Plant Sanitation For Food Processing and Food Service, Second Edition (PDFDrive - Com) - Dikompresi (1140-1190)

1080 Plant Sanitation for Food Processing and Food Service
5. “No vegetation strips” around exterior building walls and all property lines adjacent to
properties containing potential harborages are helpful for discovering and discouraging
travel by rodents.
44.6.2 Buildings
1. Provide separate and sufficient space for placement of equipment and storage of materials
necessary for proper operations.
2. Separate activities that might cause contamination of stored foods with chemicals, filth, or
other harmful material.
3. Check structural conditions, pest barriers, and repair of windows, screens, and doors
continuously.
4. Seal and clean floor–wall junctions and fill holes and cracks; a painted inspection strip is
also recommended.
5. Keep offices—including overhead offices—in the food warehouse clean and do not permit
them to become attractants or harborages for insects or vermin. Include them in the pest
control program.
6. Check false ceilings for harborage of insects and rodents.
7. Give basements, attics, elevators, and rail sidings, etc., special attention.
44.6.3 Sanitary Operations
1. Keep walls, ceilings, and rafters free of soil, insect webbing, mold, and similar materials.
2. Do not leave unscreened doors and windows open unnecessarily. Do not permit dust to
accumulate.
3. Keep floors free of product spillage, oil drippage, and buildup in all areas. Provide proper
trash and refuse storage and removal.
4. Store tools and equipment properly.
5. Clean and flush floor drains regularly.
6. Maintain railroad and truck courts free of debris and properly patrol them for pest control.
7. Keep eating and break areas, locker rooms, etc., clean and orderly. Vending machines are
often overlooked; keep them and the areas adjacent to them clean and sanitary. Maintain
equipment in a properly functioning condition and do not permit it to serve as a source of
sanitation or harborage problems.
44.6.4 Receiving and Inspection

1. Inspect the materials that are being received for evidence of damage; insect, bird, rodent,
or other vermin infestation; and moisture, odor, or chemical contamination.
2. Exclude contaminated materials, including product, pallets, and slipsheets, from the building.
3. If damaged merchandise is accepted, segregate it for special handling.
4. Make sure that incoming and outgoing vehicles are free of conditions that could contami-
nate product—no birds, rodents, insects, spillage, or objectionable odor should be evident.
5. Code or mark foods received at the receiving point to ensure proper stock rotation. To facil-
itate handling of rejected and suspect product, it is often a good idea to develop procedures
with individual shippers, carriers, and/or manufacturers for reinspections, returns, etc.
44.6.5 Storage
1. Store products in an orderly manner and stack in such a way that date codes are visible for
proper rotation.
2. Generally, it is desirable to stack foods on pallets or racks (or on slipsheets, where a clump
truck operation is utilized) away from walls so as to allow for inspection aisles between
Warehousing Sanitation and Safety 1081
stacks and walls. Painting inspection aisles in a light color is often helpful in maintaining
their effectiveness. Where full inspection aisles are not provided, take special care (such as
more frequent inspection, rotation, and removal of product for cleaning) to ensure sanitary,
pest-free conditions.
3. Separate bagged and baled foods to provide visibility between stacks.
4. Dispose of contaminated or infested merchandise, or otherwise remove it from the food
warehouse promptly.
5. Promptly remove damaged merchandise and broken containers from general food storage
areas. Handle and process salvageable merchandise separately in an area isolated from
general food storage; this area probably will require extra sanitation and pest control
attention.
6. If salvage operations include the repackaging or other manipulation of exposed foods
(other than items such as fresh produce received unpackaged or in partially open p ackages),
conduct such operations in compliance with the food sanitation practices, guidelines, or
regulations (such as 21 CFR 110, GMPs, and other FDA documents) that are applicable to
handling exposed foods.
7. Do not intermingle chemicals, including “pesticides,” with food or food products. Such
products must be kept in locked storage, separate from food-handling areas.
44.6.6 Pest Control

1. Maintain written schedules and log activity and monitor traps and bait stations
regularly.
2. Use covered bait stations that are of such types and so located as to reduce the danger of
spillage, and where appropriate, use moistureproof bait stations.
3. Keep the pesticides that are used in the food warehouse secured and separate from foods.
Permit their use only by properly trained personnel. Use only types registered and approved
by an appropriate government agency for the intended use.
4. Check especially for (1) rodent burrows in nearby grounds, (2) activity at floor–wall
junctions and doorways, and (3) insect crawl marks in duct accumulation, especially
on overhead pipes, beams, and windowsills and around flour, sugar, and pet food
storage.
5. Where feasible, seal load levelers at docks to prevent trash accumulations and rodent
harborage and entry; otherwise, clean them frequently. Look for insect activity in folds of
bagged foods.
6. Use black light, supplemented with means for distinguishing other chemicals that
fluoresce, to check for rodent urine stains; and use flashlights to check for other evidence
of contamination.
44.6.7 Shipping
Make sure that transportation equipment into which food warehouse food is loaded is maintained
in a sanitary condition comparable to that of the food warehouse. Make sure that railcars, trailers,
and trucks are (1) free of birds, rodents, and insects or contamination from them and (2) free of
accumulations of dirt or dunnage and in good repair with no holes, cracks, or crevices that could
provide entrances or harborages for pests.
44.6.8 Follow-Up
You should implement programs of follow-up and control to ensure that your employees, consul-
tants, and outside services are doing their jobs effectively.
44.7 CASE STUDY: INSPECTING INCOMING FOOD MATERIALS

AND RAW INGREDIENTS
In the last 50 years, the FDA has issued numerous instructions and guides on the inspection of
incoming food materials and raw ingredients, appearing in, among others:
1. IOM (Inspection Operations Manual)
2. GMP
3. FDA inspection forms
4. FDA warning letters
5. FDA brochures, pamphlets, press releases, directives and others
The information in Section 44.7 has been modified from such documents and presented in a case
study format to help warehouse managers to keep their warehouses safe and sanitary. The format of
discussion is that of teacher (FDA) and student (employee).
44.7.1 Introduction
If you are given the job of inspecting and unloading canons of incoming food materials, be famil-
iar with this section. It will help you make a good start. A sample inspection form (Figure 44.1) is
provided to guide you during your inspection. Discuss these materials with your supervisor and ask
him or her for any additional guidelines or instructions.
Remember a good thorough inspection of incoming food materials is the first line of defense
against producing infested or otherwise contaminated finished products. By following the guide-
lines of this inspection report and recording your findings, you will make a good beginning and
will greatly help your supervisor to make the correct decision regarding rejection or acceptance of
incoming shipments. Many firms provide additional consumer protection by notifying the local FDA
office regarding shipments they have rejected. Commercial firms are free to reproduce this form to
use as a supplement to their own inspection form or excerpt portions from it and devise a new form.
44.7.2 Why Should You Inspect Incoming Food Materials?

1. To make your money, your firm must handle only good products. Rotten, spoiled, or con-
taminated food materials will never change into good products.
2. Very often, firms that accept contaminated and spoiled food materials are forced to go out
of business. When this happens, employees lose their jobs. Contaminated and spoiled food
can make people sick, including you, your family, and anyone else who may eat this food.
3. Since most of us cannot be there to inspect the food materials as they are delivered to your
firm, we depend on you to make a good inspection and to make sure contaminated food
materials do not enter your plant.
44.7.3 Will You Inspect?

To do this right, you have to know how to inspect and what is needed to make a good inspection.
44.7.4 Before the Shipment Arrives

Before the shipment arrives, make sure of the following:
1. The storage space for the shipment is clean and dry.

2. The equipment you will use to handle incoming food materials is clean and in good repair.
3. You have the following tools so you can make a good inspection:
a. Magnifying glass
b. Flashlight
c. Black light (ultraviolet light source for identifying rodent urine)

d. Sample containers (plastic bags with self-seals or glass jars with covers)
e. Sample thief, trier, and spatula
f. Other equipment to aid inspection of specific products
g. Inspection report form
h. Marking pencil
4. You do not contaminate the product during sampling.
5. You follow specific instructions given by your supervisor.
FIGURE 44.1 A sample of an FDA inspection report form. (From the FDA public document,
www.FDA.gov.)(Continued )
FIGURE 44.1 (Continued) A sample of an FDA inspection report form. (From the FDA public document,
www.FDA.gov.)(Continued )
FIGURE 44.1 (Continued) A sample of an FDA inspection report form. (From the FDA public document,
www.FDA.gov.)
If you follow these and your supervisor’s instructions and use the equipment properly, you will
make a good inspection and help assure that only clean, wholesome ingredients and food materials
are used in the products you help manufacture.
Table 44.1 provides a sample inspection report for incoming food materials.
44.7.5 Note Outside Condition of Carrier

1. The outside condition of the carrier may indicate contents were exposed to contami-
nation while in transit. The reasons are simple; mud, dirt, water, oil stains, or heavy
insect debris on the outside of a carrier may have found its way to the products. For
example, if the outside is wet, seepage may have occurred and contaminated the
contents.
2. The shipment is more likely to be contaminated if the carrier is (1) an open-bed truck that
is not properly covered or (2) a truck or boxcar that is visibly damaged.
3. Notify your supervisor if you suspect shipment was exposed to contamination while in
transit. Also note in your inspection report the type of carrier bringing the shipment.
44.7.6 Is the Seal Broken?

The manufacturer affixed the seal to assure that you receive the high-quality products manufac-
tured and shipped; if the seal is broken, the acceptability of the products in the shipment should be
suspected. The reasons are as follows:
1. A broken seal may indicate that some of the merchandise was stolen or that poor-quality
products may have been substituted after your shipment was loaded and before arrival at
your plant.
2. Toxic nonfood items may have been added to the load, possibly contaminating your
products, and removed before delivery of your shipment.
3. Compartment doors may have been opened to air out foul odors shortly before arrival
at your receiving dock. Odors may have accumulated from trash, filth, or spillage from
previous shipment or your present shipment.
Do not accept shipment if seal is broken; notify your supervisor before proceeding further with the
inspection and receiving.
44.7.7 Open the Doors

Check for off-odors and high temperatures. If you find off-odors in any shipment or the tempera-
ture is high in refrigerated loads, it may mean the delivered products are unsafe. The reasons are
as follows:
1. Foul odors may have been caused by the failure to remove food particles, filth, and
infestation resulting from previous shipments or failure to clean the carrier properly before
loading your shipment.
2. The products may have been decomposed before being loaded, causing the off-odor.
3. The products may have absorbed harmful off-odors before shipment.
4. Toxic solvents, petroleum products, or chemicals may have been carried with your shipment
and unloaded before arrival at your receiving dock.
5. Frozen products, in the refrigerated load, may have been allowed to thaw during shipment,
permitting bacteria to grow and produce off-odors.
TABLE 44.1
A Sample Inspection Report for Incoming Food Materials
Shipment or product ________________ Date inspected _______________
Type of carrier ______________ Name of inspector ____________________
To the inspector: Check the space or spaces that indicates what you found during your inspection. Also note in the
“Remarks” section anything else you found that is not listed on the form.
Is the outside of the carrier:
Clean____ muddy ___ dim ____ oily ________ other (describe) ____________
Is the compartment door seal(s): OK _______ broken ________ missing __________
As you open the compartment door(s):
Does it smell clean ____________ Do you smell off-odors __________
• Petroleum distillate___________
• Putrid or sour____________
• Other (describe)_____________
Is the temperature (refrigerated) compartment:
high ________________low ___________OK ________________
Are boxes, cartons, or containers:
properly stacked ____ improperly stacked _________
• Crushed _____
• Broken ___________
• Scattered _________
Is there evidence of activity by:
• Insects (live or debris) ____________
• Rodents (pellets, urine) ____________
• Birds (droppings, feathers) _____________
(e.g., is there evidence of nesting in cracks, corners, or inside broken partitions, bird droppings, insect debris, or rodent
pellets or urine stains in containers, walls, or floors)
If yes, notify your supervisor immediately.
Is there evidence of misuse of pesticides? If yes, the pesticides are:
_______________, _______________, __________, _____________
Does the shipment include harmful nonfood items ______?
Describe ___________________
(e.g., petroleum distillate, chemicals, solvents, pesticides, cleaning compounds, or odor)
Sampling and examination information:
Number of cartons in shipment _________________________
Number of cartons randomly selected and set aside for examination ____________
Number of cartons opened _________________________
Number of packages taken from cartons that were examined ____________
Number of packages found contaminated
Condition of inside of carrier
• Is in good shape___________________
• Is damaged _________(describe)______________________
• Is dirty _______________________________________
• Is infested (describe) __________________
• Contains trash and wastes from previous shipment ____________(describe) ____________________
• Has been swept clean ____________________________
Add any other comments or remarks that you may wish regarding what you observed during the inspection.
Remarks:
Recommendation: Accept __________Reject __________the shipment.
Source: Adapted from the Food Safety Manual, Science Technology System (sTs), West Sacramento, CA, Copyright 2014.
Used with permission. Original information modified from the FDA public documents, www.FDA.gov.
6. High temperatures in refrigerated compartments will allow the few bacteria normally
present in the products to increase to dangerous numbers and to produce harmful decom-
position products and odors.
Do not accept shipment if off-odor or high temperature is observed. Instead, close the compartment
doors immediately and tell your supervisor. Such products can be a danger to health and therefore
may be seized.
44.7.8 Note Condition of Cargo

Packages, canons, and similar types of containers protect the products they contain. If they are
broken, crushed, or otherwise damaged, their contents will be exposed to possible contamination.
The reasons are as follows:
1. It is difficult to prevent contamination of food products in damaged packages, cartons, or

other containers.
2. Broken packages or containers may mean the product was contaminated and violative before
it was loaded and shipped. The damage may have occurred while the product was in storage
and contents exposed to insects, rodents, or other contamination while awaiting shipment.
3. Harmful chemicals or pesticides may have entered the broken containers.
4. The shipment may have been improperly stacked or mishandled while loading or not
protected while en route to your plant.
Do not invite trouble; set aside all damaged cartons, containers, and packages. Do not tape over or
repair holes or other damages you may find in packages or cartons; report to your supervisor if you
discover many broken or damaged cartons.
44.7.9 Look for Insect, Rodent, or Bird Activity

Finding insects, rodent excreta, bird feathers or droppings, or rodent urine (detected with ultraviolet
light) is an evidence that the products were exposed to contamination, making them unfit for food.
Do not accept shipments containing insect, rodent, or other filth. The reasons are as follows:
1. Insects, rodents, and birds are often carriers of disease-producing bacteria and parasites.
Rodent excreta or droppings and urine can transfer these organisms to food products.
2. Products may have been contaminated with this filth before being shipped to your plant.
3. The FDA will seize products stored in your warehouse if they are exposed to or contain
insect or rodent or other filth. The filth does not have to be found in exposed products to
make the product subject to legal actions.
Notify your supervisor as soon as possible when you find evidence of insect, rodent, bird, or other
contamination in the shipment.
44.7.10 Collect Random Samples

Random samples should be collected from the shipment and examined for contamination either on
the spot or in the laboratory. The reasons are as follows:
1. It is not possible or practical to examine the contents of every packaged product in the
shipment because the package is not saleable after opening and may become contaminated
before being used.
2. Random samples that are representative of those in the entire shipment can be relied upon
to show if products are acceptable or contaminated.
3. We can get a true picture of the entire lot “only” if the samples tore collected “randomly”
(i.e., every 10th, 12th, 13th, etc., package, depending on the number in the shipment).
If you are given the job to unload and inspect the shipment and no one is available for on-the-spot
examination of the contents of packages, ask your supervisor for instructions as to the number
of cartons of packages he or she wants you to take randomly from the load to set aside for later
examination, either on the spot or in the laboratory. Follow the instructions carefully because it is
important that samples be collected randomly.
If you are assigned to make on-the-spot examinations of collected samples, be sure you
follow proper instructions and know how to use all relevant FDA inspection tools. Proper sam-
ple collection and examination will help prevent accepting contaminated shipments that should
be rejected.
44.7.11 Are Nonfood Items in the Shipment?

Write in your report any nonfood products (liquid or dry) that you find in the shipment with the
food items. Such products may he poisonous and can be a source of food product contamination.
For example, there is no way you can be sure containers of nonfood products will not leak or break
during shipment or storage and contaminate the food items, making them poisonous or otherwise
unfit to eat, which can happen without you knowing since no change in the appearance of the food
products may take place.
You don’t have to find the poisonous stuff in the material to reject the shipment The Food, Drug,
and Cosmetic Act, which protects consumers, says in simple words that a food product is illegal
if it is prepared, packed, or held (or shipped) under conditions that may have caused it to become
contaminated with filth or that may have caused it to become dangerous to the health of consumers
(such as by exposing it to poisonous substances).
Be very careful about accepting foods shipped or stored with nonfood products that may be
poisonous.
44.7.12 Observe Inside Condition of Carrier after Unloading

Floors and walls in disrepair and residue wastes from nonfood shipments can cause contamination.
The reasons are as follows:
1. Cracks and broken boards are good hiding places for insects that could invade the shipment
while in transit.
2. Residues from nonfood items previously shipped in the carrier can contaminate food
products.
3. The presence of cracks, splinters, or broken boards may have prevented satisfactory clean-
ing and sanitizing of the carrier’s interior prior to loading your shipment, increasing the
chance for contamination.
If the inside condition of the carrier you are inspecting is bad, mention it in your inspection report.
To discourage infestation, make sure all of the paper liners and wastes from your shipment are
removed and the truck or railcar is swept clean before releasing it.
44.8 FDA CPG: FOOD STORAGE AND WAREHOUSING-ADULTERATION-FILTH

The FDA Compliance Policy Guide (CPG) Section 580.100 refers to filth adulteration of domestic
and import food storage and warehousing.
44.8.1 Criteria for Direct Reference Seizure

The following represents criteria for direct reference seizure to and for direct citation by the FDA if
the foods are not reconditioned by sampling, when one of the following conditions is met:
44.8.1.1 Rodent Contamination

1. The storage facility is rodent infested and
a. Three or more of the bags in the lot are rodent gnawed; or
b. At least five of the bags in the lot bear either rodent urine stains at least 1/4 in. in diam-
eter or two or more rodent pellets; or
c. The food in at least one container in the lot contains rodent-gnawed material or rodent
excreta or urine
2. Whether or not the warehouse is rodent infested,
a. At least three bags bear rodent urine stains of at least 1/4 in. diameter that penetrate
to the product even though the product cannot be demonstrated to have been contami-
nated; or
b. At least two bags are rodent gnawed and at least five bags bear either rodent urine
stains at least 1/4 in. in diameter, with or without penetration to the product, or two or
more rodent pellets; or
c. The food in at least one bag in the lot contains rodent-gnawed material or rodent
excreta or rodent urine and at least five bags bear either rodent urine stains at least 1/4
in. in diameter or two or more rodent pellets
44.8.1.2 Insect Contamination

The criteria involving dead insects only should not be used to seize any food if the food will
undergo further processing that will effectively remove all the dead insects present (e.g., cocoa
beans).
3. The product contains

a. One live insect in each of the two or more immediate containers or one dead insect
in each of the three or more immediate containers or three live or dead insects in one
immediate container; plus
b. Similar live or dead insect infestation present on, or in the immediate proximity of, the
lot to clearly support a charge under Section 402(a)(4) or
c. One or more live insects in each of the three or more immediate containers or
d. Two or more dead whole insects in at least five of the immediate containers:
i. This situation may follow fumigation and vacuuming of the exteriors of the bags of
a lot or
ii. The product is in cloth or burlap bags and two or more live or dead insects are pres-
ent on at least five of the containers or
iii. Some live insects must be present. Product need not be shown to have become
contaminated
44.8.1.3 Bird Contamination

1. If product is in permeable containers (paper, cloth, burlap, etc.).
2. The product contains bird excreta in one or more containers, and the insanitary storage
conditions clearly support a charge under Section 402(a)(4).
3. Bird excreta is present on the exteriors of at least five of the containers, and the product
contains bird excreta in one or more containers.
4. At least 30 of the number of the bags examined, but at least 5 bags, are contaminated with
bird excreta.
5. At least three of the bags bear excreta stains that penetrate to the product, even though the
product cannot be demonstrated by chemical analysis to have been contaminated.
Note: Bird excreta must in all instances be confirmed by positive test for uric acid.
44.8.2 Remarks
When the evidence clearly shows contamination after receipt in interstate commerce, and a charge
is made, insert the following sentence at the end of the “Examination shows …” paragraph:
“The evidence does not show article was adulterated when introduced into interstate com-
merce.” If there is doubt whether the adulteration occurred before or after shipment, omit this
sentence but still charge that the article was adulterated while held for sale after shipment in
interstate commerce. If the evidence shows that rodents have gnawed through all layers of some
of the bags and into the food, charge 342(a)(3), as shown in the attached specimen charge. If the
gnawing is not shown to be all the way through the bags, then show in the “Examination shows
…” paragraph that the article is held in rodent-gnawed bags and charge under 342(a)(4) only.
Likewise, if rodent urine, rodent excreta pellets (REPs), bird excreta, or insects are observed in
the food itself, charge 342(a)(3). If they are observed on the outsides of the bags but cannot be
found in the food, show in the “Examination shows …” paragraph that the article is held in bags
contaminated with rodent urine, rodent pellets, or bird excreta or in insect-infested bags, and
charge under 342(a)(4) only.
44.8.3 Specimen Charge
Article adulterated while held for sale after shipment in interstate commerce:
• In that it consists in part of a filthy substance by reason of the presence therein of rodent
urine and REPs
• In that it has been held under insanitary conditions whereby it may have become contami-
nated with filth
• Article adulterated while held for sale after shipment in interstate commerce in that it has
been held under insanitary conditions whereby it may have become contaminated with filth
44.8.4 Criteria for Prosecution

1. The inspection or inspections on which the prosecution recommendation is based show
substantial insect, rodent, or bird infestation of the warehouse.
2. Samples of lots from at least two different interstate shippers are found to contain insects,
bird excreta, rodent-gnawed food, rodent excreta, or rodent urine in the food itself. This
does not mean one insect-infested lot and one rodent-infested lot. If the area is rodent
infested, there must be two rodent-infested lots; if bird infested, two bird infested lots; or
if insect infested, two insect-infested lots. On insect-infested lots, there must be insects of
the same species in both lots.
3. At least one responsible individual is included in the prosecution recommendation.
4. There is substantial evidence to show that each individual included in the prosecution com-
mendation has authority to prevent or correct violative conditions found.
5. There is a background showing prior notification of the firm and all individuals included in
the prosecution recommendation for similar insanitary conditions prior to the last inspec-
tion on which the prosecution is based.
There will, of course, be cases that do not meet the aforementioned criteria but that will warrant
prosecution.
44.8.5 Regulatory Action Guidance for Import

Detain import foods on the basis of the domestic criteria in this guideline only when associated with
insanitary storage conditions on the dock, except for live insects.
Mites, aphids, psocids, and thrips must be reported separately from usual storage insect contami-
nation and are not applicable to this CPG.
44.8.5.1 Live Insect Contamination

Detain whether or not the present storage facility is insect infested if the product contains
1. One live insect in each of the two or more immediate containers; or

2. Three live insects in one immediate container
Where there are insanitary storage conditions on the dock or live infestation in or on the product,
disregard any existing defect action level (DAL) or other guidelines level for the product. When field
insect filth (other than live insects) is found in a product, use the DALs to determine whether or not
to detain the shipment. If there is no applicable DAL for the specific product in question or the evi-
dence suggests stored product insect filth, facsimile worksheets to FDA headquarters to determine
if detention action should be taken.
44.9 FSIS-USDA: FOOD SECURITY IN A WAREHOUSE

44.9.1 Background Information
The FSIS-USDA has issued a document titled Guide to Developing a Food Defense Plan for
Warehouse and Distribution Centers, www.FSIS.USDA.gov. A summary is provided here.
Food defense is putting measures in place that reduce the chances of the food supply from
becoming intentionally contaminated using a variety of chemicals, biological agents, or other harm-
ful substances by people who want to do us harm. These agents could include materials that are
not naturally occurring or substances not routinely tested for in food products. A terrorist’s goal
might be to kill people, disrupt our economy, or ruin your business. Intentional acts generally occur
infrequently, can be difficult to detect, and are hard to predict.
Food defense is “not” the same as food safety. Food safety addresses the accidental contam-
ination of food products during storage and transportation and focuses on biological, chemical,
or physical hazards. The main types of food safety hazards are microbes, chemicals, and foreign
objects. Products can become contaminated through negligence and can occur during storage and
transportation.
Some of the information you will use to create your food defense plan will already exist in your
SSOPs, HACCP plan, and other documents relating to emergency response procedures. Make sure
to consult these documents for information. There is no need to “reinvent the wheel” when develop-
ing your food defense plan.
A food defense plan helps you identify steps you can take to minimize the risk that food products
in your establishment will be intentionally contaminated or tampered with. A plan increases pre-
paredness. Although the plan should be in place at all times, it may be particularly helpful during
emergencies. During a crisis, when stress is high and response time is at a premium, a documented
set of procedures improves your ability to respond quickly. A food defense plan will help you main-
tain a safe working environment for your employees, provide a safe product to your customers, and
protect your business.
This guide assists you in developing a cost-effective food defense plan for your facility. This
guide was developed in consultation with a variety of warehouse and distribution center estab-
lishments in an attempt to ensure that the information presented is beneficial, practical, and
achievable.
The FSIS recommends you review the guidance and assess which preventive measures are suit-
able for your operation. You should determine the most cost-effective way to achieve food defense
goals based on your facility’s situation. It is important to remember that there is no “one size fits all”
approach to creating your food defense plan. The plan can be as long or as short as is appropriate
for your operation.
The following are some examples of the types of individuals who might be motivated to
intentionally adulterate food products. You should contact your local law enforcement community
for additional information about potential local threats to your facility.
1. Disgruntled current or former employee

2. Members of terrorist or activist groups posing as
a. Cleaning crew
b. Contractors
c. Temporary employees
d. Truck drivers (shipping and receiving)
e. Visitors
f. Utility representatives
Individuals that want to intentionally adulterate product and do not have authorized access to
your facility are considered intruders. Another threat may come from an internal source, such as
disgruntled current or former employees and other insiders, who typically know what procedures
are followed in the facility and often know how to bypass many security controls that would detect
or delay an outside intruder.
44.9.2 Three Steps in Developing a Food Defense Plan

The FSIS recommends using the following three steps when developing a food defense plan.
44.9.2.1 Step 1: Conduct a Food Defense Assessment

Begin by choosing a person or team to be responsible for the security of your warehouse or distri-
bution center. The team or responsible person will answer the questions in the assessment later to
help you understand which parts of your facility may be more vulnerable. When completing this
assessment, remember to consider both potential internal and external threats. The results of the
assessment should be kept confidential so that they do not provide a roadmap for future attacks.
This assessment uses questions and answers. A “Yes” response for every question is desirable
but not expected. A “No” answer on a question does not necessarily mean there is a serious problem
with security at your warehouse or distribution center. A “No” should trigger some thinking about
whether additional security measures are needed.
44.9.2.1.1 Outside Security

1. What food defense measures does your warehouse/distributorship have in place for the
exterior of the building?
2. Are the following secured with locks, seals, or sensors when unattended (after hours/
weekends) to prevent entry by unauthorized persons?
3. Does your warehouse/distributorship have food defense procedures for people and/or
vehicles entering the facility and/or parking in your lot?
44.9.2.1.2 General Inside Security

4. Does your warehouse/distributorship have food defense measures inside the facility?
5. Are the controls for the following systems restricted (e.g., by locked door/gate or limiting
access to designated employees) to prevent access by unauthorized persons?
6. Does your facility have food defense procedures in place for its computer systems?
7. Which of the following food defense procedures does your facility have in place for the
storage of hazardous materials/chemicals such as pesticides, industrial chemicals, cleaning
materials, and disinfectants?
44.9.2.1.3 Shipping and Receiving Security

8. Does your facility have food defense procedures in place for handling outgoing
shipments?
9. Which of the following food defense procedures does your facility have in place for
handling incoming shipments?
10. Does this facility allow returned goods, including returns of U.S. exported products, to
enter the plant?
11. Which of the following food defense procedures does this facility have in place for returned
goods?
44.9.2.1.4 Mail Handling Security

12. Which of the following food defense procedures does this facility have in place to ensure
mail handling security?
44.9.2.1.5 Personnel Security

13. Which of the following food defense procedures does your facility have in place for
ensuring that personnel adhere to the security requirements?
44.9.2.2 Step 2: Develop a Food Defense Plan

Now that you have identified the aspects of your warehouse or distribution center that may be vul-
nerable, you will need to identify cost-effective preventive actions that can be taken to minimize
those vulnerabilities.
At a minimum, your food defense plan should address
• Inside security
• Outside security
• Storage security
• Shipping and receiving security
There are other examples of potential vulnerabilities and food defense measures available from the
websites of the FSIS or trade association guidance material.
Using the aforementioned information, you are now ready to complete your plan, as indicated in
the following:
Step 1. Begin by answering the self-assessment questions in this guide or the attached pamphlet to
determine if changes should be made to your current practices.
Step 2. List the possible areas of vulnerability. Then, list what food defense solutions you plan to use
to reduce them. You should consider the basic areas of vulnerability:
• Outside security
• Inside security
• Shipping and receiving security
• Personnel security
If you suspect someone has tampered with food at your facility, consult the appropriate emergency
contacts.
44.9.2.3 Step 3: Implement the Food Defense Plan

Once you have a written food defense plan, these questions will help you ensure that it is functional
and up to date.
You must be prepared to implement other activities as indicated in the following.
As discussed previously, key elements of effective plan implementation include assigning respon-
sibilities, training staff, developing contact lists, and checking your recall plan.
Individual employee’s food defense responsibilities should be defined and documented in your
plan. Assign overall responsibility for food defense to a single employee, if possible, who has an
understanding of the security requirements.
Train staff in all provisions of the plan. The purpose of food defense awareness training is to
ensure your employees know their responsibilities. Training should address access control pro-
cedures, access to restricted areas, protecting critical components, and procedures for reporting
suspicious activities. Understanding the threat of intentional adulteration and the potential conse-
quences should help employees consistently execute preventive measures, increasing the overall
effectiveness of the plan. Encourage the “neighborhood watch” concept—employees can be your
“eyes and ears.”
Review your plan and revise it, as needed, at least annually or when there is a change in your
process. You may need to revise the plan to address changing conditions such as adding a new
customer and adding a new technology. Record the fact that you have done so in the space below.
In addition to warehouse employees, current local, state, and federal government homeland secu-
rity contacts and public health officials should be listed in the plan. Local law enforcement and FBI
offices should also be included in the contact list. Update the list regularly. You may wish to keep
this list near your phones for a ready reference.
You probably already have product recall procedures developed and included in some other plans
in your operation. Please review your recall procedures and determine if any updates need to be
made to address food defense concerns. If you do not have established recall procedures in place,
please contact an industry trade association for additional information.
44.10 FDA WARNING LETTERS FOR DEFICIENCIES IN FOOD

STORAGE WAREHOUSES
The FDA sends warning letters to a food company if an inspection shows sanitation deficiency in
the company’s processing operation. Examples of such deficiencies in food warehouses are provided
here. (Note: “You” refers to the company receiving the warning letters.)
44.10.1 Company A
You failed to take effective measures to exclude pests from the processing areas of your facility
and to protect against the contamination of food on the premises by pests. The conditions observed
include the following:
• A live rodent ran across the floor in the northeast area of the warehouse.
• REPs on bags and on closed and exposed boxes of spices and chilies.
• REP on pallets and shelving storing spices and chilies.
• Dead insect particles too numerous to count on more than 100 bags of food product such
as spices and chilies.
You have not provided any documentation of specific steps taken to exclude pests from your facility
and to protect against the contamination of food on the premises by pests.
You failed to maintain buildings, fixtures, and other physical facilities in sanitary condition and
failed to keep them in repair sufficient to prevent food from becoming adulterated. The conditions
observed include the following:
• Food products, such as powdered and whole spices, were located on the floor throughout
the warehouse.
• Food debris and REPs were located throughout the warehouse on the floor, pallets, and
shelving.
• Over 10 wet boxes of chile guajillo due to apparent roof leaks.
• FDA lab analysis of samples taken of chile guajillo stored at your facility indicated this
food product to be contaminated with mold.
• Five of the six glass windows in the warehouse ceiling were broken and cracked.
• A hole approximately 1 in. × 2 in. in the northeast ceiling of the restroom and mold-like
substance in this area.
You failed to provide, where necessary, adequate screening or other protection against pests. The
conditions observed include the following:
• A window in the restroom was propped open with a wadded up paper towel and was inad-
equately screened to prevent the entry of pests.
• A hole approximately 1 in. × 2 in. in the middle roll-up door about 4 in. from the bottom
serving as an entryway for pests.
• A gap approximately under the southernmost roll-up door in the east wall serving as an
entryway for pests.
• A hole approximately 6 in. long and 2–3 in. high in the lower corner of the rear man door
serving as an entryway for pests.
• Gaps greater than 1 in. along the north wall juncture at the restroom wall and between two
wood panels on the north wall serving as an entryway for pests.
You failed to provide sufficient space for storage of materials as necessary for the maintenance
of sanitary operations and the production of safe food. The conditions observed include the
following:
• Food products, utensils, and equipment were lined up two and three pallets deep in front
of walls and in the middle of aisles.
• Twenty or more boxes of corn husks were observed to be stacked at least 5 ft high and
against walls with no space between them.
• The areas along the perimeter of the warehouse were inaccessible due to the placement of
food items and boxes.
44.10.2 Company B
FDA laboratory analyses of a filth sample found evidence of pest activity adjacent to raw agricul-
tural product. Specifically, the filth sample confirmed the presence of mouse excreta pellets; bird
excreta; hairs (mouse, dog/cat, and human); feathers (sparrow and unidentified); dead, adult insects
(grain beetles, grain borers, spider beetles, flour beetles, and etc.); other whole dead insects and
fragments (pseudoscorpions, flower fly, ham beetle, humpback fly, dermestid larva and cast skins,
ants, etc.); and live house mites. Your significant violations were as follows.
You failed to take effective measures to exclude pests from your facility and to protect against
the contamination of food on the premises by pests, as evidenced by observations of live rodents
and birds in the warehouses and evidence of rodents/birds/insects throughout the warehouses that
contain uncovered bulk beans and grains (or were impending receipt of such) as follows:
1. One building: Observation in the NW corner of at least 40 REPs on a wall ledge at

floor/wall juncture and a live rodent on a hole on the ledge of the wall. This build-
ing had been used to store oats but was awaiting the next shipment, according to the
management.
2. One building: Observation of at least 36 REPs total along the west wall/floor juncture, on
a wall ledge near SW corner, on the south wall ledge, and including one on the bulk pile of
a product. This building was currently storing feed barley.
3. One building: Observation of at least eight REPs and bird excrement along the east wall
ledge (just above bulk pile of beans) and no less than five live birds flying around and
roosting above the beans. This building was currently storing pinto beans.
4. One building: Observation of at least 185 REPs, no less than eight rodent burrow holes,
and a live rodent, occurring throughout the building from north to south. This building had
been used to store soft white wheat and was due again to receive the next shipment a week
after the inspection, according to the management.
5. One building: Observation of a live rodent along the north wall on a pile of beans, at least
two live birds, and no less than two bird nests actively in use. This building was currently
storing pinto beans.
6. One building: Observation of no less than 100 scattered bird feathers, as well as a pile of
bird feathers, all along the east and north walls. According to the discussion with the man-
agement, this building was in the process of being filled with incoming soft white wheat
at the time of the inspection (both into the building and in a pile on the ground outside the
building).
Rodent pellets, bird excreta, and insect/other filth were collected from the aforementioned refer-
enced areas and laboratory analysis confirmed the pest activity.
You failed to maintain buildings and facilities in repair sufficient to prevent food from becoming
adulterated, as evidenced by holes and potential rodent/bird entryways throughout the warehouses
as follows:
1. One building: Observation of a 1 in. hole in NW corner above wall ledge, with live mouse
and REPs nearby.
2. One building: Observation of a number of 1/2 in. holes to the outside and REPs nearby, on
either side of the personnel door on the west wall.
3. One building: Observation of a 6 in. gap at the top of the north overhead door when closed,
plus gaps of undetermined size in roof cap at the north end of the building. Birds were
observed entering and exiting through these gaps.
4. One building: Observation of a crack in south wall and a 2 in. hole through to the outside,
with a live rodent attempting to exit through the hole.
5. One building: Observation of a number of holes from 1 to 3 in. along north wall, with
live rodent nearby. Missing wall panel along south wall, creating gap approximately
6 in. × 12 in. Gap of approximately 3 in. × 3 in. around an air duct penetrating the south
wall, where one bird was observed to enter. At least two live birds seen in this building.
44.10.3 Company C
You failed to take effective measures to exclude pests from the processing areas and to protect
against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).
REPs were in close proximity to stored food products in various locations throughout Unit E. More
specifically, rodent excreta were located:
• On a wooden pallet adjacent to the south wall and approximately 2 ft west of a pallet
holding 25 lb boxes of dried apricots
• On the floor in between the dried apricot pallets mentioned earlier
• On the floor in between storage racks surrounding equipment not in use
• On the floor adjacent to the east wall surrounding what appeared to be beans and approxi-
mately 1 ft away from a pallet holding boxes of bubble gum
• On a lid of a drum, labeled onion salt
• On the floor adjacent to the north wall next to equipment not in use
• Directly under and on the east and south sides of a 15 lb box of rosemary (sample c ollection
site #1)
• On a wooden pallet of nonfood items and located adjacent to the pallet of rosemary,
mentioned previously, which also held a box of onion powder (sample collection site #2)
• On the floor adjacent to the east wall and approximately 3 in. away from a pallet holding
various types of candy, such as lemon drops and milk chocolate buttons (sample collection
site #3)
Note: Rodent-like pellets were collected from each of the collection sites identified earlier and were
confirmed by laboratory analysis to be a rat/mouse excreta pellets. In addition, our analyst found rat/
mouse hairs in the collected pellets as well.
Other observations include
• One cockroach-like insect on the floor and two on the interior door frame of the walk-in
cooler where shelled walnuts were stored
• One live flying moth-type insect in the spice packaging room
• One live crawling cockroach-type insect in the spice packaging room
• Two dead rodents in a glue trap located on the north side of Unit E
• Two live crawling cockroach-type insects on the interior door frame of the walk-in
cooler
• Two live crawling cockroach-type insects near the white sink on the west wall of Unit C
where finished product is stored
You failed to store and dispose of rubbish and any offal in a manner that would minimize the poten-
tial for the waste to become an attractant and harborage or breeding place for pests. For example,
the following was observed:
• The trash dumpster, located on the immediate south exterior of Unit E, was unable to close
properly because it was overflowing with food and other types of waste. On the floor adja-
cent to the trash dumpster were other boxes of food waste including boxes of chocolates
that were melting
You failed to take reasonable measures and precautions to ensure that all persons working in direct
contact with food, food-contact surfaces, and food-packaging materials conform to hygienic prac-
tices while on duty to the extent necessary to protect against contamination of food. Accordingly,
employees must wash hands thoroughly (and sanitize if necessary to protect against contamina-
tion with undesirable microorganisms) in an adequate hand-washing facility before starting work,
after each absence from the work station, and at any other time when the hands may have become
soiled or contaminated. For example, our inspector observed:
• A female employee repacked ready-to-eat dried pears with her bare hands, then picked up
a box of the dried pears from a pallet, while simultaneously picking up a blue plastic tote
and returned to repacking pears with her bare hands—without washing or sanitizing her
hands
44.11 AN FDA INSPECTION REPORT FORM

Figure 44.1 reproduces a sample of an FDA inspection report form.
Section IX
Food Service
45 Primer on Sanitation
and Safety in the Food
Service Industries*
45.1 RETAIL AND FOOD SERVICE INDUSTRIES

What are the retail and food service industries?
According to FDA Food Code (www.FDA.gov), regulatory requirements of the 50 states, and
recommendations from the industries themselves, the general consensus is this.
Unlike many food processing operations, the retail and food service industries are not easily defined
by specific commodities or conditions. These establishments share the following characteristics:
• These industries have a wide range of employee resources, from highly trained executive
chefs to entry-level frontline employees. Employees may have a broad range of education
levels and communication skills. It may be difficult to conduct in-house training and main-
tain a trained staff because employees may speak different languages or there may be high
employee turnover.
• Many are start-up businesses operating without the benefit of a large corporate support
structure. Having a relatively low profit margin means they may have less money to work
with than other segments of the food industry.
• There are an almost endless number of production techniques, products, menu items,
and ingredients used. Suppliers, ingredients, menu items, and specifications may change
frequently.
The following is a partial listing of the types of businesses that are usually considered part of the
retail and food service industries:
1. Backcountry guided trips for groups

2. Bakeries
3. Bed-and-breakfast operations
4. Cafeterias
5. Camps—recreational, children’s, etc.
6. Casinos, bares, and taverns
7. Child and adult day care
8. Church kitchens
9. Commissaries
10. Community fund raisers
11. Convenience stores
12. Fairs
13. Food banks
* The information in this chapter has been modified from the Food Safety Manual, Science Technology System (sTs),
West Sacramento, CA. Copyright 2014. Used with permission.
1103
14. Grocery stores with specialized departments

a. Deli
b. In-store prepared foods
c. Produce
d. Meat and seafood
15. Health-care facilities
16. Interstate conveyances
17. Markets
18. Meal services for home-bound persons
19. Mobile food carts
20. Penal institutions
21. Restaurants
a. Chains
b. International specialties
c. Fast food
d. Full service
e. Independent operations
f. Roadside stands
g. Schools
22. Snack bars
23. Temporary outdoor events
24. Vending machines
For the remaining discussion in this chapter, the term food service will apply to all of the previously
mentioned 24 operations.
45.1.1 Regulatory Agencies and Jurisdiction

Most of us have heard from news media about food poisoning in restaurants, nursing homes, deli,
airplanes, picnic, and so on. Which government agencies are responsible for the safety of food
served in any of these places? It appears that the regulatory system works as follows:
Two national government agencies share responsibility as follows:
1. The safety of food served in any transport system that moves interstates is regulated by the
FDA. Also, the Food Safety and Inspection Service (FSIS) plays an important role if meat
and poultry are involved.
2. If food poisoning occurs in a local restaurant (nursing home, state prison, etc.) and one of
the food ingredients involved originated from another state, again the FDA has the regula-
tory authority. Also, the FSIS plays a regulatory role if this ingredient happens to be meat
or poultry.
3. If food poisoning occurs in any federal or federal-related institution, the FDA and FSIS
will be the regulatory authorities. Examples include federal prison and USDA-sponsored
lunch programs in any school district.
4. There are minor situations requiring FDA and/or FSIS involvement that will not be dis-
cussed here.
However, the initial government response to any safety issue in a restaurant, nursing home, etc., is
at the regional level, for example, a county public health department, especially in minor incidents.
In reality then, public health officials in each county or township have the responsibility of safety
inspection of eating facilities within its jurisdiction. The inspection frequency can be biannually,
annually, or otherwise, depending on the size and budget of the county.
Primer on Sanitation and Safety in the Food Service Industries 1105
If any food poisoning is confined to a local eatery, several scenarios are possible. If the identi-
fied ingredient comes from different parts of the state, then the state government is involved. If it
is from another state, then the FDA and FSIS may be involved. No matter what the situation is,
cooperation between federal and state governments is essential. The FDA and FSIS are the regu-
latory arms, whereas the Centers for Disease Control and Prevention (CDC) is the clinical and
investigative arm. The CDC provides surveillance and clinical data about food poisoning and the
general public.
In sum, when food poisoning breaks out, federal, state, country, and local regulatory authorities
work together to find the cause and prevent poisoning from happening. In this respect, the FDA
has led all these agencies to develop the Food Code, which forms the foundation of food safety in
the retail and food service industries. This is a handbook of hundreds of pages, revised every few
years by representatives from all government agencies involved in preventing food poisoning in our
public eateries.
The consensus is that if every retail store (e.g., deli) and every food service facility, for example,
restaurant, have a competent employee familiar with the contents of the Food Code, food poisoning
outbreaks may not be completely eliminated but their occurrences will definitely be reduced.
What are food safety hazards? Hazards are biological, physical, or chemical properties that may
cause food to be unsafe for human consumption. The goal of a food safety management system is to
control certain factors that lead to out-of-control hazards (see Chapters 5 through 9).
What are foodborne illness risk factors? The CDC has identified the most significant con-
tributing factors to foodborne illness. Five of these broad categories of contributing factors
directly relate to food safety concerns within retail and food service establishments and are
collectively termed by the FDA as “foodborne illness risk factors.” These five broad categories
are as follows:
1. Food from unsafe sources

2. Inadequate cooking
3. Improper holding temperatures
4. Contaminated equipment
5. Poor personal hygiene
45.2 GUIDES TO REGULATORS AND OPERATORS

45.2.1 FDA Food Code
One of the major tasks of the FDA is to coordinate and support stage regulatory agencies in educat-
ing and monitoring the sanitation and safety of retail and food service industries. The major success
story is the development of the Food Code that spells out the important considerations in safeguard-
ing the sanitation and safety of food served in a retail and food service establishment. This impor-
tant document has been developed under the sponsorship of the FDA with inputs from regulatory
authorities from each state and the FSIS. It is revised every few years. The information in this book
is based on the 2009 and 2013 editions. All states have adopted all or most portions of this docu-
ment in the development of state regulations. Table 45.1 provides an abbreviated table of contents
for this document. It is in a public domain and available at the FDA’s website. This document will
be referred to as the code in this chapter and Chapters 46 through 48.
This foundation of the code again encompasses good manufacturing practice (GMP), sanita-
tion standard operating procedure (SSOP), and hazard analysis and critical control point (HACCP)
systems. As will be discussed in Chapters 46 through 48, all food service operations must practice
GMP and SSOP. Some federal food service operations occurring in schools, prisons, veteran hospi-
tals, and others are required to implement an HACCP plan. As for most other food service facilities,
they are encouraged to voluntarily implement an HACCP plan.
TABLE 45.1
Abbreviated Table of Contents for the Food Code, 2009
Chapter 1: Purpose and Definitions
Chapter 2: Management and Personnel
Chapter 3: Food
Chapter 4: Equipment, Utensils, and Linens
Chapter 5: Water, Plumbing, and Waste
Chapter 6: Physical Facilities
Chapter 7: Poisonous or Toxic Materials
Chapter 8: Compliance and Enforcement
Annex 1: Compliance and Enforcement
Annex 2: References
Annex 3: Public Health Reasons/Administrative Guidelines
Annex 4: Management of Food Practices—Achieving Active Managerial Control of Foodborne Illness Risk Factors
Annex 5: Conducting Risk-Based Inspections
Annex 6: Food Processing Criteria
Annex 7: Model Forms, Guides, and Other Aids
Source: Adapted from the Food Safety Manual, Science Technology System (sTs), West Sacramento, CA, Copyright
2014. Used with permission. Original information modified from the FDA Food Code, www.FDA.gov
Sanitation and safety in restaurants are regulated by the state. However, in most situations,
county public health departments have the major responsibility of enforcing state laws and govern-
ment regulations in restaurants and other food service facilities. They make sure that all such facili-
ties comply with GMP and SSOP. At a local level, enforcement means inspection that is, of course,
subjected to the county budget.
45.2.2 Definitions Affecting the Industries

From the regulatory perspectives, federal, state, or local, there are many common terms applicable
to all food service operations. Table 45.2 lists such definitions.
45.2.3 Food Categories: Sanitation and Safety

A foodservice facility obviously has to buy food ingredients to prepare the food items that feed its
customers. The extent to which the facility will inspect and evaluate the sanitation and safety of
such ingredients depends on its size. A small neighborhood restaurant casually inspects the ingre-
dients that it buys. The actions and attitudes of small establishments are mainly governed by budget
or more appropriately profit margins.
There are many big establishments including restaurants in a big hotel, school lunches, hospital
kitchens, military feedings, and fast-food chains. For them, they have to practice preventive mea-
sures because their customer population is large and any food poisoning can ruin their businesses,
missions, or political stature. They inspect the food ingredients with more care and attention. The
U.S. Army feeding programs have required their purchasing units to look into the sanitation and
safety of the establishments that manufacture and sell food or food ingredients. Such requirements
cover the following list of food categories as listed in Table 45.3:
• Bakery requirements
• Manufactured dairy products requirements
TABLE 45.2
Definitions of Common Terms Used in the Food Service Industries
“Accredited program” means a food protection manager certification program that has been evaluated and listed by an
accrediting agency as conforming to national standards for organizations that certify individuals. It refers to the
certification process and is a designation based upon an independent evaluation of factors such as the sponsor’s mission;
organizational structure; staff resources; revenue sources; policies; public information regarding program scope, eligibility
requirements, recertification, discipline, and grievance procedures; and test development and administration. It does not
refer to training functions or educational programs.
“Additive” includes “food additive” and “color additive” as defined by law and the FDA.
“Adulterated” has the meaning defined by law and the FDA.
“Approved” means acceptable to the regulatory authority based on a determination of conformity with principles, practices,
and generally recognized standards that protect public health.
“Asymptomatic” means without obvious symptoms; not showing or producing indications of a disease or other medical
condition, such as an individual infected with a pathogen but not exhibiting or producing any signs or symptoms of
vomiting, diarrhea, or jaundice. It includes not showing symptoms because symptoms have resolved or subsided, or
because symptoms never manifested.
“aw” means water activity that is a measure of the free moisture in a food, is the quotient of the water vapor pressure of the
substance divided by the vapor pressure of pure water at the same temperature, and is indicated by the symbol aw.
“Balut” means an embryo inside a fertile egg that has been incubated for a period sufficient for the embryo to reach a
specific stage of development after which it is removed from incubation before hatching.
“Beverage” means a liquid for drinking, including water and excluding those with alcohol contents.
“Bottled drinking water” means water that is sealed in bottles, packages, or other containers and offered for sale for human
consumption, including bottled mineral water.
“Bulk food” means processed or unprocessed food in aggregate containers, from which the consumer can withdraw a
desired quantity.
“Casing” means a tubular container for sausage products made of either natural or artificial (synthetic) material.
“Certification number” means a unique combination of letters and numbers assigned by a U.S. shellfish control authority to
a molluscan shellfish dealer according to the provisions of the U.S. National Shellfish Sanitation Program.
“CIP” means cleaned in place by the circulation or flowing by mechanical means through a piping system of a detergent
solution, water rinse, and sanitizing solution onto or over equipment surfaces that require cleaning, such as the method
used, in part, to clean and sanitize a frozen dessert machine. “CIP” does not include the cleaning of equipment such as
band saws, slicers, or mixers that are subjected to in-place manual cleaning without the use of a CIP system.
“Cleanable” (see easily cleanable).
“Commingle” means to combine shellstock harvested on different days or from different growing areas as identified on the
tag or label, or to combine shucked shellfish from containers with different container codes or different shucking dates.
“Comminuted” means reduced in size by methods including chopping, flaking, grinding, or mincing. It includes fish or
meat products that are reduced in size and restructured or reformulated, such as gefilte fish, gyros, ground beef, and
sausage, and a mixture of two or more types of meat that have been reduced in size and combined, such as sausages made
from two or more meats.
“Conditional employee” means a potential food employee to whom a job offer is made, conditional on responses to subsequent
medical questions or examinations designed to identify potential food employees who may be suffering from a disease that can
be transmitted through food and done in compliance with Title 1 of the Americans with Disabilities Act of 1990.
“Confirmed disease outbreak” means a foodborne disease outbreak in which laboratory analysis of appropriate specimens
identifies a causative agent and epidemiological analysis implicates the food as the source of the illness.
“Consumer” means a person who is a member of the public, takes possession of food, is not functioning in the capacity of
an operator of a food establishment or food processing plant, and does not offer the food for resale.
“Contaminated” means adulterated or spoiled food, or food and equipment that are exposed to filth, toxic substances, or
rodent or insect contact or infestation, or potentially hazardous foods (PHFs) held at temperatures between 41°F (5°C) and
140°F (60°C) for a period of time exceeding that reasonably required for preparation, including PHFs that are not heated
or cooked to the temperatures specified, or food in or subject to any condition that could permit the introduction of
pathogenic microorganisms or foreign matter, including manual contact during service or preparation if such foods will
not be subsequently cooked or heated to the temperatures specified.
(Continued)
TABLE 45.2 (Continued)

“Contamination,” see cross-contamination.
“Corrosion-resistant material” means a material that maintains acceptable surface cleanability characteristics under
prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other
conditions of the use environment.
“Counter-mounted equipment” means equipment that is not portable and is designed to be mounted off the floor on a table,
counter, or shelf.
“Critical control point” means a point or procedure in a specific food system where loss of control may result in an
unacceptable health risk.
“Critical limit” means the maximum or minimum value to which a physical, biological, or chemical parameter must be
controlled at a CCP to minimize the risk that the identified food safety hazard may occur.
“Cross-contamination” means the act or process of rendering unfit or potentially rendering unfit the use of food as a result
of the introduction of pathogens, adulteration, or improper handling.
“Cut leafy greens” means fresh leafy greens whose leaves have been cut, shredded, sliced, chopped, or torn. The term
“leafy greens” includes iceberg lettuce, romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce (i.e., immature lettuce
or leafy greens), escarole, endive, spring mix, spinach, cabbage, kale, arugula, and chard. The term “leafy greens” does
not include herbs such as cilantro or parsley.
“Dealer” means a person who is authorized by a shellfish control authority for the activities of shellstock shipper,
shucker–packer, repacker, reshipper, or depuration processor of molluscan shellfish according to the provisions of the
National Shellfish Sanitation Program.
“Disclosure” means a written statement that clearly identifies the animal-derived foods that are, or can be ordered, raw,
undercooked, or without otherwise being processed to eliminate pathogens, or items that contain an ingredient that is raw,
undercooked, or without otherwise being processed to eliminate pathogens.
“Drain,” see indirect drain.
“Drinking water” means water that meets criteria as specified in 40 CFR 141 National Primary Drinking Water
Regulations. “Drinking water” is traditionally known as “potable water.” “Drinking water” includes the term “water”
except where the term used connotes that the water is not potable, such as “boiler water,” “mop water,” “rainwater,”
“wastewater,” and “nondrinking” water.
“Dry storage area” means a room or area designated for the storage of packaged or containerized bulk food that is not
potentially hazardous (time/temperature control for safety food) and dry goods such as single-service items.
“Easily cleanable”
It means a characteristic of a surface that
1. Allows effective removal of soil by normal cleaning methods
2. Is dependent on the material, design, construction, and installation of the surface
3. Varies with the likelihood of the surface’s role in introducing pathogenic or toxigenic agents or other contaminants
into food based on the surface’s approved placement, purpose, and use
It includes a tiered application of the criteria that qualify the surface as easily cleanable as specified earlier to different
situations in which varying degrees of cleanability are required such as the following:
1. The appropriateness of stainless steel for a food preparation surface as opposed to the lack of need for stainless steel to
be used for floors or for tables used for consumer dining
2. The need for a different degree of cleanability for a utilitarian attachment or accessory in the kitchen as opposed to a
decorative attachment or accessory in the consumer dining area
“Easily movable” means portable; mounted on casters, gliders, or rollers; or provided with a mechanical means to safely tilt
a unit of equipment for cleaning; and having no utility connection, a utility connection that disconnects quickly, or a
flexible utility connection line of sufficient length to allow the equipment to be moved for cleaning of the equipment and
adjacent area.
“Egg” means the shell egg of avian species such as chicken, duck, goose, guinea, quail, ratites, or turkey. “Egg” does not
include a balut, the egg of reptile species such as alligator, or an egg product.
“Egg product” means all, or a portion of, the contents found inside eggs separated from the shell and pasteurized in a food
processing plant, with or without added ingredients, intended for human consumption, such as dried, frozen, or liquid eggs.
“Egg product” does not include food that contains eggs only in a relatively small proportion such as cake mixes.
(Continued)

“Enterohemorrhagic Escherichia coli” (EHEC) means E. coli that cause hemorrhagic colitis, meaning bleeding enterically
or bleeding from the intestine. The term is typically used in association with E. coli that have the capacity to produce
Shiga toxins and to cause attaching and effacing lesions in the intestine. EHEC is a subset of STEC, whose members
produce additional virulence factors. Infections with EHEC may be asymptomatic but are classically associated with
bloody diarrhea (hemorrhagic colitis) and hemolytic uremic syndrome (HUS) or thrombotic thrombocytopenic purpura
(TTP). Examples of serotypes of EHEC include E. coli O157:H7; E. coli O157:NM; E. coli O26:H11; E. coli O145:NM;
E. coli O103:H2; or E. coli O111:NM. Also see Shiga toxin–producing E. coli.
“Equipment” means an article that is used in the operation of a food establishment such as a freezer, grinder, hood, ice
maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature-measuring device for
ambient air, vending machine, or warewashing machine. “Equipment” does not include apparatuses used for handling or
storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand
trucks, forklifts, dollies, pallets, racks, and skids.
“Establishment”
Although the definition of an establishment involving food varies from state to state, the difference is minor. The most
common definitions associated with a food establishment include the following:
Food service establishment
This means any establishment, place, or location, whether permanent, temporary, seasonal, or itinerant, where food is
prepared and the public is offered to be served, or is served, food, including, but not limited to, foods, vegetables, and/or
beverages not in an original package or container, food and beverages dispensed at soda fountains and delicatessens, and
sliced watermelon, ice balls, and/or water mixtures. The term includes any such places regardless of whether there is a
charge for the food. The term does not include the following:
1. Private homes where food is prepared or served and not offered for sale, retail food store operations other than
delicatessens, vending machines, or supply vehicles.
2. Grocery stores that may, incidentally, make infrequent, casual sales of uncooked foods for consumption on the
premises, or any establishment whose primary business is other than food service, which may, incidentally, make
infrequent, casual sales of coffee or prepackaged foods, or both, for consumption on the premises.
Retail food establishment (store)
This means any establishment or a section of an establishment where food and food products are offered to the consumer
and intended for off-premise consumption. The term does not include establishments that handle only prepackaged,
non–potentially hazardous foods, roadside markets that offer only fresh fruits and fresh vegetables, food and beverage
vending machines, or food service establishments not located within a retail food store.
Nonretail food processing establishment
This means a place where food is processed, prepared, stored, or packed for consumption off the premises and not given or
sold directly to the consumer. This should include but not be limited to mobile food vending commissaries, food vending
machine commissaries, and places where fish or shellfish is kept, sold, or offered for sale.
Wholesale food establishment
This means any establishment that sells food or that manufactures food other than retail sale directly to the consumer.
Permit requirements
In most states, a permit is required to operate a food establishment or nonretail food processing establishment. Such
permits prescribe the following requirements:
1. An establishment granted a permit complies with the following. The condition of the establishment, including its equipment,
utensils, personnel, mode of operation, surroundings, water supply, sewage disposal, waste handling, furnishings, food and
appurtenances, and, if applicable, past history of compliance or noncompliance, should be considered in determining
whether its operation may be dangerous or detrimental to the public health. If the prepermitting inspection indicates that
such conditions are unsatisfactory, the operator should be advised of the violations that prevent issuance of such permit.
2. P rior to new construction or major renovation of a food service establishment or nonretail food processing establishment,
where the state determines that the public health and safety requires a review of the physical plant of such establishment,
the state may require such establishment to submit sketches or plans showing the floor layout, equipment, plumbing,
ventilation, refuse storage facilities, sewage disposal facilities, and similar information. Submission and review of plans
should not relieve the operator of such establishment or his or her successor from meeting all state requirements.
(Continued)

3. An operator with a permit to operate a food establishment or nonretail food processing establishment should construct,
equip, furnish, maintain, and operate such establishment.
“Extensive remodeling” means changing seating capacity from 16 seats or less to more than 16 seats; or the alteration of
walls in food preparation or utensil washing areas; or the increase or decrease of floor size.
“Fish” means fresh or saltwater finfish, crustaceans, and other forms of aquatic life (including alligator, frog, aquatic turtle,
jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals and all mollusks, if such
animal life is intended for human consumption. “Fish” includes an edible human food product derived in whole or in part
from fish, including fish that have been processed in any manner.
“Food” means a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale
in whole or in part for human consumption, including such items as chewing gum.
“Foodborne disease outbreak” means the occurrence of two or more cases of a similar illness resulting from the ingestion
of a common food.
“Food-contact surface” means a surface of equipment or a utensil with which food normally comes into contact; or a
surface of equipment or a utensil from which food may drain, drip, or splash into a food, or onto a surface normally in
contact with food.
“Food employee” means an individual working with unpackaged food, food equipment or utensils, or food-contact
surfaces.
“Food establishment”
It means an operation that
1. Stores, prepares, packages, serves, vends food directly to the consumer, or otherwise provides food for human
consumption such as a restaurant, satellite or catered feeding location, catering operation if the operation provides
food directly to a consumer or to a conveyance used to transport people, market, vending location, conveyance used to
transport people, institution, or food bank
2. Relinquishes possession of food to a consumer directly or indirectly through a delivery service such as home delivery
of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers
It includes the following:
1. An element of the operation such as a transportation vehicle or a central preparation facility that supplies a
vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory
authority.
2. An operation that is conducted in a mobile, stationary, temporary, or permanent facility or location, where
consumption is on or off the premises, and regardless of whether there is a charge for the food
It does not include the following:
1.An establishment that offers only prepackaged foods that are not potentially hazardous (time/temperature control for
safety) foods
2. A produce stand that only offers whole, uncut fresh fruits and vegetables
3. A food processing plant, including those that are located on the premises of a food establishment
4. A kitchen in a private home if only food that is not potentially hazardous (time/temperature control for safety) food is
prepared for sale or service at a function such as a religious or charitable organization’s bake sale if allowed by law
and if the consumer is informed by a clearly visible placard at the sales or service location that the food is prepared in
a kitchen that is not subject to regulation and inspection by the regulatory authority
5. A kitchen in a private home, such as a small family day-care provider, or a bed-and-breakfast operation that prepares
and offers food to guests if the home is owner occupied, the number of available guest bedrooms does not exceed 6,
breakfast is the only meal offered, the number of guests served does not exceed 18, and the consumer is informed by
statements contained in published advertisements, mailed brochures, and placards posted at the registration area that
the food is prepared in a kitchen that is not regulated and inspected by the regulatory authority
6. A private home that receives catered or home-delivered food
“Food-grade” means intended to be used with food products, utensils, or equipment without reacting with such food
products and without imparting odor, color, or taste to such food products, or approved by the National Sanitation
Foundation or its equivalent.
(Continued)

“Food processing plant” means a commercial operation that manufactures, packages, labels, or stores food for human
consumption, and provides food for sale or distribution to other business entities such as food processing plants or food
establishments. It does not include a food establishment.
Food worker means food handler or any employee who works in a food service establishment or nonretail food processing
establishment.
“Game animal” means an animal, the products of which are food, that is not classified as livestock, sheep, swine, goat,
horse, mule, or other equine in 9 CFR 301.2 Definitions, or as poultry, or fish. It includes mammals such as reindeer, elk,
deer, antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria, or muskrat and nonaquatic reptiles such as
land snakes. It does not include ratites.
“General use pesticide” means a pesticide that is not classified by the EPA for restricted use as specified in 40 CFR 152.175
Pesticides classified for restricted use.
“Grade A standards” means the requirements of the U.S. Public Health Service/FDA “Grade A Pasteurized Milk
Ordinance” with which certain fluid and dry milk and milk products comply.
“HACCP plan” means a written document that delineates the formal procedures for following the HACCP principles
developed by the National Advisory Committee on Microbiological Criteria for Foods.
“Handwashing sink” means a lavatory, a basin or vessel for washing, a wash basin, or a plumbing fixture especially
placed for use in personal hygiene and designed for the washing of the hands. It includes an automatic handwashing
facility.
“Hazard” means a biological, chemical, or physical property that may cause an unacceptable consumer health risk.
“Hermetically sealed container” means a container that is designed and intended to be secure against the entry of
microorganisms and, in the case of low-acid canned foods, to maintain the commercial sterility of its contents after
processing.
“Highly susceptible population” means persons who are more likely than other people in the general population to
experience foodborne disease because they are immune-compromised; preschool age children or older adults; and they are
obtaining food at a facility that provides services such as custodial care, health care, or assisted living, such as a child or
adult day-care center, kidney dialysis center, hospital or nursing home, or nutritional or socialization services such as a
senior center.
“Imminent health hazard” means a significant threat or danger to health that is considered to exist when there is evidence
sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or
cessation of operation to prevent injury based on the following:
1. The number of potential injuries
2. The nature, severity, and duration of the anticipated injury
If food is considered, then imminent health hazard simply means any violation, condition, or combination of violations or
conditions making it probable that food served to the public by the establishment or its continued operation will be
injurious or dangerous to the health of any person consuming such food.
“Indirect drain” means a waste line that does not connect directly with the drainage system but conveys and discharges
liquid wastes through an air break into an approved plumbing fixture or receptacle that is directly connected to the
drainage system.
“Injected” means manipulating meat to which a solution has been introduced into its interior by processes that are referred
to as “injecting,” “pump marinating,” or “stitch pumping.”
“Juice” means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purées of the edible
portions of one or more fruits or vegetables, or any concentrates of such liquid or purée. It does not include, for purposes
of HACCP, liquids, purées, or concentrates that are not used as beverages or ingredients of beverages.
“Kitchenware” means food preparation and storage utensils.
“Linens” means fabric items such as cloth hampers, cloth napkins, tablecloths, wiping cloths, and work garments including
cloth gloves.
“Major food allergen” means
1. Milk, egg, fish (such as bass, flounder, and cod, and including crustacean shellfish such as crab, lobster, or shrimp),
tree nuts (such as almonds, pecans, or walnuts), wheat, peanuts, and soybeans
2. A food ingredient that contains protein derived from a food
(Continued)

It does not include the following:
1. Any highly refined oil derived from a food and any ingredient derived from such highly refined oil
2. Any ingredient that is exempt under the law
“Meat” means the flesh of animals used as food including the dressed flesh of cattle, swine, sheep, or goats and other edible
animals, except fish, poultry, and wild game animals as specified.
“Mechanically tenderized” means manipulating meat with deep penetration by processes that may be referred to as “blade
tenderizing,” “jaccarding,” “pinning,” “needling,” or using blades, pins, needles, or any mechanical device. It does not
include processes by which solutions are injected into meat.
“Molluscan shellfish” means any edible species of fresh or frozen oysters, clams, mussels, and scallops or edible portions
thereof, except when the scallop product consists only of the shucked adductor muscle.
“Noncontinuous cooking” means the cooking of food in a food establishment using a process in which the initial heating of
the food is intentionally halted so that it may be cooled and held for complete cooking at a later time prior to sale or
service. It does not include cooking procedures that only involve temporarily interrupting or slowing an otherwise
continuous cooking process.
“Packaged” means bottled, canned, cartoned, securely bagged, or securely wrapped, whether packaged in a food
establishment or a food processing plant. It does not include a wrapper, carryout box, or other nondurable container used
to containerize food with the purpose of facilitating food protection during service and receipt of the food by the
consumer.
“Permit” means the document issued by the regulatory authority that authorizes a person to operate a food establishment.
“Permit holder” means the entity that is legally responsible for the operation of the food establishment such as the owner,
the owner’s agent, or other person and possesses a valid permit to operate a food establishment.
“Personal care items” means items or substances that may be poisonous, toxic, or a source of contamination and are used to
maintain or enhance a person’s health, hygiene, or appearance. They include items such as medicines, first aid supplies,
and other items such as cosmetics and toiletries such as toothpaste and mouthwash.
“pH” means the symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of
acidity or alkalinity of a solution. Values between 0 and 7 indicate acidity and values between 7 and 14 indicate alkalinity.
The value for pure distilled water is 7, which is considered neutral.
“Physical facilities” means the structure and interior surfaces of a food establishment including accessories such as soap
and towel dispensers and attachments such as light fixtures and heating or air-conditioning system vents.
“Plumbing fixture” means a receptacle or device that is permanently or temporarily connected to the water distribution
system of the premises and demands a supply of water from the system or discharges used water, waste materials, or
sewage directly or indirectly to the drainage system of the premises.
“Plumbing system” means the water supply and distribution pipes; plumbing fixtures and traps; soil, waste, and vent pipes;
sanitary and storm sewers and building drains, including their respective connections, devices, and appurtenances within
the premises; and water-treating equipment.
“Poisonous or toxic materials” means substances that are not intended for ingestion and are included in four
categories:
1. Cleaners and sanitizers, which include cleaning and sanitizing agents and agents such as caustics, acids, drying agents,
polishes, and other chemicals
2. Pesticides, except sanitizers, which include substances such as insecticides and rodenticides
3. Substances necessary for the operation and maintenance of the establishment such as nonfood grade lubricants and
personal care items that may be deleterious to health
4. Substances that are not necessary for the operation and maintenance of the establishment and are on the premises for
retail sale, such as petroleum products and paints
“Potable water” means water that is safe for drinking.
“Potentially hazardous food” or PHF (time/temperature control for safety [TCS] food)
1. “Potentially hazardous food (time/temperature control for safety [TCS] food)” means a food that requires TCS to limit
pathogenic microorganism growth or toxin formation.
(Continued)

2. “Potentially hazardous food (time/temperature control for safety food)” includes the following: an animal food that is
raw or heat-treated or a plant food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut
tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic
microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are
unable to support pathogenic microorganism growth or toxin formation
3. “Potentially hazardous food (time/temperature control for safety food)” does not include the following:
a. An air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard boiled but has been
pasteurized to destroy all viable Salmonellae
b. A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain
commercial sterility under conditions of nonrefrigerated storage and distribution
c. A food that because of its pH or aw value, or interaction of aw and PH values, is designated as a non-PHF/non-TCS
food
d. Several other foods as defined by regulatory authorities
“Poultry” means any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs), whether live or dead,
and any migratory waterfowl or game bird, pheasant, partridge, quail, grouse, or pigeon, whether live or dead, as defined
by the FSIS.
“Premises” means
1. The physical facility, its contents, and the contiguous land or property under the control of the permit holder
2. The physical facility, its contents, and the land or property not described earlier if its facilities and contents are under
the control of the permit holder and may impact food establishment personnel, facilities, or operations, and a food
establishment is only one component of a larger operation such as a health-care facility, hotel, motel, school,
recreational camp, or prison
“Primal cut” means a basic major cut into which carcasses and sides of meat are separated, such as a beef round, pork loin,
lamb flank, or veal breast.
“Processed fish” means fish that has been cured, salted, marinated, dried, pickled, fermented, or smoked for human
consumption.
“Public water system” has the meaning stated in 40 CFR 141 National Primary Drinking Water Regulations.
“Ratite” means a flightless bird such as an emu, ostrich, or rhea.
“Ready-to-eat food” means food that
1. Is in a form that is edible without additional preparation to achieve food safety, as specified under requirements
2. Is a raw or partially cooked animal food and the consumer is advised as specified under requirements
3. Is prepared in accordance with a variance that is granted as specified under requirements
4. May receive additional preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes
“Ready-to-eat food” includes the following:
1. Raw animal food that is cooked or frozen as specified
2. Raw fruits and vegetables that are washed as specified
3. Fruits and vegetables that are cooked for hot holding, as specified
4. All potentially hazardous food (time/temperature control for safety food) that is cooked to the temperature and time
required for the specific food
5. Plant food for which further washing, cooking, or other processing is not required for food safety and from which
rinds, peels, husks, or shells, if naturally present, are removed
6. Substances derived from plants such as spices, seasonings, and sugar
7. A bakery item such as bread, cakes, pies, fillings, or icing for which further cooking is not required for food safety
8. The following products that are produced in accordance with USDA guidelines and that have received a lethality
treatment for pathogens: dry, fermented sausages, such as dry salami or pepperoni; salt-cured meat and poultry
products, such as prosciutto ham, country cured ham, and Parma ham; and dried meat and poultry products, such as
jerky or beef sticks
9. Foods manufactured as specified in 21 CFR Part 113, Thermally processed low-acid foods packaged in hermetically
sealed containers.
(Continued)

“Reduced oxygen packaging” means the reduction of the amount of oxygen in a package by removing oxygen, displacing
oxygen and replacing it with another gas or combination of gases, or otherwise controlling the oxygen content to a level
below that normally found in the atmosphere (approximately 21% at sea level).
“Reduced oxygen packaging” includes the following:
1. Vacuum packaging, in which air is removed from a package of food and the package is hermetically sealed so that a
vacuum remains inside the package.
2. Modified atmosphere packaging, in which the atmosphere of a package of food is modified so that its composition is
different from air, but the atmosphere may change over time due to the permeability of the packaging material or the
respiration of the food. Modified atmosphere packaging includes reduction in the proportion of oxygen, total
replacement of oxygen, or an increase in the proportion of other gases such as carbon dioxide or nitrogen.
3. Controlled atmosphere packaging, in which the atmosphere of a package of food is modified so that until the package
is opened, its composition is different from air, and continuous control of that atmosphere is maintained, such as by
using oxygen scavengers or a combination of total replacement of oxygen, nonrespiring food, and impermeable
packaging material.
4. Cook chill packaging, in which cooked food is hot filled into impermeable bags that have the air expelled and are then
sealed or crimped closed. The bagged food is rapidly chilled and refrigerated at temperatures that inhibit the growth of
psychrotrophic pathogens.
5. Sous vide packaging, in which raw or partially cooked food is placed in a hermetically sealed, impermeable bag,
cooked in the bag, rapidly chilled, and refrigerated at temperatures that inhibit the growth of psychrotrophic
pathogens.
“Refuse” means solid waste not carried by water through the sewage system.
“Regulatory authority” means the local, state, or federal enforcement body or authorized representative having jurisdiction
over the food establishment.
“Reminder” means a written statement concerning the health risk of consuming animal foods raw, undercooked, or without
otherwise being processed to eliminate pathogens.
“Reservice” means the transfer of food that is unused and returned by a consumer after being served or sold and in the
possession of the consumer, to another person.
“Restrict” means to limit the activities of a food employee so that there is no risk of transmitting a disease that is
transmissible through food and the food employee does not work with exposed food, clean equipment, utensils, linens, or
unwrapped single-service or single-use articles.
“Restricted egg” means any check, dirty egg, incubator reject, inedible, leaker, or loss as defined in 9 CFR 590.
“Restricted use pesticide” means a pesticide product that contains the active ingredients specified in 40 CFR 152.175
Pesticides classified for restricted use and that is limited to use by or under the direct supervision of a certified applicator.
“Risk” means the likelihood that an adverse health effect will occur within a population as a result of a hazard in a food.
“Sanitization” means the application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated
for efficacy, is sufficient to yield a reduction of 5 logs, which is equal to a 99.999% reduction, of representative disease
microorganisms of public health importance. Acceptable sanitization methods are as follows:
1. Immersion for at least 1½ min in clean hot water at a temperature of not less than 170°F (76.7°C)
2. Immersion for at least 1 min in a clean solution containing at least 50 parts per million (ppm) of available chlorine at a
temperature of at least 75°F (23.9°C)
3. Immersion for at least 1 min in a clean solution containing at least 12.5 ppm of available iodine and having pH not
higher than 5.0 and at a temperature of at least 75°F (23.9°C)
4. Immersion in a clean solution containing any other food grade chemical sanitizing agent that will provide the
equivalent bactericidal effect of a solution containing at least 50 ppm of available chlorine as hypochlorite that has
been held at a temperature of at least 75°F (23.9°C) for 1 min
5. Treatment with culinary-quality steam in the case of equipment too large to sanitize by immersion, but in which steam
can be confined
6. Swabbing fixed equipment with a solution of at least twice the strength required for that sanitizing solution when used
for immersion
(Continued)

“Sealed” means free of cracks or other openings that allow the entry or passage of moisture.
“Service animal” means an animal such as a guide dog, signal dog, or other animal individually trained to provide
assistance to an individual with a disability.
“Servicing area” means an operating base location to which a mobile food establishment or transportation vehicle returns
regularly for such things as vehicle and equipment cleaning, discharging liquid or solid wastes, refilling water tanks and
ice bins, and boarding food.
“Sewage” means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids
containing chemicals in solution.
“Shellfish control authority” means a state, federal, foreign, tribal, or other government entity legally responsible for
administering a program that includes certification of molluscan shellfish harvesters and dealers for interstate
commerce.
“Shellstock” means raw, in-shell molluscan shellfish.
“Shiga toxin–producing Escherichia coli” (STEC) means any E. coli capable of producing Shiga toxins (also called
verocytotoxins or “Shiga-like” toxins). Examples of serotypes of STEC include both O157 and non-O157 E. coli. Also see
Enterohemorrhagic Escherichia coli.
“Shucked shellfish” means molluscan shellfish that have one or both shells removed.
“Single-service articles” means tableware, carryout utensils, and other items such as bags, containers, placemats, stirrers,
straws, toothpicks, and wrappers that are designed and constructed for one-time, one-person use after which they are
intended for discard.
“Single-use articles” means utensils and bulk food containers designed and constructed to be used once and discarded.
They include items such as wax paper, butcher paper, plastic wrap, formed aluminum food containers, jars, plastic tubs or
buckets, bread wrappers, pickle barrels, ketchup bottles, and number 10 cans that do not meet the materials, durability,
strength, and cleanability specifications for multiuse utensils.
“Slacking” means the process of moderating the temperature of a food such as allowing a food to gradually increase from a
temperature of −23°C (−10°F) to −4°C (25°F) in preparation for deep-fat frying or to facilitate even heat penetration
during the cooking of previously block-frozen food such as shrimp.
“Smooth” means
1. A food-contact surface having a surface free of pits and inclusions with a cleanability equal to or exceeding that of
(100 grit) number three stainless steel
2. A nonfood-contact surface of equipment having a surface equal to that of commercial grade hot-rolled steel free of
visible scale
3. A floor, wall, or ceiling having an even or level surface with no roughness or projections that render it difficult to
clean
“Stand” means a movable, portable, or collapsible structure, framework, device, container, or other contrivance, other than
a vehicle or pushcart, used for displaying, keeping, or storing any food.
“Tableware” means eating, drinking, and serving utensils for table use such as flatware including forks, knives, and spoons;
hollowware including bowls, cups, serving dishes, and tumblers; and plates.
“Temperature-measuring device” means a thermometer, thermocouple, thermistor, or other device that indicates the
temperature of food, air, or water.
“Temporary food establishment” means any food service establishment that operates at a fixed location for a temporary
period of time, not to exceed 14 consecutive days, in connection with a single event or celebration such as a fair, carnival,
circus, public exhibition, advertising campaign or business promotion, religious or fraternal organization function, or
transitory gathering.
“Transportation (transported)” means the movement of food within the retail food store or the delivery of food from that
retail food store to another place while under the control of the person in charge.
“Utensil” means a food-contact implement or container used in the storage, preparation, transportation, dispensing, sale, or
service of food, such as kitchenware or tableware that is multiuse, single-service, or single-use; gloves used in contact
with food; temperature-sensing probes of food temperature–measuring devices; and probe-type price or identification tags
used in contact with food.
(Continued)

“Variance” means a written document issued by the regulatory authority that authorizes a modification or waiver of one or
more requirements if, in the opinion of the regulatory authority, a health hazard or nuisance will not result from the
modification or waiver.
“Vending machine” means a self-service device that, upon insertion of a coin, paper currency, token, card, or key, or by
optional manual operation, dispenses unit servings of food or beverage in bulk or in packages without the necessity of
replenishing the device between each vending operation. Associated definitions are as follows:
1. A controlled-location vending machine means a food vending machine that dispenses only food that is not potentially
hazardous, can be serviced in a sanitary manner by an untrained person at the location, and is located where it is
protected from environmental contamination, abuse, and vandalism.
2. A food vending machine commissary means a place where food, containers, or supplies are processed or packaged and
prepared for use in food vending machines.
3. A food vending machine operation (or location) means the place (room, enclosure, space, or area) where food vending
machines are located and includes the food vending machines, machine servicing equipment, utensils, personnel,
single-service articles, tables, chairs, that part of the premises used in connection with the food vending machine
operation, and all other appurtenances (e.g., storage area) required and used to operate and maintain the food vending
machines.
“Warewashing” means the cleaning and sanitizing of utensils and food-contact surfaces of equipment.
“Whole-muscle, intact beef” means whole-muscle beef that is not injected, mechanically tenderized, reconstructed, or
scored and marinated, from which beef steaks may be cut.
Source: Adapted from the Food Safety Manual, Science Technology System (sTs), West Sacramento, CA, Copyright 2014.
Used with permission.Original information modified from the FDA Food Code, www.FDA.gov.
• Fluid dairy requirements

• Shell egg requirements
• Frozen dessert requirements, general considerations
• Frozen dessert requirements, plant systems
• Frozen dessert requirements, specific plant operations
• Ice plant requirements
• Seafood requirements
• Pasteurized refrigerated juice requirements
• Bottled water and soft drink requirements
• Caterers and restaurant facility requirements
• Slaughter and fabrication of fresh meat products requirements (antemortem)
• Slaughter and fabrication of fresh meat products requirements (postmortem)
• Dry dairy products plant requirements
• Slaughter and fabrication of poultry products
• Fresh-cut produce requirements
• Mushroom requirements
• Vegetable sprouts requirements
• Low-acid canned food requirements
Table 45.3 describes those things you should look for when you buy a large amount of food or ingre-
dient from each processing establishment. For example, if you plan to buy 500 lb of fresh-cut apples,
you should check if the “fresh-cut produce requirements” in the commercial facility are complied
with. Such preventive measures must be implemented by a large food service facility, for example,
restaurants in a national hotel chain.
TABLE 45.3
Sanitation and Safety Requirements for Major Items (Ingredients, Stages of Processing,
Equipment, Activities, etc.) Involved in the Manufacture of Different Categories of Food
and Beverages
Major Items in
Manufacturing Sanitation and Safety Requirements
Bakery requirements
Air supply The air supply for blowers or compressors is filtered to exclude particles of 5 μm or larger.
Air systems Separate conveying air systems are provided before and after an atmospheric sifter in the system.
Bearings Bearings are outside the product zone and are sealed or self-lubricated; and design and construction
are such that lubricant cannot leak, drip, or be forced into the product zone.
Bowl drain Stationary mixer bowls drain completely. Close-coupled sanitary drain valves that are accessible or
removable are provided.
Chutes Product chutes at floor level are installed so that the rim is a minimum of 100 mm (4 in.) above
floor level. Such chutes are provided with overlapping covers.
Dry ingredients Vents on equipment for handling and storing dry ingredients are protected against entry of foreign
material and are provided with readily removable filters to exclude particles of 5 μm or larger.
Dry product Dry product handling includes a sifter.
Equipment Where equipment passes through walls, ceilings, or floors, sufficient clearance is provided between
the equipment and the wall, ceiling, or floor, and the opening is finished to permit cleaning, or the
equipment is sealed to the adjoining surface.
Floor-mounted A concrete curb is built around all floor-mounted washing equipment to confine leakage.
Hopper A removable flexible connection is provided between the inlet to the hopper and the product
delivery equipment.
Hoses Discharge piping and unloading hoses are equipped with caps.
Lubrication The system for lubricating dough-contact surfaces, as distinct from the means of mechanical
lubrication, has a reservoir readily accessible or removable for cleaning. Distribution lines, valves,
and pumps are removable for cleaning, or so designed as to permit cleaning in place (CIP).
Pans Pans used to collect spillage or drip are readily accessible or readily removable and are large
enough to catch all spillage or drips. Also, fixed pans used to collect liquid spillage or drip are
readily accessible, have drains, and are pitched to ensure complete drainage away from the
product zone.
Pans Drip or catch pans are provided under all product transfer points, as well as under cleaning
attachments, and are readily removable.
Pans Drip or catch pans are provided between overhead trolleys and product zone, on suspended
monorail-type cooler.
Proofing Proofing cloths are smooth, except they may be of absorbent material, but are readily removable for
laundering. An extra set of proofing cloths are provided.
Pumps and Pumps, valves, and pipe fittings, including those used to insert thermometers and pressure gauge
associated devices bulbs, are of the sanitary take-apart type and are readily accessible or removable.
Pumps and Pumping, piping, valves, and fittings used to dispense or convey frying fats, batter, glaze, icing,
associated devices jellies, and fillings are of sanitary take-apart type at least equal to 3A standards and are accessible
for inspection and cleaning.
Pumps and Liquid ingredient inlet pipes, valves, and fittings are of sanitary take-apart type, unless designed for
associated devices in-place cleaning, and are pitched for self-draining, back to the point where the line is
continuously filled.
Reservoir The icing and/or glazing reservoir return is readily accessible and self-draining.
Screw housings Screw conveyor housings are hinged or removable so that the area around the helical flights can be
cleaned from the outside. Sufficient clearance is provided between the bottom of the screw
housing and the floor to permit sufficient exposure of the screw for cleaning. The screw housings
are dust-tight and readily accessible.
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Straight run Straight run surfaces of pneumatic conveyors, valves, and rotary feeders are smooth and readily
surfaces accessible or removable, except that piping, tubing, valves, or feeders that are self-purging are
exempt from the requirements for accessibility.
Tubing Flexible tubing is transparent or translucent. Nozzles are readily removable.
Manufactured dairy products requirements
Brine Brine room is separately constructed with minimum corrosion.
Building Building and facilities are maintained for laboratory, starter rooms, grading rooms, etc., in
accordance with 58.126.
Bulk Bulk starter vats are equipped with tight-fitting lids and have adequate temperature controls and
indicating/recording devices.
Can washers If applicable, all can washers and associated water- and steam lines are equipped and maintained
for proper temperature and pressure controls. Steam pressure is not less than 80 lb and the final
rinse is an automatically controlled system and does not exceed 140°F (60°C).
CIP All CIP systems and weighing and receiving tanks comply with 3-A accepted practices in
accordance with 58.128.
Color additives Color additives shall be approved by the USFDA.
Cutting Separate rooms are provided for preparation of bulk cheese to be cut and wrapped into smaller
packages. Air movement is outward moving (cheese plants only).
Dry Adequate shelving, air circulation, temperature, and humidity control are provided and maintained
in drying rooms (cheese plants only).
Enzymes E1 rennet, pepsin, and other milk clotting/flavor enzymes meet the requirements of 58.436.
Equipment Mechanical agitators, shields, shafts, hubs, blades, forks, and stirrers are in accordance with 3-A
Accepted Standards.
Equipment Brine tanks, vacuumizers, and monorail systems do not contribute to the contamination of the product.
Equipment Conveyors, grinders/shredders, and cookers are maintained cleaned to prevent contamination.
Equipment All hand utensils, knives, racks, shovels, scoops, paddles, strainers, and other miscellaneous
equipment meet 3A Sanitary Standards. Wires in curd knives are stainless steel, tight, and replaced
as necessary.
Fats Fats/oils used on the surface of the cheese shall be of food grade.
Ingredients Hydrogen peroxide, catalase, cheese cultures, calcium chloride, and other authorized ingredients
comply with requirements.
Labeling Graded product is marked, labeled, and handled in accordance with Part 58.
Milk Raw milk conforms to basic quality and classification specifications of 58.132–133 and is tested at
the frequencies required, and records are maintained in accordance with 58.134–139.
Milk Receiving, holding, and processing of milk and cream and the manufacturing, handling, packaging,
storing, and delivery of dairy products is in accordance with Part 58.
Moisture Nonfat dry milk and whey shall be of USDA Extra Grade except for moisture (processed cheese).
Mold Mold counts for make rooms are not more than 15 colonies per plate/15 min.
Packaging Packaging room atmosphere is practically free from mold and verified in accordance with 58.151.
Packaging Separate rooms are provided for packaging and boxing; maintained at proper temperature to
prevent sweating prior to paraffining (cheese plants only).
Quality Based on the variety of products produced, the stated quality, identity, and analytical requirements
of Part 58 are met.
Records Records are maintained for all required tests and analyses in accordance with 58.148.
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Reuse Reuse of single-service press cloths is prohibited (cheese plants only).
Salt Salt is free flowing, white, refined sodium chloride and meets the requirements of Food Chemical
Code 58.
Salters Automatic salters meet the specific requirements (salting method, design, and steam quality) of
58.418 (cheese plants only).
Sampling Each vat and representative sample of the finished product is analyzed for milk fat, moisture, and
weight/volume control.
Scales All scales comply with the National Institute of Standards and Technology Handbook 44 (latest
version) and are accurate to the specifications of 58.128 (m).
Seal Sanitary seal assemblies are removable on all agitators, pumps, and vats and are inspected at regular
intervals and kept clean.
Starter A separate starter room or properly designed starter tank with satisfactory air movement is
provided. The air supply is filtered to 90% efficiency in accordance with ASHRAE Synthetic Dust
Arrestance Test.
Vats Vats, tanks, and drain tables are constructed of 16-gauge steel or equally corrosion-resistant metal,
properly pitched, welded, and fitted with sanitary outlets and valves for maintenance of heat to the
lines. Auto curd makers, cyclone separators, conveying systems, and curd fillers are properly
constructed and maintained.
Washing Hoop and barrel washing equipment is vented to the outside (cheese plants only).
Wax Cheese wax is kept clean. Paraffin tanks are of adequate size, are fitted with wooden racks, and
have heat controls and an indicating thermometer (cheese plants only).
Fluid dairy requirements

Additives Boiler water additives comply with 21 CFR 173.310.
Air Air under pressure is in accordance with 3-A Accepted Practices.
Atmosphere break An atmosphere break exists at least 30.48 cm above the raw milk (see high heat short time [HHST]
exception).
Batch Air space heating is accomplished when required for batch pasteurization.
Charts Pasteurization recording charts are maintained on file at the processing plant.
Charts Recording charts are complete and maintained.
CIP CIP systems are in compliance with Pasteurized Milk Ordinance (PMO). CIP systems have a
recording device installed in the return solution line or other appropriate area to record the
temperature and time at which the line or equipment is exposed to cleaning and sanitizing solution
(retained for 3 months).
CIP A record of CIP cleaning process is maintained for recirculated cleaning systems.
Contact surfaces Welded portions of food contact surfaces are smooth and free from pits, cracks, or inclusions.
Contact surfaces All milk contact surfaces of multiuse containers and equipment are constructed of American Iron
and Steel Institute (AISI) 300 series stainless steel or other noncorrosive material as described in
the PMO.
Containers Residual bacteria counts for multiuse and single-service containers meet the standards listed in the
PMO. Results are recorded and records maintained.
Cross-connection There is no cross-connection or direct contamination of pasteurized milk or milk product.
Device There is no flow promoting device between the regenerator and the air break.
Device The flow diversion devices are properly installed and functioning.
Device The flow promoting devices are properly located and of the proper speed, displacement, and capacity.
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Drug residues Raw milk and milk products are screened for drug residues.
Equipment Equipment is designed to protect against surface and overhead contamination.
Equipment Equipment complies with the sanitary design and construction standards of the PMO.
Equipment Pasteurization equipment and controls testing is performed in accordance with the PMO.
Equipment During processing, pipelines and equipment used to conduct milk are effectively separated from
cleaning and sanitizing solutions (see the PMO for methods).
Level The overflow of the top rim of the constant-level raw milk tank is lower than the lowest milk level
in the regenerator (see HHST exception).
Level Raw milk in the regenerator drains back to the constant-level tank.
Lines Filling lines are equipped with a device capable of detecting, in each container before filling,
volatile organic contaminants. The device is interconnected so that the system will not operate
unless the detection device is operational.
Milk source Milk originates from herds accredited tuberculosis-free and brucellosis-free and from countries/
regions determined to be acceptable.
Openings All openings, including valves, pipes, and milk tanker trucks, are capped or otherwise protected.
Pest Only approved rodenticides and insecticides are used.
Pressure The pasteurized side of the regenerator is always under higher pressure than the raw side.
Pump There is no pump between the raw milk inlet to regenerator and the raw milk supply tank (see
HHST exception).
Quality standards Pasteurized milk and/or milk products comply with bacteriological, chemical, and temperature
standards of Section 7. Results are recorded and records maintained.
Receiving Upon arrival, raw milk and/or raw products for pasteurization comply with bacteriological,
chemical, and temperature standards of Section 7, Table 45.1.
Repasteurization Packaged milk and milk products that have physically left the premises or processing plant are not
repasteurized for Grade A use (see the exception).
Sink Plants where containers are manually cleaned have a two-compartment sink and a steam cabinet to
sanitize containers or a three-compartment sink if a chemical sanitizer is used.
Steam Culinary steam is in accordance with PMO.
Storage Storage tanks are cleaned when emptied and are emptied at least every 72 h.
Storage Storage tanks used to store raw milk or heat-treated milk products are equipped with a 7-day
temperature-recording device.
Straining Pasteurized milk is not strained or filtered except through a perforated metal strainer.
Tank trucks A system of tagging or recording tanker trucks that have been cleaned and sanitized is established
and maintained for 15 days.
Temperature Raw milk and milk products are held at 45°F (7°C) until processed.
Temperature Pasteurized milk and milk products are cooled to 45°F (7°C) and maintained at that temperature.
Thermometer The flow control sensor (recording thermometer) is not more than 46 cm (18 in.) upstream from the
control device.
Thermometer The indicating and recorder thermometers are properly located.
Thermometer Thermometers meet requirements.
Toxic Poisonous or toxic materials are not stored in any room where milk or milk products are received,
processed, pasteurized, or stored.
Tube The holding tube is designed so that no deviations can be made to the flow rate or holding time.
Valves Manual valves meet PMO standards (stop/leak grove/close coupled).
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Water Recirculated cooling water is protected from contamination.
Water Recirculated cooling water is tested once per 6-month period.
Shell egg requirements

Equipment Shell egg processing equipment is washed, rinsed, and treated with a bactericidal agent each time
the oil is removed. It is preferable to filter and heat-treat processing oil and clean processing
equipment daily when in use.
Light The egg grading or candling area is adequately darkened to make possible the accurate quality
determination of the candled appearance of eggs. There are no other light sources or reflections of
light that interfere with or prohibit accurate quality determination of eggs in the grading or
candling area. Other light sources and equipment or facilities are provided to permit the detection
and removal of stained or dirty eggs or other undergrade eggs.
Moisture Eggs with excess moisture on the shell are not shell protected (oil processed).
Oil Oil having any off-odor, or that is obviously contaminated, is not used in shell egg protection.
Oil Processing oil that has been previously used and that has become contaminated is filtered and
heated at 180°F (82°C) for 3 min prior to use.
Rest period During any rest period, eggs are removed from the washing and rinsing area of the egg washer and
from the scanning area whenever there is a buildup of heat.
Rooms Grading and packing rooms are kept reasonably clean during grading and packaging operations and
are thoroughly cleaned at the end of each day.
Rooms The cooler room has refrigeration facilities capable of reducing within 24 h and holding the
maximum volume of eggs handled to 45°F (7°C) or below. Accurate thermometers are provided.
Temperature The temperature of the wash water is maintained at 90°F (32°C) or higher and is at least 20°F
(−6°C) warmer than the temperature of the eggs to be washed. These temperatures are maintained
throughout the cleaning cycle.
Water, iron An analysis of the iron content of the water supply, stated in parts per million, is performed. When
the iron content exceeds 2 ppm, equipment is provided to correct the excess iron content. If the
water source is changed, new tests are performed.
Water, operation The washing and drying operation is continuous and is completed as rapidly as possible. Eggs are
not allowed to stand or soak in water. Immersion washers are not used.
Water, replacement Replacement water is added continuously to the wash water of washers to maintain a continuous
overflow. Iodine sanitizing rinse is not used as part of the replacement water.
Water, rinsing Washed eggs are spray rinsed with water having a temperature equal to, or warmer than, the
temperature of the wash water and containing an approved sanitizer of not less than 50 ppm nor
more than 200 ppm of available chlorine or its equivalent. Alternate procedures, in lieu of a
sanitizer rinse, are approved by the FDA or USDA.
Frozen dessert requirements, general considerations

Areas The following areas are separate from one another: (1) the tank truck receiving area, (2) the
processing area, (3) the can or case wash areas, (4) the dry storage areas, and (5) the
packaging area.
Cross-connections Adequate physical breaks to the atmosphere (at least as large as the piping diameter) are provided
in order to eliminate cross-connections and are verifiable by walk-through with installation
drawings.
Equipment All containers, utensils, and equipment are cleaned and sanitized at least once during each day they
are used; storage tanks are emptied and cleaned at least every 72 h.
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Equipment Piping equipment and containers used to process or package aseptically processed frozen dessert
mix beyond the final heat treatment process are sterilized before any aseptically processed product
is packaged.
Ingredients Raw milk, low-fat milk, skim, or cream that was heated above 45°F (7°C), but below 160°F (71°C)
for separation, is used in frozen dessert if the following applies: (1) it was heated only once for
pasteurization; (2) after separation, it was immediately cooled to below 45°F (7°C); (3) no more
than 3 days have elapsed between separation and shipment to the frozen dessert plant; or (4) if it is
heated above 125°F (51°C), it meets 30,000 standard plate count and 10 coliforms at plant of
shipment and 100 coliforms at plant of receipt.
Line Fill line connections are made to tank fittings, and tank lids are not propped open during filling.
Openings All openings into product or onto sanitized product-contact surfaces are capped, closed, or
adequately protected.
Openings All openings in covers of tanks, vats, separators, etc., are protected by raised edges or other means
to prevent the entrance of surface drainage.
Pasteurization Pasteurized mix is frozen, dried, packaged, or shipped within 72 h of being pasteurized.
Rages and brushes Absorbent items such as rags and sponges are not used in the plant environment, and separate
brushes are used for product and nonproduct surfaces.
Temperature All milk, milk products, frozen dessert mix, liquid eggs, and dairy ingredients are maintained at
45°F (7°C) or below. Products in coolers are stored at temperatures under 45°F (7°C).
Threads There are no threads used in contact with milk, milk products, frozen desserts, or frozen dessert mixes
except where needed for functional and safety reasons, such as clarifiers, pumps, and separators.
Frozen dessert requirements, plant systems
Air Pressurizing air processing systems that incorporate air directly into the product, such as freezers,
air blows, and air agitating systems, are properly designed to reduce potential contamination. They
are equipped with filters and sanitary check valves.
Air Outside air entering the facility is filtered and free of condensates.
Defoamers If defoamers are used, they do not return product or foam to the filler bowl.
Pasteurization Dusty, raw ingredient blending operations that create powdery conditions are located away from
pasteurized product areas.
Pasteurization, Ingredients that may be added after pasteurization are limited to those flavoring and coloring
ingredients, after ingredients that are as follows: (1) subjected to prior heat treatment sufficient to destroy
pathogenic microorganisms, (2) of 0.85% water activity or less, (3) of pH less than 4.7, (4) roasted
nuts added at the freezer, (5) with high alcohol content, (6) with bacterial cultures, (7) fruits and
vegetables added at the freezer, and (8) subjected to any process that will assure that the ingredient
is free of pathogenic microorganisms.
Pasteurization, All dairy products, eggs, egg products, cocoa products, emulsifiers, stabilizers, liquid sweeteners,
ingredients, before and dry sugar are added prior to pasteurization.
Pasteurization, All reconstitution or recombination of dry, powdered, or condensed ingredients with water is done
ingredients, before prior to pasteurization.
Pasteurization, Products are pasteurized in accordance with the time/temperature tables listed in the Frozen Dessert
procedure Processing Guide.
Pasteurization, Pasteurization is in accordance with the methods explained in the Frozen Dessert Processing Guide.
procedure
Pasteurization, Milk shipped in bulk tank trucks to another location is repasteurized at that plant prior to freezing
relocation and packaging.
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Quality assurance A plant quality assurance program is in place to assure that the fresh fruit and vegetable products
are of high quality and do not contaminate the dairy product.
Steam Where steam is used to provide heat for vat or HHST processes, the water source for the boiler is
identified as potable and is in compliance with CFR, Title 21.
Tub To prevent contamination, lids of tub and canister-type containers for frozen desserts are designed
to overlap the tub or container to be overwrapped.
Water The recirculating cooling water (sweet water) and recirculating glycol and water mixtures are tested
at least every 6 months and are free of coliforms and Listeria.
Frozen dessert requirements, specific plant operations

Breaks, physical There is a physical break between pasteurized product for repasteurization when the product is
loaded in a raw product receiving area, with particular attention being paid to product and CIP
connections, so that raw product in lines and tanks is never directly connected to any line that
extends back to the pasteurized product lines or tanks. A physical break is required.
Chute When a stainless steel chute is used to convey a product (novelty) to the wrapper after extraction,
the chute is cleaned at least every 4 h during the production run.
Filler valve Adequate drip deflectors are provided at each filler valve.
Freezer The air supply in the freezer is properly filtered.
Hardening Hardening is performed immediately after mix is containerized. Rapid freezing is recommended
from 0°F (−18°C) to −15°F (−26°C).
Leakage A bright distinctive food color is added to the brine used on novelty sticks if the brine is calcium
carbonate, in order to detect leakage onto the finished product.
Microbiological Microbiological criteria for end items are not more than 50,000 cfu/g standard plate count, not
criteria more than 10 coliforms/g, and not more than 20 coliforms/g for fruits, nuts, or other bulky
flavors.
Pails Pails used for rework or adding flavors are cleaned after each use and sanitized prior to reusing.
Reclaiming For reclaiming operations, only a product that has not left the plant premises is reclaimed.
Rework Reworked product, such as ice cream, which is retained in buckets during start-up while overrun is
stabilized, is kept to a minimum. If this product is to be recycled back into the product, it is
properly protected and repasteurized.
Strainers Woven wire strainers are not used to remove bulky ingredients.
Tanks Tanks used for holding cooling media are adequately protected and are coliform- and
pathogen-free.
Water Water used to glaze a product to help prevent sticking to the paper wrapper is pasteurized or treated
to lower the pH. Water dips have a continuous overflow to minimize product accumulation
throughout the product run.
Ice plant requirements

Air Air used for water agitation is filtered or otherwise treated to remove dust, dirt, insects, and
extraneous material. Filters are placed upstream of the compressor and are easily removable for
cleaning or replacement. The compressor used to supply air for water agitation is designed to
deliver oil-free air.
Contact Hands do not come into direct contact with the ice at any time during manufacturing, processing,
packaging, and storage.
Devices, cleaning Air lines and core or sucking (vacuum) devices are used as needed to produce ice free of rust or
other foreign materials.
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Equipment Filtering equipment is designed to protect ice from contamination and is subject to periodic
treatment and cleaning.
Equipment All equipment used to store or deliver water, or in contact with ice in the freezing process, is
regularly sanitized.
Packaging and Packaged ice products are tightly sealed and clearly labeled to show the name, manufacturer,
labeling location of processing plant, date code, and net weight.
Tank Freezing tank covers of acceptable materials are designed and constructed to protect ice containers
from splash, drip, and other contamination; are easily cleanable; and are kept clean and in good
repair. Such covers are equipped with rings or similar devices when hooks are used for pulling.
Can or tank covers, and the ledges of sides of the tank upon which the cover rests, are cleaned as
often as necessary to keep them in sanitary condition.
Tests Bacteriological tests of the finished ice shall be conducted monthly, chemical and physical tests
annually, and radiological tests every 4 years.
Tests, bacteria, ice Random samples of ice produced in the plant shall be tested by an approved laboratory at least
monthly for fecal and/or total coliform organisms and heterotrophic plate count (HPC). Total
coliform is not greater than 2.2 organisms/100 mL using the most probable number (MPN)
method and not greater than 1 organism/100 mL using the membrane filtration (MF) method. The
HPC does not exceed 500 colonies/mL. Records of these tests are maintained for 2 years.
Tests, brine A testing program has been implemented to obtain background information on the chemical and
microbiological content of the brine solution as it relates to leaking cans and the subsequent
contamination of the product. Such data reflect the presence of any refrigeration defrosting
chemicals, such as ethylene or propylene glycol (if used in the plant), lead (Pb), cadmium (Cd),
zinc (Zn), chromium (Cr), and nitrate (NO2). The finished products (varying product types and
packages) shall be randomly sampled and analyzed on a quarterly basis for ethylene or propylene
glycol (if applicable) and chlorides (Cl). Reports of analyses are maintained for 2 years.
Washing and All frozen unpackaged ice blocks intended for sale for human consumption or for refrigeration of
handling food products are washed thoroughly with potable water. Ice manufactured for industrial purposes
is handled and stored separately from ice intended for human consumption.
Water Water used for washing or rinsing is not reused and is disposed of as liquid waste.
Seafood requirements
Additive The use of sodium nitrite is permitted with those species of fish allowed by regulation.
Brining Brining operations are performed IAW (if and when) the appropriate time and temperature
parameters.
Brining Different species of fish are not mixed in the same brine tank.
Brining Brines are not reused without an adequate process available to return the brine to an acceptable
microbiological level.
Brining Fish are rinsed with fresh potable water after brining, except for fish that have been injected with
brine.
Containers Identification tags containing all required information are affixed to each container.
Containers Containers used to convey, brine, or store fish are not nested (stacked) while they contain fish or
otherwise handled during processing or storage in a manner conducive to direct or indirect
contamination of their contents.
Containers Shipping containers, retail packages, and shipping records relating to processed fish are
appropriately labeled in accordance with the perishable nature of the product.
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Containers Each container of processed fish is legibly marked or labeled with an identifying code and required
identification.
Equipment Equipment and utensils used in the handling of raw or frozen fish portions are not used in the
handling, transport, or packaging of product after it has entered the smoking chamber or used in
the handling of finished product.
Equipment Equipment and utensils are marked in some way to ensure that equipment and utensils used to
handle raw fish are not used to handle product that has entered the smoking chamber, or used in
the handling of finished product.
Handling The finished product is handled only with clean, sanitized hands, gloves, or utensils. Manual
manipulation of the product is kept to a minimum.
Imports Imported fish or fishery products are obtained from approved sources.
Packaging The vacuum packaging or modified atmosphere packaging of processed fish is conducted only
within the facilities of the manufacturer.
Packaging Processed fish to be vacuum packaged or modified atmosphere packaged are chemically analyzed
for water-phase salt and for nitrate and other additives when used, with sufficient frequency to
ensure conformance with finished product specification requirements.
Process All processed fish are produced pursuant to the process as established by a competent processing
authority.
Receiving Fresh and frozen fish received are inspected and adequately washed before processing.
Records Records are kept of every transaction involving the sale and distribution of processed fish.
Records Fish processing records are legibly written in English and identify the processing procedures, the
product processed, the process time, the temperature, and the results of the chemical examination,
together with the identifying lot code, the number of containers per coding interval, the size of the
containers coded, and the year, day, and period when each lot was packed.
Records Records are maintained for the chemical examination of the finished product for the purpose of
validating the water-phased salt and sodium nitrite requirements.
Records All records relative to the scheduled process used to produce processed fish or smoked fish are
readily available to government inspection personnel.
Records Records of refrigerated and/or frozen products, the general adequacy of equipment, process used, or
results of scientific studies and evaluations are retained for the amount of time specified in 21 CFR
123.9.
Rooms Processing rooms are separated and segregated to eliminate contamination.
Salting For dry salting, the fish are returned to a refrigerated area of 38°F (3°C) or lower immediately after
the application of the salt.
Shellfish Shucked shellfish from different lots are not commingled.
Shellstock Seafood shall be derived from shellstock received from harvesters certified by a shellfish control
authority CFR 123.28.
Shellstock Chilled or iced shucked shellstock is maintained at 45°F during storage and transport.
Shellstock Ice used to store shellstock shall be potable.
Smoking Each smoking chamber is equipped with a temperature monitoring device so installed as to indicate
accurately at all times the internal temperature of the fish within the smoking chamber.
Smoking Drying of a product to be cold-smoked is carried out in a refrigerated area of 38°F (3°C) or
below.
Smoking Fish are of relatively uniform size and weight and arranged without overcrowding or touching each
other within the smokehouse oven.
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Smoking Liquid smoke, generated smoke, or a combination of liquid smoke and generated smoke is applied
to all surfaces of the product at the appropriate times.
Smoking Hot processed smoked fish is produced by a controlled process that utilizes a temperature
monitoring system to assure that all products reach the required temperature.
Smoking For hot processed smoked fish to be air packaged, a controlled process is used to heat the fish.
Smoking, cold Cold processed smoked fish are produced by a controlled process that utilizes a temperature
monitoring system assuring all products do not exceed process temperatures in accordance with
authorized methods.
Smoking, cold For cold processed smoked fish to be air packaged, fish that have brine contain not less than 2.5%
water-phase salt in the loin muscle of the finished product.
Smoking, cold For cold processed smoked fish to be vacuum or modified atmosphere packaged, fish that have been
brined contain not less than 3.5% water-phase salt in the loin muscle of the finished product, or a
combination of 3.0% water-phase salt in the loin muscle of the finished product and not less than
100 nor more than 200 ppm of sodium nitrite.
Smoking, hot For hot-processed smoked fish to be vacuum or modified atmosphere packaged, a controlled
process is used to heat the fish.
Temperature Fresh fish, except those immediately processed, are iced or otherwise refrigerated to an internal
temperature of 38°F (3°C) or below upon receipt and are maintained at that temperature until fish
are to be processed.
Temperature All fish received in a frozen state are thawed promptly and processed, or stored at a temperature
that will maintain it in a frozen state.
Temperature All processed fish are distributed and sold in a manner that ensures that the internal temperature is
maintained at 38°F (3°C) or below (see reference for exceptions).
Temperature The finished products are properly cooled to 70°F (21°C) within 2 h and further cooled to 38°F
(3°C) within an additional 4 h. Finished products are then maintained at 38°F (3°C).
Thawing After thawing, fish are washed thoroughly with a vigorous potable water spray or a continuous
water flow system. When thawing and brining occur concurrently, the fish are washed in this same
fashion following the thawing and brining.
Viscera All fish are free of viscera prior to processing (see reference document for exceptions).
Viscera The evisceration of fish is conducted in a segregated or separate processing room. The evisceration
is performed with minimal disturbance of the intestinal tract contents, and the fish, including the
body cavity, is washed thoroughly with a vigorous spray or a continuous water flow system
following evisceration.
Zones Sanitary zones are established around areas in which processed fish is handled/stored.
Pasteurized refrigerated juice requirements

(Pasteurized, refrigerated juices 21 CFR 110, 120)
5-log Process controls shall exist to achieve a 5-log reduction in microbiological load and records of
routine examination shall be available for review.
5-log Pasteurization equipment shall be validated for achieving 5-log reduction.
Complaints Customer complaint process shall be in place to determine whether complaints relate to the
performance of the HACCP plan or reveal unidentified CCPs.
Documentation Procedures, steps, and practices documented.
HACCP HACCP plan shall be validated and signed every 12 months by trained individuals.
(Continued)

and Beverages
Major Items in
HACCP Juice processors with no HACCP plan, based on validated hazard analysis, shall reassess the
adequacy of that hazard analysis whenever there are any changes in the process that could
reasonably affect whether a food hazard exists. Such changes may include changes in the
following: raw materials or source of raw materials; product formulation; processing methods or
systems, including computers and their software; packaging; finished product distribution systems;
or the intended use or intended consumers of the finished product be revalidated as required.
Import Imported juice shall originate from processors in countries with active memorandum of
understanding (MOU) with the FDA and validated and documented HACCP plans, and each
delivery shall be accompanied by Certificates of Conformance (COCs) from government
officials.
Microbile Each production batch tested for E. coli presence/absence and yeast and mold.
Records Records of equipment validation available
Bottled water and soft drink requirements

Back-siphonage Product in process other than sealed piping systems under pressure is protected from back-
siphonage and other sources of contamination.
Contact surfaces Product water contact surfaces (utensils, pipes, equipment, etc.) are clean and are adequately
sanitized daily.
Contact surfaces Product water contact surfaces (utensils, pipes, equipment, etc.) are maintained free of scale,
oxidation, and other residue. The presence of any unsanitary condition is corrected immediately.
Containers Containers, caps, or seals are purchased and stored in sanitary closures (original containers) in a
clean, dry place. They are examined before use and are handled, dispensed, and used in a sanitary
manner. They are washed, rinsed, and sanitized as needed (129.37 (c)). Filling, capping, closing,
sealing, and packaging are done in a sanitary manner.
Containers All unsanitary or defective containers are reprocessed or rendered unusable and discarded.
Multiservice primary containers are cleaned, sanitized, and inspected immediately prior to being
filled, capped, and sealed.
Containers Containers and closures are nontoxic and comply with FDA standards.
Containers Filling, capping, and sealing are monitored. Filled containers are visually or electronically
inspected.
Containers Quarterly swab and/or rinse bacterial counts, on not less than four containers and closures (prior to
filling), are performed.
Contaminants Source and finished product test results meet requirements of 21 CFR 165.110(b) for maximum
contaminant level. Product water from a public water system or water that has been treated with a
chlorine-based disinfectant or ozone shall be tested for the residual disinfectants and disinfection
by-products (DBPs) listed in 21 CFR165.110(b)(4)(iii)(H).
Filters Filters are readily cleanable or have replaceable elements.
Product code Each unit package is identified by a production code. The code identifies the particular batch or
segment of a continuous run and the production date.
Records Records of the concentration of the sanitizing agent and the duration of contact time shall be
maintained by the plant.
Records Records are maintained of product type, volume produced, date produced, lot code used, and
distribution to wholesale and retail outlets.
Records Records are maintained of sampling date, type of product, production code, and results of each
analysis.
(Continued)

and Beverages
Major Items in
Records All records are retained for 2 years. Current certificates or notifications of approval authority for
source and supply of product and operations water are on file.
Rooms The bottling room is separated from the other plant operations or storage areas by tight walls,
ceilings, self-closing doors, and size of conveyor opening. Bottle washing and sanitizing are in an
enclosed room and are positioned to minimize postsanitization contamination.
Rooms Processing, washing, and storage rooms are not directly connected to room(s) used for domestic
household purposes.
Samples Representative bacteriological samples are tested weekly for each type of finished product
produced during a day’s production.
Samples Representative chemical, physical, and radiological samples are analyzed annually for each type of
finished product water.
Samples Product water samples are taken after processing, prior to bottling, to assure uniformity and
effectiveness of the treatment process. Methods of analysis are approved by the government
agency having jurisdiction.
Sanitizing Sanitizing operations meet requirements contained in the FDA Food Code.
Shipping cases Multiservice shipping cases are maintained to assure that they will not contaminate primary
containers or the product.
Tanks Storage tanks are closed to exclude all foreign matter. Filtered vents are provided.
Treatment Treatment equipment processes and substances are used that preclude contamination or adulteration
of the product.
Treatment Treatment methods accomplish their intended purpose. Records are maintained to show type and
date of treatments and physical inspections of equipment. Conditions found, performance, and
effectiveness are noted.
Ventilation Adequate ventilation is provided to minimize odors, noxious fumes, or vapors and condensation in
processing, bottling, container washing, and sanitizing rooms. Ventilation equipment is clean.
Washers Mechanical washers are inspected. Records of physical maintenance, inspections, conditions found,
and performance of the mechanical washer are maintained by the plant.
Water Product water used for bottling is from an approved source that has been inspected and the water
sampled and found to be of a safe and sanitary quality according to applicable laws and
regulations of the government agencies having jurisdiction.
Water Source water is analyzed annually for chemical and physical parameters and once every 4 years for
radiological parameters. Source waters, other than municipal sources, are analyzed weekly for
microbiological quality.
Caterers and civilian restaurant facility requirements

Additives Prepared foods do not contain unapproved additives.
Containers Food items are stored in their original containers or are identified with their common name on
working containers.
Cross contamination Food is protected from cross contamination by separation, packaging, cleaning, or other means.
Eggs Pasteurized eggs or egg products are substituted for raw shell eggs in applicable foods, with
exceptions as noted in the reference.
Game animals If game animals are used, they have been commercially raised for food and are processed under a
regulatory inspection program and in accordance with applicable meat and poultry laws.
Gloves If used, single-use gloves are used for only one task. Slash-resistant gloves and cloth gloves are
used in an appropriate manner.
(Continued)

and Beverages
Major Items in
Ice Ice used as an external cooler is not used as food.
Packaging During preparation, unpackaged food is protected from environmental sources of contamination.
Pauses During pauses in food preparation or dispensing, food preparation and dispensing utensils are
stored in a manner to inhibit/reduce contamination.
PHF Potentially hazardous food (PHF) that is cooked, cooled, and reheated for hot holding is reheated so
that all parts of the food reach a temperature of at least 165°F (74°C) for 15 s, with exceptions as
noted in the reference (3–403.11).
PHF PHF is maintained in accordance with proper hot and cold holding procedures.
PHF, cooked Cooked PHF is cooled utilizing proper time–temperature requirements and proper cooling methods,
with exceptions as noted in the reference.
PHF, frozen Frozen PHF is slacked under refrigeration below 41°F (5°C) with exceptions as noted in the
reference.
PHF, frozen Frozen PHF is thawed under proper refrigeration, proper running water technique, proper cooking
techniques, and proper time periods.
PHF, RTE Ready-to-eat PHF prepared and held refrigerated for more than 24 h is clearly marked at the time of
preparation with appropriate date marking, with exceptions as noted in the reference.
Processing method A food establishment obtains a variance from the regulatory authority when specialized processing
methods are employed.
Raw Raw fruits and vegetables are thoroughly washed and disinfected prior to processing, with
exceptions as noted in the reference.
Raw Raw animal foods comply with cooking requirements listed in the Food Code.
Source Food prepared in a private home is not used or offered for human consumption in a food
establishment.
Taste A food employee does not use a utensil more than once to taste food that is to be sold or served.
Temperature Fruits and vegetables that are cooked for hot holding are cooked to a temperature of 140°F (60°C).
Temperature Raw, raw-marinated, partially cooked, or marinated partially cooked fish other than molluscan
shellfish are frozen throughout to a temperature of either −4°F (−20°C) or below for 168 h
(7 days) in a freezer, or −31°F (−35°C) or below for 15 h in a blast freezer, with exceptions as
noted in the reference. Records are created and retained as specified, with exceptions as noted in
the reference.
Temperature Reheating for hot holding is done to ensure the food is not between 41°F (5°C) and 165°F (74°C)
for more than 2 h.
Temperature, Food temperature–measuring devices with glass stems or sensors are encased in shatterproof
devices coatings.
Temperature, Temperature-measuring devices are properly designed, located, and easily readable.
devices
Warewashing Warewashing machines are equipped with proper temperature and pressure indicating devices.
Slaughter and fabrication of fresh meat products requirements (Antemortem)

Condemned Livestock found to be dead or in a dying condition on the premises of an establishment are
identified as condemned and disposed of.
Condemned Any swine having a temperature of 106°F (41°C) or higher and any cattle, sheep, goats, horses,
mules, or other equines having a temperature of 105°F (40°C) or higher are identified as
condemned.
Downers Seriously crippled animals, “downers,” are identified as suspects and properly disposed of.
(Continued)

and Beverages
Major Items in
E. coli Livestock must be tested for Escherichia coli biotype 1 (E. coli) at a minimum of one sample
during each week of operation.
Handling Handling of livestock, from the unloading ramps to the stunning area, is conducted in a humane
manner.
Humane Humane methods of slaughter are applied within an appropriate stunning area.
Humane Animals are adequately stunned prior to being shackled, hoisted, thrown, cast, or cut (bleeding).
Inspection Livestock entering the facility receive an adequate antemortem inspection on the day of and before
slaughter and are properly segregated when required.
Pens Pens, chutes, and alleys are paved, drained, and supplied with adequate hose connections for
cleanup purposes.
Pens Satisfactory pens, equipment, lighting, and assistants are available for conducting antemortem
inspection and for separating, marking, and holding apart passed livestock from livestock that has
been identified as suspect or condemned.
Pens Holding and shackling pens are located outside of or effectively separated from the slaughtering
department.
Pens Floors of livestock pens, ramps, and driveways are constructed and maintained as to provide good
footing for livestock.
Source Livestock originate from an approved region. Food production animals are free of communicable
disease. Animals from a quarantine region are processed in that region.
Stockyard When holding pens of an establishment are located in a public stockyard, such pens are regarded as
part of the premises of that establishment.
Water Animals have access to water in all holding pens and, if held longer than 24 h, feed is provided.
Slaughter and fabrication of fresh meat products requirements (postmortem)

Anthrax Carcasses found before evisceration to be affected with anthrax are not eviscerated but are retained,
condemned, and immediately tanked, and the complete working area is cleaned and disinfected
immediately.
Body part removal Spermatic cords and pizzles are removed from all carcasses. Preputial diverticuli are removed from
hog carcasses.
Butchers Butchers and others who dress or handle diseased carcasses or parts cleanse their hands with liquid
soap and hot water and rinse them in clear water, before handling or dressing other parts.
Contact Rails are located so as to prevent product from coming in contact with posts, walls, and other fixed
parts of the building, barrels, boxes, etc.
Contamination Carcass contamination of edible tissue by stomach contents, feces, and/or urine is unacceptable.
To prevent this contamination, any of the following are used prior to electrical stimulation:
a. Leave the sphincter muscles intact.
b. Cut the rectum (scalp the bung) and the urethra free from surrounding tissue and securely tie
each off.
c. Partially open the midline and/or slay the brisket to reduce pressure on the visceral organs.
d. Any other pressure-relieving or discharge-restricting alternative acceptable to the chief
veterinary inspector.
e. Rod (separate the esophagus from the surrounding tissue) and tie it off. When only a portion of
a carcass is to be condemned on account of slight bruises, either the bruised portion is removed
immediately and disposed of or the carcass is promptly placed in a retaining room and kept until
chilled, and the bruised portion is then removed and disposed of.
(Continued)

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1080 Plant Sanitation for Food Processing and Food Service

44.6.4 Receiving and Inspection

44.6.6 Pest Control

44.7 CASE STUDY: INSPECTING INCOMING FOOD MATERIALS

44.7.2 Why Should You Inspect Incoming Food Materials?

44.7.3 Will You Inspect?

44.7.4 Before the Shipment Arrives

1. The storage space for the shipment is clean and dry.

c. Black light (ultraviolet light source for identifying rodent urine)

44.7.5 Note Outside Condition of Carrier

44.7.6 Is the Seal Broken?

44.7.7 Open the Doors

44.7.8 Note Condition of Cargo

1. It is difficult to prevent contamination of food products in damaged packages, cartons, or

44.7.9 Look for Insect, Rodent, or Bird Activity

44.7.10 Collect Random Samples

44.7.11 Are Nonfood Items in the Shipment?

44.7.12 Observe Inside Condition of Carrier after Unloading

44.8 FDA CPG: FOOD STORAGE AND WAREHOUSING-ADULTERATION-FILTH

44.8.1 Criteria for Direct Reference Seizure

44.8.1.1 Rodent Contamination

44.8.1.2 Insect Contamination

3. The product contains

44.8.1.3 Bird Contamination

44.8.4 Criteria for Prosecution

44.8.5 Regulatory Action Guidance for Import

44.8.5.1 Live Insect Contamination

1. One live insect in each of the two or more immediate containers; or

44.9 FSIS-USDA: FOOD SECURITY IN A WAREHOUSE

1. Disgruntled current or former employee

44.9.2 Three Steps in Developing a Food Defense Plan

44.9.2.1 Step 1: Conduct a Food Defense Assessment

44.9.2.1.1 Outside Security

44.9.2.1.2 General Inside Security

44.9.2.1.3 Shipping and Receiving Security

44.9.2.1.4 Mail Handling Security

44.9.2.1.5 Personnel Security

44.9.2.2 Step 2: Develop a Food Defense Plan

44.9.2.3 Step 3: Implement the Food Defense Plan

44.10 FDA WARNING LETTERS FOR DEFICIENCIES IN FOOD

1. One building: Observation in the NW corner of at least 40 REPs on a wall ledge at

44.11 AN FDA INSPECTION REPORT FORM

45.1 RETAIL AND FOOD SERVICE INDUSTRIES

1. Backcountry guided trips for groups

14. Grocery stores with specialized departments

45.1.1 Regulatory Agencies and Jurisdiction

1. Food from unsafe sources

45.2 GUIDES TO REGULATORS AND OPERATORS

45.2.2 Definitions Affecting the Industries

45.2.3 Food Categories: Sanitation and Safety

TABLE 45.2 (Continued)

TABLE 45.2 (Continued)

TABLE 45.2 (Continued)

TABLE 45.2 (Continued)

TABLE 45.2 (Continued)

TABLE 45.2 (Continued)

TABLE 45.2 (Continued)

TABLE 45.2 (Continued)

TABLE 45.2 (Continued)

• Fluid dairy requirements

TABLE 45.3 (Continued)

TABLE 45.3 (Continued)

Fluid dairy requirements

44.7 CASE STUDY: INSPECTING INCOMING FOOD MATERIALS

44.8 FDA CPG: FOOD STORAGE AND WAREHOUSING-ADULTERATION-FILTH

44.10 FDA WARNING LETTERS FOR DEFICIENCIES IN FOOD