Regulations Amending the Health of Animals Regulations (Zoning): SOR/2019-99

Canada Gazette, Part II, Volume 153, Number 9

Registration

SOR/2019-99 April 15, 2019

HEALTH OF ANIMALS ACT

P.C. 2019-324 April 12, 2019

Her Excellency the Governor General in Council, on the recommendation of the Minister of Agriculture and Agri-Food, pursuant to section 64 ^{footnote a} of the Health of Animals Act ^{footnote b}, makes the annexed Regulations Amending the Health of Animals Regulations (Zoning).

Regulations Amending the Health of Animals Regulations (Zoning)

Amendments

1 The definitions brucellosis-accredited area, brucellosis-free area, tuberculosis-accredited advanced area, tuberculosis-accredited area and tuberculosis-free area in section 2 of the Health of Animals Regulations ^{footnote 1} are repealed.

2 Paragraph 3(1)(c) of the Regulations is replaced by the following:

• (c) is in an eradication area or control zone, or

3 Paragraph 4(c) of the Regulations is replaced by the following:

• (c) is in an eradication area or control zone; or

4 The portion of paragraph 69(1)(a) of the Regulations before subparagraph (i) is replaced by the following:

• (a) the person has obtained, before shipment, a certificate issued by a veterinary inspector or a certificate issued by an accredited veterinarian that is approved in writing by a veterinary inspector, that clearly identifies the livestock, poultry, animal embryos or animal semen and shows

5 The headings “Eradication of Diseases” and “Eradication Areas” before section 73 and sections 73 to 75 of the Regulations are replaced by the following:

Eradication and Control of Diseases

Screening Tests

73.1 Every owner or person in charge of animals in an eradication area or control zone shall, when requested to do so by a veterinary inspector or by an accredited veterinarian with the approval of a veterinary inspector, permit tests for communicable disease to be conducted on the animals.

6 (1) Subsection 76(1) of the Regulations is replaced by the following:

76 (1) No person shall, without a permit issued by the Minister under section 160, move, or cause to be moved, a member of the Cervidae family from one place in Canada to another place in Canada.

(2) Subsection 76(3) of the Regulations is replaced by the following:

(3) Every person to whom a permit referred to in subsection (1) or (2) is issued, and every person to whose premises a member of the Cervidae family is moved under a permit, shall keep a copy of the permit.

7 (1) The portion of section 79 of the Regulations before the first definition is replaced by the following:

79 The following definitions apply in this section and sections 79.14 to 79.2.

(2) The definition eradication area in section 79 of the Regulations is repealed.

8 Sections 79.1 to 79.13 of the Regulations are repealed.

9 The portion of subsection 79.19(1) of the Regulations before paragraph (a) is replaced by the following:

79.19 (1) No person shall operate a hatchery unless

10 (1) The heading before section 80 of the Regulations is replaced by the following:

Outbreaks of Communicable Diseases

(2) Section 80 of the Regulations is repealed.

11 Section 90 of the Regulations and the heading before it are replaced by the following:

Segregation and Inspection

90 The Minister may order a person who owns or has the possession, care or control of any poultry, ruminant, or equine or porcine animal to segregate the animal and to have the animal inspected in any manner and for any communicable disease that the Minister specifies.

12 Subsection 104(2) of the Regulations is replaced by the following:

(2) If an animal is required to be destroyed under section 27.6, 37 or 48 of the Act, every person in charge of a conveyance in which the animal is subsequently carried shall, immediately after the animal is unloaded from the conveyance, clean and disinfect the conveyance under the supervision of an inspector at the nearest place where facilities for that purpose are available.

13 Section 114 of the Regulations is replaced by the following:

114 A veterinary inspector may order a person who owns or has the possession, care or control of an animal that has died of, or is suspected of having died of, a communicable disease or that is destroyed under section 27.6, 37 or 48 of the Act to dispose of the carcass in any manner that the veterinary inspector specifies.

14 (1) Subsections 160(1) and (1.1) of the Regulations are replaced by the following:

160 (1) Any application for a permit or licence required under the Act shall be in a form approved by the Minister.

(1.1) The Minister shall issue a permit or licence required under the Act if the Minister determines that the activity for which the permit or licence is issued would not, or would not be likely to, result in the introduction into or spread within Canada of a vector, disease or toxic substance or its introduction into another country from Canada.

(1.2) A permit or licence issued by the Minister under these Regulations may be issued as a general permit or licence to owners or persons having the possession, care or control of an animal or thing for which the permit or licence is issued.

(2) The portion of subsection 160(2) of the Regulations before paragraph (a) is replaced by the following:

(2) Any permit or licence required under the Act shall

(3) The portion of subsection 160(3) of the Regulations before paragraph (a) is replaced by the following:

(3) The Minister may cancel or suspend a permit or licence issued under the Act if he or she has reason to believe that

(4) Paragraph 160(3)(c) of the Regulations is replaced by the following:

• (c) failure to do so could result in the introduction into or spread within Canada of a vector, disease or toxic substance or its introduction into another country from Canada.

15 Section 160.1 of the Regulations is replaced by the following:

160.1 Every person who is subject to a permit or licence issued under the Act shall comply with the conditions contained in the permit or licence.

16 The Regulations are amended by adding the following after section 161:

Amendment

161.1 The Minister may, whether on his or her own initiative or on the application of the holder, amend a permit or licence issued under the Act if the amendment is made as the result of new information, or a change in circumstance, that has been brought to the Minister’s attention and does not increase the risk of the introduction into or spread within Canada of a vector, disease or toxic substance or its introduction into another country from Canada.

17 Section 197 of the Regulations is replaced by the following:

197 Every owner or person having the possession, care or control of an aquatic animal or a thing in an eradication area shall, when requested to do so by a veterinary inspector, by an inspector or by an accredited veterinarian with the approval of a veterinary inspector, permit tests to be conducted on the aquatic animal or the thing for any of the diseases listed in the schedule to the Reportable Diseases Regulations.

18 The French version of the Regulations is amended by replacing “vétérinaire inspecteur”, “inspecteur-vétérinaire” and “inspecteur vétérinaire” with “vétérinaire-inspecteur”, with any necessary modifications, in the following provisions:

• (a) the portion of subsection 5(1) before paragraph (a) and the portion of subsection 5(3) before paragraph (a);
• (b) subsections 69(4) and (5);
• (c) paragraph 70(1)(a), subparagraph 70(1)(a)(i) and subsections 70(3) and (4);
• (d) the portion of subsection 104(1) before paragraph (a);
• (e) subsections 109(1) and (2);
• (f) paragraph 122(4)(a);
• (g) subsections 128(4) and (6);
• (h) paragraph 129(1)(a);
• (i) section 150;
• (j) subsections 152(2) to (4);
• (k) section 155;
• (l) paragraph 198(1)(a) and subparagraph 198(2)(a)(ii).

Coming into Force

19 These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

The Health of Animals Act (the Act) was amended in 2012 to enable the establishment of flexible, geographically defined zones for the purpose of eradicating foreign animal diseases or controlling diseases that have become established in certain parts of Canada and that impact (or could potentially impact) the animal sector.

To align with the changes in the Act, consequential amendments to the Health of Animals Regulations (HAR) are required to

• (i) address redundancies between the Act and section 80 and Part IX of the HAR to improve clarity in terminology and remove conflicting requirements;
• (ii) remove references to eradication areas as future outbreaks of these diseases could be managed using the new zoning authorities;
• (iii) give the Minister authority to issue permits required by the Act on the same basis as permits and licences issued under the HAR;
• (iv) authorize the Minister to amend permits or licences, which may be necessary if there is a change in circumstance (e.g. an increase or decrease in the level of risk) or where new information in relation to a disease becomes known;
• (v) add the reference to general permits in the HAR to provide that permits or licences issued by the Minister under the Act may be issued as general permits or licences; and
• (vi) remove the requirement referring to the former Canadian Environmental Assessment Act (CEAA), which was repealed when the Canadian Environmental Assessment Act, 2012 (CEAA 2012) came into force.

Background

The Canadian Food Inspection Agency (CFIA) is responsible for regulating and managing the risks associated with federally regulated diseases in animals. There are several infectious regulated animal diseases in specific geographic areas of Canada or the associated oceans that presently exist or that could cause a significant outbreak. Some of these diseases can pose significant constraints for a particular livestock sector due to public health concerns or can result in negative impacts on trade in animals and animal products if not controlled or eradicated.

Prior to the 2012 amendments to the Act, animal diseases in Canada were managed using the concept of zoning through the existing regulatory framework, which did not allow the CFIA to actually officially declare “zones,” but rather permitted the establishment of “control areas” through ministerial regulation. There were no legislative or regulatory authorities available to

• (a) declare geographic containment zones for endemic diseases (i.e. diseases present in a particular population, environment, or region) other than for bovine tuberculosis and brucellosis;
• (b) establish protection zones along the Canada–U.S. border, as necessary, for monitoring of any disease in the United States; or
• (c) remove declarations of infected places if an area was declared to be endemic for the disease.

Amendments to the Act in June 2012 gave the Minister the authority to use zoning as a tool for animal disease control, where it would be an appropriate response. These amendments to the Act introduced a zoning framework aligned with international guidelines (World Organisation for Animal Health [OIE]) that creates greater flexibility for the management of a variety of diseases.

Zoning aims to provide the flexibility to implement stringent controls to prevent the spread of a variety of diseases from high-risk parts of the country. It is the separation (based on geographic criteria within national boundaries) of an animal subpopulation with a distinct health status for disease control.

Examples of possible situations where zoning may be an appropriate risk management response would be the declaration of zones for the control of a foreign animal disease, such as foot and mouth disease in multiple species; or the declaration of zones for the control of domestic diseases, such as small hive beetle of bees or equine infectious anemia.

Under the new legislation, zoning was successfully applied in Canada for the first time in December 2014 during the highly pathogenic avian influenza outbreak in British Columbia. It was also used in other countries affected by outbreaks of foot and mouth disease or avian influenza and has allowed the affected countries to maintain exports while managing disease-affected zones within their national boundaries. The United States, Mexico, the European Union member countries, South American countries, and Australia have all applied zoning as a disease control measure.

In January 2013, under the Canada–United States Regulatory Cooperation Council, Canada and the United States agreed to an approach for the mutual recognition of zones during highly contagious foreign animal disease outbreaks. In practice, the arrangement will mean that if the CFIA were to identify a specific geographic zone as infected, the United States Department of Agriculture would continue to allow imports of live animals, animal products and by-products from the (non-zoned) disease-free areas of Canada. Once Canada releases the zone, the United States would allow trade to resume from that area. Reciprocal arrangements would apply in the case of zones established anywhere in the United States. This arrangement reduces impediments to trade and commerce during animal disease outbreaks by allowing the businesses outside of zoned areas to be able to continue exporting their products.

Objectives

These amendments align the HAR with the zoning elements that were introduced in the Act in 2012 and eliminate confusion in the interpretation of the HAR and the Act. In addition, these amendments

• reflect the new requirement of permits under the Act and authorize the amendment of permits and licences after their issuance;
• provide for the issuance of general permits and licences under the HAR; and
• remove a reference to a federal statute that has been repealed, i.e. the Canadian Environmental Assessment Act.

Description

These amendments remove redundancies respecting eradication and control areas, enable zoning permits required by the Act to be issued on the same procedural basis as the licences and permits required by the HAR, and enable effective disease management controls within a zone.

These consequential amendments reflect the introduction of zoning to the Act by

• repealing references pertaining to “eradication areas” in the HAR for bovine tuberculosis, bovine brucellosis and pullorum disease because these historical diseases have equivalent status in all areas of Canada. However, provisions referencing eradication areas for the National Aquatic Animal Health Program remain in the HAR for the present time, as these eradication areas are still relevant since the watersheds and the coastal waters across Canada are not all of equivalent disease status;
• removing the concept of a “control area” by repealing section 80 due to the redundancy created by the introduction of zoning authorities in the Act;
• amending provisions in the HAR relating to the issuance of permits or licences to include a reference to the Act since the permits used when a control zone is declared are required by the Act and not the HAR. All permits and licences required and issued for the control of animal disease have been and will continue to be issued in accordance with section 160 of the HAR. The word “Act” is added to certain provisions in order to provide clarity respecting the movement controls that may be imposed through the use of permits when zoning is used to control and/or eradicate an animal disease;
• amending wording to enable permits required by the Act to be issued consistently with those required by the HAR;
• providing authority for the Minister to amend a licence or permit in order to, as an example, reflect changes in the level of risk of the licensed or permitted activity. This authority is applicable to all licences and permits issued under the Act; and

The repeal of the CEAA is reflected by removing the words “subject to paragraph 37(1)(b) of the Canadian Environmental Assessment Act” from subsection 160(1.1).

In addition to the consequential amendments to the HAR discussed above, consequential amendments will be made to the Agriculture and Agri-Food Administrative Monetary Penalties Regulations and the Compensation for Destroyed Animals Regulations. These consequential amendments provide the Minister with the authority to issue notices of violations and to grant compensation for animals destroyed under the new zoning provisions of the Act.

Benefits and costs

These amendments are consequential in nature, do not impose any new requirements, and have no economic impacts. There are no direct costs as a result of the regulatory amendment themselves.

Disease control or eradication measures are currently undertaken when a foreign animal disease enters Canada. The only change is the legal framework under which these control measures are established and managed.

The amendments that eliminate reference to eradication areas for pullorum disease and fowl typhoid do not change the burden for stakeholders operating poultry hatcheries across Canada, as there is no effect on the status quo. Pullorum disease and fowl typhoid have been successfully eradicated from Canada, thus all of Canada is regulated as a single eradication zone. Therefore, all hatcheries are required to possess a permit and meet the requirements established in the HAR to maintain disease-free status. Removing the reference to the eradication area does not alter the need for a permit or licence to operate a hatchery, but does eliminate confusion by removing irrelevant text that refers to the historical eradication areas that now encompass all of Canada.

The amendment that authorizes the Minister to amend permits and licences has no economic impact on the CFIA since the process for issuing permits and licences remains status quo before and after the amendment. There are three units in the CFIA that are responsible for permitting and licensing under the HAR: the Centre of Administration for Permissions, the Pre-market Application Submissions Office and the Animal Health Directorate.

“One-for-One” Rule

The “One-for-One” Rule does not apply to this proposal, as there is no change in administrative costs to businesses. None of the regulatory requirements related to administrative activities have changed. Stakeholders will only see administrative costs when the legislative authority is exercised and a control zone is established in response to a disease outbreak. Administrative costs will only be experienced during times of a disease management response, and only for those located within a control zone. However, these costs would have been incurred under the current regime.

Permits and licences have been and continue to be required and issued under the HAR. The amendments do not change these requirements. The addition of the word “Act” covers the new legislative framework for the issuance of permits when a primary control zone is declared. These amendments enable permits required by the Act to be issued consistently with those required by the HAR. In the changes introduced into the Act in June 2012, the zoning framework mentions permits that would be issued directly under the authority of the Act. In and of themselves, the changes of the Act did not introduce new requirements for permits/licences. Rather, the changes introduced a new legal framework for the establishment of geographic zones of varying disease status. The permits/licences would only be issued should such a zone be established.

Small business lens

The small business lens does not apply to this proposal, as there are no compliance or administrative costs to small businesses. The amendments only change the legal framework under which these control measures are established and managed. Small businesses will only see costs when the legislative authority is exercised and a control zone is established in response to a disease outbreak.

Consultation

These regulatory amendments are consequential in nature and are not specific to one disease or any specific stakeholder groups. The CFIA previously performed consultations in 2014 to discuss options for managing animal diseases, including the use of zoning.

The National Farmed Animal Health and Welfare Council and the Canadian Animal Health Coalition support the CFIA in adopting and implementing international standards for disease response, eradication and control. These stakeholder groups expect the CFIA to have the authority to establish zones in Canada to manage regulated diseases.

Depending on the scenario, for long-term zoning programs, those industries and provinces and territories impacted by the establishment of the zone will be consulted. In the case of emergency response to a foreign animal disease, the CFIA will not conduct consultations before taking action.

A 30-day consultation period in Part I of the Canada Gazette took place from January 6, 2018, to February 4, 2018, for these amendments. In total, five comments were received from a provincial government. This stakeholder sought clarification on how the proposed amendments affect the CFIA’s use of control zones. The CFIA provided explanations that the changes are consequential in nature and limited to removing what is made redundant by the zoning provisions of the Act. Several comments were made to ensure consistency and accuracy of terms used in the French text of the HAR. In particular, the inconsistent use of the French terms “vétérinaire inspecteur,” “inspecteur-vétérinaire,” and “inspecteur vétérinaire” is replaced throughout the French version of the HAR with “vétérinaire-inspecteur,” which is consistent with its use in the Act.

Rationale

These amendments would serve to support the changes introduced to the Act in June 2012. The changes allow a more efficient and effective approach to the eradication or control of certain animal diseases that are limited to specific geographic regions of Canada. This approach to eradication or control is in accordance with acceptable international standards and models.

The amendments are needed to repeal historical references pertaining to “eradication areas” in the HAR for bovine tuberculosis, bovine brucellosis and pullorum disease because these diseases have equivalent status in all areas of Canada. Therefore, there is no longer a need for eradication areas to be established.

Without these amendments, provisions in the HAR referred only to permits and licences required by the HAR; however, permits, including general permits, can now be required under the Act when a primary control zone is declared. These amendments give the Minister authority to issue permits required by the Act on the same procedural basis as permits and licences required by the HAR. They also give the Minister authority to amend permits or licences to reflect changes in the situation, such as the level of risk. The purpose of the regulatory amendments is to enable effective disease management when a zone is created in response to an animal disease outbreak.

Implementation, enforcement and service standards

The implementation of the HAR would occur seamlessly since the regulatory amendments are consequential in nature.

As a result of the changes to the Act, within Canada, geographic zoning will be implemented when evidence has deemed it as an effective and efficient tool to address specific circumstances. The applicability of zoning is species and disease dependent, necessitating a case-by-case examination of each proposed protective step. A zoning plan must consider factors such as incubation period, mode and ease of transmission, host range, husbandry, demographics and movement, and geographic and climatic influences. The establishment of a geographic zone and its size, location, and delineation would depend on the disease, its method of spread, and sector-specific management practices and densities; therefore, of the potential disease distribution within the country. Surveillance and disease control programs will continue in zones where the disease is not known to exist or within a control zone if the object is to eradicate the disease.

Contact

Dr. Penny Greenwood
National Manager
Domestic Disease Control Section
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Telephone: 613‑773‑7433
Fax: 613‑773‑7574
Email: AnimalHealth.Regs@canada.ca