[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