**GUIDE**[^1] **TO INSPECTIONS OF**

**GRAIN PRODUCT MANUFACTURERS**

..

## TABLE OF CONTENTS

**INTRODUCTION** Pg 1

**TERMINOLOGY** Pg 1

**EQUIPMENT** Pg 2

**SECTION I: ELEVATORS** Pg 2

Safety Precautions

Raw Materials

Storage Facilities

Pesticide Usage

**SECTION II: FLOUR MILLING** Pg 4

Raw Material

Production Equipment

Packaging Equipment

Finished Flour

Food Additives

Sanitation

Quality Control

Sample Collection

**SECTION III: BAKERY PRODUCTS,**

**DOUGHS, BAKERY MIXES** Pg 8

Raw Materials

Processing

Sanitation

Standards

**Sample Collection**

**SECTION IV: MACARONI AND**

**NOODLE PRODUCTS** Pg 10

Raw Materials

Sanitation

Enrichment Operations

Economic

Standards

Sample Collection

### INTRODUCTION

This guide is divided into four Sections. Section I is applicable to
inspections of grain elevators; Section II applies to mill inspections;
Section III is applicable to bakery inspections; and Section IV is
applicable to inspections of macaroni and noodle products. Prior to
conducting inspections involving any grain product manufacturer, review
the general inspectional instructions in IOM Chapter 5 **(Establishment
Inspections)** and particularly those in IOM 530 **(Food Inspections)**.

## [TERMINOLOGY]{.underline}

**TAILINGS (OR OVERS)** - Material which does not pass through the first
sieve screen of a sifter.

**MIDDS (OR MIDDLINGS)** - The relatively fine pieces of wheat endosperm
which will be reduced to flour by the reduction rolls.

**PREBREAK OR BREAK ROLL** - Rolls used to break wheat kernels,
beginning the flour milling process. They consist of a pair of grooved,
steel rolls rotating in opposite directions. One roll turns about 2 1/2
times faster than the other.

**REDUCTION ROLLS** - Smooth, steel rolls used to reduce the size of the
endosperm particles or middlings(midds).

**STREAMS** - The various product flows in a flour milling operation,
based on various factors such as particle size, ash content, component
of the wheat kernel, i.e. endosperm (for flour), bran and germ as
by-products, etc.

**STRAIGHT FLOUR** - Flour from a given wheat intended for human
consumption.

**PATENT FLOUR** - A composite of the lowest ash content streams of a
straight flour.

**CLEAR (OR FIRST CLEAR) AND SECOND CLEAR FLOURS** - Flour from the
streams of higher ash content flour. Second clear is the highest ash
content.

**TREATED GRAIN** - Treated grain usually refers to seed grain which has
been treated with a mold inhibitor or fungicide which contains a dye
imparting color to the grain, i.e. pink wheat.

**PURIFIERS** -- Recripocating sieves using air currents to separate
bran and classify particles.

**\"THROUGH\" FLOUR** - Flour that has gone through the entire system,
including sifters**,** and is being added to the dry mixing machine.

### EQUIPMENT 

There is a variety of specialized equipment used in grain product
manufacturing inspections, and specialized terminology and equipment
used in the grain product industry.

Specialized equipment includes:

**BOOT TRIER** - a long, rectangular, shallow scoop that is used to
sample grain from the inspection port of the boot of a bucket elevator.
**Note: never use the trier in an elevator that is operating**. Material
from a boot trier is examined by slicking or sieving.

**DOCKAGE SIEVES** - a set of #10 mesh, #20 mesh, #30 mesh sieves, and a
bottom pan, used to sift grain or flour for insect contamination.

**FLOUR SLICK** - a wide stainless steel spatula used by passing the
flat side of the tool through the material being examined. This spreads
and compresses the material, and insects or other foreign objects in
will pop to the surface of the \"slicked\" material.

**GRAIN BOMB** - a weighted cylinder on a line with a v-shaped bottom
used to collect samples from bins where the grain surface cannot be
reached with a grain probe. **Note: any bomb used in a grain elevator
must be constructed of a material that will not cause sparking.**

**GRAIN CLOTH** - a cloth on which grain from a compartmented probe is
poured for examination.

**GRAIN PROBE** - a long, slotted cylinder used to sample and examine
cores of bulk grain from storage bins, rail cars, etc.

**CONVEYING SYSTEM EQUIPMENT** - devices used in elevators, mills and
manufacturing plants to move materials from one site or point to
another. Common pieces of equipment include:

**Conveyor Belts** (wide, open rubber or composition belts moving at
relatively high speeds.) They are used primarily in elevators to convey
whole grain from one bin to another, in unloading trucks and railcars,
or loading ships.

**Boots** (bottoms of bucket conveyors) - The drop-bottom type of boot
cannot be examined internally while the mill is in operation. Some boots
are mounted slightly above the floor, making the area underneath hard to
clean. Examine stock under the boot which may serve as a source of
contamination for the whole conveying system. Open slightly and note if
the stock is loosely or tightly packed. If tightly packed, the boot has
not been disturbed for some time.

Remove and sieve approximately one pint of static stock. Always examine
the boots which handle the first and second tailings and the sixth or
seventh middlings (midds). The 1st and 2nd tailings are the tailings off
the shifters just after the 1st and 2nd break rolls. This is the start
of the flour milling operation with the cleaned wheat being broken or
ground. The 6th or 7th midds occur late in the milling process and are
the fine pieces of endosperm entering the 6th or 7th reduction rolls.

**Heads** (tops of bucket conveyors) - Examine static stock which has
collected on ledges within the heads. If the heads themselves cannot be
entered, examine static stock in spouts as near to the heads as
possible.

**Spouts** - Inspect spouts through inspection ports and examine static
stock on the undersides of the port covers, felting if used, and debris
under metal lining in spouts.

**Screw conveyors** - Where there are many conveyors, concentrate on the
longer ones. Examine static stock in screw conveyors not covered under
specific mill equipment listed elsewhere. Special attention should be
directed to conveyors which have been sealed against entry, dead stock
at the ends, and to conveyor(s) moving flour from bulk storage.

**Elevator (legs)** - Examine through port openings. Check port lids for
presence of insects, larva and webbing.

**Millerato[r]{.underline}** - A separator used as an initial cleaning
step to remove coarse and fine materials from the grain stream.

### 

### SECTION I: ELEVATORS

### 

Wheat, rice, corn, oats, soybeans, and a variety or other harvested
grain products are stored in elevators pending delivery to a food
processing plant. Elevator storage should maintain these grains in a
condition suitable for processing into human foods and animal feeds.
This inspectional method is intended to evaluate the storage conditions
of these grains to determine if they are adulterated with filth,
chemicals and/or other contaminants.

Specialized equipment necessary will include **non-sparking** grain
probes, and grain bombs, dockage sieves, grain cloth, **safety**
flashlights, photography equipment **with high speed film (for use
without flash equipment)**, blacklight, and hardhat.

Inspect all wheat and other human food grains found in elevators and
storage warehouses, including grain under government loan programs, and
grain intended for export. Where violative conditions are found,
document and report in detail, including the origin, destination, and
ownership of the grain and responsibility for the violations.

### SAFETY PRECAUTIONS

Never enter a boxcar, truck, barge, bin or flat storage facility (bulk
warehouse storage) until you have assured it is safe, and a second
Investigator is standing by to render assistance. Always make sure the
plant management is aware of your location and inspection plan. Sampling
railcars, whether in a rail yard or at a firm, should always be
conducted with another Investigator. Since multiple probes are usually
necessary, a second Investigator on the ground outside the railcar
facilitates packaging the sample from each separate probe. Grain in a
boxcar, barge or truck is usually compacted, and using a grain probe can
become quite strenuous. In hot weather, this can lead to dehydration and
exhaustion. Also, there is the danger of an engine hooking onto the
railcars, causing the grain car door to shut, trapping you inside. If
you are in the process of probing, this shock can also cause injury from
the probe itself, or throw you against the railcar walls, or out of the
railcar altogether.

Become familiar with hazards and safety precautions before beginning any
elevator inspections. See IOM 140 for detailed discussion of necessary
safety precautions.

Wear a hard hat, (non-sparking, plastic, fiberglass, etc.). Be sure
man-lifts are in proper working order before using**,** and follow the
firm\'s rules on their use. Operate with caution.

Elevator storage facilities present a special hazard due to dust
formation. Dust in combination with humidity creates an explosive
atmosphere which may be triggered by sparks, arcing of photograph flash
bulbs, ordinary flashlight operation, or any type of activity which
produces sparks. In this type situation be extremely careful not to use
spark producing equipment, such as non-safety flashlights and flash
photography. Move carefully**;** striking of the nails in shoes on
metal, scraping of a metal hardhat or metal equipment against a metal
surface may also produce sparks. Wear rubber coverings (not plastic
which may create static electricity) over shoes as necessary to prevent
sparks from shoe nails.

The use of mold inhibitors in stored grains may pose a hazard to persons
working in and around grain storage areas. The most often used chemicals
are propionic acid, propionic and acetic acid mixtures, isobutyric acid,
and ammonium isobutyrate. Check with plant personnel and determine if
the stored grain has been treated**,** and when.

If grain has been treated observe safety precautions including:

1\. Avoid breathing the chemical vapors. Use a respirator if necessary.

2\. For the first few days after treatment, avoid entering closed areas
where treated grain is stored.

3\. Liquids can be absorbed through leather gloves and shoes so wear
rubber gloves and shoes or rubber shoe covers. See caution on sparks
above.

4\. If it is necessary to handle freshly treated grain, wear safety
goggles, rubber gloves and aprons or equivalent protective covering.

5\. If liquid contacts skin or eyes wash immediately and thoroughly with
water. In case of liquid spills on clothing, change and wash the
contaminated clothing as soon as possible.

6\. If liquid is accidentally swallowed, wash mouth with water and drink
milk preferably mixed with egg whites to neutralize the acids. **CONTACT
YOUR LOCAL POISON CONTROL CENTER IMMEDIATELY.**

Be especially careful using a grain probe to sample grains. The probe
has very sharp doors which close over the individual grain compartments.
If you hold the probe with your hand or fingers over the openings when
you close the doors, you can cause severe cuts to your hand or fingers.
Before closing the doors on the probe, make sure your fingers and hand
are grasping the probe at a solid point. Always look at the position of
your hands when closing the doors on a grain probe.

# RAW MATERIALS

Determine what examinations are made of incoming wheat or grain:

-Evaluate equipment and facilities used for such examinations, i.e.,
blacklight and blacklighting facilities used to detect treated kernels
(pink wheat) and aflatoxin contamination.

-Appraise the operators\' qualifications to operate testing equipment.

-Review test results for both incoming and outgoing grain shipments.

-Determine the disposition of rejected grain.

-Examine incoming and outgoing grain for evidence of contamination.

-Investigate the procedures and controls for selecting grain shipped for
human food processing.

-Inspect vehicles used to transport grain for human consumption and
determine rejection rate for such vehicles.

### STORAGE FACILITIES

Inspect exterior and interior of elevator for rodent harborages and for
evidence of rodents.

Examine elevator and boot pit area, bins, headhouse and tunnels for
evidence of rodent, insect and bird activity and the unsafe/prohibited
use of rodenticides or other pesticides.

To demonstrate actual evidence of rodent or bird contamination of stored
grain, count the number of pellets, or bird droppings on the surface in
terms of number per unit area (number/square foot, etc.). Also note any
evidence of tracks, urine stains, and nests as well as avenues of rodent
or bird traffic, etc. Count rodent pellets per pint found in the grain
from the top two inches or so in a specified area. For comparison probe
the depths of the bin and examine this grain.

Examine a sufficient number (i.e. square root of the number of bins up
to a maximum of ten) of bottom and top bin grain samples for evidence of
rodent pellets, insects, insect damaged grain, and treated grain to
assure grain is not adulterated.

Check for deliberate blending of contaminated and non-contaminated
grain.

Be alert for condensate in grain bins and moldy or moisture damaged
grain.

### PESTICIDE USAGE

Investigate the firm\'s rodent and insect control program. Obtain the
names and active ingredients of rodenticides and pesticides used,
frequency of use, and precautions taken. When careless use of
rodenticides or pesticides is suspected, obtain documentary samples**,**
with exhibits**,** and discuss with management immediately. Obtain
complete documentation to demonstrate the culpability of those
responsible for placement and use of the rodenticide or pesticide.

#### SECTION II: FLOUR MILLING

Do not conduct flour mill inspections without first receiving on-site
training. Also, become familiar with the vocabulary specific to this
industry.

Refer to IOM 140 and Section I: Elevators, of this guide for safety
precautions prior to conducting any inspections of mills or elevators.
Care must be taken when opening equipment for inspection purposes.
Pneumatic systems pose a special hazard caused by blow back. In addition
to the instructions and information provided in IOM 530 and 21 CFR 137
Cereal Flour and Related Product Standards, direct attention to the
following areas when conducting inspections of flour milling operations:

At the start of the inspection, prior to entering any equipment, collect
and examine cleaned and uncleaned wheat and correlated flour samples as
instructed below.

Inspectional equipment necessary for flour mill inspection, and
sampling, includes a flour slick, boot trier, industrial safety-type
flashlight, three sieves (#10, #20, and #30), and a deep-bottom pan.
Collect flour samples in unbreakable containers, such as clean milk type
cartons. Flour for moisture analysis should be collected in clean glass
jars Do this outside the plant because of the potential for glass
breakage.

Check wheat samples for rodent pellets, ergots, toxic weed seeds, moldy,
treated and insect damaged kernels. Examine the coarse separates from
the millerator for rodent pellets and the fine screenings for insects.

[Uncleaned wheat]{.underline} - Sample falling, blended

grain dropping on or off a conveyor immediately

before the first cleaning unit. Do not sample

grain actually on a belt or conveyor of any type.

Collect approximately one-pint portions every

Ten minutes over a half hour period (four

samplings) to yield two quarts of grain. Take a

complete cross-section of the stream each time.

When finished, visually examine for pellets,

insects, insect damaged kernels, ergots, toxic

weed seeds, moldy grain, color and odor for

treated grain. If the sample of uncleaned wheat

appears to be above defect action levels**,** inspect

grain storage on site for dirty wheat. Visual

examination of the unclean wheat will also

show the adequacy of the firms cleaning

process.

Collect one two-quart sample each day of the

inspection. However, if it appears over-tolerance

wheat (in whole, or as part of the blend) is being

used, collect additional samples at approximately

four-hour intervals during the course of the

inspection.

If the mill is blending suspect and passable wheat, obtain a two-quart
sample from each bin being used for the blend and submit to the
laboratory for analysis. See Compliance Policy Guide Manual, section
555.200- Adulterated Food Mixed with Good Food.

[Cleaned wheat]{.underline} - If contaminated wheat is being used,
collect a sample of cleaned wheat from each lot comprising the blend.
Otherwise, collect one sample of cleaned wheat without regard to the
identity of the lot. Take one-pint portions at approximately ten-minute
intervals to yield two quarts of grain. Visually examine for pellets,
insects, insect damaged kernels, and moldy grain and check for treated
grain.

Sample the cleaned wheat before it enters any equipment in the mill
which begins breaking the wheat kernel into pieces. This first equipment
is usually the break rolls (or in some mills, the prebreak rolls). If
the mill uses any kind of prebreak which makes a small amount of flour
for human food, treat this system as the first break. If, however, the
mill uses an entoleter (an impact machine used to destroy living insects
and insect eggs, break unsound wheat and remove the insect fragments and
unsound wheat), and all aspirations go into feed, sample the cleaned
wheat after this treatment. If the mill does not use an entoleter or
prebreak roll, the wheat may be sampled prior to entering one of the
first break rolls or within the roll housing. It is not necessary to
sample the streams going to all of the first break rolls.

3. [Flour]{.underline} - The flour sample should represent the
production from the lot of cleaned wheat previously sampled. To avoid
knocking insects into the stream, do not enter the flour milling
equipment for the purpose of inspection and sampling between the time of
sampling cleaned wheat and sampling flour. This sample should be
collected after the grain has passed through the entire milling stream.
This may require a twenty to thirty minute delay between sampling the
clean grain and the finished flour. Determine the time lag for grain
from first break to finished flour and collect your samples accordingly.

Sample each generally recognized flour stream which is going to food use
after the final aggregation and, if possible, after rebolting (sifting).
Make sure that no blending with flour from other sources (bulk storage
tanks, etc.), has occurred. Sample half-pint portions at approximately
ten-minute intervals until one quart from each stream has been
collected.

Include information as to the percentage of total flour production
represented by each aggregate flour stream sampled on the C/R. Report
the percentage extraction of the wheat represented by the aggregate
streams sampled. These figures will permit the calculation of the
analytical results to a straight flour.

The purpose of this sampling is to look for insect filth. For the
evaluation of sanitary conditions in a flour mill, it is important to
look for the distribution of insect filth derived from the use of
insect-infested grain. In order to follow the insects through the
milling equipment the size of the streams must be taken into
consideration. A small stream, even if highly contaminated, may carry
fewer fragments per hour than a very large stream showing much less
contamination per unit weight. The size of the individual flour streams
can be expressed as a percentage of the total flour made. When the
insect fragments are counted in the individual flour streams, and this
count is multiplied by the stream percentage, the result is the number
of fragments the stream would contribute to a straight flour.

If further inspection reveals no problem at the mill, the flour samples
may be discarded. However, if inspectional conditions warrant, submit
samples to the laboratory for examination. Collect investigational
subsamples of flour stock which exhibit the violative condition of
specific equipment (See Production Equipment, Packaging Equipment, and
Sample Collection section). Identify stock examined or collected with
its particular section of the mill flow. If gross infestation is found,
sample \"backwards\" and \"forward\" from this point to determine the
problem source and magnitude.

If you can positively identify insects found during a flour mill
inspection, list them by species such as: Tribolium (for both confused
and rust red flour beetles), weevil (for both rice and granary weevils),
flat grain beetle, saw-toothed grain beetle, etc.. If you are not
positive as to species, identify them generally as to type, e.g. weevil
type, moth type, beetle type, etc. Representative insects should be
collected for verification by the laboratory.

If mill infestation is found, obtain detailed information and
documentation covering the firm\'s fumigation practices, including the
dates of spot and general fumigations over the past year. The mill may
use methods other than fumigation, such as heat, to control infestation.
Report on those practices as well.

Mills usually produce a patent, first clear, and second clear flour, or
a combination of these. Determine the percent contribution each flour
makes to the total flour output. For example, 70% of the total flour may
be patent, 25% may be first clear and 5% may be second clear. Minor
variations in the percentage figures do occur from time to time and the
miller may use this fact to abstain from giving you such figures. Obtain
the miller\'s best estimate of these flour percentages.

Determine the firm\'s practices with regard to inspection and cleaning
of equipment. If a self-inspection program exists, review a
representative number of their reports.

Check metal detection and removal devices for effectiveness.

##### RAW MATERIAL

Inspect the elevator and grain storage facility. See \"Section I:
Elevators\" of this guide for instruction.

##### PRODUCTION EQUIPMENT

Examine flour production equipment. Use caution when examining any of
this equipment while in operation, both to protect yourself as well as
the equipment. Except in a small mill, it may not be feasible to examine
all equipment, but some of all types of equipment should be examined.
Also look for lubricant and heat transfer fluid leaks. The equipment may
be considered in seven categories, as follows:

1\. Rolls - Examine static stock in the feeder box, on ledges in upper
housing, in the housing beneath the rolls, and in the corners of the
hopper itself.

2\. Sifters - Examine static stock as far up and down from the spout
opening as possible. Square spout openings usually contain ledges within
the spout. Examine felt gaskets or packing, and tailover stock from
rebolt sifters. If insects are found, examine the systems ahead of the
rebolt.

3\. Purifiers - Examine static stock in the feeder box, on ledges in the
upper and lower housing, and the sieve to see whether or not insects are
tailing over. Examine the tailover spout and static stock at the end of
the conveyor.

4\. Conveying system - Examination of conveying system components is
addressed in the introduction to this guide. Common components include
boots (during inspection of flour mills always examine the boots which
handle the first and second tailings and the sixth or seventh midds),
heads, spouts, screw conveyors (special attention should be directed to
conveyors which have been sealed against entry, to dead stock at the
ends, and to conveyor moving flour from bulk storage), and elevators.

5\. Suction trunking - Dust collected from the break and reduction
rolls, purifiers, and sifters is almost always processed into flour, and
if infested, serves to contaminate the equipment beyond the point of
entry of these dust streams into the flour stream. Examine at elbows and
dead ends or wherever there are accumulations of dust.

6\. Dust collectors - Examine stock discharged from these collectors for
insects particularly where static stock in corresponding suction
trunking is found infested. The stocking-type dust collector is more
difficult to clean than other types**,** particularly when infested by
moths. A slight blow with the hand on a cyclone dust collector usually
serves to dislodge static stock from the inside.

7\. Bran and shorts dusters - Obtain entry to some of the bran and
shorts dusters, and examine static stock from the housing and the spouts
beneath.

##### PACKAGING EQUIPMENT

Wooden packer bins, including those with metal liners, should be
examined for crevices, shoulders, and braces which could hold static
stock and harbor insects. Infestation in packer bins is almost certain
to produce identifiable filth in packaged flour.

Some packaging machines are designed to allow a space between the bottom
of the bin and the top of the packer. This space may be caulked with
bags, or a cloth sleeve and if not properly cleaned may provide a
harborage for insects.

When flour is removed from bulk storage tanks to be blended or packed,
it may become contaminated by the passage through infested conveying
equipment. Examine the blending equipment for dead ends, static stock in
conveyors, spouts, etc. If any flour is being rebolted (sifted) after
storage in bulk, examine the rebolt tailings. Report the type of sifter
and the size of the cloth or wire with which this machine is clothed.

##### FINISHED FLOUR

Check bulk storage tanks and finished flour conveying systems for
insects. Use extreme care when examining empty bulk tanks.

Give attention to the sanitary condition of stocks of malt flour or
other flour received for blending. Malt flour is highly susceptible to
insect infestation.

Examine the small flour bin used to adjust bag net weights, and its
contents, near the semi-automatic packers. Such bins may be neglected
during clean-up.

Determine type and amount of enrichment used per batch, or per day if a
continuous mixing operation is used. Check calibration on enrichment
metering devices. If enrichment analysis is made by the firm or contract
lab, determine sample size, method of collection, and review recent
assay results.

##### FOOD ADDITIVES

Review food additives and enrichment in storage to determine if allowed
in standards (21 CFR 137). Calculate percentages or amounts in the
finished product per CWT (hundred weight or 100 lbs.) of flour (remember
to be consistent with the units utilized in the standards.). Enrichment
held for a year or more, or held at abnormally high temperatures or
humidity, may have deteriorated.

Check use of bleaching agents, artificial aging agents, optional
ingredients. Refer to 21 CFR 137.

##### SANITATION

The bag stock should be inspected for rodent or insect damage/harborage.
Also examine bags or other storage containers for chemical
contamination, e.g. oil impregnated cloth.

Check the sanitary condition of railcars, truck trailers, bulk trucks
and barges awaiting loading. Determine mill\'s rejection criteria, if
any, for contaminated transport vehicles. Ascertain cleanup procedure
for railcars and other vehicles, and determine if it is followed.

Sacks, cloth, tape, etc. used to caulk openings in elevator legs,
spouts, and other equipment should be examined for insects.

##### QUALITY CONTROL

Review assay records for compliance with flour standards (moisture, ash,
protein, enrichment) rodent hairs, insect fragments, aflatoxins or
mycotoxins (reference Compliance Policy Guide Manual, section 555.400),
and other contaminants.

##### SAMPLE COLLECTION

[Filth: 301(k)]{.underline} - Where insanitary conditions are detected
in the processing areas of an intrastate firm, consider documenting
301(k) violations for regulatory consideration, if the state or local
authorities are unable or unwilling to correct the situation, or have
requested FDA handle the case. See IOM subsection 405.4

Your sample should include the following (the 702(b) portion should be
separately identified and retained):

1\. A minimum of three quarts of flour, in duplicate: collecting 1 qt.
from each of three previously unopened bags taken from the same lot
being dumped into the conveyor. If two or more lots are being blended,
sample a minimum of three bags from each lot.

2\. Collect up to 3 quarts of flour, in duplicate, if that much is
available, from each static point. Filth exhibits should be collected to
document the insanitary conditions and made part of the sample.

3\. Collect a minimum of six quarts of \"through\" flour, in duplicate,
as the dry mix is being made. To accurately reflect the condition of the
flour passing through the system, the subs of \"through\" flour must be
obtained before the conveyor has been opened for inspection and the
static flour disturbed.

[Filth]{.underline} - Cereal products, especially flour, are sampled:
(a) on the basis of microscopic filth, or (b) because of gross filth due
to insanitary transportation or storage facilities.

1\. Microscopic filth - When sampling flour for microscopic filth,
samples should be collected from the lower grades of flour. (e.g.: clear
and straight flour). Patent flours will show a low level of microscopic
filth because of the milling and purification processes.

Select units to be sampled at random. If different codes are present,
sample each code separately. Packages of less than 11.4 kg (25 lbs):
Collect twelve intact bags and submit \"as is\". Packages of 11.5kg (25
lbs.) or larger, use a flour trier. Open bags at seams and remove top
layer of flour before inserting trier. Take about one pint sub-divisions
from each of twelve bags of the same code. See IOM 452 for sample
handling and preparation.

Gross Filth - This is \"selective sampling\" See

IOM 427 for detailed sampling instructions and

IOM 452 for sample handling and preparation.

[Vitamins and minerals]{.underline} - Samples will be

collected on assignment basis or if inspectional

conditions warrant.

1\. Retail Packages 4.5kg (10 lbs or less) -Collect twelve intact
packages in duplicate of the same code.

2\. Bulk and Retail Packages 4.5kg (Larger than 10 lbs) - Collect 12 -
453 gm (1 lb) subs in duplicate from each of twelve different containers
of the same code. Remove flour or other cereal product with a trier
inserted the full length of the container. Prepare each sub in
individual airtight containers and protect against sunlight by wrapping
in opaque paper. Do not fumigate samples.

[Net weight]{.underline} - Refer to IOM 428 for guidance. Also, obtain a
moisture sample of two cores of flour from each of six other weighed
packages. Insert the flour trier from one corner diagonally through the
package. Immediately place the two cores in a clean, dry air tight
container which has stood open for a few minutes near the lot of flour
sampled. Close the container immediately using a different one for each
package. Identify each with the gross weight of the package from which
taken. Do not fumigate.

[Mycotoxins and Aflatoxins]{.underline} - See IOM Sample Schedule Chart
6.

[Pesticides]{.underline} - See IOM Sample Schedule Chart 3.

SECTION III: BAKERY PRODUCTS, DOUGHS, BAKERY MIXES

Review IOM 530 and 21 CFR 136, Bakery Products Standards, prior to
conducting bakery inspections.

##### RAW MATERIALS

When 301(k) violations are suspected, collect a \"through\" flour sample
as the dough is being made. \"[Through\" flour]{.underline} is that
which has gone through the entire system, including sifters, and is
being added to the dough mixing chamber. To accurately reflect the
conditions of the flour passing through the system, the subs of
\"through\" flour must be obtained before the conveyor has been opened
for inspection and the static flour disturbed.

If no insanitary conditions are found, this sample can be discarded.
Report sources and types of egg and milk products. If frozen eggs are
used, determine if they are pasteurized, received under a Salmonella
free guarantee or if firm tests critical raw materials for microbial
load including Salmonella and other pathogens.

Determine what procedures and controls are in place regarding the
sanitary condition of vehicles in which raw materials are received.

Determine if raw materials requiring refrigeration are refrigerated.

Determine what examination is made of raw materials before use and any
attempt to \"blend off\" contaminated raw materials with clean raw
materials.

##### 

##### PROCESSING

Determine any areas in the process where a \"bottle-neck\" occurs
allowing in-process products amenable to microbial contamination to
remain at room temperature for long periods of time.

Determine effectiveness of metal detection and removal devices.

##### SANITATION

Open inspection ports, where possible, and examine static accumulations
for mold growth, and insect and/or rodent infestations. Particular
attention should be given to flour bins, elevator boots, conveyor
systems, sifters, dump scale apparatus, production line flouring
devices, dough proofers, overhead supports and ledges, and transport
vehicles.

Determine disposition of salvaged material and returned goods.

If possible, inspect equipment prior to production to determine adequacy
of clean-up and sanitizing operations.

Determine time-temperature abuses which may allow growth and possible
toxin formation of microbial contaminants.

Be alert for poorly designed conveyors or equipment which might add to
microbial load through product delay or \"seeding\".

##### STANDARDS

Determine method of adding enrichment to the product whether by use of
enriched flour, enriched salt, or enrichment wafers. If enrichment
analyses are made by the firm or contract laboratory, determine sample
size, method of collection, and review the most recent assay results.

Obtain formulations of standardized products and determine if the
firm\'s manufacturing and enrichment practices results in products
conforming with 21 CFR 136.115.

##### 

##### SAMPLE COLLECTION

Where sample size is indicated, 702(b) portions should be separately
identified and retained.

[Filth 301(k)]{.underline} - Where insanitary conditions are

detected in the processing areas of an intrastate firm, consider
documenting a 301(k) violation for regulatory consideration if the state
or local authorities are unable or unwilling to correct the situation,
or have requested FDA handle the case. You may also consider discussing
the situation with the Center for Food Safety and Applied Nutrition
(CFSAN) and Office of Chief Counsel (OCC). See IOM section 405.4.

Your sample should include the following:

1\. A minimum of three quarts of flour, in duplicate: Collect one quart
samples from each of three previously unopened bags from the same lot as
being dumped into the conveyor. If two or more lots are being blended,
sample a minimum of three unopened bags from each lot.

2\. Collect up to three quarts of flour, in duplicate, from each static
point. Filth exhibits should be collected to document the insanitary
conditions and should be made part of the sample.

3\. A minimum of six quarts of \"through\" flour, in duplicate, should
be collected as the dough is being made.

[Filth 301(a)]{.underline} - Sample from the square root of the number
of shipping containers in the lot with a minimum of six and a maximum of
eighteen subsamples, in duplicate. Each subsample should weigh at least
453 gm (1 lb). If the product is not in shipping cases, sample the
square root of the number of retail packages with a minimum of 6 and a
maximum of eighteen subsamples of at least 453 gm (1 lb.) each, in
duplicate. If the retail packages (loaves, cakes, etc.), do not weigh
453 gm (1 lb.), each sub should consist of sufficient retail units to
equal at least 453 gm (1 lb.).

[Microbiological]{.underline} - Collect a representative sample
consisting of a minimum of 10 intact units collected in duplicate.
Minimum size for each sub is at least 113 gm (4 oz).

If the product is to be analyzed for Salmonella, follow the Salmonella
Sampling Plan in IOM Sample Schedule Chart 1.

[Enrichment, Minerals and Nutrition Labeling]{.underline} - Bread,
rolls, baked or unbaked product: Compliance samples should consist of 12
subsamples of at least 1 lb. each (454 gm) collected in duplicate.
Collect consumer size retail packages (2 - 1 lb. subs from each of 12
cases) from separate cases of the same code. Protect enrichment samples
from sun by wrapping in opaque paper. Determine and record by sub the
gross weight.

[Standards]{.underline} - If unauthorized ingredients are being used in
a standardized product, collect a sample of the ingredient for
identification and a sample of the standardized product in which the
optional ingredient is being used.

For official 301(a) or 301(k) samples, collect a minimum of six subs
\[each 226 gm (8 oz.)\] of finished product, in duplicate, and 1 - 226
gm (8 oz.) sub of each unauthorized ingredient.

[Economic]{.underline} - See IOM 428 for instructions.

[Food Additives]{.underline} - Collect a sample consisting of 1 - 226 gm
(8 oz) sub of the food additive and a minimum of six subs of finished
product in duplicate, each sub to consist of a minimum of 226 gm (8 oz).

[Color Additives]{.underline} - See IOM Sample Schedule Chart 9. Chart 9
also contains guidance for sample size of the color additive itself.

[Sample Preparation]{.underline} - See IOM 452 for sample handling and
preparation.

SECTION IV: MACARONI AND NOODLE PRODUCTS

Review IOM 530 and 21 CFR 139 - Macaroni and Noodle Products Standards
prior to conducting these inspections.

##### RAW MATERIALS 

Describe storage and handling of raw materials that would contribute to
vermin and microbiological contamination.

Report processes in detail that are designed to remove contaminants**,**
including metal fragments, from the raw material before being
incorporated into the finished product.

Report types, egg solid content and suppliers of egg products.

Determine if egg products are pasteurized, received under a Salmonella
free guarantee, or if firm tests critical raw materials for microbial
load including Salmonella and other pathogens.

Determine what procedures and controls are in place regarding the
sanitary condition of vehicles in which raw materials are received.

##### SANITATION

Evaluate adequacy of cleanup practices before operations begin. Examine
extrusion worms, dies, kneading plates, rollers, slicers, cutting
machines, drying rods and dryer conveyors.

Determine the type, concentration, and use of sanitizing agents. Check
availability and location of handwashing facilities and hand dip
solutions.

Examine flour handling systems for evidence of insect infestation. See
Section II: Flour Milling\" of this guide for 301(k) evidence
development.

Examine scrap grinder, drying cabinets, screened bottom dryer trays and
dowels used to handle long goods (spaghetti) for evidence of insect
activity and cleanliness.

Determine disposition of scrap material, salvage, or returned goods,
etc.

Provide in-depth coverage of all time/temperature relationships
affecting possible build up of Staphylococcus, Salmonella and/or other
microbiological organisms of health significance. Particular attention
should be directed to egg-water and egg-water-flour mixing operations.

##### ENRICHMENT OPERATIONS

Determine type and amount of enrichment used per batch, or per day if a
continuous mixing operation is used. Check calibration on enrichment
metering devices. If enrichment analysis is made by the firm or contract
laboratory, determine sample size, method of collection, and review most
recent assay results.

##### ECONOMIC {#economic-1}

Slack Fill. Prepare an authentic pack as full as practical when: (1)
Elbow macaroni container is less than 80% filled, (2) Long macaroni,
spaghetti, and vermicelli containers are less than 70% filled.

##### STANDARDS

See 21 CFR 139, Macaroni and Noodle Products.

1\. Egg solids - Products under 21 CFR 139.150, 139.160, & 139.180,
except chow mein noodles, must contain 5.5% of the total solids as egg
solids. Any one of the following egg quantities added to 100 lbs. of
flour should result in compliance:

a\. 9.43 kg (20 lbs. 13oz.) commercial liquid whole eggs.(24.7% egg
solids).

b\. Approximately 187 large eggs.

c\. 4.54 kg (10 lbs.) commercial liquid yolk (51.2% egg solids).

d\. 2.40 kg (5 lbs. 5 oz.) commercial dried whole eggs (96.9% egg
solids).

5\. 2.40 kg (5 lbs. 5 oz.) commercial dried egg yolk (97% egg solids).

In continuous mixing operations it may be possible to compare the total
weight of egg ingredient with the total weight of flour used in a
production.

If the firm is using other optional ingredients in lieu of flour, such
as farina or semolina, further calculations may be necessary. CFSAN
Division of Plant Product Safety (HFS-305) \@202-205-5321 can assist in
determining if the firms formulation will result in a compliant product.

2\. Addition of artificial color to eggs - Report addition of
beta-carotene or other artificial color to eggs. Colors are not
permitted.

Compare the color of each egg ingredient being used with that in
unopened containers.

##### 

##### SAMPLE COLLECTION

[Investigational]{.underline}

1\. Filth - Collect samples of returned goods, scrap or other recycled
materials when finished product adulteration is suspected from these
sources.

2\. Microbiological - If conditions warrant collecting investigational
samples for microbiological contamination, sampling should include the
following areas:

a\. Scrapings from egg slurry mixing vessels, particularly those re-used
without cleaning and sanitizing.

b\. Scrapings from gratings over mixer blenders through which egg slurry
passes.

c\. Scrapings of macaroni dough from mixer-blender.

d\. Scrapings from production equipment such as extrusion worms and
dies, kneading plates, rollers, slicers, cutting machines, drying rods
and dryer conveyors.

e\. Scrap material where recycled into the process.

f\. Product before and after drying.

g\. Each raw material before and after blending.

h\. Sample eggs, finished egg noodles, and other egg-containing finished
products for Salmonella examination. (See IOM Sample Schedule Chart 1 -
Salmonella Sampling Plan)

i\. At least ten intact units of suspect finished product(s) from the
day\'s production, and from the previous day\'s production.

3\. Standards - Collect product formula and 113 - 226 gm (4‑8 oz.)
subsamples of egg ingredients, flour, and finished product when a
deficiency in egg solids is suspected.

Collect 113 - 170 gm (4‑6 oz.) sub-divisions of the suspect color,
finished product, egg ingredient, and subs from a previously unopened
container of egg ingredient where the addition of artificial color is
suspected.

[Official]{.underline}

1\. Filth

a\. Retail Packages 226 gm to 1.36 kg (8 oz. to 3 lbs.)

Number of subs in sample - Sample the square root of the number of
cartons in the lot with a minimum of six, and a maximum of eighteen.

Number of packages per sub

[Package Size]{.underline} [No. Pkgs/Sub]{.underline}

226 - 283 gm 3

(8 oz. - 10 oz.)

340 - 453 gm 2

(12 oz. - 1 lb.)

.906 - 1.36 kg 1

(2 lb. - 3 lb.)

b\. Bulk Cartons (9.1 kg - 20 lb)

No. Ctns. in No. Ctns. to

[Lot]{.underline} [Collect]{.underline}

2‑30 2

30‑60 3

60‑90 4

90‑120 5

over 120 6

2\. Microbiological - Collect a representative sample consisting of 20
intact units. Minimum size for each intact unit is 113 gm (4 ozs). If
egg noodles are analyzed for Salmonella, refer to IOM Sample Schedule
Chart 1 - Salmonella Sampling Plan.

3\. Enrichment (vitamin, mineral, & nutritional labeling)

Retail packages - Collect a representative sample consisting of at least
12 - 226 gm (8 oz.) intact retail units in duplicate from each lot. All
subs should be the same code.

Bulk cartons - Collect 12 - 226 gm (8 oz) subs in duplicate from
different cartons in the lot.

4\. Egg solids or other analysis

Retail packages - Collect sufficient sample to total 2.7 kg (6 lbs) in
duplicate with a minimum of three packages.

Bulk Cartons - Collect 453 gm (1 lb.) subs in duplicate from six
different bulk cartons in the lot.

5.  Slack fill - Collect five packages in duplicate from each of four
    different shipping cases.

[^1]: **    ^?^ Note: *This inspectional [guidance i]{.underline}s
    intended to provide guidance and instructions to FDA staff for
    obtaining information to help fulfill the Agency's plans regarding
    the inspection of grain product manufacturers. This Inspection Guide
    does not create or confer any rights for or on any person and does
    not operate to bind the Food and Drug Administration (FDA) or the
    public. An alternative approach may be used if such approach
    satisfies the requirements of the applicable statute and
    regulations. It is intended for FDA personnel and is available
    electronically to the public.***