Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s).
This guide is divided into multiple sections. Each section provides specific instructions and information applicable to the individual product or products covered. Prior to conducting any inspection involving any food product manufacturer, review the FD&C Act Chapter IV, Food, 21 CFR 110, GMP's on Food, and the general inspectional instructions in IOM Chapter 5.
Caution: when sampling and preparing samples, do not use preservative agents in the process areas. These agents should be kept outside the plant entirely to avoid contamination of food products.
Page 1: Section 1 - Eggs and Egg Products
Page 4: Section 2 - Candy Without Chocolate, Candy Specialties, and Chewing Gum
Page 6: Section 3 - Chocolate and Cocoa Products
Page 7: Section 4 - Tree Nuts
Page 9: Section 5 - Peanuts and Peanut Products
Page 11: Section 6 - Vegetable Oils
Page 13: Section 7 - Dressings
Page 15: Section 8 - Vinegar, Cider, Apple Juice
Page 17: Section 9 - Frozen Strawberries
Page 19: Section 10 - Orange, Other Juice
Page 21: Section 11 - Prune Juice
Page 22: Section 12 - Tomato Products
Page 25: Section 13 - Pickles
In addition to the information and instructions provided in IOM Subchapter 530, Attachments 1, 2, and 3 of this document, 7 CFR Part 56, Subpart C (U.S. Standard, Grades, and Weight Classes for Shell Eggs), 7 CFR Part 59 (Egg Products Inspection Act), CPG 7155a.04 (MOU with USDA regarding Egg Products Inspection Act), CPG 7107.02 (Eggs and Other Egg Products - Frozen Adulteration Involving Decomposition) and 21 CFR 110, direct special attention to the following areas when inspecting these types of food establishments.
Producers and/or growers, producers and/or packers (grading stations), and commercial egg breaking facilities operate under USDA jurisdiction, regardless of interstate commerce, pursuant to the Egg Products Inspection Act (EPIA). However, it may be necessary to visit such facilities during Salmonella enteritidis (Se) illness follow-ups, subsequent to the illnesses having been reported to and addressed by the CFSAN Task Force. These visits would be coordinated with USDA and state authorities, to assure the proper diversion of suspect eggs (i.e., to breakers); and that any suspect eggs remaining on the market be addressed (i.e., recall) Refer to Se follow-up procedures below.
USDA inspection is not mandatory for firms breaking eggs for their own use in processed foods. If Se follow-up type coverage involves such food processors, follow the guidelines below.
When eggs or egg products are encountered during a routine inspection, evaluate their production, handling, and use to assure the eggs are broken, stored, and utilized in compliance with the EPIA (a portion of 7 CFR part 59, specifically 59.500-Sanitary, Processing, and Facility Requirements is attached as Attachment 4), 21 CFR 110 - GMPs, and as outlined below. An egg containing food manufacturer breaking shell eggs for their own use must use grade B or better quality eggs. Restricted (prohibited) eggs are defined in 7 CFR 56 (i.e., check, dirty, incubator rejects, inedible, leakers, etc.). Attachment 1 at the end of this document summarizes Egg Quality Standards from 7 CFR 56.
Enforcement of FDA's obligations under the EPIA does not require proof of IS commerce to establish jurisdiction. When substandard (below Grade B) or restricted eggs are encountered, consult your supervisor to evaluate the need for administrative detention of the violative products (IOM 750).
Salmonella Enteritidis Follow-up
Contact the USDA Salmonella enteritidis Task Force to notify them of an outbreak (phone 202-690-2687). Coordinate further actions with CFSAN's Regulation and Enforcement Branch HFS-306 (202-205-4681) and the USDA Task Force.
Determine the type and source of egg ingredients (e.g., frozen, liquid, dried, etc.).
Review manufacturer's guarantee that eggs are salmonella free, whether or not the eggs are pasteurized.
If shell eggs are used, ascertain if they are grade B quality or better. See Attachment 1.
Egg Breaking Operations
Centrifugal Egg Breaking Machines - if the firm is using a centrifuge method of breaking and separating egg shells from the egg magma, check for the following:
- Are only USDA sanitized eggs, grade B or better used? Check expiration dates and storage conditions to insure that grade is still valid and that eggs are of acceptable condition.
- Observe the operator's visual inspection of the eggs. Are dirty and cracked eggs removed from the tray prior to placing the eggs in the centrifuge?
- Does the operator have a system to inspect the underside of the eggs (e.g., a cover to place over the egg tray so they can be turned upside down for visual inspection)?
- Liquid egg mixtures must be used only in products to be cooked or baked for at least 3 1/2 minutes at 600C (1400F) or higher.
- If the end product involves the use of uncooked eggs, a different system for breaking and separating (e.g., hand breaking or pasteurized eggs) must be used.
- Does the firm have a copy of the instruction for use from the supplier of the machine? Do these instructions include the above procedures? Are the instructions near the machine or are they easily accessible to the operator? Are the instructions followed?
Hand Breaking Operations
Breaking dirty eggs is hazardous because contamination with bacteria and filth (fecal material, feathers, animal litter, etc.) may occur. Egg cleaning methods such as brushing, sanding and washing in a detergent solution remove the natural protective film so eggs must be handled promptly to forestall bacterial invasion. Eggs with damaged shells (cracks, checks, or leakers) are subject to bacterial invasion, and must be handled and frozen with special care and rapidly.
Determine the egg breaking process in detail with attention given to:
- Candling of eggs prior to breaking (should be done with good light in a dark room).
- Disposition of eggs rejected prior to breaking. (Reject eggs have some legitimate non-food uses such as tanning. Determine denaturing practices for reject eggs.)
- Procedures to eliminate decomposed eggs.
- Handling of egg magma to avoid contamination.
- Proper egg pasteurization methods. Refer to Attachment 2-Commercial Egg Pasteurization Processes
- Freezing promptly and thoroughly to avoid spoilage, if applicable to the firm's operations.
Eggs should be broken into cups, observed and smelled by experienced operators. If two or three eggs are broken into a single cup and one is bad, the entire contents of the cup should be discarded.
Evaluate the egg-smelling procedure. Although appearance after breaking will identify most suspect eggs; odor will determine the acceptability of all others. Foreign odors, even chewing gum, will interfere with a smeller's efficiency. Occasionally, breakers give only a token smelling by passing the cup too far from the nose. Sixteen eggs per minute is maximum for most experienced breakers.
After finding a decomposed or other reject egg, the cup, breaking knife and hands of the operator should be cleaned and sanitized.
Observe the disposition of empty shells and drip form breaking knives. Egg white from these two sources is sometimes reclaimed, generally incorporating filth and large number of bacteria into the finished product.
Observe time lags and temperatures in the egg churning and straining operations. Particularly critical is the holding of egg magma before freezing.
Examine finished product cans, barrels, etc. for cleanliness and odor. New cans may be coated with an oily film and should be washed before use. Give attention to subsequent rinsing because inadequate draining may be deliberate to increase product volume.
Observe the freezing process, noting freezer type and temperature, method of stacking, forced air circulation, and any other factors bearing on adequacy of freezing. Determine the time from start of freezing to the solid state (e.g., reduce temperature to 100F or lower within 60 hours of breaking or pasteurization - 7 CFR 59.536).
Manufacturers of Egg-Containing Food
If the firm is using liquid or frozen eggs, a suitably trained egg-smeller should examine them organoleptically for decomposition.
- Thawed or liquid eggs may be examined organoleptically by stirring the contents of the can with a sterile spoon or rod.
- 2. Frozen eggs may be examined organoleptically by drilling with a sterile egg drill.
Determine the quantity of egg ingredients in finished products to calculate the egg solids content (i.e., relative to food standards).
Evaluate factors related to Salmonella growth and contamination.
- Determine heating time and temperature during manufacture. Normally, Salmonella growth range is 6.70C to 450C (440F to 1130F).
- Determine conditions allowing cross- contamination of finished product by raw egg ingredients, i.e., use of common utensils, employees switching jobs, dust, etc.
- List bacteriological controls designed to prevent and to detect production of foods contaminated by Salmonella.
During routine inspections, collect samples of eggs, egg products, or foods containing eggs and egg products as necessary to determine compliance with the EPIA and the instructions contained in this guide or as directed by specific compliance programs.
Use aseptic technique when collecting samples of eggs and egg-containing foods.
If egg-containing foods are not heated to 670C (1500F) for 45 seconds or 600C (1400F) for 3.5 minutes or higher, of if the possibility of infection by cross-contamination after cooking exists, collect subs of the egg ingredient(s) and the finished products during each plant inspection. Make the egg ingredient an Official Sample if shipped I.S.
- Egg Ingredients - Collect a maximum of 10-225 gm (8oz) subs for micro examination.
- Finished product - Refer to the Salmonella Sampling Plan, Sample Schedule Chart, attachment 7.
For Salmonella, refer to Sample Schedule Chart, attachment 7.
Collect the following samples from each lot found actionable on field examination (forward sample to the collecting district laboratory in a hard frozen condition).
- For bacteriological examination, use aseptic technique. Collect one pint of drillings from each of two cans classed as passable using the following procedure: Clean an area on the top of the contents of the can scraping with a sterilized hatchet or other suitable instrument; insert the sterilized drill and aseptically transfer the drillings accumulated in the scraped areas to sterile jars.
- For chemical examination, collect two well-packed quart jars from each of the cans already sampled for bacteriological examination. Include some material raised by the drill from the center; the balance may be chipped form the surface.
Usually only bottom-can samples will confirm factory observations. Such samples are usually collected from the ultimate user who may object to sampling a large number of cans.
Suggestions - samples may be obtained by cutting out the bottom of the can or by immersing a can in hot water for a few minutes and sliding the frozen magma out into a clean container. Take scrapings from the bottom including any visible dirt imbedded in the product. Freeze samples or submit them to the laboratory immediately.
Standards and Composition
Obtain a representative sample by drilling. Scrape the surface of each can to remove ice. Take three diagonal borings from widely scattered points. Extend drilling to near the bottom. Composite sufficient borings from each can to make a single well packed quart subsample. Do not include cans classified "decomposed".
If decomposed eggs are found on organoleptic examination, report as follow:
Classify each can examined as "passable" or "decomposed". Do not use descriptive terms. Do not classify cans "decomposed" unless the odor is definitely identified with decomposed eggs. Classify as "passable" cans having an odor which cannot be positively identified as decomposed. Report as "passable" those cans having specific or unrecognized odors, describing the odor characteristics. When classifying exceptionally objectionable cans, you may, elaborate on "decomposed," but only in terms of definitely identifiable specific odors (e.g. "H2S" or "ammonia").
In addition to the information and instructions provided in IOM Subchapter 530 and Section 402(d) of the FD&C Act, direct special attention to the following points when inspecting these types of food establishments.
Egg and milk products must be pasteurized before use or otherwise treated during processing to destroy viable Salmonella microorganisms. Steps must also be taken to insure that other raw materials susceptible to contamination by pathogenic microorganisms (i.e. gelatin, dried coconut, nuts) are free of such organisms before use unless they are pasteurized or otherwise treated before or during processing. Materials capable of supporting growth of pathogenic microorganisms must be held at appropriate temperature and relative humidity except for the period of time actually required for processing and not so long as to effect the wholesomeness of the product. Raw materials such as nuts and corn meal which are susceptible to aflatoxin contamination must comply with FDA regulations, guidelines and action levels for poisonous or deleterious substances or be received under supplier's guarantee of such compliance.
Equipment & Manufacturing Processes
Evaluate the control of foreign objects embedded or hidden within candy such as wooden splinters, glass or otherwise dangerous articles. Processors must take every reasonable precaution to insure that production procedures do not contribute contamination from any source. For example, strategically located magnets and/or metal detectors may be necessary to prevent contamination by metal.
Molding Starch & Trays
Molding starch is often contaminated. Determine how long it has been in use. Estimate amounts and frequency that fresh starch is added. In addition, if wooden starch trays are utilized, check for splitting and/or splinters.
Scrap Candy (Rework)
Evaluate the handling and reworking of scrap candy. Determine if containers used for rework can be readily distinguished from containers used for waste. Determine the source of scrap candy for rework.
Food and Color Additives
Identify the slab dressing used, and estimate the amount per batch. Slab dressings are lubricants employed as release agent on such equipment as cooling tables used in the manufacture of hard candy. If mineral oil is used at a level higher than 2000 ppm (0.2%, approximately 100 gram (3 1/2 oz) per 91 kg (200 lb) batch), obtain shipments for finished product sampling.
Section 402(d) of the FD&C Act limits the amount of alcohol that confectionery may contain to one-half of 1% by volume, and this must be derived solely from the use of flavoring extracts (except that this clause of the FD&C Act shall not apply to confectionery which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce, if the sale of such confectionery is permitted under the laws of the state in which such confectionery is intended to be offered for sale).
Collect the following subsamples when insects or rodent excreta are observed near molding starch operations:
- One pint of starch from the starch mogul.
- One pint of starch from starch trays in use.
- One pint of tailings from the starch cleaner.
Scrap Candy (Rework)
When appropriate collect exhibits and/or official samples of contaminated scrap, and describe how it is used. If contamination by filth is suspected, collect representative exhibits and/or official samples of scrap, even though no macroscopic filth is evident.
Collect samples of products (usually 3-6 units) that have sharp pointed articles or otherwise dangerous articles embedded or hidden within candy (e.g., wooden sticks, pins, trinkets) when a potential for injury exists.
Finished Product Sampling
Mislabeled Chocolate Products
The current standards for cocoa products were updated in 1993 and can be found in 21 CFR Part 163. When mislabeling is caused by a reference to chocolate, documentation shall include a reference sample of the ingredient being substituted and it's quantitative formula and labeling. Be aware that FDA may issue temporary permits for test marketing of products that deviate from the standards.
Submit specimens of flagrantly deceptive packages consisting of three filled and three empty packages with all "spacers" and fillers.
10-450 gram (1 lb) subs. in duplicate.
Collect 10 - 225 gram (8oz) subs in duplicate. If the samples is to be analyzed for Salmonella, refer to Sample Schedule Chart, attachment 7 for guidance.
In addition to the instructions and information provided in IOM 530, and 21 CFR Parts 110 and 163, direct special attention to the following areas when inspecting these types of food establishments.
Insects that commonly infest cocoa beans are stored product insects representing an avoidable defect. Cocoa beans are often fumigated to kill these insect pests and cocoa bean processing effectively removes any such filth where the insects have not invaded the interior or nib portion of the bean. During inspections, determine that effective measures such as physical barriers are in place to prevent cross contamination between cocoa bean cleaning and finished product processing operations.
If cocoa beans are received in bags proceed as follows:
- Screen a number of lots in storage by conducting a preliminary field examination. Field examine a representative number of bags in the lot. Be alert for live stored food insect pests on or around the bags including adult and larval beetles and moths. Document findings with photographs and collect samples as instructed in IOM 427. Extract approximately one pound of beans from each bag field examined utilizing an appropriate sized trier. Screen the beans on a number 3 sieve. Examine siftings for the presence of insects, rodent excreta and other extraneous material.
- Composite one-hundred cocoa beans from ten to twenty bags in the lot.
- Crack open each bean and break the interior portion (nib) of the beans into small pieces along the natural folds of the nib material. This can be accomplished with a hammer, pruning shears or pliers. Examine for mold and/or insect damage. A moldy bean is defined as any bean showing extensive mold effecting a quarter or more of the exposed nib material. Insect damaged is defined as any bean showing insects (fragments or whole insects), insect excreta, webbing or tunneling.
- Collect an official sample for laboratory examination if field exam reveals:
- 2% or more moldy beans; or
- 2% or more insect damaged beans; or
- 3% or more moldy plus insect damaged beans.
If cocoa beans are received un-bagged in cargo containers obtain the subsample from random locations and levels within the container utilizing a grain probe.
If examination of raw material beans indicates the presence of internal insect damage and/or mold, document with appropriate samples, the use of those beans in the manufacture of processed chocolate products.
Determine if critical raw materials including non-fat dry milk (NFDM) and chocolate are received under a Salmonella Free Certificate.
Evaluate the firm's testing of raw materials for bacterial load, including Salmonella and other pathogens.
Determine in detail the firm's cocoa bean processing to include:
- Pre-cleaning - Use of magnets to remove metal.
- Blending - Determine percent of different beans in blend.
- Roasting - Time temperature relationship. Determine if ovens have recording thermometers.
- Cooling - Time and to what temperature.
- Cracking and fanning operations.
- Storage of chocolate liquor - Temperature of storage tanks.
Be especially alert for avenues of contamination by water or condensation. The presence of moisture can result in conditions that can support the growth of Salmonella.
Ascertain firm's coding system.
Collect in-line samples and exhibits to document insanitary conditions which may result in contamination of the finished product with filth, mold, bacteria or other factors.
When the sample is collected for Salmonella and other bacterial examination, include 30-100 gram (4oz) subs of the finished product.
Finished Product Sampling
Filth - Cocoa Beans
Take the square root of the number of bags in the lot to determine the number of subs to collect. Multiply by three to determine the number of bags to sample. Each sub will consist of 450 grams (1lb) of beans composited by collecting approximately 170 grams (1/3 lb) from each of three bags. You can sample up to a maximum of seventy-five bags which would yield twenty-five subs but in no case collect less than six subs. Collect the subs in duplicate for the 702(b) portion.
Filth - Cocoa Powder, Press Cake, Expeller
For microscopic filth, excess shell, etc., sample the square root of the number of bags in the lot. Collect a minimum of six and a maximum of eighteen subs each consisting of 900 grams (2 lbs) taken 340 grams (2/3 lb) from each of the three bags. Collect the subs in duplicate for the 702(b) portion.
For retail size containers, sample the square root of the number of containers in the lot with a minimum of six and a maximum of 18 - 900 gram (2 lb) subs.
Collect 30 - 100 grams (4 oz) subs in duplicate.
10 - 450 grams (1 lb) subs in duplicate.
In addition to the instructions and information provided in IOM Subchapter 530, 21 CFR 164.110, and 21 CFR 164.120(c), direct special attention to the following points when inspecting these types of food establishments.
Commercial shellers, roasters, and nut in the shell processors represent the various nut processing establishments. Each type represent unique equipment and problems to consider. Shellers, especially pecan shellers, pose a problem with microbiological contamination of the finished product. Nut meats become contaminated with E. coli either from improper handling by employees, improperly cleaned equipment or from failure to adequately sanitize the in-shell nuts prior to cracking and shelling.
In-shell nut storage should be physically separated from the processing operation and should be free of any evidence of mold, insects, rodents, birds or other types of filth. Develop fully with samples and photographs any avenues of contamination.
Determine what the firm's specifications are for purchasing in-shell nuts. Does the firm examine incoming nuts for mold, rancidity, shriveled nuts, insect and rodent contamination. This is of particular concern if the firm is a processor of in-shell nuts. The firm may be knowingly buying old in-shell nuts and selling them as this years crop. Be alert for the practice of "Stove Piping", i.e., placing old inferior nuts in the center of a bag and surrounding them with good quality nuts. Some pecan shellers buy and process rejected in-shell pecans from bulk pecan cleaning plants. Reject nuts may be cracked and or broken exposing meats to environmental contamination or may contain immature or shriveled meats which depending on the growing season, may be suspect for aflatoxin contamination.
Review fumigation practices of nuts in storage. Determine what fumigants and other pesticides are being used. Have these pesticides been authorized by EPA for their intended use? Refer to IOM Appendix A - Food Additive Status List, for additional information.
Determine if equipment is cleaned and sanitized properly before use. It may be necessary to arrive at the plant before start-up in order to make an adequate evaluation. What sanitizing agents are being used to clean equipment and at what strength (200 ppm chlorine is recommended)? Does the firm have a written procedure for cleaning? Have they evaluated and/or do they monitor the effectiveness of this procedure with microbiological test, i.e., do they take swab samples?
Evaluate the firm's tempering and sanitizing of in-shell nuts to determine if these processing steps are adequate to prevent contamination of equipment down stream which could result in contamination of nut meats with E. Coli. If the firm is using hot water for this purpose is processing time and temperature adequate to sanitize in-shell nuts [see chart,Attachment 4for E. coli heat resistance (moist heat)]? If the firm is using chlorine, at what strength (1000 ppm is recommended) and for how long? Have they evaluated this procedure with microbiological test? Is it identified as a critical control point? How are they monitoring times, temperatures, chlorine concentration, etc.? Do they keep records?
Evaluate the control procedures used to insure that reject nuts (insect damaged, moldy or rancid, etc.) do not enter the finished product.
Evaluate coloring and determine if it conceals inferiority or gives nuts the appearance of better or greater value. Collect samples if the product appears violative.
Cover the flotation process if water is used to separate nut meats from the shell. Evaluate the use of chlorine in the flotation process (200 ppm is recommended). How is the firm controlling and or monitoring this processing step? If the water in the flotation tank is allowed to become contaminated with bacteria then the finished product will most likely be contaminated. Evaluate construction of dewatering screen for areas where wet meats may become trapped. Check frequency of cleaning/sanitizing. Construction of dewatering screen may not allow for disassembly and cleaning.
Evaluate employee hand washing practices. Hand dip solutions of 100 ppm Chlorine or 25 ppm Iodine should be used by employees handling nut meats after processing.
Evaluate terminal gas sterilization of finished product with propylene oxide if used, i.e., amount of gas used per weight of nuts, length of exposure, subsequent aeration and residue analysis. It should be noted this process does not alleviate the necessity for good sanitary practices; and, if poor practices exist, they should be documented with in-line samples, photographs, etc., for possible regulatory action.
Evaluate storage conditions for finished product. Are conditions controlled to retard bacterial and mold growth, i.e., finished product at 410F or lower with less than 70% relative humidity?
If inspectional conditions warrant, collect in-line samples for bacteriological examination using aseptic techniques. Do not freeze or refrigerate. Ship to district servicing laboratory as soon as possible after collection. Collect the following subdivisions for each sample:
- Two 8oz subs of in-shell nuts collected after sanitizing.
- Two 8oz subs of nuts with shell after cracking.
- Two 4oz subs of nut meats after shelling.
- Two 4oz subs of nut meats after sizing. The broken and or smaller pieces should be collected because they are more susceptible to contamination.
- Two 4oz subs of nut meat pieces after the flotation process.
- Two 4oz subs of nut meat pieces after drying process.
- Two 4oz subs of nut meat pieces after second sizing operation.
- Two 4oz subs of nut meat pieces after electronic sorters.
- At least two 4oz subs from picking table. More samples from picking table may be warranted depending on employee practices.
- Ten 4oz subs of finished product (pieces) collected from 10 finished product containers at the time of filling or from finished containers produced on same day.
- Ten 4oz subs of finished product (pieces) from previous days production.
Note: The above sampling schedule represents a minimum number of subs to collect from a typical shelling operation. Processes may differ by number of lines and equipment used. As a general rule bracket each step in the processing with 4oz subs collected in duplicate.
Where evidence of insects or rodents exist document with samples and photographs. Use selective sampling techniques described in IOM 427 and wholebag screening technique described in IOM 429. In addition to selective samples of observed filth, collect random samples of finished shelled nuts using the schedule listed in Chart 1, below, for the number of containers to sample. In the finished product lot, collect approximately 1 lb from each unit sampled. If evidence of live insect infestation exist, freeze or fumigate samples following procedures in IOM 452.
Sample Schedule - Tree Nuts
LOT SIZE UNITS SAMPLED
|Over 200||Over 20,000||36|
Using aseptic techniques, collect at least 4oz (100 gram) per sub in duplicate from cases in the lot selected at random according to the schedule listed in Chart 1, above.
Using the schedule listed in Chart 1 above, collect 1 lb (454 gram) in duplicate from each finished product unit sampled (includes the 702(b) portion).
Field Exam for Reject Nuts
Reject nuts are those which are moldy, rancid, insect or rodent contaminated, otherwise unfit for food or blank. Count a shriveled nut as one-half reject. Examine up to 100 nuts from each shipment. For mixed nuts, examine by varieties. Findings of stated number of rejects in 100 nuts or less of any one variety, warrants collection of official sample. Collect official sample for laboratory examination when findings are:
- Live storage insect infestation, or,
- Five rejects in nuts-in-shell, except 3 rejects in almonds and 10 rejects in green chestnuts, or,
- Three rejects in shelled nuts.
Official samples are collected using the same schedule listed above, collecting 1 lb (454 gram) in duplicate. Official samples of nuts-in-shell must total at least 1000 nuts.
Net Weight Examination
Make field weighing of retail-packaged nuts which are sampled objectively for unsound nuts or on assignment for filth or other examination. If preliminary weighing indicate a shortage of 1% or more of declared net weight, make the field exam for net weight (refer to IOM 428).
In addition to the information and instructions provided in IOM Subchapter 530 and 21 CFR 164, direct special attention to the following areas when inspecting these types of food establishments.
Commercial shellers, roasters, nut-in-the shell processors, and peanut butter processors represent the various types of peanut processors. contamination of the finished product with either aflatoxin, insect or rodent filth is of primary concern when inspecting peanut processors.
USDA Agriculture Marketing Service regulates raw peanuts through the marketing agreement program. FSIS inspects, grades, samples and issues certificates regarding the grade and aflatoxin level. USDA will provide FDA with a copy of the certificate of aflatoxin analysis on each lot found to exceed 25 ppb (reference CPG 7155.14, MOU with USDA/AMS concerning Aflatoxin in Peanuts, and CPG 7112.02 - Aflatoxin in Peanuts and Peanut Products).
Determine if the firm is receiving peanuts under USDA aflatoxin certification. Shipment of peanuts with aflatoxin levels greater than 25 ppb is allowed only to processors such as peanut blanchers who have the capability of removing moldy or other defective nuts that would reduce the aflatoxin level. Blending is not permitted. Determine what tests are done for aflatoxin.
Storage of in-shell peanuts (farmer's stock) should be free of mold, insect, rodent or bird contamination. Develop fully with photographs and samples any evidence of contamination.
Review fumigation practices of peanuts in storage. Determine what fumigants and other pesticides are being used. Have these pesticides been approved by EPA for their intended use (also refer to IOM Appendix A, Food Additive Status List)?
Examination of Equipment
Peanut shelling plants differ mainly by the number of cleaning, shelling, sizing and sorting operations employed. Most small peanut processors equipment is home made and may contain numerous static areas where insects can breed.
Shelling consist of:
- removing of sand, stones, sticks and trash by conveying nuts through a series of over and under screens,
- removal of metal by magnets,
- gravity flow of in-shell nuts through a series of shellers and separators,
- separation of shelled nuts into at least four grades by size screens,
- passing edible grades over inspection belts and through electronic sorters, and
Examine each piece of equipment for evidence of insects and rodents. Inspect conveying equipment, i.e., bucket elevators and horizonal screw conveyors for insect activity.
Elevator Boots - a clean-out port should be located at the bottom of each elevator. Open slightly and note whether static material is loosely or tightly packed. Using a boot trier and a set of screens examine at least a quart of this material for insects.
Screw Conveyors - the insides of these conveyors should be accessible for cleaning. Static material will build-up in these conveyors and is a good place for insects to breed and multiply. If the plant is down or some of these conveyors are not in use, have the firm open a number of these conveyors and examine the contents for insects by screening.
Examination of Finished Product
Where the firm packs in 100 lb burlap bags, examine whole bags for rodent and insect filth using the whole bag screening technique (refer to IOM 429). Insect evidence in infested lots is usually found on the top sewn seam of burlap bags. Also, check bulk cardboard containers and rail cars for insect and rodent contamination if firm ships in bulk.
Storage of finished product should be under controlled conditions, i.e., below 410F and less than 70% humidity. Examine finished product storage for evidence of rodents and insects.
Determine disposition of all reject lots, including oil stock peanuts. USDA exercises control over these peanuts including how they are labeled and final disposition.
Peanut Roasters and Peanut Butter
Equipment used to convey bulk peanuts in these facilities is similar to that used in the shelling plants and instructions listed above would also apply to inspecting these plants.
Determine if firm is receiving peanuts under USDA aflatoxin certificate and/or is analyzing raw peanuts for aflatoxin. If firm is processing peanuts with aflatoxin levels greater than 25 ppb, sampling of the finished product is warranted unless the firm can provide assurance that their processing removes the defective nuts and aflatoxin.
Review formula for modified peanut butter products such as reduced fat peanut butter. These products must comply with the standard of identity for peanut butter in 21 CFR 164.150 with the exception of the provisions outlined in the agency's new general standard of identity in 21 CFR 130.10.
Collect in-line sample from product stream as described above, i.e., static material and insects from elevator boots and screw conveyors, etc.
Using the whole bag screening technique, screen six 100 lb bags per lot sampled. Submit screening as separate subs and at least 8oz of shelled peanuts from each bag examined.
When samples are collected as a follow-up to a violative sanitation inspection, use whole bag screening technique previously described. Collect 2 sets of subsamples per bag examined. Submit one set as the 702(b) portion. If processing is such that filth is removed from the finished product prior to bagging, then documentary (DOC) samples of recent IS shipments should be collected to document 402(a)4 conditions in lieu of whole bag screening.
When official samples are collected at random for filth analysis, use the schedule outlined in Chart 1 above for tree nuts, to determine number of units sampled per lot size.
See IOM Sample Schedule Chart 6 in the exhibit section of IOM Chapter 4. Note: do not sample raw nuts for aflatoxin except as a follow-up to violative levels of aflatoxin in finished product.
Microbiological - Sample on assignment.
Peanut butter for salmonella - Collect thirty 8oz subs in duplicate.
Peanut butter for E coli - Collect ten 8oz subs in duplicate.
Collect ten 1 oz subs in duplicate.
If preliminary weighing shows a shortage of 2% or more of declared net weight, make the field net weight examination as described in IOM 428.
In addition to the instructions and information provided in IOM Subchapter 530, direct special attention to the following areas when inspecting these types of food establishments.
The production of oil from oil seed and other sources, i.e., olives, peanuts, etc., involves either mechanical pressure to crush the seed and expel the oil or the use of solvents to extract the oil from the seed. Seeds are usually heat treated, cracked and/or ground to release the oil before pressing or expelling. The resulting oil is further refined and the meal is usually sold for animal feed.
In addition to vegetable oil mills there are vegetable oil repackers and blenders. These firms are basically in the business of buying and selling vegetable oil which is either sold in bulk or in retail containers. Types of vegetable oils repacked and/or blended include: corn oil, soybean oil, cottonseed oil, peanut oil, sunflower oil, canola oil (rapeseed) and olive oil. Because the price of these oils may vary widely depending on market changes, and because some of these oils can be used interchangeably; the possibility of fraud or deception exist, i.e., the substitution of a less expensive oil for a more expensive oil without changing labeling.
The three types of olive oil are:
- Virgin olive oil produced by the first pressing of the olive. It has a characteristic pleasing, delicate flavor. It is clear and its color varies from a pale yellow through a greenish yellow.
- Strongly flavored or highly colored olive oil, usually is from the second or subsequent pressings and is not entitled to the designation "Virgin".
- Refined olive oil has been chemically refined to remove excess color or acidity and is probably indistinguishable from any other refined vegetable oil (such as refined cottonseed oil) as regards to flavor and color
Oil stock (seeds, peanuts, etc.) should be free of any evidence of mold, insects, rodents or other types of filth. Determine if the firm is routinely sampling oil stock for mycotoxins and/or receiving a certificate of analysis from the supplier. All peanuts destined for oil production for human consumption should have a USDA Aflatoxin Certificate.
Vegetable oil repackers/blenders should have a method of positive identification of bulk tanks and their contents. Are tanks used for more than one type or grade of oil? What controls are employed to prevent product mix-up?
Determine if the firm is routinely sampling incoming oil to establish identity and test for contaminants. If not, does the firm require a certificate of analysis from supplier?
In an olive oil plant determine if oils other than olive oil are on the premises.
Storage facilities and processing equipment for oil stock in vegetable oil mills should be free from mold, insects and rodents. Develop fully with photographs and samples any evidence of contamination.
Note the presence or addition to oil of flavors, colors, antioxidants, squalene, or other chemicals. Squalene is a normal indicator in olive oil and may be used to upgrade cheaper blends. Collect a small sample of each such additive being used.
Determine from direct observation and/or review of batch records the amount and type of antioxidant added to each batch of vegetable oil. Antioxidants are preservatives in vegetable oil and prevent rancidity by interfering with the oxidative process. Because they add shelf life, some manufacturers may add higher amounts than permitted. Also, repackers/blenders with bulk storage may add additional amounts of antioxidants to prolong shelf life. Antioxidants commonly used include: BHA, BHT, TBHQ, THBP, NDGA, Ionox-100 and propyl gallate. Calculate amount of antioxidants in finished product in ppm and compare with amount permitted (refer to IOM Appendix A, Food Additive Status List). Collect samples (1 pint in duplicate from each lot) if excess amounts of antioxidants or unapproved antioxidants are being used, including a subsample of the anti-oxidant itself.
Determine by reviewing receiving records, batch records, shipping records and by direct observation the type and amounts of vegetable oil blended and/or repacked.
If deception or fraud is suspected, collect samples (1 pint in duplicate) from each lot being blended or repacked which is marked with identity, either invoice or label. Also collect 1 pint in duplicate from each bulk storage tank and document identity of contents with photographs of bulk labeling or statements from responsible individuals. In the investigation of deliberate economic fraud, obtain in detail all evidence and statements of persons having knowledge or responsibility for the deception. Such evidence may support an indictment for fraudulent intent for violations of the FD&C Act. Collect an official sample (301k) of the suspect vegetable oil.
Labeling for finished product in retail size containers should be reviewed for compliance with NLEA.
Collect 1 pint in duplicate from each bulk tank.
Investigational samples should be made part of an official 301k sample if vegetable oil has moved in I.S. commerce and there is evidence of a violation; otherwise, collect surveillance samples on an INV basis.
Filth and Composition
- Retail containers up to 1 pint in size - sample the square root of the number of cases in the lot with a minimum of 6 containers and a maximum of 24 containers from the lot. Collect subs in duplicate. If multiple codes are present in one lot, collect at least 2 containers from each code, but not over 12 codes or 24 containers per lot in duplicate.
- Retail containers over 1 pint in size - collect 3 to 12 containers in duplicate depending on size of lot, but not over 6 gallons total.
- Bulk containers - collect 1 pint in duplicate from each container in lot. Sample 55 gal drums on a square root basis, collecting 1 pint from a minimum of 6 and maximum of 24 in duplicate.
In addition to the instructions and information provided in IOM Subchapter 530, 21 CFR 169 - Standard Dressings, 21 CFR 130.10 - General Standard of Identity, and 21 CFR 101 - Food Labeling, direct special attention to the following areas when inspecting these types of food establishments.
Shelf stable salad dressings usually have a finished product pH values between 2.3 and 4.0, while refrigerated salad dressings have pH values between 3.3 and 5.0. The low pH, high acid characteristics of these products act to inhibit or retard most microbial growth commonly associated with these products; however, they do not preclude the activity of yeast, lactobacillus and other spoilage organisms. Prolonged storage and adverse handling practices may nullify this inherent protection from microbial action. The addition of certain ingredients (e.g., spices, eggs, pickles, etc.) can also enhance spoilage by creating an environment capable of supporting microbial growth in the finished product. The addition of non-pasteurized ingredients or the cross contamination of finished product by poor manufacturing practices could result in a hazardous product.
Recent studies have shown that pathogenic E Coli 0157:H7 is more acid tolerant than Salmonella or Listeria Monocytogenes, which are inactivated in acid salad dressings having a pH of 4.1 or lower. Studies have shown that E Coli 0157:H7 will survive for 13 to 21 days at 680F and for 41 to 55 days at 410F in commercial mayonnaise.
Determine if only pasteurized liquid or frozen eggs are used and examine organoleptically for odors of decomposition. Determine if frozen eggs, dried eggs and other amenable raw materials are received under a Salmonella-free guarantee from suppliers. Review specifications for critical raw materials and determine what testing firm does on incoming raw materials. If they do not conduct testing, do they receive a certificate of analysis and/or a guarantee from their supplier that microbiological susceptible raw materials are free of pathogenic organisms and their toxins? Give special attention to raw materials having bacteriological significance when used in dressings having a pH above 5. Standardized dressings usually have a pH lower than 5 unless inadequately acidified. (Note: 21 CFR 101.100(d)(3) permits dressing manufacturers to receive unpasteurized eggs or egg products, if they are utilized in acidic salad dressings having a pH of 4.1 or lower , and the finished product is not shipped for seventy-two hours.)
These eggs must be labeled: "Caution: This egg product has not been pasteurized or otherwise treated to destroy viable Salmonella microorganisms," and "Unpasteurized for use in acidic dressings only."
If the firm is using unpasteurized eggs, determine if they employ any manufacturing procedure that would destroy E. Coli 0157:H7 (1400F for 3.5 min. or equivalent process- see Attachment 3) and what test are made to validate this procedure. If unpasteurized eggs are being used in salad dressings, samples of both the eggs and salad dressing should be collected and submitted for E. Coli 0157:H7 analysis. If the firm is receiving liquid eggs or other raw materials susceptible to microbiological contamination, e.g., buttermilk, etc., via bulk transport, what test and/or controls are used to assure that these raw materials have not become contaminated during shipment? Determine the following:
- Does the firm conduct microbiological test on these raw materials for evidence of cross contamination and decomposition?
- Is the temperature of these raw materials measured on receipt? Is there a record of product temperature during shipment, i.e., temperature recording charts?
- What assurance does the firm have that these transport vehicles were adequately cleaned prior to loading and have not been used to haul non-food grade material? Refer to IOM 536.3 for additional instruction for inspecting food transport vehicles and IOM 511.2 regarding issuance of FDA-482, Notice of Inspection, when inspecting vehicles not owned or leased by the firm you are inspecting.
Determine if equipment is cleaned and sanitized properly before use. It may be necessary to arrive at the plant before start-up to make an adequate evaluation. What sanitizing agents are being used to clean equipment and at what strength? Does the firm have a written procedure for cleaning? Have they evaluated this procedure with microbiological swab samples?
Salad dressings and the liquid ingredients used to manufacturer them are usually pumped from one operation or location within the plant to another through stainless steel (SS) lines. Ideally the distances between operations (e.g., holding tank to mixer and from mixer to filling machine) is short and the SS pipes are disassembled between uses and adequately cleaned. However, in some plants the distances between operations make the use of break down pipes impractical. Therefore, fixed lines are used that have to be cleaned in place (CIP). If the firm is using fixed lines, does the firm have documentation in the form of X-rays to show that the interior surfaces of the welds in these SS lines are smooth and will not entrap material during operation. If the interior surface of these pipes are not smooth it will be impossible to adequately CIP these lines. Badly dented pipes can also result in a rough interior surface. The entrapped material can become contaminated with yeast or other microorganisms and result in an adulterated finished product. Numerous product recalls have resulted from yeast contamination in salad dressings.
Holding tanks, pumps, valves, filling machines should be made of non-porous material, usually stainless steal, and should be easily cleanable. Raw material storage tanks used to hold products requiring refrigeration, e.g., eggs, buttermilk, etc., should be equipped with temperature recording devices and the temperature of these products closely monitored.
Obtain in detail the manufacturing process used for each dressing covered:
- Determine pH specifications for finished products, how pH is standardized for each batch, and procedures used for pH test. Most salad dressings are exempt from 21 CFR 114-Acidified Foods, by definition. However, since the control of pH is critical to prevent the growth of undesirable microorganisms it is necessary to closely monitor and maintain the pH of these products below 4.6. Although Part 114 is not mandatory it can be used as a guide when inspecting salad dressing manufacturers. Current GMP's for Foods, 21 CFR 110.85(15) covers the requirement for testing and the monitoring of pH in these types of products; however, there is no requirement for record keeping.
- Evaluate mixing and homogenizing operations to ensure uniform dispersion and acidification.
- Include the following information for dressings containing eggs:
- Quantities of egg ingredient in finished product.
- Time/Temperature of cooking or heating during manufacture. Egg product pasteurization effectiveness time and temperature is charted in Attachment 3.
- Conditions which may permit Salmonella growth, i.e., 6.70C to 450C (440F to 1130F).
- Conditions allowing cross-contamination of finished product with raw eggs, i.e., common equipment that has not been adequately cleaned, cross connections between raw egg holding tanks and finished product holding tanks, employees switching jobs, etc.
- Determine the controls to assure that products manufactured from unpasteurized eggs are held at least seventy-two hours prior to shipment.
- Review formula for standardized dressings for compliance with Standards.) Common problems include: Vegetable oil deficiencies in mayonnaise and salad dressing, egg yolk deficiencies in salad dressing, use of mineral oil as a substitute for vegetable oil, failure to properly declare optional ingredients, use of artificial color, failure to designate a product as "imitation" when bearing the name and having the appearance and flavor of a standardized dressing, but differing in formula, designation of a product as a standardized dressing when it differs from the standard in appearance or formula, and inconspicuous declaration of optional ingredients or other mandatory labeling. Review formula for standardized dressings for compliance with 21 CFR 169 - Standardized Dressings and the new General Standard of Identity - 21 CFR 130.10 which permits the use of a nutrient content claim with the name of a standardized food.
If inspectional conditions warrant, collect in-line samples for microbiological examination using aseptic techniques. Refrigerate and ship to district servicing laboratory as soon as possible after collection. In-line subs should be approximately 4oz of material per sub. Collect at least 30 units of finished product as part of your in-line sample.
Collect sufficient units to equal a minimum of 6 quarts.
Sample the square root of the number of cases in the lot with a minimum of 6 quarts and a maximum of 24 quarts.
Collect at least 30 retail units from each identifiable lot.
In addition to information and instructions provided in IOM Subchapter 530, review Compliance Policy Guide 7109.22 for guidance as to the identity and labeling of various kinds of vinegars. Additionally, reconstituted apple juice, reconstituted cider, and apple juice concentrate are prime candidates for intentional economic adulteration. See Section 10: Orange/Other Juice in this chapter for guidance with respect to juice adulteration. Follow the guidance in that section with respect to possible adulterants in the plant and sample collection for economic adulteration.
Direct special attention to the following areas when inspecting these types of food establishments:
Unpasteurized apple cider has been associated with outbreaks of food illness caused by pathogenic E. Coli 0157:H7. The apples used to make the cider were believed to have become contaminated with cow manure either from grazing cows in the apple orchard or from the use of cow manure as a fertilizer. Contamination of the apple cider with E. Coli resulted from improperly cleaning of the apples prior to pressing the juice and/or cross contamination from the raw apples to the finished apple cider. Studies on the survival of E. Coli 0157:H7 in unpasteurized apple cider with a pH between 3.6 and 4.0 have shown the organism to be acid tolerant. The use of sodium benzoate 0.1% was shown to reduce the survival rate and have a preservative effect.
Determine the firm's specifications for incoming apples. If "drops" are used (apples that have fallen from the tree) what precautions are taken to prevent microbiological contamination of finished product?
Inspect incoming apples for evidence of rot and worms. Refer to USDA Publication No. 168, "Market Diseases of Fruit and Vegetables, Apples, Pears, Quinces". Characteristics of bruised vs rotten apples are contrasted as follows:
1 .Bruised apples: a) skin and tissue brown, dry, and spongy; b) no disagreeable odor or taste; c) slight tissue penetration.
2. Rotten apples: a) external rot: skin and tissue substantially browned, skin sometimes in concentric circles; b) soft rot: slight skin discoloration; none in freshly cut tissue; tissue is soft and pulpy; c) off odor and taste; d) internal rot: tissue penetrated in a cone toward the core.
Conduct field examination as follows:
- Collect 100 apples at random from stock going directly to the chopper after sorting.
- Examine apples for external rot and segregate by size of rot spots.
- Cut each apple and examine for internal rot and worm damage.
- If 5% or more unfit apples are found, repeat the examinations over a sufficient period to establish a pattern.
- If stock going into chopper consist of 5% or more unfit apples, collect and examine similar samples at random from stock in storage.
- If peels and cores are used, select a representative sample and weigh. Segregate wormy cores. Trim cores with rot spots. Weigh reject material and report it as percent of the weighed sample.
If the firm is manufacturing pasteurized apple juice or pasteurized apple cider, evaluate the firm's pasteurization method and equipment. Pasteurization should be equivalent to heating the product for 30 minutes at 155F or 15 seconds at 180F. You may wish to consult with your regional milk specialist or district LACF expert before inspecting a pasteurized juice product.
Follow procedures outlined in Section 7, under Dressings, in evaluating the firm's cleaning procedures for equipment and CIP system.
Determine if there are conditions or practices that could result in contamination of the finished product from handling or processing the raw, unwashed apples, i.e., common equipment, switching jobs by employees, cross connections between raw and pasteurized product lines, etc.
If the firm is manufacturing unpasteurized apple cider, determine what controls are used and what test are conducted to assure the finished product is not contaminated. If the firm is adding a preservative, review formulation and determine what preservative is being used and at what strength. Check against the Food Additive Status List in the IOM.
If unpasteurized apple cider is being produced, collect samples of both the finished product and the raw apples and submit to the servicing laboratory for microbiological analysis.
Check for the substitution of colored acetic acid or distilled vinegar for apple cider vinegar or wine vinegar when inspecting vinegar manufacturers.
Vinegar generators may become infested with vinegar eels unless steam cleaned frequently. Vinegar eels in bulk vinegar storage tanks prior to filtration are not considered an insanitary condition. However, the presence of vinegar eels in finished bottled vinegar would render the product adulterated.
Determine what test are conducted for acidity in the vinegar. The acetic acid concentration should be 4% or higher.
If inspectional conditions warrant, collect in-line samples for microbiological examination using aseptic techniques. Refrigerate and ship to the servicing laboratory as soon as possible after collection. In-line subs should be approximately 4 oz. of material per sub. Collect at least 30 units of finished product as part of your in-line sample.
Filth (collect separate from microbiological
When wormy or rotten whole and cut apples or peels and cores are used and plant conditions are objectionable, collect exhibits and preserve in saturated borax solution containing 0.1% ascorbic acid.
- Take close-up color photographs of wormy or rotten whole and cut apples, drosophila infestation, and other objectionable conditions.
- Collect two quart sub samples of pomace, unclarified and unfiltered juice, and residue from filter. Do not sample filtered juice if it appears that contamination is being removed by filter. Preserve pomace and juice with 2 cc of formalin per 100 grams of material.
Juice or Cider
Microbiological - collect at least 30 retail units from each identifiable lot.
Filth - take sufficient sub samples to total 3 gallons, but not less than 6 individual containers.
Bottles - take sufficient sub samples to total 2 gallons.
Barrels - sample 1 gallon from each of 5 barrels.
Caution: do not use rubber tubing and do not place vinegar in metal top jars. Rinse jars with vinegar before filling.
Report the number and percent wormy apples, and then the total number and percent wormy and/or rotten apples, counting each apple only once. Report the results of examination to the firm on the FDA-483 as follows:
Wormy Apples (include wormy apples with rot spots).
In addition to the information and instructions provided in IOM Subchapter 530, direct special attention to the following areas when inspecting these types of food establishments.
Prompt and careful handling of strawberries is essential because of rapid ripening and susceptibility to mold. Since the quality of the fruit deteriorates rapidly after picking, especially in hot weather, improper handling and transporting, or processing delays may result in the deterioration of good quality raw materials.
Check the quality of incoming berries for contamination with sand, mold, or rot as follows:
- Examine 100 berries selected at random from product in storage and each lot delivered during the inspection. Cut all berries in half and examine for rot. USDA Bulletin 2140, "Strawberry Diseases" is a useful guide to various types of rot. List grit on washed and sorted berries.
- Make sufficient periodic examinations to determine the overall quality of the raw stock being used. If 5% or more berries contain rot, evaluate any processing delays, the amount of static fruit on hand, and the conditions under which it is held.
- Determine growing conditions in the area such as disease, insects, and weather bearing on the availability of fruit.
Collect 100 berry samples from each sorting line. Cut all berries in half and examine for rot. Make sufficient periodic examinations of sorted berries to determine overall quality of berries being packed.
Determine if unfit fruit (moldy, rotten, etc.) is blended with good fruit in the dumping or packing operations to form an adulterated product.
Determine the deposition of unfit fruit (trash, animal feed, etc.).
Evaluate any delays in the processing flow which allow in-process berries to rot or become moldy.
If processing equipment contains slime or build-up report and take scrapings for analysis.
Evaluate the firm's packaging and freezing operation.
Collect samples of raw materials and finished products to document:
- the presence of sand, grit or other contaminants in the finished product.
- when belt pick-outs, after sorting, run 5% or more definite rot spots.
- trade or consumer complaints which may indicate production of a violative pack.
- factory evidence of the production of strawberry juice from rotten berries.
If the firm is packing strawberries running 5% or more rot, preserve the rotten berries found in each field examination of sorted fruit. Add a teaspoon of sodium bisulfite to the sample jar and cover the berries with water.
When rotten fruit is used to produce juice, make rot pick-outs of the raw material, and collect exhibits of the fruit and pressed pulp.
Official Samples - Frozen Strawberries for Rot
Container Size = 4.5 kg (10 lbs) or less
Collect the whole package as a sub or enough packages to equal about 1.8 kg (4 lbs) per sub.
Container Size = more than 4.5 kg (10 lbs)
If possible, take subs while the fruit is still frozen. Collect subs using an electric drill with a two inch frozen fruit trier (danger: ground drill properly before operation). Take four cores about equal in length to the depth of the container, one from the center, and one from each of the three apexes of a triangle surrounding the center. Place the four cores together in a suitable container (check with the laboratory if necessary).
Refer to the table below for the number of subs to collect:
|Containers in Subs||lot|
|50 or||more 12|
Use the chart in Attachment 5 at the end of this document for the format to use on the FDA-483 to report field examination results to management.