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Extract from pdf file at  http://www.gao.gov/new.items/d05214.pdf

The United States still faces several complex challenges that limit the nation’s ability to quickly and effectively respond to a widespread attack on livestock and poultry:

..."........ until USDA evaluates the costs and benefits of using rapid diagnostic tools at the site of an outbreak, the agency may be missing an opportunity to reduce the impact of agroterrorism. Without on-site diagnosis to help monitor neighboring herds, animals would likely be slaughtered based on proximity rather than confirmed infection, unnecessarily magnifying the impact of an attack. . .."

 

Extract from pdf file at  http://www.gao.gov/new.items/d05214.pdf

Highlights Accountability IntegrityReliability www.gao.gov/cgi-bin/getrpt?GAO-05-214. To view the full product, including the scope and methodology, click on the link above. For more information, contact Robert Robinson, 202-512-3841, Robinsonr@gao.gov. Highlights of GAO-05-214, a report to congressional requesters

HOMELAND SECURITY

Much Is Being Done to Protect Agriculture from a Terrorist Attack, but Important Challenges Remain


Observations  We conducted structured interviews with nongovernment experts in the fields of animal and plant diseases, terrorism, bioterrorism, and agroterrorism. Before conducting our interviews, we reviewed the experts’ relevant studies and publications and provided them with a list of questions. We sought their views on a range of topics, including the vulnerability of U.S. agriculture, government agencies’ roles and responsibilities, and agencies’ efforts to protect against agroterrorism.

 


The United States still faces several complex challenges that limit the nation’s ability to quickly and effectively respond to a widespread attack on livestock and poultry:


(from page 60) "........ until USDA evaluates the costs and benefits of using rapid diagnostic tools at the site of an outbreak, the agency may be missing an opportunity to reduce the impact of agroterrorism. Without on-site diagnosis to help monitor neighboring herds, animals would likely be slaughtered based on proximity rather than confirmed infection, unnecessarily magnifying the impact of an attack. Once diseases have been accurately diagnosed, the United States needs to quickly decide whether vaccines should be used to control an outbreak and have the ability to deploy ready-to-use vaccines within 24 hours. Otherwise, during an emergency, valuable time could be lost while deliberating whether to use vaccines and waiting for vaccines to be transformed into a ready-to-use state. .."


(from page 58)   .......as we recommend, USDA noted that there may be opportunities to use rapid diagnostic tools to help with diagnosis of animal diseases, but said that the tools need to be validated. Further, USDA commented that the agency would in all cases still require confirmation that relies on traditional testing procedures. As stated in our report, we continue to believe that use of these tools at the site of an outbreak would help reduce the impact of a terrorist attack because, among other things, these tools would help prevent laboratories from becoming overwhelmed with test samples.

USDA’s written comments and our detailed responses to their concerns appear in appendix VI.

USDA also provided technical comments that we incorporated, as appropriate, throughout the report. DHS generally concurred with the report’s recommendations and indicated that the agency is in the process of taking several corrective actions addressing two of our recommendations. For example, as we recommend, DHS is working with USDA to identify the reasons for declining agriculture inspections and to identify potential areas for improvement. Regarding our recommendation that DHS and USDA streamline the flow of information between the two agencies’ agricultural inspectors, DHS stated that it is already working with USDA to enhance communication; that is, the two agencies are working to finalize the section in the Memorandum of Agreement governing the sharing of information. DHS also provided technical comments that we incorporated as appropriate. DHS’s written comments and our detailed responses appear in appendix VII. Overall, HHS agreed with the report’s recommendations.


 (from page 36)

According to the former Associate Administrator for Special Research Programs at USDA’s Agricultural Research Service, the impact of a disease such as FMD can be mitigated if rapid diagnostic tools are used on site to speed diagnosis. In 2000, under the direction of this official, USDA developed state-of-the-art, rapid diagnostic tools to detect FMD, classical 

swine fever, African swine fever, Rinderpest, avian influenza, and Newcastle disease.43 According to this official, the rapid diagnostic tools are designed to yield results in less than an hour and are intended to be used outside of specialized laboratories, at the site of an outbreak. Importantly, the tools can detect disease before the animal shows clinical signs of infection. According to USDA, symptoms of FMD may take up to 14 days to appear, or even longer in sheep and goats. In fact, animals may show no symptoms at all. USDA’s draft guidance for controlling FMD warns that if the first animal infected with FMD does not outwardly show clinical signs, detection may be delayed. The guidance further states that potential delays and difficulty in detection may complicate the decision-making process regarding appropriate disease control measures. According to the former Associate Administrator, rapid diagnostic tools would not only allow for a rapid diagnosis but would also permit the monitoring of nearby herds before symptoms appeared so that only infected herds would have to be killed. Slaughter would, therefore, be based not on proximity but on actual infection, thereby reducing the number of animals lost and lessening the impact of the attack.44

Overall, rapid diagnostic tools would be helpful because FMD would be detected in less than an hour, informed control measures could be implemented, and herds in the area would be under regular surveillance.

According to state officials, the use of these rapid tools on site would also help prevent laboratories from becoming overwhelmed with test samples, which would be an advantage if a terrorist attack involved the introduction of disease at multiple locations. In 2003, California state officials used rapid diagnostic tools to test animals for exotic Newcastle disease—a contagious and fatal viral disease affecting birds of all species. (See fig. 5.) These state officials told us that the tools used at the time allowed diagnostic results within 6 hours and enabled them to test up to 1,500 samples per day, many more samples than traditional testing methods. State officials also told us that rapid diagnostic tools would be useful during a widespread outbreak so that individual animals or herds could be tested in a temporary laboratory at the site of an outbreak, rather than waiting for results while samples were sent to laboratories distant from the outbreak.


The United States still faces several complex challenges that limit the nation’s ability to quickly and effectively respond to a widespread attack on livestock and poultry:

•Many United States’ veterinarians lack training needed to recognize the signs of foreign animal diseases. According to a 2004 report produced for USDA, while all U.S. veterinary schools offer information about foreign animal diseases, only about 26 percent of their graduates have taken a course specifically dedicated to foreign animal diseases. Furthermore, foreign animal disease training is not required for USDA-accredited veterinarians, the ones most likely to be called upon if livestock were attacked. Two years ago, USDA drafted a rule to make such training a prerequisite for accreditation, but other draft rules have taken precedence and caused it to be delayed.

•USDA does not use rapid diagnostic tools to test animals at the site of an outbreak. They employ this technology only within selected laboratories. According to experts, on-site use of these tools is critical to speeding diagnosis, containing the disease, and minimizing the number of animals that need to be slaughtered. DOD uses rapid diagnostic tools to identify disease agents on the battlefield, but USDA officials consider this technology to be still under development. Nevertheless, USDA officials told us that they agree it is important to evaluate the costs and benefits of developing and validating these tools for use outside of a laboratory setting.

•Vaccines cannot be deployed within 24 hours of an outbreak as called for in HSPD-9. First, supplies are limited because USDA maintains vaccines for only one foreign animal disease—foot and mouth disease—since this disease is so highly contagious. USDA generally prefers to immediately slaughter diseased animals rather than to vaccinate them. Also, these vaccines cannot be rapidly deployed because they are not stored in a "ready-to-use" state and would first need to be sent to the United Kingdom for bottling and testing. USDA officials told us that it has recently established a steering committee that will address vaccine stockpiling issues, but it is not clear that the committee will address the costs and benefits of developing ready-to-use vaccines that can be quickly deployed against animal diseases of primary concern.

•Current USDA policy requires a complex process for deciding if and when to use vaccines—a process that could be too lengthy during an attack. USDA officials agree that they can explore the possibility of designing a more rapid decision-making process but cautioned this process is complex and takes into consideration many variables, such as the location of outbreaks in relation to susceptible animal populations, as well as trade concerns and restrictions. We also found several management problems that reduce the effectiveness of the agencies’ routine efforts to protect against agroterrorism.

•Agricultural inspections at ports of entry—the first line of defense against the entry of foreign animal and plant diseases—have declined over the past 2 years at a time when imports have increased. Neither USDA nor DHS officials can fully explain why this drop occurred. Since the transfer of most USDA agricultural inspectors to DHS, data show a decline in the number of agricultural inspections at ports of entry nationwide from 40.9 million in fiscal year 2002, when USDA was fully responsible for agricultural inspections, to 37.5 million in fiscal year 2004, when DHS had primary responsibility. However, officials pointed out some factors that may be contributing to this reduction, most importantly, the large number of unfilled vacancies for agricultural inspectors. DHS officials told us they plan to address this shortage by hiring more than 500 inspectors by fiscal year 2006, but also stated that the ability to hire and deploy new inspectors is impeded by the length of time needed for background checks. Inspectors also told us that another factor contributing to the decline in inspections is that they do not always receive timely information about high-risk cargo that needs to be inspected. While DHS officials told us these instances represent a small fraction of inspections, they agreed that changes can be made to improve the flow of information.

 

•There are weaknesses regarding the flow of critical information among key stakeholders. First, DHS is not promptly and effectively seeking input from key stakeholders on critical national guidance documents. For example, officials in key agricultural states and industry representatives told us that DHS did not give them enough time to review and comment on draft federal guidance, including the National Response Plan. As a result, state officials and industry representatives we spoke with are concerned that the response plan may set unrealistic expectations regarding the states’ capabilities to meet the requirements of the plan. Second, "after-action" reports on the results of national and state-level test exercises that simulate the consequences of a major agroterrorism event and test the response capabilities needed to manage such an event, are not systematically shared among key stakeholders. DHS officials told us that they are developing a Homeland Security Information Network that could facilitate sharing this information.

 

•States are not receiving sufficient technical federal assistance in developing emergency response plans and other activities to effectively prepare them to deal with agroterrorism. This lack of assistance results in part from implementation problems associated with the Area and Regional Emergency Coordinators positions—USDA has not yet filled all 16 of these positions. USDA officials told us they face difficulties hiring these coordinators due to the extensive travel required since each coordinator must cover a broad geographic area. Federal and state officials we interviewed told us that, even if the vacancies were filled, the current number of emergency coordinators is insufficient, as each coordinator is responsible for up to 6 states on the animal health side and 27 states on the plant side.

 

•Shortcomings exist in DHS’ coordination of federal working groups and research efforts. Although DHS has lead responsibility for coordinating efforts to protect against agroterrorism, officials from other agencies told us that the tasks assigned to various interagency working groups are not consistent with activities outlined in national guidance, including important documents such as the National Response Plan. This could lead to confusion and undermine the efforts of "national" planning. DHS has also not developed controls to coordinate research efforts with other agencies, even though HSPD-9 specifically designates DHS as the agency responsible for coordinating research efforts to protect against agroterrorism. For example, some of the DHS-supported activities at the Centers of Excellence, such as vaccine research, appear to duplicate research conducted by USDA. USDA officials told us they agree that there needs to be more coordination and cooperation between USDA and DHS on research activities.

 

•Finally, while steps are being taken to integrate agencies’ diagnostic laboratory networks, USDA has not yet integrated the databases of the member laboratories within its own networks, nor have they integrated

 


The following are GAO’s comments on the U.S. Department of Agriculture’s letter dated February 23, 2005.

 

GAO Comments

 

1.Regarding USDA’s comments about the use of rapid diagnostic tools at the site of an outbreak, our report acknowledges that USDA has already utilized these tools for the control of exotic Newcastle disease and avian influenza, but notes that USDA has only done so in a laboratory setting. The report also acknowledged USDA’s concern for using this technology at the site of an outbreak. For example, we noted that rapid diagnostic tools still need to be validated for many diseases, including FMD.   Furthermore, the report acknowledges USDA’s concern that samples need to be sent to USDA’s reference laboratories for final confirmation to determine the disease subtype, which must be known to deploy the correct type of vaccine.

 However, we continue to believe that use of these tools at the site of an outbreak would help reduce the impact of a terrorist attack because the tools would allow for a more rapid diagnosis so that informed control measures could be implemented as quickly as possible, and they would also permit the monitoring of nearby herds before symptoms appeared so that only infected herds would have to be killed.

We understand that it would not be appropriate or cost-effective to test all animals within a herd for any highly infectious foreign animal disease because in all likelihood, if one tests positive, the other animals in that herd would already be infected.

Also, as noted by state officials, the use of these tools would help prevent laboratories from becoming overwhelmed with test samples in the event of a terrorist attack involving the introduction of diseases at multiple locations.

2.Regarding USDA’s comments about the use of vaccines to control an outbreak, we acknowledge that using vaccines to control an outbreak has some limitations; however, as our report states, a recent USDA test exercise of an intentional introduction of FMD in multiple locations suggests that the current "stamping out approach" would have catastrophic results.

 Also, in February 2005, the National Audit Office in the United Kingdom reported that based on experience from the 2001 FMD outbreak in the United Kingdom, the ability to vaccinate, in conjunction with culling, may be necessary to contain an FMD outbreak. The report further states that the government in the United Kingdom has substantially increased stocks of vaccines for FMD in order to better contain the spread of FMD should another outbreak occur. Furthermore, USDA’s draft response plan for an outbreak of foot  and mouth disease or other highly contagious animal disease notes that vaccines may be used strategically to create barriers between infected zones and disease-free zones.

We have added this information to the report.

Furthermore, our report does not imply that it is cost effective to maintain a supply of vaccines for every possible permutation of each disease of concern. In fact, the report clearly states that it is unlikely that vaccines will ever be developed for all strains of diseases and the report also notes that vaccines should be developed for those of primary concern to USDA.

We do not state that vaccines are necessary for all foreign animal diseases. We acknowledge, however, that our report did not address the need to develop marker vaccines, and we have modified the report to reflect this need.

Finally, in response to USDA’s comment about simplifying the decision-making process on vaccine use, we have added language to the report to clarify USDA’s position.