June 4, 2003

Background:

The purpose of this advisory is to provide information to Canadian food exporters on the various prohibitions or restrictions put in place by the Animal and Plant Health Inspection Service (APHIS) and the U.S. Food and Drug Administration (USFDA). The Canadian Food Inspection Agency (CFIA) is working closely with these organizations to obtain information and clarifications on these prohibitions.

On May 20, 2003 following the report of the occurrence of bovine spongiform encephalopathy (BSE) in Canada, the U.S. initiated measures to prohibit or restrict the importation of certain food products exported from Canada. While the measures focus on prohibitions against the importation of all live ruminants, ruminant meat, ruminant meat products and other ruminant protein products, additional restrictions have been imposed on other food products where the U.S. considers that ruminant material could potentially be present.

U.S. Prohibitions and Restrictions

The following is a list of prohibitions and import alerts from the U.S. APHIS, U.S. Department of Agriculture (USDA)

"Clarification of the Prohibition of the Importation of all Live Ruminants, Ruminant Meat, Ruminant Meat Products and Other Ruminant Protein Products from Canada due to Bovine
Spongiform Encephalopathy (BSE)"
(http://www.aphis.usda.gov/vs/ncie/pdf/can-bse.pdf)

An interim rule in support of the prohibition was published in the U.S. Code of Federal Regulations (CFR) Title 9 on May 29, 2003. Pursuant to the provisions of the CFR, the U.S.
will allow the importation of certain materials of animal origin under specific conditions. Part  94.18(a)(1) of the CFR lists regions/countries where the U.S. considers that BSE exists. Canada is included in this list. The control of import of animal by-products is described in Part 95 of the CFR, and Part 95.4 specifically outlines the import restrictions relative to BSE. Canadian exporters can find information on the details of this CFR at: http://www.access.gpo.gov/nara/cfr/waisidx/. 

In general and unless specifically excepted (e.g. ruminant hides and hide derived products), commodities that contain material that is derived from a ruminant that has ever been in a
region/country listed in subsection 94.18(a) are prohibited from entry into the U.S. or can only be imported with restrictions.

Import Permit Requirements (APHIS)

Import permits are required for processed animal proteins including fish proteins intended for animal feed. For details on products requiring import permits and to obtain information applying for import permits, the exporter should refer to the USDA/APHIS web-site at: 
http://www.aphis.usda.gov/vs/ncie/.  

The importer can also call APHIS at 301-734-3277. It should be noted however that it is the U.S. importer that is responsible to apply for the permit. Exporters are required to complete a questionnaire relative to their operations. An official from CFIA is required to endorse the completed questionnaire. There are also provisions in the CFR for the USDA to send an inspector to inspect/verify the status of the export facility at the exporter’s expense.

Cooperative Service Agreements (APHIS)

In response to the prohibitions on the importation of ruminant meat products originating from Canada some Canadian exporters have contacted CFIA to explore the possibility of exporting meat products derived from ruminants meat imported from the USA or from other countries approved to export meat products derived from ruminants to the USA (taking into
consideration the FSIS requirements).

In this regard, the CFIA has contacted the APHIS, and has obtained verbal confirmation that the USDA-APHIS import policy provides for "Cooperative Service Agreements" between
APHIS and FSIS (Food Safety Inspection Services, USDA) and the exporter under which conditions may be established for such trade.

Based on available information, exporters interested to pursue this option should:

APHIS will review the application and if found satisfactory will send to the applicant a blank "agreement" and an estimate of the costs for an on-site inspection of the facility. APHIS will conduct an on-site inspection (at a time agreeable to all parties) to verify that products are not commingled or cross-contaminated with non-eligible ruminant products.

In making the determination of acceptability of applications, available information indicates that APHIS will take into consideration the following criteria: all steps of processing and storage are carried out in a dedicated facility and the exporter demonstrate that the products
destined to the USA are transported in a manner that will prevent cross-contamination with prohibited materials. APHIS reserves the right to conduct follow-up verification when deemed necessary.

USFDA

In support of the prohibitions put in place by APHIS and USDA, the USFDA has issued several import alerts with respect to food products regulated by the FDA. Import alerts issued by the USFDA are as follows:

IA #17-04, revision 5/20/03, Import Alert #17-04, "Detention Without Physical Examination of Bulk Shipments of High Risk Bovine Tissue From BSE Countries - Bovine Spongiform
Encephalopathy" 
http://www.fda.gov/ora/fiars/ora_import_ia1704.html

IA #99-25, 5/20/03, Revision of Import Alert #99-25, "Detention Without Physical Examination of Animal Feed, Animal Feed Ingredients and Other Products for Animal Use
consisting or Containing Ingredients of Animal Origin" 
http://www.fda.gov/ora/fiars/ora_import_ia9925.html

IA #99-B14 - 5/20/03, Summary of Office of Regulatory Affairs (ORA) BSE Import Bulletin #99B–14, "Edible Ruminant Products from BSE Affected or At Risk Countries".
http://www.cfsan.fda.gov/~comm/bseimpor.html

The USFDA has alerted its import field offices to the potential importation of human food products and nutritional supplements containing ruminant material; animal feeds, feed
ingredients and other animal products that may consist of or contain ingredients of animal origin; and bulk high risk bovine tissues or products containing these tissues from BSE
affected or at risk countries.

The Import Bulletin is intended to facilitate FDA's careful review of all imports of FDA-regulated products to ensure coordination with APHIS on the prohibitions. FDA's review
will include evaluation of product ingredient lists to determine whether the products offered for import may contain certain ruminant materials. Products that appear to contain ruminant material from the identified countries will be referred to APHIS for disposition.

Present Understanding of USDA and USFDA Approach to Specific Food Products

Gelatin

Cheese

Processed foods for human consumption containing animal protein of other species

For clarification of U.S. requirements contact:

For questions related to the prohibitions/restrictions and permit procedures, contact USDA APHIS, National Centre for Import at (301) 734-3277.

For questions related to the above referenced import alerts, contact USFDA, Division of Import Operations and Policy(301) 443-6553.

To report specific difficulties with respect to food exports, contact, CFIA, Bureau of Food Safety and Consumer Protection (Greg Orriss) (613) 221-7295.