2015-07212. Notice of Determination of the African Horse Sickness Status of Saudi Arabia

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public of our determination that Saudi Arabia is free of African horse sickness (AHS). Based on our evaluation of the animal health status of Saudi Arabia, which we made available to the public for review and comment through a previous notice, the Administrator has determined that AHS is not present in Saudi Arabia and that the importation of horses, mules, zebras, and other equids from Saudi Arabia presents a low risk of introducing AHS into the United States.

DATES:

Effective March 30, 2015.

FOR FURTHER INFORMATION CONTACT:

Dr. Chip Wells, Senior Staff Veterinarian, Regionalization Evaluation Services, Sanitary Trade Issues Team, National Import Export Services, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; [phone].

SUPPLEMENTARY INFORMATION:

The regulations in 9 CFR part 93 (referred to below as the regulations) prescribe the conditions for the importation into the United States of specified animals to prevent the introduction of various animal diseases, including African horse sickness (AHS). AHS is a fatal viral equine disease that is not known to exist in the United States.

Within part 93, § 93.308 contains requirements governing the importation of horses, mules, zebras, and other equids from regions where AHS exists in order to prevent the introduction of AHS into the United States. Equids from countries where AHS exists are eligible for importation into the United States only after undergoing a 60-day quarantine.

The regulations in 9 CFR part 92, § 92.2 (hereafter referred to as the “regulations”), contain requirements for requesting the recognition of the animal health status of a region or for the approval of the export of a particular type of animal or animal product to the United States from a foreign region. If, after review and evaluation of the information submitted in support of the request the Animal and Plant Health Inspection Service (APHIS) believes the request can be safely granted, APHIS will make its evaluation available for public comment through a notice published in the Federal Register. Following the close of the comment period, APHIS will review all comments received and will make a final determination regarding the request that will be detailed in another notice published in the Federal Register.

On June 12, 2014, we published in the Federal Register (79 FR 33714-33715, Docket No. APHIS-2014-0013) a notice ^[1] in which we announced the availability for review and comment of our evaluation of the animal health status of Saudi Arabia relative to AHS. In that document, titled “APHIS Evaluation of the African Horse Sickness (AHS) Status of the Kingdom of Saudi Arabia” (November 2013), we presented the results of our evaluation of the risk of introducing AHS into the United States via the importation of equids from Saudi Arabia.

We solicited comments on the notice for 60 days ending on August 11, 2014. We received 11 comments by that date, from industry groups and State departments of agriculture. The comments we received are discussed below by topic.

Disease Status

The majority of commenters expressed concern regarding APHIS' recognition of Saudi Arabia as free of AHS because the World Organization of Animal Health (OIE) does not currently recognize Saudi Arabia as free of AHS. Two commenters asked whether Saudi Arabia has petitioned OIE to be recognized as free of AHS.

APHIS evaluations of animal disease status of countries are conducted independently of OIE evaluations in accordance with OIE standards for importing countries. Upon request by the Government of Saudi Arabia, APHIS conducted an import risk assessment using the guidelines established in the regulations. As a result of that assessment, APHIS concluded that Saudi Arabia is free of AHS.

OIE only recently (May 2014) began official recognition of the AHS status of regions in the world. Countries must formally request OIE recognition and submit a dossier of supporting information. APHIS' evaluation of Saudi Arabia was completed prior to May 2014 when OIE first published its list of regions recognized as AHS-free. APHIS has been informed by Saudi Arabian Ministry of Agriculture (MOA) officials that Saudi Arabia intends within the next few months to submit documentation to OIE requesting AHS-free recognition.

Several commenters expressed concern regarding the adequacy of the research leading to our conclusion that Saudi Arabia is free of AHS. Four commenters noted that the information used to support that conclusion was provided by Saudi Arabia.

APHIS evaluates the best available information in accordance with our regulations and with international standards set by the OIE under chapter 2.1 of their Terrestrial Animal Health Code. Often the best and only information available is supplied by the requesting country, although, whenever possible, APHIS considers third party information that is reliable and in accord with current scientific thinking. This practice is consistent with United States Government obligations under applicable international treaties governing trade.

One commenter was concerned that AHS has previously been present within Saudi Arabia.

The last case of AHS in Saudi Arabia was in 1989 and no further outbreaks have been reported since that time. The international standard for AHS-freedom set by OIE is 2 years without an outbreak. Saudi Arabia exceeds this time standard by more than 23 years. Furthermore, multiple surveillance studies since 1992 have not demonstrated the presence of AHS virus in the country. Saudi Arabian law requires mandatory notification of AHS virus throughout the country and AHS vaccination is prohibited. Based on these and other factors described in the risk assessment, APHIS has concluded that Saudi Arabia is free of AHS.

Surveillance and Control Measures

Many commenters stated that they had no confidence in Saudi Arabia's surveillance and control measures for AHS given its limited number of veterinarians and/or clinics in relation to the country's size or the size of its equid population. Two commenters expressed concern whether veterinarians in Saudi Arabia are qualified to diagnose cases of AHS.

APHIS evaluated the veterinary infrastructure of Saudi Arabia and concluded that it has a sufficient number of competent veterinarians to effectively manage its import/export surveillance and AHS disease control responsibilities. Saudi Arabia is roughly one fifth the size of the United States. However, most of the country is uninhabited desert. Therefore, its horse population is concentrated in several small areas, particularly the cities of Taif and Riyadh where most major equestrian events and races occur. In addition, the horse population of Saudi Arabia is estimated to be 16,500, which is relatively small in comparison to the estimated 9 million horses in the United States.

Saudi Arabia's MOA has an office within each of Saudi Arabia's 13 provinces, as well as over 190 branch offices and veterinary clinics in local communities throughout the kingdom. A total of 389 veterinarians and 210 veterinary assistants work under the MOA. These branch offices provide veterinary services for treatment of farm and pet animals in addition to official animal health control measures such as vaccination, sampling, and agriculture extension work. The Ministry also operates 39 mobile veterinary clinics out of the provincial or branch offices throughout the kingdom. There are also 80 private veterinary clinics in the kingdom.

There are two veterinary colleges in Saudi Arabia: King Faisal University in Al-Hofouf and King Saud University in Al Qassim. APHIS reviewed documentation of the AHS training program offered by the MOA to Saudi Arabian veterinarians in cooperation with these colleges and concluded that the content was comparable to training offered in the United States and is taught by well-qualified, internationally credentialed veterinary school faculty.

Several commenters expressed concern that the methodology behind AHS surveillance in Saudi Arabia was not explained in more detail and suggested that more surveillance be conducted. Two commenters stated that, although our evaluation cites the sampling of 750 horses and donkeys between 1997 and 2009, it fails to explain how animals were chosen for sampling or how the survey was conducted.

The MOA conducted six AHS surveillance surveys between 1997 and 2009. Surveys were conducted in 1997, 1999, 2001-2002, 2005, 2008, and 2009. APHIS evaluated the surveillance data and summarized their results in our evaluation. Several commenters incorrectly stated that 750 samples were collected during the period of 1997-2009. As mentioned in our evaluation of the animal health status of Saudi Arabia relative to AHS, a total of 750 animals (460 donkeys and 290 horses) in Saudi Arabia, out of an approximate population of 13,000, were sampled in 1997 alone. That number was chosen to provide 99 percent confidence of detecting AHS infection at a prevalence level of 1 percent. Samples were randomly selected with no more than five samples collected in any single stable or village and were collected in all regions of the country. However, a greater emphasis was placed on targeting samples, especially in donkeys, in the southwestern AHS control zone. Donkeys were targeted for increased sampling since that species would have an increased likelihood of subclinical infection and their population was higher in the AHS control zone. The AHS control zone is a region in the southwestern portion of Saudi Arabia bordering Yemen that acts as a buffer to separate the area where reintroduction of AHS would most likely occur. No equids from the control zone are allowed entry into the rest of Saudi Arabia and no equids from Yemen are allowed into Saudi Arabia. Test results indicated that no active AHS infection was present in the sampled animals.

Subsequent surveys collected additional samples in both nationwide and regionally targeted surveys. In 1999, the MOA conducted a smaller nationwide AHS statistical survey as a follow-up to the 1997 survey. In that survey, 250 samples were randomly collected from all regions of the country. The 2001-2002 survey collected 324 samples and targeted both animals in the AHS control zone and competition horses primarily stabled in the Riyadh area. The 2005 survey, which tested 79 samples, was conducted only in the southwest AHS control zone. The 2008 and 2009 surveys, both of which also focused on animals in the AHS control zone, collected 167 and 125 samples respectively. None of the surveys found evidence of viral activity. Animals that showed low level titers on the initial screening were retested after 30 and 60 days and titers were found to be either stable, decreased, or absent. Therefore, APHIS concluded that the surveys were statistically valid and sufficiently demonstrated AHS freedom.

In addition to these surveys, active surveillance data was collected from the pre-export testing of horses leaving Saudi Arabia. A total of 4,055 horses tested negative for AHS before being exported from Saudi Arabia between 1999 and 2011. All imported equids must test negative for AHS before being admitted into the country.

Two commenters expressed concern regarding Saudi Arabia's lack of a written emergency response plan to deal with a potential AHS outbreak. The commenters asked how, without a written emergency response plan, MOA can ensure that passive surveillance is done correctly and adheres to all MOA rules and regulations. The commenters further asked how MOA can maintain that Saudi Arabia is AHS free when horses could show clinical signs of AHS and be euthanized and buried without the MOA ever knowing about it.

As mentioned in the risk assessment, APHIS recommended to the MOA that Saudi Arabia would benefit by having a written AHS emergency response plan, along with periodic training and scenario exercises to simulate its implementation even though AHS virus has been absent in the country for a quarter century. APHIS believes that a written emergency plan would enhance Saudi Arabia's ability to quickly respond in the event of reintroduction of AHS. A quick response to detect, contain, and eradicate any AHS reintroduction would minimize disruption of trade. However, APHIS concludes that the lack of a written response plan does not preclude removal of Saudi Arabia from the list of regions APHIS considers affected with AHS. Reoccurrence of AHS in the country would result in suspension of equine trade. Resumption of trade would be dependent on subsequent control and eradication. APHIS believes that if the MOA has a written AHS emergency response plan then the length of time needed for this process would be minimized.

Compulsory notification of AHS suspicion and an effective veterinary infrastructure are necessary components of an AHS passive surveillance system. Saudi Arabian law requires notification of AHS suspicion. Based on observations cited in our evaluation, APHIS concludes that the MOA is an effective central veterinary authority and provides veterinary services at the regional and local levels. Specifically, APHIS cites MOA's strategy of directly providing veterinary services though government operated veterinary clinics. The MOA employs a total of 389 veterinarians and 210 veterinary assistants and operates 39 mobile veterinary clinics. APHIS believes this practice encourages horse owners to call and report suspicious signs and symptoms of illness to ministry officials. In addition to the MOA veterinary clinics, there are 80 private veterinary clinics operating in Saudi Arabia. Similar to the United States, professional ethics and standards encourage compliance with the notification requirement for AHS suspicion.

While it is possible that AHS-infected horses could be euthanized and buried without being reported to the MOA, this possibility exists for any country in the world and APHIS believes it to be an unlikely scenario. Reintroduction of AHS into Saudi Arabia would likely result in multiple cases with high mortality, an event that would be difficult to keep hidden. Because vaccination has been illegal for over 11 years, Saudi Arabia now has a large number of AHS-susceptible equids. These animals functionally serve as sentinels for the disease. APHIS believes the number of unvaccinated equids is sufficiently high that AHS would be observed if it were present.

Border Controls

Many commenters expressed their belief that Saudi Arabia's borders are “porous.” The commenters expressed concerns that equids, including feral horses and donkeys, could enter Saudi Arabia from neighboring countries such as Oman and Yemen that are not free of AHS and subsequently enter the United States without being subject to the 60-day quarantine or potentially infect other equids that could enter the United States without being subject to the 60-day quarantine. Two commenters asked for evidence that MOA has conducted active surveillance of the country's feral population of non-horse equids to establish their freedom from evidence of AHS.

APHIS evaluated Saudi Arabia's border controls, including those along its southern border with Yemen and Oman where illegal entry of equids could pose a pathway for AHS introduction. APHIS recognizes the potential for illegal smuggling along many international borders where land crossing is possible. However, the extremely harsh desert along Saudi Arabia's border with Oman and much of Yemen provides a natural barrier that is considered to be sufficient to prevent the illegal entry of equids into Saudi Arabia. In addition, Saudi Arabia's southwest border with Yemen is very mountainous and contains a very limited number of potential routes for horses and donkeys to cross into Saudi Arabia. These mountain passes are regularly patrolled by Saudi Arabia's Al-Mujahedeen (border guards). APHIS considers the potential of being caught by these border patrols and the resultant consequences to be sufficient to deter the illegal smuggling of horses and donkeys into the southwestern region of Saudi Arabia. Furthermore, as stated previously, this southwest region is included in the AHS control zone from which movement of equids to the remainder of Saudi Arabia, as well as to any third country, is prohibited. Thus the AHS control zone provides a second layer of movement controls. Saudi Arabia lacks feral equid populations. Therefore, surveillance of these populations is not necessary or possible. In addition, as stated previously, all equids must test negative for AHS before being imported into Saudi Arabia. For these reasons, APHIS considers the illegal movement of horses from Oman and Yemen to the United States via Saudi Arabia extremely unlikely.

As mentioned in our evaluation, the MOA operates a border inspection post on King Fahad's causeway, which connects Saudi Arabia with Bahrain. That causeway is the only land crossing between the two countries. Two commenters expressed concern regarding oversight of the diplomatic lane on the causeway that is reserved for use by royal families and high government officials, citing the illegal movement of eight horses from Bahrain through this lane. The commenters asked how long the horses were in Saudi Arabia before it was determined they were imported illegally, how many other horses they came into contact with, and whether the incident led to greater oversight or a change in regulations regarding the diplomatic lane.

All horses, regardless of consignee, entering Saudi Arabia are required to have an import permit and are required to stop at the border inspection station for document review and inspection. At the time of the cited incident, Saudi Arabia prohibited the importation of equids from Bahrain due to an outbreak of glanders in that country. Despite these movement restrictions, individuals illegally moved eight horses into Saudi Arabia by taking advantage of diplomatic courtesies. However, secondary safeguards that regulate and control animal identification and internal movement resulted in prompt detection and seizure of these eight horses within 1 day, upon arrival at their intended destination in the Riyadh area. Lacking proper documentation of border inspection, these animals were promptly seized and quarantined before having contact with any other horses. MOA officials indicated that the Government of Saudi Arabia has been in discussions with the Government of Bahrain regarding the misuse of the diplomatic lanes. APHIS considers this quick response to be evidence of the efficacy of Saudi Arabia's animal movement controls and gives us confidence in Saudi Arabia's commitment and ability to enforce its import regulations.

Vectors

Many commenters expressed concern regarding the possibility of AHS being introduced into Saudi Arabia via wind-borne insect vectors from regions where AHS is present. Two commenters asked how APHIS can consider the desert along Saudi Arabia's southern border an effective natural barrier against the introduction of AHS when AHS vectors can cross the Bab el-Mandeb, a 20 mile wide strait separating Djibouti and Yemen.

APHIS acknowledges the presence of competent AHS vectors in Saudi Arabia. However despite their presence, surveillance over an extended period of time has not detected the presence of the AHS virus in the country. Although theoretically plausible, the introduction of AHS into Saudi Arabia from endemic areas of Africa via windblown virus-infected vectors has never been documented. The southwestern corner of Saudi Arabia is approximately 160 miles from Eritrea. Furthermore, the southwestern coastal region of Saudi Arabia is separated from the remainder of the country by a mountain range that is sufficiently high to be considered a natural barrier for spread of the insect vectors capable of transmitting the AHS virus. As described in our evaluation, this region is incorporated into Saudi Arabia's AHS control zone from which equine movement to the remainder of the country is prohibited and is an area of intensified AHS surveillance. APHIS considers surveillance conducted in this region reasonable to detect potential AHS reintroduction. The remainder of Saudi Arabia's southern border with Yemen and Oman is also protected by a natural barrier. The Rub al Khali, or “Empty Quarter,” is a vast uninhabited desert where conditions are inhospitable for life.

Historical incursions of AHS have been associated with the movement of infected horses. Because the focus of the evaluation was on Saudi Arabia, APHIS did not mention, but does consider, Bab el Mandeb to be a natural barrier for equid movements between Djibouti and Yemen. While APHIS considers Djibouti, as well as most of the African continent, to be AHS-affected, Djibouti has never reported outbreaks of AHS to the OIE. AHS is endemic in central and southern Africa and periodically spreads to northern Africa and countries around the Mediterranean. Saudi Arabia is separated from Africa by the Red Sea, which also serves as a natural barrier for equid movement. Equine movement restrictions and the natural barrier of the mountains and desert significantly reduce the risk of spreading AHS virus into other areas of the country.

Benefits and Impacts

Several commenters noted that only eight horses were imported into the United States from Saudi Arabia between 1999 and 2011. Given the low number of horse imports, the commenters questioned the benefit of increased trade with Saudi Arabia relative to the potential risk.

APHIS believes that the low number of imports reflects the trade barrier created by the current 60-day quarantine requirement. We assessed the risk and found no scientific basis justifying the continued listing of Saudi Arabia as a region affected by AHS. Therefore, in accordance with United States obligations under the OIE's Sanitary and Phytosanitary Agreement, APHIS is taking the action to remove Saudi Arabia from this list. As a result of this action, APHIS estimates the most likely effect will be an increase in the temporary movement of horses between Saudi Arabia and the United States for racing, competitions, and breeding. The current 60-day arrival quarantine required for horses entering the United States from Saudi Arabia is costly to horse owners (including U.S. owners) and creates hardships for maintaining the conditioning of competitive animals and care of breeding mares with foals. Horses currently move in and out of Saudi Arabia to the European Union and Arabian Gulf States for racing, competition, and breeding. Saudi horse owners have expressed the desire to compete in races and other equestrian competitions in the United States, as well as transport horses for breeding, but are inhibited by the cost and limitations of the current quarantine. APHIS cannot estimate with certainty the number of horse movements to and from Saudi Arabia that will result from this action. However, we believe the number to be relatively low.

Budget

Table 1 in our evaluation shows the total budget for MOA's Animal and Plant Quarantine Department from 2011 to 2014. Saudi Arabia's animal disease control activities, including for AHS, are reflected in that budget. Two commenters noted that the budget for the Animal and Plant Quarantine Department increased by $4,571,259 since 2011 and asked how APHIS can be certain that the increase went to fund AHS control and surveillance activities. The commenters also asked what Saudi Arabia's Animal and Plant Quarantine Department's budget was in 2009 and 2010.

The budget figures cited in Table 1 of the evaluation reflect the total budget for MOA's Animal and Plant Quarantine Department. Each of those three annual budgets includes a line item of $3,999,465 specifically earmarked as a contingency fund to respond to any foreign animal disease (FAD) emergency, including AHS. In addition, MOA officials have the option to request supplemental funding if emergency response costs exceed the appropriated contingency funds. The increase in the budgets over the 3 years reflects increases in the appropriations for veterinary personnel. Our evaluation reviewed the budgets for the 3 most current years and we believe that was sufficient to determine Saudi Arabia's ability to respond to an outbreak of AHS.

Impacts

Many commenters expressed concern regarding the potential impacts to the U.S. horse industry if AHS were to enter the United States, including job losses, high mortality, and the potential destruction of the horse industry. Several commenters questioned whether APHIS has the resources to deal with a potential AHS outbreak in the United States.

While APHIS agrees that the consequences of an AHS introduction into the United States could be severe, we do not believe that an outbreak would result in the catastrophic consequences the commenters describe. Such catastrophic consequences would be more likely associated with a highly contagious disease or one that spreads widely before detection. As stated in our evaluation, AHS is an infectious, but non-contagious, insect-transmitted, viral disease with high mortality in horses and mules. Recent history indicates that AHS outbreaks in other countries have not resulted in widespread infection, including the 1989 outbreak in Saudi Arabia which was limited to affecting three horses. Disease controls currently available, such as diagnostic capabilities, vector controls, and vaccination, likely contribute to limiting the spread of AHS outbreaks. APHIS believes that an introduction of AHS into the United States would be quickly detected, contained, and eradicated. In the evaluation, APHIS considered the consequences of an AHS introduction along with the exposure and release risks and concluded the overall risk of introducing AHS into the United States via the importation of horses from Saudi Arabia to be very low.

APHIS has resources and is prepared to respond to potential FAD outbreaks, including outbreaks of AHS. APHIS has established the Foreign Animal Disease Preparedness and Response Plan (FAD PReP) to provide a framework for FAD preparedness and response. This document provides the response strategies, zone and premises designations, and critical activities for controlling, containing, and eradicating an FAD. It is available on our Web site at: http://www.aphis.usda.gov/​animal_​health/​emergency_​management/​downloads/​documents_​manuals/​fadprep_​manual_​2.pdf. A companion document, the APHIS Foreign Animal Disease Framework: Roles and Coordination, provides an overview of FAD PReP, Federal roles, APHIS authorities and funding process, incident management, and communication strategy. This document is available at: http://www.aphis.usda.gov/​animal_​health/​emergency_​management/​downloads/​documents_​manuals/​fadprep_​manual_​1.pdf. Additional APHIS FAD emergency management documents may be found at: http://www.aphis.usda.gov/​wps/​portal/​aphis/​ourfocus/​animalhealth?​1dmy&​urile=​wcm%3apath%3a%2Faphis_​content_​library%2Fsa_​our_​focus%2Fsa_​animal_​health%2Fsa_​emergency_​management%2Fct_​fadprep.

Our evaluation cites the statistic that the mortality rate for horses infected with AHS is 70 to 95 percent. Two commenters asked how APHIS can be sure of these numbers.

The numbers cited come from the consensus of global scientific knowledge regarding the mortality rates described in our evaluation. Specifically, the mortality rate for horses infected with AHS was taken from the OIE Web site (http://www.oie.int/​fileadmin/​Home/​eng/​Animal_​Health_​in_​the_​World/​docs/​pdf/​Disease_​cards/​AFRICAN_​HORSE_​SICKNESS.pdf) and the Iowa State University: The Center for Food Security & Public Health Web site (http://www.cfsph.iastate.edu/​Factsheets/​pdfs/​african_​horse_​sickness.pdf).

Compensation

Two commenters asked whether APHIS would be able to provide compensation for horses that may need to be euthanized for AHS.

APHIS has the authority to provide indemnity in the case of an FAD outbreak. In the event of an FAD outbreak such as AHS, APHIS may consider indemnity funding. Specific decisions regarding indemnity would depend on the situation and available funding sources.

Based on the evaluation and the reasons given in this document in response to comments, we are recognizing Saudi Arabia as free of AHS and removing it from the list of regions considered affected with AHS which is found on the APHIS Web site at http://www.aphis.usda.gov/​wps/​portal/​aphis/​ourfocus/​importexport and following the link to “Animal or Animal Product.” Copies of the list are also available via postal mail, fax, or email from the person listed under FOR FURTHER INFORMATION CONTACT.

Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

Done in Washington, DC, this 24th day of March 2015.

Jere L. Dick,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  To view the notice, the assessment, and the comments we received, go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2014-0013.