Export Requirements for In-Shell Pasteurized Eggs to Canada

Export Requirements for In-Shell Pasteurized Eggs to Canada
January 8, 2019

• Export Procedures - Shell Eggs to Canada
• Export Procedures – Canada Breaking Stock
• Export Procedures – Inedible Eggs to Canada
   
• List of Plants Approved to Export Table Eggs to Canada
• Export Procedures – In-Shell Pasteurized Eggs
• LP-210S Exhibit – Eggs to the Pasteurizing Facility
• LP-210S Exhibit – Pasteurizing Facility to Canada
• Record of In-Shell Pasteurization Operations (pdf)
• Environmental Sampling Log Exhibit (pdf)
• Environmental Testing Letterhead Exhibit (pdf)
• Canadian Food Inspection Agency Contact Information

Purpose

This instruction outlines the verification of validated pasteurization procedures and specific requirements for the issuance of the shipping certificate required for the export of in-shell pasteurized table eggs to Canada.

General Procedures

Product Requirements

Each producer/packer requesting certification of shell eggs destined for Canada must provide a Certificate of Conformance (CoC) on company letterhead to accompany each shipment of eggs packaged for the ultimate consumer. The CoC signed by the producer (source flock owner) must declare:

“The eggs covered by the attached USDA certificate did not originate from a flock in a layer house with an environment testing positive for the presence of Salmonella Enteritidis (SE) or from eggs testing positive for SE.”
 

Responsibilities

1. USDA Grader
   
   Prior to processing, the USDA grader will conduct a pre-operational inspection to determine that the processing and packaging equipment is clean and in sanitary condition. Record findings on the checklist (pdf).
   
   The USDA Grader will review the company’s documented pasteurization process (i.e. pasteurization temperature and residence time), the FDA approval letter for the pasteurization process, and the approval letter from Canada entitled, Health Canada Heat-Treatment- Pasteurized-Eggs-In-Shell dated 02/22/2018, for each lot to be certified as pasteurized.
   
   The USDA grader will review the Shell Egg Grading Certificate, Form LP-210S, accompanying each lot(s) of graded eggs for compliance prior to processing. Each source egg certificate must document that the eggs were derived from poultry or birds which have not been in contact with any animal or animal product, or animal by- product of a susceptible species from a zone that was not recognized by CFIA as free of Highly Pathogenic Avian Influenza. The certificate written from the origin facility to the pasteurization facility shall use the same Animal Health Statement listed in the “Certification” section. 
   
   On an hourly basis the USDA grader shall observe processing procedures, packing, packaging, and verify pasteurizing process through records checks, to confirm that the applicant is following the protocol outlined in their approved process. Use the checklist (pdf) to record hourly verification checks. More sheets may be used to accommodate longer run periods.
    
2. Quality Assurance
   
   The quality assurance system used shall monitor, on a continuous basis, and maintain records of the processing temperature and the residence time of each lot of pasteurized table eggs.
    
3. Plant Management
   
   Plant management is responsible for demonstrating continued conformance with the pasteurization treatment and describing the design function of the processing equipment and quality assurance system for the production and packaging of the pasteurized product.
   
   Plant management will provide a written procedure describing the measures implemented to maintain the identity of the shell eggs for processing from the time of the receipt until processed, packaged, and labeled.
   
   Plant management must notify a Livestock and Poultry Program representative of a pending export and provide the USDA grader referenced for appropriate labeling and certification.
    

Grade Requirements

Only shell eggs that meet or exceed US Grade A requirements and have been processed, packaged, labeled, and certified fit for human consumption in accordance with the Regulations Governing the Voluntary Grading of Shell Eggs (7 CFR Part 56) are eligible for processing and certification as in-shell pasteurized table eggs for export to Canada.

No more than 7 percent undergrade eggs (including individual underweight eggs) will be permitted at origin.
 

Weight Requirements

1. Product must meet the requirements of the marked U.S. weight class.
2. Per Canada Regulations, underweight eggs are to be included as part of the total percentage of undergrade eggs allowed (7 percent undergrades at origin, 10 percent undergrades at destination), however, the USDA tolerances of 3.3 percent maximum lot average and 5 percent maximum individual sample average for underweight eggs in the next lower weight class shall not be exceeded.
3. The minimum individual egg weight stated in the Canadian standards is declared in grams for the weight classes below:

Salmonella Enteritidis Controls
To be eligible for export to Canada, the processing plant must be found to be clean of Salmonella enteritidis (negative test results), as determined by semi-annual environmental sampling and testing of the processing plant premises and equipment. Lab results showing a sample(s) positive for SE will result in classifying the processing facility as ineligible for export to Canada, and the plant will be removed from the list on the AMS website. Retesting (swabbing) the environment will not be permitted until an AMS representative has verified that a thorough cleaning of the premises and equipment has taken place.

1. Environmental Sampling Procedures
   
   It is critical that plant management employ fundamental aseptic sampling techniques as referenced in this instruction when collecting samples.  The following sampling guidance is being provided:
   
   Sample sites must be pre-selected as described in the section "Selection of Sampling Sites".  Each plant is required to provide an environmental sampling kit, which should be checked well in advance of sampling to ensure that all of the necessary equipment has been supplied.  Refer to Exhibit II for information on environmental sampling kits.
    
2. Equipment/Supplies
   1. Sampling kit including:
      • Refrigerant packs.
      • Individually wrapped sterile cellulose sponges.
      • 10 ml of sterile neutralizing buffer (Difco Neutralizing Buffer is the preferred buffer to be used when the samples will be analyzed at the USDA laboratories listed in this instruction).  Use of other buffers will be as directed by the laboratory analyzing the samples.
      • Pre-labeled, sterile sampling bags.
      • Disposable sterile sampling gloves.
      • Polyfoam insulated shipping container.
   2. Single use seals.
   3. Plastic bags.
   4. Clean shirt, trousers (pants), lab coat, and hair and facial coverings, as appropriate, should be worn.  Boots and footwear should be cleaned and sanitized prior to sampling.
   5. Fine-tipped waterproof felt pen for labeling samples.
   6. Company letterhead stationery to record and accompany the individually identified samples sent to the laboratory.
       
3. Selection of Sampling Sites
   
   The CFIA guidance for environmental sampling states that a minimum of 50-percent of the swab samples must originate from direct product contact surfaces.  Sampling sites may vary among packing plants depending on the type of equipment in use.

• Grading Machine
  • Egg Dryer (Plenum)
  • Oiler (Plenum)
  • Scale/Conveyor Belts
  • Egg Carriage System
  • Packing Heads
  • Clam Shells
  • Main Conveyor Belt
• Grading Room
  • Wooden Pallets/Dividers
  • Carton/Box Conveyors
• Other Room
  • Washroom (Door Handle or Sink Taps)
• Graded Egg Cooler
  • Outgoing Racks (if applicable)
  • Outgoing Packaging Material
    
    Selection of Sampling Sites – DO NOT SWAB FLOOR DRAINS
     

4. Aseptic Sampling Technique
   1. The sampling will be conducted by plant management under the supervision of the USDA grader or the Federal-State supervisor (or assistant) prior to the starting operations.  Specially trained plant employees shall aseptically collect and identify samples for submission to the laboratory.  A copy of the selected sample sites will be provided to the USDA grader.
   2. It will be necessary to select environmental samples twice annually in each plant electing to export table eggs to Canada.  The sampling frequency should be random.  The USDA grader will maintain a sample frequency log and the list of sample sites.  The list will serve as a reference and may be discarded following collection of samples for a subsequent 6-month period.
   3. Prior to sample collection, plant management and the USDA representative will review proposed sample sites to assure random selection, as suggested in Section C.  The ten samples shall be collected in a manner proceeding from the finished product area(s) to the product presented for processing.
   4. The following guidance is provided for aseptic sample collections:
      1. Remove all jewelry (rings, watches, etc.) and thoroughly wash and sanitize hands.  Individuals with sores or cuts on their hands should not take samples.
      2. At each site:
         • Indicate (legible identification) on the label of the sampling bags the plant number, sample number, sampling site, or other sample information and whether the required analysis is for Salmonella or SE, as stated by plant management.
         • Rinse and sanitize hands.
         • Touching only the cuff of the glove, insert the hands into the gloves.  Should anything touch the other areas of the glove, discard it and use another glove to prevent contamination of the sample.
         • For kits containing sample bags, an assistant should open the bag by tearing along the perforation at the top, removing the plastic strip, and pulling the white tabs apart until the opening of the bag is wide enough for the sponge.  The inside of the bag is sterile and must not be touched, nor should it be left open for more than a few seconds.
         • When sampling personnel are ready, the assistant should pick up a wrapped sponge and tear off the top of the wrapper exposing a portion of the sponge.  Without touching the sponge, hold the container for access without contaminating the gloves.
         • When preparing to swab an area, remove the sponge from the wrapper with a gloved hand.  If the surface to be sampled is dry, pre-moisten the sponge with buffer solution.  This can be accomplished by removing the top of a buffer tube (being careful not to touch the opening of the tube) and pouring approximately 10 milliliters (1 tablespoon) of buffer solution on the sponge.  The buffer tube is not to be in contact with the sponge.
           
           Sampling kits can vary in design.  Some sampling kits contain sterile sponges already pre-moistened with the neutralizing buffer.
         • When swabbing an identified area, vigorously rub the sponge over the surface to be sampled until any soil is removed.  If excess fluid is present, wring the fluid in the sponge into the sampling bag, and continue rubbing the sample site.  With one sponge, sample as much of the surface in question as possible.  The assistant should aid in the sampling by exposing or stabilizing the surface to be sampled without touching it.
         • Upon completion of swabbing the area return the sponge to the sample bag without further contact to prevent contamination.  Close the bag by holding it on both sides by the yellow ties, twirl the bag around two to three times over itself, and bend the twist ties in toward each other to form a closure over the bag.  Do not twist the twist ties around each other.
         • Discard used gloves.
   5. Samples are subject to microbiological analysis and must be placed under refrigeration immediately after collection.  Do not freeze the samples.
   6. Caution shall be exercised when shipping samples for laboratory analysis.  A polyfoam- insulated container should be used for shipping.  The samples shall be properly cooled prior to packing with frozen refrigerant packs placed above and below the samples.  Additional packing material may be used as an aid to maintaining sample quality during shipment.
      
      Place the envelope containing the sampling information letter on top of the packing material and close the container securely.  Seal all official samples or shipping containers prior to mailing or giving them to management for mailing.  Laboratories will not analyze samples, which are not properly sealed.  Use one of the following methods to seal the shipping container:
       
      1. Tape Method - Strap the circumference (including the bottom and the top of either the extern al or internal shipping container) with a single piece of 1/4 to 1/2- inch nylon reinforced tape or its equivalent.  Bring the two ends of the tape through a "single-use" seal (provided by the company), locking the tape inside the seal when it is closed. Wrap the seal with additional tape to protect it during mailing.  Record the seal number(s) used in the "Remarks" section of the sampling information letter.
          
      2. Plastic Bag Method - Place the sample(s) or inner shipping container inside a plastic bag.  Close the plastic bag and "tie" it using 1/4 to 1/2-inch nylon reinforced tape.  Secure the two ends of the tape with a seal as in (a.) above.  Wrap the seal in additional tape to protect it during mailing.  Record the seal number(s) used in “Remarks” section of the sampling information letter.
   7. The materials required for preparing the samples are:
      1. Tape - Standard 1/4 or 1/2-inch nylon reinforced tape may be provided by the official plant or obtained from your supervisor.
          
      2. Plastic Bags - Appropriately sized plastic bags may be provided by the official plant or obtained from your supervisor.
          
      3. Single-Use Seals - The seals will be provided by the company.
         
         Samples shall be shipped to the laboratory immediately after collection.  The laboratory samples may be analyzed at an USDA laboratory, or another laboratory determined by the plant.  Laboratories providing environmental sampling for the detection of Salmonellae must use methodology approved by the Association of Official Analytical Chemists.
          
   8. The USDA laboratory listed below can analyze environmental samples for the presence of salmonellae:
      
      Science and Technology Program Laboratory Approval and Testing Division
      National Science Laboratory
      801 Summit Crossing Place, Suite-B Gastonia, North Carolina 28054
      
      The National Science Laboratory in Gastonia, North Carolina, will accept environmental samples every day of the week; however, prior notification to the laboratory must be made for Saturday deliveries.
      
      For non-USDA laboratories, the shipping and receiving schedule will depend on the individual laboratory.  Plant management shall assume all costs for sampling kits, shipping the samples, and laboratory analysis.
       
   9. When sending samples to either a USDA or non-USDA laboratory, prepare an original and two copies of the sampling information letter using company letterhead stationery.  The sampling information letter, if not typed, is to be prepared with ballpoint pen.  Be sure all copies are legible and signed by the company representative.
       
      1. Indicate the type of testing (Salmonella or SE) being requested.
          
      2. Under the “Sampling Site” column, list the specific sites sampled.  For example, if the brushes in the washer are sampled, under the column, list “washer brushes”.  Do not composite samples.
         
         The company will provide the USDA grader a copy of the sampling information letter for reference purposes.  The original and one copy of the sampling information letter shall be placed in a separate envelope and securely taped inside the sample container being sent to the laboratory.  Tape the envelope on the interior surface of the insulated shipping container. 
         
         The laboratory will enter the results of the analyses on a laboratory sampling report and return the original and a copy to the applicant.  The applicant will share the results with the grader, but the grader will not maintain a copy of the laboratory report.  The analysis can normally be completed within two weeks of the date of submission.
          
5. Evaluation and Follow-up
   
   Management has the option to sample and test for all species of salmonellae without serotyping the species.  However, environmental test results found to be positive for Salmonella will result in a firm being ineligible to export shell eggs to Canada unless the results are determined negative for SE.  The reporting of any positive test result(s) will require the plant to immediately clean and disinfect the facility premises and egg processing equipment, as applicable.
   
   Follow-up samples shall be taken subsequent to cleaning from sampling site(s) where positive results for Salmonella or SE were reported.  The follow-up aseptic sample collection must be completed under USDA supervision.  Samples shall be collected as described under aseptic sampling techniques and shipped to the laboratory in a cooler with freezer packs.  Certification of product for export to Canada shall be discontinued while the follow-up samples are being analyzed and until the results are found negative for SE.

Reporting of Eligible Plants

A list of plants eligible to export table eggs to Canada is available on the Agricultural Marketing Service (AMS) website at: USDA AMS Table Egg Export.  The list will be updated when a plant’s eligibility to export changes.  The USDA grader or Federal-State supervisor (or assistant) will notify the Regional Director of the date that the laboratory results were completed.  The initial swab sample results are to be forwarded to the National Office, it is not necessary to forward subsequent results.  The Regional Director is to notify the National Office on the status of plants eligible to export:

• Plant Name and Address (physical address as stated on certificate)
• Plant Number
• Approval Valid Through Date
• Date Approval Rescinded

Notification of continued approval must be received in the National Office within 15 days after the “valid through” date, as shown on the website.  Failure to report acceptable analysis results for an updated approval within this 15-day period following the “valid through” date listed on the website will result in the removal of the facility from the list.

Packaging/Packing

1. ​​​​​​​The integrity of the pasteurized eggs must be maintained subsequent to processing. This can be accomplished by marking the individual egg or packaging the product in containers designed to show evidence of opening, such as carton wrap, sealed overwrap, or in the case of loose eggs, cases taped at both ends.
2. All packing material must be new, showing no evidence of previous use. 
3. The interior packaging material (cartons and flats) must be new, showing no evidence of adhering foreign material or previous use.
4. Pallets must be new or good used, free of visible evidence of adhering foreign material, and/or structural damage.

​​​​​​​Labeling

1. Retail Package Labels
   
   Canadian regulatory labeling requirements specify that shell eggs packaged for retail sale must be labeled in English and French.
   1. Product packed in USDA shielded cartons must bear the plant number and lot number.
   2. The shell egg cartons must bear a Durable Life Date, also known as a "Best Before" date as determined by the manufacturer. The eggs in the container are expected to meet the grade and size marked on the container until the end of the durable life date. The carton may bear a Durable Life Date, including the day of pack as follows:   Best Before / Meilleur Avant:  NO 04
      
      The exception is the province of Québec, which states the “Best Before” date, may not exceed 50 days from the date of pack. When utilizing a “Best Before” date in excess of 45 days, the following statement must be placed in the comments section of the Form, LPS-210S:
      
      The expiration date declared on the product is the responsibility of the applicant.”
       
   3. The Canadian requirements also state that all shell egg cartons must bear the “Keep Refrigerated” and “Garder Refrigere” statement.
       
   4. The country of origin statement (“Product of USA” and “Produit des E.-U.A”) must appear on the top or front panel of the container.

   5. The declaration of the stock rotation date on a carton must include the abbreviation for the month as listed in the table below:
       

      Month	Abbreviation
      January	JA
      February	FE
      March	MR
      April	AL
      May	MA
      June	JN
      July	JL
      August	AU
      September	SE
      October	OC
      November	NO
      December	DE

   6. Nutritional information must be declared in the correct Canadian "Nutrition Facts Table" format.
       
   7. The carton shall be marked with the words “Pasteurized” and “Pasteurisé” and “Graded USDA A before pasteurization” and “Classé USDA A avant pasteurisation”.
       
2. Shipping Case Labeling
   1. ​​​​​​​All shipping case label markings must be clear, legible, and readily discernible. The lettering must be at least ½-inch in height, with the exception of the name and address of exporter, which must be at least ¼-inch in height.
       
   2. All shipping cases of eggs must contain label markings in French and English.
       
   3. Labels must be printed, stenciled, or stamped in a central location on one end of every shipping case or loose-packed pallet. If there is insufficient space on the end panel to place all the necessary information, the English version is to be placed on the end panel and the French translation on an adjacent right side panel.
       
   4. Stenciled markings are not to be applied over printed graphics such as name and addresses, advertising material, etc.
       
   5. The grade and size designation may not be abbreviated. (Example: U.S. Grade A Extra Large instead of “A XL”).
       
   6. The country of origin must be indicated as: "Product of USA" and “Produit des É.-U.A.”.
       
   7. The name and address of packer or shipper must be shown.
       
   8. Each shipping case or pallet must be identified in some manner that reflects the producer, flock, or houses of the shell eggs to provide traceability of the product, if necessary. This traceability system is not certified by USDA.
       
   9. All product is to be identified with the USDA Graded for Export stamp (with certificate number),  lot number, and official plant number.
       
   10. Canada will allow eggs (same size and quality) processed and packaged on five consecutive days to be identified with the same lot number with the provision that production records maintain traceability of the eggs.
        
   11. The shipping case shall be marked with the words “Pasteurized” and “Pasteurisé” and “Graded USDA A before pasteurization” and “Classé USDA A avant pasteurisation”.

Refrigeration of Product​​​​​​​

Table eggs exported to Canada must be refrigerated subsequent to packaging, and the refrigeration must be maintained during the transport of the product for export. The grader will monitor the refrigeration (temperature defined by the processor) and assure that the transport unit is capable of maintaining such a temperature.

Certification

​​​​​​​When completing the certificate (Form LP-210S) the following information must be included:

• The statement “Product of the USA.”
• Company seal number.
• Average net weight.
• The statement “Pasteurized eggs were produced from US Grade A shell eggs that meet or exceed grade requirements in the Canada Agriculture Products Act and Eggs Regulations (Canada A).
• The statement: “The pasteurization process is in accordance with US Food & Drug regulations and the process approved by Health Canada described in Decision Document for Use of Heat Treatment to Pasteurize Eggs In-Shell, dated 02-22-2018.”
• The production date.
• The expiration date.
• Disease Free Statement

The Canadian Food Inspection Agency (CFIA) requires a statement attesting that the eggs did not originate from a source flock currently under a control zone for Highly Pathogenic Avian Influenza (HPAI) or Virulent Newcastle Disease (vND).

For shell eggs derived from flocks located in states with no control zones listed on the AMS Shell Egg Export Restrictions page, AMS graders will add the following statement to the remarks section of the LP-210S certificate: 

• "I, the undersigned, salaried inspector of the Agricultural Marketing Service (AMS), after due inquiry and to the best of my knowledge, do hereby certify that the poultry or bird products/by-products within this certificate are exported from the United States, and did not originate in a current CFIA recognized quarantine control zone established due to the detection of highly pathogenic avian influenza (HPAI) or Newcastle disease (ND), as these diseases are defined by the World Organization for Animal Health (WOAH).”

For shell eggs derived from flocks located in states with HPAI or vND control zones listed on the AMS Shell Egg Export Restrictions page, management must obtain VS Form 16-4 from APHIS with the following remarks: 

• “I, the undersigned, salaried veterinarian of the USDA , after due inquiry and to the best of my knowledge, do hereby certify that the poultry or bird products/by-products within the certificate number (insert number here) are exported from the United States, and did not originate in a current CFIA recognized quarantine control zone established due to the detection of highly pathogenic avian influenza (HPAI) or Newcastle disease (ND), as these diseases are defined by the World Organization for Animal Health (WOAH)”

If a VS Form 16-4 is required, it is the exporter’s responsibility to forward the Shell Egg Grading Certificate, Form LP-210S to the applicable APHIS Service Center as part of the request for certification.  View the relevant VS Service Center on the APHIS website. Both the VS Form 16-4 and Form LP-210S (original with signature in blue ink) must be presented to CFIA authorities at the point of entry to Canada.
 

14. CFIA Contact Info (Updated July 2023)
15. Alia Blais
    National Manager, Food Imports 
    Canadian Food Inspection Agency / Government of Canada
    alia.blais@inspection.gc.ca / Tel: 613-617-8480