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United States of America (US) – Export requirements for meat and poultry products

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1. Food and Safety Inspection Service (FSIS) requirements

1.1 Eligible/ineligible products

(a) Eligible products

The majority of meat products exported from Canada to the US fall under the legal jurisdiction of the FSIS of the United States Department of Agriculture (USDA), since FSIS regulates the import of meat from common food animals, such as beef, pork and poultry. These are known as "amenable species" (Refer FSIS website or to the Guideline for product categorization – Annex G for the list of FSIS amenable species.

(b) Ineligible products

(i) Imported meat products in original imported state

Meat products imported into Canada are not eligible for re-export to the US unless processed (for example to substantially change the appearance or nature of the meat product, and includes to debone, slice, comminute, thermally process, preserve, dehydrate, ferment, render, fractionate, defibrinate or add thereto an ingredient other than a meat product permitted to be added by the Safe Food for Canadians Regulations (SFCR), but does not include to dress, trim, refrigerate, freeze or defrost). The prohibition includes imported products repackaged and placed in Canadian containers. For the eligibility requirements applicable to meat products imported for further processing refer to section 1.4 e).

(ii) Livestock lungs and horsemeat

FSIS prohibits the importation of livestock lungs and of horsemeat intended for human food.

(iii) Products returned as a result of FSIS import inspection

Products returned as a result of failure to a laboratory analysis for biological or chemical residue violation shall not be re-exported.

(iv) Specified Risk Material (SRM) as defined by the FSIS (9 CFR 310.22)

The brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae and the wings of the sacrum) and dorsal root ganglia of bovines 30 months of age and older, and the tonsils and the distal ileum of all bovines.

Note: Please also refer to the document "Tongue, Palatine and Lingual Tonsils" – Annex R-1 of the Export requirements for meat for more information on removal of tonsils when tongues are intended for export.

(v) Animal and Plant Health Inspection Service (APHIS) requirements

APHIS imposes restrictions on importation of meat derived from ruminants, poultry meat and casings. Details are provided below in section 3.2.

1.2 Pre-export approvals by competent authority (CA) of importing country

(a) Establishments

For meat products regulated by the FSIS, only establishments certified to the FSIS by the CFIA are allowed to produce meat products intended for export to the US (refer to the List of establishments eligible to export to the United States – Annex W).

(b) Labels

Some types of labels and labelling (for example, claims) need to be submitted to the FSIS for approval. Refer to the FSIS website and FSIS Compliance Guideline for Label Approval for details.

1.3 Production controls and inspection requirements – Establishments

(a) Pathogen reduction; Hazard Analysis and Critical Control Points (HACCP) Systems

(i) Pre-shipment review

Operators must include a pre-shipment review component in HACCP systems implemented at the establishment (refer to the Compliance guideline on pre-shipment review and on eligibility of incoming meat products – Annex Q for details).

(ii) Pathogen reduction

(b) Poultry abattoirs

Special procedures must be implemented in establishments operating under the Modernized Poultry Inspection Program (MPIP) to ensure that each evisceration line on which poultry carcasses are being processed have one (1) on-line carcass inspection station staffed by CFIA inspectors. Refer to the Compliance guideline for poultry abattoirs operating under the Modernized Poultry Inspection Program (MPIP) – Annex E for details.

(c) Continuous supervision

Meat food products intended for export to the USA must be prepared under "continuous supervision". This means that, when producing meat products intended for export to the United States, the establishment must receive at least one visit by a CFIA inspector during each twelve (12) hour shift every day while the plant is in production. 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) (for example bison meat) or when the establishment is not processing meat products (for example meatless/vegetarian product).

(d) Non-ambulatory disabled cattle

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 floor 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.

(e) Establishment approval procedures

A prerequisite to export is that the CFIA must certify establishments to the FSIS. The operator is responsible to design, implement and maintain appropriate control measures to ensure compliance with applicable requirements. The control programs must be effective and auditable. Well in advance of anticipated exports, 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. The form Application for establishment approval – Annex I of the Specific Requirements for Meat should be used for that purpose. For details on the steps to be followed when applying for export eligibility, refer to Operational procedure: Procedure for maintaining food export eligibility lists.

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 produced at the establishment. The Guideline for product categorization – Annex G must be consulted for guidance on FSIS products categorization. To prevent unnecessary delays at the border, it is essential that the species and products categories provided by the operator reflect accurately the products intended for export. The CFIA will certify the establishment to the FSIS using the information provided in the application submitted.

It is equally important that the Food Import/Export Division in Ottawa (FIED) be notified through the responsible CFIA inspector and the Area Office 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 Public Health Information System (PHIS). The form Application for establishment approval – Annex I must be used for that purpose.

1.4 Products specifications, production controls and inspection requirements

The operator is responsible to obtain, keep on file and make available to the CFIA inspector specific FSIS standards applicable to the product intended for export (for example, products standards and formulation, label approval when applicable or other reference or records used to confirm compliance with applicable FSIS requirements). The operator is responsible to design, implement and maintain appropriate control programs to ensure compliance with applicable requirements. The control programs must be effective and auditable.

In addition operators of establishments where eligible and non-eligible products are handled must develop, implement and maintain control programs for guaranteeing that only eligible meat products are used in the production intended for export to the US. The controls implemented must ensure that non-eligible products can be distinguished from those that are eligible through receiving, processing, storage and shipping/export. The control programs must be effective, auditable and include monitoring, verification, deviation and record keeping procedures. The written procedures must be reviewed and found satisfactory by the responsible CFIA Inspector.

a) Microbiological food safety requirements

Approved microbiological screening and cultural methods should be used for Salmonella, Listeria monocytogenes and Escherichia coli O157:H7. Approved methods can be obtained from the Health Canada Compendium of Analytical Methods site. The most recent published version of the method should be used. The "application" section of the method chosen must be appropriate for the intended purpose. It must also be noted that specific sampling requirements may apply for example, sample size. Please refer to Annex D for the list of currently approved testing methods and specific sampling requirements.

(i) Ready-to-eat meat – Listeria monocytogenes

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:

A) 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 Control measures for Listeria monocytogenes in ready-to-eat foods.

B) No RTE meat product from a lot that tested positive for L. monocytogenes is eligible for export to the United States.

C) Operators have the option to test FCS for L. monocytogenes or Listeria spp. The test result is considered unsatisfactory if:

D) 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).

E) If a FCS tests unsatisfactory due to the detection of Listeria spp. in two consecutive tests, the product can be exported if:

F) RTE products cannot be exported to the United States pending laboratory test results.

G) 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.

H) 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 Control measures for Listeria monocytogenes in ready-to-eat foods. 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 verification 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) Ready-to-eat meat – RTE products – HACCP process categories: Not heat treated – Shelf stable; heat treated – Shelf stable; and products with secondary inhibitors – Not shelf stable, RTE

In order to facilitate compliance with FSIS requirements, compliance guidelines have been developed by the FSIS for ready-to-eat products falling in categories referred to above (such as non-heated products, dry cured salted and dry cured fermented meat and poultry products that are processed without the application of heat) which requires the use of lethality treatments other than cooking (for example, fermentation, drying, salt curing and other processes) to control pathogens of interest such as Salmonella, Listeria and E. coli O157:H7, in the case of beef, to make the product safe for consumption. Operators should consult the guidance documents referred to below to help determining which treatments could be used to achieve compliance with food safety standards applicable to all RTE products.

FSIS Salmonella Compliance Guidelines for Small and Very Small Meat and Poultry Establishments that Produce Ready-to-Eat (RTE) Products and Revised Appendix A (PDF)

FSIS Compliance Guideline for Stabilization (Cooling and Hot-Holding) of Fully and Partially Heat-Treated RTE and NRTE Meat and Poultry Products Produced by Small and Very Small Establishments and Revised Appendix B (PDF).

(iii) Raw beef products

FSIS has identified the Shiga-toxin producing strains of E. coli (STEC), O26, O123, O111, O121, O45 and O145 as potential food safety hazards. The operator's HACCP system must therefore address the hazard of contamination with non-O157 STEC.

In addition, those strains are subject to a FSIS mandatory testing program. As a result, operators of abattoirs must implement a risk-based verification sampling program. For detailed requirements on the required sampling program and accepted laboratory methodologies please refer to the CFIA risk-based Shiga-toxin-producing E. coli verification sampling of beef trimmings for abattoirs eligible for export to the USA – Annex D-2.

(b) Retained water in raw meat products

The FSIS regulations (9 CFR 441) limit water retained by raw single-ingredient meat and poultry products, including mechanically separated meat and finely textured meat, from post-evisceration processing, such as carcass washing and chilling, to the amount that is unavoidable in meeting applicable food safety requirements. The FSIS 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 (for example, "up to X% retained water," "less than X% retained water," "up to X% water added from processing").

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.

Operators must develop, implement and maintain control programs to ensure traceability of eligible products, including when products are received from another establishment for use in exports to the USA (for example, letter of guarantefe from the supplying establishment specifying the maximum percentage of retained water in the product, labelling the products as per FSIS requirements, etc.) so that the exporting establishments have all the necessary information to ensure compliance with applicable FSIS requirements.

Note:

(c) Pork meat – Trichina control

Canadian control methods are deemed acceptable with following limitations constraints:

(i) Freezing method # 5 is not recognized and

(ii) The following procedures must be followed when testing fresh meat under the establishment's HACCP system using a validated pooled sample digestion technique to analyze pork for the presence of trichina:

(A) 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.

(B) 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.

(C) 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.

(D) 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.

(iii) FSIS Directive 7320.1 Revision 2, on "Prevention and Control of Trichinella in Pork Products" provide options which can be used to prevent and control Trichinella in pork and products containing pork. Note that FSIS options include high pressure processing (HPP), and irradiation which have yet to receive approval for use in Canada.

(d) Compliance with products standards requirements

Information on specific FSIS products standards is available on the FSIS website, in Directive FSIS series 7000 and in the FSIS "Food Standards and Labelling Policy Book".

The following are specific references to standards for certain raw meat products:

(i) Ground beef

Please refer to 9 CFR Section 319.15 for applicable standards. More details are also available in the FSIS "Food Standards and Labelling Policy Book".

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

Please refer to 9 CFR Section 318.24 for applicable standards. The FSIS requirements include such things as calcium content, iron content (as a measure of the presence of bone marrow), and the absence of Central Nervous System (CNS) and CNS-like tissue. The operator should consult the Federal Register Vol. 69, No. 7, to include the requirements in their Quality Assurance program. This product should not be referred to as Finely Textured Meat. If it is not labelled clearly as AMR, the export certificate should bear a mention stating that it is meat obtained from an AMR system.

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

(iii) Mechanically separated meat (MSM)

Please refer to 9 CFR Section 319.5 (for red meat species) and 381.173 (for poultry species) for applicable standards.

(e) Imported meat products

Imported meat products used to manufacture products intended for export to the USA must meet all applicable USDA requirements (APHIS and FSIS, as applicable). 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. The CFIA will determine the eligibility of imported meat on the basis of official compliance attestations provided by the competent authorities of the country of origin of the products. Operators are responsible to provide the required proof of eligibility to the CFIA inspector. Refer to the Compliance guideline on pre-shipment review and on eligibility of incoming meat products – Annex Q for details on proof of product eligibility of incoming products.

Note:

(f) Frozen meat cuts in combo bins

If combos of frozen product (for example pork skins) are exported, products must be frozen in such a way that all applicable import samples can be removed from the combo in a sanitary manner.

(g) Freezing of poultry meat (9 CFR 381.66 (f))

(i) 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. Such procedures shall not apply to raw poultry product described in 9 CFR 381.129(b)(6).

(ii) Warm packaged ready-to-cook poultry which is to be chilled by immediate entry into a freezer within the official establishment 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.

(iii) 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.

1.5 Labelling, packaging and marking requirements

Meat products exported to the US must adhere to FSIS marking and to FSIS labelling standards.

FSIS re-inspection (PDF) includes verification of labelling requirements (PDF), such as the product name and the presence of cooking or heating instructions, validated cooking instructions and in some cases safe handling instructions to verify the classification of the process and product categories.

The operator is fully accountable for the content and production of labels and should have on file evidence (for example, 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.

The Guideline for the marking and the labelling of meat and poultry meat destined to the US – Annex N should be consulted for more information.

1.6 Other information

(a) Exemption from FSIS import inspection requirements

(i) Samples

Meat products destined for laboratory examination, research, evaluative testing or trade show exhibition are not subject to FSIS import inspection. Weight restrictions for sample shipments: red meat or poultry shipments cannot exceed 50 lbs. (22.7 kg) for each species of product. Please refer to the FSIS website and FSIS Directive 9500.8 (PDF) for detailed requirements.

(ii) Meat products for personal consumption

Meat products not exceeding 50 lbs for personal consumption are exempt from FSIS import regulations but are subject to APHIS import requirements. Please refer to the FSIS website and FSIS Directive 9500.8 (PDF) for detailed requirements.

Note:

(iii) Meat products containing small amount of meat or poultry meat

Please refer to the FSIS Import Guidance for detailed requirements. It must be noted that the meat product ingredients used in the production of such FSIS exempt products must be from an FSIS eligible source for example must have been produced in a duly certified establishment.

FSIS import inspection officials or FSIS Labelling and Program Delivery Staff (LPDS) must be contacted when the jurisdiction over a specific meat product is unclear. A copy of the ruling obtained must be kept on file and made available to the CFIA inspector upon request.

(iv) Undenatured inedible meat products

FSIS permits the movement of imported undenatured inedible meat subject to approval of a permit issued by FSIS and prior notice given to FSIS in advance of the arrival of each shipment moving under this permit. Please refer to the FSIS website and FSIS Directive 9510.1 of April 23, 2015 (PDF) for detailed requirements.

Note: Inedible poultry must be denatured regardless of the intended use (9 CFR 381.193).

(v) Meat products for pharmaceutical use only

Products intended for pharmaceutical use only may be imported into the U.S. provided the containers are properly identified as "For pharmaceutical use only" and do not contain a foreign mark of inspection. An undenatured inedible permit issued by FSIS is not required. If the containers of FSIS amenable product contain a foreign mark of inspection, then the product is considered as edible and must meet all FSIS import requirements, including consignments must be accompanied by an official inspection certificate and must be presented for FSIS import re-inspection. Please refer to the FSIS Guidance for Importing Meat, Poultry and Egg Products for more details.

(vi) Meat products for Canadian Commissaries

Under the North Atlantic Treaty Organization (NATO) Agreement, (NATO member countries) importing goods for use by a foreign military force is permitted, providing foreign military and their families with food and other items sold within their country. The foreign commissary may import "provisions" (for example, meat, poultry, or egg products) from the sending country into the receiving country duty free. Although this product is not subject to re-inspection at official import inspection establishments, FSIS investigators visit foreign commissaries located in the U.S. to verify that products held for sale at these commissaries meet the following requirements: the commissary is located on a military base or is restricted to military personnel from the foreign country in which the product was produced; the purchasing of products from the commissary is restricted to only people with proper credentials from the foreign military to which the store sells; purchases are in foreign currency only; and products must be labelled "For commissary sale only."

Website: Agreement between the Parties to the North Atlantic Treaty regarding the Status of their Forces

Please refer to the FSIS Guidance for Importing Meat, Poultry and Egg Products and FSIS Directive 9500.8 for more details.

(b) Meat products consigned to an in-bond storage (ship stores) located within the US

Certification requirements apply (refer to section 4.5 on documentation).

(c) US export products returned to the US

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.

Prior to submitting a request to FSIS for approval to return exported products, the applicant must verify that APHIS will permit entry. Please refer to the FSIS website – Guidance for Importing Meat, Poultry and Egg Products for detailed requirements.

(d) Marine containers in transit in the US

The U.S. CBP, Homeland Security requires high security container 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 this requirement is met, when applicable.

(e) FSIS Port-of-entry procedures

After a shipment has met U.S. CBP and APHIS requirements, the shipment must be re-inspected by the FSIS (PDF).

All shipments of meat products that are offered for import into the United States must be presented for re-inspection (PDF) at a FSIS official import inspection establishment or at an alternative inspection location authorized by FSIS at the time of importation.

Please refer to the FSIS website for detailed US Port of Entry Procedures and to the Guideline for FSIS Port-of-Entry inspection requirements – Annex L, the Guideline for grouping products for reinspection – Annex L-3 and the Compliance Guideline for Sample Selection of Red Meat Carcasses – Annex L-6 for more information on FSIS import inspection requirements.

(f) Tanker shipments

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.

(g) 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 (Request for USDA Exemption Permit Number (Buddhist-Style Poultry)- Annex V) for an exemption permit number through their Area of Operation to the Director of Food Import and Export Division 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:

(i) specify the religious dietary requirements affecting poultry and poultry products; and

(ii) 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, Labelling 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.

(h) Import violation in meat products exported to the US

FSIS implements intensified inspection procedures when a non-compliance with applicable product inspection requirement is detected. The CFIA will be informed accordingly and will request appropriate follow-up action from interested parties. 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.

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 (Refer to the Guideline for FSIS import inspection requirements – Annex L for more information).

2. FDA requirements

The USA FDA regulates the meat imports from game and exotic animals which are the "non-amenable species" under FSIS and animal casings.

2.1 Eligible / ineligible products

(a) Eligible products

The U.S. FDA has jurisdiction over imported food commodities including meat products such as meat derived from bison, buffalo, venison, rabbit, game meat, casings and all other foods not covered by the Federal meat and Federal poultry meat products inspection laws for example not subject to the provisions of the FSIS requirements. Products from animals not amenable to the Federal Meat Inspection Act and Poultry Products Inspection Act are subject to Federal regulation by the FDA as "food" under the Federal Food, Drug, and Cosmetic Act. Similarly, products exempt from FSIS import inspection requirements due to their small amount of meat content are subject to the provisions of the FDA import inspection requirements (please refer to subsection 1.6.a) (iii) above for other applicable FSIS requirements for the latter products).

Details on FDA Import program can be found on their website at the following addresses:

How do I know if my product is regulated by FDA?

Import Basics

(b) Ineligible products

APHIS imposes restrictions on importation of meat derived from ruminants and poultry meat. Details are provided below in section 3.2.

2.2 Labelling packaging and marking requirements

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.

2.3 Other information

U.S. FDA official webpage

Imports & Exports

3. APHIS requirements

In addition to meeting the meat inspection 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.

3.1 Eligible / ineligible products

(a) Eligible products

Refer to the section on FSIS or FDA requirements as applicable.

(b) Ineligible products

APHIS imposes restrictions on importation of meat derived from ruminants, casings and poultry meat. Details are provided below in section 3.2.

3.2 Products specifications, production controls and inspection requirements

(a) Animal health restrictions on importation of certain raw meat products

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).

Currently Canada allows importation of the following meat products which are prohibited from importation by APHIS: raw poultry meat from Argentina, Brazil and Hungary.

When prohibited imported meat products are received at the establishment for processing, please refer to section 1.4 above for requirements for control programs that must be implemented by operators to ensure that only eligible meat products are used in the production intended for export to the US.

(b) Meat derived from ruminants

(i) Bovine (Bos taurus, Bos indicus and Bison bison) meat products (meat, meat by-products and meat food products as defined by FSIS) are subjected to the Bovine Spongiform Encephalopathy (BSE) requirements specified in 9 CFR 94.20.

The products must not be contaminated with either of the following:

(ii) Ovine or caprine meat products (meat, meat by-products and meat food products as defined by FSIS) are subjected to the requirements in 9 CFR 94.25. Only products derived from animals less than 12 months of age at the time of slaughter are allowed. Please refer to the compliance guideline for conditions relative to BSE controls applicable to meat products derived from ovine and caprine animals – Annex Z for detailed requirements.

Note: APHIS prohibits the importation of meat products derived from ovine and caprine animals for personal consumption.

(c) Casings

APHIS prohibition on importation of animal casings du to African swine fever (ASF) and bovine spongiform encephalopathy are outlined in 9 CFR 96.2

(i) In the case of casings from ovine species, the casings must be derived from animals of less than 12 months of age when slaughtered.

(ii) In the case of casings from bovines, the casings must be derived from bovines slaughtered, and the casings collected in a region/country of negligible risk for BSE; or the casings may be derived from bovines from a region of controlled or undetermined risk provided:

Note:

(iii) In the case of pork casings a list of regions where ASF is deemed to exist is established by APHIS under 9 CFR 94.8 (a). Importation of pork casings from such regions is prohibited. However, APHIS and CFIA regulations allow US and Canadian origin swine casings to be processed in ASF affected countries/regions under certain conditions.

(iv) Products encased in casings

Products encased in casings of ruminant origin are not eligible to be exported to the United States unless the casings are meeting the above requirements and certification attestation outlined in the section 4.4 c) of documentation – Certification of animal health requirements is issued.

(d) Tallow

(i) The tallow may contain a maximum level of insoluble impurities of 0.15 percent in weight ; or

(ii) The tallow originates from a region of negligible risk for BSE; or

(iii) The tallow originates from a region of a region of controlled risk, and has not been prepared using Specified Risk Material (SRM) as defined by the USDA-FSIS.

(e) Poultry meat

(i) The poultry meat or other poultry products must be derived from poultry slaughtered in a region designated as free of Newcastle disease (9 CFR 94.6).

(ii) The poultry meat must be derived from birds that did not originate in a current USDA, APHIS recognized Avian Influenza Control Zone(s) (quarantine control zone(s)) established due to the detection of Highly Pathogenic Avian Influenza (HPAI) in commercial poultry, or the poultry meat must be cooked throughout to reach a minimum internal temperature of 74°C (165°F).

3.3 Other information

United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) official webpages

4. Documentation

4.1 Issuance of official veterinary certificates

The CFIA and USDA have reached an agreement that allows CFIA inspectors as well as veterinarians to issue the public health certificate required by the FSIS (form CFIA/ACIA 5733) and the Veterinary certificate for bovine meat and meat by-products intended for human consumption destined to the USA and for bovine meat products in transit in the USA – Annex A-1.

Form CFIA/ACIA 5733 is completed by means of a fillable PDF document is printed on special certificate paper. 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 Specific Export Requirements for Meat for address), and one will be filed with the CFIA inspector's records.

All other veterinary certificates listed in this section must be issued by CFIA veterinarians only.

4.2. Replacement of certificates – Minor errors

Official certificates are reviewed by FSIS import inspectors. It is important to note that, when errors are detected FSIS will not proceed further with inspection procedures. FSIS will only re-inspect imported product upon receipt of the replacement foreign inspection certificate. For minor errors, FSIS is implementing procedures that allow to easily replacing within a short timeframe certificates in which they have identified such errors. 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. In other circumstances please follow routine certificate replacement procedures.

4.3 Certification of Public Health requirements

(a) Fresh meat, meat by-products, meat food products and poultry meat under FSIS jurisdiction

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

(i) The instructions for completion of the CFIA 5733 are included as part of the fillable PDF. There is no need to include the production date on the CFIA 5733 with one important exception, if the establishment has been delisted or relisted. (Reference: 9 CFR 327.2, 381.196.) In such an event the production dates are required to allow FSIS to confirm the import eligibility of the product.

(ii) Product produced at an establishment that was removed from the list of establishments eligible to export to the United States: 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:

A) at the time of manufacturing and/or processing, the establishment was eligible to export to the United States

B) the date of manufacturing or processing or a production code must appear on the

outside container of the product and

C) one of the following statements is shown on the certificate as applicable:

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.

(iii) Treatment of raw single ingredient pork muscle tissue for the control Trichinella is not required for routine export to the United States. However, at the request of the exporter, one of the following attestations can be added to the remark section of the export certificate when applicable requirements are met:

A) when the room temperature is used: "the above product was frozen at (_°C) for a period of (time) under Canadian Food Inspection Agency control" or

B) when the meat temperature is used: "the above product was frozen at an internal temperature of (_°C) for a period of (time) under Canadian Food Inspection Agency control"

(iv) Poultry Grading Certificates – USDA's Agriculture Marketing Service recognizes the Canadian Food Inspection Agency's (CFIA) poultry product grade designations provided the poultry graded for export to the U.S. satisfies the criteria for U.S. grades. Canadian product labelled with the CFIA grades will be accepted provided the shipment is accompanied by an official CFIA grading certificate stating that the product meets USDA grade standards (for example "young turkey Canada A"). Form CFIA/ACIA 1022 is to be used for that purpose. This certificate is in addition to the requirement that there be an official inspection certificate. If graded product is received without the accompanying grading certificate, FSIS will refuse entry on the shipment until either a grading certificate is provided or the reference to the poultry grade has been obliterated or removed.

(b) For meat products under FDA jurisdiction

CFIA/ACIA 1454 must be issued.

4.4 Certification of animal health requirements

Animal Health declarations may apply to products exported to the US and to products exported that will transit in the US (in transit). When required, the applicable animal health certificate must accompany the relevant public health certificate.

Below are the additional animal health certificates/attestations that must be issued along with either the CFIA/ACIA 5733 or 1454 for the various products.

Note:

(a) Meat products derived from ruminants

It must be noted that, for meat products derived from ovine and caprine, specific requirements relative to production and overland transit in the US apply as outlined in "Compliance guideline for conditions relative to TSE controls applicable to meat products derived from ovine and caprine animals" – Annex Z.

(i) for meat products derived from bovine (Bos taurus, Bos indicus and Bison bison), including in-transit of bovine meat and meat products through the USA: Annex A-1 (Veterinary certificate for bovine meat and meat by-products intended for human consumption destined to the USA and for bovine meat products in transit in the USA) must be issued;

Note: For products destined for human consumption that contain bovine, meat products and that are under the jurisdiction of FDA (for example, food that contains less than 3% of raw meat or 2% of cooked meat such as soup mixes, closed face sandwiches, etc.), the USDA/APHIS no longer requires animal health attestations for bovine meat products content.

(ii) for meat products derived from ovine and caprine: Annex A-2 (Veterinary certificate for meat, meat by-products and meat food products; derived from ovine or caprine species intended for human consumption destined to the USA) must be issued;

(iii) for edible tallow: Annex A-3 (Veterinary certificate for edible tallow destined to the USA) must be issued;

(iv) for the transit of ovine or caprine meat products: Annex A-8 (Veterinary certificate for meat products containing ovine or caprine meat products in transit in the USA) must be issued;

(v) For 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."

(b) Imported pork meat products

When imported pork meat products are used in shipments destined to the United States, the following statement is required under additional certification on CFIA 5733:

"The product is derived from eligible products originating from a country/region and an establishment which are both eligible for direct export to the US in accordance with the applicable sections of 9 CFR 94."

(c) Poultry meat products

For shipments of poultry meat that are intended for human consumption and destined to the USA and those in overland transit in the USA: Annex A-9 (Veterinary certificate for poultry meat products, cooked or fresh, intended for human consumption destined to the United States and for poultry meat products in transit in the USA) must be issued;

Note: APHIS certification applies to all poultry meat products including products containing small amount of poultry meat, bouillon cubes of poultry origin, a broth containing poultry, meat extract/broth of poultry origin, powdered chicken meat, dehydrated powders or granules of poultry origin.

(d) Animal casings

For bovine, ovine and porcine casings, Annex C (Certificate for animal casings to the United States) must be issued.

(e) Samples

APHIS should be contacted for obtaining relevant requirements for the products.

Samples can be certified either:

(i) by using the animal health certificate that would be applicable to commercial shipment or,

(ii) alternatively the importer may apply to APHIS for an import permit specific to the sample intended for export.

In the latter case, animal health certification reflecting the requirements outlined in the import permit obtained from APHIS should be issued, when applicable requirements are met.

(f) 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.

4.5 Products consigned to an in-bond storage (ship stores) located within the US

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".

4.6 Products intended for re-export to a third country

In order to facilitate trade, additional certification can be issued at the request of the exporter provided that all applicable requirements are met. It is important to note that issuing such additional attestations is not a FSIS import requirement.

(a) To confirm compliance with specific Mexican requirements

(i) Annex A-5 (Veterinary certification covering beef meat, chilled or frozen, relative to Mexican requirements) can be issued for bone-in and boneless fresh beef;

(ii) Annex A-6 (Veterinary certification covering beef viscera (tongue, rumen, reticulum, omasum, abomasum, heart, kidneys, liver, lung and thymus), relative to Mexican requirements) can be issued for beef viscera;

(iii) Annex A-10 (Veterinary certificate covering cooked, pre-cooked and smoked poultry meat (whole or in pieces), viscera and offal relative to Mexican requirements) can be issued for cooked poultry meat;

(iv) Annex A-11 (Veterinary certificate covering fresh pork meat, viscera and offal, chilled or frozen, relative to Mexican requirements) can be issued for pork and pork products;

(iv) Annex A-12 (Veterinary certification covering beef trimmings, chilled or frozen, relative to Mexican requirements) can be issued for beef trimmings.

(b) To confirm compliance with specific Japanese requirements

Annex A-7 (Certificate in relation to Japanese requirements for pork) can be issued.

5. Other information

5.1 Return of Canadian meat products from the continental United States

(a) Products refused entry by the USDA-FSIS

(b) Products inspected and passed by the USDA

The CFIA program manager will forward the approval to the applicant and the Import Service Centre (ISC) for processing and distribution as per operating procedures (Annex J-2: Operating Procedures to Import Meat Products That Have Been Exported Out of Canada). The applicant is responsible for forwarding the approval to the Customs Broker.

Note: Procedures to follow at the receiving establishment are the same as described under Procedure at the receiving establishment above except that the USDA documents will be replaced with the conditions issued by the CFIA program manager.

(c) Other considerations

5.2 FSIS audit of Canadian establishments

(a) Establishments given a thirty (30) day notice of intent to delist (NOID)

(b) Establishments judged unacceptable and marked for immediate delisting

5.3 United States acts and regulations

5.4 List of annexes

(a) List of certificates

(i) Certificate CFIA-ACIA 5733: Certificate of inspection covering meat and poultry products

(ii) Annex A: Instructions for the completion of the official meat inspection certificate for meat and poultry cfia/acia 5733.

(iii) Annex A-1: Veterinary certificate for bovine meat and meat by-products intended for human consumption destined to the USA and for bovine meat products in transit in the USA

(iv) Annex A-2: Veterinary certificate for meat, meat by-products and meat food products derived from ovine or caprine species intended for human consumption

(v) Annex A-3: Veterinary certificate for edible tallow destined to the USA

(vi) Annex A-5: Veterinary certification covering beef meat, chilled or frozen, relative to Mexican requirements

(vii) Annex A-6: Veterinary certification covering beef viscera (tongue, rumen, reticulum, omasum, abomasum, heart, kidneys, liver, lung and thymus), relative to Mexican requirements

(viii) Annex A-7: Certification in relation to Japanese requirements

(ix) Annex A-8: Veterinary certificate for meat products containing ovine or caprine meat products in transit in the USA

(x) Annex A-9: Veterinary certificate for poultry meat products cooked or fresh intended for human consumption destined to the United States

(xi) Annex A-10: Veterinary certificate covering cooked, pre-cooked and smoked poultry meat (whole or in pieces), viscera and offal relative to Mexican requirements

(xii) Annex A-11: Veterinary certificate covering fresh pork meat, viscera and offal, chilled or frozen, relative to Mexican requirements

(xiii) Annex A-12: Veterinary certification covering beef trimmings, chilled or frozen, relative to Mexican requirements

(xiv) Annex C: Certificate for animal casings to the United States

(b) List of guidance documents

(i) Annex D: Sampling methodologies for Salmonella, Listeria monocytogenes and E. coli 0157:H7

(ii) Annex D-2: CFIA risk-based shiga toxin-producing E. coli verification sampling of beef trimmings for abattoirs eligible for export to the USA

(iii) Annex E: Compliance guideline for poultry abattoirs operating under the Modernized Poultry Inspection Program (MPIP)

(iv) Annex G: Guideline on meat and poultry meat product categorization

(v) Annex H: Notice of Intent to Delist Canadian Registered Establishment for Export to the United States

(vi) Annex I: Notice of shipment of refused entry product (FSIS form 9135-1)

(vii) Annex J: Application to return Canadian products exported to the United States

(viii)Annex J-1: Flow chart of application to return a shipment exported from Canada

(ix) Annex J-2: Operating Procedures to Import Meat Products That Have Been Exported Out of Canada

(x) Annex L: Guideline for FSIS port of entry inspection requirements

(xi) Annex L-3: Guideline for grouping products for re-inspection

(xii) Annex L-6: Compliance guideline for sample selection of red meat carcasses

(xiii) Annex N: Guideline for the marking and labelling of meat and poultry meat products destined to the US

(xiv) Annex Q: Compliance guideline on pre-shipment review and on eligibility of incoming meat

(xv) Annex T: Testing for Escherichia Coli (E. coli) in slaughter establishments (ref. 9 CFR part 310.25 and part 381, subpart K)

(xvi) Annex T-1: Compliance guideline – requirements for microbiological monitoring of process controls in livestock and ratites abattoirs

(xvii) Annex U: USDA performance standards for salmonella

(xviii) Annex U-1: USDA performance standards for campylobacter on chilled carcasses of young chickens and turkeys

(xix) Annex V: Request for USDA exemption permit number (Buddhist-style poultry)

(xx) Annex W: List of establishments eligible to export to the United States

(xxi) Annex Y: Guidance for operators submitting protocols to cfia and for the Veterinarian-in-Charge (VIC) for evaluating protocols submitted by operators for CFIA acceptance

(xxii) Annex Y-1: Retained water in raw meat and poultry products; poultry chilling requirements

(xxiii) Annex Y-2: Retained water in raw meat and poultry products

(xxiv) Annex Z: Compliance guideline for conditions relative to Transmissible Spongiform Encephalopathies (TSE) controls

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