Vol. 143, No. 4 — February 18, 2009

Registration

SOR/2009-18 January 29, 2009

FEEDS ACT FERTILIZERS ACT HEALTH OF ANIMALS ACT

Regulations Amending Certain Regulations Administered and Enforced by the Canadian Food Inspection Agency

P.C. 2009-118 January 29, 2009

Her Excellency the Governor General in Council, on the recommendation of the Minister of Agriculture and Agri-Food, hereby makes the annexed Regulations Amending Certain Regulations Administered and Enforced by the Canadian Food Inspection Agency, pursuant to

(a) section 5 (see footnote a) of the Feeds Act (see footnote b);

(b) subsection 5(1) (see footnote c) of the Fertilizers Act (see footnote d); and

(c) subsection 64(1) (see footnote e) of the Health of Animals Act (see footnote f).

REGULATIONS AMENDING CERTAIN REGULATIONS ADMINISTERED AND ENFORCED BY THE CANADIAN FOOD INSPECTION AGENCY

FEEDS ACT

FEEDS REGULATIONS, 1983

1. The definition “specified risk material” in subsection 2(1) of the Feeds Regulations, 1983 (see footnote 1) is replaced by the following:

“specified risk material” means the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older, and the distal ileum of cattle of all ages, but does not include material from a country of origin as defined in section 2 of the Health of Animals Regulations, or a part of a country of origin, that is designated under section 7 of those Regulations as posing a negligible risk for Bovine Spongiform Encephalopathy; (matériel à risque spécifié)

FERTILIZERS ACT

FERTILIZERS REGULATIONS

2. The definition “specified risk material” in subsection 2(1) of the Fertilizers Regulations (see footnote 2) is replaced by the following:

“specified risk material” means the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older, and the distal ileum of cattle of all ages, but does not include material from a country of origin as defined in section 2 of the Health of Animals Regulations, or a part of a country of origin, that is designated under section 7 of those Regulations as posing a negligible risk for Bovine Spongiform Encephalopathy; (matériel à risque spécifié)

HEALTH OF ANIMALS ACT

HEALTH OF ANIMALS REGULATIONS

3. Paragraph (c) of the definition “country of origin” in section 2 of the Health of Animals Regulations (see footnote 3) is replaced by the following:

(c) with respect to an animal product or animal by-product — other than non-fertilized ova, semen and meat as defined in subsection 2(1) of the Meat Inspection Regulations, 1990 — that has undergone processing that would prevent the introduction of any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the product or by-product was derived is susceptible and that can be transmitted by the product or by-product, the country in which the product or by-product underwent that processing; (pays d’origine)

4. Section 6.1 of the Regulations is replaced by the following:

6.1 In this Part, “specified risk material” means the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older, and the distal ileum of cattle of all ages, but does not include material from a country of origin, or a part of a country of origin, that is designated under section 7 as posing a negligible risk for Bovine Spongiform Encephalopathy.

5. Section 6.5 of the Regulations is renumbered as subsection 6.5(1) and is amended by adding the following:

(2) Subsection (1) does not apply to a person who feeds a pet food, pet chew or pet treat to an animal if

(a) the country of origin of that product is the United States;

(b) the person, on entry into Canada from the United States, was in possession of the product and was accompanied by the animal to which it is fed;

(c) the person legally imported both the product and the animal into Canada; and

(d) the product is fed only to the animal that accompanied the person into Canada.

6. Section 41 of the Regulations is replaced by the following:

41. (1) A person may import into Canada an animal by-product, manure or a thing containing an animal by-product or manure, other than one described in section 45, 46, 47, 47.1, 49, 50, 51, 51.2 or 53, if

(a) the country of origin is the United States and the by-product, manure or thing is not derived from an animal of the subfamily Bovinae or Caprinae;

(b) the country of origin, or the part of that country, is designated under section 7 as being free of, or as posing a negligible risk for, any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the by-product, manure or thing was derived is susceptible and that can be transmitted by the by-product, manure or thing, and the person produces a certificate of origin signed by an official of the government of that country attesting to that origin; or

(c) the by-product, manure or thing has been collected, treated, prepared, processed, stored and handled in a manner that would prevent the introduction into Canada of any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the by-product, manure or thing was derived is susceptible and that can be transmitted by the by-product, manure or thing, and the person produces a certificate signed by an official of the government of the country of origin that

(i) attests that the by-product, manure or thing has been collected, treated, prepared, processed, stored and handled in that manner, and

(ii) shows the details of how it was collected, treated, prepared, processed, stored and handled.

(2) Subsection (1) does not apply in respect of manure found in or on a vehicle that is entering Canada from the United States if the manure was produced by animals, other than swine, that are being transported by the vehicle.

7. Subsection 41.1(1) of the Regulations is replaced by the following:

41.1 (1) Despite section 41, a person may import into Canada an animal by-product or a thing containing an animal by-product, other than one described in section 45, 46, 47, 47.1, 49, 50, 51, 51.2 or 53, if an inspector has reasonable grounds to believe that the importation of the by-product or thing, by its nature, end use or the manner in which it has been processed, would not, or would not be likely to, result in the introduction into Canada of any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the by-product was derived is susceptible and that can be transmitted by the by-product, and the by-product or thing is not intended for use as animal food or as an ingredient in animal food.

8. Subsection 42.1(2) of the Regulations is replaced by the following:

(2) An establishment referred to in subsection (1) shall process the raw glands and organs in a manner that would prevent the introduction of any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the glands and organs was taken is susceptible and that can be transmitted by the glands and organs.

9. Subsection 45(2) of the Regulations is replaced by the following:

(2) An establishment referred to in paragraph (1)(b) shall process the gluestock in a manner that would prevent the introduction of any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the gluestock was derived is susceptible and that can be transmitted by the gluestock.

10. The heading before section 46 of the French version of the Regulations is replaced by the following:

FARINE DE VIANDE ET D’OS, FARINE D’OS, FARINE DE SANG, RÉSIDUS DE GRAISSE, FARINE DE PLUMES, FARINE DE POISSON, PRODUIT D’UNE USINE DE TRAITEMENT, FUMIER ANIMAL, DÉCHETS ET REBUTS DE NAVIRES

11. Section 46 of the Regulations is replaced by the following:

46. No person shall import into Canada meat and bone meal, bone meal, blood meal, tankage (meat meal), feather meal, fish meal or any other product of a rendering plant unless, in addition to the requirements of sections 166 to 171,

(a) the country of origin, or the part of that country, is designated under section 7 as being free of, or as posing a negligible risk for, any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the product was derived is susceptible and that can be transmitted by the product, and the person produces a certificate of origin signed by an official of the government of that country attesting to that origin; and

(b) an inspector has reasonable grounds to believe that the product has been processed in a manner that would prevent the introduction of any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the product was derived is susceptible and that can be transmitted by the product.

12. (1) The definition “fumier” in subsection 47.1(1) of the French version of the Regulations is repealed.

(2) The expression “( fumier )” at the end of the definition “animal manure” in subsection 47.1(1) of the English version of the Regulations is replaced by the expression “( fumier animal )”.

(3) Subsection 47.1(1) of the French version of the Regulations is amended by adding the following in alphabetical order:

« fumier animal » Fumier produit par des animaux à bord d’un navire ou d’un aéronef pendant que celui-ci fait route vers le Canada ou après son arrivée au Canada. (animal manure)

13. Paragraph 49(1)(a) of the Regulations is replaced by the following:

(a) the Canada Border Services Agency has determined under the Customs Tariff that the carcass originated in the United States; and

14. Paragraph 50(b) of the Regulations is replaced by the following:

(b) any animal by-product or manure that was derived from an animal affected with anthrax, foot-and-mouth disease, rinderpest or Bovine Spongiform Encephalopathy or any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the by-product or manure was derived is susceptible and that can be transmitted by the by-product or manure.

15. Subsection 51.2(1) of the Regulations is replaced by the following:

51.2 (1) A person may import into Canada animal blood or animal serum, other than a veterinary biologic, if it does not contain an animal pathogen or part of one and

(a) the country of origin is the United States and the blood or serum is not derived from an animal of the subfamily Bovinae or Caprinae;

(b) the country of origin, or the part of that country, is designated under section 7 as being free of, or as posing a negligible risk for, any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the blood or serum was derived is susceptible and that can be transmitted by the blood or serum, and the person produces a certificate of origin signed by an official of the government of that country attesting to that origin; or

(c) the blood or serum has been collected, treated, prepared, processed, stored and handled in a manner that would prevent the introduction into Canada of any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the blood or serum was derived is susceptible and that can be transmitted by the blood or serum, and the person produces a certificate signed by an official of the government of the country of origin that

(i) attests that the blood or serum has been collected, treated, prepared, processed, stored and handled in that manner, and

(ii) shows the details of how the blood or serum was collected, treated, prepared, processed, stored and handled.

16. Subsection 52(1) of the Regulations is replaced by the following:

52. (1) Despite anything in this Part, a person may import into Canada an animal by-product if the person produces a document that shows the details of the treatment of the by-product and an inspector has reasonable grounds to believe — based on the source of the document, the information contained in the document and any other relevant information available to the inspector and, if necessary, on an inspection of the by-product — that the importation of the by-product would not, or would not be likely to, result in the introduction into Canada, or the spread within Canada, of a vector, disease or toxic substance.

17. Section 53 of the Regulations is replaced by the following:

53. (1) No person shall import into Canada any animal food that contains an animal product or animal by-product unless

(a) the country of origin

(i) of the animal food is the United States and the animal food is not derived from an animal of the subfamily Bovinae or Caprinae; or

(ii) or the part of that country of the animal food — and each animal product and animal by-product contained in that food — is designated under section 7 as being free of, or as posing a negligible risk for, any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the food, product or by-product was derived is susceptible and that can be transmitted by the food, product or by-product, and the person produces a certificate of origin signed by an official of the government of that country attesting to that origin; and

(b) in the case of animal food that is carried on board a vessel, the master of the vessel certifies that no ruminants or swine, other than those imported in accordance with a permit issued under section 160, were taken on board the vessel.

(2) No person shall import into Canada any animal product or animal by-product that is to be used as animal food or as an ingredient in animal food unless the country of origin, or the part of that country, is designated under section 7 as being free of, or as posing a negligible risk for, any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the product or by-product was derived is susceptible and that can be transmitted by the product or by-product, and the person produces a certificate of origin signed by an official of the government of that country attesting to that origin.

18. Section 171.1 of the Regulations is amended by adding the following after subsection (2):

(3) In this section, “specified risk material” has the same meaning as in section 6.1.

19. The French version of the Regulations is amended by replacing “fumier” with “fumier animal” wherever it occurs in the following provisions:

(a) subsection 47.1(2);

(b) subsections 47.1(5) to (8); and

(c) subsection 105(3).

COMING INTO FORCE

20. (1) These Regulations, except sections 6 to 19, come into force on the day on which they are registered.

(2) Sections 6 to 19 come into force on the earlier of June 30, 2009 and the day on which the Certain Ruminants and Their Products Importation Prohibition Regulations, No. 2 (see footnote 4) are repealed.

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issue and objectives

The import requirements related to the control of Bovine Spongiform Encephalopathy (BSE) for animal products and by-products originating in the US set out in the Health of Animals Regulations are currently not in line with those from other countries. Because of this, as an interim measure, a ministerial regulation prohibiting the importation of higher risk animals and products from the United States was made by the Minister of Agriculture and Agri-Food in January 2004, and has been amended since then.

The objective of this regulatory amendment is to

• fully implement the BSE Import Policy with respect to animal products and by-products from the US
• base the import requirements for products and by-products from the US on the existing permit system

Description and rationale

The purposes of the Health of Animals Act and its Regulations are: to prevent the introduction of animal diseases into Canada; to control and eliminate diseases in animals that either affect human health or could have a significant effect on the Canadian livestock industry; and, to provide for the humane treatment of animals during transport.

BSE, or “mad cow disease,” is a progressive, fatal neurological disease in cattle. It is part of a group of diseases known as transmissible spongiform encephalopathies (TSEs) which also includes scrapie in sheep, chronic wasting disease in deer and elk and variant Creutzfeldt-Jakob disease (vCJD) in humans. Research into BSE is ongoing, but this disease has been associated with the presence of an abnormal prion protein and, to date, there is no effective treatment or vaccine.

In response to the discovery of BSE in North America, the Canadian Food Inspection Agency (CFIA) has moved to strengthen Canada’s BSE-related control measures including removal of specified risk material (SRM) from cattle at slaughter and enhancing the animal feed ban. As well, over a period of two and a half years, the CFIA conducted a comprehensive analysis and consultation, including notification by the World Trade Organization, leading to the development of a revised BSE import policy for bovine animals and their products, which fully considers current science-based international standards for animal and public health protection and safe trade. This policy was published in December 2005 and can be found at: http://www.inspection.gc.ca/english/anima/heasan/policy/ie-2005-9e.shtml

While publication of the policy signified the future direction, and a mechanism already existed to allow implementation for countries other than the US, a regulatory amendment was required to initiate implementation for US animals and products because specific import conditions for the US are currently prescribed in regulations. As an interim measure, an emergency regulation prohibiting the importation of higher risk animals and products from the US has been in place, and amended, since January 2004.

On December 16, 2006, an amendment was published in the Canada Gazette, Part I that proposed to bring the import requirements related to the control of BSE for live animals as well as animal products and by-products originating in the US in line with those from other countries and to, thereby, eliminate the need for the ministerial regulation prohibiting the importation of bovine products from the US. The comments received demonstrated that minor modifications related to the criteria for the importation of animal products and by-products were needed. The provisions relating to the importation of live animals were retained and were final published in the Canada Gazette, Part II, on February 21, 2007. The provisions dealing with animal products and by-products have now been modified to incorporate the suggestions received during the consultation period.

The purpose of this amendment is to bring the import requirements related to the control of BSE for animal products and by-products originating in the US in line with those from other countries and to, thereby, eliminate the need for the ministerial regulation prohibiting the importation of U.S. bovine products. In order to accomplish this, the existing permitting system will serve as the basis for issuing permits for bovine animal products imported from the US. The permit conditions will now reflect the criteria set out in the BSE import policy for these products.

The amendment clarifies that the country of origin for animal products and by-products other than non-fertilized ova, semen or meat is the country in which the product or by-product has undergone processing that would prevent the introduction of serious diseases into Canada.

The definition of specified risk material in the Health of Animals Regulations, the Fertilizers Regulations and the Feeds Regulations, 1983 is modified to clarify that the named organs are not considered to be specified risk material if they are imported from countries that pose only a negligible risk for BSE.

An exemption is created to the prohibition against feeding SRM to animals in the case of people crossing the border with a pet who are, at the same time, importing pet food, pet chews or pet treats that are intended to be fed to the pet.

There are a number of significant benefits to relying primarily on the use of permits for certain ruminant products. They include:

— Increased flexibility — The use of import permits allows a more rapid response to changes in policy, following an appropriate consultation process, and enables the CFIA to respond to changing global patterns of disease and increasing requests for regionalisation and compartmentalisation in accordance with the World Organisation of Animal Health (OIE) guidelines.

— Greater control and traceability — The use of permits facilitates tracking and follow up in the event of a disease outbreak.

— Greater consistency — The use of permits brings Canada’s treatment of ruminant commodities from the US into line with Canada’s requirements for other countries by removing unique requirements and using the same system for the US. This will provide a greater assurance of applying Canada’s new BSE import policy for bovines and their products in a consistent manner.

— Comparability with other countries — Other key trading partners (e.g., Australia, New Zealand) also require permits for importation. The US, however, has confirmed that they are not able to move to a permitting system at this time.

— Facilitation of compliance verification — The use of permits enhances the Canada Border Services Agency’s awareness of the importance of an importation since the information on the permit application will be available prior to the shipment taking place.

Importing with the use of a permit is already either required or available as an option under the regulations today for ruminant animals and some of their products. The anticipated increase in the volume of imports entering the country via this permit system will be subject to existing fees (reference CFIA Fees Notice) and five-day service standard.

It should be noted that permits will not be needed for meat shipments as all requirements can be included on the export certificate.

It is not expected that moving the requirements related to the transport of veal calves from the Meat Inspection Regulations, 1990 will have any significant impact on producers, transporters or abattoirs, as these requirements were already in place.

Overall, this option is expected to result in net positive benefits to consumers, to Canada’s multi-billion animal-based industries and to our trading partners. This option provides the most opportunities for an efficient and responsive system in the complex and dynamic global environment in which Canada manages animal disease transmission and related human health risks.

Consultation

A “Draft BSE import policy for bovine animals and their products” was released for comment by Canadians and by Canada’s trading partners in May 2005. Twenty comments were received during the 60-day comment period, 14 from organizations/ industries, four from trading partners and two from private individuals. The comments were generally very supportive and did not raise substantive issues.

With respect to the issuance of permits, the US has been informed of the proposal and has not raised objections in general. The provinces were also consulted and were supportive. Comments from industry associations indicated that they would support this approach.

The regulatory requirements in this amendment were pre-published in the Canada Gazette, Part I, on December 16, 2006 with a 30-day comment period. Nine comments were received from interested organizations and individuals, including the United States Department of Agriculture (USDA). The comments dealt almost exclusively with the portions of the proposed regulation dealing with animal products and by-products. There were concerns that the proposed requirements would impose permit and certification requirements on the imports of some products that should fall outside the scope of the BSE import policy (such as cats and dogs, which pose very little risk) and that the wording of the country of origin provision was unclear.

Based on the comments received, these provisions were re-examined. The provisions related to the regulation of imports of live animals were published in the Canada Gazette, Part II, on February 21, 2007, and the current amendment contains the refined provisions dealing with animal products and by-products. These modifications respond to the comments provided during pre-publication.

The wording of the country of origin provision is clarified.

The definition of SRM is amended to reflect the fact that certain tissues (such as brain and spinal cord) can be considered to be SRM if they come from a controlled risk country but the same tissues are not considered to be SRM if they come from a negligible risk country. This is in accordance with the standards for SRM as outlined by the OIE.

As well, in response to comments received from the USDA and the pet food, gelatine and blood industries, the provisions were revised to ensure that they applied only to those species of animals susceptible to BSE and to ensure that they were not more restrictive than necessary in order to achieve the appropriate level of protection for Canada.

Implementation, enforcement and service standards

These changes do not affect the CFIA’s compliance and enforcement policies. Regulatory infractions, including those related to the need to obtain a permit and to comply with the conditions on that permit, will continue to be identified by field staff and addressed in accordance with their regulatory inspection authorities or forwarded to CFIA Enforcement and Investigation Services for consideration and enforcement action.

Contact

Dr. D. Barr
Animal Health and Production Division
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Telephone: 613-221-4608
Fax: 613-228-6630

Footnote a
S.C. 2002, c. 28, s. 83

Footnote b
R.S., c. F-9

Footnote c
S.C. 2002, c. 28, s. 84

Footnote d
R.S., c. F-10

Footnote e
S.C. 1993, c. 34, s. 76

Footnote f
S.C. 1990, c. 21

Footnote 1
SOR/83-593

Footnote 2
C.R.C., c. 666

Footnote 3
C.R.C., c. 296; SOR/91-525

Footnote 4
SOR/2006-168