Detailed Information on the
Food Safety and Inspection Service Assessment

Conducting independent assessments of Food Safety and Inspection Service programs to evaluate their scientific basis and effectiveness.

Developing a new information infrastructure to enable real-time data collection, data analysis, improve program effectiveness, and allow greater information sharing among external agencies.

Implementing effective multi-year budget planning to establish closer links between the Food Safety and Inspection Service budget and Food Safety and Inspection Service performance goals.

Measure: Reduction in the rate of human foodborne illness from Salmonella in broilers.

Explanation:Salmonella bacteria are the most frequently reported cause of foodborne illness. Salmonella present on and in raw meat and poultry can survive if the product is not cooked to a safe minimum internal temperature, as measured with a food thermometer. Salmonella is a larger concern and more prevalent problem with poultry than meat, so this measure focuses on poultry. The CDC estimates that there were 76 million total foodborne illnesses in 1997. Based upon its foodborne illness attribution work, FSIS estimated that 588,000 Salmonella foodborne illnesses were attributable to FSIS regulated meat and poultry products in CY 2006. FSIS has developed public health based performance measures targeted at reducing the rate of human foodborne illness from Salmonella in broilers. The Healthy People 2010 goal for Salmonella illnesses is 6.8 cases per 100,000 people. FSIS estimates based upon its public health attribution work that the Healthy People 2010 goal for Salmonella illnesses from broilers is 0.68 cases per 100,000 people. FSIS has translated its Salmonella category performance measures into the rate of human salmonellosis cases from broilers per 100,000 people.

Measure: Reduce the overall public exposure of E. coli O157:H7 in ground beef

Explanation:The Healthy People 2010 goal for illnesses due to E. coli O157:H7 is 1.0 cases per 100,000 people. FSIS estimates that the Healthy People 2010 goal for illnesses from E.coli O157:H7 in ground beef is 0.34 cases per 100,000 people or a volume adjusted percent positive rate of 0.32. Since FSIS has already met this goal, the FY2013 performance objective was calculated by halving the Healthy People 2010 goal for E.coli O157:H7 in ground beef.

Measure: Ground Beef Servings Inspected and Passed Nationally per FSIS dollar spent on Ground Beef

Explanation:The number of servings inspected and passed was estimated using FSIS inspection and laboratory verification data and FSIS establishment volume data. A 0.25lbs serving size was assumed. FSIS dollars spent are adjusted for inflation. The number of FSIS dollars spent on ground beef was estimated using the proportion of FSIS inspected product that consisted of ground beef. From FY 2004 - 2006, nine percent of the FSIS budget was spent on ground beef. In FY 2007, eight percent of the FSIS budget was spent on ground beef.

Measure: Ready to Eat Product Servings Inspected and Passed Nationally per FSIS dollar spent on Ready to Eat Products

Explanation:The number of servings inspected and passed was estimated using FSIS inspection and laboratory verification data and FSIS establishment volume data. A 0.19 lbs serving size was assumed and FSIS dollars spent were adjusted for inflation. The number of FSIS dollars spent on Ready-to-Eat (RTE) products was estimated using the proportion of FSIS inspected product that was RTE. In FY 2004, 14 percent of the FSIS budget was spent on RTE products. In FY 2005, 11 percent of the FSIS budget was spent on RTE products. In FY 2006 and 2007, 13 percent of the FSIS budget was spent on RTE products. Prior to FY 2008, FSIS did not utilize this efficiency measure, so a FY 2006 and 2007 target was not established.

Measure: Broilers Servings Inspected and Passed Nationally per FSIS dollar spent on Broilers

Explanation:The number of servings inspected and passed was estimated using FSIS inspection and laboratory verification data and FSIS establishment volume data. A 0.19 lbs serving size was assumed. FSIS dollars spent are adjusted for inflation. The number of FSIS dollars spent on broilers was estimated using the proportion of FSIS inspected product that consisted of broilers. In FY 2004, 26 percent of the FSIS budget was spent on broilers. In FY 2005, 44 percent of the FSIS budget was spent on broilers. In FY 2006, 41 percent of the FSIS budget was spent on broilers. In FY 2007, 43 percent of the FSIS budget was spent on broilers. Prior to FY 2008, FSIS did not utilize this efficiency measure, so a FY 2006 and 2007 target was not established.

Measure: Reduction in rate of human foodborne illness from Listeria Monocytogenes in FSIS regulated ready-to-eat Products.

Explanation:Listeria monocytogenes is a bacterium that is recognized as an important public health problem in the United States. The disease listeriosis affects primarily pregnant women, newborns, and adults with weakened immune systems. The CDC estimates that there were 76 million total foodborne illnesses in 1997. Based upon its foodborne illness attribution work, FSIS estimated that 1,150 Listeria foodborne illnesses were attributable to FSIS regulated meat and poultry products in CY 2006. FSIS has developed public health based performance measures targeted at reducing the rate of human foodborne illness from Listeria Monocytogenes in FSIS regulated ready-to-eat Products. The Healthy People 2010 goal for illnesses due to Listeria monocytogenes is 0.24 cases per 100,000 people. FSIS estimates based upon its public health attribution work that the Healthy People 2010 goal for Listeriosis illnesses from ready-to-eat products is 0.14 cases per 100,000 people. FSIS translates the Healthy People 2010 goal of cases per 100,000 people to its volume adjusted percent positive rate in order to assess its progress toward meeting this goal. FSIS estimated, based upon its laboratory verification testing for Listeria monocytogenes in ready-to-eat products, that the agency already met the Healthy People 2010 goal for listeriosis illnesses. FSIS established its FY 2013 performance objective for Listeriosis illnesses from ready-to-eat products by assuming a 1 percent annual decrease from FY 2007 in the rate of Listeria monocytogenes volume adjusted percent positives. The measure shows the decrease in the rate of human Listeriosis illnesses from ready-to-eat products per 100,000 people. Those numbers reflect the human case rate decrease expected based upon FSIS' performance objectives for Listeria monocytogenes volume adjusted percent positives.

Measure: Reduction in the rate of human foodborne illness from E.coli O157:H7 in ground beef.

Explanation:E. coli O157:H7 is one of hundreds of strains of the bacterium Escherichia coli. Although most strains are harmless, this particular strain produces a powerful toxin that can cause severe illness. E. coli O157:H7, in fact, is a leading cause of severe foodborne illness. Eating meat, especially ground beef that has not been cooked sufficiently to kill E. coli O157:H7, can cause infection. The CDC estimates that there were 76 million total foodborne illnesses in 1997. Based upon its foodborne illness attribution work, FSIS estimated that 29,700 E.coli O157:H7 foodborne illnesses were attributable to FSIS regulated meat and poultry products in CY 2006. The Healthy People 2010 goal for illnesses due to E. coli O157:H7 is 1.0 cases per 100,000 people. FSIS estimates based upon its public health attribution work that the Healthy People 2010 goal for illnesses from E.coli O157:H7 in ground beef is 0.34 cases per 100,000 people. FSIS translates the Healthy People 2010 goal of cases per 100,000 people to its volume adjusted percent positive rate in order to assess its progress toward meeting this goal. FSIS estimated, based upon its laboratory verification testing, that it already met the Healthy People 2010 goal for E. coli O157:H7 in ground beef. The FY 2013 performance objective was calculated by halving the Healthy People 2010 goal for E.coli O157:H7 in ground beef. The measure shows the decrease in the rate of human illnesses from E. coli O1567:H7 in ground beef per 100,000 people. Those numbers reflect the human case rate decrease expected based upon FSIS' performance objectives for E. coli O157:H7 volume adjusted percent positives in ground beef.

Measure: Reduce overall public exposure to generic Salmonella from broiler carcasses using existing scientific standards.

Explanation:As of June 2006, FSIS began employing a "category" system to measure establishments' Salmonella performance due to a change in how the establishments were selected for testing. FSIS compares how many establishments are in "Category 1" from one quarter to the next and from one year to the next. Category 1 represents establishments that have achieved 50 percent or less of the performance standard or baseline guidance, for two consecutive FSIS test sets. Category 2 represents establishments that have not achieved 50 percent or less of the performance standard on at least one of the two most recent FSIS test sets without exceeding the performance standard or baseline guidance. Category 3 represents establishments that have exceeded the performance standard or baseline guidance on either or both of the two more recent FSIS test sets. For example, for broiler slaughter establishments, the performance standard is constructed such that the standard is met if there are 13 or fewer positive samples in 51 daily tests. Consequently, a Category 1 establishment would have six or fewer positive results in the two most recent 51 sample sets. As more establishments reach Category 1 status, fewer people will be exposed to Salmonella from raw classes of product regulated by FSIS. FSIS set a goal of having 90 percent of establishments achieve Category 1 status by 2010. By then, FSIS will have completed one or more new baseline studies. The results of these new baselines would be to establish new performance standards or baseline guidance and to re-set Category 1, Category 2, and Category 3 criteria.

Measure: Decrease the overall percent-positive rate for Listeria monocytogenes in ready-to-eat products through the use of Food Safety Assessments.

Explanation:FSIS combats Listeria through the use of Food Safety Assessments (FSA). An FSA is a comprehensive evaluation of an establishment's food-safety system, including its sanitation controls, its compliance with microbiological performance criteria, the adequacy of slaughterhouse and processing plant HACCP systems, the design and operation of its prerequisite programs and its response to food-safety control deviations. FSIS conducts regulatory sampling of Ready-To-Eat products for the presence of Listeria monocytogenes. Listeria monocytogenes is the best indicator of sanitary operations for the Ready-To-Eat processing environment at retail. Percent positives indicate the finding of Lm in the samples. Therefore, higher percent-positives is a probable indication of higher Listeria monocytogenes in the food supply regulated by FSIS. The Healthy People 2010 goal for illnesses due to Listeria monocytogenes is 0.24 cases per 100,000 people. FSIS estimates based upon its public health attribution work that the Healthy People 2010 goal for Listeriosis illnesses from RTE products is 0.14 cases per 100,000 people or a volume adjusted percent positive rate of 0.30. FSIS met the Healthy People 2010 goal for listeriosis illnesses from RTE products in FY 2007. The FY 2013 performance objective was calculated by assuming a 1 percent annual decrease from the FY 2010 volume adjusted percent positive rate.

Is the program purpose clear?

Explanation: The Food Safety and Inspection Service (FSIS) has a clear program purpose and mission. The mission is to protect consumers by ensuring that meat, poultry, and processed egg products are safe, secure, wholesome and correctly labeled and packaged. According to the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq.), FSIS has a statutory mandate to inspect each carcass and carry out daily inspection of all processed meat, poultry, and egg products.

Evidence: FSIS Strategic Plan Fiscal Years 2008-2013, www.fsis.usda.gov/About_FSIS/Strategic_Planning/index.asp; Federal Meat Inspection Act (FMIA) 21 U.S.C., Chapter 12, P.L. 59-242 as amended through P.L. 107-1: www.fsis.usda.gov/Regulations_&_Policies/FMIA/index.asp; Poultry Products Inspection Act (PPIA) 21 U.S.C., Chapter 10, P.L. 85-172: www.fsis.usda.gov/regulations_&_policies/Poultry_Products_Inspection_Act/index.asp; Egg Products Inspection Act (EPIA) 21 U.S.C Chapter 15, Section 1034, P.L. 106-170: www.fsis.usda.gov/regulations_&_policies/EPIA/index.asp; Humane Methods of Slaughter Act of 1978 (HMSA) 7 U.S.C. 1901-1906: uscode.house.gov/download/pls/07C48.txt; Homeland Security Presidential Directive 9 - Defense of United States Agriculture and Food. January 30, 2004: www.whitehouse.gov/news/releases/2004/02/20040203-2.html

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

Explanation: FSIS' responsibility is to ensure that meat, poultry and processed egg products are safe, secure, wholesome and correctly labeled and packaged. FSIS activities reduce the incidence of foodborne illnesses associated with meat, poultry and egg products. Foodborne diseases are estimated to cause approximately 76 million cases of gastrointestinal illnesses, 325,000 hospitalizations, and 5,200 deaths in the U.S. each year (Centers for Disease Control and Prevention (CDC) data). FSIS estimates that its regulated meat, poultry, and processed egg products are responsible for 46% of illnesses due to Salmonella, 59% of illnesses due to E. coli O157:H7, and 65% of illnesses due to Listeria monocytogenes. FSIS uses approximately 7,800 full-time in-plant and other front-line personnel in over 6,200 federally-inspected establishments nationwide to protect the public health. These personnel perform inspections covering over 44 billion pounds of livestock carcasses, almost 57 billion pounds of poultry carcasses, and 3.5 billion pounds of liquid egg products. FSIS also has a field force of approximately 130 investigators responsible for conducting food safety and food defense surveillance at nearly one million food warehouses, distribution centers, retail stores, and other types of facilities throughout the United States. In addition to domestic threats, the threat of illegally imported or smuggled product entering the country requires surveillance of imported products at U.S. borders, ports-of-entry, distributors, warehouses, retail stores, and other facilities where imported meat, poultry, and processed egg products are entered, offered for entry, stored, sold, or distributed.

Evidence: CDC, Food-Related Illness and Death in the United States, www.cdc.gov/ncidod/eid/vol5no5/mead.htm; President's Budget; Testimony of Dr. Richard Raymond Under Secretary for Food Safety Before the U.S. House of Representatives Committee on Agriculture, Subcommittee on Livestock, Dairy and Poultry, November 7, 2007: www.fsis.usda.gov/PDF/Testimony_Raymond_110707.pdf; OIG-24001-3-AT, FSIS: Implementation of the Hazard Analysis and Critical Control Point System: www.usda.gov/oig/webdocs/haccp.pdf; Public Health Security and Bioterrorism Preparedness and Response Act of 2002: http://69.20.19.211/oc/bioterrorism/PL107-188.html; FSIS Fact Sheets of Foodborne Illness and Disease: www.fsis.usda.gov/Fact_Sheets/Foodborne_Illness_&_Disease_Fact_Sheets/index.asp; Written Statement of Dr. Richard Raymond, Under Secretary for Food Safety, Before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, March 5, 2008

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

Explanation: Per FMIA, PPIA and EPIA, FSIS has the sole regulatory responsibility for ensuring that meat, poultry, and processed egg products are safe, secure, wholesome, and accurately labeled and packaged. The FSIS role is unique but not conducted in a vacuum. Producers, industry, retailers and consumers all have a role in meat and poultry safety. The meat, poultry, and processed egg products industries are responsible for producing safe, secure, wholesome, and accurately labeled products, and FSIS is responsible for ensuring that the industries comply with the applicable laws and regulations to protect consumers. Thus, the role of FSIS as a regulatory, public health agency is very different from the role of the regulated industries. FSIS' role in partnering with its sister agencies within USDA, with other Federal, state, and local counterparts, and with industry groups is unique and critical to an integrated, national food safety system. FSIS is in the process of providing a more clear rationale for the Food and Drug Administration (FDA) or FSIS jurisdiction through a joint proposed regulation. For example, FDA inspects all sandwiches, but FSIS inspects meat and poultry wraps, and FDA inspects cheese-only pizzas, but FSIS inspects pizzas topped with meat or poultry. The Agencies are working together to ease any confusing or redundant issues. Currently, 27 states have meat and poultry inspection programs for products produced and sold within their jurisdictions. These states operate under cooperative agreements with FSIS and must enforce requirements "at least equal to" those of the FSIS Federal system. The state programs are in lieu of the Federal program. County and local governments administer and enforce various local laws governing meat, poultry, and processed egg products. Often, the regulatory controls are exercised through the issuance of licenses to operate, providing the firms meet local sanitation, construction, facility, and other operational standards. FSIS works with state, county, and local government officials involved with food handling establishments to carry out surveillance, investigation, and enforcement activities to protect the public health.

Evidence: FMIA 21 U.S.C., Chapter 12, Section 301: www.fsis.usda.gov/Regulations_&_Policies/FMIA/index.asp; PPIA 21 U.S.C., Chapter 20, Section 5: www.fsis.usda.gov/Regulations_&_Policies/Poultry_Products_Inspection_Act/index.asp; EPIA 21 U.S.C., Chapter 15, Section 1034: www.fsis.usda.gov/Regulations_&_Policies/Egg_Products_Inspection_Act/index.asp; National Response Plan and National Incident Management System (as directed by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Homeland Security Presidential Directives 5, 7, 8 and 9): www.usda.gov/documents/NRPallpages.pdf - p. 87 describes Directives 5, 7, 8, and 9; A list of States with cooperative agreements for state meat and poultry inspection programs is available at www.fsis.usda.gov/Regulations_&_Policies/Listing_of_Participating_States/index.asp.

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

Explanation: This program is not free of major flaws because FSIS is limited to specific carcass by carcass inspection at all slaughter plants and provides the same level of inspection at all processing plants regardless of risk. As seen in FSIS' attempts to alter this traditional inspection system, FSIS has concluded that inspection based on risk would improve efficiency and effectiveness. The Hazard Analysis and Critical Control Point (HACCP)-Based Inspection Models Project (HIMP) is a pilot effort to improve online slaughter inspection, and to maximize the reduction and/or elimination of defects that pass through traditional inspection. As a result of FSIS plans to implement a pilot risk-based inspection program after considerable time and effort went into building a foundation for the program, the USDA Office of Inspector General (OIG) in 2007 conducted an audit to determine the Agency's ability to implement the program. The OIG made 35 recommendations and concluded that FSIS did not have adequate management control processes or an integrated IT system in place to support a timely, reliable risk-based inspection program. FSIS and the OIG were able to reach a management agreement on all 35 recommendations and the Agency is currently addressing the report's recommendations. The Under Secretary for Food Safety, Dr. Richard Raymond, testified before the House Committee on Energy and Commerce on March 12, 2008 that, "We need to develop a uniform, consistent process to determine when and where inspection is warranted, based on the inherent risk of the product and a plant's demonstrated control of that risk, and when and where audits are sufficient." FSIS is designing new approaches, within statutory limits, to continually improve its effectiveness in reducing foodborne illnesses associated with the consumption of meat, poultry, and processed egg products. Through these approaches, FSIS will try to focus its resources on those establishments, and points within establishments that pose the greatest risk for food safety issues. By focusing its resources in a public-health based manner, FSIS can better protect the food supply and, subsequently, the public's health, with the resources available. This includes the development of the Public Health Information System (PHIS) that will provide the infrastructure to collect and assess data, and respond to hazards and risks.

Evidence: PR/HACCP Rule, 9 CFR Part 304, et. al.: www.fsis.usda.gov/OPPDE/rdad/FRPubs/93-016F.pdf; CDC, Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food - 10 States, 2006, April 13, 2007: www.cdc.gov/mmwr/preview/mmwrhtml/mm5614a4.htm?s_cid=mm5614a4_e; Food Safety and Inspection Service. Progress Report on Salmonella Testing of Raw Meat and Poultry Products, 1998--2006: www.fsis.usda.gov/Science/Progress_Report_Salmonella_Testing/index.asp; Salmonella Verification Sampling Program: Response to Comments and New Agency Policies, January, 28, 2008: www.fsis.usda.gov/OPPDE/rdad/FRPubs/2006-0034.htm; Food Safety and Inspection Service. Salmonella Verification Sample Result Reporting: Agency Policy and Use in Public Health Protection. www.fsis.usda.gov/OPPDE/rdad/FRPubs/04-026N.pdf; Public Health Risk Based Inspection for Processing and Slaughter: Technical Report. January 25, 2008: www.fsis.usda.gov/OPPDE/NACMPI/Feb2008/Processing_Slaughter_Tech_Report.pdf

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

Explanation: FSIS funds are used to support an inspection workforce that is responsible for ensuring that meat, poultry, and processed egg products are safe, secure, wholesome, and correctly labeled and packaged. FSIS inspects only those establishments that process meat, poultry and processed egg products. The regulation of industry and the inspections performed by FSIS lower the level of pathogens and other dangerous contaminants in the final end products. This directly impacts the intended beneficiary, the consumer, by reducing the risk of foodborne illnesses. Risk assessments and other analyses, including attribution modeling, are used to establish levels of inspection among establishments to allocate flexible resources (e.g., in-depth verification, food safety assessments) among those establishments with less process control. These efforts are allowing FSIS to target inspection resources and more effectively provide assurance of the safety of meat, poultry and processed egg products in the U.S.

Evidence: Ensuring Safe Food From Production to Consumption, National Academy of Sciences Report, 1998, p. 29-30, HACCP Systems: www.nap.edu/catalog/6163.html; PR/HACCP Rule, 9 CFR Part 304, et. al.: www.fsis.usda.gov/OPPDE/rdad/FRPubs/93-016F.pdf; National Advisory Committee on Meat and Poultry Inspection Meeting (February 5-6, 2008), Public Meeting on Public Health Based Inspection System in Poultry Slaughter (August 7, 2007), and related resource material for both meetings: www.fsis.usda.gov/Regulations_&_Policies/Public_Health_Based_Inspection/index.asp; OIG Report No. 24601-07-Hy, December 2007, on Issues Impacting the Development of Risk Based Inspection at Meat and Poultry Establishments: www.usda.gov/oig/webdocs/24601-07-HY.pdf; Public Health Risk-Based Inspection System for Poultry Slaughter, Technical Report, FSIS, January 25, 2008: www.fsis.usda.gov/OPPDE/NACMPI/Feb2008/Poultry_Slaughter_Tech_Report.pdf; Public Health Risk-Based Inspection System for Processing and Slaughter, Technical Report, FSIS, January 25, 2008: www.fsis.usda.gov/OPPDE/NACMPI/Feb2008/Processing_Slaughter_Tech_Report.pdf

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: Three long-term measures support the strategic objective of FSIS to reduce the incidence of foodborne illnesses related to meat, poultry, and processed egg products in the U.S. This strategic objective is tied directly to the program purpose of providing safe, secure, wholecome, and correctly labeled and packaged products. These performance measures are linked to the Healthy People 2010 goals, developed by FSIS, CDC, and FDA, to reduce foodborne illnesses from Salmonella, E. coli O157:H7, and Listeria monocytogenes by half by the year 2010. The goal for Listeria monocytogenes was made even more aggressive through the May 5, 2000 Presidential Memorandum on Food Safety stating that the Listeria monocytogenes goal should be reached by 2005 instead of 2010. Measure 1:Reduction in the rate of human foodborne illness from Salmonella in broilers; Measure 2: Reduction in rate of human foodborne illness from Listeria Monocytogenes in FSIS regulated Ready-to-Eat products; and Measure 3: Reduction in the rate of human foodborne illness from E. coli O157:H7 in ground beef. These three measures are quantifiable, as FSIS verification results can be used to estimate progress toward them, and they are linked to the agency's overall mission through public health goals. FSIS has used attribution data (i.e., information on the proportion of human cases of salmonellosis, E. coli O157:H7 and listeriosis that are related to FSIS-regulated products) to link these outcome objectives to the public health outcome goals related to foodborne illness outlined in Healthy People 2010.

Evidence: USDA Strategic Plan for FY 2005 to 2010: www.ocfo.usda.gov/usdasp/usdasp.htm; FSIS FY 2008-2013 Strategic Plan; USDA Performance and Accountability Reports (FY 2005-2007): www.ocfo.usda.gov/usdarpt/usdarpt.htm; FSIS Annual Performance Plans and Reports (FY 2005-2007); Healthy People 2010: www.healthypeople.gov/Document/HTML/Volume1/10Food.htm

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

Explanation: FSIS has developed ambitious targets and timeframes for its long-term measures. FSIS measures are linked to the Healthy People 2010 goals, but targets have been developed beyond those out to 2013. Using data to estimate attribution of foodborne illness to specific foods indicated that FSIS had either reached or was close to reaching the goals outlined in Healthy People 2010 for Listeria monocytogenes and E. coli O157:H7. Therefore, FSIS set as its goal a further reduction in half by 2010 for those two pathogens to ensure that the targets are ambitious ones that promote continued improvement. In addition, Listeria monocytogenes targets, beyond 2010, are based on a one percent reduction each year which, considering the low level of Listeria monocytogenes, this level of reduction is ambitious. Though Salmonella targets appear flat from 2010 to 2012, further reduction from the 2010 goal will be very difficult so these targets are considered ambitious. FSIS believes, based on past progress, that those goals are achievable. Progress towards the goals is measured quarterly using data from FSIS' regulatory testing programs.

Evidence: USDA Strategic Plan for FY 2005 to 2010: www.ocfo.usda.gov/usdasp/usdasp.htm; FSIS FY 2008-2013 Strategic Plan; USDA Performance and Accountability Reports (FY 2005-2007):www.ocfo.usda.gov/usdarpt/usdarpt.htm; FSIS Annual Performance Plans and Reports (FY 2005-2007); Healthy People 2010: www.healthypeople.gov/Document/HTML/Volume1/10Food.htm

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: Three annual outcome measures support the strategic objective of FSIS to reduce the incidence of foodborne illnesses related to meat, poultry, and processed egg products in the U.S. and the program's long-term goals. Measure 1: Reduce overall public exposure to generic Salmonella from broiler carcasses using existing scientific standards; Measure 2: Decrease the overall-percent-positive rate for Listeria monocytogenes in ready-to-eat products through the use of Food Safety Assessments; and Measure 3: Reduce overall public exposure to E-coli O157:H7 in ground beef. These annual performance measures have been developed to demonstrate progress toward FSIS goals focus on FSIS-regulated products, and facilitate FSIS tracking the progress and success of its programs and initiatives in reducing exposure to foodborne pathogens. The data for the performance measures comes from FSIS' verification sampling programs. For FY 2006, over 10,000 samples were collected and analyzed for E. coli O157:H7 testing in ground beef, for Salmonella in broiler chickens, and for Listeria monocytogenes in ready-to-eat products. These robust sampling programs, although not designed to establish national prevalence rates, provide estimates of progress in reducing the presence of these pathogens in food coming from FSIS-regulated establishments.

Evidence: USDA Strategic Plan for FY 2005 to 2010: www.ocfo.usda.gov/usdasp/usdasp.htm; FSIS FY 2008-2013 Strategic Plan; USDA Performance and Accountability Reports (FY 2005-2007): www.ocfo.usda.gov/usdarpt/usdarpt.htm; FSIS Annual Performance Plans and Reports (FY 2005-2007)

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

Explanation: FSIS has set annual performance targets that were developed with the FY 2010 USDA Strategic Plan and FY 2013 FSIS Strategic Plan goals in mind. These annual targets are quantified and progress is tracked through laboratory results of verification sampling. Performance objectives or targets are in place out to 2013, and are designed for continual improvement. The targets are more ambitious, in some cases, than those set in Healthy People 2010, but are designed to be within reason. The results of the sampling programs are reported each year as a comparison to the baseline year. FSIS' ambitious targets and constant comparisons of performance to the base year, allows the Agency to continually track its progress toward its goals and to take any necessary action or develop initiatives if progress is not in line with its goals. FSIS estimates that it had met the Healthy People 2010 goal for Listeria monocytogenes in ready-to-eat products and E. coli O157:H7 in ground beef. FSIS estimates based upon its foodborne illness attribution work that the Healthy People 2010 goal for Listeria monocytogenes is 0.14 cases per 100,000 people or a 0.30 percent positive rate for Listeria monocytogenes in ready-to-eat products. In FY 2007, the rate of illnesses from Listeria monocytogenes in ready-to-eat products was 0.17 percent. FSIS continues to strive to lower its percent positive rate and has set its FY 2013 goal for the annual measure of decreasing the percent positive rate Listeria monocytogenes in ready-to-eat products at 0.23%. As this rate decreases, so should the rate of illnesses. FSIS estimates based upon its foodborne illness attribution work that the Healthy People 2010 goal for E. coli in ground beef is 0.34 cases per 100,000 people or a 0.32 percent positive rate for E. coli O157:H7 in ground beef. In FY 2007, the volume weighted percent positive rate for E. coli O157:H7 in ground beef was 0.28 percent. FSIS continues to strive toward lowering the E. coli O157:H7 percent positive rate for ground beef and has set its FY 2013 goal at half that of the Healthy People 2010 goal (0.15 percent positives for E. coli O157:H7 in ground beef). FSIS continues to work to increase the number of establishments in Salmonella Category I. Establishments in this category have achieved 50 percent or less of the Salmonella performance standard or baseline guidance, for two consecutive FSIS test sets. In FY 2006 45% of FSIS establishments were in Category I and by FY 2007 73% of establishments were in Category I. FSIS has set the goal of having 90% of establishments in Category I by 2010 and 95% of establishments in Category I by 2013.

Evidence: USDA Strategic Plan for FY 2005 to 2010: www.ocfo.usda.gov/usdasp/usdasp.htm; FSIS FY 2008-2013 Strategic Plan; USDA Performance and Accountability Reports (FY 2005-2007): www.ocfo.usda.gov/usdarpt/usdarpt.htm; FSIS Annual Performance Plans and Reports (FY 2005-2007)

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: FSIS administers many programs to ensure that meat, poultry and processed egg products are safe for U.S. consumers, such as the State Meat and Poultry Inspection (MPI) programs and the FSIS/Food Emergency Response Network (FERN). In addition, FSIS works with CDC and FDA. These programs and organizations are all committed to improving the safety of the food supply. FSIS' MPI Programs are an integral part of the Nation's food safety system. FSIS enters into cooperative agreements with the 27 state MPI programs currently operating. Under the agreement, a state's program must enforce requirements "at least equal to" those imposed under the Federal Meat Inspection Act and the Poultry Products Inspection Act. State MPI Programs must have a verification testing program, with laboratory capacity, to address adulterants and other measures of properly operating food safety systems for meat and poultry products. This verification testing program must define selection criteria for targeting products and processes, including detailed sampling plans for raw products and for ready-to-eat product under mandatory analyses. The FERN Microbiology Cooperative Agreement Program funds and partners with 21 state labs in order to reach the necessary levels of expertise and proficiency required to quickly and accurately respond to any potential threats to the Nation's food supply. FERN improves results in meeting goals through direct oversight of the FSIS and FDA FERN National Program Offices (NPO). FSIS' state partners are held accountable for cost, schedule, and performance results through extensive oversight by the FERN NPO. Oversight includes review of mandatory quarterly and final reports submitted by the labs, monthly phone calls and site visits with assigned project. This not only helps improve results, but also allows for a timely response to any problems or issues that may negatively affect the goals of the program. FSIS also collaborates with the CDC which centrally manages the Foodborne Diseases Active Surveillance Network (FoodNet) and OutbreakNet. This partnership supports FSIS program goals through the provision of specific progress toward Healthy People 2010 objectives for human infections caused by pathogens commonly transmitted by food. FSIS, CDC, and FDA use the same objectives to measure performance for illnesses attributable to regulated food products. Each year FSIS and CDC compare the human and food data to assess the networks' performance and support of FSIS' goals.

Evidence: FERN Cooperative Agreements with State Labs: www.fsis.usda.gov/About_FSIS/Cooperative_Agreements_FERN_2005/index.asp; Listing of Participating State Meat and Poultry Inspection Programs: www.fsis.usda.gov/regulations_&_policies/Listing_of_Participating_States/index.asp; Annual FoodNet reports: Morbidity and Mortality Weekly Reports (MMWR): www.cdc.gov/mmwr/mmwrpvol.html

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: FSIS has independent external peer reviews conducted of its risk assessments, data analyses, and sampling program in compliance with the Office of Management and Budget Information Quality Bulletin on Peer Review. FSIS has standard operating procedures for its conduct of formal peer reviews that have been reviewed by the Office of Management and Budget. FSIS' peer review processes ensure the science used to inform agency policy and resource allocation decisions are sound. Responses to independent peer review comments are posted on the FSIS website to provide transparency to stakeholders regarding the soundness of the science that is the basis of agency decisions. In tandem with the many internal FSIS evaluations, audits and reviews, and similar studies are conducted by the Government Accountability Office (GAO), OIG, Research Triangle Institute International (RTI), and Science Applications International Corporation (SAIC). These outside evaluations are sometimes performed at the request of FSIS itself, and at other times are requested by Congress or other third parties. These evaluations can be as narrow as a specific activity or as broad as the entire Federal food safety system. The combination of the smaller evaluations is sufficiently comprehensive to provide information on the effectiveness of the entire program. In addition to these external reviews, FSIS has an office, Office of Program Evaluation, Enforcement and Review (OPEER), that regularly conducts both process and outcome evaluations of Agency programs. Process evaluations are generally conducted to identify ways to improve new or recently-revised programs, while outcome evaluations study whether existing programs are effective in achieving their stated goals. In addition, OPEER conducts audits Agency-wide to determine whether programs are meeting the Federal Managers Financial Integrity Act (FMFIA) requirements.

Evidence: The Role of FSIS' Data Analysis and Integration Group: www.fsis.usda.gov/PDF/RBI_Maczka_Presentation_043007.pdf; Food Safety and Inspection Service, Use of Food Safety Information Systems: OIG Audit Report No. 24601-0003-Ch, September 2004: http://www.usda.gov/oig/webdocs/24601-03-CH.pdf; Animal and Plant Health Inspection Service Bovine Spongiform Encephalopathy (BSE) Surveillance Program Phase II and Food Safety and Inspection Service Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products Phase III, OIG Audit Report No. 50601-10-KC, January 2006: http://www.usda.gov/oig/webdocs/50601-10-KC.pdf; Issues Impacting the Development of Risk-Based Inspection at Meat and Poultry Processing Establishments, OIG Audit Report No. 24601-07-Hy, December 2007: http://www.usda.gov/oig/webdocs/24601-07-HY.pdf; Annual audits of each laboratory by the American Association of Laboratory Accreditation. Annual Internal audits of each laboratory by: a. Quality Managers of Eastern, Midwestern, Western and FERN Division b. Additional audits from the Laboratory Quality Assurance Division; GAO report, GAO-07-785T, Federal Oversight of Food Safety, www.gao.gov/new.items/d07785t.pdf

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: Agency budget requests are aligned with program goals and objectives in the Strategic Plan, as well as the corporate measures that are designed to protect the public health by significantly reducing the overall public exposure of foodborne hazards from meat, poultry, and processed egg products. However, it is unclear how changes in funding, legislation or policy will impact FSIS' ability to meet the targets. In addition, FSIS has difficulties in determining the costs per activity (ground beef inspection, broiler inspection and ready-to-eat meat inspection).

Evidence: FSIS President's Budget requests to Congress; USDA Strategic Plan for FY 2005 to 2010: http://www.ocfo.usda.gov/usdasp/usdasp.htm; FSIS FY 2008-2013 Strategic Plan; USDA Performance and Accountability Reports (FY 2005-2007): www.ocfo.usda.gov/usdarpt/usdarpt.htm; FSIS Annual Performance Plans and Reports (FY 2005-2007)

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

Explanation: Between FY 2006 and FY 2008, the FSIS Management Council and their designated representatives on the Strategic Planning and Reporting Team developed the FY 2008-2013 Strategic Plan, which replaced the FY 2000-2005 Strategic Plan. The Plan's vision and six strategic goals reflect the Agency's public health responsibilities and were formulated around the FSIS Administrator's priorities and the National Academy of Sciences model for a public health regulatory agency. The approach to creating the new Strategic Plan began with Agency leaders and senior managers establishing initial goals. The FSIS Management Council then provided the goals to the FSIS Strategic Planning and Reporting Team in order to identify outcomes that would benefit the public and to provide a broad-based input into the Plan. During the Plan's development, Agency leaders and senior management were given a number of opportunities to review, discuss, and approve the ideas and management concepts included in the document. As a result of this thorough development and review process, the FY 2008-2013 Strategic Plan will play an integral part in the development of budget submissions, program plans, and performance management efforts over the next several years. The FY 2008-2013 Strategic Plan presents a limited number of specific, ambitious outcome and annual performance measures that demonstrate progress toward achieving the Agency's public health mission through 2013. FSIS is committed to developing and improving programs that are focused on producing meaningful results for the taxpayer, while at the same time protecting public health.

Evidence: FSIS FY 2008-2013 Strategic Plan; USDA Strategic Plan for FY 2005 to 2010: www.ocfo.usda.gov/usdasp/usdasp.htm

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: All regulations issued by FSIS are considered necessary to reduce the incidence of foodborne illness and to meet the mission of the Agency. The Agency is also evaluating the effectiveness of regulations through the Section 610 review process of the Regulatory Flexibility Act, which requires federal agencies to develop a plan for the periodic review of rules that have a significant economic impact on a substantial number of small entities. However, FSIS has outstanding proposed and interim final regulations that have not been finalized even after several years, for example the Listeria monocytogenes rule is interim final. There are regulations that are not consistent with HACCP, but FSIS has not remedied (HACCP is over ten years old). In addition, FSIS has not been able to address gaps and overlaps in a timely manner, for example the Egg HACCP rule and overlaps with FDA. The regulations are interpretations of the acts and explain the way the rules fit into the overall achievement of program goals to the public. The intent of the regulation is explained in the summary and background section of the regulation. For example, FSIS affirmed, with changes, the interim final rule `Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Cattle' in October 2007. In the preamble, FSIS explained that the Agency is making permanent interim measures to minimize human exposure to cattle materials that could potentially contain the Bovine Spongiform Encephalopathy (BSE) agent.

Evidence: PR/HACCP rule 9C.F.R. Part 304, et.al. www.fsis.usda.gov/OPPDE/rdad/FRPubs/93-016F.pdf; HACCP related rules, new regulations to address adulterants in meat and poultry products, such as Control of Listeria Monocytogenes in Ready-to-Eat Meat and Poultry Products (Dec 2, 2004): www.fsis.usda.gov/OPPDE/rdad/FRPubs/97-013FE.htm; Federal Register Notice - Compliance with the HACCP system regulations and request for comment - E. coli O157:H7 Contamination of Beef Products (Oct 7, 2002): www.fsis.usda.gov/OPPDE/rdad/FRPubs/00-022N.htm; Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle (July 13, 2007): www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-025F.htm; Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery (Jan 12, 2004): www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-038IF.htm; Prohibition of the Use of Certain Stunning Devices Used to Immobilize Cattle During Slaughter (Jan 12, 2004): www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-025IF.htm; A complete list of interim and final rules is available by year at: www.fsis.usda.gov/Regulations_&_Policies/2007_Interim_&_Final_Rules_Index/

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: FSIS collects data on operations at over 6,200 federally inspected plants and activities of 7,800 front-line inspectors located across the country. Activities performed by inspectors and the results of those activities are entered into an automated system on a regular basis. AssuranceNet is the Agency's new automated management control and performance measure monitoring system to help managers make informed decisions for program improvement. Using real-time data, the system generates standard reports for managers on the effectiveness of specific activities. Currently, the Office of Field Operations and Office of International Affairs are using AssuranceNet, and other program areas will follow in a phased approach. Special reports are generated on the performance of certain activities, which provide the agency with the ability to see overall trends and anomalies and adjust agency policies accordingly. Similar data is collected and analyzed within FSIS-regulated facilities that are inspected by states. In addition, FSIS has developed phase one of the Enterprise Reporting System (ERS) to provide analysts and managers access to corporate data for making efficient and effective public health decisions. The development of ERS sets the groundwork for the architectural direction and technology to be used for the future FSIS reporting systems. Data for the performance measures comes from FSIS' verification sampling programs. For FY 2006, over 10,000 samples were collected and analyzed. This data is analyzed and used to help inform program and regulatory changes necessary to improve food safety. Microbiological data are used in risk assessments to explicitly measure the public health impact of changes in microbial contamination of FSIS products and to establish performance objectives aligned with national food safety goals. The Agency develops baseline study plans to meet scientific needs to the level of detail necessary to ensure data is both useful and relevant; e.g. considerations for sampling at different time points (such as day vs. night shift), and procedural details for sampling and testing.

Evidence: Answers on FSIS Directives 10,010.1, Revision 1, 5000.2, and 6420.2 (PDF only): www.fsis.usda.gov/OPPDE/rdad/fsisdirectives/10010_1/Directives_Q&A.pdf; Questions and Answers Regarding Directives 5000.2, 6420.2 and 10,010.1, Revision 1, and the Compliance Guidelines on E. coli O157:H7 (PDF): www.fsis.usda.gov/OPPDE/rdad/fsisdirectives/10010_1/Ecoli_QA.pdf; Workshops on E. coli O157:H7 Regulations Compliance Guidelines For Establishments On The FSIS Microbiological Testing Program And Other Verification Activities For Escherichia coli O157:H7 (PDF Only, 16 pp): www.fsis.usda.gov/Science/Workshop_SmallPlants_ecoli/index.asp; Risk-based Listeria monocytogenes Sampling: Directive 10,240.4 (3/15/2006): Verification Procedures for Consumer Safety Inspectors for the Listeria monocytogenes Regulation and Introduction of Phase 2 of the LM Risk-based Verification Testing Program - Revision 1 (Mar 15, 2006) See: www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/10240.4Rev1.pdf Directive 10,240.5 (3/15/2006); Enforcement, Investigations, and Analysis Officer (EIAO) Assessment of Compliance with the Listeria monocytogenes (LM) Regulation and Introduction of Phase 2 of the LM Risk-based Verification Testing Program See: www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/10240.5.pdf; Risk-based Salmonella Sampling: Federal Register Notice 71:38, pp. 9772-9777, Salmonella Verification Sample Result Reporting: Agency Policy and Use in Public Health Protection See: www.fsis.usda.gov/OPPDE/rdad/FRPubs/04-026N.htm; A completed listing of FSIS notices appears at the following address, organized by issue date www.fsis.usda.gov/regulations_&_policies/FSIS_Notices_Index/index.asp; FSIS Notice 86-07, New Sampling Code for Escherichia coli O157:H7 Testing in Raw Ground Beef; FSIS Notice 17-07, Follow-Up Sampling of Certain Raw Ground Beef Products after an FSIS Verification Sample Tests Positive for E. coli O157:H7; FSIS Notice 18-07, Routine Sampling of Beef Manufacturing Trimmings Intended for Use in Raw Ground Beef; FSIS Notice 62-07, Instructions For Verification Sampling Programs For E. coli O157:H7 In Raw Beef Products; FSIS Notice 66-07, Multiple Follow-Up Sampling After FSIS Positive Escherichia coli (E. coli) 0157:H7 Results; FSIS Notice 68-07, Routine Sampling and Testing of Raw Ground Beef Components Other Than Trim and Imported Raw Ground Beef Components for Escherichia coli (E. coli) O157:H7

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: Since 2003, goals and performance measures were established, all FSIS Senior Executives, managers and supervisors are held to a results-oriented annual performance plan that includes performance measures consistent with the Government Performance and Results Act requirements. In addition, the Agency modified the performance management requirements to ensure all employees, including supervisors and managers are held accountable for results-oriented performance plans that are linked and measured against the Agency Strategic Plan and performance goals. The Agency further established generic performance standards which incorporate results-oriented measures into all the elements that are further defined by management/supervisors for employees', supervisors', and managers' specific duties. Data reporting and alignment are contained in the FSIS Strategic Plan, Annual Performance Plans, and Annual Program Performance Reports. FSIS' state partners are audited to ensure accountability with the "at least equal to" standard. If the state program does not meet this standard, the Agency assumes responsibility for the state's program.

Evidence: FSIS FY 2008-2013 Strategic Plan; FSIS Directive 5710.1 Designation of States for Federal Meat or Poultry Inspection: www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/5710-1.pdf ;FSIS Directive 4430.1, Revision 5, Performance Evaluation Plan (page 26 lists the generic elements and standards)

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

Explanation: Though FSIS obligates the majority of funds each year, FSIS has had difficulty estimating program needs. In 2006, FSIS had to reallocate funds and implement hiring freezes (some of which continue in 2008) to ensure adequate funding was available for front-line inspection. Though an across the board reduction was enacted, FSIS would not have had adequate funding even if they had received the full FY 2006 budget request. In addition, FSIS had to request additional funding, over the 2007 budget request, prior to the enactment of the FY 2007 full year continuing resolution. It is not clear whether FSIS has resolved the issues that led to this shortfall. FSIS uses the Financial Foundation Information System (FFIS) to record obligation of funds in a timely manner with accountability. The Agency follows the requirements set out by statute, the USDA's Office of the Chief Financial Officer (OCFO), and the FFIS. Fund control reports from FFIS are issued monthly to meet government requirements for reporting information. Requirements for program partners are also included in cooperative and reimbursable agreements. Tracking of funds is accomplished by use of an accounting code structure that is designed to identify costs by major activities to demonstrate funds are spent as intended. Unobligated balances at the end of the fiscal years are less than 1 percent of the annual appropriated agency budget. On a monthly basis, FSIS monitors spending through a status of funds process to ensure that the Agency spends resources consistently and in a timely manner. A new Financial Review Board (FRB) also meets on a monthly basis to review, identify, and make recommendations for funding actions that support the mission of FSIS. The FRB, in conjunction with the FSIS Management Council, compares planned and actual use of funds over time and evaluates financial performance for the current fiscal year and outward for three to five years. As another means of ensuring the timely obligation and outlay of funds, FSIS developed a scorecard to track program spending by program to alert management on program spending effectiveness. Implementation of these new processes will help ensure that FSIS allocations and expenditures are synchronized and that planned and actual costs of operations are monitored closely. In addition, more detailed and intensive quarterly and mid-year reviews are performed to make necessary spending and resource allocation adjustments. A Budget and Performance Management System is currently being implemented to allow automated interfaces to source financial systems and to improve data available for budget preparation and decision-making.

Evidence: FSIS Financial Statements to USDA and Treasury; Standard reports for Agency program management use; FSIS Budget Explanatory Notes; President's Budget Request to Congress; PL 110-5 Making further continuing appropriations for the fiscal year 2007, and for other purposes

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: FSIS developed new efficiency measures that calculate the number of servings inspected and passed nationally per FSIS dollar spent for each of the three pathogens??E. coli O157:H7; Salmonella; and Lm. These efficiency measures tie directly to the efficiency and effectiveness of the three pathogen measures and provide a barometer of public health. The new efficiency measures will allow FSIS to monitor progress toward meeting the Agency's performance measures and to evaluate programs targeted at specific pathogens and products. The Agency continues to review its organizational structure to maximize efficiency, eliminate duplication, and leverage resources. FSIS looked at the organization's non-frontline functions to assess the efficiency and effectiveness of program structure and delivery, including all headquarters staffs, District and Regional Offices, three laboratories, the Technical Service Center, and the Financial Processing Center. The results of an initial survey indicated that an additional more robust review was needed, which is scheduled to commence in the third quarter of FY 2008 with objectives to achieve better overall Agency mission results, better business alignment, better managed information, and more effective and efficient business and governance processes. The Agency continually works to improve overall organizational effectiveness and capabilities, for example, to fulfill the policy leadership role, personnel were reorganized around core functions to promote effective, team-oriented collaboration within the office. Program Analysis Staff was transferred from Omaha, NE to Washington, DC and staff that carried out data analysis activities were consolidated to improve organizational alignment, enhance internal coordination, and make more efficient and effective use of their resources. FSIS transferred the international audit function to consolidate mission-critical activities related to food imports into one centralized location, unifying the management and administration of the import function and facilitate regular contact with Agency leadership. Outreach and training functions were consolidated to enable FSIS to retool functions under the leadership of one Assistant Administrator, allowing for a more rapid and consistent delivery of key Agency services, thus better serving the needs of small and very small plants. FSIS will be consolidating public affairs, education and outreach organizational subcomponents to allow for more efficient and effective delivery of responsibilities. FSIS has developed the current and to-be enterprise architecture (EA) to align the agency IT needs and initiatives. FSIS is continually working towards enhancing the EA and Capital Planning and Investment Control (CPIC) processes to enable more detailed current and future infrastructure planning. As part of the EA and CPIC implementation, FSIS has developed two major investments, the Public Health Data Communications Infrastructure Systems (PHDCIS) and the Public Health Information Consolidation Systems (PHICP). This effort has enabled FSIS to better streamline the investment execution and control by consolidating the infrastructure components into the PHDCIS and system development components into the PHICP.

Evidence: Enterprise Architecture Blue Print, Version 1.0, June 14, 2006

Does the program collaborate and coordinate effectively with related programs?

Explanation: The food supply is complex with roles for numerous Federal and state agencies and programs, as well as private industry, in ensuring its safety. FSIS must and does collaborate and coordinate effectively with a number of other agencies and programs to protect the food supply. Those collaborations range from overall strategic planning for a safe food supply to coordinating jurisdiction with other agencies to planning for coordinated responses to food-related events. The Healthy People 2010 document was developed jointly by FSIS, CDC, and FDA. Through working together, the three agencies were able to develop overall national goals for improving the public's health by improving the nation's food supply. FSIS and FDA share jurisdiction at some establishments, and FSIS has procedures and directions to its field staff in place regarding activities in those establishments to decrease redundancies and ensure communication. The Food Emergency Response Network (FERN) was formed by FSIS and FDA in recognition of the need to protect the nation's food supply. FSIS and FDA fund selected state labs through cooperative agreements to address an 'all hazards response' plan. Successful implementation of FERN to increase the United States' ability to respond to food incidences is reliant on good collaboration and coordination between FSIS and FDA. FSIS coordinates with territorial, state, and local health departments to investigate foodborne illnesses potentially linked to FSIS-regulated products. This collaboration includes exchanging epidemiologic, traceback, and laboratory information in order to efficiently detect and control foodborne illnesses. FSIS and FDA work collaboratively in responding to food-related emergencies. The agencies jointly produced a risk assessment when melamine was found to have entered the food supply. FSIS partners with the CDC, FDA, and state public health agencies in the Foodborne Diseases Active Surveillance Network (FoodNet), in OutbreakNet, a network of national, state, and local foodborne disease epidemiologists, in PulseNet, the national laboratory foodborne bacterial pathogens standardized molecular pulsed-field gel electrophoresis (PFGE) subtyping network, EHS-Net, the network of environmental health specialists, and the Council to Improve Foodborne Outbreak Response. FSIS Compliance Investigators maintain cooperative relationships with state and Federal law enforcement, regulatory, health, and agricultural authorities involved with food safety and defense. FSIS Compliance Investigators participate in joint investigations of violations of food safety laws and exercises to improve emergency response capabilities. Specific activities include: a joint FSIS/FDA investigation of products contaminated with melamine; coordination with the Washington State Homeland Security Subcommittee for Agro-Terrorism; the FBI Agro-Terrorism Work Group and the Joint Terrorism Task Force; and a joint pilot of the Automated Tracking System with Customs and Border Protection to identify potentially hazardous shipments at ports of entry. FSIS collaborates with the Agricultural Research Service (ARS), which is instrumental in obtaining pertinent research data to meet FSIS policy, risk assessment, laboratory, and inspection needs. A yearly research meeting is held to prioritize FSIS' research needs and to update FSIS on ARS' research progress. FSIS partners with the FDA, the CDC, the National Marine Fisheries Service, and the Department of the Defense Veterinary Service Activity to manage and coordinate the National Advisory Committee on Microbiological Criteria for Foods for an interagency approach to microbiological criteria for food.

Evidence: FSIS Directive 5730.1 - FSIS Responsibilities in Dual Jurisdiction Facilities. www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/5730.1.pdf; Food Defense Exercises: www.fsis.usda.gov/Food_Defense_&_Emergency_Response/Exercise_Reports/index.asp; FSIS Constituent Update: Scientists Conclude Very Low Risk from Food Containing Melamine. May 11, 2007: www.fsis.usda.gov/PDF/Const_Update_051107.pdf; FoodNet: www.cdc.gov/foodnet/; OutbreakNet: www.cdc.gov/about/stateofcdc/everyday/pulseNet.htm; PulseNet: www.cdc.gov/PULSENET/; Cooperative Agreement Between ARS and FSIS on Data Sharing: www.fsis.usda.gov/PDF/Coop_Agree_58-0101-7N-131.pdf; The Council to Improve Foodborne Outbreak Response (CIFOR): www.cifor.us/; "USDA has unveiled a new Internet resource to help smaller companies answer food safety questions." The portal is available at www.ars.usda.gov/naa/errc/mfsru/portal; Evidence of coordination/collaboration with NACMCF. owa.fsis.usda.gov/exchweb/bin/redir.asp?URL=http://www.fsis.usda.gov/PDF/Young_Chicken_Baseline_Data_Collection.pdf

Does the program use strong financial management practices?

Explanation: Program financial managers track financial data through the existing FFIS accounting system. The OIG conducts and supervises audits and investigations to prevent and detect fraud and to improve the effectiveness of USDA programs. In the past several years, there has been no material weaknesses directly or indirectly found in the FSIS FFIS accounting system by the OIG or FSIS internal control reviews under OMB Circular A-123. OMB Circular A-123, Appendix A, requires annual assessments of management controls over financial reporting. As a result, FSIS tested and documented the effectiveness of FSIS' financial processes. The FSIS audit testing has not identified any material weaknesses and only minimum control deficiencies. Standard Operating Procedures, flowcharts and control matrices provide additional resources and guidance that managers need to improve the accountability and effectiveness of programs and operations. Known deficiencies are corrected within established timeframes. Through documentation, monitoring, testing, and evaluation, FSIS reports the effectiveness of implemented management controls over financial reporting and operations. FSIS develops and maintains management controls to ensure the effectiveness of operations, reliability of financial reporting, compliance with applicable laws and regulations, and the safeguarding of assets. FSIS has conducted its annual evaluations of management controls and financial systems pursuant to Section 2 and Section 4 of the Federal Managers' Financial Integrity Act, respectively, for the period ending September 30, 2007, and there are no new or existing material weaknesses or significant deficiencies. FSIS is proactively addressing its responsibility for monitoring and correcting all control deficiencies. Based on the results of the evaluations, FSIS can provide reasonable assurance that management controls are operating effectively. Strong FSIS financial management policies and procedures, as well as management controls, are in place to help management avoid material weaknesses and financial abuses from occurring. Among these policies and procedures are spending controls at the highest levels within FSIS, status of funds meetings held on a monthly basis, mid-year and quarterly reviews, and the use of financial system application tools such as the Budget Performance Management System to help monitor program expenditures.

Evidence: Annual and quarterly financial statement certifications, OIG audit review, Annual A-123, Appendix A, FFMIA and FMFIA assurance statements.

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

Explanation: FSIS develops and maintains internal controls to ensure the effectiveness of operations, reliability of financial reporting, compliance with applicable laws and regulations, and the safeguarding of assets. According to OIG, the major management challenges faced by FSIS in the most recent OIG Management Challenges Report, August 2007, are: (1) Continuing improvements needed in information technology (IT) security; and (2) Improved controls needed for food safety inspection programs. FSIS has responded to the first challenge through major investments and improvements in IT security including: the Agency's re-accreditation of 9 major applications, which is a consolidation of the prior 12 major applications, and general support systems (as defined by OMB A-130) is in process; FSIS completed a program review of its requisite security controls September 30, 2007; and FSIS is developing an internal Incident Response Team which will respond to operational IT security breaches identified through a set of continuous monitoring procedures. FSIS has responded to the second challenge through major investments and improvements in operational and development activities. For example, FSIS has developed an Agency Enterprise Architecture plan to serve as a blueprint of the FSIS organization that integrates business functions with information technology, data, and performance measures. The Public Health Information Consolidation Project (PHICP) will enable integration among FSIS systems; leveraging technology to build a new Public Health Information System for processing, tracking, and storing data regarding domestic products, imported and exported products, and products in commerce. FSIS is developing a written, time-phase plan to complete Food Safety Assessments (FSAs) of all establishments. FSAs assess the design and validity of an establishment's hazard analysis, HACCP plan, Sanitation Standard Operating Procedures, prerequisite programs, and testing programs.

Evidence: USDA/OIG management challenges report dated August 1, 2007: http://www.usda.gov/oig/webdocs/MgmtChallenges2007.pdf; Memorandum to Charles R. Christopherson, Jr., USDA Chief Financial Officer, dated August 31, 2007, that provides the FSIS assertions to support the Secretary?s annual assurances for the FMFIA; FSIS small plant web page: www.fsis.usda.gov/Small_Very_Small_Plants/index.asp; Small Plant News editions www.fsis.usda.gov/News_&_Events/Small_Plant_News/index.asp; Compliance assistance materials and workshops shown at: www.fsis.usda.gov/Science/Small_Very_Small_Plant_Outreach/index.asp

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: Through the Advanced Notice of Proposed Rulemaking (ANPR), FSIS solicits comments regarding the Agency's intent to publish regulations on a specific topic. All comments are addressed within the preamble either as a group or individually in the proposed rule. The Docket Room is open to the public to review dockets. FSIS holds monthly conference calls with state representatives to discuss issues where their input and concerns are taken into account. FSIS has reaffirmed its pledge to be open and transparent. AskFSIS was established to further provide industry with the opportunity to seek clarification and have their views taken into account through the web. FSIS has expanded its comprehensive outreach effort to build consensus among large, small, and very small plants, the National Advisory Committee on Microbiological Criteria for Foods, Codex Alimentarius, and the National Advisory Committee on Meat and Poultry Inspection. FSIS conducts numerous public meetings and scientific symposia each year to maintain a dialogue with industry, academia, scientific, and consumer communities. The Agency also conducts separate monthly meetings with industry associations and consumer representatives. Recent public meetings have covered a wide variety of topics such as public health risk-based inspection, and the use of the term 'Natural' on labels. In addition, conferences are held with state governments in conjunction with other food safety agencies. However, FSIS has received criticism from small businesses that FSIS does not address their concerns during the regulatory review process. In addition, FSIS does not always adequately address industry and consumer groups comments and concerns.

Evidence: AskFSIS link: askfsis.custhelp.com/cgi-bin/askfsis.cfg/php/enduser/std_alp.php; All Advanced Notice of Proposed Rulemaking (ANPR)s and proposed rules: www.fsis.usda.gov/Regulations_&_Policies/2008_Notices_Index/index.asp; Docket Room is open to the public: U.S. Department of Agriculture, 1400 Independence Avenue, SW., Room 2534 South Building, Washington, DC 20250, between 8:30 a.m. and 4:30 p.m., Monday through Friday; FSIS FY 2008-2013 Strategic Plan; FSIS Strategic Implementation Plan for Strengthening Small and Very Small Plant Outreach, 2006-2007: www.fsis.usda.gov/PDF/SVSP_Strategic_Plan_FY06FY07.pdf

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: FSIS prepares regulatory impact analyses (RIAs), regulatory flexibility analyses, and cost-benefit analyses for all rules deemed significant as required by OMB guidelines. RIAs describe how the rulemaking maximizes net benefits. In addition, since 2005 FSIS RIAs have been subject to peer review by other government agencies like the FDA and USDA's Economic Research Service, and by state agencies. FSIS proposes rulemaking on a wide range of issues that affect food safety for consumers and the regulation of the 6,200 slaughter, food processing, and import establishments. For example, for a proposed rule on nutrition labeling, several alternatives were considered in detail during the regulatory impact analysis, including 1) continuing with the existing voluntary program, 2) making the voluntary program mandatory, 3) requiring nutrition information on labels of all ground or chopped products and making the voluntary program mandatory for the major cuts of single-ingredient, raw meat and poultry products, 4) requiring nutrition information on labels of the major cuts of single-ingredient, raw meat and poultry products and on all ground or chopped products, and 5) requiring nutrition information on labels of all single-ingredient, raw meat and poultry products and all ground or chopped products. While FSIS proposed option 3, the public was offered the opportunity to comment on all the options and the possible costs and benefits of the alternatives presented.

Evidence: All rules deemed significant must have a RIA. An example is the SRM rule: www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-025F.htm

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

Explanation: FSIS conducts evaluations to determine whether implemented regulations meet program goals. For example, FSIS contracted with the Research Triangle Institute (RTI) to conduct a multi-year evaluation of the final rule for HACCP systems. For all significant proposed rules, regulatory impact analyses are completed to determine whether the contemplated regulatory action maximizes overall net benefits. FSIS' regulatory impact analyses, particularly its analyses of benefit-cost and cost effectiveness, explain how the alternative selected in FSIS' rulemaking results in the highest overall net benefits as compared to other feasible alternatives that FSIS has evaluated. In promulgating its regulations, for a given level of benefits, FSIS allows alternative methods for compliance and recordkeeping to minimize the cost burden on regulated entities. FSIS' regulatory activity maximizes net benefits to the extent possible under the applicable statute.

Evidence: Food Standards: General Principles and Food Standards Modernization (May 20, 2005)- http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/92-024F.htm; Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle (Jan 12, 2004) - http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-025IF.htm

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

Explanation: FSIS has developed new measures so there are no comparisons of targets to actual results. However, data exists for this program reflecting some progress towards meeting long-term goals to reduce foodborne illness from Salmonella in broilers, Listeria monocytogenese in ready-to-eat meat, and E.coli O157:H7 in ground beef.

Evidence: Foodborne illness from Salmonella in broilers measure results, reflected by the rate of human salmonellosis cases from broilers per 100,000 people, show a reduction from 1.4 to 0.9 since 2004, though progress from 2004 through 2006 was flat. Foodborne illness from Listeria monocytogenese in ready-to-eat meat measure results, reflected by the rate of human listeriosis cases from ready-to-eat meat per 100,000 people, show a slight increase from 0.16 to 0.17 since 2004 and no change since 2000 (rate of 0.17). Foodborne illness from E.coli O157:H7 in ground beef measure results, reflected by the rate of human E.coli cases from ground beef per 100,000 people, show a slight decrease from 0.31 to 0.29 since 2004, though 2005 and 2006 were higher than 0.31 but the rate has been trending down since 2000.

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

Explanation: FSIS developed new measures so there is only one measure with one year of comparisons of targets to actual results. However, additional data exists for this program reflecting some progress towards meeting annual goals. Two years of data exists for all three measures reflecting a reduction in exposure to E.coli O157:H7 from 0.4% to 0.28%, an increase in the percentage of establishments in category 1 for Salmonella from 45% to 73%, and a decrease in exposure to Listeria monocytogenes from 0.33% to 0.29%. However, data from previous measures reflects varying results including no progress in reducing the percentage of positive test results for salmonella, except in recent years.

Evidence: The measure to reduce overall public exposure to generic Salmonella from broiler carcasses using existing scientific standards has targets and actuals for 2007 with 2006 being the baseline year. 2007 data shows a significant improvement over 2006 - an increase from 45% to 73%. The measure to decrease the overall percent-positive rate for Listeria monocytogenes in ready-to-eat products through the use of Food Safety Assessments has actuals for two years but no targets. The measure to reduce the overall public exposure of E.coli O157:H7 in ground beef has actuals for two years but no targets. However 2007 data reflects an improvement over 2006 for both Listeria monocytogenes and E.coli O157:H7. In addition, FSIS tracks the percentage of regulatory samples testing positive for Salmonella, Listeria monocytogenes, and E.coli O157:H7. However, data from these measures is inconclusive. Salmonella data reflect a slight increase since 2000 (8.7% in 2000 and 9.04% in 2007), though there has been a decline since the high of 16.9% in 2005. Volume weighted data also show a decrease since 2005. Listeria Monocytogenes data reflects a steady decline since 2000 (1.54% in 2000 and 0.37% in 2007). However, the volume weighted data reflects an increase since 2004 (0.12% in 2004 and 0.29% in 2007). E.coli O157:H7 data reflects a downward trend since 2000 (0.87% in 2000 and 0.2% in 2007). However, the volume weighted data reflects an increase since 2004 (0.04% in 2004 and 0.28% in 2007).

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

Explanation: FSIS has developed new efficiency measures to replace the old efficiency measure of total pounds inspected pre FTE. Results of the old measure show that the pounds inspected per FTE increased in every year. FSIS realigned a number of functions to save resources and improve program delivery. Consolidation of outreach and training activities provide easy access to information, technical assistance and answers to questions. This consolidation is estimated to annually save $517,000 in travel and lease costs. A reorganization of risk management, policy analysis, policy development, and policy issuances and training is estimated to annually save over $189,000. Transferring the international audit functions and associated resources is estimated to annually save over $95,000. In addition, FSIS has implemented new systems for its management controls. AssuranceNet, launched in 2006, is providing real-time data on program effectiveness and achievement of public health performance measures. A 2007 update increased the monitored performance measures from 50 to over 100. The system is being enhanced again in 2008 to include the In-Commerce System for compliance and investigations data entry and performance measures. Future planned enhancements are adding additional inspection measures, integrating a case management system and geographic mapping information, and adding measures for policy. FSIS has developed the first phase of the Enterprise Reporting System (ERS) to provide analysts and managers access to corporate data for making efficient and effective public health decisions. The development of the Public Health Information System under the Public Health Information Consolidation Project incorporates the replacement for the Domestic Inspection System, the replacement of the Automated Import Information System, the development of new functionality to support Domestic Inspection, Import Re-inspection, Export Certification, and Predictive Analytics, and also provides enhancements for the Consumer Complaint Monitoring System II that will allow state programs to share their public health data directly with the Agency.

Evidence: AssuranceNet, Statement of Dr. David Goldman, FSIS Acting Administrator, before the Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, www.fsis.usda.gov/PDF/Testimony_Goldman_041907.pdf - p.11-22; Enterprise Reporting System, Data Collection and Analysis at FSIS: Standard Operating Procedures, National Advisory Committee on Meat and Poultry Inspection, August 8-9, 2007, www.fsis.usda.gov/OPPDE/NACMPI/Aug2007/NACMPI_Issue_SOP.pdf - p. 4

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

Explanation: The performance of FSIS compares very favorably to state inspection programs, to FDA's food program, and to foreign food safety programs. In the case of state programs, FSIS has agreements with and audits 27 state inspection system to ensure that their programs are "at least equal to" the Federal inspection conducted in the other States. The FSIS Field Service Laboratories are accredited by the American Association of Laboratory Accreditation to perform microbiological, food chemistry and residue testing. FSIS has provided the state meat and poultry inspection programs with information and materials that will help them meet the requirements for accurate and timely laboratory testing of state inspected products. Therefore, the state programs look to the FSIS International Organization for Standardization (ISO) Management System as the gold standard to which their programs will be compared. To assure that FSIS laboratory testing data is accurate and timely, FSIS' laboratories are all ISO 17025 accredited, which requires regular independent outside audits that examine all laboratory procedures and requires well-documented laboratory practices and quality assurance procedures. This accreditation exceeds the requirements for most state laboratories. In addition, the FSIS laboratory system is a world leader for analytical accountability, having an extensive infrastructure for ensuring and documenting the accuracy of test results, and easily exceeding the requirements for most federal, state and international laboratories that conduct testing for foodborne hazards. Under international trade rules, as mandated by the World Trade Organization's Sanitary and Phytosanitary Agreement, FSIS' inspection program and the food regulatory programs of its trading partners must have "equivalent" food safety standards to trade meat and poultry products. FSIS currently recognizes 34 countries as having equivalent food safety and inspection programs. FSIS performs over 100,000 microbiological tests each year, which is more extensive than other federal and state regulatory testing programs for foodborne hazards. The targeted and extensive nature of these programs have resulted in dramatic decreases in the overall public exposure of foodborne pathogens in meat, poultry and processed egg products (e.g., approximate ten-fold decrease for percentage of Listeria monocytogenes-positive ready-to-eat products from early 1990s to the present, significant decreases for Salmonella in raw poultry and E. coli O157:H7 in raw beef products).

Evidence: ISO/IEC Standard 17025: www.fsis.usda.gov/Fact_Sheets/ISO_Accreditation/index.asp; FSIS Quality Manual; FSIS Field Service Laboratory Accreditation Certificates issued by the American Association of Laboratory Accreditation: a2la.org/dirsearchnew/newsearch/cfm; FMIA 21 U.S.C., Chapter 12, Section 301: www.fsis.usda.gov/Regulations_&_Policies/FMIA/index.asp; PPIA 21 U.S.C., Chapter 20, Section 5: www.fsis.usda.gov/Regulations_&_Policies/Poultry_Products_Inspection_Act/index.asp; EPIA 21 U.S.C., Chapter 15, Section 1034: www.fsis.usda.gov/Regulations_&_Policies/Egg_Products_Inspection_Act/index.asp; A list of agreements with States is available on the web page: www.fsis.usda.gov/Regulations_&_Policies/Listing_of_Participating_States/index.asp; FSIS' process for evaluating equivalence with foreign countries can be found at www.fsis.usda.gov/OPPDE/IPS/EQ/EQProcess.pdf.

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

Explanation: Independent evaluations performed by OIG and GAO provide multiple recommendations for program improvement. Eleven OIG reports from FY2006 to current included 82 recommendations. Since 2000, the OIG has made 313 recommendations to FSIS for revisiting its programs and policies and 238 have been closed. In addition, in FY2007 GAO added Federal oversight of food safety to the GAO High Risk List. Though none of these audits indicated that FSIS was not ensuring the safety of meat, poultry and processed egg products, the audits did indicate that improvements to the program could be made. For example, one audit found that FSIS had not integrated processed egg products into their overall management control structure after 12 years. In addition, another audit found that controls over Salmonella testing needed to be materially strengthened because the OIG found that a significant number of establishments were excluded from FSIS' sampling database. Multi-year evaluations completed by the Research Triangle Institute (RTI) on implementation of the final rule on HACCP systems provided independent findings on consumer confidence, food safety knowledge, the effects of HACCP on plant revenues, and the effects of the rule on exports of meat and poultry products. Results of the evaluations showed generally positive results for implementation of the rule. Based on the number of recommendations and the placement of food safety on the GAO High Risk List, significant credit for this question is not warranted.

Evidence: Federal Oversight of Food Safeyt GAO-07-785T and GAO-07-449T; OIG audits, including report numbers: 24601-07-Hy, 24601-0008-Ch, 24601-0007-Ch, 50601-11-HQ, and 50601-10-KC; HACCP-based Inspection Model Project (HIMP) Webpage: www.fsis.usda.gov/Science/HACCP_Based_Inspection_Models_Project/index.asp; The RTI PR/HACCP evaluation studies are not available on the Web, but are available upon request.

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

Explanation: FSIS does not appear to have a process or plan to routinely analyze the actual effects of all significant regulations or an established smaller subset. Limited data is available supporting completion of analyses and the results. FSIS does evaluate the effectiveness of regulations as required by Section 610 of the Regulatory Flexibility Act, however this Act does not require an analysis of net benefits. FSIS does analyze regulations on an ad hoc basis. For example, FSIS did have the HACCP regulation analyzed by RTI. RTI studied the impact of HACCP on foodborne illness, the hazard levels in meat and poultry, inspection effectiveness, the meat and poultry industry, and consumers. Data indicated that the FSIS program was effective and achieving results to a large extent. In addition, FSIS uses a data analysis project matrix to track information on projects that are being conducted by each program office of FSIS, who's responsible for the project, what reports are being generated, what directives or notices are related to the project, and the expected completion date. The net benefit findings typically meet or exceed the programs' original estimates. For example - with the LM RTE rule, FSIS has analyzed costs in anticipation of a final rule. These costs were higher than the original projections in the Interim Final Rule. However, the net benefits were higher than the original projections.

Evidence: FSIS, Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods, 2003: www.foodsafety.gov/~dms/lmr2-toc.html; CDC, Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food-10 States, 2006: www.cdc.gov/mmwr/preview/mmwrhtml/mm5614a4.htm?s_cid=mm5614a4_e; FSIS, Microbiological Testing Program for Ready-to-Eat (RTE) Meat and Poultry Products, 1990-2006: www.fsis.usda.gov/Science/Micro_Testing_RTE/index.asp#trends; Executive Order 12866 (amended by E.O. 13258 & E.O. 13422): www.gsa.gov/Portal/gsa/ep/contentView.do?pageTypeId=8199&channelId=-13339&P=PLAE&contentId=16921&contentType=GSA_BASIC; Office of Management and Budget Circular A-4: www.whitehouse.gov/OMB/circulars/a004/a-4.pdf; Office of Management and Budget Information Quality Act: www.whitehouse.gov/omb/fedreg/reproducible.html; FSIS Strategic Plan FY 2008-2013; FSIS Risk Assessment web page: www.fsis.usda.gov/Science/Risk_Assessments/index.asp