1. POLICY

Products imported in rigid metal or glass containers, semi-rigid containers which have double seams, and retorted pouches are subject to sampling and inspection of the condition of such containers. The inspection is intended to determine if the containers have any critical or major defects. These defects may indicate under-processing of the products or the defects themselves may substantially affect the integrity or usability of the containers. Abnormal containers (as defined in 9 CFR 318.300) are critical defects and shall be forwarded for microbiological analyses at an FSIS Field Services Laboratory (FSL) to determine if the product in the suspect containers presents a public health risk. Lots with defective containers that have been found unacceptable may be sorted (within limits) and presented for tightened reinspection, under reimbursable services.

2. CANCELLATION

Part 4, Section 6, "Condition of Container", dated April 1, 2002

3. SAMPLING AND REINSPECTION PROCEDURES

1. Condition of container examinations are performed only on product in hermetically sealed (airtight) rigid metal or glass containers, semi-rigid containers which have double seams, and retorted pouches. Retorted pouches should not be confused with other types of flexible packaging (e.g. hams cooked in plastic bags).

2. The sample size is determined by the number of immediate containers in the lot.
   

   SAMPLING PLAN NO.	LOT SIZE (No. of containers in lot)	SAMPLE SIZE (Containers)
   N2	6,000 or LESS	84
   N3	6,001 TO 12,000	168
   N4	12,001 TO 36,000	315
   N5	36,001 TO 72,000	500
   N6	Optional plan for unusually large or suspicious lots	800

    

3. The inspector shall select the appropriate number of immediate container samples identified in III.2. from the shipping containers within the lot, using the criteria in Table name below. Random numbers generated by the AIIS are used to determine which shipping containers to select.

   1. The inspector randomly selects immediate containers from the sample cartons according to the following table.
      

      NUMBER OF CONTAINERS IN EACH SHIPPING CONTAINER	NUMBER OF SAMPLE UNITS TO SELECT FROM EACH SHIPPING CONTAINER
      5 or less	All
      6 to 12	6
      13 to 60	12
      61 to 230	16
      231 to 500	24
      501 or more	See III.C.4.

       

   2. If the number of shipping containers in the lot is not sufficient for a full sample using the table, the inspector selects more samples from each shipping carton to fulfill sampling requirements.

   3. If the total number of containers in a lot is equal to or less than the required sample size, the inspector examines the entire lot.

   4. Shipments which have more than 500 cans on a pallet and are not in trays or cartons will be inspected in the following steps. The inspector

      1. Determines the number of containers in the lot.

      2. Determines per III.B. the number of sample units needed for the condition of container reinspection.

      3. Divides that number by 100. Rounds the number up to the next whole number, if needed. This is how many pallets from which samples are selected.

      4. Divides the number of sample units needed for the condition of container reinspection by the number determined in step C. This is how many sample units will be selected from each sample pallet.

      5. Using the number determined in step C, uses the random number generator to generate that many random numbers from 1 to however many pallets in the lot. These are the pallets from which samples are selected.

      6. Again using the random number generator, obtains a set of random numbers for each of the sample pallets based on how many samples were determined to be selected per step d.

      7. Selects samples and performs the condition of container reinspection.

4. The inspector visually and manually examines each container drawn for the sample.

   1. For each rigid metal container and semi-rigid container with a double seam, the inspector

      1. Examines the label (if the can has a paper label) for stains that may be evidence of leakage, rust, etc.

      2. Puts slight pressure on one end and observes any movement at either end. Repeats the procedure on the other end.

      3. Gently runs a finger along all double seams to detect any defects.

      4. Visually examines the double seam or seams, the side seam, and any container score lines on easy-open and pull-top devices for defects, leakage, etc.

      5. Checks the embossed container code impression to ensure there is no metal fracture or stress.

   2. For glass containers, the inspector

      1. Examines jar surfaces for obvious defects or crooked caps, etc.

      2. Examines the exterior of the jar closures for food particles or foreign materials.

      3. Places slight pressure on the center of the cap and observes any movement that may be an indication of a swell, flipper, short vacuum, loose cap, etc.

      4. Checks the safety button, if any, on the cap.

   3. For retorted pouch (flexible) containers, the inspector

      1. Notes exterior condition of package and quality of seals or seams; observe and feel for gross abnormalities, mechanical defects, perforation, malformations, crushing, flex cracks, delamination and swelling.

      2. Uses his/her fingers to rub over flat surfaces to feel for folds and ridges. Rub fingers over flat surfaces to feel for delamination, roughness, or unevenness.

      3. Checks the tightness of both head and side seals by squeezing pouches. Important points are corners and the crossing of the head and side seals.

      4. Carefully inspect the edges of each head and side seal for any evidence of product in the seal areas. No product should be visible.

      5. Observe the width of each seal area for uniformity.

      6. Apply a manual kneading action to force product against the interior seal surface. Examine all seal areas for evidence of product leakage or delamination.

      7. Products that exhibit delamination of the outer ply on the seal area (but not at product edge) should be further tested by again manually flexing the suspect area 10 times and examining all seal areas for leakage or short width.

5. The inspector records all defects on the FSIS Form 9530-1 (Table 13) in the "Defects in Container Condition" section.

4. CLASSIFICATION OF DEFECTS

1. Defects for cans and glass containers.
   
   Critical Defects = Abnormal Containers

   1. Swells (Code 210) - any container that is bulged by excess internal pressure. Also includes any burst or leaking containers.

   2. Flipper (Code 211) - a rigid metal container that normally appears flat, but when its end is brought down sharply on a flat surface, one end will flip out. When pressure is applied to this end, it will flip in, and the can will again appear flat (i.e., normal).

   3. Springer (Code 211) - a container with one end permanently bulged. When sufficient pressure is applied to this end, it will flip in but the other end will flip out.

   4. Loose tin (Code 212) - a rigid container whose end or ends do not show evidence of full vacuum, thus allowing movement of either end.

   5. Overstuffed (Code 213) - excess product in a container causing can ends to bulge.
      
      Major Defects = Defective Containers

   6. Punctured cans (Code 220) - a puncture through the plate of a rigid metal container.

   7. Major dent (Code 222) - a substantial dent on the top, bottom, or side seam of a can or on the opening key seam.

   8. Improper seams (Code 224) - cut-over, cut seam, droops, lips, excessive countersink, jumped seam, false seam, long or short body or cover hooks, spinner (slip, skid, dead head), or similar defects that may compromise the integrity of the container.

   9. Buckled seams (Code 226) - a permanent distortion of the container end, due to excessive internal pressures developed during heat processing, which affects the integrity of a seam.

   10. Cable cut (Code 221) - an abrasion of the top of the container double seam caused by the action of cable conveyors moving on stationary cans.

   11. Rust (Code 223) - rust that has pitted the tin plate of the can and cannot be wiped off with a soft cloth.

   12.  Missing label (Code 225) - all or part of the label of the immediate container has been removed or stained to such an extent that the required features of the label are not present or cannot be read.

   13. Other (Code 227) - any other major defect in the container that compromises the integrity or usability of the container.

2. Defects for retorted pouches.
   
   The retort pouch is a flexible laminated food package that can withstand thermal processing. It has the advantage of offering the shelf stability of metal cans, coupled with the texture and nutrient value associated with frozen foods.

   1. Abnormal Containers
      
      A container with displaying signs of swelling, product leakage or evidence that the contents of the unopened container may be spoiled. Abnormal containers are forwarded for microbiological analysis at an FSIS Field Service Laboratory. Abnormal containers exhibit evidence that

      1. There is, or has been, microbial growth in the container contents; or

      2. The hermetic seal of the container has been either lost or seriously compromised; or

      3. The container is unsuitable for distribution and sale.

      Abnormal containers are scored under Code 210 or 213 on the FSIS Form 9530-1, "Imported Meat and Poultry Product Reinspection Record".

   2. Critical Defects
      
      The following are critical defects characteristic of flexible pouches. The code behind the defect name refers to which block on the 9530-1 the defect should be recorded. The defect name on the form will not match the defect as indicated below. The form will be revised in the future to accommodate recording flexible pouch defects.

      1. Channel leaker (Code 210) a patch of non-bonded area across the width of the seal creating a leak. This defect can sometimes be detected visually by the absence of a portion of the seal impression in a seal. If a pouch has a channel leaker, it will usually be detected by applying pressure toward the seal.

      2. Non-bonding (Code 212) failure of two sealant films to combine during the sealing process. This can be detected visually by the sealing bar impression on a pouch. If it is in only one area, there will be a faint void in the seal. If it is in the whole seal, the seal impression will be very faint. Applying pressure to the seal area will cause the seal to separate.

   3. Major Defects
      
      A major defect is one which does not result in the loss of, or potential loss of, container integrity (hermeticity), and consequently does not represent a potential public health risk.
      
      The following are major defects characteristic of flexible pouches. The code behind the defect name refers to which block on the 9530-1 the defect should be recorded. The defect name on the form will not match the defect as indicated below. The form will be revised in the future to accommodate recording flexible pouch defects.

      1. Abrasion/scratch (Code 221) a scratch partially through the surface layer(s) of the package caused by mechanically rubbing or scuffing. The abrasion will appear as streaks, some darker in color, on the container.

      2. Blister (Code 224) a void within the bonded seal. This defect will appear to resemble a bubble in the sealed area. On a foil pouch, the blister will cause a raised appearance on the seal.

      3. Crooked Seal/short seal (Code 224) a seal that is not parallel to the cut edge of the pouch. When on the edge of the pouch with a narrowing on one end, must not be less than 3mm (3/32-inch) wide. A hermetic seal that is on an angle with any amount of unsealed material above the closure seal will not be classified.

      4. Cuts (Code 221) a mechanical slash or slice that penetrates the package, causing a loss of hermetic integrity. A cut will have a clean appearance on the edges of the material separated.

      5. Flex cracks/seal cracking (Code 227) small breaks in one or more layers of the package, due to flexing, but not a leaker. Will appear as a deep, rough textured wrinkle on a pouch. Cracking in the seal area may not be adjacent to the inner seal and light may not pass through.

      6. Hole/puncture (Code 220) a mechanical penetration of the package, causing loss of hermetic integrity. A hole or puncture is normally small in size.

      7. Seal creep (Code 224) partial opening of the inner border of the seal. This problem normally is detected by applying some pressure upward toward the seal.

      8. Tear (Code 221) a mechanical rip that penetrates the package, causing a loss of hermetic integrity. A tear will have a jagged appearance on the edges of the separated material.

      9. Wrinkle (Code 224) a fold of material in the seal area. This problem is highly visual, since the seal will have a pleated appearance from the foldover of the pouch material and can be seen on the unsealed area above the seal. Foldover wrinkles and deep multiple wrinkles are scored as major defects. If the fold in the seal area leaves less than 3 mm (3/32-inch) continuous acceptable seal; or if the fold-over wrinkle extends through all plies across the seal area.

   4. Minor Defects (Not Recorded on 9530-1)

      1. Convolution A slight visual impression in the seal indented on one side and raised on the other.

      2. Heat ripples Thin, multiple ripples on a seal caused by heat/tension. Ripples are on the two outer layers and do not affect the inner layer or seal integrity.

      3. Hot fold A permanent bend in a seal formed after sealing but before the seal area has cooled. This may appear as a large wrinkle or a fold that has been sealed over.

      4. Marks on seal Flat, unraised marks appearing on one or both sides of a pouch seal. Common causes are plastic build-up on the seal die, a dirty die, or a nick in the die.

      5. Uneven seal juncture Wavy or rough appearance of bonded polymer at the seal juncture. This will appear as small wrinkles but not the fold-over type. The inner seal juncture may also have a wavy appearance.

      6. Waffling embossing caused by racks during thermal processing that appears on the surface of the pouch and is easily recognized. The tray rack pattern is embossed on the container causing a "waffling" effect.

3. Meat extracts and fluid extracts of meat are not heat-processed (retorted) but are preserved by low moisture and high salt levels. The container protects the product from direct contamination. Defects in the condition of such containers are scored on the FSIS Form 9530-1 as major defects (defective containers), as follows, and the other code blocks (abnormal containers) are not used.

   1. Punctures, slits, cracks, or openings in the metal are scored as punctured cans (Code 220).

   2. Broken, cracked, fractured, or malformed seams, with an indication that an opening in the seam exists, are scored as improper seams (Code 224).

   3. Leaking product, or evidence of prior leakage, is scored as other (Code 227).

   4. Any part of the container which is crushed to the extent that it results in an opening into the container - or that it cannot be determined whether or not an opening exists - is scored as a major dent (Code 222);

   5. Deep-pitted rust which perforates, or nearly perforates, the container is scored as rust (Code 223). (Rust that can be wiped off the container with a soft cloth and has only etched or slightly pitted the metal is not scored.)

6. DISPOSITION

1. Disposition of lots in which no abnormal containers are found.

   1. If no abnormal containers are found, the inspector determines the disposition of the lot using the following table.
      

      SAMPLING PLAN	MAJOR DEFECTS--ACCEPT	MAJOR DEFECTS--REJECT
      N2	4	5
      N3	7	8
      N4	13	14
      N5	18	19
      N6	27	28

       

   2. If the lot is rejected, the results of the reinspection must also be entered immediately into the AIIS. The inspector will complete, but not immediately distribute, FSIS Form 9840-3 (Refused Entry Notification) and immediately notify the importer or his/her representative of the rejection and the option to sort the lot to remove the defective containers.

   3. The importer/representative has 5 working days to request, in writing, approval from the inspector to sort all defective containers out of the lot and present the lot for further reinspection at the tightened level under reimbursable services. If the inspector does not receive such a request within the 5 working day time frame, s/he shall distribute FSIS Form 9840-3 and request that the entire lot be presented and marked "United States Refused Entry".

   4. Sorting of the lot must occur during the assigned inspector’s tour of duty. However, the inspector need not be present during the sorting. When sorted and presented for tightened reinspection, the lot shall be sampled according to the following tightened sampling plan.
      

      SAMPLING PLAN NO.	LOT SIZE (Containers remaining in lot)	SAMPLE SIZE (Containers)
      T3	6,000 OR LESS	168
      T4	6,001 – 12,000	315
      T5	12,001 – 36,000	500
      T6	36,000 AND OVER	800

       

   5. The inspector selects the appropriate number of immediate container samples specified in the tightened sampling plan from the shipping containers within the lot, using the criteria in the Table X below. Random numbers generated by the AIIS or the random number generator are used to determine which shipping containers to select.

   6. The inspector randomly selects immediate containers from the sample cartons according to the following table.
      

      NUMBER OF CONTAINERS IN EACH SHIPPING CARTON	NUMBER OF SAMPLE UNITS TO SELECT FROM EACH CARTON
      5 or less	All
      6 to 12	6
      13 to 60	12
      61 to 230	16
      231 or more	24

       

   7. The inspector randomly examines the containers that were sorted out of the lot to determine if any critically defective containers were present. If any abnormal containers are found, the inspector follows the procedures for handling abnormal containers before making final disposition of the lot (see Part 3, Section 2 of the Import Manual of Procedures).

   8. If no abnormal containers or critical defects are found, the inspector determines the disposition of the reinspected lot using the following table.
      

      PLAN NO.	MAJOR DEFECTS ACCEPT	MAJOR DEFECTS REJECT
      T3	5	6
      T4	8	9
      T5	12	13
      T6	18	19

       

   9. If the lot is acceptable, the results of the tightened reinspection are entered/amended in the AIIS. The date inspected and the amount of the refused entry must be changed to reflect the tightened reinspection date and the actual amount of refused entry product after sorting.

   10. If the lot is rejected, it is refused entry without further sorting.

2. Disposition of lots in which abnormal containers are found

   1. The inspector retains the lot and follows the procedures for Handling Abnormal Containers (Part 3 Section 2).

   2. Upon OIA receipt of the microbiological analyses of the samples submitted to the laboratory, the inspector is instructed, through channels, to

      1. refuse entry on the lot;

      2. allow the lot to be sorted; or

      3. release the lot without sorting.

      The lot is refused entry, without sorting or tightened reinspection, if the number of critical defects - other than loose tins - found during the original condition of container examination equals or exceeds the limits in the following table.
      

      PLAN NO.	BLOWN TINS/POUCHES HARD SWELLS	TOTAL CRITICAL DEFECTS 1/	LOOSE TINS
      N2	1	7	No Limit
      N3	2	11	No Limit
      N4	3	19	No Limit
      N5	5	28	No Limit
      N6	7	42	No Limit

      1/ Do not include loose tins.
      

   3. When sorting is permitted, the inspector performs a tightened reinspection, under reimbursable services, after all abnormal and defective containers have been removed from the lot. The inspector randomly selects immediate containers from the sample cartons according to the following table on the next page.
      

      NUMBER OF CONTAINERS IN EACH SHIPPING CARTON	NUMBER OF SAMPLE UNITS TO SELECT FROM EACH CARTON
      5 or less	All
      6 to 12	6
      13 to 60	12
      61 to 230	16
      231 or more	24

       

   4. The inspector selects the appropriate number of shipping containers from the lot, using the criteria in the previous table to determine the appropriate number of shipping containers to select. A random number generator is used to determine which shipping containers to select. The lot disposition is based on the following table.
      
      

      Lot Size	Plan No.	Sample Size	Critical Accept	Defects Reject	Total Accept	Defects Reject
      6,000 or less	T3	168	0	1	5	6
      6,001-12,000	T4	315	0	1	8	9
      12,001-36,000	T5	500	0	1	12	13
      36,001 AND OVER	T6	800	0	1	18	19

 

[Return to Main Table of Contents]