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4. Control Area Procedures

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4.1 Emergency Response Structure

The emergency response structure is described in Section 2.5 of this FMD strategy. More detail can also be found in Part A, Sections 2 and 3 of the FAD-MOP and in the CFIA Emergency Book.

4.2 Control Area Declaration

Epidemiological assessment of the estimated extent of the outbreak will be factored into determination of the limits of the control area (see FAD-MOP C.5). Tracing of movements of potentially exposed animals and locating all infected and potentially infected herds will be conducted on a 24-hour, 7-day-a-week basis until the extent of the outbreak can be determined.

Coincidently with the drafting of the Ministerial order for a control area (animal movement standstill), the Area Emergency Response Team (AERT) Director will liaise with provincial/ regional industry representatives to impose the Canadian Animal Health Coalition voluntary cease movement in cooperation with the appropriate agencies, as per the Area contingency plans, until the extent of the control area is legally defined. Similarly, national industry representatives will be consulted to effect their national livestock cease movement as described in the national industry's voluntary cease movement plan.

The initial restriction of movement and conditions on places, risk goods, conveyances and risk activities imposed are prescribed by a Controlled Area Notice. The standstill will apply until restrictions and conditions can be focused on infected and at-risk places. Some conditions on risk activities will continue at a national level until the declaration of freedom.

4.2.1 Livestock Standstill (Control Area or National)

The purpose of a livestock standstill is to minimize the risk of significant FMD spread and allow the extent of the outbreak to be determined. It has potentially major financial and social impacts on the livestock industry sector of the economy and thus the necessity and extent of the standstill must be carefully considered. Whether the standstill is national or restricted to the anticipated initial control area (province or multi-province) is contingent upon risk. A national standstill must be of national interest but balance the interests of all parties affected.

Procedures for livestock on the road at the time of a Control Area declaration will be managed as follows:

• The CFIA will notify provincial transport authorities/police of a livestock standstill.
• Provincial transport authorities will broadcast messages via road transport networks.
• No trucks carrying livestock are to depart present locations if not already on the road.
• All trucks carrying livestock on the road are to find a convenient rest station suitable for holding for up to 6 hours, identify themselves to the CFIA and provincial transport authorities directly or through their company management, and provide the following information:
  • Name, company and registration number
  • Present location, origin(s) and destination(s)
  • Species and number of animals on board
• Police/provincial transport authorities will convey this information to the CFIA Movement Control Supervisor.
• The Movement Control Supervisor will provide directions to the police/provincial transport authorities to convey back to transport operators, using guidelines as follows:
  • In the case of livestock with destination to slaughter and origin not within 50 km of any known infected place, proceed to slaughter (with advance notification to the slaughter plant by the Movement Control Unit) with slaughter as soon as possible. No additional contact with livestock en route.
  • In the case of livestock from a single property, return to the property of origin.
  • In the case of livestock from multiple properties (e.g. mixed-origin sale yard lots) none of which are within 50 km of any known infected place, proceed to destination with quarantine at destination.
  • In the case of livestock from multiple properties (e.g. mixed-origin sale yard lots) any of which are within 50 km of a known infected place, re-direct to slaughter (with advance notification to slaughter plant by the Movement Control Unit), with isolation of livestock groups in premises yards and end of day slaughter.
  • Movement control will record the directions provided and schedule follow-up surveillance of livestock in accordance with a risk assessment.

In all cases listed above, the welfare of the animals must be considered.

4.3 Zones Within the Control Area

4.3.1 OIE and EU Principles

The OIE's Terrestrial Animal Health Code 2005 defines a FMD infected zone as "a zone in which the absence of FMD has not been demonstrated by the requirements specified in the Code." In Canada, the legislative equivalent of the OIE infected zone is the Control Area as specified in Article 27 of the Health of Animals Act and is implemented by a Ministerial Order. During an FMD outbreak, the CFIA would create "inner infected zone" having a radius of 3 km from an infected place that would become the centre of the zone. The CFIA would also create "inner surveillance zones" having a radius of 10 km surrounding the infected zone.

Note: Currently, CFIA Legal Services advises against using the internationally accepted terminology for infected zone in favour of high-risk area, which was used during the avian influenza outbreak in 2004.

4.3.2 Establishment of Zones

The limits of the Control Area are defined in the Ministerial declaration and will include the Infected Zone, Surveillance Zone, and possibly a Vaccination Zone. The zones will be sign-posted on roads to alert the public on entering the zones (see FAD-MOP C.7).

The Area Executive Director, in conjunction with the Limits Committee of the Program Support Unit of the NERT, will determine zone boundaries as outlined in Part A, Section 5, Module 1 of the FAD-MOP. The Infected Zone contains all FMD positive premises. The outer boundary is at least 3 km from any FMD positive premises (EU standard) adjusted to geography, epidemiology, climatology, and resources available to control the epidemic. A Surveillance Zone will separate the Infected Zone from the remainder of the country. A Vaccination Zone will be put in place as part of the Surveillance Zone only if vaccination is authorised (see Section 7).

To facilitate implementation of disease control and eradication activities, the extent of the Control Area and limits of zones should take into consideration:

• natural and man-made barriers
• supervision facilities
• administrative boundaries (e.g. municipality, county, township)
• cultural features (e.g. roads, towns, cities)
• meteorological factors (e.g. possibility of transmission by winds of virus plumes)
• livestock movement patterns
• processing operations (livestock and products)
• species involved (both livestock and wildlife)
• nature of outbreak (expanding or localized) and technological ability to predict the probable dispersion of FMD virus.

The remainder of the country will be negotiated for acceptance as a free zone for international trade as soon as possible.

Movement of susceptible livestock must be strictly controlled within the Infected Zone. There may be more than one Infected Zone encircled by a common Surveillance Zone, but when FMD has been confirmed in numerous and closely located premises, Infected Zones may be amalgamated into a larger Infected Zone to facilitate control activities. To take into account the possibility of virus transmission by winds, the Surveillance Zone should be at least 10 km from a positive FMD infected place (EU standard) and surround the Infected Zone although it may be elongated in the downwind direction. Conditions at the time of outbreak (wind speed, direction, relative humidity, temperature, sunlight, nature of the topography, presence of feedlots or large swine production units) will need to be factored into the limits of the Surveillance Zone

The CFIA will contain FMD within the Control Area by movement restrictions on animals, animal products, and things as specified in the Control Area Regulations. The issuance of licences for the movement of live animals, products, by-products, and things in and out of the Control Area will be effected according to Part C, Section 7 of the FAD-MOP and the FMD present strategy. Intended movements will be prohibited, permitted with treatment, permitted without treatment/conditions, or non-regulated-depending on nature of the commodity or animal, risk assessment, effectiveness of the treatment, direction of the intended movement, welfare considerations, source and destination place status, source, and destination zone status. Movement controls generally meet or exceed those in the Terrestrial Animal Health Code Articles 2.1.1.6; 10; 13; 17; 18; 21; 24; 26 (see Appendix 4).

4.3.3 Perimeter Control

The CFIA will place prominent signage at entry and exit points of the Control Area as well as the Infected Zone. Perimeter controls will range from merely signage to roadblocks or checkpoints with or without C&D facilities depending on risk and volume of traffic. This information will be provided to the public as outlined below.

4.4 Public Notification

Public notification is immediately arranged by the Communications officers at both Headquarters and Area levels, as per the Area and national contingency plans, FAD-MOP C.5 and C.17, as well as documented in the Tripartite Animal Health Emergency Outbreak Communications Plan, C.12. Objectives are to keep the agricultural sector, rural communities, and the animal health industry apprised of updated information, ongoing procedures and new developments. It is critical to keep the public informed and support the media with background material, regular briefings, news releases, and information bulletins as required. Sharing information with Members of Parliament, other federal departments, other levels of government, and trading partners is also essential.

This will be achieved by:

• Immediate notices to provincial departments of agriculture, veterinary colleges, veterinary associations, particularly practitioners, other agricultural service personal such as feeds, dairy industry, artificial insemination agencies, etc. to cease farm visits for any purposes other than disease investigation until the extent of the outbreak can be determined.
• Immediate notice to national livestock associations who will in turn advise producers particularly those in the Control Area as per their FMD contingency plans regarding disease and movement restrictions.
• Communication with Animal Health counterparts in the USA and Mexico as per the Tripartite Animal Health Emergency Outbreak Communications Plan, Chapter 12.
• News releases - television, radio, newspapers - announcing confirmation of FMD, Control Area and export/import measures, and advising the public to avoid unnecessary travel in the Control Area.
• Enhancing the dedicated CFIA 1-800 information line.
• Establishing a Web site to facilitate rapid communication with stakeholders, which will include a map of the affected area and movement restriction zones in the Control Area, as well as ensuring links are in place with appropriate sites such as OIE and trading partners.
• Liaising with other federal departments such as National Defence to suspend training exercises or manoeuvres or confine to roads any other such activities and follow any other restrictions imposed by CFIA.
• Liaising with Foreign Affairs Canada and International Trade Canada to assist in coordinating with international posts.
• Arranging daily briefing schedule to include federal government contacts, industry officials, media, other levels of government, industry and provincial communication officers.
• Providing information kits for Members of Parliament and Senators.
• Coordinating distribution of appropriate information materials to public sites such as agricultural supply stores and public places such as post offices, airports, auction barns, livestock markets, dealers, abattoirs (federally and provincial), agricultural fairs and shows as may be legally required.
• Posting signage on roads at appropriate locations as per FAD-MOP C.7, and as may be legally required.
• Organizing the development of additional video materials for public service announcements.
• Following up on emerging issues and designating ancillary communications as necessary: trade implications, vaccination plans, source of disease, expansion of Control Areas, confirmation of disease and international reporting obligations, emphasizing the safety of human health and veterinary biologics restrictions.

4.5 Outbreak Surveillance

4.5.1 AERT Surveillance Personnel

An AERT Movement Control Unit (previously Security, Quarantine and Permits (SQP)) must be established to conduct routine veterinary inspection of susceptible animals as well as to enforce movement restrictions within the Control Area. In addition, a diagnostic unit to respond to all calls involving cases of suspected disease (sick calls or report cases), investigation of positive surveillance findings and tracing investigations is established according to the AERT organization (Part A, Section 3 of the FAD-MOP). Roles and responsibilities of the field operations response team are described in the FAD-MOP (Part C). Producers in the Control Area are required to report any illness or deaths immediately. These reports will be investigated by a FAD diagnostician immediately as suspect cases or sick calls.

4.5.2 Outbreak Surveillance in the Infected Zone

As time permits, each premises within the Infected Zone will be individually quarantined (declared a suspect infected place) under the Health of Animals Act, Section 22 with an inventory of all animals on each premises. All premises must periodically undergo veterinary inspection carried out in a bio-secure manner to avoid unintentional spread of disease. The inspection will include both the susceptible animals and the measures in place to prevent introduction or transmission.

The need for surveillance and early detection of FMD infection must be balanced with the risk of introduction of FMD virus by inspection visits. Surveillance patrol personnel must make every effort to avoid exposure to FMD virus. On the initial visit, producers should be educated about the clinical signs and to report suspect cases (sick calls). Upon entry to the premises, the owner is closely questioned regarding suspect signs and if present, the visit is referred to the diagnostic unit of the AERT.

Within the Infected Zone, all premises with susceptible animals will be monitored weekly (ruminants) or twice a week for the first the two weeks, then weekly (pigs) following the discovery of clinical FMD within a 3-km radius. Monitoring may include clinical examination or telephone contact for experienced producers with intensive contact (i.e. milking cows) or in a long-standing outbreak. The decision is made by the AERT Movement Control Supervisor. As far as possible, direct contact should be minimized to prevent any possibility of FMD transmission. Surveillance will continue until the completion of the C&D on the last infected premises in the zone. Serology from sentinel animals on re-stocked premises will be available to supplement clinical examinations on non-infected premises in the Infected Zone.

When surveillance patrollers suspect infection on a premises during an inspection, they must remain on the premises and relay their observations to the supervisor who may decide to have an experienced FAD diagnostician sent to the premises. Diagnosticians will base their diagnosis on clinical, epidemiological and gross post-mortem findings. An FMD-positive premises may be declared on the basis of clinical signs and known epidemiological link to a laboratory confirmed premises. In cases where doubts persist despite the on-site investigation, a decision concerning the diagnosis should be reached through discussions with the Diagnostic Unit Supervisor.

4.5.3 Outbreak Surveillance in the Surveillance Zone

Surveillance in the Surveillance Zone will include monitoring of quarantined and high risk premises (swine, feedlots) similarly to Infected Zone surveillance. Requests for movement permits will involve whole herd clinical inspection by veterinarians. Any suspicions reported by private practitioners, owners, transporters will be treated as sick calls and responded to by a trained FAD diagnostician (Diagnostic Unit) not working in the (inner) infected zone. Blood samples of animals presented to veterinary diagnostic laboratories in the Surveillance Zone will be submitted for antibody detection (solid phase competitive ELISA) and/or PCR for the detection of pre-clinical viremia.

4.5.4 Outbreak Surveillance in the Vaccination Zone

Within the Vaccination Zone (should vaccination take place), vaccination teams will perform a clinical inspection on all animals before vaccination. Any suspicions will be treated as sick calls and responded to by a trained FAD diagnostician not working in the Infected Zone. Serological surveys within herds undergoing vaccination will also be taken for epidemiological investigations.

4.5.5 Outbreak Surveillance in FMD-Free Zones

Within FMD-free zones, surveillance will be restricted to investigations of sick calls by a trained FAD diagnostician not working in the Control Area. Animal cases presented to veterinary diagnostic laboratories with undetermined aetiology will be tested serologically for antibodies to FMDV. Serological surveys from abattoirs operating adjacent to the Control Area will be conducted. Designated FMD-free zones wishing to obtain international free-zone status must meet the surveillance criteria established in Appendix 3.8.7 of the Terrestrial Animal Health Code or meet the specific conditions of trading partners.

4.5.6 Clean and Dirty Surveillance Personnel

If the premises is declared FMD positive, the eradication procedures will be followed immediately by the AERT as described in the FAD-MOP. Because humans and their activity may mechanically transmit FMD virus to animals, in high-risk situations, neither the diagnostician(s) nor any other person, should visit any other non positive FMD herds without strict adherence to the prescribed protocol for personal disinfection.

Personal disinfection for people in contact with infected animals includes complete disrobing (clothing to be disinfected) and showering with at least one minute of soaping and two minutes of rinsing the soap off the entire body. Clean clothes need to be used after showering; footwear needs to be disinfected according to indicated procedures. For household members not in contact with the infected animals, a change to clean clothing and footwear disinfection is practical and sufficient.

Experimentally, humans can retain FMD virus in their nasal passages and throat for 4 to 5 hours, exceptionally, up to 28 hours under laboratory conditions working in high containment cubicles housing infected pigs. It would be expected that this time would be considerably reduced under open field conditions.

During the UK 2001 outbreak, generally 72 hours was used between "dirty" positive FMD premises visits and "clean" non-suspect FMD premises visits. However, at the peak of the UK outbreak, staff shortages reduced the dirty period to 24 hours without apparent adverse effects. Historically, Canadian policy is a minimum of 48 hours based on the limited experimental evidence of 28 hours maximum. When staffing levels permit, 72 hours (i.e. more than double the maximum) may be used for international consistency.

4.6 Movement Restrictions within the Control Area

4.6.1 AERT Movement Control Personnel

The AERT Movement Control Unit is responsible for enforcing movement restrictions within the Control Area. Issuance of licences for movements of animals or animal products is under that jurisdiction.

In large outbreaks, it may be necessary to delegate local agricultural authorities the responsibility for issuance of licences for movements for farm premises in the Surveillance Zone, following CFIA guidelines with appropriate monitoring and verification. The CFIA should retain responsibility in the Infected Zone(s). In the UK, licences were not generally issued for any movements within 3 km of the positive FMD premises within 14 days of confirmation of disease unless an emergency situation arises (i.e. to immediate slaughter within the Infected Zone along a prescribed route to avoid positive FMD premises undergoing depopulation).

4.6.2 Animals

After the Ministerial declaration, conditions as described in Section 4.3 apply to all premises in the Infected Zone with susceptible livestock, as if they were individually declared infected (quarantined). No movement of animals, animal products, carcasses, embryos, ova, semen, poultry, poultry carcasses is permitted onto or from declared infected places without appropriate licenses. In general, no animals may move, except under permit for slaughter at an approved site within the Infected Zone or Surveillance Zone. Movement between different parts of an owner's premises (e.g. across road or pasture to building) may be facilitated under a multiple use permit.

Susceptible animals from premises that have no epidemiological links to known infected premises or exposed premises may be allowed to move under license. Within the Control Area, animals may move to a farm or abattoir or deadstock yard situated not less than 3 km from a positive premises or in a contiguous Infected Zone, under permit but the animals must be detained on the premises to which moved for 14 days or be slaughtered immediately. There will be no movement to any point of assembly such as sales yard, fairground, marketing yard, community pasture, certification or collection centre.

Susceptible animals may be transported from outside the Control Area along designated major routes to specific abattoirs for immediate slaughter only. All vehicles used for such transport must undergo C&D under veterinary supervision at the abattoir and such decontamination recorded in the vehicle log book. The route shall be specified, the movement under permit and a copy of the movement permit provided to police or those monitoring the route for animal movement to ensure compliance with the license. Similarly, transport of non-susceptible animals and generally transit of animals of all species under license should be restricted to designated major routes through the Infected Zone. Events involving gatherings of people with possible contact to animals of susceptible species should be minimized.

Susceptible livestock from non-quarantined premises in the Surveillance Zone are permitted to move under licence to:

• abattoirs located within the Surveillance Zone; or
• for emergency slaughter outside the zone and designated by the competent authority as near to the zone as possible and only if there is insufficient slaughter capacity within the Surveillance Zone; or
• other premises within the Surveillance Zone with the same owner as the original premises.

Conditions of the licence are as follows:

• no animal in herd of origin has shown clinical signs of FMD within 14 days
• there have been no additions to herd of origin for 14 days
• no clinical FMD occurred within 10 km for 14 days
• the origin and destination premises are not under quarantine
• transport conveyances meet C&D requirements of zone
• the susceptible species of animals have been inspected by a veterinarian and found free of clinical evidence of FMD within two days preceding movement.

Movement outside the Surveillance Zone is generally prohibited except under a specific risk assessment and then under permit. If moved onto a farm (any place other than a slaughterhouse, market, fairground, sale yard, collecting centre, or certification centre) the animal must be held for 14 days.

Movement from quarantined (suspect) premises is as for those in the Infected Zone. As a high-risk premises within the Surveillance Zone, swine premises will be individually declared infected places and closely monitored including regular PCR and serological sampling.

Non-susceptible animal species that may function as mechanical vectors should be confined. Eggs and poultry may move freely within the Surveillance Zone. Permits for eggs shipped outside the Surveillance Zone may be issued provided the egg cases or other containers are cleaned and disinfected.

Conditions for live animal movement to slaughter outside Infected/Surveillance Zones in the absence of an abattoir in the area are provided in Appendix 4.

Permits for movement within the Control Area must ensure animals are identified to enable identification of their premises of origin, or premises from which they originate so that their movements can be traced rapidly for all bovine, ovine, caprine and swine. Owners and transporters of animals are obliged to maintain records of the above and supply such on request to the CFIA.

4.6.3 People and Vehicles

People and service vehicles present the greatest risk for fomite transmission of FMD. Vehicles and equipment may leave suspect premises in the Infected Zone provided they are suitably cleaned and disinfected. Trucks that have been used to transport animals or animal products within the Infected Zone may not leave the Infected Zone without a cleaning and disinfection at an approved C&D station under CFIA inspection.

All premises within the Surveillance Zone should implement enhanced bio-security.

Trucks that have been used to transport animals or animal products within the Surveillance Zone should have an external C&D at origin prior to departure and a thorough C&D at destination. They may not leave the Surveillance Zone without a thorough C&D under CFIA inspection at an approved C&D station.

4.6.4 Animal Service Industries

All animal service personnel including veterinary practitioners, inseminators, feed delivery, and transporters working within the Infected Zone must restrict service to the Infected Zone.

Suitable overall clothing and boots equivalent to those required for CFIA surveillance staff must be adopted such as disposable clothing and boots. Clothing/boots supplied by premises' owner would also be suitable. The prescribed personal cleaning and disinfection protocol must be strictly followed. Provision exists under Section 61 of the Health of Animals Act to recover from any person costs incurred in taking measures under Section 27 in respect of a Control Area from persons who through their fault or negligence caused or contributed to the spread of disease of which the Control Area was declared.

When working in the Infected Zone, practitioners should carry a minimum of equipment and drug supplies in their vehicles; refrain from using multiple dose vials; and use disposable equipment whenever possible and leave such equipment on the premises. If FMD is suspected, the practitioner or other animal service personnel must remain on site until permission is given to leave by the investigating CFIA diagnostician. Itinerant artificial insemination service for susceptible animals is prohibited by the EU.

In addition, all service personnel should clean and immerse equipment used on the premises in an appropriate disinfectant solution before removing it from the premises. They must leave vehicles outside the premises, or at least outside the livestock area if possible. Otherwise, follow C&D protocol for vehicles.

Similarly, all animal service personnel including veterinary practitioners, inseminators, feed delivery, and transporters working within the Surveillance Zone must restrict service to that zone. The cleaning and disinfection protocol should be strictly followed. Recommended practices are as for the Infected Zone.

4.6.5 Abattoirs and Animal Products, Animal By-products and Milk

Animal products such as milk or milk products and by-products such as hides and skins, wool or bristles derived from susceptible animals in the Infected Zone, unless produced before the estimated date of infection and stored separately from those produced after the date, will be subject to FMD virus denaturing treatment as specified in Appendix 3.

To allow abattoirs to operate within the Infected Zone, consideration should be given to the following:

• not eligible for export;
• receive only animals for which a permit has been issued;
• receive only enough animals for one day's operation;
• all carcasses are chilled and not frozen and remain in the plant for a minimum of three days;
• fresh meat derived from animals of susceptible species originating in the Infected Zone must be treated sufficiently to destroy FMD virus (see Appendix 3) or be marked and transported in sealed containers under permit to an establishment for treatment sufficient to destroy FMD virus;
• no employee may have contact with susceptible livestock off the premises;
• a cleaning and disinfection protocol is established for all personnel and equipment leaving the plant;
• offal and waste products removed from the plant for rendering must be moved under license in a closed leak-proof vehicle;
• effluent from slaughter plants should be treated sufficiently to destroy FMD virus;
• provision for storage of product processed during the outbreak if not able to treat.

Abattoirs operating within the Surveillance Zone are subject to similar but not as rigid restrictions as those in the Infected Zone (see Appendix 4). Animal products sales and distribution is restricted to the Control Area unless treated to meet OIE standards (see Appendix 3).

Milk pick up is permitted in the Infected Zone from premises where the disease has not been confirmed, provided:

• Movement is conducted under licence to a designated dairy, and the truck route involves collection only from premises in the Infected Zone.
• The truck driver wears protective waterproof clothing and boots, and takes suitable sanitary precautions to prevent the spread of FMD virus on his clothing, footwear or hands. The driver cleans and disinfects protective clothing and boots before entering the farm and again upon leaving the farm. The driver does not enter barns or contact cattle or other cloven-hoofed animals.
• The wheels, wheel wells and collection hoses of the truck are suitably cleaned and disinfected prior to leaving the premises.
• Milk or milk products and by-products originating from milk collected from premises in the Infected Zone are prohibited from use as animal feed or for human consumption unless they have been subjected to an appropriate thermal treatment (see Appendix 3).
• A route plan for pick up is filed in advance with the Movement Control Unit Supervisor of the AERT at the Field Operation Centre.
• Periodic monitoring of milk carriers should be conducted to determine compliance.

Restrictions for milk in the Surveillance Zone are similar but separate routes should be designated in the Infected Zone and Surveillance Zone so that the transmission of FMD outside the Infected Zone is minimized.

Other animal products in the Infected Zone that may potentially function as fomites must be moved under license. Permits for eggs may be issued provided the egg cases or other containers are cleaned and disinfected with formaldehyde gas or other appropriate disinfectant. Feed and hay may only be moved if produced before the date of infection as well as being stored and transported separate from material produced after that date. Products intended for use within the zone may be licensed between non-suspect premises.

4.6.6 Germplasm

Collection of embryos from the bovine species, appropriately washed according to the International Embryo Transfer Society (IETS) protocol may be allowed in Canada. For international trade purposes, this procedure would be subject to the position of the respective importing country.

No artificial insemination (AI), embryo collection (EC) or embryo transfer (ET) is allowed to operate without restriction in the Infected Zone or Surveillance Zone. The FMD virus enters semen as a result of viremia or lesions around the prepucial orifice. FMDV has been found in bull semen four days prior, during and up to 37 days after clinical signs. Centres in the Infected Zone will be declared infected places under the Health of Animals Act and subject to movement restrictions.

Within ruminant centres, semen, ova and embryo collection may continue for freezing and storage provided each lot is identified, maintained separately, and tested for FMD virus before being moved from the premises under permit. Quarantine and permit conditions will reflect Article 2.1.1.10 & 13 of the Terrestrial Animal Health Code. No animals are permitted to enter the centre during the outbreak. Donor animals must also be regularly serologically monitored.

Personnel from these establishments in both the Infected Zone and Surveillance Zones must practice approved personal cleaning and disinfection procedures upon entering and leaving the establishment and must not visit other premises where susceptible livestock are kept.

Swine AI, EC or ET centres pose a significant risk due to the concentration of animals. As a high-risk premises within the Infected Zone, pre-emptive slaughter or intense biosecurity practices and monitoring may be indicated. As a high risk premises within the Surveillance Zone, swine germplasm units will be declared infected places and intensively monitored including regular serological sampling. Exceptions from this general rule must be epidemiologically evaluated with industry using risk assessments.

No semen, ova or embryos collected in the Infected Zone can be placed on the market unless they were produced at least 14 days before the estimated date of infection on the holding.

4.6.7 Animal By-Products and Residues

Animal by-products including hides, skins, wool, bristles or manure that are potentially infected with FMD virus cannot be moved except under permit after being treated to destroy the virus. Manure and litter can be composted or acid treated (if liquid manure). Details on appropriate manure treatment are provided in Section 3.7.2.

Manure may be spread on fields and immediately ploughed under. In the case of liquid manure to be sprayed on fields, the discharge nozzle for spray must be directed downwards at an angle of not less than 45 degrees from the horizontal, not more than one meter above ground level. Caution must also be taken when moving any manure or litter to avoid public roads.

Non-quarantined premises in the Surveillance Zone are under no restriction for manure and litter transport within the Surveillance Zone. For quarantined premises (suspect) animal by-products including manure cannot be moved except under permit when treated to destroy the virus as in premises in the Infected Zone. Movement is only permitted to sites located at a sufficient distance from holdings where susceptible animals are kept. Where the potential exists to expose other livestock, the means of transport will be C&D prior to and after use.

4.6.8 Feed and Equipment

Movement of feed is prohibited unless unexposed or cleaned and disinfected as per the Terrestrial Animal Health Code 2.2.10.28. in both the Infected Zone and Surveillance Zone.

4.6.9 Special Premises

All stockyards, auction markets, sales, fairs, zoos, assembly points, and other livestock concentration points will be closed in the Infected Zone. Any concentration points that may have been exposed must be cleaned and disinfected.

Special premises with animals at the time of closure will be handled according to risk. If any consigned animals are known to have originated from a suspect premises, all livestock at the special premises will be destroyed or licensed directly to slaughter, if there is an abattoir in the area, so as not to expose additional livestock. Products of slaughtered suspect animals will be treated to ensure destruction of virus (see Appendix 3).

In exceptional circumstances, where no direct nor indirect contact can be documented between the animals from the suspect premises and the animals in question (i.e. genetically valuable cattle that had not yet been unloaded), the animals may be held at the special premises for the maximum incubation period (14 days) and all provisions for them made at the expense of the owner. They may then be licensed to destination. Due to the nature of FMD, additional clinical signs will generally appear by 72 to 96 hours if they were exposed to an active case. However, provision for potential airborne or indirect transmission must be considered until the virus is typed.

Edible residual material of non-meat material from sources other than direct from the manufacturer will be immediately prohibited in the Control Area. All licenses nationally will be revoked. As a high-risk premises, edible residual material feeding premises will be quarantined and closely monitored, clinically and serologically. Pre-emptive slaughter within the Infected Zone should be seriously considered.

Only livestock markets for animals for immediate slaughter may operate in the Surveillance Zone. These markets must be located at least 10 km from a positive FMD premises and must be licensed to operate (may be multiple times on same license). The license should specify the hours (i.e. latest time animals may arrive in a closed vehicle) and not be more than one day. Any stock not sold must move to a slaughterhouse. They must NOT return home. Sale yards must hold movement records. Adequate facilities and equipment for C&D must be available for all conveyances. All susceptible livestock will be subject to veterinary inspection. Once the outbreak has been controlled and there have been no new cases for a minimum of 14 days within the adjacent Infected Zone, unsold livestock may be licensed back to the premises of origin and held there for 14 days.

4.6.10 Transportation through the Control Area

Transportation through the Infected Zone of susceptible animals is prohibited. The Movement Control Unit Supervisor will ensure re-routing of livestock transport vehicles including notification of transport companies and signage.

Transportation through the Surveillance Zone of susceptible animals will be permitted if by direct movement when the origin and destination are outside the Surveillance Zone and vehicles are sealed. If for any reason susceptible animals are off loaded in the Control Area they must move to a farm or a slaughterhouse within the Control Area under permit following animal provisions for that zone.

4.6.11 Wildlife

The CFIA does not have jurisdiction over wildlife. Susceptible wildlife in the Infected Zone will undergo a risk assessment considering information on population density and distribution; social structure; habitat; contact with domestic species; FMD virus strain and length of time of potential exposure. These will be factored into three non-exclusive options: containment; surveillance and sampling or population reduction. It should be appreciated that wildlife depopulation even on a local area basis is extremely difficult.

4.6.12 Human Traffic

People who exit an Infected Zone, particularly those on or close to positive FMD infected places or suspect FMD infected places, should wear clean clothes and footwear and avoid contact with livestock for at least five days. This is the standard protocol for entry of human visitors to Canada from an FMD affected country. See Section 1.9.

4.7 Vaccination

The latest FMD outbreak that occurred in the UK (2001), which also involved other countries on the continent, has raised concerns about a disease control policy based exclusively on stamping out infected and contaminated animals. From an economic, ethical and environmental point of view, stamping-out is less and less accepted as the sole disease control method, and alternatives have to be found. It is thus incumbent upon Canada to develop a FMD vaccination strategy.

4.7.1 North American FMD Vaccine Bank

Should FMD be diagnosed in Canada, the preferred policy is stamping-out to eradicate the disease and eliminate the presence of FMD virus (see Section 2.1). However, Europe's recent outbreak experience suggests that stamping out alone may not be suitable to control the virus, given current animal densities and trade interactions. Vaccination will extend international market disruption, and thus costs must be weighed against benefits through a decision process.

Canada is a contributing member of the North American FMD vaccine bank (NAFMDVB), along with the United States and Mexico. Current justifications for the emergency use of FMD vaccination are as follows:

• outbreaks in areas of high densities of susceptible animals with inadequate resources for slaughter and disposal or high-risk potential for rapid airborne spread (i.e. large swine operations or feedlots)
• availability of safe vaccines of high potency
• test to discriminate vaccinated from infected animals
• animal welfare concerns regarding large-scale depopulation
• limit animal suffering from FMD through vaccination

Factors to be considered in making the decision to vaccinate as an adjunct to stamping-out and pre-emptive slaughter in Canada are described below.

4.7.2 Office International des Épizooties Standards

Under the OIE Terrestrial Animal Health Code, if an FMD outbreak occurs, in a country where FMD vaccination is not routinely practised, Canada may regain its country FMD-free status without vaccination:

• three months after the last case where stamping-out and serological surveillance are applied; OR
• three months after the last slaughter of the last vaccinated animal where stamping-out, serological surveillance and emergency vaccination are applied.

If the extent of the FMD outbreak is such that all FMD vaccinates are not slaughtered, Canada may regain its FMD-free status where vaccination is not practised:

• six months after the last case where stamping-out policy, emergency vaccination and serological surveillance in accordance with Appendix 3.8.7 are applied, provided that the serological surveillance based on the detection of antibodies to non-structural proteins of FMD demonstrates the absence of virus circulation; OR
• 18 months after the last case where stamping-out policy is not applied.

4.7.3 Domestic Considerations

The option to vaccinate will be considered depending on circumstances. The economic impact of vaccination may be such that compensation related to vaccination and post vaccination control costs may override the benefits of a decreased epidemic through vaccination. National livestock associations and other important stakeholders concerned will be involved in the decision process. A summary listing of factors is provided below. A working document for the decision tree/matrix is available at headquarters.

The decision must consider the following:

• Nature of the farm operation (i.e. presence of high risk operations - AI units, feedlots)
• Species involved and their density¹ (e.g. hog operations)
• Number of interactions (contacts) of initially infected herds
• Estimation of FMD extent and projected duration of the epidemic
• Livestock industry and management in affected area (cultural geography)
• Season, climate and natural physical barriers (physical geography)
• Physical resources available for stamping-out (technology)
• Human resources available for stamping-out and/or vaccination
• Societal values and public opinion (i.e. animal welfare issues)
• Economic factors (i.e. cost-benefit of lost export markets versus cost of eradication)
• Characteristics of the vaccine and the outbreak strain(s)
• International acceptance of zoning/regionalization of vaccination zone (or at least by major trading partners)
• Technical ability and international acceptance of laboratory tests to differentiate vaccinated and naturally infected animals

The key to deciding to vaccinate will be the ability to predict the rate of spread and the contact rate among susceptible animals. If vaccines are to be employed as part of the control, vaccination would be used only in the Vaccination Zone. Suppressive emergency vaccination may take place in the Infected Zone while protective emergency vaccination will occur in the Surveillance Zone.

¹ Council Directive 2003/85/EC of 29 September, 2003 has a definition of densely populated livestock area (DPLA). In the case of susceptible species, a DPLA is a geographical area, with a radius of 10 km around a holding containing animals of susceptible species suspected of or infected with foot and mouth disease, where there is a density of susceptible species higher than 1000 head per km². The holding in question must be situated either in a sub-region where there is a density of animals of susceptible species higher than 450 head per km² or at a distance of less than 20 km from such a region. Such DLPA have not yet been identified in Canada.

4.7.4 Vaccine Decision-making Process

Upon declaration of an outbreak of FMD in Canada, the Chief Veterinary Officer (CVO) who is also a commissioner on the North American FMD Vaccine Bank will request the Chair of the Technical Committee of the NAFMDVB to assess the capacity of the stored vaccine antigen concentrates to protect against the virus type implicated.

If the serotype of the isolate does not match any vaccine antigen concentrate in the NAFMDVB, the CFIA can place an order to the manufacturer to purchase a commercial vaccine deemed to be protective against the strain in question. In the unlikely event that an outbreak is caused by a virus for which there is no commercial vaccine available, an autologous vaccine could be requested from a manufacturer of FMD vaccine. In this case, at the request of the CVO, the National Centre for Foreign Animal Disease in Winnipeg will be responsible to ship the isolate to the vaccine manufacturer (see Section 1.6.4).

Concurrently with the official declaration of an outbreak of FMD, the CVO would request the AHPD Program Support Unit to apply the decision tree to the situation in Canada and make recommendation(s) through the Director, AHPD as described in FAD-MOP A2. Representatives of the FAD Steering Sub-committee of the CAHCC would represent the affected livestock industry on the Policy and Procedures Committee.

The CVO and/or the NERT may elect to hold separate consultative meetings with the affected industry/public/other government and non-government stakeholders to review the recommendations from the Policy and Procedures Committee.

4.7.5 NAFMDVB Mobilization

When FMD is isolated in North America, the Chief Veterinary Officer convenes a conference call of the Commissioners of the NAFMDVB to seek their agreement in the purchase of vaccine. In the event that more than one member country requests vaccine, the Commissioners will determine vaccine allocation based on the pre-existing Tripartite risk assessment agreement considering respective animal populations at risk.

The CVO confirms Canada's share of the vaccine with the NAFMDVB and indicates that CFIA will incur the additional charges for the delivery of the finished vaccine directly to Canada at the designated port of entry. The CVO must also specify that bilingual labels in English and French are required for Canada.

The National Manager (NM) of the Veterinary Biologics Section (VBS) of the Animal Health and Production Division will issue the required emergency import permit as authorized under Section 131.1 (1) of the Health of Animals Regulations. The Director, Field Operations will provide to the NM-VBS: (1) the name and address of the CFIA veterinarian in charge of receiving the vaccine, (2) the international port of entry where the vaccine will arrive in Canada that is the nearest possible to the outbreak with a direct flight from the airport nearest to the manufacturer, and (3) the serotype of the requested vaccine. The NM-VBS will have on file the name and address of the manufacturer supplying the finished vaccine. The NM-VBS supervises the preparation of the official emergency import permit, signs it, and sends a copy by fax to the manufacturer and to the NAFMDVB. The manufacturer will attach a copy of that emergency import permit with each shipment of the finished vaccine.

4.7.6 Vaccine Distribution within Canada

Upon receiving the finished vaccine, a representative sample of each lot must be retained for sending to the NC-FAD and/or Plum Island Animal Disease Centre for additional tests on safety, efficacy and sterility if deemed necessary. Details are outlined in FAD-MOP C7a (AERT Vaccination Officer).

It will be necessary to acquire an import permit issued by the USDA to ship these samples to Plum Island. The National Manager Imports/Exports will facilitate import permit acquisition for shipments of finished vaccine.

Details on care and handling of vaccine as well as record keeping are in FAD-MOP C7a (AERT Vaccination Officer). In the event that the cold chain is broken at any time during transportation, the vaccine will be used as there is no other immediate replacement for it. The Area vaccination officer or veterinarian receiving the shipment should keep a record of the status of the cold chain. The retained samples (6-20mL vials) will be immediately forwarded to the NC-FAD and/or Plum Island to be evaluated for efficacy/residual activity of the shipment.

4.7.7 Vaccine Administration

Legal authority to require treatment of animal to eliminate or prevent the spread of FMD is given in Section 48 (2) of the Act. Vaccination is one such form of treatment. The purpose of emergency vaccination is a temporary measure to delay destruction of high-risk animals and minimize further virus production in an expanding outbreak. The aim is to vaccinate the minimum number of livestock to ensure secure protection against further FMD spread. When in doubt about balancing these two contradictory objectives (minimizing number of vaccinates but ensuring protection), decision makers should favour securing an adequate vaccination protective zone. Consequences of a secondary outbreak of FMD far outweigh surplus vaccination.

Provision for slaughter, milk collection, and insemination services for Vaccination Zones must be considered. Emergency vaccination within Vaccination Zones may include a combination of the following:

• ring vaccination
• high-risk herd/flock or "dampening down" suppressive vaccination (e.g. large feedlots with their great potential for production of plumes of airborne virus and environmental contamination downwind)
• genetics preservation by vaccination.

The geographic boundary of the Vaccination Zone will initially coincide with the outer 10 km boundary of the Surveillance Zone, which is the general limit for airborne spread of FMD.

Vaccination priorities and administration within the Vaccination Zone will have to be determined. Emergency Ring Vaccination has been extensively used in FMD control. Generally rings are 5 to 10 km wide with vaccination proceeding from the outside to the centre. The area of protective emergency vaccination should be as small as possible and its shape related to geography and meteorology not merely concentric rings. The objective is to set up a protective "wall" of immunity between the outbreak area and susceptible livestock populations.

High-risk enterprise vaccination are applied to large cattle operations and feedlots that present the risk of production of large quantities of virus that could create a virus plume capable of "jumping" the Vaccination Zone. Vaccination will reduce the risk of infection, limit virus production if infected and thus slow the rate of FMD spread. High-risk enterprise vaccination would apply particularly to beef feedlots. Pigs are not as susceptible as cattle to aerosol infection and may remain uninfected under strict bio-security conditions. Pre-emptive slaughter is an option for commercial swine production units due to the large quantities of virus they generate (1 swine = 1000-3000 cattle, in terms of virus production).

Note: Pigs take 21 days to acquire FMD immunity with aluminium hydroxide adjuvanted vaccine. Oil adjuvanted vaccines are preferred in swine.

The issue of the loss of years of selective breeding genetics must be weighed against the impact on the socio-economic fabric of the country. Although the AI units may consider donors to be unique and irreplaceable, these genetics may be preserved in the form of frozen semen or embryos.

Vaccination may be desired as a temporary measure to allow harvesting of semen and/or embryos prior to slaughter of vaccinates after the outbreak. On the other hand, a unit may resist slaughter of vaccinates after the outbreak and make application to CFIA. This would impact on the time required to regain freedom status (six months versus three months) plus market loss of countries with import requirements exceeding OIE standards for all commodities. An appropriate risk and cost-benefit analysis must be performed by the industry in its application not to slaughter vaccinates.

Alternatively, market share and the potential necessity to slaughter vaccinates after the outbreak, may make it desirable for an AI unit located in the Vaccination Zone not to vaccinate and rely on the surrounding vaccinated livestock and bio-security to protect it from FMD. Risk assessment would have to be undertaken for this possibility and consider AI donors as sentinel animals.

4.7.8 Vaccinate Records

The OIE requires all susceptible animals in the Vaccination Zone to be vaccinated and vaccinates are identified by a specific permanent mark; and have their movements controlled. Authority to regulate the marking of an animal with a tag or in other such manner as the Minister may direct to identify the animal is contained in Section 64 (x) of the Act. Duplicate marking of FMD vaccinates will be by one of the official identification systems approved by CFIA and a unique specially coloured H of A FMD vaccinate ear tag inserted in the animal's left ear. It will be a nickel-plated tag that has alpha-numeric characters engraved on the "out" side and is stamped with "H of A FMD Vaccinate" on the "in" side.

Vaccination records will take advantage of existing official identification databases. Collaboration with livestock industry associations is critical. Cattle identified under the Canadian Cattle Identification Program (CCIP) have mandatory records in a national database maintained by the industry effective July 2001.

CFIA Area offices must maintain the official secure records for tracing vaccinates. At a minimum, the following fields are required in the database:

• owner
• address
• location (legal land description, + /- GIS coordinates)
• telephone/email if available
• vaccination date
• vaccination team
• vaccine serial number and expiry date
• any licensed movements (origin and destination)
• disposition of animal
• animal characteristics - species, sex, age, colour, registration (if purebred)
• "H of A FMD Vaccinate" ear tag
• official ear tag (H of A tag, CCIP tag or tattoo)
• any other unofficial ear tag, brands or electronic implants.

4.7.9 Movement Restrictions in the Vaccination Zone

A Vaccination Zone will be created if vaccination is authorized and regionalization of the Vaccination Zone is accepted by trading partners. Where the Vaccination Zone includes parts or the entire Infected Zone or Surveillance Zone, the conditions of those zones will continue to apply. Suppressive vaccination is practised only within Infected Zone on clearly identified quarantined premises with depopulation of animals on such holdings delayed only as long as necessary. Movement control measures for the Vaccination Zone apply only to protective vaccination in the Surveillance Zone.

Conditions below shall apply from the beginning of the emergency vaccination to at least 30 days following completion of vaccination. Further less-restrictive measures may be applied after 30 days and until the completion of a clinical and serological survey designed to determine infection/ non infection with FMD virus by clinical inspection of all susceptible animals in vaccination zone and serological testing for NSP. Probang sampling to exclude the presence of circulating FMD virus will be implemented. If FMD virus is found, herds will be depopulated, decontaminated and restocked using infected premises provisions and all animal products and by-products treated to decontaminate for FMD virus.

Animals

No movement of animals is permitted onto or from vaccinated premises without appropriate licenses. Upon vaccination, premises are quarantined (infected place declaration). Movement permit conditions will require:

• no animal in herd of origin has shown clinical signs of FMD within 21 days
• no additions to herd of origin for 21 days
• no clinical FMD within 10 km for 21 days
• a vaccinated animal may only move to another vaccinated premises
• transport conveyances meet C&D requirements of the zone.

Vaccinated animals may be moved under licence within the Vaccination Zone but may not leave the zone except for transport to slaughter. In the absence of an abattoir in the Vaccination Zone or Buffer -Surveillance Zone, vaccinated animals can be transported to the nearest abattoir for immediate slaughter at the end of the day, provided suitable C&D procedures were followed. As the absence of carrier state cannot be guaranteed, animal products from vaccinated animals shall be considered potentially infected and their distribution restricted to the Control Area unless treated (see Appendix 3).

Vaccinate movement regulations will be modified should international recognition of a discriminatory test for vaccinates be accepted by the OIE and by trading partners.

Movement of non-vaccinated susceptible animals may be authorized 12 months after completion of vaccination where vaccinates are not slaughtered or not earlier than 3 months if vaccinates are slaughtered, according to the OIE Code and the EU Directive 2003/85. Non-vaccinated offspring of vaccinated dams that are sero-positive for antibody shall not move except to slaughter or "fattening holding." Otherwise movement requires a negative serological test for antibody.

People and Vehicles

People and service vehicles will continue to follow the same restrictions as the Buffer -Surveillance Zone. Vehicles shall not leave the Vaccination Zone without a thorough cleaning and disinfection under official inspection at cleaning and disinfection facility approved by the CFIA. Periodic monitoring of transport carriers should be conducted to determine compliance.

Animal Service Industries

All animal service personnel including veterinary practitioners, inseminators, feed delivery, and transporters working on vaccinated premises in the Vaccination Zone should restrict service to the Vaccination Zone and the Buffer -Surveillance Zone. It should be remembered that vaccinated premises may more readily mask the presence of FMD virus than non-vaccinated premises in the Surveillance Zone. All personnel must strictly adhere to the prescribed C&D protocol. Vaccinated premises should be visited after non-vaccinated premises.

Abattoirs and Animal Products Including Milk

Abattoirs operating within the Vaccination Zone are subject to similar restrictions as those in the Surveillance Zone. Animal product sales and distribution are restricted to the surveillance and infected zones. Meat originating from vaccinated animals shall be identified separately from that from non-vaccinated animals and shall be treated according to Appendix 3 until a discriminatory test is internationally acceptable and then no distinction is necessary if serologically negative.

Milk and milk products from vaccinates may be marketed within or out of Vaccination Zone if treated according to EU standards at establishments in the Vaccination Zone or exceptionally close to that zone with the treatment certified by the competent authority.

Milk pick up is permitted under license in the Vaccination Zone. As vaccinated premises can more readily mask the presence of FMD virus than non-vaccinated premises, it is recommended that milk be picked up at vaccinated premises at the end of the day. The C&D protocol must be strictly followed. Milk originating from premises where animals were vaccinated will be processed in the Surveillance Zone and its distribution restricted to the surveillance/infected zone unless treated (see Appendix 3) and then movement only under permit. Periodic monitoring of milk carriers should be conducted to determine compliance.

Germplasm

Semen and embryo collection within the Vaccination Zone shall be suspended unless it is frozen and stored separately for at least 30 days then dispatched only if the vaccinated donors meet conditions stipulated in the Terrestrial Animal Health Code 2005 Article 2.2.10.12, Article 2.2.10.13 and Article 2.2.10.14 as appropriate.

Animal By-products

Restrictions are as per Surveillance Zone.

Feed and Equipment

Restrictions are as per Surveillance Zone. Straw and forage must meet conditions stipulated in the Terrestrial Animal Health Code 2005 Article 2.2.10.28 and are moved under permit.

Special Premises

All stockyards, auction markets, sales, fairs, zoos, assembly points, and other livestock concentration points will operate under CFIA inspection. Only vaccinates may enter special premises in the Vaccination Zone under permit. Zoos within the Vaccination Zone may be vaccinated pending risk assessment. Disposition of zoo animals that were vaccinated to preserve genetics will be determined following a risk assessment. Any concentration points must be cleaned and disinfected after assembly of animals.

Transportation

Transportation of susceptible (non-vaccinated) animals through the Vaccination Zone will be permitted if by direct movement when the origin and destination are outside the zone and vehicles are sealed by CFIA.

Wildlife

Susceptible wildlife in the Vaccination Zone will be subject the same measures as the buffer zone. Vaccination of wildlife will not be considered for emergency vaccination. Should blanket vaccination be considered, vaccination of wildlife will be re-evaluated.

4.7.10 Cessation of Vaccination

FMD vaccination will be stopped in the following circumstances once effective movement control is established in the Control Area:

• Either; No new cases for maximum incubation period (OIE standard = 14 days for swine and cattle, 21 days for sheep and goats) in Infected Zone(s) with no pending suspect cases; or
• All premises in the Vaccination Zone are vaccinated.

In the latter case, although infection is still present in the Infected Zone and stamping-out continues, an effective barrier has been created to prevent continued FMD spread. If there was an indication that FMD was present in wildlife, the outbreak could not be considered under control and stopping vaccination would have to be assessed at the time.

For example, if delivery of FMD vaccine was delayed and no new cases of FMD were uncovered after the index case, FMD vaccination would not take place in Canada.

The decision to stop vaccination will be made by the CVO upon recommendations from the Program Support Unit to the NERT.

Serological surveillance will be undertaken following cessation of vaccination as part of the application for country freedom recognition.

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