[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]]