[Response to Comments Received: External Consultation on the Framework for Implementing and Maintaining the Arrangement between Canadian Food Inspection Agency and United States Department of Agriculture for the Recognition of Foreign Animal Disease Control and Eradication Zones ]

-Introduction-

Foreign Animal Disease (FAD) Zoning Recognition is an initiative under the United States (U.S.) - Canada Regulatory Cooperation Council (RCC). President Obama and then Prime Minister Harper created the RCC in 2011 to promote regulatory cooperation and facilitate trade, with resulting benefits for industry and consumers.

The first step in the FAD Zoning Recognition initiative was reciprocal evaluations of each country's veterinary infrastructure and emergency response capabilities, focusing on zoning to control FAD outbreaks. Based on the favorable outcome of these evaluations, the Animal and Plant Health Inspection Service (APHIS) and the Canadian Food Inspection Agency (CFIA) entered into an ArrangementFootnote 1 to recognize each other's zoning decisions in the event of a highly contagious (HCFAD) outbreak (note, the scope was limited to those FADs that have the ability to spread in an extremely rapid manner). The intent of the Arrangement was to facilitate trade between zones that remain free of the disease, while safeguarding animal health in both countries.

The CFIA and APHIS subsequently developed a frameworkFootnote 2 to implement and maintain the Arrangement over time. The agencies conducted an external consultation process for this framework over the spring and summer of 2014. APHIS published the Framework and associated documents on May 13, 2014, for a 60-day public comment period. The CFIA published the same documents for comment from June 11, 2014, to August 31, 2014.

APHIS received 11 unique comments during, and subsequent to, the public comment period, including recommendations from the Secretary of Agriculture's Advisory Committee on Animal Health. One comment consisted of 19,062 form letters opposing both Framework and Arrangement received from a citizen health advocacy group. The remainder were received from national and State livestock, meat, and dairy organizations and a national veterinary group.

The CFIA received 17 comments: two from individuals, five from national and provincial poultry organizations, seven from national swine, beef, dairy and meat organizations and a provincial sheep association, one from a packer/exporter, one from a consumer group, one from a provincial representative, and one from a farmers union.

-General-

The comments received by CFIA ranged from highly supportive to neutral. Although no commenters opposed the Arrangement or Framework, many raised concerns over the potential impact of zoning recognition on international markets. Poultry organizations recommended the recognition of compartments as well as zones, and asked for assurances that the Framework and Arrangement would not interfere with the emergency preparedness work previously completed with the CFIA.

The comments received by APHIS were primarily supportive, but some were opposed to the Arrangement and Framework, stating that they would undermine U.S. notice and public comment procedures and unnecessarily endanger U.S. livestock producers and herds.

Industry groups on both sides of the border highlighted the importance of cross-border trade and supported the development of tools such as the Arrangement and Framework for minimising trade restrictions during outbreaks. Most groups expressed their support for continued stakeholder engagement and desire to participate in cross-border working groups to foster relationships. Some groups raised industry-specific questions and/or offered suggestions for improving the Framework.

The CFIA and APHIS have grouped the comments into seven categories, namely international acceptance, emerging diseases, traceability, political pressures, communications and stakeholder engagement, vaccination zones, and other topics. The comments within each category are discussed in greater detail below.

1. International Acceptance
-Several commenters raised concerns with respect to potential loss of international markets if zoning recognition were implemented, and recommended that Canada and the U.S. seek the acceptance of international trading partners and champion zoning recognition at the World Organization for Animal Health (OIE).
The objective of the Arrangement is to open the Canada-U.S. border as quickly as possible to trade between disease-free zones in the event of a highly contagious FAD (HCFAD) outbreak, while protecting each country from the further spread of disease. The Arrangement acknowledges the fact that a prolonged border closure would result in major structural changes to industry and reaffirms our long history of friendly relations and trading partnerships. There is certainly precedence for this approach among the 28 countries composing the European Union, which zone for HCFADs while permitting trade between non-infected areas.

That being said, the potential impact of the Arrangement on international markets is important, particularly for diseases such as foot and mouth disease (FMD). The CFIA and APHIS have initiated a project to model the consequences of decisions related to resumption of trade under a number of different outbreak scenarios, specifically for FMD. The goal is to develop a tool for exploring options with respect to the timing of trade resumption, along with the expected economic benefits to each country and expected impacts on international markets. This tool will provide assistance in determining the most beneficial point in time to reopen trade in the event of an FMD outbreak.

Canada and the U.S. have also proposed some changes to the OIE Terrestrial Animal Health Code chapter on zoning, specifically on recognition of disease containment zones, which are in line with zoning recognition under the FAD Zoning Initiative. The OIE has accepted the proposal for further discussion.

-Some commenters suggested that the Arrangement be used as a template for other key markets, perhaps moving to a North American approach, and emphasized the importance of relying on accepted science-based standards. However, a U.S. commenter noted that Canada is likely one of the few countries for which this type of Arrangement is feasible and cautioned against expanding this type of initiative to other countries at this time.
APHIS and CFIA agree that the high degree of cross-border trade and industry integration create a unique situation for Canada and the United States. However, both countries currently have measures in place to recognize zoning for certain diseases in the European Union and some form of zoning recognition may be feasible in other countries as well. This approach is in accordance with the OIE Terrestrial Animal Health Code chapter on zoning, which encourages trading partners to work out zoning processes in advance of a disease outbreak, to minimize trade disruptions.Footnote 3

For example, discussion on zoning recognition has recently taken place under the auspices of the Quadrilateral Countries (Australia, New Zealand, United States and Canada). There is interest in developing a zoning recognition arrangement among all four countries, and work has been initiated to that end. One commenter stated that consideration of zoning with other countries must include an open and honest assessment of how well what really happens in the foreign country matches the plan and reports ? e.g., the infrastructure and commitment demonstrate conclusively that surveillance and reporting claims match reality ? to which we fully agree.

2. Emerging Diseases
-Three commenters asked how the Framework would be applied for emerging diseases, and in particular for emerging diseases that are not reportable, or that are reportable in one country but not the other. One suggestion was to define the diseases covered by the Arrangement and Framework, perhaps by using the OIE highly contagious disease list, so that currently endemic diseases do not trigger the need to zone.
We anticipate that the Arrangement and Framework would apply to a highly contagious emerging disease as they would to known HCFADs. In the draft Framework, emerging diseases are explicitly included among FADs as defined for the purposes of the Framework. This means implementation of the Framework during an HCFAD or emerging disease outbreak does not rely on the disease being notifiable or reportable in Canada or the United States, or both. Instead implementation is contingent on notification by the official veterinary services in the affected country of the occurrence of the HCFAD or emerging disease and on its control through zoning.

3. Traceability
-Some commenters stated that Canada, in particular the Province of Quebec, has a stronger livestock traceability system than the United States. One asked whether APHIS and CFIA had taken that difference into consideration and if it would impact on the United States' ability to zone for FADs. Another questioned the reliability of traceability in general, as well as the impact on timing to secure a zone.
We agree that traceability systems differ between Canada and the United States. These differences were considered in the evaluations underlying the zoning Arrangement, namely the "APHIS Evaluation of Zoning for Foreign Animal Disease Control in Canada" and the "CFIA Evaluation of the Zoning for Foreign Animal Disease Control in the United States," Appendices 2 and 3 respectively of the Framework. The conclusion in both cases was that, despite the differences, each country has a sufficiently strong veterinary infrastructure, organization and expertise to control a limited HCFAD outbreak through zoning. The CFIA and APHIS intend to review the evaluations at least annually and update them as necessary to reflect changes in veterinary infrastructure, including those affecting traceability, in each country.

4. Political Pressures/States versus Provinces
-Some commenters expressed concern that decisions to allow trade will still be at the discretion of the importing country and political pressures may prevail.
We recognize this potential but remain committed to transparent, science-based decision making as described in the Framework document. The agencies view limiting the negative impact of an FAD outbreak in either country as a responsibility shared with all stakeholders, and will continue efforts to build credibility in the zoning recognition process.

-One commenter expressed concern that split State and Federal responsibilities may negatively impact U.S. capacity to combat HCFADs.
We note that responding to an FAD outbreak is already a collaborative effort in the United States, as it is in Canada. Primary authority typically lies with the affected State in single-State outbreaks and with APHIS in multi-State outbreaks. Either way, the Incident Command System promotes cooperation and efficient use of resources through a unified State-Federal command structure. This system both increases response capacity and leverages the knowledge of the States regarding the affected area.

-Several commenters inquired as to the statutory authority in each country to ensure that State and Provincial animal health authorities comply with the Arrangement, and emphasized the importance of agreement and commitment by these authorities.
There is no direct statutory authority to enforce compliance. However, the Arrangement is designed to minimize the very serious consequences of a closed border by facilitating trade between disease-free zones, while protecting animal health. Considering the integration of the North American livestock and livestock products markets, this would result in direct or indirect economic benefits to individual States and Provinces-and industry within those States and Provinces. The Arrangement has been favorably received to date by both sets of authorities, and APHIS and CFIA intend to continue building credibility in that regard. For example, we will continue to engage with provincial and state authorities on the Arrangement and to partner in exercises and workshops as time and resources permit.

-Two commenters expressed concern that USDA is giving up its authority to prevent animal diseases from entering the United States in order to facilitate trade with Canada, to make it easier for multinational meat companies to import animals from Canada with few restrictions.
On the contrary, APHIS and CFIA entered into the Arrangement only after thoroughly evaluating each other's ability to contain and control HCFAD outbreaks through zoning, with favorable results. Both the Arrangement and Framework contain numerous safeguards to protect animal health, from provisions to request additional information about response measures to the ability of each country's veterinary authority to embed in and monitor the outbreak response. Neither requires APHIS or CFIA to recognize a zoning decision if legitimate concerns exist as to the integrity of the zone or efficacy of the outbreak response.

-One commenter stated that the Arrangement requires a redirection of already scarce resources to create a new bureaucracy and governance structure. Furthermore, governance will consist of foreign officials who are not accountable to citizens of the United States.
We note that one goal of the RCC is to decrease regulatory burden and make the most of resources on both sides of the border. By entering into the Arrangement, APHIS no longer needs to devote scarce resources to the previous lengthy regulatory process of reopening the U.S.-Canada border following each HCFAD outbreak.

Considering the nature of this initiative, a bilateral governance structure is appropriate, particularly while the initiative is new and the agencies are engaged in building acceptance and credibility among other stakeholders. APHIS officials within the governance structure represent and are accountable to U.S. citizens. However, the ultimate goal is to phase out the governance structure. We have amended the Framework as follows to make that clear:

Part II, paragraph 1 (page 7):

Part II-Establishing and Maintaining the Arrangement

Initial efforts to establish the Arrangement require both a governance structure to provide guidance and oversight, and ongoing projects and initiatives to foster credibility of the Arrangement among all stakeholders. Once the concept and mechanisms are established, APHIS and CFIA anticipate that the governance function will be largely limited to keeping the Arrangement and underlying evaluations current and maintaining open lines of communication with stakeholders.

-Some commenters expressed concern that the Arrangement undermines the U.S. notice and public comment procedures for important policy changes.
APHIS followed U.S. notice and public comment procedures by publishing a Notice of Availability in the Federal Register to solicit public comment on the Framework. There is precedent for this approach in U.S. policy regarding avian and swine disease outbreaks in the European Union.

The Framework will remain a living document subject to annual review and APHIS welcomes an ongoing dialogue with stakeholders to improve the document and approach. APHIS and CFIA anticipate annual stakeholder consultation on projects and priorities for the FAD Zoning Recognition initiative, as well as targeted stakeholder engagement through webinars, stakeholder meetings, and other means. APHIS will notify stakeholders of any significant changes through the APHIS Stakeholder Registry.

-One commenter stated that the Arrangement puts too much control over trade matters in the hands of APHIS' Chief Veterinary Officer (CVO). However, another commenter strongly agreed that the U.S. CVO is the appropriate authority to make zoning decisions for the United States and recognize zoning decisions by Canada.
Title 7 of the Code of Federal Regulations, Part 371, delegates certain authorities provided to the Secretary of Agriculture by the Animal Health Protection Act ? specifically authority to prevent and control diseases of animals ? to the Deputy Administrator of Veterinary Services (VS), who is also the CVO of the United States. APHIS therefore considers the CVO to be the appropriate person to make and recognize zoning decisions for the United States.

Recognizing zoning decisions made by Canada is consistent with the integral role that the U.S. CVO and VS currently play in international trade in live animals, animal products, and animal by-products. The staff of VS' National Import Export Services works closely with other federal agencies, states, foreign governments, industry, and professional groups to enhance international trade and cooperation while preventing the introduction of dangerous and costly pests and diseases.

5. Communications/Stakeholder Engagement
-Numerous comments focused on communications and stakeholder engagement. There was almost unanimous agreement on the importance of ongoing consultation, communications, and government-industry collaboration. Several commenters noted the importance of involving all pertinent stakeholders, including veterinary medical organizations and animal industry, in discussions on the FAD Zoning Recognition Initiative. Others applauded the commitment that the CFIA and APHIS have made to engage stakeholders through ongoing dialogue and joint activities, and recommended further outreach to ensure buy-in from producers and state, provincial, and federal authorities. One commenter recommended regular stakeholder updates and opportunities for stakeholders to offer their viewpoints regarding implementation of the initiative, as well as activities to increase awareness and understanding of the Arrangement. Another suggested adding communications expertise to the working group.
-Several commenters suggested recognizing the involvement of provinces, states, and other stakeholders in emergency response to an HCFAD outbreak in the Framework, to strengthen the document and help garner stakeholder support.
The evaluations underlying the Zoning Arrangement highlight the essential roles of states, provinces, and other stakeholders in control of an HCFAD through zoning or other means. APHIS and CFIA will modify the Framework to reflect this fact as follows:

Zoning for HCFADs - paragraph 1 (page 2)

The Arrangement is based on reciprocal evaluations of veterinary infrastructure and emergency response capacity. The evaluations highlight the integral role of states, provinces, and other stakeholders in zoning for HCFADs; in both the United States and Canada, emergency response is a collaborative effort. The evaluations concluded that both countries can effectively use zoning to control and eradicate an FAD outbreak (see Appendices 2 and 3).

-One commenter noted that embedding an APHIS or CFIA liaison from the partner country in the Incident Command Structure of the affected country during an HCFAD outbreak is a good strategy and suggested including a public health liaison as well.
We note that the Arrangement and Framework were developed by APHIS and CFIA in their capacity as animal health regulatory agencies. Public health concerns are largely beyond the scope of this initiative but are addressed through other avenues, including collaboration between the U.S. Centers for Disease Control and Prevention, and Health Canada on emergency response plans.

-Three commenters focused on the nature of stakeholder interaction with the working group and suggested representation directly or through a panel.
We view other stakeholder groups to be equal partners in this endeavor; however, considering the diversity of stakeholders and different means of engaging with stakeholders in each country, direct representation on the working group is not feasible. APHIS and CFIA are committed to fostering an ongoing dialogue and creating opportunities for stakeholder input and direction on implementation of the FAD Zoning Initiative, as described in the communication and outreach plan. Stakeholder input is also welcome at any time by email at APHIS-RCC@aphis.usda.gov or by mail at:

APHIS-RCC
c/o APHIS VS National Import-Export Services
4700 River Road
Riverdale, MD 20737

On the Canadian side, stakeholder input is welcome at any time by email at consultations@inspection.gc.ca

-One commenter inquired how communication with the media and general public would occur during an outbreak.
We have addressed this issue in Part I, section 4, of the Framework document. We expect that each country would follow the internal and external communication procedures established in its own emergency response plans, guidelines, manuals, and/or standard operating procedures in the event of an HCFAD outbreak within its territory. Each country would also follow procedures established by pertinent APHIS and CFIA staff to communicate import restrictions to the ports, industry, states and provinces, and other stakeholders. We further expect that the two countries would coordinate communications regarding questions about the Arrangement and trade with disease-free zones in the affected country.

-One commenter raised a question about information on endemic diseases in horses.
Since the initiative covers HCFADs only, that particular comment does not apply to the current Arrangement and has been answered separately.

6. Vaccination Zones
-Several commenters recommended including recognition of vaccination zones in the Framework.
Both APHIS and CFIA animal health emergency response plans recognize vaccination as a tool to aid in efforts to eradicate an HCFAD outbreak. CFIA plans call for vaccination only in pre-existing areas of control that would be covered under the Arrangement and Framework. APHIS plans allow for vaccination in pre-existing areas of control and also in separate vaccination zones under certain circumstances; for example, to protect animals of high genetic value or zoo populations. In both cases, movement controls would be applied to the vaccinated animals. Since the Framework does not directly address recognition of vaccination zones outside of an area of control, recognition would likely occur on a case-by-case basis.

7. Other
-One commenter indicated that Part I, Section 2.4, of the Framework document on extenuating circumstances is not clear enough, but the commenter did not provide specific points to clarify.
Section 2.4 refers to situations where it may not be possible to immediately contain an outbreak through zoning and the consequent suspension of the zoning recognition process. APHIS employed the approach described in Section 2.4 during the height of the 2014-2015 highly pathogenic avian influenza (HPAI) outbreaks to good effect. We have made no changes to Section 2.4 at this time.

-One commenter asked why "Canada and the United States anticipate that most HCFAD outbreaks will be small, focal, and well within the resources of the affected country to contain" [Framework Part I, Section 2.4].
This statement is based on the experience of the two countries with regard to HCFAD outbreaks over the last several decades.

-Some commenters noted that the poultry industry has worked closely with CFIA in developing zoning principles and expressed concern that the Arrangement would impede this work.
Under the Arrangement and Framework, each country follows its own established zoning procedures in responding to an FAD outbreak, so this should not be an issue. However, the CFIA and APHIS intend to assess the use of the Arrangement during the 2014-2015 HPAI outbreaks in Canada and the United States, and will consider the impact on zoning principles developed in collaboration between the CFIA and Canadian industry.

-One commenter asked if there are processes in place to mitigate disagreements when there are differences between how the two countries proceed with an outbreak.
It is important to note that differences exist in zoning procedures between the United States and Canada, as described in the evaluations underlying the zoning Arrangement. These differences do not negatively affect the ability of either country to contain an FAD through zoning. That said, if a major disagreement were to occur during an outbreak, it would be handled at the level of the steering committee described in the Framework, if necessary with the aid of the working group. This is an important issue and we will be exploring it in greater detail in our assessment of the implementation of zoning recognition during the 2014-2015 HPAI outbreaks in Canada and the United States.

-One commenter expressed concern that the FAD Zoning Recognition initiative would impede the work of the CFIA on the development of FAD programs.
This would not be the case as each country is internally evaluated on its FAD emergency preparedness, including quarantine, disease control, eradication plans and the training for such preparedness.

-A commenter asked for which products export health certificates would be required. Another commenter asked whether meat transported in a sealed truck could pass through an infected zone.
These points created some confusion during the 2014-2015 HPAI outbreaks and we plan to explore them further. An export health certificate would most likely be required for commercial shipments of live animals, animal products, and animal by-products, attesting to either the origin or treatment as appropriate. However, the issue of commodities for personal consumption requires further consideration. Similarly, the Framework currently requires that commodities for export "did not reside in or pass through an established area of control" [Framework Part 1, Section 5], which is likely not necessary for certain commodities. APHIS and CFIA plan to adjust these elements based on the findings of a planned assessment to evaluate the operation of the Arrangement and Framework in recent HPAI outbreaks.

-One commenter highlighted the importance of early detection and biosecurity to avoid an overwhelming outbreak and asked what additional risk mitigation measures would be applied to prevent such a situation. Several other commenters suggested that the initiative include a major information campaign on disease control and emergency management.
The CFIA and APHIS agree that good biosecurity is important in preventing HCFAD outbreaks. Both agencies have mounted extensive information campaigns in recent years aimed at prevention and detection of certain FADs. Although outreach on biosecurity is beyond the scope of this initiative, both agencies plan to continue efforts in other venues.

Emergency preparedness is also a high priority, including contingency planning, animal traceability, movement controls, disease surveillance, and laboratory support. Numerous measures are implemented to prevent the spread of an HCFAD, once detected. Such measures are fully defined in disease-specific plans, response strategies, and guidelines so that immediate actions can be taken at the field level. In addition to enhanced biosecurity, the measures may include vector and wildlife control, epidemiological investigation and tracing, surveillance, disposal of contaminated material, stamping-out, vaccination, zone boundary controls, decontamination of vehicles and machinery, and cleaning.

-One commenter stated that the CFIA and APHIS need the ability to recognize compartments as well as zoning, particularly with regard to poultry facilities with excellent biosecurity.
Recognition of compartments is not within the scope of the current Arrangement. However, this is an area that could be considered for further work under the RCC, particularly if there is support from the industry in both countries.

-One commenter asked whether there are agreed-upon performance measures to provide a basis to assess how well the Framework is working to protect the public.
There are currently no such measures in the Framework; however, it will be subject to annual bilateral review, including after-action assessments, and adjustments made as necessary.

-One commenter asked whether ducks, geese, and other specialty birds are included in the definition of domestic livestock.
Both APHIS and CFIA define 'poultry' to include ducks, geese, and specialty birds that are raised in captivity. Poultry is considered domestic livestock, and would therefore be covered under the Framework.

-One commenter asked whether zoo animals are included in the scope of the Framework. If a zoo were in an area of control, any susceptible animals within the zoo would be subject to movement controls applicable to the FAD response.
-One commenter stated that any description of a zone should include latitude and longitude coordinates for greater precision.
There is no scientific evidence that specifying latitude and longitude is essential for effective definition of disease control and eradication zones, nor have these coordinates proven useful for border personnel. Consistent with this, the OIE does not specify latitude and longitude as essential components of zone definition; rather, the OIE Terrestrial Animal Health Code states that zones should be "clearly defined," "primarily on a geographical basis (using natural, artificial or legal boundaries)."Footnote 4 In an effort to avoid imposing unnecessarily prescriptive conditions on Canada and the United States for the purposes of implementing the Arrangement, we will not amend the Framework to require that latitude and longitude be specified in zone definitions.

-One commenter suggested changing this sentence on page 2 of the Framework to highlight the potential impact of a disease agent, rather than the consequences of failing to contain the disease.
Page 2, paragraph 7:

An area of control may initially be quite large relative to the apparent distribution of cases, particularly if the consequences of failing to contain the disease agent are high. The affected country may elect to modify or redefine the boundaries of an area of control during the course of an outbreak.

We believe that "the consequences of failing to contain the disease agent" is more accurate in the context of this sentence, as "the potential impact of the disease agent" is very broad and encompasses factors that do not pertain to the size of the initial area of control. We are therefore not amending this statement.

-One commenter suggested identifying both parties' commitment to the process and implementation of the Framework in the "Guiding Principles and Approaches" section.
We have amended point 2 of the section as follows:

Cooperation: An on-going cooperative effort between CFIA, APHIS, and other stakeholders in both countries is necessary to maintain the Arrangement over the long term. It is the intent of CFIA and APHIS to:
-Remain committed to jointly implementing the Arrangement and Framework;
-Develop a governance structure and forums to support the sustained effort; and
-Create an environment in which openness, sharing, and consensus building are encouraged.

-One commenter suggested adding background on acceptable response and control policies.
The draft Framework includes, as appendices, two evaluations that APHIS and CFIA conducted of the veterinary infrastructure and emergency response capacity of Canada and the United States, respectively. The evaluations include descriptions of the FAD response and control policies and procedures in place in Canada and the United States, as well as the veterinary infrastructure context in which these policies and procedures are developed and applied. These evaluations support and provide detailed background for the mutual acceptance by APHIS and CFIA of the other's zoning decisions as noted in the Framework: "[t]he Arrangement is based on reciprocal evaluations of veterinary infrastructure and emergency response capacity which concluded that both countries can effectively use zoning to control and eradicate an FAD outbreak."

-One commenter focused substantially on surveillance, noting that consideration of zoning between the United States and other countries must include adequate surveillance plans and transparency of test results. The commenter also noted that surveillance must be robust enough-including sufficient funding-that we can detect disease in one country if the other becomes infected.
As seen in the 2014-2015 HPAI outbreaks, when an HCFAD occurs in either Canada or the United States, awareness and surveillance increase in the other country. Increased passive and active surveillance led to detection of the disease in additional states and provinces as the outbreak progressed. Both CFIA and APHIS agree that surveillance for HCFADs is a priority and both are working to ensure sufficient funding and coverage.

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