11.7.3 United States of America

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Table of Contents

11.7.3.1. General information

There are two departments in the United States that have responsibilities for meat products, the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS), and the Food and Drug Administration (FDA). The majority of meat products exported from Canada to the United States fall under the legal jurisdiction of the FSIS, since FSIS regulates the import of meat from common food animals, such as beef, pork and poultry. These are known as "amenable species" (refer to Annex Q, paragraph Q.1.2 for details on amenable species). The FDA regulates the meat imports from game and exotic animals which are the "non-amenable species" under FSIS. The FDA is also responsible for products that contain a very small quantity of meat (less than 2% cooked or 3% raw), and casings. It should be noted that the meat included in products containing small amount of meat falling under the jurisdiction of the FDA must originate from a source approved by the FSIS, when applicable (e.g., beef, pork, poultry meat). All Canadian registered establishments are eligible to export meat products under FDA jurisdiction, while there is a list of approved establishments to export products under the jurisdiction of FSIS (refer to Annex W). It is important that the exporter know which Department regulates the meat products to be exported because the certification requirements for FSIS and FDA regulated products are very different.

It is important to note, that in addition to meeting the meat hygiene requirements of either the FDA or FSIS, all meat products must also fulfill the animal health requirements of the Animal and Plant Health Inspection Service (APHIS) branch of the USDA. These restrictions may be found in this section on the United States under "Import Prohibitions or Restrictions" (11.7.3.2). APHIS is also responsible for issuing import permits, when required.

11.7.3.1.1 Equivalence of inspection systems

The conditions for export to the United States are influenced by the fact that the FSIS recognizes the Canadian federal meat inspection system as equivalent to the United States system. Equivalence means that Canada's system does not have to be the same as the importing country's system (i.e. the United States), but is based on the ability of an exporting country's system or a sanitary measure to achieve the same outcome or, in the language of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), provides the same "appropriate level of sanitary or phytosanitary protection" as the importing country's system or sanitary measure. Determinations of equivalence generally entail a thorough review and assessment by the importing country of all aspects of the exporting country's system, including all relevant legislation, policies, standards, procedures and infrastructure, to support a judgement on whether the system achieves the same level of sanitary protection as the importing country's system. The FSIS carries out regular reviews of the Canadian meat inspection system to verify that equivalence is being maintained. During these reviews, the FSIS uses the Canadian legislation and manuals of procedures to assess ongoing equivalence. The only items that are judged according to FSIS standards are those for which Canada does not have equivalence, (e.g. frequency of inspection, pre-shipment review, etc.). It is these additional requirements which are described in this section.

11.7.3.1.2 Export of samples

For detailed and most current procedures applicable to samples and to obtain Form 9540-5, the applicant must visit the USDA/FSIS web site.

The FSIS authorizes requests for the importation of samples of meat and or poultry products destined for laboratory examination, research, evaluative testing or trade show exhibition. Provided there are no animal health restrictions imposed by the USDA, APHIS, meat and poultry samples can originate from any foreign country. Importers who want to import samples into the United States that originate in countries with animal health restrictions shall apply to APHIS for a permit prior to importing.

Samples are certified to be exported to the United States with a CFIA/ACIA 5733 stating "Samples intended for laboratory examination, research, evaluative testing, or trade show exhibition."

Further details are provided in Annex B. Exporters should advise the CFIA should the information obtained from the FSIS differ from the information provided in this section.

It should be noted that products exported as samples are not permitted to be consumed. In addition, samples do not require label approval in order to be certified for export.

11.7.3.1.3 Products for personal consumption

The USDA/FSIS is responsible for the adherence of the requirements of all shipments of imported Red Meat and/or Poultry products intended for personal consumption. Products for personal consumption are exempted from FSIS import requirements when the following conditions are met.

  • The product must be presented to an USDA, APHIS inspector at the port of entry;
  • A personal consumption shipment cannot exceed 50 lb (22.7 kg);
  • The use of a shipment is limited to personal use, and must be purchased by the importer while outside the United States. Mail order shipments or Internet purchases do not fall under the personal consumption exemption rule and must comply with all FSIS requirements;
  • No item in the shipment can be sold or distributed; and
  • When requested by FSIS, the shipment will be inspected to determine whether it is eligible to be imported under the personal consumption category.

Personal consumption shipments of Red Meat and/or Poultry products must also meet USDA, APHIS requirements. It is the responsibility of the person(s) bringing the product into the United States to notify APHIS of the shipment.

Meat products derived from ovine and caprine animals are prohibited.

In the case of hunter harvested cervid meat, the importers will need to present to the Customs and Border Protection (CBP) inspector evidence that the product is cervid meat, (e.g. a hunting license or commercially prepared labels found on unopened packages or other official documents).

11.7.3.1.4 Products consigned to an in-bond storage (ship stores) located within the United States

The following conditions apply:

  • The shipment must be accompanied by CFIA/ACIA 1454.
  • In the block: "Country of Destination/Pays de destination" - "Ship stores" shall be entered.
  • The statement "For ship stores only. Not for commerce within the United States" must appear in the block "Additional certification/Attestation supplémentaire".

11.7.3.1.5 United States Customs and Border Protection, Homeland Security requirement for high security seals

All marine containers that are in transit through the United States or arriving by vessel at a port of entry in the United States must be sealed with a seal that meets the ISO/PAS 17712 standard. It is the responsibility of the exporter to ensure that an acceptable seal is applied when required. For more information on High Security Seals visit the Global Security section of the APL website.

11.7.3.1.6 Port of Entry procedures

(i) FSIS

After a shipment has met U.S. Customs and Border Protection and Animal and Plant Health Inspection Service (APHIS) requirements, the shipment must be reinspected by the FSIS.

All Shipments of meat, poultry, and egg products that are offered for import into the United States must be presented for FSIS Import Reinspection at a FSIS official Import Inspection Establishment or at an alternative inspection location authorized by FSIS at the time of importation.

The importer of record (IOR) or designated agent must:

  • apply for FSIS inspection of imported product and provide the Import Inspection Application (Meat, Poultry & Egg Products) – PDF (629 kb) to FSIS no later than the time the entry is made with U.S. Customs and Border Protection;
  • ensure that product offered for import is inspected by FSIS at the designated official import inspection establishment after the product has met U.S. Customs and Border Protection (CBP) and USDA- Animal and Plant Health Inspection Service (APHIS) requirements at the Port of Entry. CBP's conditional release of the shipment at the Port of Entry allows the shipment to transfer to the official import inspection establishment. It does not mean that FSIS import inspection requirements have been met;
  • maintain awareness and control of imported product through the importation and border crossing process; and
  • work closely with the Customs broker, the official import inspection establishment, carriers, and any other agents in the supply chain acting on behalf of the IOR to ensure that FSIS import inspection requirements are met.

FSIS import inspectors first check the documents to assure the shipment is properly certified by the foreign country. Inspectors next examine each shipment for general condition and labeling and then conduct the inspection assignments.

Port-of-entry re-inspection is directed by the Public Health Information System (PHIS), a centralized computer database that stores re-inspection results from all ports-of-entry for each country and for each establishment. Re-inspection of products is performance-based in that better performing foreign establishments have their products re-inspected less frequently. Many of the procedures for product re-inspection that FSIS follows are contained in the PHIS Import Directives.

The PHIS determines the type of re-inspection based on compliance history of the establishment and country. Several types of inspection (TOI) may be assigned by the PHIS including net weight checks of retail packages; examination of the containers' condition; examination for product defects; incubation of canned goods; and laboratory analysis for product composition, microbiological contamination and species. Additionally, FSIS randomly samples products at ports for drug and chemical residues.

An annual import residue plan sets the initial sampling rate for each country based on its volume of product exported to the U.S. For more information, the U.S. National Residue Program: 2015 Residue Sampling Plans – PDF (239 kb) (also referred as the "Blue Book") and the National Residue Data – PDF (1404 kb) (also referred to as The "Red Book") are available on line, or by contacting USDA, FSIS, Food Animal Science Division (FASD), 202-690-6566, or Fax at 202-690-6565.

Note:

Any shipment of meat, poultry, or egg product that has entered commerce without FSIS import inspection violates the Federal Meat Inspection Act (FMIA); the Poultry Products Inspection Act (PPIA); or the Egg Products Inspection Act (EPIA), as well as the implementing regulations (9 CFR 327.6; 381.199; 590.925). Meat, poultry and egg products from outside the U.S. are considered "in-commerce" when they are off-loaded at a location other than the official import inspection establishment or other FSIS approved location designated on the import inspection application. FSIS considers such product to be in-commerce and a Failure to Present (FTP) – PDF (154 kb), and therefore ineligible for FSIS inspection. When a product has been identified as a FTP, FSIS will request, through CBP, a redelivery of the shipment and appropriate penalties.

FTP product still in the original shipping containers may either be destroyed or returned to the country of origin. If any imported product identified as FTP has been removed from the original cartons or further processed, FSIS will initiate a regulatory control action on the product, including any further processed product that contains the FTP product, to ensure appropriate disposition (i.e., destruction). FSIS will likely request that the importer of record recall the FTP product.

(ii) FDA

The import procedures and the export certificate for meat products under the jurisdiction of the USA Food and Drug Administration (FDA) are different than those for FSIS. Depending on the meat product exported, an APHIS certificate may also be required to allow the product to enter the USA (see section 11.7.3.4.2.2 for certification requirements).

For full details, exporters are advised to consult the FDA directly or visit FDA's website. A flowchart of the import procedures may also be viewed.

(iii) Export of Products Returned to the United States

U.S. produced meat and poultry products that have been exported and are to return to the United States must be approved by FSIS prior to arriving at the U.S. port of entry.

The exporter/applicant must complete the FSIS Form 9010-1, "Application for the Return of Exported Products to the United States". The form should be completed and submitted by email to USReturnedExports@fsis.usda.gov along with a copy of the export certificate (FSIS Form 9060-5 or 9135-3) and any additional supporting documentation related to the product prior to the shipment arriving in the U.S.

11.7.3.1.7 Labelling requirements

(i) FSIS

FSIS's Labelling and Program Delivery Division (LPDD) develops policies, inspection methods and administers programs to protect consumers from misbranded meat and poultry products. Imported products must meet the same labelling requirements as the United States domestically-produced products. Canadian operators exporting to the United States must adhere to the labelling standards incorporated in Federal meat and poultry inspection regulations (USDA).

The following are examples of the labels that must be submitted to FSIS for label approval: 1) temporary approval, 2) products produced under religious exemption, and 3) labels with claims and special statements. Except where specifically required by FSIS, it is no longer a requirement that all recipes and labels for processed products be submitted to FSIS for label approval prior to the meat product being exported to the US. However, operators may still chose to submit labels for FSIS approval. In any event, operators are fully accountable for the content and production of all labels, whether generically approved, modified without resubmission, or submitted to FSIS for review and approval. Annex N provides more details on this topic.

The operator should have on file evidence (e.g., FSIS approved label, reference to applicable FSIS requirements) that the product intended for export and label meet applicable FSIS requirements. The information must be made available to the inspector on request for verification, or when requested by the FSIS as part of the audit procedures.

(ii) FDA

The FDA does not require prior label approval for food products under its jurisdiction. The FDA monitors labelling compliance primarily through random post-marketing surveillance.

The trading parties are fully responsible to ensure compliance with all applicable requirements. The Labelling and Nutrition Guidance Document and Regulatory Information can be consulted for applicable requirements.

11.7.3.2 Import prohibitions or restrictions

11.7.3.2.1 Prohibitions

11.7.3.2.1.1 Frozen meat cuts in combo bins

Frozen meat cuts in combo bins are not acceptable for export unless the product has been frozen in such a way that any individual meat cut can be removed for inspection without the need to thaw the entire combo.

11.7.3.2.1.2 Mechanically Separated Beef

The export of mechanically separated beef is prohibited by the FSIS

11.7.3.2.1.3 Imported product in original containers

Meat products imported into Canada are not eligible for export to the United States unless processed as defined in the Meat Inspection Regulations, 1990 (includes imported products repackaged and placed in Canadian containers).

Only imported shipments that are considered by the USDA as a trans-shipment (i.e. in bond), and covered by an original certificate from the country of origin showing the name and address of a consignee located in the United States will be accepted.

11.7.3.2.1.4 Livestock lungs intended for human food is prohibited by FSIS

11.7.3.2.2 Restrictions

11.7.3.2.2.1 Restrictions on an establishment

Operators who want to have their establishment added to the eligibility list must submit a written request for approval through their inspector and Area Office. Annex I from the introduction to Chapter 11 should be used for that purpose. For details on the steps to be followed when applying for export eligibility, refer to Chapter 11, Introduction, section 11.2.3.2 (2). At the time of application, it is necessary to specify on the Annex I the species, and the process category corresponding to the type of products that are intended for export as found in Annex G of this section. Upon receipt of recommendation for approval from the appropriate Area Office, the CFIA will certify to FSIS that the establishment meets USDA/FSIS requirements for the products specified in the application.

Note:

1. Process categories are FSIS product classifications based on preparation procedures used in the foreign establishment, and the following is the list of the process categories for imported product. For full details, please refer to chapter 11, USA section, Annex G:

  • Raw product – non intact
  • Raw product – intact
  • Thermally processed – commercially stable
  • Not heat treated – shelf stable
  • Heat treated – shelf stable
  • Fully cooked – not shelf stable
  • Heat treated but not fully cooked – not shelf stable
  • Products with secondary inhibitors – not shelf stable

These categories were formally identified as 03B, 03C, 03D, 03E, 03F,03G, 03H and 03I respectively. Although these codes have not completely disappeared from use in the field, they are not acceptable when applying for export eligibility.

2. 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. Note that the term "poultry" is not acceptable.

To prevent unnecessary delays at the border, it is important that operators prepare and apply well in advance of their anticipated start of export to the United States and that the details submitted at the time of application (species and process categories) reflect accurately the products exported, and that all required export requirements be fully implemented at the time the Annex I is submitted to the CFIA. It is equally important that Ottawa FIED be notified of any changes to either the species or process category for product exported to the US so that FSIS can be requested to update the PHIS. Annex I of Introduction must be used for that purpose.

In addition to the animal health restrictions outlined in sub-section 11.7.3.2.2.1.1 below, operators of establishments where eligible and non-eligible products are handled must develop, implement and maintain control programs that will ensure that non-eligible products can be distinguished from those that are eligible through receiving, processing, shipping and distribution. These control programs must be implemented as written, be effective and verifiable.

The written procedures must be reviewed and found satisfactory by the Inspector in Charge (IIC). Inspectors are then responsible for monitoring the operator's controls to ensure that they are adequately followed. This verification task is addressed by completing the appropriate Compliance Verification System (CVS) task at the prescribed frequency.

3. Non-ambulatory disabled cattle as defined by FSIS ("that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis fractured vertebral column or metabolic conditions". [This definition includes cattle that are non-ambulatory due to an acute injury on route to the establishment, during unloading, or anywhere on the premises.]) are banned from slaughter in Canadian registered establishments eligible for export to the United States. Such cattle cannot enter the slaughter facility and must, if on the premises and alive, be humanely handled until they are euthanized. For humane reasons, any non-ambulatory cattle on the premises of a registered establishment eligible to export to the United States must be euthanized on site. Refer to Annex Z section 2.1.1 for details.

11.7.3.2.2.1.1 Animal health restrictions related to the receiving of raw poultry meat from Argentina, Brazil or Hungary

USDA/APHIS regulations prohibit the importation (directly or indirectly through third countries) of raw meat products from regions not recognized as being free of disease of concern to them (prohibited meat products).

In Canada it is permitted to import raw poultry meat from Argentina, Brazil and Hungary under the conditions outlined in Chapter 10 of the Meat Hygiene Manual Of Procedures (MOP). However, Brazil and Hungary are not recognized by APHIS as being free of exotic Newcastle disease (9 CFR section 94.6) and Argentina, though recognized as free from Newcastle disease is subject to restrictions specified in 9 CFR 94.33. Thus the raw poultry meat products imported from Argentina, Brazil and Hungary are therefore considered to be "prohibited poultry meat products". As a result, APHIS has advised that the following animal health restrictions will apply:

(A) Establishments handling exposed prohibited poultry meat products

Unless requirements outlined in subsection (C) regarding approved segregation procedures below have been fulfilled, Canadian registered establishments, other than storages (S-XXX) where import inspection is performed, that receive and handle exposed prohibited poultry meat products become ineligible to export poultry meat products to the United States. Refer to Annex W-1 for a list of establishments that are not eligible to export poultry meat to the United States or to supply establishments eligible to export poultry meat products to the United States. Establishments eligible to export poultry meat to the United States that wish to keep their privileges to export poultry meat to the United States must not handle exposed poultry meat from those establishments.

An establishment may be removed from Annex W-1, in circumstances other than those described in subsection (C) below, when the operator of the establishment is able to demonstrate to the satisfaction of the CFIA that handling of exposed prohibited poultry meat products has been discontinued and that measures are taken to prevent handling of exposed prohibited poultry meat products in the facilities. The application to remove an establishment from Annex W-1 must be submitted through the CFIA inspector and the Area Office Export specialist. When an application is accepted, the CFIA will amend Annex W-1 accordingly. Once the establishment has been removed from Annex W-1, operators interested in obtaining approval for export of poultry meat products to the United States must submit an application as per routine procedures (see section 11.2.3.2).

Auditable receiving procedures should be developed, implemented and maintained by the operator to address this animal health requirement (e.g., to include a letter from the suppliers to guarantee that they do not receive prohibited poultry meat products). Inventory records must be maintained by the operator regarding the origin of the poultry meat products present in the establishment and the destination of the poultry meat products shipped from the establishment. These records must be made available to the Inspector in Charge (IIC) upon request.

(B) Establishments where packaged prohibited poultry meat products are stored

Prohibited poultry meat products may be received and stored in any registered establishments provided they are stored separately from products derived from poultry destined for export. The separation must include separate stacking of the packaged products not in contact with eligible packaged products and clear identification of the ineligible product (e.g., poultry meat from Argentina, Brazil or Hungary) with respect to its origin and export restriction (not eligible for export to the United States). The CFIA IIC will monitor the operator's control procedures to verify that the storage of non-eligible meat products is being done in the prescribed manner in order to prevent the export of non-eligible poultry meat products to the United States.

Inventory records must be maintained by the operator regarding the origin of the poultry meat products present in the establishment and the destination of the poultry meat products shipped from the establishment. These records must be made available to the IIC upon request.

(C) Approval requirements for establishments handling exposed prohibited poultry meat products
  1. To become eligible to export poultry meat products to the United States, operators of establishments must develop, implement and maintain effective and verifiable control programs for ensuring that only eligible poultry meat products are exported to the United States and that eligible poultry meat products do not enter in contact with ineligible poultry meat products. The control programs must include receiving procedures (e.g., to include a letter from the suppliers to guarantee that they do not receive prohibited poultry meat products or that, if they receive such products, approved segregation procedures are in place and the products shipped does not contain prohibited poultry meat products). The control programs must ensure that ineligible products can be distinguished from those that are eligible through receiving, processing, packaging and shipping. The control programs must include monitoring, verification and deviation procedures.
  2. The control programs must be reviewed by the CFIA inspector and be recommended for approval through the applicable Area Office Export Specialist. Then they will be submitted to the FSIS for approval.
  3. Once approval is received from the FSIS, the establishment will be certified for export of poultry meat to the United States and all concerned will be informed accordingly. The inspector will verify compliance with approved control programs through usual inspection activities.

Inventory records must be maintained by the operator regarding the origin of the poultry meat products present in the establishment and the destination of the poultry meat products shipped from the establishment. These records must be made available to the IIC upon request.

Note: In the case of poultry meat products derived from species not falling under the jurisdiction of the USDA/FSIS (e.g., quail), the approval of the segregation procedures referred to above is the responsibility of the CFIA inspector only.

11.7.3.2.2.1.2 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems

Special procedures related to Hazard Analysis Critical Control Point (HACCP) systems as well as specific E. coli and Salmonella spp. testing programs are required because of the implementation of the "Pathogen Reduction and (HACCP) Systems; Final Rule" published July 25, 1996. All establishments exporting to the United States must meet the requirements of the Final Rule. Furthermore, all product used in the fabrication of meat products exported to the United States must come from establishments which also meet these requirements.

The requirements of this Final Rule include: HACCP implementation, Standard Sanitary Operating Procedures (SSOP), generic Escherichia coli (Biotype 1) in slaughter plants and Salmonella performance standards where applicable. The Canadian Requirements are considered equivalent to the United States with the exception of pre-shipment review, generic E. coli, and the Salmonella performance standards. For a full description of the additional requirements, refer to Annex Q, Annex T, Annex U and Annex U-1.

11.7.3.2.2.1.3 Poultry Products

Special procedures must be implemented in poultry abattoirs in order to meet FSIS import requirements, and all such establishments exporting to the United States must meet these requirements. This means that each evisceration line on which poultry carcasses are being processed must have one (1) on-line carcass inspection station staffed by CFIA inspectors. Furthermore, all meat ingredients used in the production of meat products destined to the United States must come from establishments which also meet the applicable requirements. Please refer to Annex E for details.

11.7.3.2.2.1.4 Chilling Poultry Carcasses
Poultry carcasses shall be chilled to 4°C (40°F) or lower within the following specified times:
Weight of carcass Time (hours)
Under 1.8 kg (4 lb) 4
1.8 - 3.6 kg (4 to 8 lb) 6
Over 3.6 kg (8 lb) 8

11.7.3.2.2.2 Restrictions on meat products

The operator is responsible to develop, implement and maintain control programs to ensure that all applicable specific FSIS product requirements are met. The control programs must be effective and auditable.

11.7.3.2.2.2.1 Microbiological requirements

(i) Ready-to-eat meat

The USDA/FSIS implements a zero tolerance level for Listeria monocytogenes in all categories of Ready-to-Eat (RTE) meat and poultry products. The following conditions apply to all Canadian establishments producing RTE meat and poultry products for export to the US:

  1. All establishments will treat Category 1, 2A and 2B products as equivalent to Category 1 products and will perform RTE product and Food Contact Surface (FCS) sampling, testing, assessment and follow-up procedures similar to those intended for Category 1 RTE products and Category 1 production lines, respectively, as described in the MHMOP Chapter 4, Annex H.
  2. No RTE meat product from a lot that tested positive for L. monocytogenes is eligible for export to the United States.
  3. Operators have the option to test FCS for L. monocytogenes or Listeria spp. The test result is considered unsatisfactory if:
    1. L. monocytogenes is detected on the FCS; or
    2. Listeria spp. is detected on the same FCS in two consecutive tests, including the original and the follow up test(s).
  4. Any RTE meat and poultry product that contacts a FCS that has tested positive for L. monocytogenes is not eligible for export to the United States without first having undergone a process that is destructive of L. monocytogenes (9 CFR § 430.4b).
  5. If a FCS tests unsatisfactory due to the detection of Listeria spp. in two consecutive tests, the product can be exported if:
    1. The RTE product is tested from the second FCS test day production lot and is confirmed negative for L. monocytogenes; or
    2. Further testing of the Listeria spp. from the second FCS test culture confirms that it is not L. monocytogenes.
  6. RTE products cannot be exported to the United States pending laboratory test results.
  7. The signing veterinarian or inspector shall review the test results for RTE product(s) and FCS, as applicable, to ensure that product being exported to the United States is free of L. monocytogenes before signing the health certificate.
  8. Establishments must implement verification sampling plan for detection of Listeria spp. on Non-Food Contact Surface (NFCS). The recommended procedure for NFCS testing and follow-up procedure is described in MHMOP Chapter 4 (Annex H, Section 5.4 and Appendix 6). NFCS samples will be collected by the operator under CFIA oversight. Listeria spp. positive NFCS test results that occurs with satisfactory FCS and RTE product results will not have any export implications. However, in the event of any positive NFCS result, CFIA will conduct the appropriate CVS task and issue Inspection Report/ Corrective Action Request (CAR). Corrective actions must be taken by the operator, which will be evaluated by CFIA. Each US export eligible establishment will collect NFCS sample once in 24 months. The NFCS sample will be collected in alternate fiscal year at the time of first sampling of FCS under random sampling plan M205. Mandated NFCS samples must be analysed in private accredited laboratories.

(ii) RTE products - HACCP Process Categories: Not Heat Treated - Shelf Stable; Heat Treated - Shelf Stable; and Products with Secondary Inhibitors - Not Shelf Stable, RTE

Ready-to-Eat (RTE) non-heated products, such as dry cured salted and dry cured fermented meat and poultry products that are processed without the application of heat require a 5 log reduction of Salmonella in meat products and a 7 log reduction of Salmonella in poultry products because of the synergistic antimicrobial effect of lower pH and/or lower water activity. Also the operator must implement stringent controls, such as using source material prepared under Good Manufacturing Practices (GMPs) designed to minimize contamination and the presence and growth of pathogens of public health concern and implementing tighter verification controls over the products (e.g., finished product testing programs). The establishment operator is responsible for validating the process and this process must be acceptable to Inspector in Charge (IIC). The validation may be done through the combination of scientific peer reviewed journal articles which includes critical operational parameters that align with the establishment's process/product composition or challenges study/inoculated pack. Further guidance for such products may be obtained by accessing the link - Further guidance for such products - PDF (131 kb).

The CFIA inspector must perform monthly CVS tasks for RTE meat and poultry products to verify compliance with FSIS requirements for such products. The IIC must monitor production procedures and plant records to determine compliance and must not certify shipments of products which do not meet FSIS requirements.

Note: in the absence of a validated 5/7 log Salmonella reduction, or during the period the program is under evaluation, it is not permissible for an Operator to use a "hold a test" program in order to meet US requirements. In addition, no products can only be exported from these process categories unless all the products have a validated 5/7 log salmonella reduction.

(iii) Raw beef products

It is generally accepted that E. coli O157:H7 contamination is a food safety hazard that is reasonably likely to occur in establishments that process raw beef products, such as ground beef, other non-intact beef products, and raw intact beef products. Therefore, this hazard must be addressed in the establishment's HACCP plan (refer to Chapter 17 for details on applicable control measures). More details on the laboratory methodology, including the list of methods deemed equivalent to those of FSIS can be found in Annex D and Annex D-1.

Other Shiga-toxin producing strains of E. coli (STEC), O26, O123, O111, O121, O45 and O145, are also the subject of a FSIS mandatory testing program. The establishment's HACCP plan must address the hazard of contamination with non-O157 STEC. Refer to Annex D-2 for details on a risk-based verification sampling procedure and accepted laboratory methodology.

11.7.3.2.2.2.2 Pork jowls

Pork jowls do not need to be incised for abscess detection if intended for export to the United States. However, the operator is responsible for ensuring that jowls are free of all pathology. The operator must develop and implement a control program to ensure the products are free of pathology.

11.7.3.2.2.2.3 Retained water in raw meat products

The FSIS regulations limit water retained by raw single-ingredient meat and poultry products Footnote 1 from post-evisceration processing, such as carcass washing and chilling, to the amount that is unavoidable in meeting applicable food safety requirements. The Regulations also require labelling for the amount of water retained in the product. Raw livestock and poultry carcasses and parts are not permitted to retain water resulting from post-evisceration processing unless the establishment preparing the carcasses and parts demonstrates, with data collected in accordance with a written protocol, that any water retained in the carcasses and parts is an inevitable consequence of the process used to meet applicable food safety requirements. Where water is retained, the establishment is required to disclose on the label of the meat or poultry product the maximum percentage of retained water in the raw product. Establishments having data demonstrating that there is no retained water in their products can choose not to label the products with the retained-water statement or they can choose to make a no-retained-water claim on the product label. The labelling requirements apply to all raw single-ingredient products destined to the United States.

The same requirements are being incorporated into the Canadian federal red meat inspection program so that no additional requirements will apply for exported red meat products and for meat from ratites. As an interim measure, establishments that have not yet implemented water retention protocols for all - products subject to the FSIS requirements must, if they wish to remain eligible to export to the United States, identify non-complying products as being ineligible for export to the United States as raw single-ingredient products when they leave the establishment.

In the case of the poultry sector, the FSIS requirements will be implemented as an export requirement, i.e. without concomitant changes to the domestic program. The operator will be responsible for processing raw single-ingredient poultry products destined to the United States in accordance with the FSIS water retention requirements. In addition, all raw single-ingredient poultry products intended for direct or indirect export to the United States as raw single-ingredient products must be labelled with a water retention declaration (if the products have retained water) and a positive declaration clearly indicating that the product is eligible for export to the United States (e.g. "eligible for the United States"). The requirement to clearly identify the product as eligible for the United States is to facilitate the rapid identification of eligible poultry product without the need for tracking and verifying transfer certificates and log books. The declaration "eligible for the United States" can be waived for raw single-ingredient poultry exported directly to the United States from the slaughter establishment of origin.

It should be noted that all pre-evisceration and some post-evisceration processes do not require a written water retention protocol (see Annex Y, point 1-A for details). Also, meat products not subject to Salmonella standards, such as offal, cheek meat and giblets, must be chilled according to an approved protocol which demonstrates that water retention has been minimized to the extent possible with the existing chilling equipment and facilities.

Detailed information on the requirements is provided in Annex Y, Annex Y-1 and Annex Y-2. They will need to be implemented to the satisfaction of the CFIA by operators who wish to export raw single-ingredient meat and poultry products to the United States.

Prepared and multi-ingredient meat and poultry products are not affected by the new requirements as retained water is not considered to be an ingredient.

Operators of establishments that use a post-eviscerating process that results in water retention in raw meat or poultry carcasses or parts must maintain on file a written data-collection protocol in accordance with the above mentioned annexes and advise the IIC when a new protocol is developed or an existing protocol is modified, or when processing procedures have been changed in a manner that would require a new or revised protocol. An operator does not have to maintain a protocol on file if they have data or information that clearly demonstrate that their products do not retain water as a result of the process (e.g., spraying boneless meat with an antimicrobial solution where the end product does not retain water from the antimicrobial application process).

The IIC will verify that the establishment has on file and available to CFIA its written data collection protocol or data that demonstrate that post-evisceration contact with water does not result in retained water in excess of naturally occurring moisture and will review revised and new protocols. The IIC will verify that the establishment is following its protocols, and that the protocols reflect the actual processing system in use. The inspector will also verify the labelling of products produced under the applicable protocols.

11.7.3.2.2.2.4 Products encased in casings

APHIS requirements are that products encased in casings of ruminant origin are not eligible to be exported to the United States. The only exceptions are:

  • bovine or sheep casings meeting requirements of Annex C of this section, or
  • casings derived from collagen obtained from skins or hides (the mention to the effect that the casings are regenerated collagen casings must be indicated on the label).
11.7.3.2.2.2.5 Pork meat - Trichina Control

Freezing for trichina treatment is not required for routine exports of raw pork to the United States. The following Trichinella control measures are acceptable:

  1. Fresh meat: treatment by freezing

    Canadian procedures to treat pork for trichina by freezing are in accordance with USDA / FSIS domestic requirements. Except in the case of method 5 outlined in section B.3 of Annex B to Chapter 4, pork treated according to the requirements of Chapter 4 of the Manual of Procedures can be certified to the United States as treated for trichina. The export certificate should bear one of the following statements as applicable in the remarks section:

    1. when the room temperature is used: "the above product was frozen at (space °C) for a period of (time) under Canadian Food Inspection Agency control"; or
    2. when the meat temperature is used: "the above product was frozen at an internal temperature of (space °C) for a period of (time) under Canadian Food Inspection Agency control".
  2. Pork products

    Section 318.10 of the USDA meat and poultry inspection regulations indicates the "prescribed treatment of pork and products containing pork to destroy trichinae". The prescribed treatment methods include heating, freezing (see point (i) above), salting and drying.

    Additional methods for the destruction of trichinae in pork products are described in the USDA/FSIS document 9 CFR Part 318.

  3. Fresh meat: testing under establishment's HACCP system

    Pork from carcasses or carcass parts must be found free of trichinae using a pooled sample digestion technique to analyze pork for the presence of trichina cysts in accordance with the following requirements:

    1. The establishment shall develop, implement and maintain procedures for identifying and pooling carcasses, collecting and pooling samples, testing samples (including the name and address of the laboratory), communicating test results, retesting individual carcasses, and maintaining positive identification and clear separation of pork found to be trichina-free from untested pork or trichina-positive pork.
    2. The establishment shall use the services of a laboratory acceptable to the CFIA for all required testing. Such acceptance shall be based on adequacy of facilities, reagents, and equipment, and on demonstration of continuing competency and reliability in performing the pooled sample digestion technique for trichinae.
    3. The establishment shall sample no less than 5 grams of diaphragm muscle or tongue tissue from each carcass or no less than 10 grams of other muscle tissue. Samples may be pooled but a pool shall not consist of more than 100 grams of sample. Sampling and sample preparation are subject to inspection supervision.
    4. Pork or products made from tested pork shall not be released as trichina free from the official establishment without treatment until the inspector in charge receives a laboratory report that the tested pork is free of trichina cysts.
11.7.3.2.2.2.6 Meat products derived from ruminants

Specific Bovine Spongiform Encephalopathy (BSE) related requirements apply to certain products derived from ruminants. Refer to Annex Z for details.

11.7.3.2.2.2.7 Compliance with US products standards requirements

The operator is responsible to develop, implement and maintain control programs to ensure that all applicable specific FSIS product standards requirements are met (e.g., ground beef or hamburger (9 CFR - 319.15), mechanically separated meat (9 CFR - 319.5 and 381.173, AMR (advanced meat recovery systems - 9 CFR - 318.24)). The control programs must be effective and auditable. The CFIA inspector will verify compliance through routine inspection activities.

Information on specific FSIS products standards is also available in Directive FSIS series 7000.

(i) As an example in Directive 7000.1, cured pork bellies prepared for slicing and labelling as bacon must not exceed the weight of the fresh uncured pork bellies. Establishments that manufacture cured pork bellies that will be exported to the United States either as bellies or bacon must utilize processing procedures that will produce product that is in compliance with the applicable regulations.

To demonstrate compliance, the following information must be documented on a production lot basis as part of the establishment's quality control program:

  1. ingredients of cure (pickle formulation) by percentage;
  2. intended (target) pickle pick-up (pump/immersion) percentage;
  3. drain time if any;
  4. actual pickle pick-up (pump immersion) percentage;
  5. cooling shrink (smokehouse/water bath, etc.) percentage;
  6. cooler shrink percentage.

For bacon yield determination, the guidelines to be used can be found in the above Directive.

(ii) Specific standards for certain raw meat products

a) Ground beef:

FSIS product standards for ground beef differ from Canadian standards. Please refer to 9 CFR Section 319.15 for applicable standards. More details are also available in the FSIS "Food Standards and Labeling Policy Book".

b) Meat recovered using advanced meat recovery systems (AMR)

FSIS product standards for meat recovered using AMR systems differ from Canadian standards. Please refer to 9 CFR Section 318.24 for applicable standards.

Operators recovering meat using AMR systems intended for export to the United States must develop, implement and maintain appropriate control programs to ensure compliance with applicable requirements.

Note: Dorsal Root Ganglia (DRG) is not allowed in meat (all red meat,) recovered using AMR system as per U.S. Regulations.

c) Mechanically separated meat (MSM)

FSIS product standards for MSM differ from Canadian standards. Please refer to 9 CFR Section 319.5 (for red meat species) and 381.173 (for poultry species) for applicable standards.

Operators preparing MSM intended for export to the United States must develop, implement and maintain appropriate control programs to ensure compliance with applicable requirements.

Note: MSM derived from bovine is prohibited (ref. MOP 11.7.3.2.1.2).

11.7.3.2.2.2.8 Imported meat products

In addition to requirements outlined in a) above, when imported meat products are used to manufacture meat and poultry products intended for export to the USA, the imported products must meet all FSIS requirements. Canada and the USA may differ regarding the countries that are permitted to export into the respective country, so it must never be assumed that because meat is legally into Canada that it can be used as such in the production of meat products for the USA. Refer to subsection Q 2.2 of Annex Q of this section for more details on applicable export requirements. The FSIS website - PDF (160 kb) can be consulted for general information.

Note: the CFIA/ACIA 5733 requires the country of origin and the foreign establishment number to be identified if the exported product is manufactured from imported meat products.

11.7.3.3 Specific or additional inspection procedures

11.7.3.3.1 Ante-mortem and post-mortem inspection

Ante-mortem and post-mortem inspection must be conducted according to Canadian requirements as described elsewhere in this Manual (Chapter 17 - red meat and Chapter 19 and section 11.7.3.2.2.1.3 - poultry). This means that the inspections were carried out by a CFIA veterinarian or under the direct supervision of a CFIA veterinarian. This requires that a veterinarian has been assigned to carry out these functions or to provide line or functional supervision to the inspector(s) Footnote 2 responsible for carrying out them out. Direct supervision means that the veterinarian has direct authority over the inspector(s) in relation to these duties. When inspectors are performing such duties, a veterinarian must be available on a timely basis to fulfil the supervisory role, as well as specific veterinary responsibilities which, as an example in the case of ante-mortem inspection, would include the diagnosis and disposition of suspect animals.

11.7.3.3.2 Continuous supervision

Meat food products must be prepared under "continuous supervision", which means prepared in an establishment to which an official inspector has been assigned by the CFIA to carry out inspection in accordance with this Manual.

Frequency of CFIA visits to establishments eligible to export to the United States

The USDA/FSIS has informed the CFIA that every plant that produces meat products for export to the United States must receive at least one visit by a CFIA inspector during each twelve (12) hour shift every day while the plant is in production. These visits are required because of a legal interpretation indicating they must be performed to satisfy the United States regulatory requirement for "continuous inspection". It is important that the visits are planned so that the times chosen are random during each of the twelve (12) hour shifts. These visits must be recorded on the CVS Verification Worksheet.

Note: this requirement does not apply to establishments when they are only producing meat products that fall under the jurisdiction of the Food and Drug Administration (FDA) (e.g. bison meat) or when the establishment is not processing meat products (e.g. meatless/vegetarian product).

11.7.3.4 Certification

As indicated in section 11.7.3.1, meat products for export to the USA are under the jurisdiction of either the USDA/FSIS or the FDA. Meat products under the jurisdiction of the FDA are certified using the standard export certificate, the CFIA/ACIA 1454, and meat products under FSIS jurisdiction are certified with the CFIA/ACIA 5733. Both of these certificates meet the public health requirements for export certification.

The CFIA and USDA have reached an agreement that allows CFIA inspectors as well as veterinarians to certify meat products under FSIS jurisdiction to the USA, and this change has been incorporated in the export certificate, the CFIA/ACIA 5733. This certificate that is completed by means of a fillable PDF document which is printed on special certificate paper, and the completed certificate may legally be signed by either the CFIA veterinarian or inspector. The original certificate will accompany the shipment to the USA, and copies must be made of the original, one of which is sent to Ottawa (see chapter 11 introduction for address), and one will be filed with the CFIA records.

In order to meet USA animal health import requirements, an additional Annex may also be required depending on the product and species. Below is a list of the export certificates, the various annexes, a brief description of their use, and the CFIA official who can legally sign each document

A. The following documents can be signed by CFIA inspectors or veterinarians:

  1. certificate CFIA/ACIA 5733
  2. US Annex A-1 for bovine meat and meat products, and the bovine meat products in transit through the USA.

B. The following must be signed by official CFIA veterinarians only:

  1. CFIA/ACIA 1454
  2. US Annex A-2, for ovine and caprine meat and meat products
  3. A-3, tallow
  4. A-5, boneless beef relative to Mexican requirements
  5. A-6, bovine viscera relative to Mexican requirements
  6. A-7, in relation to Japanese requirements
  7. A-8, ovine or caprine meat and meat products in transit through the US
  8. A-9, poultry meat and meat products,
  9. A-10, cooked, pre-cooked and smoked poultry meat, viscera and offal relative to Mexican requirements
  10. A-11, fresh pork meat, viscera and offal, chilled or frozen, relative to Mexican requirements
  11. Annex C for casings of bovine, porcine, ovine or caprine origin

Note: meat samples for export to the USA are certified by means of completing the CFIA/ACIA 5733 and the appropriate annex, as required.

30 Day Guaranteed Replacement Certificates

FSIS no longer accepts guaranteed replacement certificates if there are minor errors on a certificate. FSIS has also discontinued its practice of re-inspecting imported product based on the guarantee to replace incorrect export certificate. If certificates contain mistakes, they can easily be replaced within a short timeframe by sending a replacement certificate can be sent to FSIS in a Portable Document File (PDF) by email (importinspection@fsis.usda.gov) or by an expedited mail service. FSIS will only re-inspect imported product upon receipt of the replacement foreign inspection certificate.

11.7.3.4.1 Certification of Animal health requirements: Animal Health declarations apply to products exported to the United States and to products exported that will transit in the United States (in transit).

11.7.3.4.1.1 For poultry meat products

Annex A-9 is required for all commercial shipments of poultry meat, including shipments that containing less than 2% poultry (cooked or raw) and are intended for human consumption destined to the United States and those in overland transit in the United States.

11.7.3.4.1.2 Meat products derived from ruminants

For meat products derived from ruminants, the specific requirements relative to overland transit in the United States of meat derived from ruminants are described in Annex Z. Below are the annexes that must be issued along with either the CFIA/ACIA 5733 or 1454 for the various ruminant products:

  • meat products derived from bovine, and in-transit of bovine meat and meat products through the USA (ref. Annex Z, section 2.1): Annex A-1;
  • meat products derived from ovine and caprine (ref. Annex Z, section 2.2): Annex A-2;
  • edible tallow, (ref. Annex Z, section 2.3): Annex A-3;
  • bovine and ovine casings, (ref. Annex Z, section 2.4): Annex C;
  • sausage in sheep casings, the following attestation must appear in the "remarks" section of form CFIA/ACIA 5733: "The sheep casings were derived from animals less than 12 months of age" when slaughtered and were subject to a ruminant feed ban equivalent to the requirements established by the US Food and Drug Administration at 21 CFR 589.200. See also section 11.7.3.2.2.2.5 for more details on applicable requirements;
  • In the case of eligible imported meat products (ref. Annex , section 2.5), the applicable Annex for the exported product must be issued; and
  • transit of ovine or caprine meat products, (ref. Annex Z, section 2.9) Annex A-8.

11.7.3.4.2 Public Health

11.7.3.4.2.1 For fresh meat, meat by-products, meat food products and poultry products amenable to FSIS jurisdiction

Form CFIA/ACIA 5733 Certificate of Inspection Covering Meat and Poultry Products) must be issued.

  1. The instructions for completion of the CFIA/ACIA 5733 are included as part of the fillable PDF. There is no need to include the production date on the CFIA/ACIA 5733 with one important exception, if the establishment has been delisted or relisted. (Reference: 9 CFR 27.2, 381.196.) In such an event the production dates are required to allow FSIS to confirm the import eligibility of the product.
  2. Product produced at an establishment that was removed from the list of establishments eligible to export to the United States

With the exception of the animal health restrictions outlined in section 11.7.3.2.2.1.1, a meat product manufactured or processed at an establishment not currently eligible to export to the United States may be exported to the United States under the following conditions:

  • at the time of manufacturing and/or processing, the establishment was eligible to export to the United States;
  • the date of manufacturing or processing or a production code must appear on the outside container of the product; and
  • one of the following statements is shown on the certificate as applicable:
    1. In the case of establishments delisted during the previous year, a statement is shown on the certificate stipulating that "The product was produced prior to (specify the delistment date)."
    2. In the case of establishments that were delisted and relisted during the previous year, a statement is shown on the certificate stipulating that "The product was produced either prior (specify the delistment date) or after (relistment date)."

Note: When a production code is used, it must be linked to a production date readily verifiable by the inspector and would have to be made available to the FSIS on request.

11.7.3.4.2.2 For meat products under FDA jurisdiction

  1. Game and farmed game meat

    CFIA/ACIA 1454 shall be issued for export of meat products derived from food animals which in the United States fall under voluntary inspection (e.g. bison, rabbit, quail, etc.) and require inspection by the FDA in the United States upon entry.

    In the case of bison meat products, Annex A-1 shall also be issued.

  2. Animal casings

    Use CFIA/ACIA 1454 and Annex C. See Annex Z for restrictions in the case of ovine casings.

11.7.3.4.2.3 Additional certification when Canadian meat (beef, pork and poultry) is used in the production of meat products in the United States for export to Mexico

Bone-in and boneless fresh beef - Annex A-5
Beef viscera - Annex A-6
Cooked poultry - Annex A-10
Fresh pork - Annex A-11
Annex A-5, A-6, A-10 or A-11 can be issued as applicable

It is important to note that issuing the above annexes is not a FSIS import requirement. It can however be issued at the request of the exporter, provided that all applicable Mexican requirements are met.

11.7.3.4.2.4 Additional certification when pork exported to the United States is used in the production of United States pork products exported to Japan

Annex A-7 can be issued.

It is important to note that Annex A-7 is not a FSIS import requirement. It can however be issued at the request of the exporter, provided that all applicable Japanese requirements are met.

11.7.3.4.2.5 Products consigned to an in-bond storage (ship stores) located within the United States

The shipment must be accompanied by CFIA/ACIA 1454. In the block: "Country of Destination/Pays de destination" - "Ship stores" shall be entered. The statement "For ship stores only. Not for commerce within the United States" must appear in the block "Additional certification/Attestation supplémentaire".

11.7.3.4.3 Products not intended for human consumption

The certification for these products is provided by the Terrestrial Animal Health Division. CFIA inspectors must use certificates available for this purpose.

As required, please contact your local Terrestrial Animal Health District office for additional information.

11.7.3.5 Special marking and packaging requirements

As indicated in 11.7.3.1.7, the operator is responsible for obtaining and maintaining label approvals and records for all products destined to the United States market.

The following is some supplementary marking and packaging information that can be of use to exporters. However, the information is not exhaustive and should be complemented with information obtained from the FSIS, as required. More information can also be found in Annex N and Annex N-1.

11.7.3.5.1 Net Weight

If a net weight is declared, it must be in avoirdupois weight (i.e. pounds, ounces) or liquid measure (i.e. fluid ounces, quart). It is acceptable to state the net weight in metric weight in addition to the avoirdupois weight.

11.7.3.5.2 Stamping requirements for carcasses, halves, quarters, primal cuts, and offal

Specific requirements apply. Refer to Annex N for details.

11.7.3.5.3 Horsemeat

The larger cuts of horsemeat must be stamped "horsemeat" with green ink. At least one stamp is required for each ten pounds of boneless meat in bulk.

11.7.3.5.4 Country of Origin Labelling (COOL)

In Canada, country of origin in a voluntary claim that may be applied when the product meets the requirement for the claim. Meat products may not meet the Canadian standard to be labelled as "Product of Canada" as they are manufactured with imported meat.

"Product of Canada" is generally required on a label for export to the United States. For example, the phrase "Product of" is required on all immediate containers of meat and/or poultry products. However, the phrase is not required on a red meat carcass, primal or subprimal cut that prominently displays the name of the foreign country within the marking itself, (the Canadian mark of inspection is a circle surrounding the word Canada and the establishment number).

Note: The difference between Canadian and United States requirements of "Product of Canada" may require exporters to develop procedures to ensure the correct labelling for export to the United States.

11.7.3.5.5 Label declaration requirements: microbial claims

Labels that bear certain declarations used on products destined to the United States and that are not approved by the FSIS, such as labels used to make claims to address microbial requirements, are not permitted for use.

A product claim such as: "for cooking only," "not for grinding," or any other similar claims to address E. coli O157:H7 or any other microbiological issue is not permitted on imported products. FSIS Labeling and Program Delivery Division (LPDD) will not approve such claims for imported products from any foreign country and/or establishment. Labels, previously approved with such claims have been rescinded.

11.7.3.5.6 Product in casings

Products encased in casings must be labelled as to the source of its casings i.e. natural casings (indicating the species of origin) when not derived from the same species as the meat products contained in the casings or indicate that the casings are regenerated collagen casings in other cases.

Note: APHIS has restrictions on the use of casings of ruminant origin. Please refer to sub-section 11.7.3.2.2.2.5 on Import Restrictions for details.

11.7.3.6 Other requirements

11.7.3.6.1 Antioxidants

Antioxidants used in the preparation of rendered animal fat exported by tank or similar bulk container must be identified on the placard attached to the tank or the container. They also must be identified on the accompanying certificate. Should antioxidants not be present, this information should also be indicated. The serial number of official seals used on the vehicle or bulk container must be recorded on the certificate.

11.7.3.6.2 Freezing of poultry meat

  1. Ready-to-cook poultry which is to be or is labelled with descriptive terms such as "fresh frozen", "quick frozen" or "frozen fresh" or any other term implying a rapid change from a fresh state to a frozen state shall be placed into a freezer within 48 hours after initial chilling. During this period, if such poultry is not immediately placed into a freezer after chilling and packaging, it shall be held at 36°F (2.2°C) or lower.
  2. Ready-to-cook poultry shall be frozen in a manner so as to bring the internal temperature of the poultry carcasses at the centre of the package to 0°F (-17.8°C) or below within 72 hours from the time of entering the freezer.
  3. Warm packaged ready-to-cook poultry which is to be frozen without prior chilling shall within 2 hours from time of slaughter be placed in a plate freezer or a freezer with a functioning circulating air system where a temperature of -10°F (-23°C) or lower is maintained.
  4. Frozen poultry shall be held under conditions which will maintain product in a solid frozen state with temperature maintained as constant as possible under good commercial practice.

11.7.3.6.3 Products falling under the jurisdiction of the Food and Drug Administration (FDA)

The import into the United States of meat products not regulated by the USDA/FSIS, such as game meat, and casings which meet the requirements under section 11.7.3.2.2.2.5, falls under the jurisdiction of the FDA. Exporters should contact the FDA for entry requirements applicable to the products they wish to export. For example, as a result of the implementation of the provisions of The Bioterrorism Act, registration requirements for establishments and products, record maintenance, and prior notice of intent to export requirements will apply.

11.7.3.6.4 Poultry carcasses prepared under religious dietary laws

The product prepared under religious dietary laws must be distinguished from product slaughtered under the Poultry Act and Regulations by a USDA exemption permit number.

All persons desiring exemptions as provided by under CFR 9 381.11-381.14 based on religious dietary laws are required to send an application (Annex V) for an exemption permit number through their Area of Operation to the Director of Food Import and Export Division (FIED) together with a statement from an official of the religion having authority over the enforcement of the religious dietary laws with respect to poultry and poultry products. The statement shall:

  1. specify the religious dietary requirements affecting poultry and poultry products; and
  2. certify that such requirements are in conflict with specific provisions of the Act and cite the regulations from which exemption is sought.

Upon receiving the exemption permit number, the Canadian establishment is required to submit labels for approval prior to shipping, to

USDA, FSIS, OPPD, Labeling and Program Delivery Division
1400 Independence Avenue, SW
Room 2540 - South Building
Washington, DC 20250-3700

All mandatory labelling requirements must be present on the package, including product name that specifies the exemption. In addition, the shipping container labels for slaughtered poultry processed under exemption must bear the packer's name, address, plant number and the statement "Eviscerated Poultry Slaughtered / Processed under CFIA Inspection - USDA Exemption Permit No. 000". Product may or may not carry the mark of inspection.

Note: Poultry feet and heads detached from the carcasses cannot be exported for edible purpose under Buddhist ritual. They are considered as inedible meat product and may be exported for animal food only.

11.7.3.6.5 Return of Canadian meat products from the continental United States

11.7.3.6.5.1 Products refused entry by the USDA/FSIS

Section 11.5 must be consulted as needed for basic requirements applicable to exported meat products returned to Canada.

In the case of a shipment which has been refused entry by FSIS, a written Application to return the product into Canada must be presented by the Exporter identified on the export certificate CFIA/ACIA 5733 to an Import Service Centre (ISC). The application should be sent to the ISC of the area where the product will land in Canada (Annex J of this section). The details concerning the application procedures and the distribution of the documents are outlined in Annex J-1. Permission will not be refused except under exceptional circumstances.

  1. Procedure to follow to obtain permission:
    • The applicant (this is limited to the exporter identified on the CFIA/ACIA 5733), shall complete Part 1 of Annex J and forward it along with a copy of the CFIA/ACIA 5733, the FSIS form 9840-3 (Refused Entry Notification) or 9135-3 (FSIS, Export Certificate for Canada) to the appropriate Import Service Center (ISC); and
    • The CFIA inspector receiving the application shall review the information and if found satisfactory, shall sign Part 2 of Annex J and process the application as per operating procedures (see Annex J-2 for details). The applicant is responsible to, in turn, forward the signed application to the Customs Broker.

    When returning refused products to Canada, the USDA Import Inspector will seal the truck using a tamper-evident seal. The applicant must inform all concerned not to break the USDA seal until permission is obtained from a CFIA inspector.

  2. Procedure to follow at the receiving establishment:
    • The truck should arrive sealed (FSIS/USDA or CFIA seal).
    • Verification of documentation to ensure that it is complete and positively identifies the shipment. The inspection should not be conducted until the documents accompanying the shipment have been verified and found to be satisfactory;
    • Returned products must be kept under CFIA control until the inspection and disposition is completed. The reason for the refusal will determine the level of inspection. See section 2.5 of Annex J-2 for more information on this subject. After inspection, the CFIA inspector will complete form CFIA/ACIA 2367, "Exported shipments of Canadian Products returned by the importing country" (Introduction - Annex K). Further details are also found in section 11.5 of the introduction;
    • The reason for refusal is detailed on the FSIS documents sent with the shipment. At the time of refusal, the USDA Import Inspector will complete sections A, B, C and E of FSIS Form 9135-1 (Notice of Shipment of Refused Entry Product) and will enter the USDA seal number. FSIS Form 9135-1, FSIS Form 9840- 3 (Refused Entry Notification), and a copy of the original CFIA/ACIA 5733 will be placed in an envelope marked "Attention: CFIA" and will be placed inside the truck returning to Canada. The shipment will be sealed and allowed to return to Canada;
    • FSIS will inform the National and Area Export Specialists when a Canadian shipment has been officially rejected, including the reason for rejection, and the Area Export Specialists will inform the IIC at the exporting establishment. The IIC will inform the Export Specialist when the shipment returns to Canada so the Specialist can advise FSIS. The IIC will follow-up with the exporter as required to ensure effective proper disposition of the refused product, and that corrective actions and preventative measures have been implemented where applicable; and
    • Once the inspection of the product is concluded, form CFIA/ACIA 2367 is completed and sent to PM together with other pertinent documents. The PM will review the documentation, ensure that it is complete (export certificate, form FSIS 9840.3, 9135-1, Annex J, detailed inspection report and a letter from the operator of the producing establishment giving the corrective measures taken as necessary) and that all necessary measures have been taken and will forward it afterwards to the Director FIED.

11.7.3.6.5.2 Products inspected and passed by the USDA

Canadian exported meat products which have passed USDA import inspection become ipso facto American meat products. These products may be imported into Canada in their original and unopened containers, provided an application is made using Annex J of this section as indicated above in section 11.7.3.6.5.1 and the condition in either (i) or (ii) below are met:

  1. the shipment is accompanied by a statement on an official letterhead issued by a USDA official veterinarian that certifies that: "The products originated in Canada. The product has been under USDA control for the duration of its stay in the United States". FSIS form 9135-3 can be used for that purpose. In such cases, the procedures described in section 11.7.3.6.5.1 above applies except for (ii) (second item), or
  2. when the USDA is not able to certify that the product was under its continuous supervision and cannot issue certification, the applicant may request in writing, to the PM of the appropriate area, permission to return the product to Canada (Annex J of this section). The PM will then permit the importation if the following conditions are met (with appropriate written guarantees provided by the applicant):
    • the product is not condemned in the United States;
    • the product is in its original, fully marked containers and the immediate product containers do not show any evidence of changes by any means;
    • upon entry into Canada, the product is placed under an official seal at the port of landing for transport to a registered establishment for reinspection (necessary arrangements to be made by the applicant); and
    • the product is subjected to 100% inspection.

The PM will forward the approval to the applicant and the ISC for processing and distribution as per operating procedures (see Annex J-2). The applicant is responsible for forwarding the approval to the Customs Broker.

Procedures to follow at the receiving establishment are the same as described in section 11.7.3.6.5.1 (ii) above except that the USDA documents will be replaced with the conditions issued by the PM.

11.7.3.6.5.3 Other considerations

  • The inspection shall be carried out as soon as possible;
  • Meat products returned because of failure to meet the USDA/FSIS requirements or found with defects when inspected in Canada shall not be re-certified for export unless the product has been reconditioned and subsequently packaged and labelled to the satisfaction of an inspector. Products returned as a result of failure to a laboratory analysis for biological or chemical residue violation shall not be re-exported;
  • It is important that the above described procedures be followed as closely as possible and that all documents are completed and forwarded with as little delay as possible;
  • No matter what the reasons for refusal given by the importing country are, a reinspection of this type of product must be done by an inspector before any decision is taken with regard to the product. If the shipment has been refused due to problems with labelling or documentation, reinspection should be performed on a square root sample to ensure that the product has not deteriorated during transportation. In those instances where the product has been refused entry to another country by reason of an unsatisfactory condition, (e.g. spoilage, contamination, pathological conditions, improper processing, damaged or rusted cans, etc.), the returned shipment should be reinspected in its entirety or until sufficient product has been examined, to determine that there is no alternative but total condemnation of the shipment. If condemned, the product must not leave the establishment at which the reinspection is performed until sterilized or denatured prior to treatment, as per section 54 of the Regulations. Shipments refused entry and returned because of the detection of residues should be dealt with as indicated in Chapter 5;
  • Inspection procedures: see Chapter 17 of the Meat Hygiene Manual for red meat or Chapter 19 for Poultry; and
  • Composition and labelling must be taken into account by the inspector when deciding on whether corrective action is required prior to final disposition.

11.7.3.6.6 FSIS audits of Canadian establishments

FSIS carries out regular reviews of the Canadian meat inspection system to verify that equivalence is being maintained. The outcome may be (1) acceptable, (2) marginally acceptable (plant receives a 30 day notice of intent to delist), or (3) unacceptable (immediate delistment from export eligibility). During these reviews, a number of establishments from across Canada may be audited. They may be chosen at random, or may be targeted based on a specific concern (i.e. BSE, food pathogen of interest), or a history of non-compliance at a facility. During these audits, the FSIS uses the Canadian legislation and manuals of procedures to assess ongoing equivalence except where there are specific United States requirements.

If the plant is found acceptable, this means it meets the United States requirements, and the establishment maintains its export eligibility to the United States. While only minor issues may have been identified during the audit, these issues must be recorded, corrected and tracked in the CVS.

11.7.3.6.6.1 Establishments to which a notice of intent to delist was issued (30 day NOID)

USDA/FSIS has advised of the following policy for establishments judged marginally acceptable as a result of their audit.

Operators of establishments to which a notice of intent to de-list was issued by the CFIA at the request of the FSIS reviewer will be required to correct the deviations identified during the visit. The deviations will be reported on the CVS Verification Worksheet and the Inspection Report - Corrective Action Request (CVS task 3301) and include a statement to the effect that an action plan must be developed to re-establish full compliance with requirements if the establishment wishes to maintain its export privileges. Annex H of this section will also be issued to the operator in such cases. Annex H will have to accompany the documentation forwarded to confirm that appropriate action was taken to correct deficiencies observed and prevent reoccurrence, as applicable.

The CFIA designated area supervisor for the establishment and the IIC will conduct the necessary on-site follow-up review(s) of the establishment and determine if the necessary corrective actions were taken (CVS task 3301 recorded on the Inspection Report - Corrective Action Request). When preparing the action plan and taking the necessary measures, all concerned have to keep in mind that the necessary information has to be provided to FSIS, within 30 days following the visit, by the Director of the FIED. When applicable, the CFIA designated supervisor has to provide the necessary information (action plan by the operator, IIC and supervisor confirmation that all deviations were corrected) to the Director of the FIED through the Area Office (export officer). The information will be forwarded to the FSIS by the Director of the FIED. Establishments for which the required information will not be provided to the FSIS within the prescribed period of time will be removed from the list of establishments eligible to export to the United States.

In addition, any establishment to which a notice of intent to delist was issued during an audit, will be re audited at the time of the FSIS next systems audit of Canada's inspection system, provided that establishment was successful in maintaining its eligibility status for export to the United States.

11.7.3.6.6.2 Establishments judged unacceptable (immediate delistment)

In the event that an establishment is judged unacceptable by the FSIS reviewer and is de-listed as a result of deficiencies observed during an audit, FSIS will not accept the establishment as re-certified until the government of Canada provides FSIS with a written description of all corrective actions that have been taken.

At the time of the FSIS review, the deviations observed will be reported on the CVS Verification Worksheet and the Inspection Report - Corrective Action Request (CVS task 3301) and include a statement to the effect that the establishment is removed from the eligibility list and that an action plan has to be developed to re-establish compliance with requirements if the establishment wishes to regain its export privileges.

The CFIA designated area supervisor for the establishment and the IIC will conduct the necessary on-site follow-up review(s) of the establishment to determine that all the necessary corrective actions were taken (CVS task 3301 recorded on the Inspection Report - Corrective Action Request).

When applicable, the CFIA designated supervisor has to provide the necessary information (action plan by the operator, IIC and supervisor confirmation that all deviations were corrected) to the Director of the FIED through the Area Office (export officer). The information will be forwarded to the FSIS by the Director of the FIED.

In addition, any establishment that is de-listed during an audit, will be re audited at the time of the FSIS next systems audit of Canada's inspection system, provided that establishment was successfully re certified for export to the United States.

If a re-certified establishment is de-listed again during the following up audit, FSIS will not list the establishment as re certified until FSIS auditors return for another follow up audit and are able to verify that all deficiencies have been corrected.

11.7.3.6.7 Import violations in meat product exported to the United States

Products under intensified inspection due to laboratory violations will be sampled upon re-inspection in the United States and will be held at the import establishment pending laboratory results.

The follow-up for such non-compliances to the United States import requirements will have to be conducted as provided by the CVS (task 3302) and any other FSIS specific requests, as applicable. Unless advised otherwise, the operator will have to conduct the required follow-up within 30 days of the date of notification of the non-compliance to allow the CFIA to provide the information requested by the FSIS in response to the non-compliance within the prescribed timeframe and avoid that the establishment be removed from the list of establishments eligible to export to the United States.

11.7.3.6.8 Inedible products exported for animal foods - Denaturation

FSIS is responsible for ensuring that domestic and imported meat, poultry and egg products distributed in U.S. commerce as human food are wholesome, unadulterated, and properly labeled. This authority extends to the control of undenatured inedible meat products that have the appearance of being fit for human consumption, but are intended for the manufacture of articles not for human food. FSIS permits the movement of imported undenatured inedible meat products, subject to approval of a permit issued by FSIS and prior notice given in advance of the arrival of each shipment moving under this permit. Inedible poultry must be denatured regardless of the intended use (9 CFR 381.193). Undenatured inedible permits (9540-4) are not issued by FSIS for any inedible product that is denatured. To request an approval to import undenatured inedible meat or egg products, applicants may contact the Office of International Affairs, Import Inspection Division In Washington DC or e-mail importinspection@fsis.usda.gov for more details. FSIS Directive 9510.1 of April 23, 2015 - PDF (55.9 kb) must be consulted for applicable requirements.

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