5.6 Equipment Monitoring

The use of temperature monitoring devices should be required
during refrigerated storage of these temperature-sensitive
products. Instruments used for monitoring should also be
capable of recording temperatures. These records should be
maintained, The temperature recording devices should be made of
materials other than glass since glass is easily broken. Glass
thermometers may, however, be used for calibration.
Additionally, calibrations should be performed at regular
intervals using certified thermometers.

5.7 Regulatory Inspection and Review

Processors must have, and maintain on file, a verified HAccP
plan prior to production and marketing. Further, the HACCP plan
must be sufficient to assure that the processing procedures
outlined in the plan are sufficient to control microbial
pathogens. In the case of these products, a demonstrated
control of ¢. botulinum, L. monocytogenes, and Salmonella spp.
would normally be sufficient to control the presence of the
other pathogens of concern. Both C. botulinum and |.
monocytogenes have been classified by the International
Commission on Microbiological Specifications for Foods (ICMSF)
as severe direct health hazards. (See: ICMSF (International
Commission on Microbiological Specifications for Foods) 1986.
ie] »_Sam Li o: Obio. ical
A i 2 d_ Speci ic Ss. Univ. of
Toronto Press. Buffalo, NY). For molicato in this
classification, no practical sampling plans can be devised that
would be sufficient to quarantee consumer safety. The optimal
way to control the occurrence of these organisms is through
process control such as that provided through a HACCP system.

Verification procedures are needed to ensure that the HACCP
system is operating correctly (See: HACCP, sec. 4.7). Such
procedures should be product and/or process specific and should
be a part of the approved HACCP plan to assist in assuring a
safe product. Microbiological testing and criteria have
limitations in a HACCP system but can be valuable-as a means of
establishing and verifying the effectiveness of CCP’s. The
frequency of microbiological testing should be based on the
regulatory compliance history of the product and/or process.
Evidence of a problem may require the utilization of a different
process, Since the sensitivity of microbiological tests and the
anticipated low prevalence of pathogens will greatly influence
the results of verification testing, negative results obtained
with a sample lot must be interpreted with care.

Specific tests for individual pathogens and/or indicator
organisms may be appropriate but will be product or process
specific. Routine analysis of product for total bacterial count
or indicator organisms that grow at refrigeration temperature
are inappropriate at retail level. Regulatory agencies,

15


Table 1, (1) Summary of D-Values and Regression Statistics for
Survivor Curve of Listeria monocytogenes Scott A

APPENDIX D

in Lean and Fatty Ground Beef

Temp. Meat Culture Correlation Slope Y-intercept D-value
°F _Type Media Coefficent. Log_ CFU/g Min.
125 Lean CBNA -.9427 -0.7382- 5.5354 81.3
125 Fatty CBNA ~.9792 ~0.8438 5.9994 71.1
135 Lean CBNA =.9667 0.3852 8.2370 2.6
135 Patty CBNA -.9197 71.1735' 5.6143 5.8
145 Lean CBNA ~.8859 “1.7303 4.2014 0.6
145 Fatty CBNA =.6232 “0.8226 3.1168 1.2

1 table derived from: Fain, Alfred R., et. al.,

to Listeria monocytogenes Scott A D-value and Z-value Determinations
in Ground Beef and Turkey, ABC Research 1989, Publication in review.

Lethality of Heat


REHYDRATING - CCP No. 3

The process for rehydrating the gravy for this example will
involve adding a dry gravy mix to water in a tank with a mixer.
When rehydration is complete, ice is added to chill the gravy to
40°F or below and obtain the correct final water-to-gravy ratio.
This rehydration process would normally be of short duration and
may involve multiple production lots during the day. The
temperature of the water used for rehydration will influence the
quantity of ice that must be added. The reason for chilling the
gravy is to restrict microbial growth after rehydration. Also,
the gravy equipment will be in use throughout the production
day. The colder temperature will limit microbial growth which
might occur in the equipment as subsequent lots of gravy are
produced. The operation instructions will require that all
unused gravy be discarded at the end of the production day.

Conditions--Upon completing the rehydration process the gravy
must be at <40°F.

Verification--The accuracy of the thermometer must be checked.
The possibility of microbial growth in the equipment and with
sequential lots of gravy should be investigated. The fact that
this does not occur or cause concern can be verified by testing
each lot of gravy throughout the production day. The frequency
with which such verification is needed will depend upon
experience and the accumulated data with the specific process
and equipment in this production plant.

PASTEURIZATION ~ CCP No. 4

After the turkey roll has been sliced, placed into a pouch, and
the gravy added, the pouches ara then vacuum sealed. Since this
product has been sliced, thus causing. contamination, the
pasteurization process must be designed to destroy the
contaminating flora in the product at the center of the

package. If the product had been cut into chunks, contamination
would have been on the surface as opposed to the center. ‘The
process for this example involves combining sliced turkey and
gravy, both of which have temperatures of 40°F or below. The
product is not subjected to conditions which result in product
temperatures below a certain minimum temperature. For the
purposes of this example, the minimum will be 32°F at the time
of pasteurization. The pasteurization process will be based
upon heating a packaged product from 32° to 40°F to a specified
higher minimum internal temperature for pasteurization. This
process must assure the destruction of nonsporeforming
contaminants such as Ll. monocytogenes which might occur during
chilling, slicing and filling the pouches. Furthermore, the
rehydrated gravy will contain a mixed microbial flora. The
gravy will be purchased with a microbiological specification for
total plate count (2 days/35°C with Spc agar). The acceptable


7. Heating of Products. Traditional techniques for thermal
death time studies should be used to verify the decimal
reduction times decided as appropriate for the product. The
Committee suggests a 4D reduction as the minimum process for
meat and poultry products.

The product should be heated using the desired time/temperature
relationship. Triplicate zero time and heated samples should be
examined microbiologically using the procedures described in
Section 8 to determine log reductions. A minimum of two such
trials are recommended.

8. Determination of D and % Values in the Laboratory. A single
method is recommended for determining the effectiveness of
Listeria control procedures. This mathod is outlined below:

This procedure involves the actual determination of D and Z
values at specific temperatures in individual products. For
this procedure, the product must be thorgughly mixed with an
inoculum containing approximately 1 x 10° per ml. of the L.
monocytogenes suspension. One gram: portionés*can be added to
each of the! stérile thermal.death tim “(TDT) ‘tubes. The tubes
are sealad(with'a flame, and placed it ‘baskets’ for ease and
speed.of handling: Tine/temperaturedata should be monitored
with thermocouplés for both product and tha heating medium, The
TPT tubes must be completely ‘submerged during the heating
process. Appropriate time intervals should be selected at 125°,
135°, and 145° since preliminary data for y. monocytogenes
indicate: Djog-p = 90.1 - 96.2 minutes, Dy35-p = 2.60 ~ 6.63
minutes. Da4s°r = 0.58 - 1.22 minutes, and ‘} value of 9.0 to
-B°F.

Come up times should be recorded and zero time is indicated as
the time when triplicate temperature monitoring tubes reach the
test temperature. Triplicate product tubes should be removed at
each time interval and immediately transferred to an ice’ bath
until analyzed. After cooling, the TDT contents should be
transferred to sterile 0.1% peptone diluent and thoroughly
mixed. Appropriate dilutions should he prepared and surface
plated on either TPA or LPM (See section 9). At least duplicate
runs should be performed. D and Z values in minutes can be
determined from the survivor curve as described in the
Laboratory Manual for Food Canners and Processors, Volume 1.,
National Canners Association, (1968).

Literature and company data file searches can be conducted to
list D values and Z values for L. monocytogenes in various major
product. classes so that data for integrated lethality may be
established. As an alternative to inoculated pack studies,
processors may use an integrated lethality procedure using an
approved process authority.

Methods demonstrated to give comparable results should be
considered.


4.0 Processing and Packaging
4.1 Process Types

“Refrigerated foods containing cooked, uncured meat
or poultry products that are packaged for extended
refrigerated shelf life and that are ready-to-eat or
prepared with little or no additional heat treatment."

These processes may be categorized into at least nine types.

The Committee recognizes that individual manufacturers may
employ variant procedures, however, the following examples are
outlined to provide a basic understanding of the manner in which
these processes are utilized.

Type 1.

Example--sous vide .
Raw ingredients --- Pre-cook (optional) --~ Formulate ---
Vacuum package --= Pasteurize --- Chill* --- Distribute

Examples: rolls and roasts
Raw ingredients <== Formulate --~ Vacuum package --- . Cook
we- Chill* --= Distribute . .

Examples: roast or fried chicken, other roasts, and
uncured sausages.
Raw ingredients --- Cook <-=<=. Chill* <=<= Package ---
Distribute ,

Examples: Some uncured luncheon meats and diced meats,

Raw ingredients --- Formulate --- Cook --- cChill* ---
Slice or dice --- Package --- Distribute
Type 5.

Examples: Meat and pasta, meat and sauces, dinners,
. sandwiches, pizza
Raw ingredients wee Cook <== Chill* --- Assemble --~
Package -~- Distribute

Type 6.
Examples: Chef salad, chicken salad, and sandwiches
or pizza with raw ingredients.
Raw ingredients <== cChill* -=<=— Formulate --=- Recook and
chill (optional) --- Package --- Distribute

Type 7.

Examples: Meat pies, quiches, patties, and pates
Raw ingredients --~ Formulate --- Cook (optional) --=-
Fill into dough --- Cook (optional) --- cChill* ---

Package -=- Distribute
9


10 Principles

id) the public:
(ce) regulatory personnel:
(2) persons who conduct HACCP evaluations,

The level of knowledge required by persons in these groups varies
with the role they play in the overalt process. The minimum
information required by individuals in these groups is listed in Tables
§.1-8.6. The systematic appheation of this information is the corner-
stone of the HACCP system

8.2 Producers

Table 8.1 shows the information basic to controlling of minimizing
microbial: hazards at the. producer level. It must begin with sound
animal husbandry and horticultural practices. It requires a knowledge
of the sources of microorganisms as these relate to animal diseases and
to food spoilage. It requires an appreciation that pathogens can be
carried by growing plants and animals. ‘consequently leading to the
harvested plant and slaughtered animal being potential sources of
infection to man. The need for proper’ cleaning and temperature
control is of pnme importance. The type of knowledge required by
fishermen is somewhat different from tnose in other agricultural
businesses. as is shown in Table 8.1.

8.3 Processors and food service personnel

The food processing segment of the industry includes line operators.
quality control (QC) personnel and management. Each of these
subgroups requires qualitatively and quantitatively different knowledge
10 be effective in minimizing micrubial hazards. The requirements are
shown in Tabie §.2.

Line operators are the persunnel who are directly responsible for
food processing. preparation and storage. They are concerned with a
segment of a sequence of operations that leads from raw material 10
finished product. As indicated in Table 8.2, part A, these persons
should have a knowledge of the microbiological hazards associated
with that phase of the operation for which they are responsible. In
some cases the microbiological implications may be broad, ¢.g. the
hand-boning of cooked poultry, *hereas in others they may be trivial
or even absent (c.g. the check-weighing of finished packaged product
units). Thus the extent of knowledge required will vary accordingly.

The QC personnel have much wider technical responsibility than


of sampling, but if this is not possible, samples should he
homogenized or extracted in 0.05 M sodium phosphate-gel buffer
(pH 6.2), sedimented by centrifugation. (27,000 x g, 20 min,
4°C), and the supernatant fluids (at least 10 ml; adjusted to pH
6.2, if necessary) stored at ~20°C.

An alternate procedure (such as an ELISA method) for the mouse
bioassay test may be used providing the alternate method has

been documented to be of equal or greater sensitivity than the
mouse bioassay. .

I, Product Analyses :

In addition to botulinal toxin testing and C. botulinum spore
enumeration, the product (duplicate samples) at "9"-time should
be assayed for moisture, fat, pH, and aerobic plate count.
Depending on the type of product, other analyses (such as
protein, salt content, water activity, titratable acidity,
nitrite content, sorbate content, psychrotroph count, spore
count, lactic acid bacteria count, anaerobe count) also should
_be done. If the product is packaged under modified atmosphere
conditions, gas analysis should be done at the initial sampling
time. Visual appearance (including gas formation (puffiness of
samples]) and odor of samples should be determined and recorded
at each sampling time to indicated degree of spoilage.


134 Principles

Table §.4 Basic knowledge required by the public

‘The public should know:

© The cause and effect relationship of individual actions on food safety and spoilage

* Practical measures to ensure the safety of the foods they prepare. process or store

© Proper processing and home preservation methods (¢.g. home canning of foods,
fermentation) and the consequences of using improper procedures

‘© That improper food hoiding practices. such as leaving foods in ovens at low
temperarures or at room tempararires or placing large containers of unchilled
foods in refrigerators, will allow bacteria to multiply to high numbers.

© The hearing procedures necessary to kill vegetagive forms of pathogens in raw
foods of anual origin and left-over chilled foods

© That raw foods (#.g, meat. pauitry, fish. shell eggs) carry pathogens when they:
enter kitchens .

© That by handling raw foods, mictobes can pass to hands and then to other foods

© That clothes, sponges and brushes used to clean food preparation surfaces can:
‘transfer microbes from raw foods co equipment and surfaces that will be used for
cooked foods

© That cooked foods shouid not pass over the same surfaces or through equipment

that have beet in contact with raw foods unless chose, surfaces have been properly
loaned .

industry, the understanding that microbes cause both disease and
spoilage is paramount. Knowing the potential sources of microbes (e.g.
taw ingredients, persons who load and unload the carrier, animals and
products previously hauied, vermin, unclean vehicles, bins) and
understanding the beneficial effects of temperature control and proper
cleaning and disinfection are essential to maintaining control of the
operation.

8.5. The public

As noted above, the number of food-related disease incidents could be
significantly reduced if the public were better informed about proper
handling of food. The core elements of the knowledge that all persons
should have are shown in Table 8.4. The most fundamental concept is
that raw food materials harbour microbes that will spoil it in time
unless it is frozen or processed (cooked) before the spoilage occurs.
They must be aware that certain raw foods (primarily those of animal
origin) are likely to be contaminated with disease-producing micro-
organisms. They must be aware of the measures for control of
pathogens in raw foods, in particular those of animal origin. As noted


For foods that are fluid or that can be prepared with spores
uniformly distributed throughout, a minimum inoculum level of 50
to 100 spores per gram is recommended. No more than 5000 spores
per gram should be used.

For foods that require surface inoculation and in which spores
cannot be uniformly distributed throughout, a minimum inoculum
level of 100 to 1000 spores per square centimeter surface area
is recommended.

The inoculum level may be adjusted for particular products
depending on the spore load that may be expected under worst
case conditions.

D. Methods of Inoculation

Spores should be heat shocked either immediately before
inoculation (proteolytic types, 30°C, 10 minutes; nonproteolytic
types, 60°C, 10 minutes) or as part of the process the food will
receiva after ifioculation (e.g., process cheese may be heated at
82°C before ging) . -

ting’ spores may vaty’ depending on the

prodict en: iid: may 'be applied without’ substantially.”
disrupting'’the/ properties! of thé food, ‘spore’ suspensions’ in
sterila distilled-water may be added to the product and mixed in
for uniform distribution. Large solid products may be surface
inoculated by dropwise (up to 0.1 ml per drop) addition of
inoculum that is spread out in a thin layer using sterile
utensils (@.g., sterile gloves or best glass rods).

For products that possess inhibitory properties attributed to
water activity, ‘salt content, or some other factor that may he
affected by dilution if water is added, then the inoculum should
be applied via a suitable dry, sterile carrier (such as sand) or
in a homogenate of the particular food (adjusting the :
formulation of the food to compensate for the added water). For
gome products, a point inoculation technique may be used.

Spores should be inoculated into the most permissive area of the
food (such as meat chunks that may have a higher pH than
surrounding sauce).

E. Packaging of Product

For products that are packaged under special conditions such as
controlled or modified atmospheres, an inoculation scheme should
be used which duplicates the condition of the product as it is
normally packaged. Such products should be inoculated in a
manner that does not affect the normal course of changes within
the package relative to the gas mixture. Alternative packaging
may be used provided conditions within the package approximate
the conditions within commercially packaged product.

4


1, Ability to maintain adequate facilities to ensure the
temperature of the product at 40°F or less and establish
procedures and documentation to assure temperature maintenance.

2. Program to monitor "sell by" or "use by" dates and
procedures whereby products exceeding those dates are removed
from retail sale.

3. Assignment of a permanent full-time employee, preferably an
assistant manager or other management representative, who is
responsible for assuring product handling.

5.10 Imported and Exported Products

1. The Committee recommends that imported products and products
for export be produced according to the requirements of
federally inspected plants.

2. The Committee also recommends that, where appropriate,
sampling plans be based on the recommendations and lot
acceptance criteria of ICMSF.

5.12 Labeling

Evidence suggests that consumers have difficulty distinguishing
the differences between various food label instructions and
their relationship to product safety. For that reason, and
because of the greater temperature sensitivity of these
products, the Committee recommends that retail and consumer
packages carry a uniform standardized label statement and
corresponding lago. More specifically, it is recommended that
the following label be used on packaged foods that pose a safety
hazard when subject to temperature abuse.

* IMPORTANT *
MUST BE KEPT
REFRIGERATED

For products shipped frozen, the shipping carton should be
labeled~-"KEEP FROZEN,"

As is the case with uniform labeling and logo systems, time/
temperature integrators (TTIs) can provide retailers and
consumers with additional information regarding product storage
and handling. TTIs appear to be a means whereby potentially
unsafe food could be easily recognized and disposed of before
consumption.

19


Table 2.(2) Recommended Minimum Processing Times at
Specified Temperatures

Temperature Time in Temperature Time in
“F Minutes °F Minutes
125 244. 143 6.18
126 199. 144 5.04
127 162. 145 | 4.11
128 132. 146 3.35
129 109. 147 2.73
130 87.8 . 148 2,23
131 71.6 149 1.82
132 58.4 150 1.48
133 47.6 : 151 1.21
134 38.8 152 0.98
135 31.6 153 0.80
136 25.8 154 0.65
137 21.0 155 0.53
138 17.2 156 0.44
139 14.0 157 0.36
140 11.4 . 158 0.29
141 » 9.30 159 0.24
142 7.58 | 160 0.19

(2) Derived from values in Table 1, 4-D value calculated.


Dr. James Jay

Professor

Dept. of Biological Sciences
Wayne State University

Dr. John Kvenberg

Program Manager

Foodborne Biological Hazards
FDA

Dr. Ranzell Nickelson, II

President . :

Applied Microbiological
Service, Inc.

Dr. Merle D. Pierson

Head, Dept. of Food Science
and Technology

Virginia Polytechnic Institute
and State University

Dr. Martha Rhodes

Assistant Commissioner

Florida~Department of Agriculture
and Consumer Services

iv

Dr. Durwood B. Rowley

Biological Sciences Division

U.S. Army-Natick Research
Development and Engineering
Center

Dr. R. B. Sleeth

Vice President

Research and Technical Services
Armour Foods

Dr. David M. Theno, Jr.
Director, Technical Services
Foster Farms

Dr. Bruce Tompkin

Chief Microbiologist and

Director, Basic Science
Swift-Eckrich, Inc.

* pe. Michael Wehr

Administrator
Laboratory Services Division

- Oregon Department of

Agriculture


STORING, DISTRIBUTING, DISPLAYING - CCP No. 6

Conditions Monitoring Verification
1) Temperature la) Temperature la) Cheek accuracy
S40°F sensor
2) Safe shelf life 2a) Calendar and 2a) Accelerated
printed "Use By" shelf life

dates incubation test

2b) Rotation
schedule

The conditions necessary to control each CCP are noted along
with how the step in the process is to be monitored. Procedures
for verifying control are also provided. A more detailed
discussion of the six CCPs follows:

COOKING ~ CCP No. 1

In this example the stuffed turkey breast meat is placed onto
racks for’ cooking in a tank of water.

Conditions--The required USDA minimum internal temperature of
160°F provides a substantial margin of safety for destroying
nonsporeforming pathogens. The product is relatively large in
diameter and requires a long period of time for heating and
chilling at temperatures which are lethal to vegetative cells.
To assure uniform compliance with meeting the product
temperature requirement and assure safety, it is necessary to
control the thickness of the product and the uniformity of the
heat distribution within the cook tank.

Monitering--The temperature of the water is monitored. The
minimum internal temperature of the product is monitored by a
temperature sensor placed at the center of a turkey roll, The
temperature measurement can be either continuously measured and
recorded or the product can be checked with a thermometer to
assure compliance before the chilling process is begun. Water
circulation or agitation to assure uniform heating can be
monitored visually.

Verification--Temperature sensors should be periodically checked
for accuracy. Heat distribution should be tested using multiple
temperature sensors placed throughout the cook tank. The
frequency of verification depends upon experience with the
equipment.


including state and local governments, must assure that the
HACCP plan addresses appropriate verification procedures,
including microbiological tests and criteria, if appropriate,
throughout the processing, distribution and retail sale process,

In instances where the product or process significantly varies
from known systems, or for which there is a Limited historical
record, we would encourage the reviewer to seek validation and
verification data from the producer to assure that the product
is safe.

5.8 Production Guidelines for Nonfederally
Inspected Establishments

5.8.1 Introduction

The Committee recognizes that the preparation and handling of
fresh prepared refrigerated foods containing uncured meat and
poultry by institutional food service and retail establishments
can increase the potential food safety problems associated with
these products. Specific concerns relate to:

1. he ability of the producer to control ¢. botulinum where no
barrier-to its outgrowth exists, and

2. The manufacturer’s knowledge of microbiological control,
microbiological sensitivity of these products, quality control,
and HACCP systems, and the processing capability and equipment
needed to produce these products under good manufacturing
practices.

The ability of establishments to assure product safety will
differ depending upon the type of operation. Although size is
not necessarily a governing factor, it would be expected that
larger astablishments are better able to provide the resources
needed to assure product safety.

5.8.2 Unlimited Production

It is recommended that size of the establishment not be the
determining factor in allowing the production of these
products. Rather, the determining factor should be the
application of microbiological control procedures that assure
product safety, It is recommended that unlimited production
be extended to any institutional, retail, food service, or
similar establishment that can provide demonstrated assurances
to the appropriate regulatory authority that the manufacturing
is adequate to control C. botulinum, L. monocytogenes, and
Salmonella spp. In addition to a HACCP system, the
establishment must have a verifiable control plan that includes:

16


Cooling Requirements

- Guidelines for refrigerated storage 40°F
temperature and internal temperature (4.4°C)
control point.

- Recommended refrigerated storage 35°F
temperature for periods exceeding (1.7°¢)
one week (FSIS Directive 7110.3)

- Cooling procedures require that the
product’s internal temperature not
remain between 130°F (54.4°C) and
80°F (26.7°C) for more than 1.5 hrs.
nor between 80°F (26.7°C) and 40°F
(4.4°C) for more than 5 hrs. (FSIS
Directive 7110.3)

> Cooling procedures for products consisting
of intact muscle (e.g., roast beef) require
that chilling be initiated within 90 min. of
the cooking cycle. Product shall be chilled
from 120°F. (48°C.) to 55°F. (12.7°C.) in not
more than 6 hrs. Chilling shall continue and
the product shall not be packed for shipment
until it has reached 40°F, (4.4°C.).
(9 CFR 318.17)

~ Roast beef for export to the United Kingdom
must be chilled to 68°F, (20°C.) or less
within 5 hrs. after leaving the cooker and
to 46°F. (7°C.) or less within the following
3 hrs.


7. Procedures and requirements for manufacturer use and/or sale
of these products must be reviewed and approved by the
regulatory authority licensing the establishment for food
handling.

8. The manufacturer or owner shall certify that the individual
responsible for the processing and vacuum packaging operation is
knowledgeable and has been trained in the monitoring and control
of critical points in the processing and vacuum packaging
operation, as well as all other parts of the control program.
The individual responsible shall supervise all processing and
vacuum packaging.

5.8.3 Limited Production

Establishments not able to satisfy the requirements outlined in
5.8.2 for control of ¢. botulinum other than through the use of
secondary barriers shall be limited to the production of
products that have:

1. An a, of < than 0.93;
2. A pH of 4.6 or less; or

3. Been otherwise formulated to prevent the outgrowth of c.
botulinum as determined by the regulatory authority licensing
the establishment for food handling. .

Additionally, the establishment shall utilize a HACCP based
control plan to ensure compliance with the critical limits that
have been established for botulinal control. :

5.8.4 Excluded from Production

Failure of the establishment to meet all of the requirements
outlined for unrestricted production or for limited production
will preclude the operation from manufacturing products within
this class,

It is the intent of these recommendations to prohibit
institutional, food service, and retail establishments from
producing these microbiologically sensitive products unless
adequate facilities, personnel, and quality control programs
exist to consistently ensure microbiological safety.

5.9 Distributors and Retailers

Because of the temperature sensitivity of these products, we
recommend that distribution and retail sale also be restricted
to only those firms that meet the following conditions:

18


CHILLING - CCP No. 2

After the product reaches 160°F, the hot water is drained and
replaced with fresh water to begin the chilling process. After
the temperature has been reduced to about 70°F the product is
removed from the water and transferred to a cooler to complete
the final chilling process. Chilling is essential to restrict
the outgrowth of spores which may be present, as well as to
reach an optimal temperature for proper slicing. The time
required for chilling the product must be controlled.

The most critical phase is when’ the product temperature
decreases from about 125°F to below 70°F. This is the
temperature range in which the outgrowth of sporeformers is of
greatest concern,

The use of tap water for chilling influences the initial phase
of the chilling process. Depending upon the source of water,
the geographical location of the plant, and the season of the
year, the temperature of the tap water may vary from 40° to
85°F. The water should be agitated in the tank. Also, fresh
water should be continuously added so there is a continuous
overflow. Obviously, the water temperature will influence when
the product is transferred to the cooler to complete the
chilling process. Some other options which can be used to
facilitate cooling include the addition of ice to the chill
tank, using a recycled refrigerated brine solution or water, or
blast chilling with air.

Conditions--The internal product temperature should pass through
the temperature range of 125° to 70°F within 4 hours. :
Subsequent chilling to 40°F should occur within an additional 16
hours. The transfer from the chill tank to the holding cooler
should occur in a timely manner to assure the chilling process
is continuous and complete. The water in the tank should be
agitated and continuously replaced with fresh water so there is
an overflow. The holding cooler must be set for less than

40°F. The ambient air temperature may increase during the
production day as warm product is placed into the cooler.
However, the refrigeration capacity in the cooler must he
adequate to assure complete chilling of the product within the
specified time limit. :

Monitoring--The temperature of the product must be monitored to
assure the temperature requirements are met within the time
specified. The water should be observed to confirm that it is
being properly agitated and is overflowing. The holding cooler
temperature must be checked.

Verification--The temperature sensors must be checked to verify
their accuracy. The uniformity of the chilling process must be
checked by testing the internal temperature of product in
various lecations within the tank.


Listeria monocytogenes is one of the most heat resistant
vegetative bacterial pathogens known. Initial loads of L.
monocytogenes of around 100/g may be possible; therefore,
thermal processes should be designed to kill a minimum of 104

L. monocytogenes per gram.

A guideline for evaluating the efficacy of a thermal process for
killing Ll. monocytogenes is provided in Appendix E.

Similarly, it is incumbent upon the processor to verify that
production of botulinal toxin in these -products can be
controlled from the time of production to consumption. In the
absence of adequate scientific evidence documenting the safety
of the product, appropriate challenge studies with ¢. botulinum
should be conducted. Because both proteolytic and
nonproteolytic C. botulinum have been associated with meat and
poultry, both types of this organism must be controlled.
Secondary barriers such as salt, water activity, and approved
preservatives, may serve as an effective alternative to full
thermal processing. A guideline for determining the potential
for ¢. botulinum toxin in refrigerated foods is provided in
Appendix F. The procedures in Appendix F are intended to serve
only as guidelines and may not be suitable for all types of
refrigerated foods; other, protocols that provide assurance ‘o
safety are also acceptable. .

If the product supports the formation of botulinal toxin within
’ the timeframe described in the: attached guidelines or other
acceptable protocol, then the processor must either reformulate
the product to prevent botulinal toxin production or design a
strategy to assure that the consumer can identify that a product
has been temperature abused before the point that botulinal
toxin may be produced. If a time/temperature integrator is to
be used, studies must be done to correlate safety with
temperature abuse and the response of the integrator.

5.3 Process Categories

With respect to individual process categories, it is recommended
that special attention be given to the following points in the
development and review of the producer’s HACCP plan.

Ca ory 1. sembled and_¢coo oducts.

Even though a portion of the normal spoilage flora has been
eliminated by the heating process applied after packaging; the
heat treatment may be insufficient to destroy Cc. botulinum
spores. Consequently, the time/temperature control procedures
applied to these products must assure their ultimate safety.

13


2.0 Product Definition
The products addressed in this document are defined as:

Refrigerated foods containing cooked, uncured meat or
poultry products that are packaged for extended refrigerated
shelf life and that are ready-to-eat or prepared with

little or no additional heat treatment.

Of particular concern are those products that rely on
refrigeration as the primary barrier to the growth of microbial
pathogens or for those products not having some form of
secondary barriers, such as a water activity (a,) <0.93 or a

pH <4.6. Included are products containing cured meat or poultry
as an ingredient where the nitrite in the meat or poultry
ingredient is insufficient to protect the entire food product,
e.g., ham salad, beans and franks. Excluded are certain
perishable products for which there is extensive commercial
‘experience, the processes are well known, the products are under
regulatory control, and there is a favorable record of safety
(e.g., cooked beef and roast heef products--ineluding sectioned
and formed roasts, chunked and formed roasts, cooked poultry
rolls and similar comminuted products). This exclusion should
be reconsidered if a new process is used, there is evidence of
an increased public health risk, or if verification programs
indicate a failure to control and a need for corrective action.

This document'is further divided into sections addressing:
epidemiological and microbiological information, and the
processing and packaging of these products, Section 5 contains
recommendations relative to the production, packaging and
distribution of these products. Even though the principle -
targets are those products that fall primarily under FSIS
jurisdiction, a segment of the recommendations focuses on

those producers regulated by state and local authorities.
Recommendations regarding labeling, education, and research are
also included.

This document presents the recommendations of the Committee for
the manufacture and handling of prepared refrigerated products
containing uncured meat or poultry.


As outlined in this example, the process has six critical

control points (CCPs):

cooking, chilling, rehydrating,

pasteurizing, chilling, and storing-distributing-displaying.
Components of each of the CCPs are summarized in the following

tables.

COOKING ~ CCP No. 1

Conditions
1) Water and product
temperature. Cook
to 160°F internal
temperature

2) Uniform thickness

3) Uniform heat
distribution
din tank

- CHILLING ~ CCP No. 2

Conditions
1) Water and product
temperature. Tima to
reach <40°F,

2) Uniform chilling

Monitoring

1) Temperature
sensor

2) Visual check of
casing size at time
of stuffing

3) Observe that
water is being
agitated or
circulated during
heating

Monitoring

1) Clock,
temperature sensor

2) Observe that
water is being
agitated or
circulated during
chilling

Verification

1) Check accuracy
of temperature
sensor

3) Periodic check
of water tank by

multiple tempera-
ture sensors

Verification

1) Check accuracy
of temperature
sensor .

2) Periodic check
of water tank by
multiple tempera-
ture sensors


APPENDIX ¢

Examples for the Application of HACCP Principles
for the Production of Foods in Categories 1-2-3

The following example will provide further directions on how
HACCP can be used to assure the production of safe foods.

Figures 1-3 illustrate the process flows for the three product
categories under discussion.

Figure 1 outlines the steps in the production of a sous vide
product, sliced cooked turkey breast with gravy, which has been
vacuum sealed in a flexible plastic pouch and then given a final
heat treatment prior to distribution. In this example, raw
turkey breasts are trimmed, pumped with a solution containing
sodium chloride and sodium phosphate, the meat is then Placed
into a tumbler. After tumbling, the meat is stuffed into a
casing, placed onto racks, and moved to a cook oven where it is
heated to at least the minimum internal temperature required by
the USDA, (ise., 160°F.) After chilling the meat is sliced and

i to which gravy is then added, The ,product
ealed, heated, chilled, placed into cartons, and
. a for subsequent distribution.

Model Process Flow for Categories 1-3
Figure 1. Example: Cooked, sliced turkey breast with gravy,
vacuum packaged and then pasteurized
Raw turkey braast
trim, pump, tumble/massage

stuff into casing

GCP (1) cook

Dry gravy mix
SGR (2) chill

| COP (3) rehydrate
slice

fill into pouch
vacuum seal
GOP (4) pasteurize
GCP (5) chill

QGR (6) storage, distribution, retail


MISSION STATEMENT

The National Advisory Committee on Microbiological criteria
for Foods (Committee) is charged with providing advice and
recommendations that can be incorporated into food
protection programs to assure the microbiological safety of
foods provided consumers. For meat and poultry products,
this can best be achieved through the development of an
integrated product safety systems approach from slaughter
through processing to consumption. This approach involves
the application of Hazard Analysis Critical Control Point
(HACCP) principles, and includes microbiological risk
assessment, the judicious use of product sampling,
microbiological testing, and acceptance/rejection criteria,
for both domestic and imported product.


Executive Summary,

The first meeting of the National Advisory Committee for
Microbiological Criteria for Foods was held April 5-6, 1988,
bringing together scientific experts in the areas of
microbiology, epidemiology and food processing. The Committee
was divided into two working groups--meat and poultry, and
seafood. .

This document was drafted by the Meat and Poultry Working Group
and contains advice and recommendations for incorporation into
food protection programs responsible for assuring the
microbiological safety of foods. The primary focus being:

“Refrigerated foods containing cooked, uncured meat
or poultry products that are packaged for extended
refrigerated shelf life and that are ready-to-eat or
prepared with little or no additional heat treatment."

Even though this type of product is relatively new and
epidemiological data are lacking, the potential for microbial
contamination and recontamination were deemed sufficient to
warrant the preparation of these recommendations as a first
priority. The reasons for the heightened concern over these
products are related to the growth of foodborne pathogens at
refrigeration temperatures, toxin production from Clostridium
botulinum, and.other hazards associated with temperature abuse:

After a thorough review of the various product types falling
within this category, common characteristics of the products,
process flows and packaging systems, specific recommendations
were formulated. These recommendations would require that
producers operate under a verified Hazard Analysis Critical
Control Point program: Producers would be required to
demonstrate a process sufficient to achieve a minimum 4 log
reduction for Listeria monocytogenes and that toxin production
by nonproteolytic and proteolytic Clostridium botulinum,
including psychrotrophic species, is controlled. Additional
sections are included to address packaging systems,
distribution, refrigeration equipment, labeling, education and
research. .

This document also contains recommendations for the production
of these type products in nonfederally inspected establishments.
Rather than banning production for such operations, the document
outlines criteria that would need to be met by the producer
prior to manufacture. The regulatory authority licensing the
establishment would then determine whether to grant permission
for unlimited production, limited production, or to prohibit
production entirely.

The National Advisory Committee for Microbiological Criteria for
Foods adopted this document on January 31, 1990.


Category 2... Cooked and assembled, and Category 3. Assembled
with, cooked and raw ingredients.

Cooked ingredients must receive a heat treatment sufficient to
destroy nonsporeforming pathogens, ¢.g., L. monocytogenes. and
Salmonella. The lethal treatment required should take into
account a number of factors including the initial raw ingredient
quality and microbial load, distribution temperature of the
product, shelf life and final product use. Of particular
concern is that cooked products are not contaminated by
pathogens during assembly and packing. It is essential that raw
ingredients and the assembly process be controlled to prevent
recontamination by pathogens.

5.4 Packaging

Since the packaging systems for these products are important in
assuring safety, the producer’s HACCP system must ensure that:

1. Approved packaging materials are stored and handled in a
manner consistent with maintaining microbiological integrity.

2. Equipment sanitation programs, employee practices, and
product handling procedures must. minimize product contamination
during the packaging process. : .

3. Key factors such as product temperature, vacuum level,
modified atmosphere delivery systems, etc., must be monitored
and controlled.

4. |Packages must be clearly identified as to production lot
in the event of a process deviation.

5. The use of containers which have heen traditionally used for
the marketing of shelf stable foods is not recommended for these
keep refrigerated products until such time as appropriate
safeguards are in place to avoid consumer confusion and the risk
of temperature abuse. This concern centers on the possibility
that consumer misconception may lead to temperature abuse and a
botulism hazard. -

5.5 Product Distribution

As a result of the perishable nature and finite shelf life. of
fresh prepared refrigerated products, the manufacturer should
also be required to adequately address product distribution in
the HACCP plan. Monitoring and verification parameters
demonstrating temperature control during distribution must be
included. The manufacturer should also be required to include a
plan for handling and removing suspect, outdated, or failed
product.

14


Additionally, the changing American lifestyle has prompted
corresponding changes in the way meat and poultry products are
produced and marketed. The development of pasteurized, uncured
meat and poultry products in hermetically-sealed containers
designed for extended refrigerated storage is a specific
example. The microbial safety of these prepared refrigerated
foods. has been questioned because of pathogens capable of growth
at refrigeration temperatures and under conditions of
temperature abuse.

In light of the foregoing, and a review of epidemiological data
(including opportunities for contamination), processing
procedures, growth and survival capabilities, and susceptability
of probable consumers, the Committee has prepared its first
recommendations to address Prepared Refrigerated Food Products
Containing Cooked, Uncured Meat and Poultry.


The use of appropriate TTIs is recommended wherever feasible,
However, the Committee does not believe their use should be
mandated at the present time. Rather, it encourages tha further
development of these products.

5.12 Education and Training

Effective education and training programs could greatly reduce
the risks associated with the production, storage, distribution,
and handling of these temperature sensitive foods. Appendix G
(ICMSF (International Commission on Microbiological
Specifications for Foods) 1988. Microorganisms in Foods 4.
Chapter 8. ow Le: equi Pe: and the Public.
Blackwell Scientific Publications, London, England) provides a
guideline for educating consumers and personnel involved in
regulatory inspection, production, and distribution.

5.13 Research

The Committee recommends that additional resources be devoted to
research:

1. To determine the true incidence of disease related to the |
consumption of meat and poultry by funding active surveillance
programs that include microbiological, patient, and food data.
To establish on the basis of these’ data a baseline for
evaluating the effectiveness of various controls or
interventions, e.g., the implementation of the Ccommittee’s
recommendations. .

2. To determine microbiological criteria for each of these
products based on prevalence and survival studies of pathogens
and other microorganisms in modified atmosphere and under .
extended periods of refrigeration. To address organisms of
particular concern at this time, in priority order, e.g.,

L. monocytogenes, E. coli 0157:H7, Salmonella spp., and c.
botulinum.

3. To develop reliable, consumer-friendly, TYIs, or similar
indicators, specifically adapted to the extended refrigerated
product shelf life,

4. To determine fundamental microbiological data and improved
diagnostic approaches for those pathogens known or thought to
exist in the components or environmental conditions unique to
these products.

20


RECOMMENDATIONS
OF THE

NATIONAL ADVISORY COMMITTEE ON
MICROBLOLOGICAL CRITERIA FOR FOODS

FOR

REFRIGERATED FOODS CONTAINING COOKED, UNCURED MEAT
OR POULTRY PRODUCTS THAT ARE PACKAGED FOR EXTENDED
REFRIGERATED SHELF LIFE AND THAT ARE READY~TO-EAT
OR PREPARED WITH LITTLE OR NO ADDITIONAL HEAT TREATMENT
ADOPTED
JANUARY 31, 1990




3.3 Potential for Microbial Contamination/Recontamination

The products under consideration share one or more of the
following characteristics: (1) pre-cooked packaged products
intended to receive little or no additional heat treatment prior
to consumption, (2) extended refrigerated shelf life, (3) not
typically prepared using a conventional preservation system,
@.g., water activity or acidification, and (4) marketed under
vacuum, modified atmosphere packaging (MAP), and/or in sealed
containers. The safety of these products is dependent upon: (1)
sufficient heating during processing to destroy vegetative cells
of pathogens, (2) avoidance of recontamination with bacterial
pathogens, (3) proper refrigeration temperatures throughout the
life of the product, and/or (4) appropriate shelf life.

Vacuum packaging and MAP have the effect of diminishing the
growth of most bacteria commonly associated with fresh foods
except the lactic acid bacteria, Brochothrix spp. and the
clostridia. The most important of these for sensitive
refrigerated products are the nonproteolytic strains of ¢.
botulinum (types B, E, and F) because they can grow below 5°C.
The proteolytic strains (types A, B, F, and G) do not grow below
10°c. The prevalence of proteolytic ¢. botulinum strains in
fresh and processed meat and poultry products examined in the
United States and Canada has been found to be about 0.2% A
recent CDC review of botulism in the United States indicates
that no cases of botulism from nonproteolytic strains have been
attributed to foods stored at refrigeration temperature. .
Temperature abuse has been a common error in perishable foods
implicated in botulism.

Research during the past 20 years employing inoculated packs for
a variety of meat and seafood products using proteolytic and
nonproteolytic strains of C. botulinum with storage in MAP of
varying composition and incubation temperatures from 4* to 30°C
report the following:

- toxigenesis is positively related to numbers of ¢.
botulinum spores and increasing temperature and time of
incubation. To develop toxigenesis at 4°C required more spores
and/or longer periods of incubation than at higher temperatures.

- while product spoilage often precedes toxigenesis, it is
not always the case.

~ product storage at 4°C for up to 3 weeks should he safe
provided that the spore load is <1 spore/g.

- toxin production by ¢. botulinum in foods in MAP is
affected by the interrelationship of MAP, pH, a,, temperature,
nutrients, salt, time, and microbial competition, the spore
level, and the type and strain of C. botulinun.

7


3.0 Epidemiological and Microbiological Considerations
3.1 Foodborne Illness Attributed to Meat and Poultry

In preparing its recommendations, the Committee has relied upon
data supplied by the Centers for Disease Control (CDC), which
tabulate foodborne disease outbreaks as reported by state
epidemiologists. . Although the products under consideration are
a relatively new market entrant for which epidemiological
information is lacking, meat and poultry products have
historically represented a significant percentage of foods
implicated as the cause of foodhorne illness. Between 1973 and
1982, meat and poultry products accounted for 28% of all
reported outbreaks of foodborne disease in the United States for
which an etiological vehicle was identified. The primary
etiological agents for meat related outbreaks were

aureus (21%), Salmonella spp. (15%), and
Clostridium perfringens (11%). For poultry related outbreaks,
the etiological agents were Salmonella spp. (22%), S. aureus
(16%), and ¢. perfringens (13%). From 1982 to 1989, CDC data
indicate two sporadic cases of listeriosis related to meat and
poultry in the United States.

The presence of E. coli 0157:H7, a recently recognized foodborne
pathogen, is also of concern. While it is not a particularly
heat resistant microorganism, the temperature during the cooking
process must be adequate to kill the pathogen. outbreaks have
been associated with meat and dairy products and may have been
caused by low levels of the organism. Children and the elderly
may be particularly vulnerable to infection with E. coli
0157:H7, which may cause serious illnesses such as hemorrhagic
colitis, hemolytic uremic syndrome and thrombotic
thrombocytopenic purpura.

3.2 Bacterial Pathogens of Meat and Poultry

Pathogenic microorganisms (e.g., Salmonella spp., Staphylococcus
spp., C. perfringens, L. monocytogenes, E. coli 0157:H7, and
Campylobacter jejuni) occur in raw meat and poultry and must be
controlled during processing. -As these products receive little
or no subsequent heat treatment prior to consumption, a failure
to eliminate infectious organisms and control sporeformers
during and after processing may lead to illness should
temperature abuse or other improper handling occur. Since
naturally occurring competitive microflora are destroyed during
heat processing, pathogenic microorganisms would be allowed to
proliferate.

Psychrotrophic pathogens such as L. monocytogenes are of
particular concern. Failure to destroy these organisms during
processing or prevent their reentry after processing may lead to
an unsafe product even though subsequent handling and storage
are carried out properly.


2. Methods for Production umeration, and Standardi
Inoculum. The organisms should have been stored since initial
isolation or receipt in the laboratory by a method that
minimizes or eliminates transfers (such as a frozen or
lyophilized suspension).

The inoculum should be prepared by inoculating Tryptose
Phosphate Broth and incubating for 24 tg 26 hours at 30°C ina
static condition to obtain about 1 x 10 cells/ml of

stationary phase cells. Cultures should be inoculated the day
prior to product inoculation with a minimum holding period prior
to actual use. Each strain should be centrifuged, washed and
resuspended in Phosphate Buffered Saline (PBS). Dilutions of
each strain should be made to yield approximately equal numbers
of each of the five strains. The five strains should be
thoroughly mixed prior to being used as an inoculum.

3. Size of Inoculum. After the mixed working inoculum is
prepared, the viable count of the mixture should be determined
using Tryptose Phosphate Agar (TPA) or Tryptie Soy Agar with
0.6% Yeast Extract (TSAYE). The actual inoculum level in the
food should be confirmed by sampling the inoculated food
immediately after inoculation using either of the above media.
Other media recomnended by regulatory agencies lmay be used.

Each of the individual strains in the inoculum should contribute
about 20 pegcent of the total intended inoculym that may vary
from 1 x 10° per package of product to 1 x 10° per ml./gram

of product (see section 7).

4. ‘oO ocw i jfifere oducts.

Surface inoculation of solid foods to simulate‘ post-heating
contamination can be performed by dipping the food into the
inoculum suspension for a standardized period. This procedure
requires correction of the solution to provide the same a, as
the food. Some researchers prefer to inject a point inoculum
through a septum on a barrier bag with vacuum or MAP atmosphere.

Tt is recommended that an inoculum size of no more than 1% of
the product weight or volume be added to the product as the
mixed Listeria inoculum to achieve the desired inoculum level.

Semi~solid foods that are subjected to post cooking treatment
such as mixing, extruding, or molding can be mixed in a sterile
Colworth "StomacherTM" bag. If the product is not manipulated
after cooking, the inoculum can be surface smeared over the
semi-solid food by using a sterile bent glass rod or a sterile
swab.


Eigure 3. Example; Turkey salad

Raw turkey breast .
trim, pump, tumble/massage

stuff into casing
ccP Wash, chop: raw
ccP cook celery, bell peppers

mushrooms, and

cce chill cooked eggs
: . . oo
cce dice or chop + cep , Chill

add pickle relish

mayonnaise
cep blend (assemble)
ccP package
coe chill

CCP storage, distribution, retail


APPENDIX F

Guidelines for Clostridium botulinum Inoculation Studies
to Evaluate the Potential Risk of “New
Generation" Refrigerated Foods with Extended Shelf Life

Clostridium botulinum inoculation studies for this category of
foods are done to identify the risk of botulinal toxin
production in products: (1) held under refrigerated storage at
the highest temperature used in approximately .5% of household
or retail refrigeration units,.and (2) held at a temperature
that represents conditions if the product was mistakenly not
refrigerated by the consumer. For the latter situation it is
important to relate time of overt spoilage (unfit for human
consumption) to time to botulinal toxin production. Additional
reasons for doing ¢. botulinum inoculation studies are: (1) to
verify that time/temperature integrators (TTI’s) used to monitor
temperature abuse of product will truly indicate temperature
abuse before botulinal toxin formation could occur in a product,
and (2) to avaluate if product modifications (such as adding
preservatives or lowering pH or a,,) will prevent toxin
formation.

Considering the extreme toxicity of botulinal toxin, it is
imperative that ¢c. botulinum inoculation studies be designed and
conducted only by experts who understand the hazards of
potulinal toxin and are familiar with proper safety precautions
for handling ¢. botulinum.

Several points should be considered in designing a ¢c. botulinum
challenge study. Examples include:

1. Types and number of strains of Cc. botulinum to be used.

2. Methods for spore production, preparation, and
enumeration.

3. Number of spores to be inoculated.

4. Methods for inoculating product with spores.

5. Packaging of product.

6. Time and temperature(s) of incubation of product.

7. Sample size, sampling times, number of samples to test.

8. Botulinal toxin testing procedure.

9. Types of product analyses at different stages of the
study.


Eiqure.2. Example: Sliced turkey breast dinner packaged in
a tray with a modified atmosphere (MAP)

Raw turkey breast
trim, pump, tumble/massage

stuff into casing
SCR Wash, cook: peas,
cep cook potatoes, carrots
Dry gravy mix
rehydrate with - ‘cee Chill ‘
yee. cold water

‘
assemble into tray
Soe package (MAP)

cee chill

cep storage, distribution, retail


PREPARED REFRIGERATED PRODUCTS CONTAINING
COOKED, UNCURED MEAT AND POULTRY

1.0 . Background
1.1 Introduction

This document addresses those issues regarding prepared
refrigerated products of the meat and poultry industry. The
development of pasteurized uncured meat and poultry products in
sealed containers designed for extended refrigerated storage has
raised questions pertaining to their microbial safety. of
particular concern are pathogenic microorganisms capable of
growth at refrigeration temperatures and the safety of these
products when they are temperature abused. These
recommendations focus on those products under the regulatory
authority of the U.S. Department of Agriculture (USDA), Food
Safety and Inspectiion Service (FSIS). It does, however,
incorporate recommendations for products produced in
nonfederally inspected establishments, including retail markets.
This document includes advice and recommendations for
consideration by federal, state, and local authorities.

The Committee recognizes that some types of prepared
réfrigerated foods may exclude meat and poultry items in their
formulation, e.g., seafood and vegetable or pasta entrees. It
is the desire of the Committee that these products be the
subject of a review at a later date.

1.2 Selection of Issues

In formulating the attached recommendations, the Committee has
considered a number of issues including increased awareness of
the potential for the nation’s food supply to harbor organisms
of public health concern. For example, incidents involving
Salmonella spp. and Listeria monocytogenes in dairy products,

and Salmonella spp. in raw poultry have received.a great deal of
attention.

Three reports of the National Academy of Sciences address, in
part, the increasing need to better evaluate and assess the
microbial safety of meat and poultry products--"An .Evaluation of
the Role of Microbiological Criteria for Foods and Food
Ingredients," 1985; "Meat and Poultry Inspection: The Scientific
Basis of the Nation’s Program," 1985; and "Poultry Inspection:
The Basis for a Risk~Assessment Approach," 1987.


1. (a) A complete written description of the processing,
packaging, and storage procedures. ccP’s and monitoring and
control procedures must be included for each. Those steps that
are being taken to minimize excessive handling are to be
reflected in the plan, as are the physical barriers or
separations that are in place to minimize cross-contamination
from raw products.

(b) Procedures and frequencies for cleaning and sanitizing
food contact surfaces, including documentation to verify
compliance.

(c) The name(s) of the responsible individual(s) for
acceptance/rejection and/or rework of products including a
description of procedures to be followed if a process deviation
occurs. :

(a) A description of the lot identification system.

. {e) A description of initial and continuing employee
training program,

(f) Procedures and documentation for assuring
microbiological adequacy of incoming ingredients and final
manufactured products. .

2. Maintenance of proper product temperature control, including
maintenance of product temperatures not to exceed 40°F and
procedures to document that such temperatures have not been
exceeded from manufacturing through point of sale.

3. Establishment of a specific product shelf life and use of
product "sell by" or "use by" dates as appropriate. Shelf life
is to be determined and documented by the manufacturer. In the
event documentation cannot be provided, shelf life from ¢
manufacturer to retail sale shall not exceed 10 days at 40°F,

4. Establishment of initial and continuing employee training to
ensure adequate knowledge of product processing and handling
procedures.

5. Development and utilization of clear product labeling to
communicate to the consumer the need for proper refrigeration of
these products and the need for utilization of the product by
the "use by" date.

6. Cross contamination hazards must be carefully monitored in
manufacturing and during retail display of products. Cooked and
raw products and preparation utensils are to be clearly
separated for manufacture and display. Cooked and raw products
should be displayed in separate sections.

17


Knowledge required by personnel 133
© The value of showing the resuits of a HACCP monitoring programme to legal and
reguiatory authorities

© The sources of microbes, their importance in disease and spoilage and the benefits
of good personal hygiene of line workers

© That it is its cesponsibility to ensure that line workers and QC personnel are
brought to a knowledge level commensurate with the needs of their jobs

most line workers. Therefore they must have the same basic knowicdge
of the sources of microbes and their importance in disease and
spoilage not only for a particular operation but also for the overall
manufacturing of preparation process, In addition they must be
conversant with the techniques required to monitor CCPx, their
interpretation, the recommendations emanating therefrom and proper
maintenance of the QC records,

To management falls the responsibility for understanding the
benefits of HACCP, its implementation and coordination. It is not
expected that their level of technical knowledge will exceed that of the
line workers, with respect to sources of microorganisms and their
importance in disease and spoilage, but that their appreciation of this
mandates that an overall control programme must be established.
Management should appreciate the value of the HACCP programme
not only in internal control, but also in its relationship with regulatory
agencies with whom it should not hesitate to share the results of the
monitoring integral to HACCP.

8.4 Transport and storage personnel

Those involved in transporting and storing foods have an equal
responsibility ‘0 acquire knowledge of how microbiological hazards can
be minimized (Table 8.3). As with personnel in other segments of the

Table 8.3 Basic knowledge required by those involved in warehousing (storage and
transporting foods)

‘Those invoived in warehousing should know:
© ‘That contaminated foods can cause illness and that microbes spoil foods
© The practices necesaary for the safe transport of the products with which they mre
concerned

© That vehicles must be cleaned and the means for achieving this task
® The influence of temperature on product quality and microbial growth
‘© The importance of controlling insects and rodents



certain minimum temperature. This offers a visual check that
the product on the rack has been through the pasteurization
tank. Operating instructions specify that all damaged or
otherwise unacceptable packages which have been through the
pasteurizer will be destroyed and not be repackaged or
reprocessed.

Conditions--The initial internal product temperature (232°R),
water temperature (>180°F), time of heating, and distribution of
the pouches on the rack must be controlled to meet the
pasteurization requirements. In addition, all product must
either be pasteurized on the day of packaging or destroyed.
Moni ing--the time-temperature requirements are monitored with
a clock and temperature sensors. The other requirements are
monitored visually.

erifi ion--Timing and temperature sensing devices must be
checked for accuracy.

CHILLING = CCP No. 5

This chilling procedure is similar to that in CCP No. 6 with one
major difference--the smaller product size and more rapid
chilling rate of the pouches. ‘This procedure is physically
separated from the previous steps in the process. The water
used for chilling is chlorinated to minimize the risk of product
contamination in the event a leaker pouch should occur and go
undetected during labeling and boxing. The water is agitated to
facilitate the chilling process.

~-The temperature of the product must be monitored to
assure a controlled, continuous rate of chilling to a final
product temperature of <40°F. The water must contain a residual
available chlorine level of 0.5-1.0 ppm.

Monitoring-~The rate of chilling and the final product
temperature are monitored. The chlorine level of the water is
checked using a paper test strip for chlorine content.

Verification=-The accuracy of the temperature sensor is
checked. The accuracy of the paper test strip for available
chlorine content can be checked using an on-site chemical assay.

STORING, DISTRIBUTING, DISPLAYING - CCP No. 6

After chilling the pouches are labeled, boxed, palletized, and
then moved into storage for distribution. This particular
product must be maintained at <40°F throughout these processing
steps and during distribution and display at the retail level
because this product has not been formulated to provide a
secondary barrier and relies upon refrigeration as the sole
means to prevent the growth of sporeforming pathogens.

10


The product contains a label with a "Use By" date and
instructions for proper refrigeration.

Conditions--Product temperature must be maintained at 40°F,
The product must move through the distribution system in a
timely manner. The product must be used within the "Use By"
date.

Monitoring-~The product temperature through distribution and
display is checked with a temperature sensor. The TTIs are
checked visually. The "Use By" date and movement of product are
checked visually.

Verification--The accuracy of the temperature sensor and TTIs
are checked.

11


APPENDIX G

8

Knowledge required by personnel
and the public

81 Introduction

82 Producers:

83 Processors and food service personnel

a4 Transport and storage personnel

85 The public

8.6 Regulatory personnel .
8.7 Persons who develop HACCP programmes

8.1 Introduction

The incidence of food-borne illness is high throughout the world, and
where data are available it is readily demonstrable that the majority of
incidents take place in food Service establishments and homes (see
Table 1.12). The principal factors that contribute to these incidents are
shown in Table 1.11. As indicated in Chapter 1, losses due to microbial
spoilage of foods are enormous. A portion of these losses takes place
prior to harvest and slaughter. Further losses may occur at each step in
the chain from producer to ultimate consumer. Accordingly it is
important that those involved at all links in the food chain be
knowledgeable as to the measures they can take to reduce the
incidence and the magnitude of these losses.

Food-borne disease and spoilage result from ‘negligence or
ignorance or both. Problems develop when those who are involved in
handling food do not possess the knowledge necessary to control
microbiological hazards. It follows that a number of specific groups
must be educated if the incidence of spoilage and disease is to be
reduced. These groups include:

(a) producers;
(b) processors and food service personnel;
(c) those involved in transportation and storage;

129

Reprinted with permission of ICMSF and Blackwell
Scientific Publications


APPENDIX B
Packaging Materials and Packaging Systems

Fibrous Casings are manufactured from casings coated with
cellulose, Generally, the product is heat processed in the
casing. The nonmoisture proof casing permits smoke to penetrate
through the casing into the product and evaporation of moisture
from the product during processing. In many cases,. this
processing package is also the final package for shipment and
distribution. This is most commonly used for deli and food
service product but is used for some specialty consumer products
like Kosher salami. The casing is relatively impervious to
microorganisms when it is dry. Because the casing is
nonnoisture proof, moisture evaporates relatively fast and the
surface stays dry retarding the development of spoilage
organisms. Spoilage, when it does occur, is generally yeasts
and molds and some slime forming bacteria. With the evaporation
of moisture from the product, some case hardening occurs that
further restricts growth of microorganisms. Commonly, shrinkage
will amount to 1% a day depending on storage conditions.

Barrier shrink bags are’ most commonly ‘used for irregularly
shaped products, such as primal cuts of beef, hams, and deli
loaves. Barrier bags are moisture proof and have low oxygen
permeability. To use, the product is inserted into the bag, the
air evacuated from the bag with a snorkel or vacuum chamber,
sealed using an aluminum slip or a heat seal, then passed
through a hot water shrink tunnel (95° to 100°F) that shrinks
away the excess film. The final package has an intimate contact
to the product providing an anaerobic condition. The resident
time in the hot water shrink tunnel is very short and does not
provide enough time to surface pasteurize the product.

Form-Fill-Seal Modified Atmosphere Packaging (MAP)

Vacuum packaging is the most. common form of MAP used to extend
the shelf life and maintain the natural integrity of fresh and
cured meats. ‘The vacuum package using oxygen barrier films
provides an intimate contact of the film to the product and
subsequently provides an anaerobic condition. One of the big
advantages of vacuum MAP is that it is easy to identify leaker
packages and police the packaging operation,

In form-fill-seal packaging, thermoformable film or rigid
plastic is heated to a soft pliable condition and thermoformed
into a pocket essentially the same shape and size of the product
to he packaged. The product is placed in the pocket and a
lidding film is hermetically sealed under vacuum or with vacuum
and a gas backfill. With the vacuum package there is a small
amount of air containing 20% oxygen entrapped in the product and


132 Principles

‘Table 8.2 Basic knowledge required by food industry personnel

A. Line operarars
Line operators should know:

‘© The major sources of microorganisms in the product for which they are
responsible

© The role of microbes in disease and food spoilage -

‘© Why good personal hygiene is required

‘© The importance of reporting iliness. {esions and cuts to supervisory personnet

© The nature of the contral required at their point in the process

© The proper procedures and frequency for cleaning equipment for which they are
responsible

© The procedures necessary to repart deviations from control specifications

© The characteristics of normal and abnormal product at their given step in the
process (e.g. colour. texture, package integrity, odour)

© The importance of maintaining proper records

® How to monitor CCP of operations within their responsibility

B. Quality control personnel
QC personnel should know: .

© The sources of microbes, their importance in disease and spoilage. and how they
can be controlled

© How to perform and interpret all chemical, physical and mics ybiological analyses
relevant to thei operation

@ Why (hese are relevant to the operation

® The objectives of the HACCP system and in particular the importance of
monitoring to determine whether a process is under control

© The prescribed action ro be taken when monitoring results indicate the process is
going out of control and the procedure for reporting this to the person in authority
to determine the nature of action required

© How to investigate the most likely causes of process deviations, and, if the solution
is not readily apparent, the procedure for obtaining additional help

© How to maintain and transmit pertinent QC records
C. Management
Management shauld know:

® That the HACCP programme focuses on those points that are critical to the
operation

© That the microbiological and economic consequences af a process being out of
control can be enormous

© That it is through monitoring of CCPs that it can be determined whether a process
is under control

@ Where the responsibility and knowledge level of the line operators. QC personnel
and technical experts begin and end


NATIONAL ADVISORY COMMITTEE ON
MICROBIOLOGICAL CRITERIA FOR FOODS

CHAIRMAN

Dr. Lester M. Crawford
Administrator
Food Safety and Inspection Service

MEMBERS

Dr. Catherine E. Adams
Special Asst. to Administrator
USDA, FSIS

Dr. Douglas. Archer

Acting Deputy Director

Center for Food Safety and
Applied Nutrition, FDA

Dr. Howard Bauman
consultant

Dr. William L. Brown
President . ’
ABC Research Corporations

Dr. Robert L. Buchanan
Supervisory Microbiologist
Eastern Regional Research Center
USDA, ARS

Dr. Frank M. Calia
Director of Medical Education
University of Maryland Hospital

Mr. Jerry Carosella
Microbiology Division
USDA, FSIS

Dr. Mitchell Cohen

Deputy Director

Division of Bacterial Diseases
Centers for Disease Control

VICE CHAIRMAN

Dr. Fred R. Shank

Director, Center for Food
Safety and Applied Nutrition
Food and Drug Administration

Dr. Donald Corlett:
Technical Director

Food Safety and Evaluation
Escagenetics Corporation

Mr. Cleve Denny

Director

Research Services

National Food Processors Assn.

Dr.. Michael Doyle
Associate Professor
Food Research Institute
University of Wisconsin

‘Dr. David W. .Dreesen

Associate Professor
College of Veterinary Medicine
University of Georgia

Dr. Damien Gabis
President
Silliker Laboratories, Inc.

Mr. Spencer Garrett
Director, National Seafood
Inspection Laboratory
National Marine Fisheries

Dr. Phil Hudspeth

Director

Poultry Research

Campbell Research Laboratories


9. Enumeration methods employed for the procedure in Section 8
should permit recovery of heat injured cells; therefore, the
current acceptable methods recommended by the requlatory agency
will be used. The Fraser~Sperber technique may be useful, but
offers no advantage for food containing large numbers of
enterococci.

Backup enrichment methods should be prepared to confirm that
there are no surviving L. monocytogenes cells below the
detection limit of less than 100 per gram when direct plating
methods are used.

10. Product Composition. In addition to detecting or
quantifying L. monocytogenes in product, duplicate uninoculated
samples of the product at zero time should be assayed for
moisture, fat, protein, salt content, pH, and if a meat or
poultry containing product. Product analyses s ould be designed
toa determine major product characteristics and may need to be
modified if the product is chiefly vegetable or pasta, in
nature, Depending on the type of product, other analyses (such
as titratable acidity, nitrite content, or preservative level)
also should be performed. If the product is packaged under
modified atmosphere conditions, gas analysis should be performed
at zero time.

Any change in product formulation will require re-determination
of the heat resistance characteristics.


Liquid products are most easily inoculated by adding the
smallest volume (< 1%) of inoculum that is practical and
thoroughly mixing it into the food.

Assay of the inoculated products may have to include .
homogenization, rinse techniques, or specific site sampling
depending upon specific product type and inoculation route.

5. Packaging of Product (1). Products that are to be packaged
under special conditions such as vacuum or modified atmosphere
packaging should use an inoculation and packaging scheme that
duplicates the actual packaging conditions of the product. The
atmospheres should be defined and analytically determined. Any
post-packaging treatments that are to be conducted should be
defined and well controlled.

The entire inoculation, packaging, and post-packaging
handling process should be performed such that the normal course
of changes of the package and atmosphere are not. altered.

The inoculated product should be packaged as intended for retail
gale using vacuum or modified atmospheres and suitable
thermocouples inserted into the coldest heating spot of each
product using a special double gasketed packing gland to seal
the thermocouple assembly to the plastic barrier package. An
accurate (+ 1°F) time/temperature data logger should be used to
measure product and processing water temperatures. Zero time
counts should be performed on inoculated packages.

6. Sample Sizes and Number of Samples to Test. The sample size
used for each data point should be as large as practical to
reduce variation around the data points. A minimum sample size
of 25 grams should be used for analysig that is blended or
homogenized using a Colworth Stomache laboratory blender.

A minimum of three replicates, and preferably five of a given
type of food, should be taken at zaro time and each sampling
interval. A minimum of duplicate heating runs should be
performed.

1 Conventional. plastic barrier packaging is defined as plastic
resin film of,PvDC (saran) or EVOH that has an oxygen
transmission rate measured at 73°F (m*, 24 hours, one
atmosphere) of hetween 5 to 100c¢c, Common oxygen transmission
ranges for various types of films include:

Barrier - 5 to 20cec 0, (as determined above)

High barrier - 1 to 5ce 0

Very high barrier - <lec 3,

3


Examples; Uncured jellied meats

Raw ingredients --- Cook --- cChill* --- Add raw
ingredients --- Final chill --- Package --- Distribute
Type 9.

Examples: Stews, sauces, and soups
Raw ingredients --- Formulate --- Cook --- Fill while hot
--- Seal --- Hold (optional) --- Chill* --- Distribute

* Denotes continuous chilling at the given step with the
asterisk and through all subsequent steps to consumption.

4.2 Process Categories

These nine process types can be further delineated into three
categories relative to the inherent microbial risks during pre-
and post-processing:

ti —~; ed.

For these products, after the ingredients are prepared and
packaged, a final heat treatment is applied to cook,the product
which will destroy contaminating organisms. When properly
controlled, the final heat treatment can assure the destruction
of nonsporeforming pathogens, as well as the normal spoilage
flora, resulting in products with a relatively long refrigerated
shelf life. However, if the final heat treatment does not
destroy sporeformers, the possibility of germination and
outgrowth exists, resulting in a potential botulinal hazard,
particularly if temperature abused. Category 1 includes sous
vide and cook-in-bag products with raw or slightly precooked
components assembled and packaged, then cooked. .-

Category 2--Cooked and assembled.

In the case of these products, the ingredients are prepared and
then assembled into the final package with no heat treatment
being applied after final packaging. Thus, the microbial flora
of the packaged product reflects the flora associated with the
various ingredients and any flora acquired during the assembly
and packaging steps. The refrigerated shelf life of these
products is strongly influenced by the number and type of
microbial flora in the packaged product. The potential hazard
from sporeformers is the same as in category 1 products.
However, there is the additional risk of contamination with
nonsporeforming pathogens prior to or during packaging.
Category 2 includes products with all components cooked
individually then assembled and packaged. These products are
not further heated before distribution.

10


Knowledge required by personnel 31

Table 8.1 Basic knowledge required by those producing food

A. General
All food producers should know: -

@ That microorganisms are the prme cause of food spoilage and food-borne disease

© The primacy sources of organisms causing spoilage and disease

© The role of contamination in contributing disease-causing organisms ta foods

© The infuence of temperature on the microbiological quality and safety of the foods
B, Animal foods

Producers of animal foods should also know:

© The principles of animal husbandry

© The role of feedstuffs in animal disease

# That hatardous contaminants, ¢.g. aflatoxins and salmonella. can pass through to
the final product. .

© That the animal is major source of contamination of milk and that appropriate
milking practices can minimize contamination

‘© The need for cleantiness of milking facilities, viz. milking machines. pipes and
tanks

© The risks and benefits of egg cleaning procedures
© The influence of temperature and humidity on the quality of storey eggs
C. Plant foods
Producers of plant foods shauid also know:
© The basic principles of good agricultural or horticultural practices
© The indications of spoilage at the time of harvest
© The meens to minimize contamination by spoilage organisms during harvesting
© The appropriate handling techniques to minimize damage

D. Marine foods

Producers of marine foods should also know:

© That macine animais harvested from polluted waters are likely to be contaminated
with enters pathogens:

@ The need for cleanliness of implements and storage facilities utilized in the
capture, storage and, where applicable, processing of marine animals

@ That evisceration will influence the keeping quality of fish

@ That spoiled fish should not be further processed because of the risk of scombrotd
poisoning



5.0 Recommendations
5.1 HACCP

Based. on the preceding analyses, the Committee recommends that a
HACCP system be used in the production and distribution of these
prepared refrigerated foods. Such systems must be based on
sound scientific principles following a thorough risk .
assessment. (See: Hazard Analysis Critical Control Point
System, National Advisory Committee on Microbiological Criteria
for Foods, November 1989, Sec, 4.0.) In order to develop a
HACCP plan, the producer should follow these essential
guidelines:

1. Assess hazards and risks associated with growing,
harvesting, raw materials and ingredients, processing,
manufacturing, distribution, marketing, preparation and
consumption of the food.

2. Determine critical control points (CCP) required to control
the identified hazards.

3. Establish the critical limits that must be met at each
identified cCcP.

4. Establish procedures to monitor Cccp.

5, Establish corrective action to be taken when there isa
deviation identified by monitoring a CCP.

6. Establish effective recordkeeping systems that document the
HACCP plan.

7. stablish procedures for verification that the HACCP system
is working correctly.

A detailed example outlining the application of the HACCP
principles to the products under consideration is included as
Appendix c.

5.2 Process Controls

Microbiological challenge studies or alternative procedures,
such as integrated lethality calculations of thermal processes
demonstrating that cooked products have been heated sufficiently
to achieve a minimum 4-D kill for Listeria monocytogenes should
be considered adequate to validate the cooking process (See:
Appendix D). The heat treatment used to cook these products
must be sufficient to kill vegetative bacterial pathogens,
especially those types that may be infectious at low levels.

12


Appendix
Appendix

Appendix

Appendix

Appendix

Appendix

Appendix

A.

c.

Dd.

G.

Appendices
Cooking and Cooling Parameters
Packaging Materials and Packaging Systems

Examples for the Application of HACCP Principles
for the Production of Foods in Categories 1-2-3

Integrated Lethality Calculations of Thermal
Processes

Guideline for Evaluating the Efficacy of a Thermal
Process for Killing L. monocytogenes

Guideline for Determining the. Potential for
&. botulinum Toxin in Refrigerated Foods

Recommendations for Education and Training -

B
Be


level will reflect a dry gravy mix produced by a company using
good manufacturing practices (GMP’s). No other microbiological
specifications will be required. Occasional incoming lots will
be tested and the results shared with the supplier.

In this example, the sealed pouches are Placed onto a rack which
is lowered into a tank of hot water. After the required time,
the rack is raised and transferred to another tank for rapid
chilling. It is important that the pouches of product be
properly distributed on the rack so that none of the pouches
overlap. To facilitate this, the rack should be designed so
each pouch fits into a depression in the rack. This will

reduce the risk that the pouches will shift as the rack is moved
into the tank for heating.

Additional requirements in this_process are that sealed pouches
of product will not be held over and pasteurized on a later

day. This will avoid microbial growth in the product. prior to
pasteurization. Also, the thickness of the pouches will be
controlled to assure uniform heating during pasteurization. ‘The
conditions of pasteurization are of greater concern than in the
cooking of the turkey roll. This is because the pouches are
smaller in size and the time requirement for heating will be
much shorter. Particular care must be given to controlling a
high temperature-short time process since there is less room for
error,

In this example, the pasteurization process has been designed to
achieve a minimum destruction of 104 L. monocytogenes per gram
based upon a starting temperature of 32°F and in the thickest
possible: pouch with the film and vacuum sealing equipment that
is used. Rather than monitoring time and temperature, the
process should be designed to maintain a water temperature of
2180°F. It has been thoroughly tested and verified that all
pouches of product will have met the conditions for
pasteurization when a center product temperature of 150°F has
been reached. The maximum time for this to occur has been
established under various possible conditions. In this example
the conditions which must be met for the pasteurization process
have been reduced ta the initial product temperature (232°F),
water temperature (>180°F), and time from the moment the product
is placed into the water tank until it is removed.

A requirement of the overall plant design has been to assure
that the product will flow in one direction. The layout of the
Plant directs product flow from packaging to pasteurization to
Chilling and then to final boxing. As an additional precaution,
each rack of product carries an identification tag. Each tag
contains an indicator which changes color when heated to a


APPENDIX A

Cooking and Cooling Parameters

Cooking Parameters

USDA/FSIS has established minimal internal temperatures required
for coaking perishable uncured meat and poultry products, These
temperature requirements are referenced in Title 9 of the CFR’s
(CFR 301-390) or in policies disseminated through the FSIS
Policy Book or Notices.

Cooking Requirements

- Cooked beef and roast beef 130° ~ 145°F
(9CFR 318.17) (54.4° + 62.7°C)
(121 min. at 130°F. to instantaneous at 145°F)

- Baked meatloaf 160°F
(9CFR 317.8) (71.1°¢)

~ Baked pork cut ‘ 170°C
(9CFR 317.8) . (76.7°C)

- Pork (to destroy trichinae) 120° - 144°F
(9CFR 318.10) (48.9° - 62.2°C)
(21 hrs. at 120°F. to instantaneous at 144°F

~ Cooked poultry rolls and other 160°F
uncured poultry products (71.1°C)

(9CFR 381.150)

- Cooked duck, salted 155°F
(FSIS Policy Book) (68.3°C)

- Jellied chicken loaf 160°F
(FSIS Policy Book) (71.1°C)

- Partially cooked, comminuted products
(FSIS Notice 92-85) 2151°F for 1 min.
2148°F for 2 min.
2146°F for 3 min.
2145°F for 4 min.
2144°F for 5 min,

Cooling Parameters

Similarly, parameters for cooling and storing refrigerated
products including temperatures and times, are reflected in
agency regulations (9 CFR) and policies.


fable of Contents

Table of Contents. 2.6 6 6 eee he ee ee es Jt
Committee Members. . 0s 6 ee ee ee et et te te dai

Executive Summary. 6-6 ee ee ee ee ee Ee 1
Mission Statement. . 6. 6 6 ee ee ee ee ee 2
2.0 Background . - ee eet ee tee ee ee 3
1.1 Introduction 2.6 6 eee ee ee ee 3
1.2 Selection of Issues . 6 - ee ee te ee 3
2.0 Product Definition «+. 6 ee ee ee et et 5
3.0 Epidemiological and Microbiological Considerations. . . . 6
3.1 Foodborne Illness Attributed to Meat and Poultry. ...- 6
3.2 Bacterial Pathogens of Meat and Poultry ..- ++: +++ 6
3.3 Potential for Microbial Contamination/Recontamination . . 7
3.4 Population Groups of Special Concern . . se ee et ee 8
3.5 Temperature Controls. 2. . + 6 ee ete tt hr tt 8
4.0 Processing and Packaging. - «+ + + 6 et 8 se tet tor tis 9
4,1 Process Types «6 6 6 ee et ee eH ee te ee eS 9
4.2 Process Categories. 6. 6 6 ee ee ee ee ee ‘10
4.3 Packaging. - 6 6 ee ee et ee ee ee ee 11
5,0 Recommendations .. - - 6 6 6 6 8 eee ee ee ee 12
5.1 HACCP 2 6 ww ee ee ee ee 12
5.2 Process Controls . 6. + 2 6 se ee ee ee te ee «12
5.3 Process Categories. . 6 6s 6 6 fe ee ee ee ee -13
5.4 Packaging... 6 ee ee ee tee ee 44
5.5 Product Distribution. 2. 6 6 ee ee ee ee ee ee we dd
5,6 Equipment Monitoring. . 6-6 se ee ee et ee et .15
5.7 Regulatory Inspection Review. ©. es + ee tee ens 215
5.8 Production Guidelines for Nonfederally Inspected
Establishments, . 2 eee ee ee ee te ee ee ee DG
§.8.1 Introduction. . 6. eee et et eee ee ee Wl
5.8.2 Unlimited Production, . 6. eee ee ee ee ee ee HG
5.8.3 Limited Production. . 2. 6 ee ee ee ee eee ew dB
5.8.4 Excluded from Production. . . . ee ee ee ee et 08
5.9 Distributors and Retailers... - +e ee ee ee ee 08
5.10 Imported and Exported Products. . 6 + + + 6 se eet 18
5.11 Labeling. . 6. 6 ee ee ee ee ee ee ee +19
5,12 Education and Training. . - - - + + ee ee th et es .20
5.13 Research. . 6 6 6 8 6 ee ee ee ee ee 20

He


The following are suggested procedures to use for ¢. botulinum
inoculation studies. These procedures are intended to serve
only as guidelines; equivalent protocols are also acceptable.
These procedures may not be suitable for all types of
refrigerated foods; modifications of procedures may be necessary
to accommodate the type of food being evaluated.

A. Types and Number of C. botulinum Strains

Proteolytic and nonproteolytic types of C. botulinum used in
challenge studies should be tested separately. A mixture of a
minimum of five strains each of type A and proteolytic type B is
suggested for studies of proteolytic c. botulinum. Strains that
may be used include: type A~-56A, 62A, 69A, 77A, or 90A and
proteolytic type B--53B, 1138, 213B, 13983B, or Lamanna-okra B.
Strains 62A and 213B should be used in all studies. Additional
strains such as isolates from refrigerated foods may also be
used in combination with these strains. If practical, strains
may be screened to select those that grow best in principal
components of the product to be evaluated.

A mixture of a minimum of three strains each of nonproteolytic
type B and E, and one strain of nonproteolytic type F is
suggested for studies of nonproteolytic ¢. botulinum. Strains
that may be used include: nonproteolytic type B-~2B, 17B, 21298,
17844B, or 25765B; type E--Beluga, Saratoga, Minnesota, Iwanii
or Alaska; and nonprotecloytic type F=-83, 187 or 3194. Strains
17B and Beluga should be used in all studies. :

Each strain of both proteolytic and nonproteolytic ¢. botulinum
used for inoculation studies periodically (yearly) should be
assayed by the mouse bioassay for toxin production. Any culture
producing less than 1000 MLD/ml should not be used; either a
productive culture of the same strain should be obtained or a
different strain should be used in lieu of the nonproductiv
culture.

B. Methods for Spore Production, Preparation, and Enumeration

Spore crops may be produced by a variety of methods. Examples
include: (1) the use of many different sporulation broths that.
are selected on the basis of strain sporulation characteristics;
(2) biphasic methods using different.types of liquid media over
different types of agar media; and (3) agar media (such as
anaerobic egg yolk agar) held under anaerobic conditions. There
appears to be no common approach to producing spore crops. Most
investigators use an incubation temperature for proteolytic
strains of 35°C and for nonproteolytic strains of 26° to 30°C.
Time to sporulation depends on the cultural conditions and the
strain of ¢. botulinum, and is determined by periodic


REHYDRATING ~ CCP No.

Conditions
1) Time for
rehydration and

chilling gravy
to <40°F.

PASTEURIZING - CCP No.

Conditions

Monitoring

1) Clock,
temperature sensor

4

Monitoring

1) Time and temperature 1) Clock,

of heating

2) Avoid
packages:

3) No packages held
for pasteurization on
later day :

CHILLING - CCP No. 5

Conditions
1) Water and product
temperature. Time to
reach <40°F.

2) Uniform chilling

3) Avoid overlapping
packages

temperature sensor,

Py Me

2) Visual sensor
vee en ag Ln

3) Visual

Monitoring

1) Clock,

sensor
an ae

Verification

1) Check accuracy
of temperature
sensor

2) Total count in
subsequent lots

ef gravy produced
throughout the day

Verification

1) Check accuracy
of temperature

1) Check accuracy

temperature sensor of temperature

2) Observe that
water is being
agitated or
circulated during
chilling

3) Visual

sensor



APPENDIX E

Guidelines for Listeria monocytogenes Thermal Inactivation
Studies in Extended Shelf Life
Pre=cooked Refrigerated Foods

There are many factors that must be considered in designing a
Listeria monocytogenes thermal inactivation study to evaluate
the microbiological safety of a refrigerated food with extended
shelf life. Such factors include:
1. Types and number of strains of L. monocytogenes to use
as an inoculum.
2. Methods for production, enumeration and standardization
of inoculum.
3. Size of inoculum to be used.
4. Methods for inoculating different types of products.
5. Packaging of products.
6. Sample size and number of samples to test.
7. Heatingy.of products... yi,
8. Determination of D and Z values in.the laboratory.
9. Enumerabion.and detaction media.
10. Product composition.

The following procedures are ‘suggested as guidelines for use in
designing L. monocytogenes thermal inactivation studies. The
procedures described may not be suitable for all types of
refrigerated foods and modifications may be necessary to
accommodate the type of food being evaluated. such studies
should be conducted and interpreted by an experienced food
microbiologist.

.1. Type and number of ft. monocytogenes strains. At least five
strains of L. monocytogenes should be used including
representatives of serotypes 1 and 4b. Suggested strains
include: Scott A, Type 4b, clinical; Brie 1, Type 4b, cheese;
Murray B, Type 4b, clinical; LCDC 81-861, Type 4b, cole slaw;
v7, Type 1, raw milk; and HOVJS, Type 1, hamburger.

Preferably, strains isolated from a particular food should be
used to inoculate a similar food such as HOVJS being used to
inoculate a meat product. Strains Scott A and V7 should be used
as reference strains in the mixed strain inoculum in all
studies.


the package. Within 24 to 48 hours this residual oxygen is
dissipated by the product and anaerobic conditions exist in the
package. With gas backfill packages, the residual oxygen in the
package is diluted by the backfill gas. The final residual
oxygen is directly related to the amount of residual oxygen in
the package and amount of backfill gas. Various types of gas
mixtures are being used depending on the product. With cured
meats and some uncured white meats, the gas may be pure nitrogen
or mixture of nitrogen and carbon dioxide. ‘The carbon dioxide
gas and the carbonic acid formed from the reaction of carbon -
dioxide and water does extend shelf life. ‘with fresh red meats,
a high concentration of oxygen (40 to 45%) is used to maintain
the bloom; 20% Co, to extend shelf life and remainder No.

MAP packages can also be made using preformed pouches or trays.

Cook in vacuum packages are primarily used for cooked ham for
slicing or deli using preformed bags or form-fill-seal

packages. The cured tumbled macerated meats are vacuum packaged
in the bar or form-fill-seal, placed in mold and cooked. As a
result of the processing, the film adheres to the meat creating
an anaerobic package.

Tray shrink wrap packages generally use a moisture proof and
high oxygen permeable film. They are generally used for fresh‘
sausage, fresh meat, and frozen precooked patties that are sold.
frozen or in refrigerated cases. The high 0 permeability of
the film provides the necessary 0, to maintain the red
oymyoglobin color of the fresh sausage or red meat. The package
provides an aerobic condition. With the frozen cooked patties
that are sold refrigerated, there are some special problems of
visible indicators or spoilage that must be addressed. In some
cases, these frozen patties are prepackaged at a central
location while in others the store buys the patties bulk and
repacks them into consumer packages in overwrapped foam trays.


3.4 Population Groups of Special Concern

At this time, the minimum infective dese for most foodborne
pathogens cannot be accurately ascertained. Infective dose is,
at a minimum, a function of the sum total of virulence factors
possessed by a microorganism and frequently il1-defined or
poorly understood host susceptability.

However, some generalities are possible. For example, the
elderly, particularly the institutionalized elderly, frequently
experience more severe outcomes , even death, from certain

pathogens such as §. enteritidis, 8. dublin, and L.
monocytogenes. Foods likely to be consumed by these and other

high at-risk groups (e.g. infants, cancer patients, individuals
with extreme neutropenia, transplant recipients) require that
particular care be taken in establishing, monitoring, and
verifying critical control points to prevent low level
contamination,

3.5 Yemperature Controls

As a result of the foregoing, proper temperature controls are
essential to the safety of these products. While we recognize
that temperature abuse can occur at all stages of product
manufacture, storage and distribution, the greatest potential
occurs throughout the distribution cycle, including consumer
purchase, storage and preparation. Temperature must be
controlled and monitored by the manufacturer, distributor, and
retailer. Since prepared refrigerated products will be promoted
to consumers as requiring little, if any, additional heat
treatment, the manner of their preparation, packaging,
distribution, and storage is critical. Not only must the
manufacturer, distributor, and retailer understand that these
products require particular care to ensure their safety, but so
must the consumer.

current USDA cooking and cooling requirements are included as
Appendix A.


microscopic examination of the culture. If a defined protocol
for producing spore crops is to be recommended, we need a better
consensus among investigators in the field of the best
procedure(s) for producing spores.

Spores during harvesting should be washed at least five times
with sterile distilled water and appropriate centrifugation.
Following washing, spores should be treated by sonication to
destroy sporangia and vegetative cells and free the spores. The
sonicated spores should be washed with sterile distilled water
at least 10 more times using centrifugation and resuspension.
The spore suspension in sterile distilled water or in 50%
glycerol plus 0.25% Tween 80 in sterile distilled water should
be stored in vials at -20°C or -15°C, respectively. When
needed, a frozen spore suspension should be thawed by placing
the vial in lukewarm (ca. 30°C) water for several minutes.
Spore suspensions in glycerol - Tween 80 solution are not
frozen.

Spores may, be enumerated by a 5-tube most probable number (MPN)
procedure. Dilutions of heat-shocked (80°C, 10 minutes for
proteolytid' strains or 60°C, 10 minutes for nonproteolytic
strains) ‘spores (or product) are inoculated into tubes of TPGY
medium. (ttypticase 5%, peptone 0.5%, yeast extract. 2%, dextrose
0.4%, and" sodium: thioglycollate 0.1%) and the TPGY tubes are
incubated anderobically in Gas-Pak jars at 35°C for 7 days for
proteolytic strains and at 30°C for 7 days (with subsequent
trypsinization if the mouse bioassay for toxin detection is
used) for nonproteolytic strains. Pure spore suspensions can be
enumerated by visually examining tubes for growth; however, for
food samples which contain other organisms, the mouse test or an
equivalent assay to confirm the presence of botulinal toxin must
be done. The MPN procedure generally is preferred for
enumerating spores in inoculated foods which may contain too few
spores for detection by direct plating methods.

Alternatively, spore crops with sufficient numbers of spores can
be enumerated by direct plating procedures. Heat~shocked spores
are diluted and plated onto anaerobic egg yolk agar or an
equivalent medium held at 35°C for 48-72 hours under anaerobic
conditions for proteolytic strains or at 26° or 30°C for 48-72
hours under anaerobic conditions for nonproteolytic strains.

c. Number of Spores Inoculated .

Spore mixtures to be used an inocula should contain an
approximately equivalent number of spores of each strain of C.
botulinum in the cocktail. Spore counts should be done on each
strain before the spores are pooled into a cocktail. Spores
should be diluted appropriately in sterile distilled water or in
50% glycerol - 0.25% Tween 80 and stored at -20°C or 15°C,
respectively.

3


F. ‘Time and Temperatures of Incubation of Product

The recommended conditions for inoculated pack studies with
nonproteolytic ¢. botulinum are at 55°F for one and one-half
times the product‘s shelf life or for up to the time when the
product is overtly spoiled (unfit for human consumption).
Studies with the proteolytic C. botulinum are recommended at
80.6°F (27°C) for up to the time when the product is overtly
spoiled (unfit for human comsumptign) or for one-half the
refrigerated shelf life if the product does not appear spoiled
by that time. If the product contains multicomponents, then
testing should terminate 1 day Keyond the time the last
component of the product is overtly spoiled (unfit for human
consumption) .

If TTI‘s are used as indicators of temperature abuse, time to
toxicity studies should be done with nonproteolytic ¢. botulinum
at least at 6", 10°, and 20°C and with proteolytic ¢. botulinum
at least at 20° and 27°C to verify that the TTI’s will change
before toxin can be produced. :

G. Sampleisizé, Sampling’ Times, and Number’ of Samples to Test

Ideally, thé entire sampldé should’ be hoiidgenized or extracted
for botulinal toxin testing: If samples aré'large (>300 g), a
minimum sample size of 50 g is recommended.

Sampling times should be adjusted according to the expected
shelf life of the product. Samples for botulinal toxin assay
should be taken at "O"+time (day of inoculation) and at a
minimum of four additional times, with at least three sampling
times between halfway and the final’ testing time. Product
incubated at 27°C should be tested at the time it becomes
overtly spoiled. ‘

The recommended minimum number of samples assayed for botulinal
toxin at each sampling time is five. A minimum of three samples
taken at "O"-time and at the final sampling time is recommended
for ¢. botulinum spore enumeration. It is not necessary to

continue sampling at times after the first toxic sample is
detected.

H. Botulinal Toxin Testing Procedure

The mouse bioassay procedure as described in the U.S. Food and
Drug Administration Bacteriological Analytical Manual (6th ed.,
1984) is the recommend method for hotulinal toxin testing. Only
individuals properly immunized with botulinal toxoid should
perform these tests. Samples inoculated with nonproteolytic C.
botulinum spores should be tested first without trypsinization.
If mice survive, then tests should be done on trypsinized
samples. Preferably, toxin analysis should be done on the day

5


Category 3-~Assembled with cooked and raw ingredients.

Category 3 includes products with components cooked
individually, combined with raw ingredients, then assembled and
packaged. The steps in the process for these products are very
Similar to category 2 products. The major difference is that
raw ingredients (e.g. raw vegetables) are added prior to final
packaging. This provides the additional risk that the raw
ingredients will introduce pathogens into the product that would
not otherwise be present if the ingredients were cooked. The
potential hazards for these products are very similar to those
in category 2 products. These products might not be further
heated before distribution.

4.3 Packaging

The manner in which these products are manufactured illustrates
that the packaging system used is very important in assuring the
stability and safety of these products. Packages and packaging
systems are designed to meet marketing and production needs,
with specific packaging media being dictated by the product
itself and shelf life required to move it through distribution
for ultimate consumption. Obviously, the packaging system can
be determinative of the type and rate of microbial growth.
Product in packages with defective seals would be expected to

spoil more quickly and thereby could become contaminated with
pathogens in the environment.

The package may be as simple as a moisture barrier for some
refrigerated products or a controlled moisture barrier to permit
evaporation of moisture from the surface; or it may be more
complex, such as MAP using high moisture and gas barrier films.
Regardless of the medium used, the packaging system must be
designed to assure product safety.

A detailed description of packaging materials and’ systems is
included as Appendix B.

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