Detailed Information on the
Plant and Animal Health Monitoring Programs Assessment

Measure: Change in the average number of days that it takes to investigate and resolve violations in cases settled through APHIS administrative procedures.

Explanation:Timely enforcement action fosters confidence in APHIS regulations and deters noncompliance. APHIS' regulations are in place to prevent the spread of pests and diseases and mitigate the damage they cause. Note: This measure is being replaced by the "Change in the average number of days required to complete field investigations of alleged violations and fully resolve cases through appropriate enforcement actions."

Measure: Value of damage prevented or mitigated by the Monitoring and Surveillance programs

Explanation:Value represents the loss prevented or mitigated in animal and plant agriculture due to surveillance activities performed by APHIS. Preventing the spread of animal and plant pests and diseases is a key responsibility of APHIS.

Measure: Improved efficiency through the use of targeted samplings vs. the use of random sampling.

Explanation:This measure compares the cost of samples taken through a targeted approach to the cost taken through random sampling, where the percentage shown represents the percentage of the cost of targeted samples to the previous methodology of random sampling. This measure is linked to the long term outcome of the value of damage prevented or mitigated.

Measure: Value of damage prevented or mitigated by the Monitoring and Surveillance programs per dollar spent

Explanation:Measure indicates the return on investment for Monitoring and Surveillance activities. Return on investment is derived by dividing the value of damage prevented by the AHMS and Pest Detection appropriation

Measure: Number of exotic pests for which national surveys are conducted.

Explanation:By increasing the number of exotic pests for which national surveys are conducted, the Agency can address the rising threat of pest introduction due to increased international trade and increase the likelihood of early detection of the most damaging pests.By increasing the number of exotic pests for which national surveys are conducted, the Agency can address the rising threat of pest introduction due to increased international trade and increase the likelihood of early detection of the most damaging pests.

Measure: Number of different biotechnology permits with violations.

Explanation:This measure is used to determine the compliance rate of biotechnology permit holders. This measure does not track multiple violations per permit. The program will use the measure to determine the effectiveness of activities such as outreach and education. At the end of FY 2007 there were 3,085 active permits. The program assumed a constant level of active permits when establishing targets for the outyears.

Measure: Change in the average number of days required to complete field investigations of alleged violations and fully resolve cases through appropriate enforcement actions.

Explanation:In FY 2008, APHIS is revising the scope of the information collected for the following measure: 'Change in the that it takes to investigate and resolve violations in cases settled through APHIS administrative procedures' (see measure number 1). The new measure reads 'Change in the average number of days required to complete field investigations of alleged violations and fully resolve cases through appropriate enforcement actions.' The original measure tracked only those cases settled through administrative procedures, and the program is expanding it to include all types of investigations. This will allow the program to track the timeliness of its broader investigative efforts and use the information to make sound business decisions. While the old measure did not provide all of the information required, it provides a subset of the new measure and demonstrates the program's progress in conducting timely investigations and taking enforcement action.

Measure: Number of investigations conducted in support of APHIS' mission

Explanation:This measure enables the Agency to plan for and distribute available resources in the most efficient manner. The measure supports Agency activities related to compliance.

Measure: Number of hours, from the time when a decision has been made to respond to an animal health event, to when resources have been deployed to the local incident site and are fully operational

Explanation:The measure allows the Agency to ensure the effective deployment of materials to incident locations. This measure supports the long term outcome of damage prevented or mitigated due to animal disease outbreaks.

Is the program purpose clear?

Explanation: The purpose of the Animal and Plant Health Inspection Service's (APHIS) Plant and Animal Health Monitoring and Surveillance Programs is to protect the health and value of America's agricultural and natural resources through early detection of pest and disease outbreaks. This allows the Agency to take appropriate action before the pest or disease can spread and cause significant damage.

Evidence: APHIS' monitoring and surveillance efforts are carried out by 10 programs. APHIS activities support the purpose by: the design and delivery of programs that rapidly detect endemic foreign and emerging diseases, significant plant pests, and weeds; enhancing surveillance activities for endemic disease eradication and control programs; and ensuring that timely and accurate laboratory support is provided by a nationwide diagnostic system and that select agents and toxins for research, education, and other legitimate purposes are available. Early detection of new pest and disease outbreaks is also accomplished by regulating the introduction (importation, interstate movement, and release) into the environment of genetically engineered organisms that may pose a risk to plant health; and by applying scientific expertise to the development of methods and information to resolve human wildlife conflicts related to agriculture, human health and safety, invasive and endangered species, while monitoring the quality of the environment shared with wildlife. Effective investigative and enforcement activities of APHIS regulations support the mission of providing for a secure agricultural production and healthy food supply to consumers by defending against diseases, minimizing production losses, maintaining market viability, and containing environmental damage. Authorizing legislation comes from the Animal Health Protection Act (2002) (P.L. 107-171, 21 U.S.C. 114, SC3291a (3)), 7 U.S.C. 8301 et seq); Animal Industry Act of 1884 as amended (21 U.S.C. 117); the Virus-Serum-Toxin Act of 1913, amended in 1985 (21 U.S.C., Section 151 et seq); the Plant Protection Act (7 U.S.C. 7701-7772, Section 431); and, the Public Health Security and Bioterrorism Response Act of 2002 (P.L. 107-188, Section 211-231). The Homeland Security Presidential Directive (HSPD) -9 establishes a national policy to defend the agriculture and food system against terrorist attacks, major disasters, and other emergencies. Closely related to APHIS? role in HSPD-9 is the Agency lead role in animal agriculture in the National Strategy for Pandemic Influenza. Under the National Strategy, the APHIS purpose of rapidly detecting and responding to a zoonotic disease, e.g. HPAI, addresses not only monitoring and surveillance, but also serves in protecting human health.

Does the program address a specific and existing problem, interest, or need?

Explanation: The APHIS Monitoring and Surveillance programs guard against the introduction, reemergence, or spread of animal and plant pests and diseases that could limit production and/or damage export markets. As part of this protection focus, these programs monitor for and respond to emergencies of varying types and scopes. The role of the programs becomes increasingly important because the movement of goods through the global marketplace has increased the risk of introduction of foreign animal diseases and plant pests. Incursions of animal diseases and plant pests in the United States can cost billions of dollars in lost domestic and international market trade; have a substantial impact on domestic production; create loss of consumer confidence in the U.S. food supply; and cost millions of dollars to state and federal animal health agencies in control and recovery programs. APHIS? Plant and Animal Health Monitoring and Surveillance Programs are part of a comprehensive approach to preventing and responding to pest and disease incursions. They minimize introduction of animal disease and plant pests, mitigate emergencies to agriculture, respond to violations of regulations, address the need for laboratory diagnostic services when testing for prevalence, regulate veterinary biologics to ensure they are pure, safe, potent and effective, and regulate select agents and toxins to prevent introduction into the environment.

Evidence: Recent detections of pests in the U.S. such as light brown apple moth and other pests demonstrate that continued domestic surveillance efforts are needed. In March 2007, APHIS confirmed the first detection of the light brown apple moth on the U.S. mainland in California. The program began regulatory activities to minimize human-assisted spread. Additional detections of the pest led to the establishment of an eradication program. Early detection and containment efforts have minimized the impact of this devastating pest. However, we must continue our surveillance efforts to ensure the control measures are effective and to prove to our trading partners that the pest is not widespread. Monitoring and surveillance for foreign animal diseases is also critical in protecting American animal agriculture, not only to protect the U.S. food supply, but to maintain confidence in the Nation?s products for foreign trade. For example, in May of 2003, the United States identified a cow with bovine spongiform encephalopathy (BSE). Almost overnight, more than $2.5 billion in trade markets were lost and a ripple of uncertainty went through consumer's confidence in American beef. USDA/APHIS moved forward to address the problems with augmented mitigation measures and surveillance. This effort had lead to a rapid increase in consumer confidence and the reopening of the beef export markets. (APHIS: PROVIDE INFORMATION ON VALUE OF POTENTIAL RESOURCES AT RISK)

Is the program designed so that it is not redundant or duplicative of any other Federal, state, local or private effort?

Explanation: Under its various authorities. APHIS is the lead Federal agency responsible for national plant and animal health including disease prevention and pest detection, control and eradication. APHIS works with stakeholders to implement unique and unified programs at all levels. APHIS works with State and local agencies as well as industry cooperators to detect pest and disease spread and to implement eradication or control programs for economically significant pests and diseases. In the case of other monitoring and surveillance programs, no other Federal, State, or local entities coordinate national efforts related to animal and plant health emergencies, provide diagnostic testing for foreign and domestic animal diseases, implement the provisions of the Virus-Serum-Toxin Act, or grant accreditation status to private veterinarians or carry out the breadth and scope of the methods development research for human-wildlife conflicts.

Evidence: The Animal Health Protection Act authorizes the Agency to provide effective and efficient science-based responses to modern-day challenges that could threaten the health and safety of U.S. animal agriculture. The Animal Health Monitoring and Surveillance program provides national uniform methods and standards for animal health surveillance programs conducted by State, Federal, and industry cooperators that are not fulfilled by any other entity. In addition, according to the Plant Protection Act of 2000 (7 USC sec. 8301), APHIS has sole authority over the regulation and control of pests and diseases of regulatory significance. The Pest Detection program cooperates with State departments of agriculture, other Federal agencies (such as USDA?s Forest Service and the Department of the Interior?s Bureau of Land Management), and numerous universities to prioritize projects and conduct surveys. In 1986, the Federal Government?s Office of Science and Technology Policy (OSTP) published the Coordinated Framework for the Regulation of Biotechnology. This policy specifies that APHIS, the Food and Drug Administration, and the Environmental Protection Agency share responsibility for regulating biotechnology in the U.S. These products are regulated according to their intended use to ensure maximum protection of agriculture and the environment. In addition, the Center for Veterinary Biologics implements the provisions of the Virus-Serum-Toxin Act which meets a need that is not filled by any other entity[EXPLAIN THE NEED].

Is the program design free of major flaws that would limit the program's effectiveness or efficiency?

Explanation: Through strategic planning, operational systems and controls, and technical expertise, the program is designed effectively and efficiently and without major flaws. The expertise is not only used in program design and implementation, but also in evaluation of program effectiveness in relation to the achievement of a variety of goals and objectives. For example, the Agency employs an integrated approach to animal health monitoring and surveillance that is part of an overall safeguarding continuum for early detection of foreign animal diseases, newly emerging diseases and endemic diseases under an eradication or control program. Furthermore, APHIS' monitoring and surveillance programs address plant and animal health issues of concern through reporting networks involving diagnostic laboratories, producers, industries, practitioners, and other State, Federal, and international government agencies. This framework of involving stakeholders and partners provides a mechanism for timely feedback to APHIS regarding existing or emerging issues with programs, program successes or failures, and changing needs of stakeholders. APHIS continually assesses feedback from organizations such as the United States Animal Health Association (USAHA), the National Plant Board, the National Stockpile Steering Committee, and the Cooperative Agricultural Pest Survey cooperators to determine if program adjustments are required and are economically feasible and responsible. APHIS often uses cooperative agreements to help accomplish surveillance goals efficiently and effectively. In the majority of cases, we prefer to use cooperative agreements when providing funds to cooperators rather than grants because the agreements enable us to delegate certain activities while still maintaining ultimate control of these activities. We delegate activities to entities that have local infrastructure, local expertise, and contacts. In the case of the Emergency Management Systems program's National Veterinary Stockpile, APHIS uses a variety of procurement options such as vendor managed contracts or just-in-time delivery contracts to increase the program's effectiveness and efficiency. These types of contracts allow the program to maintain a steady supply of products (such as disinfectants, protective equipment for employees, vaccines, and other emergency response supplies) for deployment during emergencies without actually having to manage an enormous inventory, much of which might come with an expiration date.

Evidence: Continual evaluations, including national program standards and administration, are conducted by the USAHA's animal disease committees. The USAHA, a science-based, non-profit, voluntary organization, has been the nation's animal health forum for over a century. USAHA works with state and federal governments, universities, veterinarians, livestock producers, national livestock and poultry organizations, research scientists, the extension service and seven foreign countries to control livestock diseases in the United States. This close scrutiny assures that programs are scientifically based, epidemiologically sound, justifiably prudent, appropriately effective and fiscally resourceful. The committee's resolutions and recommendations can be found at the following website: http://www.usaha.org/committees/resolutions/. All of the national animal disease programs are measured against the World Organization for Animal Health (OIE) Standards. Other countries use these standards to conduct evaluations of the programs and to set import requirements. These standards can be found at the following website: http://www.oie.int/eng/normes/mcode/en_titre_3.8.htm. For FY 2007, the program and its cooperators targeted 12 high-risk pests for survey, prioritized by the National CAPS Committee, and 27 other exotic pests with the potential to cause significant economic or environmental damage. The program was able to increase its survey capacity and exceeded its performance measure target for the number of exotic pests surveyed. In addition, the cost of each individual survey was $1,200 below what was anticipated in the previous year. The CAPS program detected two pests (Sirex woodwasp and lobate loc scale) and one pathogen (citrus greening) during directed surveys in areas where they were previously not known to occur in FY 2007. The program detected 88 percent of known significant introductions of plant pests or diseases before they spread from the area of original colonization and cause significant economic or environmental damage.

Is the program design effectively targeted so that resources will address the program's purpose directly and will reach intended beneficiaries?

Explanation: The Agency uses resources to carry out activities required by regulations, program standards, certification, and quality assurance programs such as inspections, investigations, testing, and data analyses in order to prevent, diagnose, control, and evaluate a wide range of livestock, poultry, wildlife diseases, and plant pests. All resources are expended to monitor for and prepare for plant pests and animal disease outbreaks. These resources either directly support surveillance programs or State, Tribal, and local government emergency preparedness efforts or help the program coordinate these efforts. APHIS assesses each individual threat to U.S. agriculture to determine and target the highest risk pests and diseases. The beneficiaries of these activities include agricultural producers, who avoid severe production and trade losses associated with widespread pest and disease outbreaks, and U.S. taxpayers, who do not have to bear the costs of large-scale eradication programs and/or increased prices that could result from outbreaks. Without the national coordination and expertise provided by the APHIS Monitoring and Surveillance programs, surveillance activities conducted by individual States would focus on local priorities and introductions of exotic pests and diseases could go unnoticed and become widespread.

Evidence: APHIS uses various strategies to ensure that its programs are effectively targeted. For example, animal disease surveillance plans utilized within the Animal Health Monitoring and Surveillance program are being updated to identify targeted populations of animals based on accepted risk values. For example, the program uses a focused, targeted surveillance strategy in its bovine spongiform encephalopathy (BSE) testing effort, gathering the vast majority of samples from animals exhibiting signs of central nervous system disorders and animals over 30 months of age (those most likely to have developed BSE), rather than randomly sampling the entire cattle population. Development of methods for targeting and analysis of BSE sampling to certain groups of animals allowed APHIS to gather information from 40,000 tests instead of over 400,000 tests required by conventional random sampling techniques. This improved efficiency has led the program to re-evaluate other sample collection methods currently conducted in the surveillance programs. Providing disease prevalence through fewer samples creates opportunity for resources to be shifted for greatest efficiency. Once sampling needs have been determined under the new targeted approach, the program will be able to further maximize resources. Using similar methodology to the animal health surveillance program, the Pest Detection program is prioritizing its Cooperative Agricultural Pest Survey (CAPS) projects based on commodities at risk in specific areas and the targeted pest's risk of entry and potential to cause significant economic and environmental damage. The program is also developing commodity-based pest surveys to maximize the program's capacity for prevention, preparedness, response, and recovery from invasive pests of regulatory significance. The National Plant Board, the association that represents State plant regulatory agencies, conducted a review of APHIS' plant safeguarding programs and recommended this approach for the Pest Detection program. This approach allows APHIS and its cooperators to identify and target pests that pose significant threats and provides national leadership. Stakeholders teleconference once a month to evaluate the status of current surveying efforts and a stakeholder meeting is held bi-annually to ensure all partners are consistent and targeting their efforts effectively.

Does the program have a limited number of specific long-term performance measures that focus on outcomes and meaningfully reflect the purpose of the program?

Explanation: The overall goal of the Plant and Animal Health Monitoring and Surveillance programs is to detect animal and plants pests and diseases early to prevent widespread and costly infestation. This goal is linked to APHIS? mission of protecting the health and value of U.S. agricultural, natural and other resources. APHIS has developed a limited number of long-term performance measures that focus on the intended outcomes of the monitoring and surveillance programs. The measures include: the value of damage prevented and mitigated as a result of the monitoring and surveillance programs, the reduction in the average time it takes to complete field investigations of alleged violations and fully resolve cases through appropriate enforcement actions, and the time it takes to deploy resources to a local incident site in response to an animal disease outbreak. These measures allow the programs to provide an accurate assessment of program effectiveness and progress towards protecting the nation?s animal and plant resources against foreign and domestic pests and diseases.

Evidence: The overall long-term measure for the Plant and Animal Health Monitoring and Surveillance programs is the value of damage prevented and mitigated as a result of program activities. The measure enables the Agency to determine the return on investment of resources dedicated to monitoring and surveillance activities, thereby identifying the value of activity in an objective, quantifiable manner. The Animal and Plant Health Regulatory Enforcement program mission is to protect the health and value of America?s agricultural and natural resources through effective investigative and enforcement services. The program's current long-term performance goal is to measure the time it takes to investigate and resolve violations in cases settled through APHIS administrative procedures. The program is transitioning to a new measure because it more accurately represents the core activities of the program and will provide a quality indication of program performance. The new long-term performance measure is the average number of days required to complete field investigations and fully resolve cases through appropriate enforcement actions. The new measure will not include non-investigative cases, and will provide the program the ability to track progress of the investigative process as well as the enforcement process. The Emergency Management Systems long-term performance measure focuses on the primary goals of the program: preparedness, response, and mitigation capabilities. The long-term performance measure is the number of hours, from the time when a decision has been made to respond to an animal health event, to when National Veterinary Stockpile resources have been deployed to the local incident site and is fully operational. The measure allows the Agency to ensure the effective deployment of materials to incident locations and supports the overall goal of preventing widespread outbreaks of pests and diseases.

Does the program have ambitious targets and timeframes for its long-term measures?

Explanation: Most of the monitoring and surveillance programs have increasing targets or targets that maintain current performance despite the increased volume of international trade and the increased likelihood for pest and disease introduction. In addition, several of the programs have made changes to improve processes and techniques to achieve the ambitious performance targets. The targets for the value of damage prevented and mitigated increase from $1.41 billion to $1.595 billion, and can be considered ambitious because they require APHIS to address any potential threat and prevent it from having a large impact on U.S. producers and consumers. As APHIS programs work to detect new introductions of pests and diseases, they face continually increasing volumes of travel and trade. Maintaining the current value of the services will require that the programs develop new techniques to identify the highest-risk pests and diseases and be prepared for those that are most likely to reach the United States. Similarly, the Emergency Management Systems program's target of deploying resources to an incident within 24 hours of when a decision has been made to respond to an animal health event is ambitious because the program is moving large quantities of material from a storage location or contractor to any location in the United States, regardless of factors such as weather, remoteness, or the actual volume of material. Maintaining this target requires the Agency to have the most effective and efficient procedures in place. APHIS does not believe that a target below 24 hours is realistic. Finally, APHIS has determined that it can reduce the number of days to complete field investigations from 220 to 200. This is a new measure, but one that has been developed from an exiting measure on the investigation and resolution of cases settled through adminstrative procedures.

Evidence: The monitoring and surveillance programs have set a target of increasing the value of damage prevented and mitigated from $1.41 billion to $1.595 billion, much greater than the amount of resources dedicated to the program activities. This increase is an ambitious target given the various pests and diseases that exist worldwide, the risks they pose if introduced, and the need to detect and respond to introductions early. The Animal and Plant Health Regulatory Enforcement program established a target of reducing the 220 days for its current long-term measure, the change in the average time it takes to investigate and resolve violations in cases settled through APHIS administrative procedures, to 200 days despite a rapidly increasing number of cases each year. During FY 2005, it took IES 257 days on the average to investigate and resolve violations in cases settled through APHIS administrative procedures. The Emergency Management Systems program has established a target of deploying resources to an incident within 24 hours of when a decision has been made to respond to an animal health event. This is an ambitious target given the uncertainty of when or where an incident will occur and the maintenance required to ensure these critical materials and adequate resources will be available. To move the materials, APHIS has contracted with one of the world's largest material transportation companies. This ensures that the required infrastructure is the most effective and efficient for the movement of large quantities of material. APHIS has evaluated other alternatives and determined that the use of this contracting mechanism provides for the fastest and most efficient way to deploy the resources in an emergency situation

Does the program have a limited number of specific annual performance measures that can demonstrate progress toward achieving the program's long-term goals?

Explanation: The Monitoring and Surveillance program's annual measurements demonstrate the relationship between rapidly detecting potential foreign animal disease and plant pest outbreaks and reducing the severity of animal and plant incidents in the United States, contributing to the value of damages prevented through our monitoring and surveillance efforts. The activities measured include the number of exotic pests for which national surveys are conducted; the cost ratio of samples defined by targeted animal health surveillance plans to samples taken under random sampling methods (annual efficiency); the number of different biotechnology permits with violations, and the number of investigations to support APHIS' mission. The link between each measure and the long-term goals is discussed below. The annual measures listed above support the Agency's ability to conduct effective monitoring and surveillance programs, and progress in these measures allows the programs to prevent additional damages by finding pests and disease outbreaks at an early stage. Increasing the number of exotic pests surveyed for increases the probability that the presence of a newly introduced pest would be detected, allowing the program to show an increased return on its investment. Tracking the cost ratio of animal disease samples taken under targeted surveillance plans compared to those gathered through traditional random sampling methods allows the program to demonstrate efficiency in its animal health monitoring efforts. Employing methods that are both effective at finding new infestations and less-resource intensive will allow the program to increase the value of the damages it prevents. Tracking the number of biotechnology permits with violations supports the Biotechnology Regulatory Services (BRS) program's long-term measure, percent of facilities in compliance with biotechnology permit conditions. Compliance with permit conditions is essential to ensuring that genetically engineered organisms being field tested stay within the confines of the field test site while they are being evaluated. The Animal and Plant Health Regulatory Enforcement program will track the number of cases investigated annually. This measure demonstrates the increasing level of the program?s workload. Coupled with the long-term measure, the average days required to complete investigations and fully resolve cases through appropriate enforcement actions, these measures enable the program to demonstrate its ability to handle its increasing caseload efficiently. Resolving cases as quickly as possible prevents alleged violators from forgetting about their cases and acts as a deterrent against future noncompliance with APHIS regulations.

Evidence: The annual performance measure for Pest Detection is the number of exotic pests for which national survey are conducted. This measure is designed to measure a progressive increase in pest detection and show continued efficiency in the methods used by the program. The Animal Health Monitoring and Surveillance program?s annual performance measure compares the cost ratio of samples defined by targeted surveillance plans to samples taken under random sampling methods. The annual performance measure for the BRS program is the number of permits with violations. The Animal and Plant Health Regulatory Enforcement program tracks the number of cases investigated annually. The Biotechnology Regulatory Services (BRS) program?s overall performance goal is to protect U.S. agriculture and the environment using a dynamic and science-based regulatory framework that allows for the safe development and use of genetically engineered (GE) organisms without posing a risk to plant and animal health, human health, and the environment. To do so, the program requires that entities evaluating newly developed GE organisms conduct field tests and other activities under strict conditions and either under a permit from BRS or under notification procedures. BRS?s performance measure is the percent of facilities (including field test sites, storage facilities, and any other facilities connected with a permit) in compliance with permit conditions. This is measured by dividing the number of permits with no violations by the number of currently active permits.

Does the program have baselines and ambitious targets for its annual measures?

Explanation: This question received a "no" because not all measures had ambitious targets. The Monitoring and Surveillance programs have baselines for all of the annual measures discussed here. Each of the programs assesses its workload, resources, and long-term goals in developing ambitious, quantified targets for the measures. Together, these annual measures allow APHIS to view the effectiveness of the monitoring and surveillance mission area, make timely management decisions when and where required, and align resources to address existing and emerging threats in order to effectively protect American agriculture and increase consumer confidence, world wide, in U.S. agricultural products.

Evidence: The one measure which appears to have ambitious targets is the number of pests surveyed, which increased from 9 to 37 between FY 2003 and FY 2007 and aims to continue to increase the number of exotic pests for which national surveys are conducted by five per year (from 40 to 65) from 2008 to 2013, allowing the program to address the rising threat of introduction due to increased international trade. While the target for 2013 for the number of biotechnology permits with violations, shows a reduction from the actual level of 93 in 2007, it is the same as the target for 2007. The program also plans to keep the cost of individual surveys at current or reduced levels despite the increased number of pests being surveyed. The measure is designed to track a progressive increase in pest detection and show continued efficiency in the methods used by the program. The Animal Health Monitoring and Surveillance program's targets demonstrate a continual cost savings over the next five years associated with the transition to targeted animal surveillance, indicating the efficiency of the targeted surveillance approach. However, the target shows no change in its target from 2010 to 2013. In addition, the target for the number of individual permits for biotech products (60), while a significant reduction from the previous actual, shows no change in future years. Finally, the number of investigations to support the APHIS mission only inceases by about 900 (+14%) from the 2007 actual to the target in 2013, despite the fact that the increase from 2006 to 2007 was about 1,400 (+28%). That does not appear to be ambitious.

Do all partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) commit to and work toward the annual and/or long-term goals of the program?

Explanation: APHIS' Plant and Animal Health Monitoring and Surveillance programs collaborate with many private, State, Federal, and university partners to help achieve the Agency's mission and achieve its goals. APHIS works closely with cooperators, grantees, and contractors in order for these partners to understand how their work supports program objectives, program and Agency goals in support of the Agency mission. These collaborative partnerships bring specific needed expertise to problem solving team efforts, while utilizing non-Federal resources which enable the Agency to realize cost efficiencies. The Agency finalizes partnerships through tools such as cooperative agreements. APHIS establishes relations with a variety of cooperative resources. The Agency communicates needs and expectations to the perspective cooperator. Cooperators submit work and financial plans, which the Agency reviews to ensure the desired overall program goals will be met through the cooperators efforts. Cooperators are required to provide, at a minimum, quarterly status reports that include budget object class breakouts and documentation, actual performance data, and milestones for the next reporting period. Additionally, APHIS strictly follows the Federal Acquisition Regulations. Through the contracting process APHIS creates statements of work (SOW) for contracts. SOWs contain clear performance requirements that establish expectations on deliverables.

Evidence: APHIS, the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), and the Department of Justice are part of a cooperative select agent program that serves the same stakeholder base and is designed to maximize stakeholder benefit. Universities or scientific laboratories wishing to possess or transport select agents and toxins must do so through the joint National Select Agent Registry to be in compliance with the law. The APHIS Select Agents program has established Memoranda of Understanding with each of the participating Agencies that clearly identify specific operational plans that tie to program goals. The roles and responsibilities of each Agency are defined and the leadership structure is established, based on the area in which the threat of the agent or toxin occurs. Partners of APHIS' Cooperative Agricultural Pest Survey (CAPS) program agree to operate towards program goals through cooperative agreements. These agreements outline mission-related goals, objectives, and anticipated accomplishments, as well as the technical approach for conducting surveys. Under the cooperative agreements, cooperators must identify the benefits of proposed cooperation; identify roles and responsibilities; submit a plan of action; provide a budget; and agree to the conditions, identified by the CAPS program, that are essential to the program's success. The program provides State cooperators with enough funds to hire full-time State survey coordinators. Having full-time coordinators allows States to focus efforts on the program goals and collect the resulting information. The information gathered through partner activities is consolidated in the National Agricultural Pest Informational Pest System and used to determine the value of the program?s surveillance efforts. The National Veterinary Services Laboratories (NVSL), through its coordination of the National Animal Health Laboratory Network (NAHLN), routinely works with State and university laboratories to leverage efficiencies of coordinated animal disease testing in a network setting. As part of NAHLN membership, laboratories agree to use standardized testing methods, defined quality standards, and standardized information technology systems to share information. This cooperative effort expands the Agency's diagnostic capacity, increasing the number of laboratories participating in surveillance efforts and the speed with which new outbreaks can be detected. Two premier examples of contractors committing to program goals include the National Veterinary Stockpile (NVS) logistics support contract and the material delivery contract. The NVS is a relatively new program designed to provide supplies and materials to the site of an animal disease emergency. The contractor has met and exceeded all of the contract requirements and expectations. This contractor has enabled APHIS to ensure delivery of NVS supplies to incident locations within 24 hours and establish vendor managed contracts for bulk supplies, which enables the Agency to have access to supplies, materials, and vaccines on an as needed basis, thereby reducing the initial costs and foregoing storage and stock rotation costs that would have otherwise been incurred. Each of these contracts have established delivery requirements which directly support the program and Agency goals, objectives, and mission.

Are independent evaluations of sufficient scope and quality conducted on a regular basis or as needed to support program improvements and evaluate effectiveness and relevance to the problem, interest, or need?

Explanation: APHIS' Plant and Animal Health Monitoring and Surveillance programs undergo frequent evaluations by several independent parties such as the Department's Office of Inspector General (OIG) and scientific groups such as the National Plant Board, the United States Animal Health Association, and the National Wildlife Services Advisory Committee. OIG is independent of APHIS and conducts audits to promote program effectiveness and efficiency and to prevent waste and abuse. OIG audits are broad in scope and consider the program's strategic design, operations, financial management, and results. In June 2006, the OIG issued an audit report on avian influenza activities. While the report made eight recommendations, APHIS' response indicated that actions had been taken, or were in the process of being taken, to address the recommendations identified in the report. The OIG accepted APHIS' responses and incorporated them in the final audit report. OIG also conducted an audit that evaluated APHIS' surveillance program for bovine spongiform encephalopathy (BSE), along with USDA's Food Safety and Inspection Service's controls to prevent banned specified risk materials from entering the food supply. This audit followed up on previous reviews of the two Agencies BSE programs and evaluated the Agencies' implementation of the recommendations. OIG noted that USDA made significant efforts to implement an expanded BSE surveillance program after the first detection of BSE in this country and faced many challenges. While OIG made additional recommendations for APHIS and noted areas where APHIS had not fully addressed its original findings, it stated that the Agency obtained significantly more samples for testing than originally anticipated. OIG agreed with APHIS' responses to its recommendations and incorporated them into its final report. Many of the Monitoring and Surveillance programs also seek certification of their processes by the International Standardization Organization (ISO). ISO certification indicates that a program has implemented and documented rigorous controls over its processes and has strong quality assurance procedures in place. The Animal and Plant Health Regulatory Enforcement (APHRE) program attained ISO 9001 certification for its enforcement operations in December 2006. The program underwent a follow-up management system certification audit in 2007 by the SGS Company, an independent control and inspection company. The audit found that the program "has established and maintained its management system in line with the requirements of the standard and demonstrated the ability of the system to systematically achieve agreed requirements for products and services within the scope and organization's policy and objectives." SGS identified one minor non-conformity in its report that has since been corrected.

Evidence: To correspond to the explanations, APHIS is providing documentation of major evaluations of the Plant and Animal Health Monitoring and Surveillance Programs. APHIS' Oversight of Avian Influenza (Audit #33099-11-HY), issued June 2006. The audit report states that "APHIS has made commendable progress in developing plans and establishing the networks necessary to prepare for, and respond to, outbreaks of AI." APHIS BSE Surveillance Program (Phase II) and FSIS Controls over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products (Phase III) (Audit #24601-03-KC and 50601-10-KC), issued January 2006. The audit report noted that USDA made significant efforts to implemented an expanded BSE surveillance program after the first detection of BSE in this country and faced many challenges. Also see the audit report by the SGS Company regarding the APHRE program, finding that the program was maintaining ISO certification standards.

Are Budget requests explicitly tied to accomplishment of the annual and long-term performance goals, and are the resource needs presented in a complete and transparent manner in the program's budget?

Explanation: APHIS' planning and budgeting process specifically relates past performance and expected performance results to changes in funding, policy, or legislative mandates. However, the Congressional Justification (Explanatory Notes) did not tie changes in funding with specific performance measures.

Evidence: The Agency requested a $19.202 million increase for FY 2009 to enhance surveillance and expand diagnostic capacity for activities within the Animal Health Monitoring and Surveillance program. The program has been able to reduce the likelihood for foreign animal disease introductions. The Agency requested funding to ensure capacity for continuing to increase the number of herds under surveillance, further reducing the potential damage caused by animal diseases. In addition, the Agency requested $3.833 million for the Pest Detection program to increase the Agency's support and collaboration with States on pest surveillance. The Agency will be able to include more exotic pests in its plant surveillance efforts. The program has been successful in early detection of at least 86 percent of known significant pest introductions since FY 2002. In addition, the Agency requested $4.429 million to strengthen its regulatory biotechnology oversight through enhanced environmental review and assessments, monitoring and surveillance, and capacity building, both domestically and internationally. The Agency will be able to reduce the number of violations with biotechnology permits. The funding will allow the program to maintain the percent of compliance with biotechnology regulations at a minimum of 97 percent. The 2009 Budget Justification (Explanatory Notes), pages 15-26 through 16-35 includes some discussion of performance, but does not include specific measures.

Has the program taken meaningful steps to correct its strategic planning deficiencies?

Explanation: The programs regularly review their progress toward meeting their goals in conjunction with strategic plans and work to address any deficiencies. A recent step that the Monitoring and Surveillance programs have taken to improve strategic planning is the implementation of a new long-term performance measure that tracks the value of the damage prevented by the programs. By preventing and reducing damage caused by agricultural pests and diseases, APHIS saves money for agricultural producers and U.S. taxpayers and supports U.S. producers? ability to export their products. Individual programs such as the Animal Health Monitoring and Surveillance, and the Animal Health Regulatory Enforcement programs have also recently developed or are refining their performance measures to ensure that they are tracking strategically important facets of their operations that will help them achieve their overall goals. Other programs, such as the Pest Detection program, are developing strategic guidance documents for State partners to ensure that all cooperators share the same goals. APHIS recently revised its strategic plan to update key objectives. After doing so, APHIS? Plant Methods Development Laboratories program and the National Wildlife Research Center (NWRC) realigned their strategies to ensure consistency with the Agency?s Strategic Plan. The Plant Methods program developed a strategic plan to align itself with the Agency objectives. NWRC reorganized the Center to make sure methods developed were consistent with the Agency objectives of safeguarding and emergency response.

Evidence: The Monitoring and Surveillance programs established baseline data for its new performance measure, the value of damage prevented or mitigated, based on FY 2007 conditions. In working to implement this measure, APHIS held workshops with key program managers on performance measurement, budget and performance integration, program logic modeling, and data needed to calculate the new performance measure. Based on these efforts, we estimate that the program?s surveillance activities saved producers and taxpayers $1.371 billion in FY 2007. The Animal Health Monitoring and Surveillance program recently established a new annual performance measure tracking the cost ratio of samples gathered under targeted surveillance plans with those gathered under random sampling methods. This measure will demonstrate not only the program?s efficiency in achieving its surveillance objectives but also help spur the development and implementation of one of the program?s strategic objective of using targeted surveillance plans. The Animal and Plant Health Regulatory Enforcement program is refining its long-term performance measure to reflect more accurately the complete process of investigating and taking appropriate action on alleged violations of APHIS regulations. Instead of tracking the number of days required to investigate and resolve cases through APHIS? administrative procedures, the program will track the number of days required to complete field investigations of alleged violations and fully resolve cases through appropriate enforcement actions. This adjustment expands the types of cases that are tracked for this performance measure and, unlike the previous measure, includes cases that must go before an administrative law judge. The program aims to maintain a performance level of 220 days, reflecting its goal of resolving cases as quickly as possible to deter noncompliance. The Pest Detection has developed a Cooperative Agricultural Pest Survey program guidebook for State cooperators and recently updated it for FY 2008. The guidebook defines program goals, leadership structure, operational procedures, and funding requirements, helping to ensure that all partners are implementing the program consistently and in accordance with the program?s strategic goal of detecting exotic pests as early as possible after they have arrived.

Are all regulations issued by the program/agency necessary to meet the stated goals of the program, and do all regulations clearly indicate how the rules contribute to achievement of the goals?

Explanation:

Evidence: 1

Does the agency regularly collect timely and credible performance information, including information from key program partners, and use it to manage the program and improve performance?

Explanation: This question received a "no" because it did not show the use of baseline data in future planning. Performance data is integral to the managers' decision-making abilities for the surveillance and monitoring programs. The Agency utilizes many tools to collect performance information. The programs have measures in place to gather information, while also looking to partners to provide certain types of data that the programs cannot collect on their own. Without accurate survey and other performance measure data collected by cooperators and reported to APHIS according to the terms set by cooperative agreement, APHIS would not be able to make effective program management decisions, determine whether pests or diseases have been introduced and respond, set quarantine boundaries, determine resource distribution, or plan activities for upcoming periods. However, the question received a "no" because there was no explanantion or evidence of how the program uses "baseline performance data to determine meaningful ambitious performance targets."

Evidence: Program partners submit data at regular intervals or as specified by the agreements. For example, State cooperators that conduct surveys under the Cooperative Agricultural Pest Survey (CAPS) framework develop workplans with the Pest Detection program to determine what surveys will be conducted during the upcoming year. These workplans also specify when cooperators must submit survey data and reports back to APHIS. Without this data, APHIS would not be able to determine the damages prevented by the program or determine whether the new introductions had occurred. For example, detections of high-risk pests on the CAPS pest list must be reported to APHIS within 48 hours or less. When such detections are reported, APHIS responds immediately to assess the introduction and implement containment efforts to prevent significant damage from occurring. The program has also made adjustments to its national survey structure based on performance results. For example, in FY 2005, the program did not meet its target for the number of pests for which national surveys were conducted, partly because State cooperators did not share the program's national priorities. The program held additional meetings with State cooperators to engage all stakeholders in the prioritization process. The Biotechnology Regulatory Services (BRS) program also depends on performance information to manage its inspection and permitting processes. The program collects performance data through its inspections to monitor the compliance of permit holders with BRS permit conditions and uses the data to determine which sites require more frequent monitoring. In FY 2007, the number of permits with violations increased. Accordingly, in FY 2008, the program is launching a voluntary, audit-based compliance assistance effort, the Biotechnology Quality Management System, to provide additional guidance and assistance to participating permit holders. The goal of the new system is to assist permit holders and others analyze their operations in the context of APHIS' biotechnology regulations, and identify control points where problems could occur and apply mitigation measures to those vulnerable points. This system will hopefully improve compliance rates among participants and prevent any unintentional releases of genetically engineered organisms into the environment. Additionally, the Emergency Management Systems program uses its performance data (the number of hours required to deploy resources to animal disease events) to measure its emergency response success. If the time required to deploy resources increased, the program would have to adjust its logistical and management planning.

Are Federal managers and program partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) held accountable for cost, schedule and performance results?

Explanation: The program managers are responsible for formulating plans and applying resources to achieve the goals and objectives of the program. Program managers are responsible for assessing and directing program policies and regulations to assure alignment with program goals and objectives. Cooperators submit work and financial plans, which must be approved by the program to ensure the desired overall program result. Cooperators are required to provide quarterly status reports that include budget object class breakouts and documentation, actual performance data, and milestones for the next reporting period. In addition, the cooperator must submit an accomplishment report. If the cooperator does not produce the desired results, the agreement is not renewed without demonstration of significant improvement. The success or failures of program performance are a direct reflection of program management at all levels and are reflected in employee performance evaluations.

Evidence: The Agency Administrator holds APHIS program Deputy Administrators accountable by having quarterly performance and budgeting meetings. The information garnered from these meetings influences each Deputy's performance appraisal. For example, in June 2006, APHIS revised its Performance Appraisal Program from a two level pass-fail system to a four level system that differentiates excellent performance from marginal performance and links personal performance to accomplishment of program goals. Also, managers are evaluated annually. For example, to receive a "fully successful" rating, a manager must "provide effective leadership and timely action in establishing, implementing, and achieving program goals and objectives." Cooperative agreements are tracked and reviewed by higher administration. As an example, the National Wildlife Research Center requires its cooperators to provide quarterly status reports that include object class breakouts and documentation, actual performance data, and milestones for the next reporting period. Based on the information provided, the National Wildlife Research Center releases the funding. The cooperator must also submit an accomplishment report within 90 days of the expired agreement. If the cooperator does not produce the desired results or demonstrate significant improvement, the agreement is not renewed. For example, the National Wildlife Research Center renewed its cooperative agreement with Colorado State University. Renewal was based upon the successful completions of guidelines for an avian influenza environmental sampling plan and proposal for an avian influenza risk assessment. In addition, each disease program has performance goals that must be met. One of the Uniform Methods and Rules of the Brucellosis program is that a brucellosis milk surveillance test must be conducted at least two times per year, at approximately six-month intervals for a State to attain and maintain Class Free Status. Annual reports that show deficiencies are reviewed by Veterinary Service and State officials to determine the correct status for the State. The cooperators and also held responsible for cost, schedule, and performance results. For example, the Illinois Department of Agriculture is subject to quarterly and annual reports of surveillance expenditures and results, which are reviewed by the Authorized Departmental Officer's Designated Representative.

Are funds (Federal and partners') obligated in a timely manner, spent for the intended purpose and accurately reported?

Explanation: This question received a "no" because it did not demonstrate that "program awards are reported promptly and accurately." Funds appropriated to the Agency are obligated in conjunction with the mission of protecting the health and value of American agricultural. APHIS monitors spending through its monthly status-of-funds process to ensure that funds are being spent in a timely manner and for their intended purpose. The Monitoring and Surveillance programs obligated 93 percent of the funds appropriated to them in FY 2007. The funds not obligated were no-year funds carried over for specific purposes. Additionally, each program develops allocation and spending plans at the national and regional levels, based upon the personnel and other resources needed to operate the program. On a monthly basis, actual data on expenditures is compared with planning data to ensure that funds are utilized as planned. APHIS programs use standard query mechanisms to review, research, and monitor funds. A monthly status of funds is prepared for the Agency?s Administrator to review spending by each appropriation and program type. APHIS accountants and program financial managers collaborate throughout the year and at the end-of-the-year close-out to ensure that spending estimates are accurate. In addition, special reports are prepared to monitor specific types of expenses. These tools are used by program level staffs to monitor spending and compare it to allocation plans made at the beginning of each year and by Agency level budget execution and formulation staffs. Program and Agency analysts research and address any questionable spending patterns as they occur. APHIS also reviews partner requests for payments related to cooperative efforts. Agency analysts not only review the partner?s supporting documentation but also ensure that work is progressing and in line with workplans (which establish schedules for work to be accomplished and for funds to be obligated) associated with the cooperative agreement or grant.

Evidence: Programs are required to submit a spending plan, broken out by budget object class, into the APHIS Cost Management System. This system tracks the amount spent and the time it takes to spend it. APHIS programs record spending as it occurs in a USDA-wide system, the Foundation Financial Information System. All Program expenses incurred by APHIS are reflected in another USDA system, the Federal Data Warehouse. The financial managers and other budget personnel track spending throughout the year, using these systems, and compare it to the original operating plans. Each month, program financial managers and Agency financial staffs review current spending results and projections to assure funds are being obligated in a timely manner and for their intended purpose. In FY 2007, the Monitoring and Surveillance program obligated 93 percent of the funds appropriated to them. The funds left unobligated at the end of the year were for the National Animal Identification System and the Highly Pathogenic Avian Influenza program, both of which have no-year funds and carried the funds over for specific purposes for FY 2008.

Does the program have procedures (e.g. competitive sourcing/cost comparisons, IT improvements, appropriate incentives) to measure and achieve efficiencies and cost effectiveness in program execution?

Explanation: APHIS has adopted an efficiency measure that shows the value of damage prevented and mitigated as a result of the Agency?s monitoring and surveillance programs per dollar spent, demonstrating the outcome per dollar spent. It provides the right incentives to program managers to maximize the amount of prevention and mitigation due to pests and disease, without mandating specific procedures. Individual programs have also established efficiency measures. For example, the Animal Health Monitoring and Surveillance program is establishing a new efficiency measure to compare the cost of sampling conducted under new targeted surveillance plans to the cost of the traditional random sampling techniques. The program established a baseline ratio of 1:0.0654 (random to targeted sampling) for this measure and set ambitious targets to reflect the wider implementation of targeted sampling throughout the program. The measure will show the cost savings that result from more targeted sampling techniques, which will be both more effective in detecting the presence of a disease and more efficient. The Select Agents program has an efficiency measure that tracks the time spent on reviewing applications for select agent and toxin registrations. The Pest Detection program is becoming more efficient by implementing commodity-based surveys, which target multiple pests that affect a commodity rather than a single pest. Many of the Monitoring and Surveillance programs have also achieved certification by the International Standardization Organization (ISO) or are working toward ISO certification, which allows the programs to document their business processes and implement quality assurance measures, improving their efficiency.

Evidence: The efficiency measure, the value of damage prevented and mitigated by the monitoring and surveillance programs per dollar spent shows that the program returned an investment of $5.67 for every dollar spent in FY 2007. The program aims to increase efficiency overall by FY 2009 with targets of returning $8.86 for every dollar spent. The Animal Health Monitoring and Surveillance program also has ambitious targets for its efficiency measure, reflecting aggressive implementation of the new sampling methods. The Select Agents program established a baseline of an average of 7 days for its efficiency measure in FY 2005 and is working to reduce the average number of days spent on reviewing applications to 5 by FY 2010. The APHRE program attained ISO certification for its enforcement operations, greatly improving the efficiency of the processes APHIS controls. The Veterinary Diagnostics program has also achieved ISO certification for its overall quality management system and for several specific tests, and the Biotechnology Regulatory Services (BRS) program has achieved ISO certification for its permitting and notification processes. BRS has also improved its efficiency by integrating all applications and notifications into one system (ePermits), which has helped to reduce costs and create a controlled work flow. The Pest Detection program has been conducting the Exotic Wood Boring and Bark Beetle Survey nationwide for several years. This survey can cover approximately 10 pests at once rather than surveying for a single pest. In FY 2008, the program is expanding this approach to the citrus industry. Commodity survey protocols have also been developed for soybeans and oak forests; these will be implemented in FY 2009.

Does the program collaborate and coordinate effectively with related programs?

Explanation: APHIS' Monitoring and Surveillance programs cooperate with all related programs including, State, local, or Federal. APHIS is committed to sharing strategies at all levels to achieve effective program management. Examples of effective collaboration include the Select Agents program, jointly managed by APHIS and the U.S. Department of Health and Human Services? (HHS) Centers for Disease Control and Prevention (CDC), and the Biotechnology Regulatory Services program?s coordination with the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA).

Evidence: APHIS and the CDC have formed a cohesive National Select Agent program. The Agencies developed consistent charters which lay out the purpose and scope of the problem. While each Agency promulgated regulations, the two worked closely together in developing them and ensured that the regulations were consistent. In the final rule adopted for the Select Agents program, APHIS noted that even the section numbers, titles, and information contained in each section would mirror those in CDC?s final rule for ease of use by facilities and the public (see page 13244 of the final rule, published in the Federal Register on March 18, 2005, Volume 70, Number 52, pages 13241-13292). APHIS and the CDC conduct regular meetings and/or phone conferences to update the other on program performance and accomplishments. Also, the Agencies have collaborated to create a National Select Agent Registry, which is a jointly administered website that catalogues information regarding select agents. This information can be found at http://www.selectagents.gov/. APHIS, through the Secretary of Agriculture, routinely collaborates with the Department of Homeland Security, among others, as indicated specifically in the Homeland Security Presidential Directives 9 and 11. Sections 6 through 26 in the 9th Presidential Directive outline the responsibilities of all Departments concerned. Sections 4 and 7 in the Presidential Directive 11 outline the responsibilities of all Departments concerned. Biotechnology Regulatory Services coordinates the Agency?s regulations for genetically engineered organisms which may pose a risk to plant health with the EPA and the FDA through joint planning documents and efforts, including the Federal Coordinated Framework for the Regulation of Biotechnology. The Coordinated Framework (51 CFR 23302, 1986) is based upon health and safety laws developed to address specific product classes. The authority for APHIS focuses on plant health, and both the EPA and FDA have the responsibility to ensure the safety of human food and animal feed derived from genetically engineered plants.

Does the program use strong financial management practices?

Explanation: This question received a "no" becuase of the one material weakness discussed in the evidence section. APHIS receives an annual appropriation and is held accountable for keeping its spending within this amount. Program financial managers track financial data through the USDA-wide accounting system (Foundation Financial Information System) and reporting system (Financial Data Warehouse). During the course of the year, they meet with the Budget staffs to review spending and to ensure that payments are made properly for the intended purpose. The USDA/Office of the Inspector General (OIG) conducts and supervises audits and investigations to prevent and detect fraud and to improve the effectiveness of USDA programs by recommending changes that will increase efficiency and reduce waste. APHIS continues to strengthen the Agency?s internal control program, and to comply with OMB Circular A-123, Management?s Responsibility for Internal Controls. APHIS is in the third year of ensuring compliance with Appendix A of circular A-123, which provides guidance for assessing the effectiveness of internal controls over financial reporting and includes financial processes and systems. We strive to have no material weaknesses and to remediate all control deficiencies timely. The program ensures that payments are made in accordance with the intended purpose to minimize erroneous payments. APHIS auditors routinely assess the programs? vulnerabilities to improper payment, the internal controls in place to prevent them, and (based on these identified vulnerabilities and controls) the programs? level of risk of making improper payments. The auditors concluded that the programs are at low risk for improper payments because of internal checks and balances within the automated financial systems and in-house investigative reviews and audits of APHIS cooperative agreements and employee misconduct.

Evidence: APHIS met all of the target dates set by the Department?s Office of the Chief Financial Officer (OCFO) for various tasks related to preparing the FY 2007 financial statements. APHIS certified and submitted its financial statements to OCFO, who in turn consolidated all Agency statements into the USDA consolidated financial statements and provided them to OMB. APHIS also improved its process for reviewing all open unliquidated obligations; Agency staffs are encouraged to review open obligations each month during the preparation of monthly status of funds reports. In addition, each major program unit is required to review open obligations and provide explanations for open items older than 12 months. The program's Deputy Administrators are required to certify that the review has taken place. Procurement for these programs is based on established procedures, controls, and competitive practices. APHIS? Finance Staff reviews spending for these programs on a monthly basis, and the Agency?s financial management system (the USDA Foundation Financial Information System or FFIS) meets statutory requirements as well as those established by the Financial Systems Integration Office. Financial information from FFIS is downloaded nightly into USDA?s reporting system for tracking and analysis, and system assurance routines are run to ensure that the data is accurate. USDA?s OCFO reviews APHIS? financial statements on a quarterly basis. Among the areas of concern to the OCFO are abnormal general ledger balances (accounting inconsistencies). For FY 2007, APHIS had no material abnormal balances. If any material abnormal balances are found, they are researched and corrected within 30 days. For the FY 2007 Performance and Accountability Report, APHIS contributed to one material weakness at the Department level, which was that improvements are needed in information technology security and controls. The Department and its Agencies are in the process of implementing corrective actions to remediate the deficiencies identified.

Has the program taken meaningful steps to address its management deficiencies?

Explanation: Program effectiveness is reviewed by program managers on a regular basis and improvements to program management are made as needed. For example, the Animal and Plant Health Regulatory Enforcement program realigned its investigative operations in the field, streamlined the supervisory structure, expanded and redefined responsibilities for its Area Managers (formerly Field Supervisors), and reassigned staff in order to reduce employee to supervisor ratios. The program?s long-term goal is to physically locate Area Managers as close to assigned investigators as possible. This will result in a more effective program structure as it provides better support for the new investigators and increased liaison with program clients. The Emergency Management Systems (EMS) program utilizes after-action reviews and reports to analyze the effectiveness of actions taken. This allows the managers to see the strengths and weaknesses of the program and to take steps to correct any problems. The Pest Detection program is looking at aspects of both its strategic direction and operational management of the Cooperative Agricultural Pest Survey (CAPS) activities and has made several changes to improve the CAPS process in FY 2007-2008.

Evidence: The EMS program recently conducted a tabletop discussion with the State of Iowa followed by a full-scale deployment exercise of the APHIS National Veterinary Stockpile (NVS). The deployment exercise was a success for both the program and the State of Iowa and valuable lessons were learned. Both the State of Iowa and the NVS were able to identify weaknesses in logistical operations. The program has since modified its policies and procedures to address the issues identified from the exercise. The program also recently conducted an after-action evaluation of its response to a potential foot-and-mouth disease (FMD) outbreak in the United States. While the detection in question turned out not to be FMD, the after-action report indicated that several corrective steps are needed to improve the Agency?s ability to respond to such emergency situations. The program is working with the Agency-level Program Evaluation and Monitoring group to review its response and implement improvements. The Pest Detection program implemented changes in FY 2007 to improve strategic planning and management at the national, regional, and State levels. The program finalized a CAPS guide for FY 2008 to be used by all program employees and cooperators. Additionally, the program has recently reviewed its allocation process and made changes to ensure uniformity in both the Eastern and Western regions (funds are allocated to the program?s regional offices, which sign cooperative agreements with the States and disperse the funds).

Did the program seek and take into account the views of all affected parties (e.g., consumers; large and small businesses; State, local and tribal governments; beneficiaries; and the general public) when developing significant regulations?

Explanation: APHIS consults with State, local, and tribal officials, as well as industry stakeholders and the general public, on an ongoing basis about animal and plant health issues of concern. All APHIS programs are committed to a rulemaking process that provides for full participation. Additionally, APHIS conducts all necessary analyses, such as those required by the Regulatory Flexibility and Paperwork Reduction Acts, as well as considers and responds to all comments received before finalizing regulations. For example, the Agency finalized regulations implementing the Agricultural Bioterrorism Protection of 2002 in March 2005 and published a final rule in the Federal Register that included economic and Regulatory Flexibility Act analyses as well as a detailed response to all comments received. In addition to 36 written comments received during the 60-day public comment period for the rule, the program held a public meeting to get additional input from affected parties (held December 16, 2002) and responded to those comments as well. The preamble to the rule contained a detailed response to all comments and explains what changes were made in response to concerns raised by public comments. In another example of taking concerns raised by comments into consideration when making regulatory changes, APHIS published a notice in the Federal Register on January 5, 2004 announcing that it was conducting an environmental impact statement to evaluate a petition from Monsanto Corporation to deregulate creeping bentgrass that had been genetically engineered for tolerance to the herbicide glyphosate. APHIS had originally notified the public of the petition in April 2003 and requested public comments. The program?s decision to embark on the full environmental impact statement was based, in part, on comments received that raised concerns about the plants? potential as an invader of prairie habitat and riparian areas as well as the potential for the genetically engineered plan to cross-breed with wild grasses, spreading tolerance to glyphosate and reducing its effectiveness against invasive perennial grasses. The notice solicited additional public input. When the environmental impact statement was completed, the program sought additional public input.

Evidence: See the final rule, Agricultural Bioterrorism Potection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins (Docket No. 02-088-4), published March 18, 2005 in the Federal Register, Volume 70, Number 52, pages 13,241 to 13,292. The discussion of public comments begins on page 13,245 and ends on page 13,269. Examples of changes made in response to concerns raised by commenters include ensuring that both APHIS? requirements for select agents and the terminology used in the regulations were consistent with those set forth by the Centers for Disease Control and Prevention for its portion of the Select Agents program and removing the plum pox potivirus from the list of regulated agents because it is not spread easily without specific insect vectors and thus is unlikely to be used as an agent of bioterrorism. Summaries of the economic and Regulatory Flexibility Act Analyses begin on page 13,269 and discuss the benefits of the rule as well as the costs for implementing the new security requirements. See the notice, Monsanto Co. and The Scotts Co.; Availability of Petition for Determination of Nonregulated Status for Genetically Engineered Glyphosate-Tolerant Creeping Bentgrass; Request for Information and Comment (Docket No. 03-101-1), published January 5, 2004 in the Federal Register (Volume 69, Number 2), pages 315-317. The comments and decision to embark on the full environmental impact statement are discussed in a subsequent notice, published in the Federal Register on September 24, 2004 (Volume 69, Number 185), pages 57,257 to 57,260. See the follow-up notice, Environmental Impact Statement; Petition for Deregulation of Genetically Engineered Glyphosate-Tolerant Creeping Bentgrass, published April 11, 2005 in the Federal Register (Volume 70, Number 68), pages 18,352-18,353.

Did the program prepare adequate regulatory impact analyses if required by Executive Order 12866, regulatory flexibility analyses if required by the Regulatory Flexibility Act and SBREFA, and cost-benefit analyses if required under the Unfunded Mandates Reform Act; and did those analyses comply with OMB guidelines?

Explanation: Whenever a rule is deemed significant, APHIS prepares a regulatory impact analysis that complies with OMB guidelines and Executive Order 12866. Economic analyses always receive review outside of the program, for example, from economists of the Agency?s Policy and Program Development (PPD) unit, staff from USDA?s Office of Budget and Program Analysis, and Office of the Chief Economist. The rules include a statement of purpose, explaining why they are being implemented and how they will help achieve APHIS? goals of preventing or minimizing damage to agricultural and natural resources. As part of the process of developing the regulations to implement the Agricultural Bioterrorism Protection Act of 2002, the program developed all analyses required by Executive Order 12866, including a regulatory impact analysis considering the impact of the regulations on small entities, an economic analysis (including a cost-benefit analysis considering the costs of complying vs. the costs associated with the risks the regulations are designed to mitigate), and considered alternatives to the approach adopted in the final rule. The final rule, published in the Federal Register on March 18, 2005, allowed for entities that wish to possess agents and toxins on the Select Agents list to meet certain performance standards based on their facilities? individual situations and agents possessed rather than meeting a set of prescriptive requirements. The interim and final rules also discuss the need for the regulations in the background sections, including the passage of the Agricultural Bioterrorism Protection Act of 2002 that required APHIS and the Department of Health and Human Services? Centers for Disease Control and Prevention (CDC) to regulate certain agents and toxins to protect human and agricultural health in the United States. In addition to discussing the legislative mandate for the regulations, the rule also discusses the risks that agents and toxins on the Select Agents list pose to U.S. agriculture.

Evidence: See Docket No. 02-088-4, Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins; Final Rule, published March 18, 2005, Federal Register, Volume 70, No. 52. The discussion of analyses conducted under Executive Order 12866 begins on page 13,269. The rule contains a summary of the economic analysis and cost-benefit analysis conducted for the regulation, as well as an analysis of the rule?s affect on small entities and a paperwork reduction analysis. The rule also discusses the incremental costs for affected entities associated with implementing the requirements of the rule. These include the costs of obtaining background checks and fingerprints for employees, the costs of developing security plans the costs of security and biosecurity upgrades, and training and other associated costs. The discussion of the alternatives considered (including remaining at the status quo or adopting prescriptive requirements for all facilities) can be found on page 13,277.

Are the regulations designed to achieve program goals, to the extent practicable, by maximizing the net benefits of its regulatory activity?

Explanation: The regulations are designed to achieve the program's goal of mitigating the damage caused by the pests and diseases addressed within the regulations, and safeguarding U.S. agriculture. Each significant regulation must undergo regular economic analysis to ensure that its design yield the maximum benefits.

Evidence: In the case of the Select Agents program, regulatory analyses can be found in the final rule implementing regulations for the program (cited above in 3.RG1 and 3RG2) starting on page 13,269, The rule states that the benefits of implementing the requirements for entities that wish to possess agents and toxins on the Select Agents list include preventing the misuse or intentional introduction of dangerous agents and toxins such as foot-and-mouth disease (FMD). The 2002 outbreak of FMD in the United Kingdom, which was believed to have been unintentional, cost that country more than $4.7 billion in losses to agriculture and the food chain and control costs. As stated in the rule, an intentional introduction could be even more severe than an unintentional one because the perpetrators could use highly virulent strains, multiple introductions of the same agents, and timing of events to maximize the damages. The total estimated costs to comply with the rule were $11.5 million in one-time costs and $3.9 million in recurring costs. Based on a 1999 study conducted by University of California at Davis economists, the estimated cost of an FMD outbreak in the State of California alone ranges between $8.5 and $13.5 billion. These potential risks far outweigh the cost of implementing the new security requirements contained in the Select Agents rule and designed to prevent intentional releases of agents like FMD. The analysis conducted for rule also studied two alternatives, including remaining at the status quo and using prescriptive requirements for meeting security needs. Both were rejected. Remaining at the current ?status quo? leaves the risks unmitigated and does not comply with Agricultural Bioterrorism Protection of 2002 Prescriptive requirements call for a ?one size fits all? approach, which is inappropriate because each agent or toxin is different. Instead, performance standards based on the risks presented by each agent or toxin were developed, which allow the requirements to be met in the most cost-effective way possible. The rule also provides for exemptions from the requirements of the rule for certain entities, including those that possess certain attenuated forms of the agents and toxins that would pose little or no risks to U.S. agriculture. APHIS also recently published a proposal to increase the user fee rates for veterinary diagnostic services to reflect changes in operating costs and expenses (published on July 23, 2007, in the Federal Register, Volume 72, Number 140, pages 40082 to 40089). The rule explains that the fees were authorized by the Food, Agriculture, Conservation, and Trade (FACT) Act of 1990 as amended to allow the Secretary of Agriculture to recover the costs of providing veterinary diagnostic services, These services enhance livestock production, trade, and research, and charging user fees for the services allows us to charge those who use and benefit from the services rather than the public as a whole. Accordingly, the rule is designed to maximize the overall benefits to society. Additionally, after conducting an economic analysis and Regulatory Flexibility Act analysis, APHIS concluded that the overall impacts of the changes (which will allow the program to meet increased operating expenses due to inflation and increased pay costs) would not be significant on businesses, including small businesses. More than 51 percent of the fees will increase by $5.00 or less, more than 76 percent increase by less than $10.00, and more than 83 percent are associated with fewer than 500 users (page 40084). Moreover, these services enhance the international marketability of the users' products.

Has the program demonstrated adequate progress in achieving its long-term performance goals?

Explanation: This question received a "no" because only one long term measure (reducing the number of hours it takes to respond to an animal health event) showed progress toward achieving its long term targets. The Plant and Animal Health Monitoring and Surveillance programs' goal is to minimize the damage caused by pests and diseases through the early detection of pests and diseases of regulatory concern and monitor the areas where these pests and diseases are present. The program and its State and industry partners maintain a comprehensive survey and emergency response network designed to maximize the security of American agriculture. The program is measuring its success through tracking the value of damages prevented and mitigated by conducting these surveillance activities. The agency has one year of data, and so cannot evaluate progress toward meeting its targets associate with the goal reducing the damage caused by pests and diseases. In addition to implementing this measure, the programs have also made progress in the measure that tracks the number of hours it takes the Emergency Management System program to respond to an animal health event. This measure supports the monitoring and surveillance programs goal of preventing damage by ensuring that resources needed to contain animal disease outbreaks are available at the site of an animal health incident within 24 hours. Additionally, the program has made considerable progress in reducing the time it takes to investigate and resolve violations in cases settled through APHIS administrative procedures.

Evidence: In FY 2007, the Monitoring and Surveillance programs saved $1.371 billion in damages to agricultural production and costs to U.S. taxpayers through early detection efforts. The Emergency Management Systems (EMS) program has exceeded its targets for deploying resources to the sites of animal disease outbreaks in recent years. The program's target in FY 2005 was 120 hours, and the program actually managed to get the resources in place within 48 hours that year. Uncertain of whether that level of performance was sustainable, the program set its target for FY 2006 at 96 hours. EMS's actual performance in both FY 2006 and FY 2007 was 24 hours. Being able to respond with all necessary equipment and supplies within a day's time increases the programs' ability to prevent significant damage from occurring and spreading. The Animal and Plant Health Regulatory Enforcement (APHRE) program has also been able to reduce the time it takes to investigate and resolve violations in cases settled through APHIS administrative procedures from 257 days in FY 2004 to 143 days in FY 2007. The program exceeded its targets in each of these years. For example, the FY 2005 target was 257 days and the actual number of days required was 209. During this time, APHRE implemented International Organization for Standardization (ISO) procedures for its enforcement operations and attained ISO Certification in FY 2007. The ISO procedures have greatly improved the program's efficiency in case processing. The program is expanding the types of cases and investigations tracked for this measure in FY 2008 to improve its ability to analyze its entire range of activities. (However, thsi measure is being phased out, and does not have long term targets).

Does the program (including program partners) achieve its annual performance goals?

Explanation: This question received a "small extent" because question 2.4 received a "no" due to a lack of ambitious targets. In addition, only one measure had targets that were met on a consistent basis. APHIS' monitoring and surveillance programs achieved their annual performance targets for 2006 and 2007 in measures that track the number of exotic pests for which surveys are conducted, and in 2005 through 2007 in the number of investigations conducted in support of APHIS' mission, but fell below its 2007 target for the number of biotechnology field test permit holders with violations. These measures support the programs' early detection and damage prevention goals by tracking the level of surveillance conducted for various aspects of the programs nationwide. The agency holds its partners accountable through the use of cooperative agreements that specify exactly what work is to be conducted and the performance information required. For example, State departments of agriculture conduct the surveys for exotic plant pests under APHIS' direction and in cooperation with APHIS' specialists in each State. These cooperators provide the information on what surveys were accomplished as well as the results of the surveys. APHIS also has agreements and contracts in place with State and university laboratories to conduct disease surveillance tests that specify what information the laboratories must submit back to APHIS. These agreements help coordinate program efforts and ensure achievement of annual performance goals.

Evidence: The Pest Detection program and its partners have exceeded the target number of exotic pests for which national surveys are conducted. The number has increased from 16 in FY 2005 to 37 in FY 2007. This dramatic increase is due to improvements in project coordination with stakeholders, and advancements in survey techniques that allow the program to test for a range of pests and diseases within a single survey. The Animal and Plant Health Regulatory Enforcement program initiated 6,566 investigations in FY 2007. This is a 28 percent increase from FY 2006. From FY 2002 to FY2007, the program has increased its investigation capacity more than 400 percent within a budget that has increased only 30 percent in the last five fiscal years. The Biotechnology Regulatory Services program works to educate the biotechnology field test permit holders to reduce the number of violations and maintain a high level of compliance. The program reduced the number of permit holders with violations from 77 in FY 2005 to 60 in FY 2006. The increase in FY 2007 was due to increased outreach and education activities with the permit holders who voluntarily reported issues to the program.

Does the program demonstrate improved efficiencies or cost effectiveness in achieving program goals each year?

Explanation: This question received a "small extent" because the two efficiency measures are new measures and therefore cannot demonstrate progress toward achieving targets. For the long term efficiency measure related to the value of damage prevented or mitigated per dollar spent, there is only one year of data. For the annual effficney measure dealing with the transition from random sampling to targetted sampling, one year of data exists. However, assuming a pre-transition ratio of 1:1, the data for that measure does show a significant effiiciency improvement. APHIS has achieved efficiencies and cost effectiveness by employing measures such as automating processes; and sharing resources, infrastructure, and contracts with other Federal agencies. These measures have shortened review and processing times, and reduced the cost of investigations and the time required for data collection. Earlier detection of plant and animal pests and diseases and timely deployment of resources will enable APHIS to minimize the damage caused by these pests and diseases. The programs' new efficiency measure, the value of damages prevented through monitoring and surveillance efforts per dollar spent, demonstrates the return on investment for taxpayers gained through these programs. The Pest Detection and Animal Health Monitoring System (AHMS) programs are also improving their efficiency through new strategies such as commodity-based surveys that target multiple pests at once and animal disease sampling techniques that target high-risk populations rather than randomly selected animals. Other programs such as Biotechnology Regulatory Services (BRS) and Animal and Plant Health Regulatory Enforcement have also shown significant gains in efficiency in recent years through the use of new information technology and better management processes, like ISO certification.

Evidence: In FY 2007, the Monitoring and Surveillance programs prevented $9.50 worth of damage for every dollar spent. The program estimates that it will return at least as many benefits per dollar for the foreseeable future, even though the risks to U.S. agriculture continue to increase with expanding global trade and potential threats of bio-terrorism. In 2006, APHIS launched e-Permits to streamline the biotechnology permitting process. This web-based system allows the electronic filing, processing, and tracking of permit applications. It reduces mailing and copying costs, and enables BRS to more efficiently ensure the safe research, release, and movement of agricultural biotechnology products. Through this system, APHIS has reduced the average time needed to apply for and receive a permit from 4 days to 1 day. The Monitoring and Surveillance programs have also demonstrated efficiency by reducing the number of days required to investigate and settle violations in cases settled through APHIS administrative procedures??the number of days has been reduced from 257 in FY 2004 to 143 in FY 2007 while the total number of cases closed each year increased from 2,248 in FY 2004 to 6,566 in FY 2007. During the same time period, the program reduced the cost per investigation from $2,590 to $1,583. The Pest Detection program is transitioning from pest-based surveys to commodity-based surveys, which target many commodity-specific pests at once with no additional costs. For example, APHIS and State cooperators have been conducting exotic wood-boring and bark beetle surveys to survey for a variety of invasive pests, rather than targeting single pests and conducting multiple surveys. The Pest Detection program is conducting citrus commodity surveys in FY 2008 and will continue to expand this approach to other commodities. The AHMS program is implementing a new measure to compare the cost of sampling conducted under new targeted surveillance plans to the cost of the random sampling techniques traditionally used. Baseline data for FY 2007 shows a cost ratio of $15.29 for traditional random sampling to $1.00 for targeted sampling. This measure will show the cost savings that result from more targeted sampling techniques, which will be both more effective in detecting the presence of a disease and more efficient.

Does the performance of this program compare favorably to other programs, including government, private, etc., with similar purpose and goals?

Explanation: APHIS is the lead Federal Agency in conducting monitoring and surveillance programs for high-risk exotic and regulated pests and diseases in the United States. The APHIS Monitoring and Surveillance programs coordinate national surveillance programs and work cooperatively with State and other Federal agencies such as USDA's Forest Service involved in these efforts, but there is no other comparable Federal or non-Federal programs on the same scale in the United States. Because APHIS coordinates eradication efforts with State and Federal partners, often working through cooperative agreements in the case of State partners, we cannot objectively compare APHIS' performance with those programs. However, the APHIS Monitoring and Surveillance programs are very successful and lead national efforts.

Evidence: The Animal Health Monitoring and Surveillance program, which is unique in Federal government, has the expertise and infrastructure to work with multiple government and private entities to protect animal health, veterinary public health, social welfare, and food security by collecting and analyzing animal health data and promptly disseminating vital information. The National Veterinary Services Laboratory, which conducts diagnostic testing and develops/validates diagnostic methods for animal disease surveillance efforts in the United States, serves as the official U.S. reference laboratory for the World Organization for Animal Health, a responsibility no other entity in the United States fills. Similarly, the Pest Detection program coordinates a national effort to detect and ensure early response to plant pests and diseases of regulatory significance. While not unique, the APHIS' Select Agents program functions as part of a wider national Select Agents program managed by the Centers for Disease Control and Prevention and the U.S. Department of Justice. Similarly, the APHIS Highly Pathogenic Avian Influenza program is an extension of the National Strategy for Pandemic Influenza. Each Federal agency involved in this strategy was tasked with achieving several objectives. APHIS was assigned 16 percent of these tasks and completed them in the program's first year. Because APHIS is either the coordinator of or an integral part of these programs, objective comparisons are not possible.

Do independent evaluations of sufficient scope and quality indicate that the program is effective and achieving results?

Explanation: USDA's Office of the Inspector General (OIG) conducts frequent audits of APHIS' programs, including the Monitoring and Surveillance programs. OIG is independent of APHIS and conducts audits to promote program effectiveness and efficiency and to prevent waste and abuse. OIG audits are broad in scope and consider the program's strategic design, operations, financial management, and results. OIG audits and peer reviews of several of APHIS' monitoring and surveillance programs have demonstrated that they are effective. For example, OIG conducted an audit of APHIS' avian influenza (AI) surveillance program in which it assessed the adequacy of APHIS' procedures to identify the occurrence of AI in the United States and limit its impact on the general public and the poultry industry. In the executive summary of its report issued in June 2006, OIG concluded that APHIS has made commendable progress in developing plans and establishing the networks necessary to prepare for, and respond to, outbreaks of AI. OIG made eight recommendations to enhance APHIS' efforts to establish a comprehensive national surveillance system, but stated that APHIS' National AI Preparedness and Response Plan incorporates best practices and procedures from incident management disciplines and integrates them into a unified structure, forming the basis for how the Federal Government would coordinate with State, local, and Tribal Governments, and the private sector if an outbreak occurred. OIG concurred with APHIS' response to each recommendation and incorporated them into its final report. OIG also conducted an audit that evaluated APHIS' surveillance program for bovine spongiform encephalopathy (BSE), along with USDA's Food Safety and Inspection Service's controls to prevent banned specified risk materials from entering the food supply. This audit, completed in January 2006, followed up on previous reviews of the two Agencies BSE programs and evaluated the Agencies' implementation of the recommendations. OIG noted that USDA made significant efforts to implement an expanded BSE surveillance program after the first detection of BSE in this country and faced many challenges. While OIG made additional recommendations for APHIS and noted areas where APHIS had not fully addressed its original findings, it stated that the Agency obtained significantly more samples for testing than originally anticipated. OIG agreed with APHIS' responses to its recommendations and incorporated them into its final report. Many of the Monitoring and Surveillance programs also seek certification of their processes by the International Standardization Origanization (ISO). ISO certification indicates that a program has implemented and documented rigorous controls over its processes and has strong quality assurance procedures in place. The Animal and Plant Health Regulatory Enforcement (APHRE) program attained ISO 9001 certification for its enforcement operations in December 2006. The program underwent a follow-up management system certification audit in 2007 by the SGS Company, an independent control and inspection company. The audit found that the program has established and maintained its management system in line with the requirements of the standard and demonstrated the ability of the system to systematically achieve agreed requirements for products and services within the scope and organization's policy and objectives. SGS identified one minor non-conformity in its report that has since been corrected.

Evidence: See the following OIG audit reports: APHIS? Oversight of Avian Influenza (Audit #33099-11-HY), issued June 2006. The audit report states that APHIS has made commendable progress in developing plans and establishing the networks necessary to prepare for, and respond to, outbreaks of AI. APHIS BSE Surveillance Program (Phase II) and FSIS Controls over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products (Phase III) (Audit #24601-03-KC and 50601-10-KC), issued January 2006. The audit report noted that USDA made significant efforts to implemented an expanded BSE surveillance program after the first detection of BSE in this country and faced many challenges. Also see the audit report by the SGS Company regarding the APHRE program, finding that the program was maintaining ISO certification standards.

Were programmatic goals (and benefits) achieved at the least incremental societal cost and did the program maximize net benefits?

Explanation: This question received a "no" because it did not demonstrate that the program conducted subsequent analyses of the impacts of regulations to determine "that the findings meet or exceed the program's original estimates of net benefits." Through regulatory impact analyses of significant rules, APHIS ensures that its goals and benefits are achieved with minimum societal cost and maximum benefit. For example, the regulation implementing the Select Agent registry required commercial, State, and university laboratories, whose security measures were not current with those defined in the regulation, to update their security protocols. The laboratories were also required to apply for permits to possess select agents, which are then renewed every three years. These new requirements involved additional costs to affected laboratories; however, the benefits of ensuring that the pathogens and toxins on the Select Agents list are properly secured greatly outweigh these costs. As APHIS developed the program, it was able to implement the new requirements without the registration fees. While facilities still face the costs of complying with the Select Agents requirements, they do not have to pay registration fees. The costs of these improvements and permits are greatly outweighed by the benefits of preventing a deliberate introduction of a listed agent or toxin into the United States.

Evidence: The interim final rule (Docket No. 02-082-1, published in the Federal Register on August 12, 2002) implementing the regulations estimated that upgrading a facility with 10,000 square feet (approximately 80 percent of affected entities) would cost an average of $62,500 and that a facility with 30,000 square feet would cost an average of $187,000. The program also originally planned to charge initial fees of $29,000 to register facilities that possessed select agents and toxins with renewal fees of $21,000 every 3 years to cover the costs of the program. As APHIS developed the program, it was able to implement the new requirements without the registration fees (see the final rule, Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins, Docket No. 02-088-4, published in the Federal Register on March 18, 2005). While facilities still face the costs of complying with the Select Agents requirements, they do not have to pay registration fees. The costs of these improvements are greatly outweighed by the benefits of preventing a deliberate introduction of a listed agent or toxin into the United States. Should a deliberate introduction occur, the consequences would be significant. This is demonstrated by natural outbreaks of diseases on the select agent list that have occurred, like the foot-and-mouth disease (FMD) outbreak in the United Kingdom in 2001. This outbreak led many countries, including the United States and the European Union, to ban imports of all British milk, meat, and livestock and cost the United Kingdom more than $3.1 billion dollars. Another outbreak occurred in the United Kingdom in 2007, which is suspected to be linked to insufficient security protocols at a lab run by the United Kingdom's Institute of Animal Health in Pirbright.