Vol. 152, No. 1 — January 6, 2018
Regulations Amending the Health of Animals Regulations
Health of Animals Act
Canadian Food Inspection Agency
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
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 potentially 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) Make the Minister’s authority explicit to amend permits or licences, which may be necessary to reflect an increase or decrease in the level of risk or where new information in relation to a disease becomes known;
- (v) Add the explicit reference to general permits in the HAR so that general permits referenced by the Act can be issued; 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- (vi) Remove the requirement referring to the former Canadian Environmental Assessment Act (CEAA), which was repealed when the Canadian Environmental Assessment Act, 2012 (CEAA 2012) came into force.
The Canadian Food Inspection Agency (CFIA) is responsible for regulating and managing the risks associated with federally regulated diseases in farmed 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 and international trade purposes. (see footnote 1) Zoning allows the trade constraints to be limited to discrete geographic areas instead of them being applied at the commodity level regardless of where the disease originates in Canada. This helps keep market opportunities open for Canadian producers during a disease outbreak while protecting plant and animal health.
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.
In addition to the proposed consequential amendments to the HAR discussed below, consequential amendments to the Agriculture and Agri-Food Administrative Monetary Penalties Regulations and the Compensation for Destroyed Animals Regulations will proceed concurrently. These consequential amendments of other CFIA regulations are required to 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.
These proposed amendments would 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 are required to
- Reflect the new requirement of permits under the Act and authorize the amendment of permits after their issuance;
- Clarify provisions authorizing the issuance of general permits and licences under the Act; and
- Remove a reference to a federal statute that has been repealed, i.e. the Canadian Environmental Assessment Act (CEAA).
These proposed amendments would remove redundancies respecting eradication and control areas, align the permit requirements of the Act so that permits are issued on the same basis as the licences and permits required by the HAR, and enable effective disease management controls within a zone.
These consequential amendments would 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 (NAAHP) would remain in the Regulations 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;
- Repealing the concept of a “control area” in 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 Regulations. 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. None of the requirements of section 160 would change. The word “Act” would be 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 explicit 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 would be applicable to all licences and permits issued under the Act; and
- Clarifying the language of section 160 so the provision would authorize the issuance not only of individual permits and licences but also general permits and licences issued to a class of persons required to manage zones.
The repeal of the CEAA would be reflected by removing the words “subject to paragraph 37(1)(b) of the Canadian Environmental Assessment Act” from subsection 160(1.1).
These proposed amendments are consequential in nature, would not impose any new requirements, and would have no economic impacts. There would be no direct costs as a result of the proposed 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. These amendments would not increase compliance or administrative burden on or costs to small businesses.
The proposed amendments that would eliminate reference to eradication areas for pullorum disease and fowl typhoid would 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 would not alter the need for a permit or licence to operate a hatchery, but would eliminate confusion by removing irrelevant text that refers to the historical eradication areas that now encompass all of Canada.
The proposed amendment that would add an explicit authority for the Minister to amend permits would have no economic impacts on the CFIA since the process for issuing permits and licences remains status quo before and after the amendment. Further, there are no economic impacts on stakeholders since the application process for amendments to permits and licences would not change. 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. The processes for applying for an amendment and for issuing amendments to permits and licences are already in place within the three units and would not change under the proposed amendment to the Regulations.
The ‘‘One-for-One’’ Rule would not apply to this proposal, as there is no change in administrative costs to businesses. None of the regulatory requirements related to administrative activities would change. Stakeholders would only see administrative costs when the legislative authority is exercised and a control zone is established in response to a disease outbreak. Administrative costs would 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. These proposed amendments would not change these requirements. The addition of the word “Act” would cover the new legislative framework for the issuance of permits when a primary control zone is declared. These amendments would 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 framework for the legal and administrative establishment of geographic zones of varying disease status. The permits/licences would only be issued as required should such a zone be established.
Small business lens
The small business lens does not apply to this proposal, as there are no costs to small businesses. These proposed amendments would not change compliance or administrative burden on or costs to small businesses. The only change is the legal framework under which these control measures are established and managed. Small businesses would only see costs when the legislative authority is exercised and a control zone is established in response to a disease outbreak. However, the compliance and administrative costs associated with these control measures would have been incurred under the current regime.
These proposed regulatory amendments are consequential in nature and are not specific to one disease or any specific stakeholder groups. Industry and stakeholders have not been consulted on these specific amendments; however, the CFIA has previously performed consultations in 2014 to discuss options for managing animal diseases, including the use of zoning.
In general, 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.
These proposed amendments would serve to support the changes introduced to the Act in June 2012. These 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 proposed 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 proposed amendments, provisions in the HAR refer 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 would give the Minister authority to issue permits required by the Act on the same basis as permits and licences required by the HAR. They would also give the Minister explicit authority to amend permits or licences to reflect changes in the situation, such as the level of risk. The purpose of the proposed regulatory amendments is to enable effective interpretation of the Regulations, thus, of disease management, when a zone is created in response to an animal disease outbreak.
Implementation, enforcement and service standards
The implementation of the proposed Regulations would occur seamlessly since the proposed regulatory amendments are consequential in nature.
As a result of the changes to the Act, within Canada, geographic zoning would 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.
Dr. Penny Greenwood
Domestic Disease Control Section
Canadian Food Inspection Agency
59 Camelot Drive
PROPOSED REGULATORY TEXT
Notice is given that the Governor in Council, pursuant to section 64 (see footnote a) of the Health of Animals Act (see footnote b), proposes to make the annexed Regulations Amending the Health of Animals Regulations.
Interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Dr. Penny Greenwood, National Manager, Domestic Disease Control Section, Canadian Food Inspection Agency, 59 Camelot Drive, Ottawa, Ontario K1A 0Y9 (tel.: 613-773-7433; fax: 613-773-7574; email: AnimalHealth.Regs@inspection.gc.ca).
Ottawa, December 7, 2017
Assistant Clerk of the Privy Council
Regulations Amending the Health of Animals Regulations
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 (see footnote 2) 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 French version of the Regulations before subparagraph (i) is replaced by the following:
- a) l’exportateur a obtenu un certificat délivré par un vétérinaire-inspecteur ou un certificat délivré par un vétérinaire accrédité agréé à cette fin par un vétérinaire-inspecteur avant l’expédition, qui identifie clairement les animaux de ferme, la volaille, les embryons animaux ou le sperme animal et indique :
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
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 an accredited veterinarian endorsed by 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 mentioned 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 may 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.
(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 English version 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:
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.
Coming into Force
17 These Regulations come into force on the day on which they are registered.