Annex L

Import Inspection Procedures for Canadian Meat Products Exported to the USA

1. Introduction

The U.S. Import Inspection Procedures for meat products of Canadian origin require that (see also Annex L-5 for the flow chart):

1.1 The exporter notifies in advance the operator of the import inspection facility of all shipments exported to the USA that will be presented for assignment/inspection to that facility

1.2 The exporter ensures that all shipments stop at the border for assignment and at the designated import inspection facility for reinspection as instructed by an officer of the Food Safety and Inspection Services (FSIS) of the United States Department of Agriculture (USDA).

It cannot be overemphasized that the exporting establishment will be held responsible for failure to present a shipment to FSIS for inspection (Failure to Present - FTP). It is the responsibility of the exporting establishment to ensure that the truck driver receives adequate instructions (see Annex L-4) and fulfill his obligations. Failure to present is considered to be very serious. Severe monetary penalties will be imposed against the person responsible for it (importer of record with U.S. Customs). Products involved in FTP will be subject to other enforcement measures deemed appropriate by FSIS.

In addition, the following actions will be taken against plants responsible for FTP:

1.2.1 For the first and second violation, USDA will issue a warning letter to the Canadian Food Inspection Agency (CFIA), requesting a review of the incident and a report of the findings.

1.2.2 If a third violation occurs within a two-year period, USDA will suspend the eligibility of the Canadian establishment to export meat or poultry products to the USA. USDA will also request CFIA to conduct an investigation of the incident and report the findings and planned corrective actions to USDA. The findings and planned corrective actions will be reviewed by FSIS and relisting of the establishment will take place when found satisfactory.

In order to avoid major disruption in their exports to the USA, operators of exporting establishments are urged to take all necessary measures, such as the ones mentioned above, to ensure that FTPs will not occur.

2. General

Definitions

2.1 Assignment. The reinspection instructions for a specific lot of imported meat or poultry product.

2.2 Automated Import Information system (AIIS). A computerized system that receives and stores daily reinspection results from USA ports-of-entry and compiles histories for every foreign country exporting meat and/or poultry products to the United States. The AIIS generates the reinspection assignment(s).

2.3 Destination Import Facility. An approved establishment located in the interior of the United States and an end user of Canadian product. Such facilities are eligible to receive only Canadian shipments for FSIS reinspection. Exporting plants under intensified inspection cannot have re-inspection conducted at a destination facility.

2.4 Failure-to-Present. A failure-to-present (FTP) is defined as "any eligible shipment of meat or poultry products entering the United States that fails to stop for reinspection at an official FSIS import establishment." When product has not been presented to the USDA inspector for an assignment at the border entry point, it will be considered a failure-to-present (FTP). Products must not be distributed in commerce and the FSIS must be contacted for instructions. Products must return to the USA border facility designated on the 9540-1 for an assignment/reinspection. Shipments that enter commerce (and cannot be returned intact to the FSIS import establishment) or are further processed without FSIS port-of-entry reinspection will be subject to destruction. Failure to present for FSIS inspection will also result in U.S. Customs penalties. The shipment is considered a FTP if it cannot be accounted for as in-transit to the import establishment, in storage at the import establishment or has not arrived:

• within 72 hours (3 days) and the ETA has not been amended (Canadian shipments at border);
• by the established ETA (Canadian shipments air, water, rail).

2.5 Level of Reinspection. A status indicating the compliance history of a particular foreign establishment and country with respect to a Type of Inspection (TOI) for that specific product. There are three possible levels of reinspection:

2.5.1 Normal. A level of reinspection where the lot is randomly selected for reinspection from the annual allocation assigned to the country for the process category. Under the Normal level of reinspection, lots are not retained pending outcome of the physical reinspection.

2.5.2 Increased. An increased level of sampling above the Normal level of sampling which occurs as a result of an Agency management decision rather than from a failed TOI. Under the Increased level of reinspection, the lot is not usually retained pending outcome of the physical reinspection.

2.5.3 Intensified. A level of reinspection where a previous reinspection for a TOI has failed to meet USA requirements. This usually affects an individual establishment only. Under an Intensified level of reinspection, lots are held pending outcome of the physical TOI that is at the Intensified level.

2.6 Lot. A group of similarly processed/packaged product from one country, one establishment, and consisting entirely of the same species, process category, and product standard of identity (sub-category).

2.7.1 Inspectors will use the labelled information, such as the product name, handling statements and cooking/heating instructions to verify the exporting establishment's classification of further processed products.

2.7.2 The AIIS will assign every lot a unique, system-generated identification number that can be used to track import information. Note there can be multiple lots included on a single health certificate.

2.8 Process Categories. Process categories are product classifications based on preparation procedures used in the foreign establishment.

• 03B Raw product – ground
• 03C Raw product – not ground
• 03D Thermally processed – commercially stable
• 03E Not heat treated – shelf stable
• 03F Heat treated – shelf stable
• 03G Fully cooked – not shelf stable
• 03H Heat treated but not fully cooked – not shelf stable
• 03I Products with secondary inhibitors – not shelf stable

FSIS samples and tests RTE products produced in process categories O3E, O3F, O3G and O3I. Analyses will include Listeria monocytogenes AND Salmonella testing for all RTE products, and E. coli O157:H7 for cooked patties and dry or semi-dry fermented sausages.

More information on process categories can be found on the FSIS website at: http://www.fsis.usda.gov/oppde/op/IIM/TOCIIM.htm. Go to Part 1, section 2, Process Categories, Subcategories and Types of Inspections for AIIS

2.9 Sample. A sample consists of one or more units of product randomly selected from a lot that are used to determine whether or not the lot is acceptable. Sample size is the number of units of product in a sample.

2.10 Skipped Lot. A lot that is not assigned a TOI, but the inspector verifies the lot for general condition (including transportation damage), shipping container labelling, count, and accuracy of the product label and accompanying foreign health certificate. Note: Product imported from Canada receiving a "skipped" assignment is not staged and only has a cursory check at the rear of the truck.

3. USA Import establishment facility requirements

Import establishments in existence as of August 10, 1992, and located on the USA-Canada border are not required to have either sufficient refrigerated or freezer space to properly hold perishable product that is stored or retained. NOTE: Shipments that are on Intensified reinspection level or on Voluntary HOLD by the importer cannot be moved from the import establishment's premises while on HOLD, but may be stored under refrigeration in a truck or trailer on premises pending the outcome of inspection results.

4. Canadian establishment requirements

4.1 Import Inspection Application and Report (9540-1)

4.1.1 Prior to entry into the USA, an employee of the Canadian establishment exporting meat or poultry to the United States will:

1. Complete FSIS Form 9540-1, "Import Inspection Application and Report," (See Annex L-1 and L-2); and fax directly to the USA border import facility of their choice.
2. In the case of questions concerning completion of the form or where to fax the form, the contact is:

   Office of International Affairs (OIA), Import Inspection Division
   Washington, DC
   Phone: 202-720-9904
   FAX: 202-720-7900
   Hours of Operation: 0700 – 1630 ET, Monday through Friday, excluding holidays

3. For shipments from Canada that are presented at the border (truck shipments) the exporter must:
   1. indicate an Estimated Time of Arrival (ETA) in block 31 (Remarks) of the faxed FSIS Form 9540-1 to advise FSIS of the estimated time and date for the shipment to arrive at the import establishment; and
   2. ensure that the ETA is within 72 hours from the date in block 26 of FSIS Form 9540-1; and
   3. ensure that the shipment arrives for inspection at the FSIS approved import establishment within 72 hours, including the weekends and holidays, from the time the FSIS Form 9540-1 is received by import inspection personnel.
4. Shipments from Canada that do not cross into the USA by truck are not expected to adhere to the 72 hour (3 working days) rule referred to in 4.1.3 below. Exporters of shipments by air, water, or rail car (except edible fats) to the USA are required to fax the FSIS Form 9540-1 to the import facility designated in blocks 12 and 13 of the form. The exporter shall include an estimated time of arrival (ETA) in the remarks block for the shipment to arrive at the designated import facility. Inspection personnel, upon receipt of the form from import plant management, shall verify the presence of an ETA on the form. If an ETA has not been declared, the form shall be returned to plant management and have them request the ETA from the producing establishment, shipper, or applicant. Plant management shall return the form to inspection personnel with a declared ETA. Inspection personnel shall monitor the shipment's arrival by referring to the ETA on the FSIS Form 9540-1.

Note: If an ETA is still not obtained on Canadian shipments, the import inspector will e-mail the details of the shipment (producing establishment, product, etc.) to IID- HQ (Import Inspection Division-Headquarters) at importinspection@fsis.usda.gov for follow-up with the Canadian Food Inspection Agency (CFIA).

If the shipment has not arrived at the designated import establishment by the ETA, import inspection personnel will query the AIIS to verify that the shipment has not been reinspected at another import establishment.

1. If a Canadian shipment received a skipped assignment at another import establishment, there will be no further action taken.
2. If a Canadian shipment received an inspection other than skipped, import inspection personnel will confirm the status of the shipment with inspection personnel at the location where the assignment was drawn.
3. If the shipment does not have an assignment issued in the AIIS, the import inspector will request that import establishment management confirm the shipment's status.

If the shipment is in route, import inspection personnel will obtain an updated (ETA) from import establishment management. Import establishment management is responsible for tracking any missed ETA within the day (24 hours) the ETA was missed.

Note: If the shipment is cancelled, the exporting or producing establishment representative must fax notification of the cancellation to the RIFO (Regional Import Field Office). The RIFO will cancel the shipment in the AIIS and forward notification of the shipment cancellation to the import establishment listed on the 9540-1.

If the shipment entered the USA without obtaining an inspection assignment, the shipment is considered a failure-to-present (FTP).

A. If the shipment has not arrived at the designated I-house by the ETA provided, the FSIS inspector at the designated I-house shall request import plant management to confirm the status of the shipment.

1. If the shipment is in route, obtain a revised ETA.
2. If the shipment was cancelled, the Canadian exporter must cancel the FSIS Form 9540-1, which is kept on file at the import establishment.
3. If the shipment entered the USA without obtaining an inspection assignment, it is considered a failure-to-present.

4.1.2 Amendments - Canadian exporters are encouraged to fax the application (FSIS Form 9540-1) as close as possible to the time of shipment to the USA to avoid the need for amendments.

1. The faxed copy of FSIS Form 9540-1 serves as advance notification that a shipment is proceeding to the United States. Additional lots may be added to the Canadian health certificate; however, an amended FSIS Form 9540-1 must be presented to FSIS with the shipment. NOTE: This may result in delays in inspection at the import establishment.
2. Regardless where the truck is, once FSIS Form 9540-1 has been faxed, amendments to FSIS Form 9540-1 regarding the reinspection establishment (blocks 12 and 13) will not be allowed except in emergency situations or the closing of the designated USA Point of Entry border crossing (block 3) by USA or Canadian authorities that would result in unusual delays for shipments. Emergencies are defined as fires, explosions, chemical spills, leaks and releases, bombings, bomb threats, civil disturbances, hurricanes, tornadoes, earthquakes, blizzards, floods, power failures, and personal injuries.
3. The Office of International Affairs (OIA) must be consulted prior to amending any application for the reasons mentioned above. On weekends and holidays, callers to the OIA will be referred to emergency contacts and numbers.
4. After receiving permission to amend FSIS Form 9540-1, shipments will proceed to the new designated import establishment.
5. Any establishment placed on intensified inspection while shipments are in transit will be permitted to amend FSIS Form 9540-1 to reflect the actual weights. The shipment is to proceed to the designated USA point of entry or import facility for reinspection. The Canadian exporter must submit the amended 9540-1 with the actual weights directly to the designated import establishment.

4.1.3 Cancellations. The Canadian exporter must notify the import inspector at the designated import establishment in writing prior to the expiration of the 3 day limit if the shipment is cancelled. Failure to notify FSIS of a cancelled shipment may result in delays for subsequent shipments. When a shipment is cancelled, the CFIA health certificate CFIA/ACIA 4546, the shipping marks (export stamp number) as well as the FSIS Form 9540-1, cannot be used again. Product will have to be re-certified by the CFIA prior to shipping.

4.1.4 The original FSIS Form 9540-1 and the original health certificate must accompany the shipment to the United States. Once the 9540-1 has been faxed, the shipment must be presented for FSIS reinspection within three (3) working days, or the exporting establishment must notify the designated import establishment when the shipment will arrive. NOTE: The U.S. Customs Entry Number MUST be entered on FSIS Form 9540-1 that arrives with the shipment. An inspection assignment will not be drawn until this requirement is fulfilled.

4.2 Lotting of Product

A lot is defined as a group of similarly packaged products from one establishment consisting entirely of one species, process category and product standard of identity (sub-category).

4.2.1 Species are categorized as follows: beef, veal, pork, lamb, mutton, goat, equine, chicken, turkey, guinea, squab, duck, geese, ratite, poultry combination and red meat/poultry combination.

4.2.2 Processes are categorized as follows:

• 03B Raw product - ground
• 03C Raw product - not ground
• 03D Thermally processed - commercially sterile
• 03E Not heat treated - shelf stable
• 03F Heat treated - shelf stable
• 03G Fully cooked - not shelf stable
• 03H Heat treated - not fully cooked - not shelf stable
• 03I Products with secondary inhibitors - not shelf stable

4.2.3 Packaging is categorized as follows:

• sides, carcasses
• packages
• cans

4.2.4 Description of the product - Block 17

The description of the product must accurately reflect the product name on the label and that is certified on the export certificate. If there is a standard or definition in the regulations, the name of the product should be reflected as prescribed (refer to approved label). Otherwise the common or usual name of the product or a truthful descriptive designation should be specified. Animal production raising claims are not considered to be part of the product name and are not required to be present on the health certificate or on the application form (9540-1).

Single ingredient products, such as primal cuts and subprimal meat cuts, bone-in or boneless, can be grouped as such on the application. As an example, a shipment containing 50 cartons of boneless beef loins totalling 2500 lbs and 50 cartons of bone-in beef rib loins totalling 2500 lbs could be listed on the application form 9540-1 as one lot of meat cuts, with a net weight of 5000 lbs, provided they have the same shipping marks. If the shipment contained ground beef or boneless meat for manufacturing (trimmings), these products must be listed as separate lots (see Annex L-3 for specific examples on how to enter products on form 9540-1).

Note:

1. The maximum number of lots that could be included on the 9540-1 is 9. If necessary, use a second form on which you will indicate that it is a continuation sheet (box #1).
2. The export certificate (CFIA/ACIA 4546) may include lots from more than one establishment, process category or species. In these cases a continuation sheet to the initial 9540-1 must also be completed for each additional establishment, process category, and species.
3. Block 22 of 9540-1: Net weight must be rounded-up. Do not enter decimals.
4. Distribution of 9540-1: Point A, in the case of Canada, form 9540-1 does not need to be distributed to the U.S. Customs official prior to submission to the FSIS inspector at the border.

4.3 Selecting an Import Establishment

Any approved United States Import Establishment can be identified on the FSIS Form 9540-1 by the Canadian exporting establishment for conducting the inspection, provided it has the capability to inspect the particular product being shipped. However, the inspection assignment MUST be received at a border inspection facility if the shipment is moving by land.

EXCEPTION: Rail car shipments moving "in bond" for transloading to a ship destined to an island state (Hawaii) or a USA territory (e.g. Puerto Rico, Guam) shall obtain the inspection assignment at the designated import establishment. The most current, up-to-date copy is available through the OIA. Contact the specific facility to determine its capabilities.

4.4 Canadian Establishments on Intensified Inspection

Exporting plants under intensified inspection cannot have re-inspection conducted at a destination facility.

4.5 Placement of Containers on Trucks

Shipping containers at the rear of the truck must be loaded on the truck so that the labelling features face the rear of the truck allowing the USDA-FSIS inspector to conduct the verification required in 8.4.1 of this section. Label verification will be performed only on products visible at the rear of the vehicle (Skipped lots).

4.6 Entry into the USA

Upon entry into the United States, the trucker will obtain the assignment from the FSIS inspector at any USA import establishment along the USA-Canadian border. This establishment may differ from the designated reinspection establishment, which is identified in Block 12 on FSIS Form 9540-1. However, if any part of the shipment is designated as an "inspect", the shipment can only be inspected at the FSIS facility designated on the original FSIS Form 9540-1.

5. USA Import establishment (Plant Responsibility)

The import establishment representative can, but is not required to acknowledge receipt of the FSIS Form 9540-1. However, plant management will be expected to deliver the form to the FSIS import inspector on the day it is received.

It is strongly recommended that the exporter makes arrangements with the operator of the import inspection facility to be notified immediately should the shipment not arrive within the expected time.

The exporter will then be able to contact the carrier and to take appropriate action to ensure that the shipment is presented for inspection as required.

6. Obtaining the assignment

6.1 The assignment will be obtained from an FSIS inspector at any import establishment at the USA-Canadian border, once the shipment has arrived at the import establishment. Inspection assignments are NOT to be drawn prior to product arrival, unless there is scheduled downtime for the AIIS during the shift of operation. In this case, assignments can be obtained but not shared with the exporter or import management until the shipment has arrived on the premises. Inspection personnel will verify the accuracy of the information entered into the AIIS from the advance (faxed) copy of the FSIS Form 9540-1 and the health certificate as well as the 9540-1 arriving with the shipment, prior to drawing the assignment.

6.1.1 If the assignment is a "Skipped," the inspector will check the shipment and documents according to the procedures in 8.4.1 of this section.

6.1.2 If the assignment is an "Inspection", the shipment must proceed to the USA import establishment designated in block 12 on the FSIS Form 9540-1, if different than where the shipment is located, to be inspected according to 8.5 of this section. The inspector will complete block 27 of FSIS Form 9540-1, and forward the shipment in the AIIS to the designated import establishment where the shipment is destined for reinspection.

6.2 Shipments that are not presented to an FSIS inspector upon arrival at the USA-Canadian border for an assignment will be considered a failure-to-present (FTP). Products must not be distributed in commerce and the FSIS must be contacted for instructions. The product must return to the designated USA border facility for an assignment/reinspection. Shipments that enter commerce (and cannot be returned intact to the FSIS import establishment) or are further processed without FSIS port-of-entry reinspection will be subject to destruction. FSIS will also request that U.S. Customs issue a re-delivery notice, and also pursue applicable fines/penalties. In addition, see 1.2.

7. Destination inspection (Establishment's Responsibilities)

7.1 A grant of inspection for destination facilities will be applicable only to Canadian shipments. Establishments desiring to receive a grant of inspection for destination facilities should make application to the District Office with jurisdiction in their area.

7.2 The destination import facility is responsible for providing the District Office with sufficient notification including date and time of arrival of Canadian shipments. This will facilitate the scheduling of inspectors. The shipment owner/importer is responsible for making arrangements to receive assignments outside of normal working hours.

7.3 All shipments going to destination establishments must stop at a USA import establishment along the USA-Canadian border to receive an inspection assignment. If a "Skipped" inspection reveals transportation damage, health certificate irregularities, or improper labelling, corrections must be accomplished at the border location before the shipment may proceed.

7.4 Exporting plants under intensified inspection cannot have re-inspection conducted at a destination facility.

8. USDA Import inspector responsibilities

8.1 Failures-to-Present (FTP). The FSIS inspector will follow the protocol found in the FSIS Import Manual for Failure-to-Present (FTP) Shipments. More information about this can be found on the FSIS website (Part 4, Section 1, Enclosure 5):  http://www.fsis.usda.gov/oppde/op/IIM/TOCIIM.htm

8.2 Upon arrival of the shipment, the inspector will:

8.2.1 Review the original Canadian health certificate in accordance with current verification procedures.

8.2.2 Review FSIS Form 9540-1 and compare it to the faxed copy.

8.2.3 If either of these documents do not accompany the shipment, the inspector should not proceed with import reinspection until proper documentation is provided. Information provided on the FSIS Form 9540-1 accompanying the shipment must agree with the information on the Canadian health certificate. The inspector shall correct the 9540-1 information which was entered into the Automated Import Information System (AIIS) from the advanced copy of the FSIS Form 9540-1 if necessary. At this time, the inspection assignment can be requested.

8.2.4 Amendments. If the designated import establishment has been changed on the FSIS Form 9540-1, verify the emergency situation or the border closure causing the amendment (as defined in 4.1.2(2) above). If it is not a valid reason to change designated import establishments, shipments receiving an assignment for reinspection will be directed to the import facility identified on the original 9540-1. Inspectors may need to verify the emergency situation or border closure with inspection personnel at the original designated I-house or with OIA staff.

8.2.5 If the emergency situation can be verified, the import inspector obtains the inspection assignment from the AIIS.

Meat carcass shipments that are not presented in a shipping container (other than the trailer) will have the samples selected and identified by the CFIA. These shipments are to be sealed by CFIA and the seal numbers are to be identified on the health certificate. Inspection personnel shall verify the seals are intact and match those identified on the health certificate. If the seal is broken, missing or the wrong type, the load shall be rejected unless sufficient evidence can be presented to the FSIS inspector that the shipment should not be rejected. Example: APHIS/Customs/CBP broke the seal and the inspector verifies this prior to obtaining an assignment.

It is possible that a seal other than a CFIA seal will be used on the shipment and not match what is on the certificate. If the seal is from another branch of the Canadian Government or from another USA Government Agency, the shipment should be acceptable, but may need to be accompanies with an official letter explaining why the seal was changed.

8.3 All loads must be presented to the FSIS import inspector. If the assignment is a "Skip," the inspector will check the shipment and documents according to the procedures in 8.4.1 of this section. If the assignment is an "Inspection," the inspector will complete block 27 of FSIS Form 9540-1, and the shipment must proceed to the USA import establishment designated in block 12 on the FSIS Form 9540-1 for inspection as prescribed in 8.5 of this section.

8.4 Stamping of product

• Products and shipping containers from Canada will not be stamped "U.S. Inspected and Passed".
• With the exception of red meat carcasses, all products and shipping containers refused entry at import reinspection will be legibly stamped "U.S. Refused Entry". The location of the "U.S. Refused Entry" imprint must be such that the refused entry is easily identifiable.

8.4.1 "Skipped" loads

8.4.1.1 Skip loads will not be staged but verification of the skip lot must be performed on the official premises of the import establishment (i.e. shipping bay or loading dock).

8.4.1.2 Without entering the vehicle, have the truck doors opened and observe the general condition of the portion of the shipment that is at the rear of the vehicle. Any obvious transportation damage will be handled in accordance with Part 4, Section 11 of the FSIS Import Manual.

8.4.1.3 Check the portion of the shipment at the rear of the vehicle to determine that it coincides with the applicable health certificate. Verify that the placard or shipping container label(s) of the products visible at the rear of the vehicle includes the shipping marks, name or kind of product, foreign establishment number, and the country of origin. If these labelling features cannot be seen, the inspector should request that a shipping container at the rear be removed from the vehicle or turned to reveal the label.

8.4.1.4 Refuse entry on the shipment if the vehicle contains other cargo with the potential to contaminate or adulterate edible product. Inspectors should consult with supervisory officials before refusing entry.

8.4.2 Stamping of Health Certificate

1. For "skipped" shipments or "inspected and passed" product, stamp the health certificate "U.S. Inspected and Passed," and file with related documents in the inspector's file.
2. For refused entry product, stamp the health certificate "Refused Entry" and refer to FSIS Import Manual Part 4, Section 11.

8.4.3 Stamping and Signing FSIS Form FSIS 9540-1

For lots that have passed reinspection, sign block 29, stamp the FSIS Form 9540-1 "U.S. Inspected and Passed". The import establishment can make a copy of the stamped 9540-1 and return the original to the inspector. File the stamped original 9540-1 with related documents in the inspector's file. For lots that have failed reinspection, stamp the FSIS Form 9540-1 "U.S. Refused Entry." The import establishment can make a copy of the stamped 9540-1, and return the original to the inspector. File the stamped original 9540-1 with related documents in the inspector's file.

8.5 Reinspection procedures

8.5.1 Data Entry – AIIS Assignments (or TOI).

8.5.1.1 Information must be entered into the AIIS Initial Entry Screen from FSIS Form 9540-1 and the foreign health certificate.

8.5.1.2 The assignment(s) should be obtained only when the product is presented for reinspection.

8.5.1.3 The inspector shall perform every TOI assigned by the AIIS, unless otherwise instructed.

8.5.1.4 When the inspector suspects the authenticity, wholesomeness, or integrity of any product, he/she shall, upon approval from the circuit supervisor, perform any appropriate TOI in addition to the AIIS assignment(s).

8.5.2 Presentation of the Lot

8.5.2.1 Importers will designate each lot from the foreign health certificate on FSIS Form 9540-1, including the size of the lot to be presented for reinspection.

8.5.2.2 The import facility shall present the lot in a manner that:

1. Its placement ensures the safety of the inspector;
2. Each unit in the lot has an equal chance of being selected as a sample;
3. The lot is distributed uniformly to facilitate the verification of the lot size. For example, when product is presented on pallets, each pallet shall contain the same number of cartons. However, if the carton count of each pallet is not the same, the facility will provide the inspector with a list indicating the number of pallets in the lot and the shipping container count of each pallet;
4. The panel(s) of each shipping container, subject to label approval or verification, is plainly visible by the inspector. That is, the inspector shall be able to easily read the required labelling features (name of product; country of origin; foreign est. number; shipping marks; name and address of either the foreign est., distributor or importer; and when necessary, the special handling statement). In addition, the end panel of each shipping container shall be plainly visible; and
5. Its placement allows adequate space for the inspector to select samples, visually perform label verification, and examine the lot for transportation damage and count.
6. Its presentation is not intermixed with products from another lot.

Note: The requirements listed above (a-f) must be met, however, they do not necessarily preclude a facility from presenting lots in a manner that facilitates its operations, e.g., double stacking of product.

8.5.3 Routine Inspection

8.5.3.1 The inspector shall conduct a routine inspection for every lot which includes general condition, label verification, count, and accuracy of the information specified on FSIS Form 9540-1 and the foreign inspection certificate.

8.5.3.2 If the number of shipping units offered for reinspection differs from the amount of product certified on the foreign health certificate, refer to applicable section (Enclosure 3 of Part 4 of the FSIS Import Manual) for guidance.

8.5.3.3 The inspector shall identify, and cause to be sorted out of the lot, any container that has obvious transportation damage resulting in product being exposed to unsanitary conditions. Such transportation-damaged product shall be refused entry.

8.5.4 Sampling

8.5.4.1 The inspector shall use the appropriate sampling plan(s) for the TOI(s) involved and shall use the random numbers generated by the AIIS, except when adjustments are made to the number of units in the lot.

8.5.4.2 When assigning numbers to sample cartons, combo bin sites, etc., for sampling purposes, the inspector shall begin numbering at the lower left-hand corner of the first pallet or combo bin and number in either a clockwise or counter-clockwise pattern, circling each layer of the pallet or combo bin. Regardless of which direction is chosen, it shall be the same for each pallet or combo bin within that lot. For carcasses, quarters, and similar product hanging on rails, the inspector shall number the units in consecutive order beginning with the first unit approached.

8.5.4.3 The inspector shall directly control the selection of samples and the stamping of each sample with the "USDA OFFICIAL IMPORT SAMPLE" stamp. Every sample shall be stamped once and second-step samples, if applicable, shall be stamped twice. Samples of non-packaged product (e.g., carcasses, quarters, etc.) may be selected without stamping, but if they are stamped the inspector shall assure that only approved edible ink is used. Stamped tags to attach to the sample unit may also be used.

8.5.4.4 The inspector shall require the establishment to remove all samples from the lot, including any second-step samples, and present them in a manner that will facilitate the further selection of specific sample units and the appropriate type(s) of reinspection.

8.5.4.5 The inspector shall maintain control of the samples at all times until the lot has been reinspected and passed or refused entry. When personal control is not possible, the samples shall be secured under official lock or seal.

8.5.4.6 Samples shall be handled at all times in a manner that will maintain their wholesomeness and integrity.

8.5.4.7 When practical, samples shall be returned to the lot following reinspection.

8.5.4.8 Canned and Packaged Product (e.g., Canned Hams or Tubes of Cooked Beef) presented in Combo Bins/Pallets:

1. In addition to the other requirements, the importer shall place an "X" in block "19" for cans or packages, as applicable, of FSIS Form 9540-1 (see Annex L-1). The total number of combo bins should be entered in Block "20" and the number of units per combo bin in Block "21" of the same form.
2. The sample size and the maximum number of combo bins from which the samples are selected will be determined by the AIIS, based on the total number of combo bins in the lot and the total units per combo bin that is entered by the inspector.
3. The inspector shall randomly select the sample units from the entire combo bin (top, middle, and bottom).

8.5.4.9 Bulk Packed Canned and Packaged Product (e.g., Jerky, Chicken Nuggets) presented in Combo Bins or unusually large containers:

1. In addition to the other requirements, the importer shall enter an "X" in block "19" for packages of FSIS Form 9540-1(see Annex L-1) and enter the total number of combo bins in block "20". The importer shall also enter the number 18 in block "21" of the same form to represent the number of sample selection sites per combo.
2. The inspector shall multiply the number of combos by 18 and enter that number as the number of units and enter a 1 to designate the package amount in the AIIS.
3. As an example, for a lot size of 30,000 pounds (15 combos @ 2,000 pounds each) assigned at the Normal monitoring level, the AIIS will generate a sample size of 6 numbers which represents 6 of the possible 270 (15 x 18) sample selection sites.
4. Sample selection sites of each combo bin shall be identified with the "USDA OFFICIAL IMPORT SAMPLE" stamp. If an identified sample is not on the top layer of the combo bin, the import facility shall remove product until the entire layer containing the sample area has been exposed. Product removed to provide access to the sample area shall be placed in a sanitary receptacle until it is returned to the combo bin following sample selection.

8.5.4.10 Fresh Bone-In or Boneless Cuts or Boneless Manufacturing Meat Presented in Combo Bins/Pallets.

1. In addition to the other requirements, the importer shall enter an "X" in block "19" (packages) of FSIS Form 9540-1 and enter the total number of combo bins in block "20". The importer shall also enter the number 18 in block "21" of the same form to represent the number of sample selection sites per combo.
2. The inspector shall enter the number of combos as "number of units" and 18 as the "package amount" in the AIIS to generate the sample selection sites for the lot.
3. As an example, for a lot size of 30,000 pounds (15 combos at 2,000 pounds each), the AIIS will generate a sample size of 30 numbers (15 and 15) which represents 30 of the possible 270 (15 x 18) sample selection sites.
4. Sample selection sites of each combo bin shall be identified with the "USDA OFFICIAL IMPORT SAMPLE" stamp. If an identified sample is not on the top layer of the combo bin, the inspector shall require the import facility to remove product until the entire layer containing the sample has been exposed. Removed product shall be placed in a sanitary receptacle unit it is returned to the combo bin following sample selection.

8.6 Sampling for Laboratory Analysis

Reinspection activities include the sampling of imported products for laboratory analyses (e.g., chemical or biological residues, products standards (PFF, moisture/protein ratio)).

The USDA-FSIS implements a zero tolerance level of protection for Listeria monocytogenes in all categories of ready-to-eat meat products.

9. Appeal procedures following an import inspection decision

When imported product has been determined to be non-compliant, the importer/broker/appropriate representative may appeal the inspector's decision to the supervisor. When this occurs, the following procedures shall be conducted.

The importer/broker/applicant or representative shall:

1. advise the inspector that an appeal will be requested and provide him/her with the reason(s) for the appeal; and
2. within five working days of rejection, request an appeal in writing to the supervisor and provide the reason for the appeal.

Inspection personnel shall:

1. upon notification by the importer/broker/applicant or representative, place the appealed lot on hold and make sure the lot is stored intact and segregated from all other product. Lots for which an appeal is pending shall be sufficiently controlled;
2. when applicable, secure the samples and defects that resulted in the appeal; and
3. following the outcome of an appeal, place the samples with the lot for further disposition.

The FSIS supervisor shall:

1. discuss the reason for the appeal with the representative making the appeal;
2. contact the inspector and discuss the reason(s) for the appeal; and
3. review the product/samples as soon as possible and make a final determination.

9.1 Reinspection and Verification of Red Meat Carcasses

9.1.1 Canadian Inspector and Establishment Responsibilities

9.1.2 Sample Selection at Canadian Establishment

The Canadian inspectors shall identify the randomly selected samples by either numbering each carcass side or by marking the carcasses in such a way as they can be readily identified from the remainder of the lot. The selected samples shall be placed at the rear of the truck and sealed by CFIA. The truck seal number will be identified on the health certificate.

A written procedure for carcass sampling must be in place. It must clearly establish the responsibilities of all involved, describe the way random sampling will be achieved (table, computer...), where and when the carcass selection will be done and other pertinent details specific to the plant situation (see annex L-6 and L-7 for more details).

9.1.3 Shipping Marks On Carcasses or Parts

Carcasses or parts may be shipped with shipping marks applied or displayed in one of two ways:

1. Carcasses must bear the foreign establishment number; a unique shipping or lot identification mark; and the name of the country of origin, preceded by the words "product of". If the name of the country of origin appears as part of an official mark and it is prominently and legibly displayed, then the words "product of" may be omitted. These markings shall be applied either to the product, to the packaging encasing the product, or to a tag attached to the product.
2. Carcasses must be shipped under CFIA seal with identifying shipping marks on a placard inside the truck. The CFIA seal number must be recorded on the original Canadian health certificate.

9.2 Carcass Reinspection at Port-of-Entry

9.2.1 All shipments will receive the inspection assignment at a USA import establishment along the USA-Canadian border.

9.2.2 Inspection Assignment. For "inspect" loads, the import inspector will check the seal and have the marked samples unloaded and staged at the designated import establishment. Inspections will be performed on each sampled carcass using existing inspection procedures and standards. The shipment will either pass or fail.

For "skipped" loads, the inspector will check the shipment and documents according to the procedures in 8.4.1 of this section.

10. Tightened and hold

10.1 Any lot of meat or poultry products of Canadian origin that is designated as "an inspect" and fails laboratory testing will trigger intensified inspection (tightened and hold) of products falling in the same process category for the next 15 shipments / 15 times the weight. If a shipment is refused entry for product deficiencies, this will trigger intensified inspection of products falling in the same process category and the establishment must submit ten (10) consecutive lots for full inspection prior to being considered for a reduced rate of inspection. If one of these ten (10) consecutive lots is refused entry, then the process will start over until ten (10) consecutive lots are found satisfactory.

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