its reports and 
congressional testimony, and in numerous publications, GAO has endorsed 
HACCP as the most scientific system available to protect consumers from 
foodborne illness. This sentiment is most clearly expressed in a May 
1994 report, ``Food Safety: Risk-Based Inspections and Microbial 
Monitoring Needed for Meat and Poultry,'' in which GAO recommended 
development of a mandatory HACCP program that includes microbial 
testing guidelines. GAO urged USDA to assist meat and poultry 
establishments in the development of their microbial testing programs 
by, among other things, disseminating information on the programs 
already in operation.
    A third major proponent of HACCP is the National Advisory Committee 
on Microbiological Criteria for Foods (NACMCF), which was established 
in 1988 by the Secretary of Agriculture to advise and provide 
recommendations to the Secretaries of Agriculture and Health and Human 
Services on developing microbiological criteria to assess food safety 
and wholesomeness. Since 1989, NACMCF has prepared a series of reports 
on the development and implementation of HACCP. As one of its first 
tasks, the Committee developed ``HACCP Principles for Food Production'' 
in November 1989. In this report, the Committee endorsed HACCP as a 
rational approach to ensure food safety and set forth principles to 
standardize the technique. In 1992, the Committee issued an updated 
guide, ``Hazard Analysis and Critical Control Point System.''
    In 1993 NACMCF defined the roles of regulatory agencies and 
industry in implementing HACCP. ``The Role of Regulatory Agencies and 
Industry in HACCP'' proposed responsibilities for FDA, USDA, and other 
agencies and industry during various phases of HACCP implementation. 
Similar suggestions for program change have been voiced by consumers, 
industry, state and local government representatives, as well as other 
constituent groups. For example, consumers at recent public hearings 
and the HACCP Round Table supported implementation of mandatory HACCP 
throughout the meat and poultry industry.
    The meat and poultry industry has itself provided broad support for 
HACCP as a means to control pathogens, emphasizing that HACCP-based 
food production, distribution, and preparation can do more to protect 
public health than any Federal inspection program. They have 
recommended that HACCP be used to anticipate microbiological hazards in 
food systems and to identify risks in new and traditional products. 
State departments of health and agriculture have also endorsed the 
HACCP approach.
2. Alternatives to Mandatory HACCP
    FSIS examined six other approaches before determining that 
mandatory HACCP was the most effective means for assuring process 
control in the meat and poultry industries.
    1. Status quo
    2. Intensify present inspection
    3. Voluntary HACCP regulatory program
    4. Mandatory HACCP regulation with exemption for small businesses
    5. Mandatory HACCP regulation only for ready-to-eat products

[[Page 38953]]

    6. Modified HACCP--recording deviations and responses only
    These alternatives were assessed using the five effectiveness 
criteria presented in the previous section. The following six sections 
summarize the appraisal of each alternative.
Status Quo
    This option would essentially continue establishment processing 
controls and Federal inspection as they are now. Good establishments 
with adequate methods for managing process lines would probably remain 
under control. The Agency, under its present authority, cannot shift 
resources out of good establishments so the situation of poor 
performing establishments is unlikely to change. This situation raises 
immediate questions about the first factor--controls production safety 
hazards--being met. Experience has proven that Federal inspection 
cannot substitute for management in establishments which have 
difficulty producing safe product consistently. Also, inspection cannot 
be as effective in the current establishment environment as in a 
process control establishment environment.
    The status quo does not target industry and inspection resources on 
those hazards that lead to the greatest reduction in foodborne illness 
(factor two). In addition, food safety experts, consumers, and other 
observers have told USDA they are not satisfied with pathogen control 
by organoleptic methods as practiced in the present inspection program. 
Doing nothing new would perpetuate consumer doubts about the ability of 
Federal inspection to regulate pathogens which is counter to factor 
four. Consequently, the Department has concluded that business as usual 
is not an acceptable response to pathogens associated with meat and 
poultry products. Agency public health responsibilities alone require 
that more positive actions be taken.
Intensify Present Inspection
    As one alternative to the proposed mandatory HACCP regulation, FSIS 
could intensify its present inspection system, i.e., focus new 
resources on suspected areas of risk in each establishment. This 
approach would assign to FSIS responsibility for designing, testing and 
mandating by specific regulation, process control systems for all meat 
and poultry products with potential safety hazards. A major flaw with 
this approach is that the burden of ensuring a safe product would be 
placed largely on FSIS instead of industry establishments where it 
belongs. Establishment management would have little motivation to 
become knowledgeable about process control or to implement process 
control systems.
    The mandating of specific process controls has sometimes succeeded, 
as a regulatory strategy, for example, in correcting food safety 
problems in certain ready-to-eat products. However, these controls 
largely consisted of lethal heat treatments applied during final 
product processing. This approach is obviously inappropriate for 
product that is marketed raw which is most frequently associated with 
meat and poultry foodborne illness. The identification of processes 
that can be applied to raw product in every establishment would be much 
more difficult, if not impossible. Thus, intensified command-and-
control regulation fails to meet the primary criterion for process 
control, i.e., control production safety hazards at all stages of meat 
and poultry slaughter and processing. Related to this failing, 
inspection would be ineffective without all establishments maintaining 
process control systems (factor three.) This option would not only 
require significant resource increases, it represents government taking 
on more, not less, responsibility for the production process, making it 
more difficult to focus on the highest risks of foodborne illness. With 
the burden of control and monitoring on USDA's inspection force rather 
than on establishment managers, industry performance in reducing 
foodborne illness would be unlikely to improve (factor two).
Voluntary HACCP Regulatory Program
    A voluntary HACCP program would not provide reduction of pathogens 
uniformly across the processing spectrum because many in industry would 
choose not to participate. Therefore voluntary HACCP would not be 
sufficient to attain the necessary reduction in foodborne illness 
(factor two).
    Voluntary HACCP would be implemented most frequently in 
establishments with good processing controls already, while 
establishments with unsophisticated controls would be less likely to 
participate. The explanation for this flaw is to be found in simple 
economics and, to a large degree, the attitudes of establishment 
management. Establishments with good processing controls now are most 
likely to adopt HACCP voluntarily because their management understands 
the linkage between how a product is handled during preparation and its 
finished quality and safety.
    Conversely, establishments without good processing controls today 
are much less likely to participate in a voluntary HACCP program. These 
establishments are more often operated by management that lacks the 
knowledge or motivation to institute better processing controls. 
Nevertheless, it is precisely this group of low performing 
establishments that FSIS must reach to attain its public health goal. 
Nothing short of a mandatory HACCP regulatory program will be effective 
in bringing processing improvements to these marginal performers.
    The Agency's regulation permitting the use of voluntary Total 
Quality Control (TQC) Systems provides a useful analogy to how 
effective a voluntary HACCP program would be. TQC focuses on 
establishment responsibility for meeting or exceeding the standards set 
by FSIS for all operations that are conducted in an establishment, 
including incoming raw materials, processing procedures, critical 
limits for product standards, and action limits for establishment 
quality control personnel. These systems operate under Agency oversight 
with an emphasis on timely and accurate recordkeeping and the necessity 
for appropriate action to be taken by an establishment when a limit set 
forth in an approved system is met or exceeded. However, over the last 
10 years the number of establishments with active TQC Systems has 
declined from a high of around 500 (approximately 8% of all 
establishments) to the present 351 participating establishments 
(approximately 5% of all establishments). USDA experience has shown 
that a voluntary approach to HACCP would provide little assurance that 
a major portion of meat and poultry products had been produced under 
controls designed to minimize food safety hazards.0
Mandatory HACCP Regulation With Exemption for Small Businesses
    Under this alternative, FSIS would mandate HACCP, but also provide 
an exemption for some category of small businesses as was done with 
nutrition labeling. While this final regulatory impact analysis does 
develop very specific definitions for small and very small 
establishments, the following discussion of comments uses the term 
``small'' in a generic sense because many of the comments address small 
establishments or small businesses without defining these terms. There 
was a mix of public comments on whether or not HACCP should be 
mandatory for small businesses.

[[Page 38954]]

    Comments supporting an exemption from HACCP for small 
establishments noted that many owner-operators of small establishments 
oversee the entire operation on a daily basis and can pay closer 
attention to procedures than can a large establishment. Similar 
comments pointed out that small establishments pose a minimal potential 
public health hazard because of the simplicity of their operations, the 
slow pace of operations, and the small number of potentially affected 
customers. Other comments pointed out that they sell their product to 
family, friends and neighbors and that type of market provides the 
greatest incentive for producing safe product.
    Some commenters opposing an exemption did not want to create a two-
tiered system. Others opposing an exemption for small establishments 
would require HACCP for everyone while easing the burden through 
flexibility of implementation. Several of the commenters opposing any 
type of exemption from HACCP identified themselves as owners of small 
establishments. One commenter noted that just because small businesses 
produce only 2 percent of the product does not mean they are 
responsible for only 2 percent of the foodborne illness attributable to 
meat and poultry.
    The Agency used the evaluative factors presented above to consider 
the application of the rule to small establishments. Since major goals 
in implementing HACCP are to improve processing controls and 
establishment performance across all of industry (factor one) as a 
means to achieve foodborne illness reduction (factor two), the option 
to exempt establishments that perform the least process control is 
inherently flawed. USDA inspection experience shows that some of the 
small establishments which would be exempted under this option have 
particular difficulties maintaining control over their processing 
system.
    While it is true that small establishments produce a minimal amount 
of the total meat and poultry supply, they do produce a full range of 
products, including those most frequently associated with foodborne 
illness from the meat and poultry supply.
    This option also fails on factor three--provide more effective 
inspection. Two different inspection systems would be needed: one risk-
based system to inspect HACCP establishments with good processing 
controls; the other to provide resource intensive coverage for 
establishments that largely do not. If the number of small 
establishments were to increase, more inspection resources would be 
required.
    For these reasons, the final rule does not include an exemption for 
small businesses. However, the Agency has made significant changes to 
ease the burden on small business, including basing microbial sampling 
programs on production volume and deferring implementation of mandatory 
HACCP for small and very small businesses as defined in Section V.
Mandatory HACCP Regulation Only for Ready-to-Eat Products
    This option would mandate HACCP only for establishments that 
prepare ready-to-eat meat and poultry products, but not for 
establishments that produce raw products. However, this decision would 
leave the public without adequate protection from pathogenic 
microorganisms clearly associated with product marketed in raw form. 
Very little reduction in the most frequent causes of foodborne illness 
(factor two) could be anticipated from this approach.
    Government inspection costs would continue to increase to provide 
traditional resource-intensive inspection for slaughtering and allied 
processing establishments that would not be subject to mandatory HACCP. 
Since most of the unsolved problems with pathogenic microorganisms are 
associated with raw product and not with those products that would be 
the subject of this HACCP option, this is an especially inappropriate 
regulatory approach.
Modified HACCP--Recording Deviations and Responses Only
    A final alternative considered would be to mandate HACCP, modified 
to eliminate the record keeping burden to the inspected industry, 
especially small establishments. Specifically, this option would modify 
the HACCP record-keeping principles so that instead of demanding 
continuous records at critical control points, companies would need to 
record only deviations from critical limits and the response to them. 
This would mean that HACCP-controlled operations would not generate 
continuous monitoring data to reflect the operation at critical control 
points, but would only record data when deviations occurred. This 
arrangement eliminates the continuous picture of establishment 
operations which is the underpinning of factor three--make inspection 
more effective.
    Such an approach would substantially reduce the paperwork burdens 
associated with mandatory HACCP as recommended by NACMCF and recognized 
by CODEX. However, it would also seriously compromise the usefulness of 
HACCP as a means to make inspection more effective and avoid program 
cost increases. Regulatory officials need to have a system which can be 
reviewed in its entirety, so that a comprehensive picture of the 
process is available, not just the truncated version which grows out of 
recording deviations.

E. Comments on Analysis of Regulatory Alternatives

    There were several general comments related to either the 
alternatives discussed in the proposed rule or the level of analysis 
conducted. There were comments noting that FSIS did not quantify the 
costs and benefits of the regulatory alternatives. Similar comments 
suggested that FSIS should have determined cost-benefit ratios for the 
processed food industry or for ready-to-eat products or for small 
businesses.
    Generating quantitative benefit estimates for different types of 
products or different industry sectors would be very difficult. The 
estimates for foodborne illness attributable to meat and poultry have 
not been broken down by industry sector or type of product. There are 
no existing estimates for the portion of foodborne illness attributable 
to meat versus poultry or raw product versus cooked or partially cooked 
product.
    Production volume can not be used as an indicator of potential 
benefits. Foodborne illness is not proportionally related to production 
volume because pathogen levels vary significantly by type of product. 
As noted above, a commenter also pointed out that just because small 
businesses account for only 2 percent of production does not mean that 
small businesses account for only 2 percent of foodborne illness.
    On the cost side, the estimates are, for the most part, based on 
industry averages. In reality, costs will vary by industry sector based 
on the hazards presented and the existing presence of process control. 
Thus, in response to a comment that suggests that few benefits are 
available from changing the process for the manufacture of processed 
foods which are now produced under a zero pathogen standard, the 
Department would suggest that the costs for implementing HACCP for 
these products will also be low. Many ready-to-eat products such as 
cooked patties and roast beef are presently produced under 
comprehensive process control regulations.
    One comment suggested that FSIS consider mandatory HACCP for only 
firms that produce raw meat and poultry products because that sector of 
the industry generates most of the problems

[[Page 38955]]

and would provide the greatest pathogen reduction benefits per dollar 
of cost expended. The same commenter found it odd that the Agency did 
include an alternative for mandatory HACCP for only ready-to-eat 
products after acknowledging that most of the unsolved problems with 
pathogenic microorganisms are associated with raw meat and poultry 
products, rather than ready-to-eat products. In the above discussion of 
regulatory alternatives, it was noted that mandatory HACCP for only 
ready-to-eat products is an especially inappropriate regulatory 
approach. In contrast, a raw product option appears attractive since 
most of the unsolved problems with pathogenic microorganisms are 
associated with raw product. Most establishments handle raw product 
ingredients or prepare a finished raw product. Most of the cost of this 
rule is associated with controlling the safety hazards of raw product 
production. Extending the rule to cover all production adds little cost 
while allowing a single inspection approach, avoiding confusion where 
raw product production ends and ready-to-eat production begins, and 
assuring that the potential hazard of recontaminating ready-to-eat 
product by contact with raw ingredients is always covered by 
comprehensive HACCP programs.
    Other comments noted that FSIS did not analyze an option that 
accounted for the savings associated with streamlining and modernizing 
the inspection system or that FSIS should revise the cost-benefit 
analysis to consider the savings from eliminating the current 
inspection program. The savings referred to will be used to focus on 
food safety risks that need more coverage.

III. Summary of Impacts

A. Introduction

    This section provides a summary of the costs and benefits that will 
be discussed in detail in Sections IV and V. The benefits analysis in 
Section IV and this summary discuss benefits in terms of the reduction 
in the cost of foodborne illness that results from reductions in 
pathogen levels. There are other public health benefits beyond the 
reduction of foodborne illness due to pathogenic bacteria. HACCP 
systems will also provide increased public protection from risks posed 
by chemical and physical hazards. There are also benefits beyond public 
health benefits. As discussed in Section I, the SOP and HACCP 
requirements have social benefits that derive from the capacity to 
reallocate inspection resources to other activities where the payoff in 
terms of reducing the risk of foodborne illness may be greater.
    The February 1995 proposal and the subsequent public comment 
recognized that the HACCP/Pathogen Reduction regulations would also 
generate benefits for meat and poultry processors. For example, a 
commenter at a public hearing provided confirmation that the insurance 
industry is aware of HACCP and has offered reduced liability insurance 
for firms with improved food safety controls. Other comments noted that 
improved production efficiency has always been associated with improved 
process control. Increased customer confidence can also be a benefit to 
the extent that it has a positive influence on demand.
    The benefits analysis in the preliminary RIA noted that benefits 
also accrue through the reduction of operating costs like the cost of 
product recalls or the cost of settling product liability claims. Other 
operating costs include the loss of establishment production due to 
suspensions for sanitation problems that could be reduced by improved 
process control, premiums for product liability insurance, loss of 
product reputation, and reduced demand when a foodborne illness 
outbreak is publicized identifying a product or company.
    The cost analysis in Section V addresses two types of costs 
associated with this rule. There are the predictable costs associated 
with requirements directing all establishments or a specific category 
of establishments to take a well-defined action. Examples include the 
requirements to develop SOP's and HACCP plans or the requirement to 
have access to a HACCP-trained individual. This final RIA provides 
point estimates for all predictable costs. There are also potential 
costs that may impact some establishments because of current 
establishment-specific situations. This analysis provides a range of 
potential costs developed from two different scenarios of possible 
establishment responses to new pathogen standards.
    This summary compares both types of costs with the potential public 
health benefits related to pathogen reduction, recognizing that there 
are other potential benefits. The discussion in Section V notes how 
this rule will set new requirements and also improve compliance with 
existing requirements. Some of the potential costs discussed in Section 
V are costs associated with improved compliance with existing standards 
and should not necessarily be considered costs of this rulemaking.
    Public comments demonstrate that the controversy in this rulemaking 
derives not from the benefit cost ratio itself, which is very 
favorable, but from the fact that the processors will bear most of the 
costs while the public, in general, will experience the benefits. The 
public includes both the consumers of meat and poultry and those who do 
not consume meat or poultry but who bear the costs of illness in the 
society. Another area of controversy arises from the lack of proof that 
the estimated benefits will result from the promulgation of the rule. 
These doubts are particularly troublesome to those who would have to 
make resource investments under the rule while benefits largely accrue 
to others. This is, of course, the standard controversy facing 
government regulators. The essence of government regulation is that 
there is a situation where the public undergoes unacceptable risk 
because the current distribution of costs and benefits is unlikely to 
change without government intervention. This rule represents the 
Department's belief that the food safety risks being borne by the 
public are unacceptable, that they can be reduced through the use of 
readily available current technologies, and that the uncertainties 
involved in just how much risks can be reduced should not prevent the 
Department from making its best effort to reduce the risks.

B. Net Benefit Analysis

    Because costs and benefits accrue at different rates over different 
time periods, to compare costs and benefits it is necessary to examine 
present value estimates for both cost and benefit streams. To make 
these comparisons, both the preliminary analysis and this final RIA use 
a 20-year time period. The present values for costs and benefits are 
based on a discount rate of 7 percent, the current standard recommended 
by the Office of Management and Budget.
    As discussed above, the cost analysis (Section V) addresses two 
types of costs. FSIS was able to develop point estimates for the direct 
costs of complying with the requirements outlined in the rule that all 
establishments must meet. These predictable costs include the costs of 
developing and operating HACCP plans and SOP's and the costs of 
required recordkeeping. There are also potential costs for 
establishments that may have to purchase new equipment, or modify their 
production practices to meet the pathogen reduction performance 
standards for Salmonella, or actually implement Salmonella testing 
programs to assure compliance with the new standards. The cost analysis 
develops a range of cost estimates for these potential costs.


[[Continued on page 38956]]