Certification Requirements - U.S.

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Acts and Regulations

Farm Security and Rural Investment Act of 2002

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act)

What Facilities Need to be Registered?

  • Facility means any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States. (Section 1.227 (2))
  • Fishing vessels which harvest, transport, and minimally prepare fish for holding on board the vessel, such as heading, eviscerating or freezing, do not need to be registered. (Section 1.226(f))
  • Fishing vessels engaged in processing fish, such as handling, storing, preparing, shucking, changing into different market forms, manufacturing, preserving, packing, labelling, dockside unloading, or holding do need to be registered. (Section 1.226(f))
  • Aquaculture farms which are in one general location and devoted to the raising and harvesting of animals, including seafood, do not need to be registered. Harvesting includes the washing and trimming of seafood. (Section 1.227(3))

Food and Drug Administration - Registration of Food Facilities


Information of all food for use, storage or distribution in the United States and includes gifts, trade samples and quality assurance/quality control samples, food for transhipment through the United States to another country and food for future export being exported to the United States must be notified prior to import.

Food includes those articles intended for direct human or animal consumption and all ingredients or components of food intended for processing into food for consumption.

  • Prior notice must be received and confirmed electronically by USFDA.
  • No more than five days before arrival and no fewer than:
    • 2 hours before arrival by land by road;
    • 4 hours before arrival by air or by land by rail;
    • 8 hours before arrival by water.

Food and Drug Administration - Prior Notice System Interface

Tolerances or Guidelines

Aldrin + Dieldrin - 0.30 ppm
Carbaryl - oysters - 0.25 ppm
Chlordane - 0.30 ppm
DDT total - 5.00 ppm
Diquat - 0.10 ppm
Endrin - 0.30 ppm
Glyphosate - 0.25 ppm
Heptachlor, Heptachlor Epoxide - 0.30 ppm
Kepone - in fish and shellfish - 0.30 ppm
- in crab meat - 0.40 ppm
Mercury - 1.00 ppm
Mirex - 0.10 ppm
PCB total - 2.00 ppm
Toxaphene - 5.00 ppm
Histamine (canned albacore, skipjack or yellowfish tuna) - 20 mg/100g

Infestation Tolerance Limits

Whitefish and Tullibee - 40 cysts/100 lbs. (whole fish or fillets).

Certification Requirements

New York State

  1. Lake Sturgeon: Certificate of Inspection, Content (FP 1408 (11/91)) with the following Statement "This is to certify that the Lake Sturgeon described herein originates from Canadian water".
  2. Whitefish & Tullibee: Certificate of Inspection, Freshwater Fish. (FP 1409)
  3. All other fish products: Certificate of Inspection, Content. (FP 1408 (11/91))

All other States:

  1. Whitefish and Tullibee: Certificate of Inspection - Freshwater Fish. (FP 1409)
  2. Live or unprocessed (fresh or frozen) bivalve molluscan shellfish except scallop meat:
    Exporting establishments must be listed on the Interstate Certified Shellfish Shippers List (ICSSL) and meet all applicable requirements.

Export of Fish by-products to the U.S.

Background Information

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) Veterinary Services, which regulates the importation of animals and animal-derived materials requires import permits for processed animal proteins including fish proteins and fish oil intended for animal feed. These import permits are issued only to U.S. importers. 

Import Permit

When a U.S. importer applies for an import permit, they are given a questionnaire entitled Questionnaire to determine cross contamination risk . This questionnaire must be filled out by the processor for the product in question. The processor must then forward the completed questionnaire to their regional CFIA office for endorsement. The CFIA Fish Inspection program will be involved with the endorsement of this questionnaire for facilities registered under the Fish Inspection Regulations. An inspector must first review and verify that the information provided by the processor is valid and accurate. This will require an on-site verification at the processing facility to review records of the incoming material used to produce the fish by-product to ensure that there is no risk that the incoming material was in contact with ruminant products as well as to verify that there are no ruminant products passing though the processing facility. Once the inspector is satisfied with the findings from the verification, they can then sign and stamp the questionnaire and return it to the processor. The processor will then return the questionnaire to the U.S. importer who will present it to the APHIS veterinarians.

When an import permit is issued, it is valid for a period of one year, and applies only to the products and processor identified in the questionnaire. APHIS will inform the importer of the required certificate attestations upon issuance of the permit.

The permit process allows the APHIS veterinarians on staff to examine the processing method and determine whether the product is safeguarded from possible contamination with commingled ruminant material . Please note that there are provisions for the USDA to send an inspector to inspect/verify the status of the export facility at the exporter's expense.


The certification of the fish by-products affected by the U.S. restrictions will also be done under the Fish Inspection program. In order for CFIA to proceed with the certification of these fish by-products, the processing facility must develop a protocol to describe the controls they will put in place to ensure that the U.S. requirements are respected. The protocol must be submitted to the regional CFIA office to be reviewed and accepted. On-site verification of conformity with the protocol must be effected by CFIA at least once a year.

Each shipment exported to the U.S. must be accompanied by an original certificate signed by a CFIA official (fish inspector). APHIS will be providing the required attestations which will be specific to the fish by-product. A template of the certificate to be issued is available however the required attestations will need to be included when they become available. Please note that a copy of a USDA import permit for the product in question must accompany the request for certification. Ensure that the statement provided by APHIS on the import permit contains the following wording: "Each shipment must be accompanied by an original certificate endorsed by a designated Canadian Food Inspection Agency official or a veterinarian from CFIA".

Present Understanding of USDA and USFDA Approach to Specific Food Products

Processed foods for human consumption containing animal protein of other species

  • APHIS has no prohibition on such products related to BSE.

Edible fish

  • These restrictions do not apply to fish or seafood food products for human consumption.

Fish Oil

  • An import permit is required for fish oil and each shipment must be accompanied by a certificate.

Inedible products containing fish

  1. If the product is fish meal or contains fish meal, an import permit is required. The importer should contact NCIE at 301-734-3277.
  2. If the product is fish that has simply been dried, chopped, minced, or ground or is a product that contains fish that has simply been dried, chopped, minced, or ground, an import permit is not required. The processor however needs to provide a signed statement on their company letterhead with each shipment that states:
    • The fish product or fish ingredient(s) contained in this product is not rendered; and
    • The fish product has not been commingled with ruminant derived materials.

Fish Gelatin

APHIS has confirmed that fish gelatin does not require an import permit, however each shipment must be accompanied by an official CFIA letter certifying the species of origin used in the production of the fish gelatin.

Fish offal

If the product is fish offal (here defined as soft tissue such as liver, kidney, or brain), an import permit is required and each shipment must be accompanied by a certificate.

Pet Food

Although fish, poultry, and pork have not been known to carry BSE, the restriction on pet food and animal proteins is apparently based on APHIS concerns related to potential co-mingling or cross-contamination. Therefore your shipment may be permitted entry depending on the way the animal meal is processed and the paperwork that accompanies it. To determine if your product will be permitted entry, APHIS, Veterinary Services requires copies of all paperwork associated with each of your products imported. Veterinary Services may call your company for clarification, but after reviewing the documents, they will be able to advise you if you need to apply for a Veterinary Services permit.

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