International Markets

The Department of Agriculture’s Animal and Plant Health Inspection Service is seeking comments by 27 February on a proposal to revise the list of factors that the agency considers when evaluating the animal health status of a foreign region. APHIS is also proposing criteria for considering a region to be historically free of a specific disease. According to APHIS, these amendments would clarify the type of information it requires from a requesting region in order to conduct an investigation as expeditiously as possible.

APHIS receives a number of requests every year to evaluate the animal health status of foreign regions. However, the initial information is generally incomplete and requires APHIS to contact the requesting government for additional information. To prevent this from happening, APHIS is proposing to consolidate from eleven to eight the number of factors set forth in Section 92.2(b) of the U.S. Code of Federal Regulations and provide more detailed guidance as to the specific type of information encompassed by each factor. The type of information required would not change substantively from what is currently required, however. The new eight factors proposed by APHIS are summarised below.

• Scope of the evaluation being requested. This factor would require identification of the disease(s) for which an APHIS evaluation is requested; a detailed description of the region, including maps; identification of the animal commodities proposed for export to the U.S.; and an estimate of the projected annual volume of export for each commodity. Although this type of information is not specifically referenced in the current regulations and guidance document, it is standard practice for APHIS to require such information from a requesting region before beginning an evaluation.
• Veterinary control and oversight. This factor would require sufficient information for APHIS to assess the infrastructure of the official veterinary services in the region and the ability of the veterinary services to oversee animal health activities, monitor for disease and implement disease control measures.
• Disease history and vaccination practices. This factor would require sufficient information to enable APHIS to understand the history of the disease(s) being evaluated in the region, including prior control measures, revisions to those measures as applicable, and the vaccination status and history in the region.
• Livestock demographics and traceability. This factor would require sufficient information for APHIS to assess the geographic distribution of livestock and wildlife species that are susceptible to the disease(s) under evaluation, patterns of livestock movement within the region, and the ability of the official veterinary services of the region to trace livestock movements in the event of a disease outbreak.
• Epidemiological separation from potential sources of infection. This factor would require sufficient information to enable APHIS to evaluate the ability of the region to prevent incursions of the disease(s) under evaluation. Relevant risk factors that APHIS would evaluate include the presence of the disease(s) in adjacent regions or in regions with epidemiological links to the requesting region, natural and man-made barriers to disease introduction, and trading inspection practices.
• Surveillance. This factor would require sufficient information to enable APHIS to determine whether the surveillance system in the region is sufficient to ensure early detection of the disease(s) under evaluation. Countries would need to submit information regarding active and/or passive surveillance as applicable. Documentation regarding collection and analysis of disease and infection data would have to be sufficient to provide confidence in the disease status of the region.
• Diagnostic laboratory capabilities. This factor would require sufficient information to enable APHIS to determine whether the animal health laboratory system, diagnostic procedures, and quality assurance measures in the region are sufficient to effectively support surveillance for the disease(s) under evaluation.
• Emergency preparedness and response. This factor would require information sufficient for APHIS to assess emergency preparedness measures and response capabilities in the region, as well as procedures in place to notify trading partners and other international entities of a disease outbreak.

APHIS states that certain information would not be applicable or necessary to regions in which a significant period of time has elapsed since a particular disease or infection has occurred, if it has ever occurred. An example of this would be some of the information on surveillance, particularly active pathogen-specific surveillance.

Consistent with World Organisation for Animal Health practices, the new regulations would indicate that, for a region to be considered historically free of a disease, the disease must not have occurred in domestic livestock for at least the past 25 years and must not have been reported in wildlife for at least the past 10 years. APHIS would consider the following six factors to evaluate whether a region can be considered historically free of a disease.

• Scope of the evaluation being requested. The information APHIS would require for this factor is the same as that described for the eight factors above.
• Veterinary control and oversight. This factor would require sufficient information to enable APHIS to determine whether the veterinary services in the region have had and continue to have sufficient legal authority, organisation and infrastructure to effectively investigate, diagnose and report the disease(s) under evaluation, if detected.
• Disease history and vaccination practices. For this factor, the requesting authority would need to indicate when each disease under evaluation was last reported, if ever, in domestic livestock and wildlife in the region. Additionally, if vaccination against the disease(s) has occurred within the past 10 years, the request must include information indicating the reasons for vaccination, the source and type of vaccines used, target populations, recordkeeping requirements, and procedures to distinguish vaccinated animals.
• Disease reporting. This factor would require sufficient information to enable APHIS to determine whether each disease under evaluation has been legally notifiable in the region for at least the past 10 years.
• Disease detection. This factor would require sufficient information for APHIS to determine whether an effective early detection system has been in place for at least the past 10 years for the disease(s) under evaluation. An effective early detection system would include, among other things, representative coverage of susceptible animal populations by field services, a training programme for detecting and reporting unusual animal health incidents, the ability to undertake effective disease investigation and reporting, and access to labs capable of diagnosing and differentiating relevant diseases.
• Barriers to disease introduction. This factor would require sufficient information for APHIS to determine whether measures have been in place for at least the past 10 years to prevent introduction of the disease(s) under evaluation.

As with the eight factors discussed previously, more detailed guidance as to the specific types of information encompassed by each factor for regions historically free of a disease would be set forth in a guidance document available on the APHIS Web site.