Vol. 148, No. 12 — June 4, 2014

Registration

SOR/2014-127 May 20, 2014

HEALTH OF ANIMALS ACT

Regulations Amending the Reportable Diseases Regulations

The Minister of Agriculture and Agri-Food, pursuant to subsection 2(2) of the Health of Animals Act (see footnote a), makes the annexed Regulations Amending the Reportable Diseases Regulations.

Ottawa, May 16, 2014

GERRY RITZ
Minister of Agriculture and Agri-Food

REGULATIONS AMENDING THE REPORTABLE DISEASES REGULATIONS

AMENDMENT

1. The schedule to the Reportable Diseases Regulations (see footnote 1) is amended by repealing the following:

anaplasmosis
anaplasmose

COMING INTO FORCE

2. 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.)

Executive summary

Issues: This regulatory amendment addresses the Budget 2012 commitments of the Government of Canada (GC) and constitutes the response of the Canadian Food Inspection Agency (CFIA) to GC commitments to streamline services and find economies.

Description: This regulatory amendment is one part of two complementary amendments that seek to change the status of anaplasmosis by removing it from the Schedule to the Reportable Diseases Regulations (RDR) and adding it to the list of immediately notifiable diseases under Schedule VII of the Health of Animals Regulations (HAR).

Cost-benefit statement: Based on constant 2012 dollars, the amendment to move anaplasmosis from the Schedule to the Reportable Diseases Regulations to the immediately notifiable list in Schedule VII of the Health of Animals Regulations will result in a total savings of $4.8 million over a 10-year period for the Government of Canada. Of the $4.8 million, there will be savings of $2.2 million for the CFIA because of the changes in some of the operational and science-related activities. The remainder of the savings (estimated at $2.6 million based on historical compensation payment data) will be achieved through cost avoidance, since compensation to owners of animals destroyed will no longer be available as a direct result of anaplasmosis being removed from the reportable diseases list.

“One-for-One” Rule and small business lens: The “Onefor-One” Rule does not apply, as the amendment to remove anaplasmosis from the reportable diseases list and add it to the immediately notifiable list will not increase nor decrease the administrative or compliance costs to industry. While producers will no longer be required to report the disease to the CFIA, all recent incidences of anaplasmosis were discovered through surveillance activities conducted by the CFIA. There are no savings or costs values available that could be used for the small business lens.

Domestic and international coordination and cooperation: Canada currently works with the United States, the United Kingdom, Australia, New Zealand and Mexico, along with many other countries, to coordinate animal disease control programs. Canada, as a certifying “competent authority” recognized by the World Organization for Animal Health (OIE), is expected to have in place the regulatory infrastructure to control imports, the requirement to report regulated diseases and the ability to respond to an animal health disease. With this amendment, Canada will continue to meet that expectation. The CFIA’s involvement in immediately notifiable diseases will be limited to notifying trading partners and the OIE in case of an outbreak.

Background

To protect human and animal health, the Canadian Food Inspection Agency (CFIA) conducts inspections and has monitoring and testing programs in place to prevent and control the spread of diseases to the livestock and poultry sectors. The CFIA carries out programs related to animal health and production to guard against the entry of foreign animal diseases and to prevent the spread of certain domestic animal diseases.

The inspections and the monitoring and testing programs are carried out pursuant to the authorities of the Health of Animals Act (the Act), Health of Animals Regulations (HAR), and Reportable Diseases Regulations (RDR). Among other things, the Act and these two regulations establish the requirements needed to prevent the introduction of animal diseases into Canada and to control and eliminate diseases in Canada that could affect human health or that could have a significant economic effect on the Canadian livestock industry. The Act and these regulations are recognized as providing Canada with a solid basis for meeting domestic and import disease control requirements for animals, thus allowing Canada to comply with the export demands of our trading partners. Pursuant to the Act and these two regulations, diseases are classified into different categories, such as, “reportable,” “immediately notifiable,” or “annually notifiable.”

“Reportable” diseases are diseases of significant importance to human or animal health or to the Canadian economy and are prescribed as reportable by the Minister of Agriculture and Agri-Food Canada pursuant to the Act. Animal owners, veterinarians and laboratories are required to immediately report the presence of an animal that is contaminated or suspected of being contaminated with a reportable disease to the CFIA for immediate investigation. Following detection of a reportable disease, a variety of measures are available to the CFIA to control the spread of the disease (for example individual premises quarantine, area control) and to eradicate it.

“Immediately notifiable” diseases are prescribed by Schedule VII of the HAR. In general, immediately notifiable diseases are diseases exotic to Canada for which there are no control or eradication programs. These diseases are of a lesser concern to Canada than reportable diseases. Only laboratories are required to contact the CFIA regarding the suspicion or diagnosis of one of these diseases. This enables prevalence verification and supports international reporting and certification requirements. The CFIA can undertake control measures for such diseases when notified of their presence in Canada, but typically plays a more limited role relative to diseases classified as immediately notifiable. The CFIA’s involvement upon the identification of an immediately notifiable disease is usually limited to notifying trading partners and the OIE.

The key distinction between these two disease categories (reportable and immediately notifiable) relates to the reporting requirements and the response actions for each.

Anaplasmosis is currently listed as a reportable disease in the Schedule to the RDR, made pursuant to the Act, and has been regulated as such since December 1969 after Canada’s first outbreak occurred in Manitoba. Until recently, Canada was considered free from the disease. While anaplasmosis does not pose human health or food safety risks, it is a disease of economic importance to the cattle and dairy industries of both infected and non-infected countries. Anaplasmosis is found on all six continents and especially in countries with warmer climates. Anaplasmosis is common in tropical and subtropical regions of most of the world and is widespread in most countries with which Canada trades internationally. It is endemic to the United States (U.S.) and is not regulated at a federal level in that country.

Also known as “tick fever,” anaplasmosis is an infectious but noncontagious disease caused by a micro-organism. It is most often spread naturally through bites by infected ticks or flies, but can be spread through a mechanical transfer of fresh red blood cells by contaminated equipment such as needles, dehorning and castration equipment, and tattooing instruments. Ticks capable of transmitting anaplasmosis exist in Canada.

The disease affects domestic and wild ruminants, such as cattle, sheep, goats, elk and deer, but only cattle are clinically affected. Diagnosis is based on clinical signs and the examination of blood under microscope for evidence of the parasite. The disease causes anemia, fever, weight loss, breathlessness, uncoordinated movements, abortion and death. Cattle of all ages are susceptible to infection with anaplasmosis, but the severity of the disease is age-dependent. In calves under one year of age, signs of the disease are rarely apparent and few deaths result. Animals between one and two years suffer from mild disease; however, in cattle over two years of age the disease is acute and often fatal with increasing age. Anaplasmosis is observed more frequently in beef breeding cattle, which is associated with the extensive husbandry on pasture range, resulting in an increased exposure to ticks and insect vectors. Once an animal is infected, it remains a source of the disease for life even after it has recovered.

Science has shown that the entry of the disease into Canada occurs periodically and is inevitable. Further, it is anticipated that the frequency of incursions of anaplasmosis will increase in the coming years due to climate changes and the current warming trend.

Under the current RDR, the CFIA employs quarantine, test and slaughter measures in response to detections of anaplasmosis. To date, Canada has eradicated all incursions of the disease.

Issues

This regulatory amendment constitutes the CFIA’s response to GC 2012 Budget commitments to streamline services and find economies. The decision to remove anaplasmosis from the Schedule to the RDR is based on scientific assessments.

The CFIA is changing the status of anaplasmosis so that it is no longer a reportable disease that will trigger disease control actions. The CFIA’s current approach to excluding the disease will not prevent re-introduction of anaplasmosis into Canada. Given this disease can be spread by the movement of infected animals, it is no longer cost-effective or feasible to control this disease with eradication efforts. A shift in the management of the disease is needed to enable the CFIA to align with current disease realities.

Objectives

The objective of this regulatory amendment is to change the disease status of anaplasmosis (A. marginale) so that it is no longer a reportable disease that will trigger federally mandated disease control actions. By taking steps to modernize the response to certain animal diseases, the CFIA can refocus its limited resources in areas of higher risk.

As a consequence, the CFIA will be able to renew its focus on its core mandate to protect the health and safety of Canadians and to protect Canada’s plant and animal resource base, thereby fulfilling the GC’s 2012 budget commitment.

Description

The CFIA is adjusting its approach to the management of certain reportable diseases in Canada. Changes in approach will include capitalizing on any existing prevention tools and collaborating with partner organizations, such as provinces, territories and stakeholders.

This regulatory amendment is one part of two complementary amendments that seek to change the status of anaplasmosis from a reportable disease under the Schedule to the RDR to an immediately notifiable disease under Schedule VII of the HAR. This amendment will repeal the disease anaplasmosis from the list of reportable diseases under the RDR, while a concurrent regulatory amendment to Schedule VII of the HAR will add anaplasmosis (A. marginale) to the list of immediately notifiable diseases.

The change will mean that

Notably, there is no federal requirement for provinces and/or territories to implement any disease control programs for anaplasmosis as a result of this change. Any provincial or territorial program implementation is at the sole discretion of that jurisdiction.

Removing anaplasmosis from the list of reportable diseases and adding it to the list of immediately notifiable diseases will allow the CFIA to move from an eradication program to a policy of disease reporting. This amendment will allow the CFIA to change its policy and thus realize considerable savings in operational and laboratory resources.

Regulatory and non-regulatory options considered

Option 1 — Status quo

Maintain anaplasmosis as a reportable disease under the RDR: This is not an acceptable option in light of the CFIA’s necessary response to the GC’s Budget 2012 commitment. The CFIA’s current involvement with anaplasmosis will not prevent the reintroduction of the disease into Canada. It is therefore not cost-effective to maintain an eradication approach.

Option 2 — Preferred Option

Add the disease anaplasmosis (A. marginale) to the list of immediately notifiable diseases under Schedule VII to the HAR, while concurrently repealing it as a reportable disease under the Schedule to the RDR. This will allow the CFIA to take a management approach to the disease and to focus its limited resources on emerging and foreign animal diseases. This is consistent with the CFIA’s current approach to the management of certain reportable diseases in Canada when they become endemic.

Benefits and costs

Science has shown that the entry of anaplasmosis (A. marginale) into Canada from the U.S. on a periodic basis continues and is inevitable, as the disease is endemic in that country. As such, it is no longer cost-effective to continue to respond to detection with an eradication effort.

The control approach, adopted by the CFIA (i.e. considering anaplasmosis [A. marginale] as an immediately notifiable disease), results in compensation no longer being provided to producers. In the last 20 years, over $1.3 million has been paid to producers in compensation for anaplasmosis. More than 93% of this amount was paid in the past 4 years.

Based on constant 2012 dollars and over a 10-year period, the amendment to move anaplasmosis from the reportable diseases list to the immediately notifiable list will result in total savings of $4.8 million to the GC.

Of the $4.8 million, the savings to the CFIA will amount to $2.2 million ($1.5 million coming from the potential changes in activities associated with disease surveillance activities, laboratory testing and analysis and $754,248 from operational delivery affecting 2.3 full-time equivalent positions). The rest of the projected savings ($2.6 million) will come from cost avoidance as compensation will no longer be available to producers for animals destroyed as a direct result of anaplasmosis being removed from the reportable diseases list. The savings derived from compensation payments no longer being available to producers is difficult to measure as it is predicated upon the disease occurring. As a result, the savings were calculated based on historical data.

Cost-benefit statement

Anaplasmosis does not pose human health or food safety risks. Humans cannot contract anaplasmosis through either contact with animals or by eating meat or by drinking milk products. A human disease, human granuloctic ehrlichiosis was renamed as “human anaplasmosis” in 2003, but the human form of the disease is caused by a different micro-organism (i.e. not A. marginale).

The CFIA’s mandate includes controlling animal diseases that would have a major impact on international trade. The CFIA will continue to play a role in programs related to the detection and prevention of reportable animal diseases, including those which may impact human health (i.e. zoonotic diseases). By taking steps to modernize the management of anaplasmosis, the CFIA can focus its limited resources on emerging diseases and foreign animal diseases like avian influenza. This is where federal involvement is critical and aligns with current disease realities.

It is not anticipated that this regulatory change will have a significant impact on the environment as the organism dies with the animal. No special handling of the carcass is required.

This regulatory amendment will not result in any additional compliance or administrative costs to the industry. Producers and animal owners will no longer be required to report cases to the CFIA. The CFIA’s Office of Biosecurity has worked closely with industry to develop National On-farm Biosecurity Standards for both beef and dairy. By following these guidelines, producers will be able to minimize the possibility of entry of anaplasmosis into their herds.

By focusing on prevention, the CFIA, in collaboration with industry, is refocusing its level of activity with regards to anaplasmosis in accordance with the disease’s level of risk within Canada.

“One-for-One” Rule

The “One-for-One” Rule does not apply as the amendment to remove anaplasmosis from the reportable diseases list will not increase nor decrease the administrative or compliance costs to the industry. There are no savings or costs values available from regulated parties that could be used for the “One-for-One” Rule.

There has not been a case where a regulated party reported the disease. The CFIA has become aware of the occurrence of the disease via the National Bovine Serological survey or tests recommended by the World Organization for Animal Health (OIE).

Given the industry has not reported a case, there is no cost data available that can be associated to producers reporting cases to the CFIA. Therefore, the CFIA is unable to quantify or monetize the reduction in burden.

Small business lens

The small business lens does not apply to this amendment. Given the relatively infrequent occurrence of the disease in Canada over more than 40 years (i.e. five occurrences of anaplasmosis reported in Canada between 1968 and 2000 and six herds found to be infected in 2011) and given the fact that the cases of the disease were detected through CFIA surveillance activities only, the CFIA is unable to retrieve or analyze data in respect of incremental impacts for producers. There are no savings or costs values available that could be used for the small business lens.

As a result of this amendment, producers and animal owners will no longer be required to report cases to the CFIA, which would suggest a gradual reduction in burden. Any administrative or compliance costs associated with reporting suspected or confirmed cases would no longer be imposed on the industry.

Consultation

This regulatory amendment constitutes the CFIA’s necessary response to GC Budget 2012 commitments to streamline services and find economies. For this reason, industry and stakeholders have not been consulted through prepublication in the Canada Gazette, Part I, on these changes. The CFIA has, however, performed consultations in the past to discuss options for managing this disease. Based on these previous consultations, industry reaction is expected to be mixed. While there was general consensus among stakeholders that the current approach was likely to change, there was not unanimous support for a path forward.

In 2007, the CFIA conducted consultations with industry and stakeholders to discuss options for managing this disease. More recently, in February 2010, the CFIA hosted an Anaplasmosis Regulatory and Policy Options workshop, bringing together stakeholders who are or could be affected by regulatory and policy approaches to the disease, now and in the future. The workshop provided an opportunity to discuss the potential impacts of the different regulatory and policy options and to gain a better understanding of key stakeholder perceptions, issues and concerns. This workshop was a preliminary step in a longer-term review of the policy for managing anaplasmosis (A. marginale) in farmed animals. Six major stakeholder organizations participated, representing cattlemen, dairy farmers, beef breeders, cattle feeders, and sheep and goat producers. Manitoba and New Brunswick provincial governments participated in the workshop, as did officials from Health Canada and Agriculture and Agri-Food Canada.

In February 2012, the CFIA adopted a communications approach with industry and external stakeholders informing them of the decision to remove the disease from the RDR and changes in management of this disease. A fact sheet on the disease was posted to CFIA’s Internet site. In February 2013, the CFIA communicated the program adjustments that would be resulting in the management of anaplasmosis as a disease (www.inspection.gc.ca/animals/terrestrial-animals/diseases/reportable/anaplasmosis/2013-02-24/eng/1361763159979/1361763263785).

In February 2013, the Canadian Cattlemens’ Association, in an article appearing in an online periodical, indicated support for removing anaplasmosis from the reportable disease listing because of their belief there is a low level of prevalence of the disease in Canada and because trade in feeder cattle with the U.S., in their view, would be facilitated (www.betterfarming.com/online-news/cfia-delists-anaplasmosis-11735). The Dairy Farmers of Canada has objected to the removal of anaplasmosis from the reportable diseases list. Since anaplasmosis generally affects older cattle and not young animals, dairy and cow-calf operations within the cattle industry were less supportive of any change in disease status. Feeder cattle never get old enough before they are sent to slaughter to show clinical signs of being infected, giving rise to the Canadian cattlemen being supportive. The Canadian Sheep Federation does not object to the change in disease status.

The CFIA has also engaged the provinces and territories in multilateral and bilateral discussions regarding the change to the disease status. There is no federal requirement for provinces and territories to implement any disease control programs for anaplasmosis as a result of this change. At this time, no jurisdiction has announced implementation of a disease control program for anaplasmosis after April 1, 2014.

Regulatory cooperation

The CFIA remains committed to its role in animal disease control in Canada and will continue to play a leadership role both nationally and internationally. Canada currently works with the U.S., the United Kingdom, Australia, New Zealand and Mexico, along with many other countries, to coordinate animal disease programs.

Anaplasmosis is common in tropical and subtropical regions of most of the world and is widespread in most countries with which Canada trades internationally. It is endemic to the U.S. and is not regulated at a federal level in that country.

Partners such as provincial and territorial governments, industry and private veterinarians will become more involved where it makes sense and where we have good collaborative policy or partnerships.

Canada’s terrestrial animal health program has been recognized around the world as having achieved one of the world’s highest heath statuses in terrestrial animals. While this regulatory amendment has no direct impact on the CFIA’s ability to certify individual animals or products for international trade, the CFIA will need to renegotiate a number of certificates with trading partners for live animals and disease status. Minimal impact on market opportunities for Canadian producers is expected.

The OIE, of which Canada is a member, sets international standards for the prevention, control and eradication of animal disease of importance. This approach will not impact Canada’s international reporting obligations to trading partners and the OIE. The CFIA will continue to report confirmed anaplasmosis cases to the OIE in compliance with OIE’s requirements for notification of immediately notifiable diseases.

Rationale

The decision to remove anaplasmosis from the federally reportable diseases list and to shift away from eradication was based on scientific assessment. The decision reflects the fact that anaplasmosis is established in the U.S. As a result, there is a strong probability that anaplasmosis (A. marginale) will enter Canada from the U.S., in which case, the continuing attempt to eradicate the disease in Canada may not be feasible.

By taking steps to modernize the management of the disease, the CFIA can focus its limited resources on emerging and foreign animal diseases, like avian influenza. This is where federal involvement is critical and aligns with current disease realities.

Producers can protect their animals and their industry by practising farm-level biosecurity and by contacting their veterinarian about testing if they suspect their herd may be infected.

Implementation, enforcement and service standards

Cessation of the CFIA’s control measures for anaplasmosis will be implemented on April 1 or on the date of registration of this amendment if after April 1, 2014. The change in management of anaplasmosis is expected to be fully implemented during 2014–15.

With this change, the CFIA will no longer investigate animals suspected of having anaplasmosis, collect and submit samples for anaplasmosis testing, order animals destroyed, pay compensation, or conduct surveillance to determine the disease prevalence in Canada.

The CFIA will continue to report confirmed anaplasmosis cases to the OIE and endorse export certifications. Once anaplasmosis is removed from the reportable diseases list, producers and animal owners will no longer be required to report cases to the CFIA.

The CFIA will no longer verify Canada’s disease-free status for anaplasmosis and will no longer require the import of animals and animal products to be free of anaplasmosis. This will eventually affect Canada’s “country-free” status for anaplasmosis, but should have only minimal impact on exports of Canadian cattle or beef because anaplasmosis is widespread in most countries with which Canada trades internationally.

The CFIA is exploring with its partners and stakeholders approaches to make these adjustments while maintaining its overall animal health program. During the transition period, the CFIA will continue to inform producers if their animals may have been exposed to the disease.

The CFIA is working with provincial laboratories to develop testing capacity for anaplasmosis. A list of approved laboratories is currently available from the CFIA upon request.

The CFIA will collaborate with provinces and territories, stakeholder groups, as well as the Canadian Veterinary Medical Association as these changes are implemented.

Contact

Tom Smylie
Senior Staff Veterinarian
Animal Health, Welfare and Biosecurity Division
Animal Health Directorate
Canadian Food Inspection Agency
59 Camelot Drive, 3rd Floor East
Ottawa, Ontario
K1A 0Y9
Telephone: 613-773-7450
Fax: 613-773-7567
Email: Tom.Smylie@inspection.gc.ca