Regulations Amending the Health of Animals Regulations: SOR/2021-41

Canada Gazette, Part II, Volume 155, Number 7

Registration
SOR/2021-41 March 18, 2021

HEALTH OF ANIMALS ACT

P.C. 2021-154 March 17, 2021

His Excellency the Administrator of the Government of Canada in Council, on the recommendation of the Minister of Agriculture and Agri-Food, pursuant to paragraph 64(1)(a) footnote a of the Health of Animals Act footnote b, makes the annexed Regulations Amending the Health of Animals Regulations.

Regulations Amending the Health of Animals Regulations

Amendments

1 The Health of Animals Regulations footnote 1 are amended by adding the following after section 2:

2.1 For the purposes of interpreting any document prepared by the Agency that is incorporated by reference into these Regulations, words and expressions that are used but not defined in that document have the same meaning as in these Regulations.

2 (1) The definition germplasm in section 190 of the English version of the Regulations is replaced by the following:

germplasm
means semen, male or female germ cells, or genetic material taken from a male or female germ cell for the purpose of producing a zygote. (matériel génétique)

(2) Section 190 of the Regulations is amended by adding the following in alphabetical order:

Susceptible Species of Aquatic Animals List
means the document entitled Susceptible Species of Aquatic Animals that is published on the Agency's website, as amended from time to time. (liste des espèces d'animaux aquatiques vulnérables)

3 Paragraph 192(1)(a) of the Regulations is replaced by the following:

4 Subsection 195(1) of the English version of the Regulations is renumbered as section 195.

5 Schedule III to the Regulations is repealed.

6 The Regulations are amended by replacing “listed in Schedule III” with “set out in the Susceptible Species of Aquatic Animals List”, with any necessary modifications, in the following provisions:

Coming into Force

7 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

Aquatic animal diseases have the potential to seriously impact wild and farmed aquatic animal resources, the Canadian economy and international trade. The Canadian Food Inspection Agency (CFIA) implements import and domestic disease control programs to prevent the introduction into, or spread within, Canada of aquatic animal diseases of finfish, molluscs and crustaceans in this quickly changing environment.

As a member of the World Trade Organization (WTO), under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), Canada must base its sanitary and phytosanitary measures (SPS) on international standards, guidelines and recommendations where they exist, unless there is scientific justification to maintain SPS measures that achieve a higher level of SPS protection. As the science of susceptibility to diseases is constantly evolving, changes in international standards for the prevention of the spread of aquatic diseases through trade can occur quickly. The WTO SPS Agreement recognizes the World Organisation for Animal Health (OIE) as the international standard-setting body for animal health and zoonosis standards, guidelines, and recommendations. The OIE regularly updates the OIE Aquatic Animal Health Code (OIE Code) as new scientific information comes to light.

Schedule III of the Health of Animals Regulations (HAR) lists aquatic animal species (finfish, molluscs and crustaceans) that are susceptible to diseases of national and international significance. Schedule III is a static list that has not been updated since 2010. A comparison of Schedule III to the 2018 OIE Code revealed that the two are no longer aligned. Seven species currently listed in Schedule III are not listed in the OIE Code as they are no longer considered susceptible to an OIE listed disease. Additionally, 12 species that are currently included in the OIE Code are not listed in Schedule III.

In order to reduce the threat of aquatic diseases being introduced into Canada, remove unnecessary burden on importers, and ensure that it continues to meet its WTO obligations, CFIA must maintain and update its list of susceptible aquatic animal species to reflect changes made to the OIE Code.

Background

In 2010, CFIA implemented changes to the HAR to extend the authorities to include aquatic animals and allow for the establishment of Canada's National Aquatic Animal Health Program (NAAHP). These regulatory changes made CFIA the internationally recognized competent authority for aquatic animal health for Canada and gave it the authority to require mandatory reporting of diseases and implement import and domestic disease control programs to prevent aquatic animal diseases from being introduced into, or spread within, Canada.

The 2010 HAR amendments added Schedule III, which is a list of aquatic animals regulated for import that were susceptible to diseases of national and international significance as listed in Schedule VII and VIII of the HAR as well as the Reportable Diseases Regulations. Schedule III was intended to ensure specificity for Canadian importers on which species were subject to import controls (i.e. permits) to prevent introduction of regulated diseases in accordance with the OIE standards.

Subject to a few exceptions, aquatic animals listed in Schedule III need a valid CFIA import permit to be eligible for import into Canada. The permit contains requirements that apply to the importer in Canada as well as the disease-related requirements that must be undertaken in the exporting country. CFIA negotiates export certificates with the Competent Authority in exporting countries which contain the animal health-related requirements that must be met prior to import.

Objective

The objective of the amendments is to repeal Schedule III of the HAR and include an ambulatory reference to a list of susceptible species of aquatic animals. This new list will update the Regulations to align them with the 2018 OIE Code by adding 12 susceptible species of aquatic animals to the Regulations and removing 7 species. Aligning the Regulations with the 2018 OIE Code will reduce the risk of introducing disease into Canada by adding animal health requirements for susceptible species, avoid challenges from international trading partners on Canada's certification requirements for species not listed by the OIE, and remove the requirement for the renewal of permits for species that are not susceptible to disease.

Incorporating the list of susceptible species by reference will also support CFIA's responsive regulatory system and allow it to regularly update the Susceptible Species of Aquatic Animals List in response to changes in international standards and thereby help prevent the introduction of aquatic disease into Canada.

Description

Schedule III — Susceptible Species of Aquatic Animals

Schedule III of the HAR is a static list of susceptible species that, as per section 191 of the HAR, require a CFIA import permit to prevent disease introduction. The list includes 235 species of finfish, 54 species of molluscs and 116 species of crustaceans. To align with the 2018 OIE Code, 7 (Acipenser transmontanus, Aulorhynchus flavidus, Leuciscus idus, Maccullochella peelii, Poecilia reticulate, Salvelinus leucomaenis, and Tinca tinca) susceptible species of aquatic animals will be removed from and 12 (Cyclopterus lumpus, Gambusia holbrooki, Lampetra planeri, Melanotaenia fluviatilis, Notemigonus crysoleucas, Pungitius pungitius, Rutilus kutum, Rutilus frisii, Salmo marmoratus, Salmo obtusirostris, Sander lucioperca, and Palaemonetes pugio) will be added to the list.

The amendments will incorporate by reference the list of susceptible species of aquatic animals.

The document incorporated by reference will be adjusted from time to time to reflect any changes made to the OIE Code. This list will be published on CFIA's website and follow CFIA's incorporation by reference policy when updated.

Minor amendments

Aquatic animals may be imported without a permit, provided they are to be used as pets and they meet the conditions for such an exemption under section 192 of the HAR. The list of aquatic animals in this section currently includes Poecilia reticulata or the guppy. As this species is no longer susceptible to an OIE disease, it is not listed in the OIE Code and will no longer require an import permit, a minor change to section 192 will be made to delete the reference to Poecilia reticulata.

In addition, minor amendments will be made to remove reference to Schedule III and replace it with the Susceptible Species of Aquatic Animals List.

Regulatory development

Consultation

Significant consultations were conducted with Canadians and international trading partners from 2007 to 2009 prior to completion of the 2010 amendments to the HAR. These amendments included the addition of Schedule III. As the original regulatory amendments represented a major regulatory change with high impacts, face-to-face cross-country consultations were completed with all affected stakeholders. In addition, the WTO was notified of the changes, and they were prepublished in Part I of the Canada Gazette for stakeholder comment. They were subsequently published in Part II of the Canada Gazette in 2010.

To gather greater insight into the costs and benefits of this regulatory change, CFIA conducted a survey in winter 2020. The survey included 12 businesses that had been identified as having imported one of the 12 species proposed to be added to the Susceptible Species of Aquatic Animals List. In total, five responses were received. Two of the respondents indicated that despite the declaration of import, they had not actually imported any of the 12 species (i.e. new) being added and, therefore, did not participate further in the survey.

For the three remaining respondents, one self-identified as a large business and the other two self-identified as small businesses, per the definition of the Treasury Board Secretariat of Canada. One of the small businesses indicated that only a sample of one of the species was imported and that they did not plan to further import that species. Therefore, there remained a total of nine importers that were identified as potentially impacted. Overall, none of the nine stakeholders expressed concerns about being impacted.

In line with the WTO SPS Agreement transparency obligations, the WTO Committee on Sanitary and Phytosanitary Measures will be notified of the changes.

Instrument choice

Status quo

As a signatory to the SPS Agreement, CFIA must update its list of susceptible aquatic animal species to align it with the currently adopted OIE Code.

Currently, CFIA is unable to require permits for some susceptible species, and risks the introduction of disease that can negatively impact Canada farmed and wild aquatic resources. In addition, Canada will remain vulnerable to trade challenges for controlling species that are not susceptible to disease nor listed in the OIE Code. Both scenarios could result in trade disruption for Canada in the aquatic animal, fish and seafood sectors.

Regulatory amendment and incorporation by reference option

The regulatory option, which utilizes incorporation by reference, will align the Regulations with the OIE Code and enable CFIA to make regular updates to its list of susceptible species in the future. These amendments will thereby support CFIA in meeting its international obligations and reduce the risk related to the introduction of aquatic animal diseases in Canada.

Regulatory analysis

Benefits and costs

This section assesses the incremental impacts (i.e. costs and benefits) resulting from the difference between the baseline and the regulatory scenarios.

Baseline scenario

As per Part XVI (Aquatic Animals) of the HAR, all aquatic animals are currently regulated, but only those that are listed in Schedule III require an import permit, unless exempted under sections 192 and 193. This list was last updated in 2010 and is a static list (not ambulatory). Unless exempt, all regulated parties wishing to import a species listed in Schedule III must obtain a permit from CFIA because those species pose a risk of introduction and spread of aquatic animal diseases. Import permits stipulate the requirements to mitigate the introduction of diseases to Canada. Without the amendments in the regulatory scenario, the list will remain static and not aligned with a current list of species susceptible to disease, set out by the OIE Code.

Regulatory scenario

In the regulatory scenario, Schedule III of the HAR will be repealed and replaced by the incorporated by reference susceptible species of aquatic animals list to ensure that Canada follows through on its commitment to the OIE. The incorporation by reference will use the 2018 OIE Code and will result in 12 species being added to the HAR and 7 species removed.

The OIE Code is typically updated on an annual basis, including review of susceptible species. Changes to the listed species in the Code occur as a result of the recommendations of an expert group that reviews scientific information on species susceptibility. Member countries (including Canada) have an opportunity to comment once a list is presented and before it is proposed for adoption by the World Assembly of Delegates at its annual general meeting.

Affected stakeholders

While the intent was to complete a full cost-benefit analysis, given the low number of impacted stakeholders and even weaker responses to the survey, this was not achievable. As a result, a qualitative analysis was completed. However, to assess and quantify the administrative burden, the survey data has been used.

The following stakeholders will be impacted:

Methodology

To assess impacts, CFIA conducted a survey in winter 2020 of the 12 businesses that had been identified as likely having imported one of the 12 species proposed to be added in Schedule III. The respondents were identified based on historical data from a CFIA import database. After several follow-up attempts, five responses were received.

Two of these respondents indicated that they had not imported any of the 12 species. Another respondent (one business) indicated that only a sample was imported and that there is no plan to further import that species. These businesses were therefore removed from being considered for the cost-benefit analysis. Thus a small number of businesses, nine in total, were identified as being impacted.

Alignment with the 2018 OIE Code results in

As with other species currently listed in the HAR, the addition of the new species will mean that an importer will require permits if

Within the 9 businesses impacted by this change, CFIA's import database along with survey results indicate that 7 small businesses have imported one or more of the 12 species proposed for addition to the OIE Code. The data also indicates that these seven importers had not previously required a permit for any other regulated species and, therefore, will be impacted if applying for a permit once the species is listed. Finally, the data indicates that two of the nine importers (including one small business) have had a permit for other susceptible species of aquatic animals.

As a result, and for the purposes of the analysis presented below, it is assumed that of the nine businesses being identified as impacted

It is also assumed that the removal of the seven species does not result in cost savings because these permits contain multiple regulated species. Therefore, the businesses holding the permits will continue to renew them for the other species they import.

Qualitative benefits

The repeal of Schedule III and the incorporation by reference of an ambulatory list of susceptible species that is updated to align with the OIE Code is estimated to benefit Canadians and potentially some businesses importing aquatic species. Benefits are listed below by theme, and include which stakeholder is impacted.

Potential cost savings: renewal of permits for removed species

Stakeholder: businesses importing aquatic species

As a result of the removal of the seven species, there was the potential for importers to be relieved from the costs of having a permit. Fifteen importers will have been relieved from the requirement to obtain an import permit; however, CFIA's data indicates that these businesses already hold a permit for at least one other listed species currently on Schedule III. As there is no cost incurred for removing a species from a permit when the permit is issued for multiple species, there will be no cost reduction for the 2018 OIE alignment.

Reduced risk of disease introduction

Stakeholder: Canadians

It is estimated that the risk of aquatic animal diseases entering via import into Canada will be minimized. The species that are internationally recognized as susceptible to disease will be listed in the new ambulatory list which will align Canada's list of species that require an import permit with the OIE standards.

Currently, Schedule III does not include 12 species that are in the OIE Code and are considered susceptible to disease. As a result, these species currently do not require an import permit and are not subject to the import requirements to prevent disease introduction into Canada.

The alignment of the list with OIE standards will mean the import of the additional 12 species will need import permits and export certification from the foreign country of origin as being free of disease. Once this change is made, it is estimated that any risks associated with the introduction of disease through imports will be minimized.

Maintain Canada's reputation with international organizations

Stakeholder: Canadians

Canada is seen as a global leader in the area of aquatic animal health and is often asked to assist other countries that are seeking to strengthen their aquatic animal health regulatory controls. It is estimated that with these amendments, Canada will support its international reputation as a science-based regulator.

Qualitative costs
Fee costs for import permit applications and ongoing permit renewals incurred by importers to align with the 2018 OIE list

Stakeholder: businesses importing aquatic species

The repeal of Schedule III and incorporation by reference of a list of susceptible species of aquatic animals will result in an immediate addition of 12 new aquatic species. The addition of these new species will mean that importers will require permits if

In other words, if an importer is importing one of the 12 species that is currently listed in the OIE Code, they will be required to apply for an import permit if they do not already have a valid one. Importers are charged a fee for import permit applications associated with the proposed incorporation by reference. The fee charged by the CFIA is $65 for a new permit application. The cost for an annual permit renewal is $65.

For importers who already have an import permit for listed species other than the 12 and are requesting modification of the permit (e.g. to add a new species), there is no additional fee. A fee associated with an import permit is a flat fee, regardless of the number of species included.

In the first year, seven new applications are anticipated because there are seven businesses that have imported at least one of the newly added species in the past. These seven businesses will incur a fee of $65. In the future, a $65 fee will be charged to annually renew these permits.

Administrative costs for import permit applications and ongoing permit renewals incurred by importers to align with the 2018 OIE Code

Stakeholder: businesses importing aquatic species

The permit requirement described directly above results in an increased administrative burden cost, referring to the time that will be spent by importers preparing and submitting an application. This activity includes filling out the application form online, and submitting the application to CFIA.

Administrative costs to modify permits to align with the 2018 OIE Code

Stakeholder: businesses importing aquatic species

Businesses who have an existing permit will only need to have their permit modified to include the species proposed for addition to Schedule III. CFIA's import database along with survey results suggest that two importers (one small business, and one medium or large business) have an existing permit for other susceptible species of aquatic animals. These two importers will incur administrative burden in terms of time spent to contact the National Centre for Permission to add the species to the existing import permit. This is a one-time modification cost from the immediate alignment with the 2018 OIE. No fees are charged for this request.

CFIA resource costs

Stakeholder: CFIA

CFIA will incur resource costs associated with managing import permit applications for the species that will be added to the susceptible species of aquatic animals list. Given the small number of permits anticipated, CFIA resource costs are expected to be minimal.

Small business lens

The small business lens applies, as there are impacts on small businesses associated with the regulatory amendments. These impacts are assessed qualitatively, with assumptions described below.

As stated, alignment with the 2018 OIE Code will involve the addition of 12 species deemed to be susceptible to disease. Their addition will result in the import requirements under the HAR being applied and CFIA has identified nine businesses that will be impacted. One of these nine businesses self-identified as large, and using a Statistics Canada statistic that 97.9% of businesses in Canada are small, it was assumed in the analysis that 98% of businesses are small. If this ratio is applied to the total number of businesses impacted in this proposal (nine), one of them is medium or large, then the number of small businesses is eight.

The impacts on small businesses are expected to be minimal. The regulatory framework already limits regulatory burden on small businesses to the extent possible. For example, fees are not charged to businesses that apply to add new species to an existing permit.

As the regulatory framework is already established under the HAR, no additional flexibilities were considered possible for this amendment.

One-for-one rule

A qualitative cost-benefit analysis was conducted due to a low number of affected stakeholders and a lack of data as a result of the low survey response rate. The analysis qualitatively describes the costs and benefits of the amendments, for which there are costs considered as an administrative burden. This section describes in greater detail this administrative burden, and for the purpose of complying with the one-for-one rule, uses the survey data to quantify the administrative impacts.

The one-for-one rule applies, since there is an incremental increase in administrative burden on businesses, and the proposal is considered an “IN” under Element A of the rule.

Model parameters and key assumptions

The key parameters and assumptions are

Key data sources

Two sources of data were utilized including

Monetized administrative costs

The amendments will result in an immediate addition of 12 new species. The addition of these new species will impact importers as follows:

Results and discussion

To align with the 2018 OIE Code, the annualized increase in administrative costs, in 2012 constant dollar, is estimated to be $51 or $6 per business annually under the rule.

Since this regulatory initiative is amending the existing HAR, no new title will be introduced nor will an existing regulatory title be repealed.

Regulatory cooperation and alignment

United States and international alignment

Currently, Schedule III of the HAR does not align with the OIE Code. As WTO members, Canada, along with the United States, European Union countries, and other trading partners, are obligated under the SPS Agreement to base SPS measures on internationally accepted standards, guidelines and recommendations where they exist, unless there is scientific justification to maintain SPS measures that achieve a higher level of SPS protection. For aquatic animal health, the international standard-setting body recognized in the SPS Agreement is the OIE. As members of the OIE, Canada and the United States provide comments annually on the lists of diseases and susceptible species that are included in the OIE Code.

The proposed amendments will modernize the way in which CFIA updates its list of susceptible species of aquatic animals and align it with international standards.

Federal, provinces and territories alignment

CFIA is the sole federal regulator responsible for preventing the import of animal and public health diseases of aquatic animals, fish and seafood. CFIA provides the provinces and industry with copies of the annual amendments to the OIE Code, invites them to provide comments and shares the Canadian positions with the interested stakeholders in Canada. This annual review process ensures collaboration and consultation with the provinces and territories.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for these Regulations.

Rationale

These changes are considered to be a low impact on stakeholders. It is estimated that the Regulations will impose new administrative burden to 9 businesses that historically imported at least one of the 12 species that are listed in the OIE disease chapters, but not in Schedule III. However, this burden is considered to be minimal given the cost of the permit, the frequency of reapplying (once per year), and the number of impacted businesses overall. Moreover, importers who already have permits for species in Schedule III and chose to add one of the 12 species will not be impacted, as their permit already exists (fees are charged by permit, not by species).

The species to be added to the Susceptible Species of Aquatic Animals List when Schedule III is incorporated by reference are not highly traded or valued, and it is not anticipated that this trend of importing these specific species will change in the future. This is evidenced by the small number of businesses that have imported those species over the past six years that were surveyed, as well as the responses of businesses who were surveyed indicating that they either had not imported those species, or would not in the future.

When CFIA re-examined this initiative in the context of the COVID-19 pandemic and economic recovery, it found that the Regulations presented a low impact and cost-effective way to align the HAR with international standards with very minimal administrative burden.

Implementation, compliance and enforcement, and service standards

The amendments will come into force upon registration. The Susceptible Species of Aquatic Animals List, that is currently available on the CFIA external website to facilitate easy access for importers to the taxonomic names of regulated species, will be incorporated by reference.

Going forward, the Susceptible Species of Aquatic Animals List is expected to be updated on a regular basis whenever changes are made to the OIE Code. All changes will follow CFIA Incorporation by Reference Policy.

Service standards

The amendments will not impact the application of existing CFIA service standards.

Contact

Dr. Nancy Rheault
Senior Director
Animal Import/Export Division
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Telephone: 613‑773‑7127
Fax: 613‑773‑7573
Email: nancy.rheault@canada.ca