Animal and Plant Health Inspection Service

September 2016

U.S. National List of Reportable Animal Diseases (NLRAD) Framework

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Table of Contents

Table of Contents List of Figures Executive Summary Section 1. Introduction

1.1 Stakeholders

1.2 Authority

1.3 Existing Guidance

1.4 Regulatory Plan

Section 2. NLRAD Structure and Reporting

2.1 Format of the Reportable Animal Disease List

2.2 United States National List of Reportable Diseases

2.2.1 Overview of Notifiable Diseases and Conditions

2.2.2 Overview of Monitored Disease(s)

Section 3. NLRAD List Maintenance and Standard Operating Procedures

3.1 Approval and Annual Review of the NLRAD

3.2 Updates and Edits to the NLRAD

3.3 Standard Procedures and Structure of the NLRAD Review and Approval Process

3.3.1 Routine Updates of the NLRAD

3.3.2 Addition of an Emergency Issue or Emerging Disease to the NLRAD

3.3.3 Addition of a Non OIE-Listed Disease or Condition to the NLRAD

Section 4. Laboratory Role in NLRAD

4.1 Disease Definitions

4.1.1 Known Agents

4.1.2 Emerging Animal Disease

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4.2 Case Definitions

4.3 Case Classification

4.3.1 Monitoring and Notifiable Diseases

4.3.2 Emerging Animal Diseases

Section 5. NLRAD Communication

5.1 Reporting an NLRAD Disease

5.1.1 Who Should Report and To Whom

5.1.2 Data Reporting Responsibilities

5.1.3 When Disease Reporting Should Occur

5.1.3.1 Laboratory Requirements for Monitored Disease List Reporting

5.1.4 What Information Should Be Reported

5.2 Communication within APHIS

Section 6. Data Management

6.1 Reporting Needs

6.1.1 Monitored Diseases

6.1.2 Notifiable Diseases

6.2 Mechanism for Reporting: How Will Data be Reported?

6.2.1 Reporting Monitored Diseases

6.2.2 Reporting Emerging Disease Incidents

6.2.3 Reporting Emergency Disease Incidents and Regulated Disease Incidents

6.3 Next Steps

Section 7. Information Release Section 8. Summary Section 9. Acronyms Section 10. References Section 11. Appendices

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11.1 Appendix A. U.S. National List of Reportable Animal Diseases

11.2 Appendix B: Laboratory Case Classification and Reporting Requirements

11.2.1 Monitored Disease List Reporting Guidance for Laboratories

11.2.2 Notifiable Disease List Reporting Guidance for Laboratories

11.2.3 Emerging Disease Reporting Guidance for Laboratories

List of Figures

Figure 1. REPORTABLE DISEASES, CONDITIONS, AND INCIDENTS Figure 2. PROPOSED DATA FLOWS FOR NLRAD DIAGNOsTIC RESULTS

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Executive Summary

The development of the United States National List of Reportable Animal Diseases list and this Framework has been a joint effort on the part of Veterinary Services and numerous stakeholders. In July 2014, a concept paper was shared for review. Based on the interest and comments received on the concept paper, this Framework was developed to more specifically address NLRAD implementation. Prior to the implementation of the NLRAD, the Animal and Plant Health Inspection Service (APHIS) will follow the rule making process and, when complete, will publish in the Federal Register.

The NLRAD is divided into two categories: Notifiable Diseases and Conditions and Monitored Diseases (see Appendix A). Monitored diseases are reported through periodic summary reporting of occurrence. The Notifiable Diseases and Conditions section is subdivided into emergency incidents, emerging disease incidents, and regulated disease incidents. A disease or condition listed as notifiable must be brought to the attention of the Federal and State veterinary authorities within prompt, defined timeframes, in accordance with national and State regulations. NLRAD regulatory authorities will require Federal and State reporting from any individual, producer, veterinarian, laboratory personnel, wildlife or zoo personnel, researcher, public health official, or others with knowledge of occurrence or suspected occurrence of a notifiable disease.

The NLRAD list is intended to be a dynamic document that will be reviewed annually to determine if there are any diseases that need to be added to or removed from the list or change the category in which a disease has been placed. Standard operating procedures (SOP) have been developed for the process to update the list. A VS internal cross-unit team will be established to consider any updates and stakeholders will be given the opportunity to submit suggested revisions. The VS Deputy Administrator will provide the final approval of the list and all changes will be codified via a Federal Register notice.

Laboratories will play a key role in the implementation of the NLRAD Framework including: definitions, reporting criteria, and details involving information sharing and communication. The actions and responsibilities identified in the NLRAD Framework are applicable to both publically funded veterinary diagnostic laboratories and private diagnostic laboratories; all laboratories, both National Animal Health Laboratory Network (NAHLN) and non- NAHLN, performing diagnostic testing in the United States are required to recognize and abide by the NLRAD rule. This Framework includes laboratory case classifications and a Reporting Guidance for Laboratories table in Appendix B.

NLRAD reporting is required at many levels, from Federal and State officials to the general public, making both internal and external communication critical. The NLRAD rule will not change how national reporting is accomplished for monitored diseases, FADs, or regulatory program diseases. Regulations and requirements for these diseases will continue to follow established guidance. For non-FADs or non-regulatory program notifiable diseases (such as high priority or emerging diseases): anyone who identifies an occurrence or suspected occurrence is required to report it to the VS Deputy Administrator and State Animal Health Officials.

Data management will play a central role in NLRAD activities and processes including: data acquisition, processing, analysis, and reporting in alignment with defined reporting criteria for NLRAD-listed diseases and

6 | P a g e incidents. There are existing IT systems currently used for monitored diseases, emergency incidents, and regulated disease incidents. A component in the data system to support Comprehensive and Integrated Surveillance (CIS) will be used for emerging disease incidents.

APHIS ensures confidentiality to the extent possible and treats sensitive producer information with the respect and security it deserves. This will not change with the implementation of NLRAD.

Section 1. Introduction

The United States National List of Reportable Animal Diseases (NLRAD) is a uniform, science- and policy-based, nationally supported standardized list of animal diseases. It provides the basis for consistent reporting with uniform case findings and reporting criteria. It facilitates domestic and international commerce; assists in meeting international reporting obligations to the World Organization for Animal Health (OIE) and trading partners; supports the generation of export certifications; contributes to the assessment and reporting of listed zoonotic and endemic animal diseases; and facilitates response to an emerging disease or issue in the United States.

Regulatory action will officially recognize the NLRAD and codify specific reporting requirements for laboratory personnel, veterinarians, producers, and others to State and Federal animal health authorities. The U.S.

agriculture infrastructure is vulnerable to significant damage from listed as well as emerging diseases. Creating the NLRAD provides consistent reporting across the United States and helps animal health officials protect the U.S. agriculture infrastructure.

The NLRAD was developed in direct collaboration with numerous stakeholders including the United States Animal Health Association (USAHA), American Association of Veterinary Laboratory Diagnosticians (AAVLD), and National Assembly of State Animal Health Officials (NASAHO). The NLRAD list (Appendix A) is primarily based on the OIE list of reportable diseases. It is intended to complement and supplement State reportable disease lists and builds on the current National Animal Health Reporting System (NAHRS). The NLRAD focuses primarily on livestock, poultry and aquaculture species; however, it is recognized that wildlife, companion animals, and zoo animals have the potential to play a significant epidemiologic role in a disease affecting our Nation’s agriculture industry.

1.1 Stakeholders

A partial list of likely stakeholders and responsible parties, along with their anticipated roles, is presented below:

Stakeholders Interest

Representatives of industries:

• Aquatic

• Avian/poultry

• Beef & bison

• Cervid

• Dairy

- Industry-specific scientific, policy, and trade issues

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• Equine

• Pork

• Small ruminant

State Animal Health Officials - State diagnostics and regulatory disease control programs

- Significant input and influence on the diseases on the list and the reporting process, including routine reporting of disease occurrences

Veterinary, wildlife, and public health diagnostic laboratories

- Animal disease diagnostics and communication of results

Tribal leaders - Tribal-specific policy and disease control issues, reporting

Responsible Parties Responsibility

Veterinary Services (VS) - Cooperative data sharing and reporting

• Surveillance, Preparedness and Response Services (SPRS)

• National Import and Export Services (NIES)

• Science, Technology, and Analysis Services

(STAS)

• Program Support Services (PSS)

- Implementation and management of VS disease activities

- Import, export and international health status management

- Development of Federal emergency response plans for notifiable and emerging diseases

- Development of VS documents and stakeholder communication

SPRS

• National Veterinary Accreditation Program

(NVAP)

• Directors, Assistant Directors (ADs), Epidemiologists and Field Staff

• One Health Coordination Center (OHCC)

- Oversee the regulation of, education and communication to accredited veterinarians

- Passive and active surveillance support, field investigations, implementation of Federal response plans if necessary, disease reporting

- Zoonotic related considerations related to an NLRAD-listed disease incident

STAS

• Surveillance, Design, and Analysis (SDA)

• Office of STAS Interagency Coordination

(OSIC)

• Risk Identification and Risk Analysis (RIRA)

• National Veterinary Services Laboratories

(NVSL)

• National Animal Health Laboratory Network

(NAHLN) Program Office

- Development of reporting criteria and case definitions for the NLRAD-listed diseases, data collection, NAHRS and OIE reporting

- Risk-based analysis, spatial analysis, epidemiologic investigation support

- Coordination with other governmental entities

- Diagnostic laboratory support; expertise, reference laboratory services

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- Uphold NAHLN lab standards and quality;

coordination of laboratory data reporting and payment to laboratories

PSS

• Division of Information Technology (DIT)

• Writing, Outreach, and Regulatory Division

(WORD)

• Writing, Editing, and Regulatory

Coordination (WERC)

- IT systems for data management

- Planning and coordinating stakeholder communications such as GovDelivery notices and outreach events

- Preparation of regulatory workplans to implement and update the NLRAD

- Issue and maintain guidance documents and program standards

APHIS Wildlife Services (WS) and State wildlife management agencies

- Passive and active surveillance support related to NLRAD-listed diseases that affect wildlife

Veterinary, wildlife, and public health diagnostic laboratories

- Sample testing and test reporting (notifiable and monitored)

- Reporting animal or farm location if relationship found to a human case of an NLRAD-listed disease

Producers, veterinarians, laboratories, animal owners, or anyone with knowledge of a ‘NLRAD Notifiable’ disease in an animal

- Reporting of suspected/or known disease occurrences

1.2 Authority

The authority for the NLRAD comes primarily from the Animal Health Protection Act (AHPA) codified in 7 U.S.C.

8301-8322, which grants the USDA Secretary the authority over the control and eradication of animal diseases.

Further, the Homeland Security Presidential Directive (HSPD-9) requires the establishment of a

“…national policy to defend the agriculture and food system against terrorist attacks, major disasters, and other emergencies. The [Secretary of Agriculture and other, relevant Department heads] shall develop robust, comprehensive, and fully coordinated surveillance and monitoring systems, including international information, for animal disease…that provides early detection and awareness of disease, pests, or poisonous agents; develop systems that as appropriate, track specific animals and plants, as well as specific commodities and food…”

Additionally, a December 2015 U.S. Government Accountability Office (GAO) report entitled: Emerging Animal Diseases- Actions Needed to Better Position USDA to Address Future Risks recommended that USDA better define roles and responsibilities related to how the agency will respond to emerging animal diseases. These actions would include the laboratories’ role in the detection and identification of disease incidents as well as the communication and reporting of findings.

https://www.gpo.gov/fdsys/pkg/USCODE-2014-title7/pdf/USCODE-2014-title7-chap109.pdf https://www.gpo.gov/fdsys/pkg/USCODE-2014-title7/pdf/USCODE-2014-title7-chap109.pdf https://www.aphis.usda.gov/animal_health/emergency_management/downloads/hspd-9.pdf http://www.gao.gov/products/GAO-16-132 http://www.gao.gov/products/GAO-16-132

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1.3 Existing Guidance

In 2014, VS Guidance 12001 Policy for the Investigation of Potential Foreign Animal Disease/Emerging Disease Incidents (FAD/EDI) was updated and provides VS policy for the investigation and communication of a potential Foreign Animal Disease/Emerging Disease Incident (FAD/EDI). Specific communication and operational procedures are provided in the Foreign Animal Disease Investigation Manual.

Veterinary Services has also developed a Veterinary Services Proposed Framework for Response to Emerging Animal Diseases in the United States and a subsequent Emerging Animal Disease Preparedness and Response Plan. The framework describes four goals for addressing emerging diseases that include:

1) Undertake global awareness, assessment, and preparedness for animal diseases or pathogens not currently in the United States that may be of animal or public health concern or have trade implications;

2) Detect, identify, and characterize disease incidents;

3) Communicate findings and inform stakeholders; and

4) Respond quickly to minimize the impact of disease incidents.

While the NLRAD Framework describes the reporting requirements for specified diseases as well as emerging diseases, the Emerging Animal Disease Preparedness and Response Plan describes the processes by which USDA will identify, evaluate and respond to emerging diseases in animal populations. It should be noted that with regard to emerging diseases VS will undertake adaptive response measures, rather than a predetermined control action.

The codified reference to the NLRAD is intended to indicate that the actual list will be in VS Guidance Document format. This rulemaking will be flexible and responsive to essential updates and changes to the list as needed.

1.4 Regulatory Plan

Veterinary Services intends to proceed as quickly as possible with codification of the NLRAD in regulation. Once comments on this document are received and reviewed, APHIS will begin drafting the proposed rule.

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Section 2. NLRAD Structure and Reporting

2.1 Format of the Reportable Animal Disease List

FIGURE 1. REPORTABLE DISEASES, CONDITIONS, AND INCIDENTS

2.2 United States National List of Reportable Diseases

The NLRAD is a list of diseases reportable to VS, the U.S. national veterinary authority. The NLRAD is divided into two categories: Monitored Diseases and Notifiable Diseases and Conditions. The Notifiable Diseases and Conditions section is subdivided into emergency incidents, emerging disease incidents, and regulated disease incidents. The category in which a disease is placed is not finite but can be moved from one category to another in accordance with NLRAD updates and editing procedures. VS and State animal health officials (SAHO) must closely communicate and cooperate on required reporting. Monitored diseases are reported through periodic summary reporting of occurrence.

2.2.1 Overview of Notifiable Diseases and Conditions

A disease or condition listed as notifiable by the national veterinary authority must be brought to the attention of the Federal and State veterinary authorities within prompt, defined timeframes, in accordance with national and State regulations. NLRAD regulatory authorities will require Federal and State reporting from any individual, producer, veterinarian, laboratory personnel, wildlife or zoo personnel, researcher, public health official, or others with knowledge of occurrence or suspected occurrence of a notifiable disease.

United States National List of Reportable Animal Diseases

(NLRAD)

Emerging Disease Incidents Reported as soon as a herd or premises is believed to be infected, identified by laboratory diagnosis or knowledge of disease

Monitored Diseases Periodic summary reporting

Notifiable Diseases and Conditions

Specific Federal and/or State reporting requirements

Regulated Disease Incidents

Reporting in accordance with Federal and/or State regulations and guidance

Emergency Incidents FADs, exotic vectors, and high priority diseases Immediate Reporting

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The vast majority of reporting of NLRAD notifiable diseases is expected to be through veterinarians and diagnostic laboratories; however, due to the serious nature of notifiable diseases and their possible deleterious impact on U.S. animal agriculture, reporting of these diseases is required by anyone who has knowledge or suspicion of these diseases.

2.2.1.1 Emergency Incidents (FADs, exotic vectors, and high priority diseases)

VS Guidance 12001 describes the investigation response to an FAD or EDI. It defines a FAD as a terrestrial animal disease or pest, or an aquatic animal disease or pest not known to exist in the United States or its territories, and reporting is required by accredited veterinarians (see 5.1.2). Regulations and requirements for these diseases remain in place. Authority under the NLRAD rule would require reporting by anyone identifying or suspecting a notifiable disease or condition; the implementation of the. NLRAD will not otherwise change how national reporting and investigation is accomplished for FADs or regulated diseases.

2.2.1.2 Emerging Animal Disease Incidents

An emerging animal disease (Appendix A) is defined as: A disease, infection, or infestation in domestic or wild animals that is a threat to terrestrial animals, aquatic animals, or humans, and meets one of the following criteria:

1. An unknown agent that is causing disease, infection, or infestation in a herd/flock/premises and has the potential to result in a significant animal or public health impact, and applied diagnostic tests have yielded negative or non- definitive results; OR

2. A newly identified agent that is causing disease, infection, or infestation in a herd/flock/premises and has the potential to cause significant animal or public health impact, or is occurring in multiple herds/flocks/premises; OR

3. A previously identified or known pathogenic agent that has a change in epidemiology, such as:

a. Increased pathogenicity,

b. Expanded host range,

c. Change in geography of an agent with the potential to cause a significant animal or public health impact, or

d. Unexpected morbidity/mortality

For reporting purposes:

A list of SAHOs can be found at: http://www.usaha.org/Members.aspx

A list of the contact information for VS Assistant Director (AD) offices in each state can be found at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/contact-us http://www.usaha.org/Members.aspx https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/contact-us

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Suspected emerging animal diseases must be reported immediately to both State and Federal animal health authorities. A case must be reported as soon as the herd or animal is determined to be infected through observation of case-compatible signs (if developed) or other knowledge of infection. Specific details on continued disease reporting once an emerging disease has been identified will be determined on an incident basis.

2.2.1.3 Regulated Disease Incidents

The implementation of the NLRAD expands the reporting requirement to anyone with knowledge of occurrence, but does not otherwise change national reporting requirements for FADs or regulated diseases. Current regulations and requirements for these diseases remain in place.

2.2.2 Overview of Monitored Disease(s)

A monitored disease is a disease or condition where occurrence is routinely tracked and data are used to monitor changes in a given population and its environment, or to report on disease occurrence. SAHOs and VS ADs are the primary responsible parties for collecting, collating, and reporting data on monitored diseases.

Laboratories will report positive testing and occurrence information to the SAHO in the State where the laboratory is located and the State where the animal is located (if different). SAHOs collect monitored disease occurrence data on diseases that meet case definitions; data are primarily from veterinary, wildlife, and public health diagnostic laboratories but can include data from any verifiable source.

Monthly summary data on all NLRAD reportable diseases, including both notifiable and monitored diseases will continue to be routinely reported by SAHOs to VS through a national reporting system such as the NAHRS, in accordance with program guidance. Monitored diseases usually have no Federal regulatory action associated with identification.

Section 3. NLRAD List Maintenance and Standard Operating Procedures

The NLRAD SOPs emphasize that the OIE-listed diseases are the basis of the NLRAD. These SOPs describe processes for approving, maintaining, and reporting of NLRAD-listed diseases or incidents. These procedures include the annual review, updating, editing, and approval of the NLRAD criteria for revising case definitions, and disease reporting.

3.1 Approval and Annual Review of the NLRAD

On an annual basis, VS, in collaboration with SAHOs, the USAHA and AAVLD, the industries, and other stakeholders will review the NLRAD and make recommendations for any changes to the NLRAD-listed diseases.

The routine review process for the NLRAD list will be initiated no later than May of each year. May is the month when the OIE General Assembly meets and adopts changes to the OIE-listed diseases. The NLRAD review will evaluate diseases that are added to or removed from the OIE-listed diseases; diseases that are recommended for addition or removal by VS or by stakeholders; diseases recommended to be moved from one category to

13 | P a g e another; and new pathogens that emerge. The VS Deputy Administrator will have the final authority for approval and maintenance of the NLRAD. All changes to the NLRAD will be communicated via a Federal Register notice.

3.2 Updates and Edits to the NLRAD

Updates and edits to the NLRAD will be considered when:

• Changes are made to the OIE List of Reportable Diseases

• An emerging disease or issue is identified with significant animal or public health impact

• Changes are made in VS regulations, memoranda, or guidance documents

• Changes are made on the National Veterinary Stockpile (NVS) list; Health and Human Services

(HHS)/USDA Select Agent List; or Centers for Disease Control and Prevention (CDC) Category A, B, C bioterrorism agent/disease list

• Changes or additions are requested by stakeholders

3.3 Standard Procedures and Structure of the NLRAD Review and Approval Process

3.3.1 Routine Updates of the NLRAD

1. Each year in May, the OIE World Assembly of Delegates General Assembly meets to review and adopt or reject recommended changes to the international standards for animal health (terrestrial and aquaculture) including the OIE-listed diseases for the following year.

2. VS will establish an internal cross-unit team to conduct an internal review of the NLRAD list and process.

Consideration will be given to updates and edits to the NLRAD described under 3.2. Recommendations from the cross-unit team will be recorded.

a. Additions to the OIE-listed diseases will be incorporated into the recommended NLRAD list for the following calendar year.

b. Deletions of diseases from the OIE-listed diseases will be reviewed and considered for deletion versus continued listing on the NLRAD.

c. Written proposals addressed to the VS Deputy Administrator requesting the addition or deletion of a non OIE-listed disease to the NLRAD will be reviewed.

i. The VS SPRS Commodity Health Center with the main responsibility for the submitted, proposed disease changes will present the proposal to the entire NLRAD review group with a recommendation to accept or reject the proposal to change the NLRAD.

ii. The VS cross-unit team will develop a recommendation to accept or reject the proposed changes to the NLRAD.

d. All other updates and edits to the NLRAD will be reviewed.

e. On a quorum majority of the internal VS cross-unit team, recommendations will be provided to the VS Executive Team (VSET) regarding the composition of the NLRAD for the following calendar year. All dissenting opinions from the majority also will be made available for the VSET to review.

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f. Case definitions for all recommended diseases will be reviewed by VS. Definitions will be updated or created as necessary.

3. The USAHA/AAVLD NAHRS Steering Committee, a subcommittee of the USAHA/AAVLD Committee on Animal Health Surveillance and Information Systems, will review the recommended NLRAD and provide recommendations, if any, to the VS cross-unit team. The NAHRS Steering Committee includes broad membership representation from APHIS, laboratories, SAHOs, and industry commodity groups. The NAHRS Steering Committee has been closely involved in the development of a NLRAD and the NAHRS.

The VS cross-unit team will consider the NAHRS Steering Committee recommendations and evaluate if any changes should be made to the NLRAD prior to VS leadership review. These recommendations will also be available to the VSET for review.

4. The VSET will review and provide initial approval or disapproval of the recommended NLRAD. If not approved, the recommended NLRAD list will go back to the VS cross-unit team to address concerns expressed by the VSET.

5. The NASAHO reviews recommended changes to the proposed NLRAD.

6. Additional stakeholder input is requested (e.g., USDA Stakeholder Announcement)

7. The internal VS cross-unit team will evaluate feedback, and with VSET input, decide if changes or edits are required to the recommended NLRAD.

8. VS Deputy Administrator will provide the final approval for the NLRAD, which will go into effect the following calendar year. (Completed November timeframe, this will allow time for NLRAD preparation for upcoming year)

9. All changes to the NLRAD will be codified via a Federal Register notice.

3.3.2 Addition of an Emergency Issue or Emerging Disease to the NLRAD

In situations where additions to the NLRAD-listed diseases require expedited action, such as in the case of an emergency issue or newly identified emerging disease or incident, the updates and edits to the NLRAD will follow this emergency approval procedure:

a. The VS cross-unit team recommends the expedient addition of a disease(s) to the NLRAD and the recommended reporting requirements.

b. A case definition for the disease proposed for addition to the NLRAD will be developed.

c. VSET decides on initial approval or disapproval of an expedient addition/edit to NLRAD.

d. NASAHO reviews the request and provides input.

e. The VS Deputy Administrator accepts or rejects the final approval for the emergency addition of the disease to the NLRAD.

f. Implementation of reporting requirements with notification of stakeholders will take effect as soon as feasible.

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3.3.3 Addition of a Non OIE-Listed Disease or Condition to the NLRAD

In conjunction and collaboration with VS, stakeholders may recommend adding a disease or condition to the NLRAD. The disease or condition could include:

1. The disease has a history of causing significant production losses in susceptible species and morbidity or mortality are related to the agent and not solely management or environmental factors. There is a direct economic impact from the disease linked to its associated morbidity, mortality, or effects on product quality; OR

a. The disease has been shown to have, or scientific evidence indicates that it is likely to have, a significant negative effect on wildlife; OR

b. The agent that causes the disease is of high public health concern (zoonotic); natural transmission to humans has been proven and human infection is associated with severe consequences.

2. The infectious etiology of the disease is proven, or if the etiology is not yet known, an infectious agent is strongly associated with the disease; AND

a. A repeatable and robust means of detection/diagnosis exists; AND

b. A robust case definition is available to clearly identify cases and how cases are to be distinguished from other pathologies.

3. The disease has met the definition of an Emerging Disease (Appendix A).

A written proposal addressed to the VS Deputy Administrator should be submitted stating the reasoning for the suggested addition. The written proposal will include evidence of the significance of production losses or morbidity/mortality related to the agent of the disease or condition; or on the significant impact to animals or public health. If the disease is determined to be reportable, the information collected on the disease should assist VS and stakeholders with controlling, eradicating, managing, or developing baseline information related to the disease. The approval of the proposal to add a non OIE-listed disease will go through the standard procedures outlined in 3.3.1, Routine Updates of the NLRAD.

Section 4. Laboratory Role in NLRAD

Laboratories will play a key role in the implementation of NLRAD including: definitions, reporting criteria, and details involving information sharing and communication. The actions and responsibilities identified in the NLRAD Framework are applicable to both publically funded veterinary diagnostic laboratories and private diagnostic laboratories; all laboratories, both NAHLN and non-NAHLN, performing diagnostic testing in the United States are required to recognize and abide by the NLRAD.

The NLRAD Framework focuses on the diseases in the two NLRAD categories—notifiable and monitored disease lists, which include emerging diseases. The laboratories further classify the agents into known and unknown agents until they can be identified via a diagnostic test.

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4.1 Disease Definitions

4.1.1 Known Agents

Notifiable diseases and conditions and monitored diseases are those defined by the most current version of the NLRAD list. Most diseases on the notifiable diseases and conditions and monitored diseases lists already have a defined case definition based on known diagnostics and epidemiology of the agent. VS maintains a library of case definitions for known agents.

4.1.2 Emerging Animal Disease

A complete case definition for an emerging animal disease can be found in Appendix A. In summary, an emerging disease is a disease, infection, or infestation in domestic or wild animals that is a threat to terrestrial animals, aquatic animals, or humans.

4.2 Case Definitions

Standardized national case definitions and reporting criteria are essential to the usefulness of reported animal disease data. The development of national standardized case definitions requires collaboration and coordination between many internal and external partners. VS STAS Center for Epidemiology and Animal Health (CEAH) coordinates the development of case definitions for all diseases on the NLRAD and is responsible for ensuring that the necessary expertise is collated into the document (e.g., epidemiology, disease specialists, laboratory, and emergency response). Case definitions will include input from State and Federal animal health officials. For FADs and regulatory program diseases, final approval is at the VS Deputy Administrator level. For endemic diseases, initial approval is at the VS SPRS Commodity Health Centers level.

4.3 Case Classification

The case classification or state of the disease is used to define the trigger for communication/reporting. The state of the disease can be classified into three categories (suspect, presumptive, and confirmed):

4.3.1 Monitoring and Notifiable Diseases

In general, known agents from the monitoring and notifiable lists can be classified as the following:

• Suspect case: Epidemiological information indicative of exposure, or clinical signs consistent with the disease of concern.

• Presumptive case: A suspect case that has epidemiological information indicative of exposure and positive screening test. In some instances, a presumptive case classification can be considered as a final or confirmed case with no further diagnostics planned. This will be stated in the specific disease case definitions.

• Confirmed case: A laboratory confirmation has been made using the accepted diagnostic test(s) for the disease of concern that unequivocally determines the presence of the agent of concern.

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4.3.2 Emerging Animal Diseases

The case classification for emerging diseases is:

• Suspect: Presence of clinical signs and meets the case definition for emerging disease, laboratory has received submissions from multiple sources/farms; applied diagnostic tests yielded negative or non-definitive results.

• Presumptive: Laboratory receives preliminary diagnostic results identifying a new or known agent meeting the case definition for emerging animal disease.

• Confirmed: Confirmed presence of a newly identified or known agent via sequencing, virus isolation, or other technologies.

Section 5. NLRAD Communication

Communication will play an integral role in NLRAD implementation. NLRAD reporting is required at multiple layers of society from Federal and State officials to the general public, making both internal and external communication critical. An outline of who must report what information, when, and to whom is presented below.

5.1 Reporting an NLRAD Disease

NLRAD will not change how national reporting is accomplished for monitored diseases, FADs, or regulatory program diseases. Regulations and requirements for these diseases will continue to follow established guidance as provided by the U.S. Code of Federal Regulations (CFR) or VS guidance documents. For non-FADs or non-regulatory program notifiable diseases (such as high priority or emerging diseases), anyone who identifies an occurrence or suspected occurrence of a notifiable disease is required to report it to the VS AD and SAHO.

SAHOs and VS ADs must closely communicate and cooperate on required reporting to ensure all responsible parties are in the notification (reporting) process and duplication of reporting does not become an issue. A standardized reporting process related to non-FADs or non-regulatory program notifiable diseases will be cooperatively developed and information and data sharing on NLRAD will be expanded to provide appropriate feedback to stakeholders and responsible parties. Inclusion of Tribal Nations as cooperators will occur through SAHOs and the APHIS Native American Program Coordinator.

For reporting purposes:

A list of SAHOs can be found at: http://www.usaha.org/Members.aspx

A list of the contact information for VS AD offices in each State can be found at:

http://www.usaha.org/Members.aspx

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5.1.1 Who Should Report and To Whom

5.1.1.1 Notifiable Diseases

NLRAD regulatory authorities will require reporting to the VS AD and the SAHO by anyone with knowledge of occurrence/or suspected occurrence of all diseases or conditions listed as NLRAD notifiable. This includes any individual, producer, veterinarian, laboratory personnel, wildlife or zoo personnel, researcher, public health official, or others with knowledge of occurrence or suspected occurrence of a notifiable disease. As an example, accredited veterinarians are currently required by regulation to immediately report to the VS AD and the SAHO all diagnosed or suspected cases of a communicable disease for which VS has a control or eradication program, or animal diseases not known to exist in the United States. The vast majority of reporting of NLRAD notifiable diseases is expected to be through veterinarians and diagnostic laboratories; however, due to the serious nature of notifiable diseases and their possible deleterious impact on U.S. animal agriculture, reporting of these diseases is required by anyone who has knowledge or suspicion of these diseases.

5.1.1.2 Monitored Diseases

SAHOs are the primary responsible parties for collecting, collating, and reporting data on monitored diseases to the VS AD or through an established State reporting process. Laboratories are required to report positive testing and occurrence information to the SAHO in the State where the laboratory is located and the State where animal is located (if different). SAHOs collect monitored disease occurrence data on diseases that meet case definitions; data are primarily from veterinary, wildlife, and public health diagnostic laboratories but can include data from any verifiable source.

5.1.2 Data Reporting Responsibilities

• Diagnostic Laboratories- Laboratories, including publically funded, private, NAHLN, or non-NAHLN, are responsible for reporting the diagnostic information related to an NLRAD-listed monitored disease to the SAHO, both where the laboratory is located and where the sample was collected; back to the submitter of the sample; and to other parties as needed. For NLRAD-listed notifiable diseases and conditions, the VS AD must also be notified. [See Appendix B for detailed timeframes for laboratory reporting based on NLRAD category of disease and case classification.]

• Accredited Veterinarians- Accredited veterinarians are required to report disease occurrence for NLRAD-listed notifiable diseases and conditions, as well as each State’s supplemental reporting disease list. 9 CFR 161.4 (f) states that “an accredited veterinarian shall immediately report to the Veterinarian-in-Charge [note: now referred to as the VS AD] and the SAHO all diagnosed or suspected cases of a communicable animal disease for which APHIS has a control or eradication program in 9 CFR chapter I, and all diagnosed or suspected cases of any animal disease not known to exist in the United States as provided by §71.3(b) of this chapter.” For NLRAD-listed monitored disease and conditions, reporting is required only to the SAHO.

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• Non-accredited Veterinarians- Although not required by the current CFR to report, anyone with knowledge of occurrence/or suspected occurrence of all NLRAD-listed diseases or conditions is required by NLRAD to report (for monitored diseases and conditions only to the SAHO, for notifiable disease and conditions to the VS AD and SAHO).

• Others – NLRAD requires reporting by anyone with knowledge of occurrence/or suspected occurrence of all NLRAD-listed diseases or conditions (for monitored diseases and conditions only to the SAHO, for notifiable disease and conditions to the VS AD and SAHO). This includes any individual, producer, wildlife or zoo personnel, public health official, or others with knowledge of occurrence or suspected occurrence of an NLRAD-listed disease.

• State Officials- the SAHO is one of the initial and primary points of contact on all NLRAD-listed disease categories; direct communication with the SAHO is important. Generally, as much data and information as available and requested will be provided to the SAHO(s) both where the laboratory is located and where the sample was collected. SAHOs must closely communicate and cooperate on required reporting with VS ADs, especially on NLRAD-listed notifiable diseases and conditions. For NLRAD-listed monitored diseases and conditions, SAHOs are the primary responsible parties for collecting, collating, and reporting data, within established time frames, directly to the VS AD or through an established State reporting process.

• Federal Officials- VS Guidance 12001 provides detailed guidance on notification to Federal officials for FAD investigations, confirmations, and emerging disease investigations. The key Federal officials include the VS AD and NVSL officials. For other notifiable diseases and conditions and emerging diseases, the same Federal officials need to be included in the communication. For monitored diseases, select VS analysts receive the information from SAHOs to include in U.S. OIE reports.

• Industry associations- Summary information will be shared as determined appropriate by the laboratory and SAHO based on industry expectations and relationships in each State. In cases of FADs and emerging diseases, the content and timing of this communication should be agreed upon and well-coordinated among State and Federal officials.

5.1.3 When Disease Reporting Should Occur

The vast majority of reporting of NLRAD-listed diseases and conditions is expected to be through veterinarians and diagnostic laboratories; however, due to the serious nature of notifiable diseases and their possible deleterious impact on U.S. animal agriculture, immediate reporting of these diseases is required by anyone who has knowledge or suspicion of these diseases.

While the NLRAD Framework provides standardized guidance at a national level for reporting the known and unknown agents/diseases for each of the NLRAD disease categories, it is vital that each State and Federal animal health authority and diagnostic laboratory(ies) within that State have specific discussions about the expectations for the trigger and timeline for reporting diseases and agents of significance in that State.

As the vast majority of NLRAD-listed diseases will be reported through laboratories, more specific guidelines have been established.

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5.1.3.1 Laboratory Requirements for Monitored Disease List Reporting

Monitored diseases are those that are generally endemic in the United States and are required to be reported to the OIE; associated data are used to monitor changes in disease occurrence over time.

• Case classification: These diseases are usually reported once confirmed by diagnostic results. These are not reported at the suspect level.

• Timeframe: The minimum reporting timeframe for agents on the monitored disease list is monthly. The monitored diseases reporting timeframe may vary by State, based on the disease conditions in that State and expectations of the State and Federal animal health officials.

5.1.3.2 Laboratory Requirements for Notifiable Diseases and Conditions Reporting

These are divided into FADs, non-FADs, and emerging diseases.

5.1.3.2.1 Foreign Animal Disease (FAD) Laboratory Reporting Requirements

The diseases on the notifiable list are of highest reporting priority.

• Case classification: These diseases are reported at least at the suspect level upon receipt of preliminary diagnostic results.

• Timeframe: Due to the high priority and concern, a FAD must be brought to the attention of the State and Federal veterinary authorities immediately –no later than the same day presumptive diagnostic results are available. In most instances, State and Federal authorities are aware of suspect cases based on clinical signs and epidemiology that trigger FAD investigations.

5.1.3.2.2 Non-Foreign Animal Disease (non-FAD) Laboratory Reporting Requirements

These include regulatory and high-priority endemic diseases.

• Case classification: Non-FADs on the Notifiable Diseases and Conditions List can be reported as presumptive (triggered by preliminary positive diagnostic results and epidemiological information) or as a confirmed case, depending on the disease. The distinction is made based on the level of concern within each State, specific VS program disease guidance, CFR requirements for reporting, and/or OIE standards.

• Timeframe: In general, these diseases will be reported to the State and Federal veterinary authorities immediately, no later than the next day following generation of either preliminary or confirmatory diagnostic results for that disease; the case classification for reporting will be in either preliminary or

Appendix B consist of tables that outline the laboratory reporting specifics for monitored, notifiable, and emerging diseases, respectively, for each case classification including the trigger at the laboratory for reporting results, timeframe, and reporting mechanism.

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5.1.3.2.3 Emerging Diseases Laboratory Reporting Requirements

• Case classification: A suspect case triggers initial reporting by the laboratory when specific or known assays have been conducted yielding a negative or non-definitive result and it meets one or more criterion of the emerging disease definition (Appendix A). The presentation/submission of similar cases from multiple sources or farms will also trigger reporting. The reporting will rely upon the professional judgment and expertise of the veterinarian and laboratorian.

o Follow-up reporting upon presumptive and confirmatory laboratory results is required.

• Timeframe: The case should be reported immediately, once the definition of emerging disease is met and classified as suspect. The exact timeframe will depend upon the evolution and behavior of the specific disease/agent. The expectation is that initial reporting will occur as soon as possible from initial case presentation; however, highly infectious agents of concern should be reported immediately.

o Follow-up reporting should occur immediately, no later than the same day that diagnostic results are available.

5.1.4 What Information Should Be Reported

Successful implementation of the NLRAD and emerging disease reporting requires a thorough understanding of what specifically will be reported, who will receive the information and how they will receive it, and clear expectations from all involved about how that information will be used.

Information required will vary based on the time of reporting and the type of NLRAD category of disease. For example, suspect cases may not have diagnostic methodology or results reported. The minimum data that should be reported in each NLRAD disease category are described in this section.

5.1.4.1 Monitored Diseases

Required data reporting for a monitored disease can range from simple occurrence information reporting (yes/no) to expanded case and testing information requested for certain diseases. State, Federal, and industry representatives will collaborate to identify significant diseases in which expanded case and testing information may be collected. The collection, analysis, and reporting of this additional case and epidemiological information will help State, Federal, and industry officials document and monitor national and State disease trends; help meet travel and movement requirements; and evaluate and implement management, control, response, and prevention activities. Expanded information on NLRAD-listed monitored diseases will only occur when there is a cooperative effort between Federal, SAHO, and industry requesting that additional information be collected.

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5.1.4.2 Notifiable Diseases and Conditions

VS Guidance 12001 includes the critical data and information that needs to be collected during an investigation.

An example of the ideal data set for these diseases would include information found on most laboratory’s accession forms:

• Sample identification-- sample ID, animal ID, species, accession number, +/- FAD number, sample type

• Location information-- Owner information, State where sample was collected, and premises identification number (or other approved identification, in coordination with the SAHO)

• Testing information-- Diagnostic methodology, results, and interpretation

• Dates--Date collected, date tested

• Epidemiological information-- clinical signs, case/herd history and type, reason for submission, (+/-) vaccination history

5.2 Communication within APHIS

NLRAD will not change how APHIS internal communication occurs for NLRAD-listed diseases or incidents.

Procedures will continue to follow established guidance as provided in existing VS documents.

Section 6. Data Management

Data management will play a critical role in NLRAD activities and processes including data acquisition, processing, analysis, and reporting in alignment with defined reporting criteria for NLRAD-listed diseases and incidents. There are existing IT systems currently used for monitored diseases, emergency incidents, and regulated disease incidents. To fill the remaining gaps, a data system that supports Comprehensive and Integrated Surveillance (CIS) is under design which will leverage existing assets in conjunction with new acquisition and reporting components. This data system will have multiple components to support the remaining NLRAD data needs, such as those for emerging disease incidents and other regulated disease incidents, as well as serve as a point of data integration for users and analysts.

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FIGURE 2. PROPOSED DATA FLOWS FOR NLRAD DIAGNOSTIC RESULTS.

State B Database

State A Database (e.g. USAHerds, SCS)

State A

State B

Laboratory State A

Laboratory State B

SALMS

LMS

EMRS

VSLS

SCS

Data system to support CIS

Monitored (NAHRS-like)

Emerging

Non-FADs

Web interface

Web interface

Web interface

Regulated

Emergency/FADs Proposed Data Flows for NLRAD Diagnostic Results

HL7

HL7

HL7

Solid: established connection or system Dashed: proposed connection or system Colors and shapes denote separate entities (e.g. a laboratory, a database, etc.)

SCS =…