Contents

SUBCHAPTER 420 - COLLECTION TECHNIQUE

Sampling operations must be carried out using techniques that ensure the sample is representative of the lot, the sample of the product is in the same condition as it was before sampling, and that the collection technique does not compromise the compliance status of the lot.

420.01 - Responsibility

It is your responsibility to collect your own samples using techniques and methods which will provide the most ideal sample, yet not be objectionable to management. This subchapter and the sampling schedules that follow, contain many sampling techniques, but not all. Your training and experience will enable you to become proficient in most sampling operations. However, in new or unusual situations it is your responsibility to use imagination and ingenuity in getting the job done and, if necessary, to consult with your supervisor.

421 - LOT RESTORATION & IDENTIFICATION

421.01 - Restoring Lot(s) Sampled

Restore lots to their original condition. Do not leave partially filled shipping cases, short weight or short volume containers in the lot after sampling. Do not leave the lot in any condition, which might encourage pilferage, or make it unsalable.

When collecting from either full cases or bulk containers, replace sampled units by back filling from a container selected for that purpose. Avoid contaminating the back-filled units. If necessary, correct the contents declaration on the container(s) from which sampled to reflect the actual contents present. Refer to IOM 410.02 if the dealer objects to back filling because of company policy, different codes involved, or for other reasons. As a last resort, accede to the dealer's wishes and sample intact units, but record the facts in your diary and place a brief explanation on the C/R.

Carefully re-close all containers and shipping cases. (Commercially available glues in spray cans or plastic squeeze-type bottles are an effective means of re-gluing cartons and cases without defacing with tape or other methods.) Re-cooper or reseal barrels and drums, re-sew bags, etc. If necessary, request use of the dealer's employees in helping to restore the lot, or arrange through the dealer to employ outside help. See IOM 416.04.

421.02 - Identifying Lot(s) Sampled

Identify each container from which units are taken with the date, your initials and the sample number, or you may complete and affix an FDA 2426, Examination Label, to each shipping case or bulk container sampled. For burlap or woven bags, the FDA 2426 may be glued to tags, and the tags attached to the bags.

Should the dealer object to your identification procedure, attempt to reach a compromise (e.g., placing the ID in an obscure location, etc.). If the dealer still objects, accede to his wishes, but record the facts in your diary.

Positive identification of the containers sampled is important if it becomes necessary to resample the lot(s), or if an embargo, seizure, or other action ensues. It also aids the dealer to differentiate between containers that have been opened by FDA as opposed to those opened by pilferage or torn opened by rough handling. It may be necessary to mark more containers than sampled to assure proper identification of the lot. This can be done by using the Examination Label, a handwritten ID or by using a rubber stamp.

Do not use industrial or permanent type markers on sample containers which allow penetration by ink. Many inks will penetrate to the product and act as a contaminant, interfering with the analysis. Water base markers will run when damp and must be covered with tape. See IOM 451.03 for identification techniques.

Do not permanently identify articles that are borrowed and will be returned to the dealer.

422 - SAMPLE SIZE

To determine sample size, first consult your assignment. If the assignment doesn't specify the sample size, follow the guidance in the applicable Compliance Program. The IOM SAMPLE SCHEDULE, should be used if the Compliance Program doesn't state the sample size. If none of these furnish the sample size, consult with your supervisor or the laboratory. Collect sufficient sample to allow for the FDA reserve portion and the 702(b) portion. See IOM 422.02 & 422.03.

422.01 - Medical Device Samples

The following table represents the devices for which there are sampling instructions in Compliance Policy Guides:

In addition to providing instructions on sample size, these compliance policy guides provide guidance on criteria to determine adulteration and whether or not regulatory action should be recommended.

422.02 - 702(b) Requirement

When the sample schedule, assignment or other instruction does not specifically provide for the 702(b) portion, collect a sufficient amount to provide this required portion. You are not required to obtain a 702(b) portion in the following instances exempted by statute or by regulation 21 CFR 2.10(b):

1. Devices are not included in the statutory requirement of Section 702(b).
2. The amount available for sampling is less than twice the quantity estimated to be sufficient for analysis, in which case, collect all that is available.
3. The cost of twice the quantity estimated to be sufficient for analysis exceeds $150.00. (Currently 21 CFR 2.10 uses $50.00 as the amount. However, ORA policy sets a limit of $150.00. If the sample is critical, and the cost exceeds $150.00, check with your supervisor.
4. Import samples, collected from a shipment being imported or offered for entry into the United States.
5. The sample is collected from a person named on the label of the article or his agent, and such person is also owner of the article. For example, it is not necessary to obtain a 702(b) portion if the sample is collected from a lot owned by and in the possession of the manufacturer whose name appears on the label.
6. The sample is collected from the owner of the article or his agent, and the article bears no label, or if it bears a label, no person is named thereon.

Note: Regardless of the exemptions under 21 CFR 2.10(b) listed above, a good rule of thumb to follow for most filth samples, is to collect the 702(b) portion.

422.03 - Collecting the 702(b) Portion

Whenever possible, collect separate subdivisions in order to provide the firm a portion as required by Section 702(b). Each duplicate subdivision should be collected from the same bag, box, case, or container. The total sample should be at least twice the quantity estimated to be sufficient for analysis, including a reserve portion for FDA's laboratory. If unable to collect separate subdivisions, assure that the total amount collected for each sample subdivision, or the total amount collected from an undivided sample, is at least twice the amount estimated to be sufficient for analysis. See IOM 427.04.

424 - IN-TRANSIT SAMPLES

The exterior of any domestic package thought to contain an article subject to FDA regulation and in the possession, control, or custody of a common carrier may be examined (photographed, information on the outside copied, etc.) and records of the shipment may be obtained. Such package may not be opened either by an FDA employee or by an employee of the common carrier at the request of an FDA employee except as provided below.

The Office of Chief Counsel has advised FDA employees may, without a warrant, open, examine the contents and/or sample a package which is part of a domestic commercial interstate shipment in the possession, control, or custody of a common carrier only if:

1. The consignor or consignee affirmatively consents to examination and/or sampling of the contents; or
2. The Agency has reliable information the carrier regularly carries FDA regulated articles, and the facility where the sampling is contemplated is subject to FDA inspection. Reliable information may come from agency files, the carrier itself, other customers of the carrier, etc.

and the Agency has reliable information a particular package sought to be examined is destined for, or received from another state, and contains an FDA regulated article. [Such information may be found on the exterior of the package and/or shipping documents in specific terms. Information may also come from reliable sources, which establish the consignor is in the business of manufacturing and/or shipping FDA regulated articles using a distinctive type of package (shipping container); and the package in question meets such description and shows the consignor to be such firm.]

Confer with your supervisor on any question concerning the need for a warrant. However, headquarters approval must be obtained because such inspection and sampling may require a search warrant. Contact the Division of Field Investigations (DFI) (HFC-130) at (301) 827-5653 to discuss the matter. They will coordinate as necessary with Office of Enforcement (HFC-200) and Chief Counsel (GCF-1) and provide further instructions.

If a decision has already been made by the district office to obtain a warrant, follow the procedures outlined in the Regulatory Procedures Manual, Chapter 6.

If a common carrier reports a violative article which it discovers under its own package opening procedures, independent of any request by an FDA employee or any standing FDA cooperative program with the carrier, FDA may still need a warrant to examine the material. Unless all the conditions for independent sampling in 1 or 2 above exist, you must consult with your supervisor, who will arrange for headquarters consultation as outlined above.

Note: Where the identity of an Interstate product is known by virtue of it being visible in bulk, or being in labeled containers or packages which are verified as to contents by shipping records, and where such product is under FDA jurisdiction at a given location, it may be sampled according to established IOM procedures.

Resealing Conveyances - If it is necessary to break the commercial seal to enter a railcar or other conveyance, reseal the door with a numbered self-locking "U.S. Food & Drug" metal seal. Record in your regulatory notes (and on C/R if sample taken) the number of the car or conveyance, the identifying number on any car seals removed, and the number of the FDA metal seals applied.

425 - SPECIAL SAMPLING SITUATIONS

Do not collect human or animal biological materials (urine, feces, sputum, blood, blood products, organs, tissue etc.) unless arrangements for special handling and special treatment have been made in advance. Most ORA servicing laboratories are not prepared or certified to handle these materials. In addition to guidance for special sampling situations provided below, sampling guidance may also be found in these areas of the IOM:
IOM 140 - Safety
IOM 143 - Sampling

Sampling Containers for Lemon Oil or Other essential Oils - Plastic or paraffin-coated liners in caps of containers used to hold samples of this type product are not satisfactory in that the plastic or paraffin is soluble in the oils and interferes with the analysis. Use glass, cork, foil covered, or non-plastic, non-paraffin closures.

Sampling medicinal and other gasses - Gasses represent a special sampling situation. Please contact your servicing lab to determine an appropriate sampling container and sample size.

425.01 - Complaints, Counterfeiting / Tampering, Foodborne Disease, Injury Illness

Detailed instructions for investigating and sampling products in connection with consumer complaints, tampering, foodborne outbreaks, injury and adverse reactions, etc. appear in the following sections of the IOM:
IOM 900 - Complaints
IOM 902.08 - Sample Collection
IOM 910 - Investigation of Foodborne Outbreaks
IOM 912 - Sampling Procedure
IOM 920 - Investigation - Injury & Illness Reactions
IOM 970 - Counterfeiting / Tampering
IOM 975.03 - Sampling

Be cognizant of conserving scarce resources when investigating consumer complaints that do not involve injury, illness, or product counterfeiting / tampering. Unnecessary samples waste both operational and administrative resources. Use judgment as to whether or not it is necessary to collect the consumer's portion in situations that do not involve injury, illness, or product tampering. For example, there is little need to collect a physical sample of an insect infested box of cereal from the complainant. Both you and the consumer can readily see it is insect infested. The laboratory would find it insect infested, and the district would merely report the same thing back to the complainant. No practical purpose would be served by either collecting or examining such a sample.

425.02 - Recalls

See IOM 800 & IOM 801.02.

425.03 - Natural Disasters

See IOM 940.

425.04 - Induced Samples

If this type sample is desired your supervisor will provide specific instructions and procedures to be followed. This may involve:

1. Whether to use your correct name or an alias. Caution: if you use an alias, do not use a similar name or a name with initials the same as yours (e.g., Sidney H. Rogers should not use Samuel H. Right). In addition, do not use a district office or resident post as a return address when ordering products or literature.
2. Do not telephone your order in from the office or your home phone because the firm may have "Caller ID" and be able to identify your location by the phone number.
3. Whether to use order blanks contained in the promotional package, advertisement, or promotional activity; or whether false ones will be used.
4. Whether money orders, your charge plate numbers, bank checks, or your personal checks should be used for payment. It depends on the situation, but money orders are preferred since these do not involve personal accounts.
5. Where the requested items are to be sent: rented P.O. Box, home address, General Delivery, or other address.
6. How the address and/or your name is to be recorded on the order blank. A code may be used either in your name or address so any follow-up promotional material sent to that name and address can be keyed to your original order.

When it has been decided to induce a sample and you have discussed the procedures with your supervisor, prepare the order and obtain the money order, or payment document. When all documents for ordering the item(s) are prepared, photocopy all the material, including the addressed envelope, for your record and submit the order.

When the order is received, identify the sample item, all accompanying material such as pamphlets, brochures, etc. (including all wrappings containing any type of printing, identification, numbers, post marks, addresses, etc.), and submit the item and exhibits in the same manner as any other official sample. If payment of the item was by personal check or credit card number, attach a photocopy of the canceled check or credit card receipt if available. You may do this later, after clearance of the check or charge slip.

425.05 - Undercover Buy

See IOM 405.06.

426 - ASEPTIC SAMPLE

Aseptic sampling is a sampling technique used to assure you are not increasing the microbial load of a product sample by your sampling method. The use of sterile sampling implements and containers and a prescribed sampling method defines aseptic sampling. This method of sampling also assures that you are not contaminating what remains in the container from which you sample. Collecting and delivering samples to the laboratory using aseptic technique, will permit testimony that the bacteriological findings accurately reflect the condition of the lot at the time of sampling and, ideally, at the time of the original shipment. Whenever possible collect intact, unopened containers. Aseptic sampling is often used in the collection of in-line samples, environmental samples, product samples from bulk containers and collection of unpackaged product that is being collected for microbial analysis.

Note: Products in 55 gallon drums, or similar large containers, either aseptically filled or heat processed, should not be sampled while the shipment is en route unless the owner accepts responsibility for the portion remaining after sampling. Try to arrange sampling of these products at the consignee (user) so the opened containers can be immediately used or stored under refrigerated conditions. Use ASEPTIC TECHNIQUE when sampling these products.

For more guidance on aseptic technique, you may consult the course Food Microbiological Control 10: Aseptic Sampling, which is available to FDA employees through the ORA U intranet site.

426.01 - General Procedures

If it is necessary to open containers, draw the sample and submit it under conditions, which will prevent multiplication or undue reduction of the bacterial population. Follow the basic principles of aseptic sampling technique. Take steps to minimize exposure of product, sampling equipment, and the interior of sampling containers to the environment.

1. Sterilized Equipment - Use only sterilized equipment and containers. These should be obtained from the servicing laboratory or in emergency, at local cooperating health agencies. Pre-sterilized plastic or metal tools should be used. However, if unavailable, the metal tools can be sterilized immediately before use with a propane torch. Permit the tool to cool in the air or inside a sterile container before using. Soaking with 70% alcohol and flaming off is an acceptable method of field sterilization, and may be used as a last resort.

1. If it is necessary to drill, saw, or cut the item being sampled (such as large frozen fish, cheese wheels, frozen fruit, etc.), if at all possible, use stainless steel bits, blades, knives, etc. Wooden handled sampling instruments are particularly susceptible to bacterial contamination, are difficult to sterilize, and should be avoided.
   Caution: Be extremely careful when using a propane torch or other flame when sterilizing tools and equipment. Evaluate the conditions pertaining to explosive vapors, dusty air, flame-restricted areas, firm's policy or management's wishes. The use of supportive devices should be considered when torch is not being hand held. Also be sure all flammable liquids, such as alcohol, in your filth kit are in metal safety cans and not in breakable containers.
2. If it is necessary to handle the items being sampled, use sterile disposable type gloves (rubber, vinyl, plastic, etc. - surgeon's gloves are good). Use a fresh glove for each sub and submit one unused glove in a sterile container as a control. See IOM 426.05.
3. Opening Sterile Sampling Containers - Work rapidly. Open sterile sampling containers only to admit the sample and close it immediately. Do not touch the inside of the sterile container, lip, or lid. Submit one empty sterile container similarly opened and closed as a control. See IOM 426.05.
4. Dusty Areas - Do not collect samples in areas where dust or atmospheric conditions may cause contamination of the sample, unless such contamination may be considered a part of the sample.

426.02 - Sampling Dried Powders

Cautions - The proper aseptic sampling of dried milk powder, dried eggs, dried yeast, and similar type products is difficult because they are generally packed in multilayer poly-lined paper bags. These may be stitched across the entire top, may have filler spouts, or the top of the poly-liner may be closed or sealed with some type of "twists".

1. The practice of cutting an "X" or "V" or slitting the bag and folding the cut part back to expose the contents for sampling should not be used because it creates a resealing problem; the opening cannot be properly repaired.
2. Procedure - The following procedure has been approved by the scientific units in Headquarters and should be used when sampling this type product:
   1. Bag and Poly-liner Stitched Together Across Top Seam.
      1. Remove as much dust as possible from the seam end by brushing and then wiping with a cloth dampened with alcohol. Note: This does not sterilize the bag as porous paper cannot be sterilized.
      2. Remove the seam stitching carefully (and dust cover, if any) and spread the walls of the bag and the poly-liner open enough to permit sampling being careful that no extraneous material such as dust, bits of twine, paper, etc., drops into the product.
      3. Carefully scrape off the surface of the product with a sterile device and aseptically draw the sample from the material below.
      4. Carefully reclose the bag and restitch by hand, or by machine if firm or FDA portable sewing machine is available.
   2. Bag Stitched Across Top and Poly-liner Twist-Closed and Sealed with "twist" Device - Wire, Plastic, etc.
      1. Brush, alcohol wipe, and remove stitching as described.
      2. Remove "twist" seal and carefully open poly-liner using caution that no extraneous material drops into the product.
      3. Draw aseptic sample in same manner as in (1)(c) above.
      4. Carefully close the poly-liner with a twisting motion and reseal with "twist" seal arranging it so it will not puncture the poly-liner, and resew bag as in (1)(d) above.
   3. Bags With Filling Spouts. The filling spout will be located at one side of the top stitching and will either pull out to form a top or side spout.
      1. Brush and alcohol wipe the area around the spout and carefully pull it out to reveal the opening. It is better to have the bag on its side while pulling the spout so any dust in the opening falls outside the bag.
      2. Carefully spread the sides of the spout apart and aseptically draw the sample. A trier or long handled device is usually better for this type opening because of the limited opening.
      3. Carefully close the spout with a firm twisting motion and be sure the opening is closed prior to pushing back into the bag.

426.03 - Collecting Water Samples

When it is necessary to collect water samples for bacteriological examination, use the following procedures:

1. Use sterile bottles. If dechlorination of sample is necessary, sodium thiosulfate sufficient to provide 100 mg/l should be placed in the clean bottles prior to sterilization. The sodium thiosulfate will prevent the chlorine from acting on the bacteria and assures, when the sample is analyzed, the bacterial load is the same as when collected.
2. Carefully inspect the outside of the faucet from which the sample will be drawn. Do not collect sample from a faucet with leaks around handle.
3. Clean and dry outside of faucet.
4. Let the water run from the fully open faucet for at least 1/2 minute or for 2 or 3 minutes if the faucet is on a long service line.
5. Partially close faucet to permit collecting sample without splashing. Carefully open sample bottle to prevent contamination, as for any other aseptic sampling operation.
6. Fill bottle carefully without splashing and be sure no water from your hands or other objects enters the bottle. Do not over fill, but leave a small air bubble at top.
7. Unless otherwise instructed, minimum sample size for bacteriological examination is 100 ml.
8. Deliver sample to lab promptly. If sample is not examined within 24 hours after collection, the results may be inaccurate.

Note: When documenting specific situations in a plant, you may need to vary this procedure to mimic the actual conditions used by the firm.

426.04 - Sample Handling

For frozen samples, pre-chill sterile containers before use and keep frozen with dry ice. Use ordinary ice or ice packs for holding and transporting unfrozen samples that require refrigeration. See IOM 452.05 & 912.03. Under normal circumstances dried products may be shipped unrefrigerated except in cases where they would be exposed to high temperatures, i.e., above 37.8^oC (100^oF).

Submit samples subject to rapid spoilage (specimens of foods involved in poisoning cases, etc.) by immediate personal delivery to the bacteriologist where feasible.

426.05 - Controls

When collecting samples using aseptic technique and the subs are collected using presterilized containers and equipment, submit a number of control subs. If the sampling covers a long period of time you should submit controls which show environmental conditions during the time of sampling. The controls should be collected at the start, during, and at the end of the sampling period. List control subs on your C/R.

Examples of various control subs are:

1. Sterile Containers - Where sterile containers are used to collect aseptic samples, submit one unopened container, which was sterilized in the same manner as containers used for sampling. Also submit at least one empty sterile container which has been opened and closed in the sampling area.
2. Sterile Disposable Gloves - If sterile disposable gloves are used to handle the product, submit one unused glove in a sterile container as a control.
3. Sterile Sampling Equipment - Where presterilized sampling tools are used (e.g., spoons, spatulas, triers, etc.), submit at least one unopened and one opened sampling tool as controls. Place tool, which was opened but not used, in a sterile container for submission.
4. Bagging or Container Material - Collect control subs of unstained bagging, or portion of container, and product when a sample is collected for rodent contamination. See IOM 427.04.