UNITED STATES DEPARTMENT OF AGRICULTURE
OFFICE OF INSPECTOR GENERAL
STATEMENT OF THE HONORABLE PHYLLIS K. FONG
INSPECTOR GENERAL
Before the
HOUSE APPROPRIATIONS SUBCOMMITTEE
ON
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION,
AND
RELATED AGENCIES
March 1, 2006
For release only by the House Committee on Appropriations
Good morning, Mr. Chairman and Members of the Subcommittee. I thank you for inviting me to testify before you today to discuss the activities of the Office of Inspector General (OIG) and to provide information about our oversight of the Department of Agriculture's (USDA) programs and operations.
I would like to introduce the members of the OIG senior management team who are here with me today: Kathy Tighe, our new Deputy Inspector General; Robert Young, Assistant Inspector General for Audit; Mark Woods, Assistant Inspector General for Investigations; and Suzanne Murrin, Assistant Inspector General for Policy Development and Resources Management.
I welcome this opportunity to provide the Subcommittee with an overview of the highlights of our audit and investigative activity over the past year. Fiscal Year 2005 presented many difficult challenges for the USDA and our country's agricultural producers and consumers. In addition to administering programs relied upon by farmers and rural communities and managing the $128 billion in public resources entrusted to the Department, USDA assumed significant responsibilities responding to the hurricanes that ravaged the Gulf Coast in 2005 and addressing the threat of plant and animal disease.
To best serve the Department, our Congressional oversight committees, and the general public, OIG has formally prioritized, organized, and planned our work according to three
2
central objectives. I will present my testimony to the Subcommittee according to the framework of these three objectives: supporting Safety, Security, and Public Health in USDA programs and operations; protecting Program Integrity as USDA provides assistance to individuals and entities; and improving the Department's Management of Public Resources.
I. Safety, Security, and Public Health
The BSE Surveillance Program and SRM Controls
We recently issued our second report focusing on the Department's efforts to establish and enforce effective, interlocking safeguards to protect producers and consumers from Bovine Spongiform Encephalopathy (BSE), commonly referred to as "mad cow disease." Our February 2006 report reviewed the Animal and Plant Health Inspection Service's (APHIS) implementation of its expanded BSE surveillance program and the Food Safety and Inspection Service's (FSIS) controls to prevent banned specified risk materials (SRM) from entering our Nation's food supply. We found that USDA made significant efforts to implement and improve the expanded surveillance program. The Department faced many challenges in a short period of time to establish the necessary processes, controls, and infrastructure needed for this massive effort. In our recent report, we discuss specific areas where we believe corrective actions were not fully effective in addressing our prior findings and recommendations on issues such as obtaining representative samples of the U.S. herd, identifying and obtaining samples from high-risk surveillance streams, and ensuring the completeness/accuracy of data. The Department
3
has responded to our report with immediate actions. For example, at the Secretary's direction, APHIS revised its testing protocols to provide for additional confirmatory procedures when inconclusive test results occur. Also, both APHIS and FSIS agreed with all OIG recommendations, and they have corrected, or have developed action plans to correct, the program weaknesses identified.
APHIS' Implementation of the Expanded Surveillance Plan
APHIS obtained significantly more samples for testing than it originally anticipated would be needed to achieve its stated level of confidence in estimating the prevalence of BSE in the U.S. herd. The voluntary nature of the surveillance program, however, makes it difficult to determine how successful USDA was in obtaining a representative proportion of high-risk cattle for testing. OIG found that APHIS' various statistical approaches to determining the prevalence of BSE mitigate some, but not all, of the limitations associated with its data and the agency's underlying assumptions in the design and implementation of its surveillance program. The accuracy of the underlying data is critical to the development of a future maintenance surveillance program. We recommended that APHIS disclose the limitations in its surveillance program and underlying data when it makes its final assessment of the prevalence of BSE in the U.S.
We also found that USDA needed to strengthen its processes to ensure the quality and capability of its BSE testing program, especially when inconclusive test results occur. We recommended that USDA re-evaluate and adjust its testing protocols based on its
4
evaluation of emerging science and strengthen its proficiency testing and quality assurance reviews at participating laboratories.
Evaluation of FSIS Processes Regarding SRMs
To examine FSIS' inspection procedures to enforce regulations to prevent risk materials in meat products, OIG reviewed the SRM plans of several meat processing facilities, observed FSIS inspections, and evaluated the effectiveness of controls during the slaughter process. FSIS technical experts assisted us in these reviews. We did not identify SRMs entering the food supply during our plant visits. However, we could not determine whether required SRM procedures were followed or were adequate due to the lack of specificity in the plans. We found that the plants lacked documentation of compliance with SRM control procedures and FSIS actions to validate such compliance.
In addition to the control issues we identified regarding SRM procedures at slaughter and processing establishments, we found that FSIS' information system could not readily provide FSIS with the data it needed to identify trends in SRM violations.
The expanded stage of USDA's BSE surveillance program is now nearing its end. Accordingly, it is important that the issues we have raised be considered as USDA completes its BSE surveillance program and reports on the prevalence of BSE in the U.S. herd. The Department has responded to our report with immediate action and agreed to address all of our findings and recommendations.
5
Assessing USDA Controls for Beef Exported to Japan
On January 20, 2006, Japanese officials announced that they had banned any further imports of beef products from the United States, based on the discovery that a U.S. plant had shipped a veal product containing vertebral column material that was prohibited by the terms of an agreement with Japan. On the same date, in response to Japan's decision, the Secretary announced 12 actions USDA would undertake to facilitate resuming trade. These actions include delisting and investigating the plant that exported the ineligible product, requiring a second signature on export certificates, providing training to inspection personnel on export certification, and holding meetings with inspection officials and industry representatives to reaffirm program requirements. Shortly thereafter, the Secretary requested OIG to audit the adequacy of USDA's coordination and control processes for the Beef Export Verification (BEV) program for Japan.
OIG's report, issued on February 16, 2006, concluded that the Agricultural Marketing Service (AMS) and FSIS could strengthen their controls over the BEV program by improving processes used to communicate BEV program requirements, clearly defining roles and responsibilities, and implementing additional oversight of FSIS inspection personnel. In response to our recommendations, the agencies agreed to an array of actions. AMS agreed to maintain a list of specific, export-eligible products for each facility with an approved BEV program; to systematically notify FSIS when any establishment is approved/delisted from a BEV program; and to review all establishments in the BEV program to ensure that they adhere to program requirements. FSIS agreed to
6
clarify the roles and responsibilities of FSIS personnel involved at each stage of the export verification process; expedite the development of export certification training; and increase supervisory oversight of the export certification process. OIG believes that the full implementation of these measures will strengthen and improve the Department's compliance with BEV program requirements.
Assessment of the Equivalence of the Canadian Beef Inspection System
Last year, my testimony discussed OIG's findings from our audit of APHIS' oversight of the importation of beef products from Canada. Our work on that audit led us to conduct an evaluation of FSIS' assessment of the equivalence of the Canadian food safety inspection system, which we issued in December 2005.
The then FSIS Administrator and the Under Secretary for Food Safety had identified concerns with the Canadian inspection system in late 2003. Our audit determined that FSIS did not fully address the issues raised by USDA officials in a timely manner. For example, in July 2003 FSIS found that Canadian inspection officials were not enforcing certain pathogen reduction and HACCP system regulations. These same types of concerns were identified again in June 2005.
At the time of our audit, FSIS did not have protocols for evaluating deficiencies in a foreign country's inspection system which could be used to question the system's equivalence to U.S. standards. In addition, FSIS had not instituted compensating controls (such as increased port-of-entry testing) to strengthen public health protections while
7
deficiencies were present. During the period of January 2003–May 2005, 4.4 billion pounds of Canadian processed product entered the U.S., even though FSIS officials questioned the equivalence of the Canadian inspection system.
FSIS agreed with OIG's five recommendations, which included implementing protocols to determine which deficiencies would lead FSIS to question whether a foreign country's inspection system is equivalent to the U.S. system. In response to the report, FSIS committed to develop these protocols by March 2006 and to implement them immediately thereafter.
Oversight of FSIS Recalls
For the past several years we have testified about our continuing work regarding adulterated beef product recalls. In July 2004, a Pennsylvania firm initiated a recall of approximately 170,000 pounds of ground beef patties because of mislabeling. Approximately one-fourth of this product was made, in part, from beef trim from Canada which was not eligible for import to the U.S., following the detection of a Canadian cow with BSE. In May 2005, we reported on the adequacy of FSIS' effectiveness checks and the agency's oversight of the recall. Overall, we concluded that FSIS had strengthened its procedures regarding the agency's oversight of recalls. However, we noted that FSIS personnel did not determine the amount of product purchased by firms on 26 of the 58 completed effectiveness checks. This resulted in reduced assurance that mislabeled product was completely retrieved from distribution. Agency officials concurred with the firms' assertions that the product had been removed from the marketplace. In response to
8
our recommendations, FSIS agreed to provide more specific direction to its personnel on identifying and evaluating the amount of product purchased.
The Subcommittee has been interested in OIG's investigation of a Pennsylvania company's recall of meat products. This remains an ongoing civil fraud investigation and we will be pleased to provide information on its resolution to the Subcommittee upon its conclusion.
snip...
III. Management of USDA's Public Resources
GIPSA's Management and Oversight of the Packers and Stockyards Programs (P&SP)
The Grain Inspection, Packers and Stockyards Administration (GIPSA) has regulatory authority within USDA to ensure a productive and competitive global marketplace for agricultural products such as livestock and poultry. In response to a Congressional
26
request in April 2005, we initiated an audit to evaluate GIPSA's management and oversight of P&SP to ensure anti-competitive and unfair practices in the livestock and poultry markets were accurately and effectively examined, reported, and resolved.
We concluded that GIPSA had not established an adequate control structure and environment to oversee and manage its investigative activities for P&SP. We found that P&SP had difficulties defining and tracking investigations, planning and conducting anti-competitive investigations, and making agency policy. Also, GIPSA did not fully implement agreed upon corrective actions in response to prior OIG and GAO findings. For example, P&SP did not effectively integrate economists into its investigations.
GIPSA agreed with the report's 10 recommendations. Based on its written response, the agency has completed corrective action on four recommendations and is working to complete actions on the remaining ones by September 2006. The new leadership at GIPSA has committed to take significant corrective actions to address the issues identified in OIG's report.
Implementing Research Misconduct Policies in USDA Agencies
In December 2000, the Executive Office of the President, Office of Science and Technology Policy (OSTP), issued the Federal Policy on Research Misconduct to govern all federally funded research and proposals submitted for research funding. OSTP allowed Federal agencies 1 year to implement the Government-wide policy, which included requirements to establish sound processes for identifying, adjudicating, and
27
taking potential administrative actions against research misconduct. In light of USDA's large investment in research – $2.1 billion in FY 2004 – OIG assessed the Department's compliance with OSTP's policy.
In our report issued on March 31, 2005, we determined that the Department had not implemented OSTP's requirements. Except for the Forest Service, USDA agencies were operating under a patchwork of policies. Seven USDA agencies with FY 2004 research appropriations totaling an estimated $733 million did not have official research misconduct policies. Some USDA agencies had not issued policies applicable to extramural research misconduct.
The Department generally concurred with our recommendations and agreed that a centralized oversight body for research misconduct within USDA would be established in the Office of the Undersecretary for Research, Education, and Economics. In December 2005, USDA provided OIG with information describing administrative measures which, if implemented, would substantially address our concerns.
snip...
http://appropriations.house.gov/_files/FongTestimony.pdf
TSS
OFFICE OF INSPECTOR GENERAL
STATEMENT OF THE HONORABLE PHYLLIS K. FONG
INSPECTOR GENERAL
Before the
HOUSE APPROPRIATIONS SUBCOMMITTEE
ON
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION,
AND
RELATED AGENCIES
March 1, 2006
For release only by the House Committee on Appropriations
Good morning, Mr. Chairman and Members of the Subcommittee. I thank you for inviting me to testify before you today to discuss the activities of the Office of Inspector General (OIG) and to provide information about our oversight of the Department of Agriculture's (USDA) programs and operations.
I would like to introduce the members of the OIG senior management team who are here with me today: Kathy Tighe, our new Deputy Inspector General; Robert Young, Assistant Inspector General for Audit; Mark Woods, Assistant Inspector General for Investigations; and Suzanne Murrin, Assistant Inspector General for Policy Development and Resources Management.
I welcome this opportunity to provide the Subcommittee with an overview of the highlights of our audit and investigative activity over the past year. Fiscal Year 2005 presented many difficult challenges for the USDA and our country's agricultural producers and consumers. In addition to administering programs relied upon by farmers and rural communities and managing the $128 billion in public resources entrusted to the Department, USDA assumed significant responsibilities responding to the hurricanes that ravaged the Gulf Coast in 2005 and addressing the threat of plant and animal disease.
To best serve the Department, our Congressional oversight committees, and the general public, OIG has formally prioritized, organized, and planned our work according to three
2
central objectives. I will present my testimony to the Subcommittee according to the framework of these three objectives: supporting Safety, Security, and Public Health in USDA programs and operations; protecting Program Integrity as USDA provides assistance to individuals and entities; and improving the Department's Management of Public Resources.
I. Safety, Security, and Public Health
The BSE Surveillance Program and SRM Controls
We recently issued our second report focusing on the Department's efforts to establish and enforce effective, interlocking safeguards to protect producers and consumers from Bovine Spongiform Encephalopathy (BSE), commonly referred to as "mad cow disease." Our February 2006 report reviewed the Animal and Plant Health Inspection Service's (APHIS) implementation of its expanded BSE surveillance program and the Food Safety and Inspection Service's (FSIS) controls to prevent banned specified risk materials (SRM) from entering our Nation's food supply. We found that USDA made significant efforts to implement and improve the expanded surveillance program. The Department faced many challenges in a short period of time to establish the necessary processes, controls, and infrastructure needed for this massive effort. In our recent report, we discuss specific areas where we believe corrective actions were not fully effective in addressing our prior findings and recommendations on issues such as obtaining representative samples of the U.S. herd, identifying and obtaining samples from high-risk surveillance streams, and ensuring the completeness/accuracy of data. The Department
3
has responded to our report with immediate actions. For example, at the Secretary's direction, APHIS revised its testing protocols to provide for additional confirmatory procedures when inconclusive test results occur. Also, both APHIS and FSIS agreed with all OIG recommendations, and they have corrected, or have developed action plans to correct, the program weaknesses identified.
APHIS' Implementation of the Expanded Surveillance Plan
APHIS obtained significantly more samples for testing than it originally anticipated would be needed to achieve its stated level of confidence in estimating the prevalence of BSE in the U.S. herd. The voluntary nature of the surveillance program, however, makes it difficult to determine how successful USDA was in obtaining a representative proportion of high-risk cattle for testing. OIG found that APHIS' various statistical approaches to determining the prevalence of BSE mitigate some, but not all, of the limitations associated with its data and the agency's underlying assumptions in the design and implementation of its surveillance program. The accuracy of the underlying data is critical to the development of a future maintenance surveillance program. We recommended that APHIS disclose the limitations in its surveillance program and underlying data when it makes its final assessment of the prevalence of BSE in the U.S.
We also found that USDA needed to strengthen its processes to ensure the quality and capability of its BSE testing program, especially when inconclusive test results occur. We recommended that USDA re-evaluate and adjust its testing protocols based on its
4
evaluation of emerging science and strengthen its proficiency testing and quality assurance reviews at participating laboratories.
Evaluation of FSIS Processes Regarding SRMs
To examine FSIS' inspection procedures to enforce regulations to prevent risk materials in meat products, OIG reviewed the SRM plans of several meat processing facilities, observed FSIS inspections, and evaluated the effectiveness of controls during the slaughter process. FSIS technical experts assisted us in these reviews. We did not identify SRMs entering the food supply during our plant visits. However, we could not determine whether required SRM procedures were followed or were adequate due to the lack of specificity in the plans. We found that the plants lacked documentation of compliance with SRM control procedures and FSIS actions to validate such compliance.
In addition to the control issues we identified regarding SRM procedures at slaughter and processing establishments, we found that FSIS' information system could not readily provide FSIS with the data it needed to identify trends in SRM violations.
The expanded stage of USDA's BSE surveillance program is now nearing its end. Accordingly, it is important that the issues we have raised be considered as USDA completes its BSE surveillance program and reports on the prevalence of BSE in the U.S. herd. The Department has responded to our report with immediate action and agreed to address all of our findings and recommendations.
5
Assessing USDA Controls for Beef Exported to Japan
On January 20, 2006, Japanese officials announced that they had banned any further imports of beef products from the United States, based on the discovery that a U.S. plant had shipped a veal product containing vertebral column material that was prohibited by the terms of an agreement with Japan. On the same date, in response to Japan's decision, the Secretary announced 12 actions USDA would undertake to facilitate resuming trade. These actions include delisting and investigating the plant that exported the ineligible product, requiring a second signature on export certificates, providing training to inspection personnel on export certification, and holding meetings with inspection officials and industry representatives to reaffirm program requirements. Shortly thereafter, the Secretary requested OIG to audit the adequacy of USDA's coordination and control processes for the Beef Export Verification (BEV) program for Japan.
OIG's report, issued on February 16, 2006, concluded that the Agricultural Marketing Service (AMS) and FSIS could strengthen their controls over the BEV program by improving processes used to communicate BEV program requirements, clearly defining roles and responsibilities, and implementing additional oversight of FSIS inspection personnel. In response to our recommendations, the agencies agreed to an array of actions. AMS agreed to maintain a list of specific, export-eligible products for each facility with an approved BEV program; to systematically notify FSIS when any establishment is approved/delisted from a BEV program; and to review all establishments in the BEV program to ensure that they adhere to program requirements. FSIS agreed to
6
clarify the roles and responsibilities of FSIS personnel involved at each stage of the export verification process; expedite the development of export certification training; and increase supervisory oversight of the export certification process. OIG believes that the full implementation of these measures will strengthen and improve the Department's compliance with BEV program requirements.
Assessment of the Equivalence of the Canadian Beef Inspection System
Last year, my testimony discussed OIG's findings from our audit of APHIS' oversight of the importation of beef products from Canada. Our work on that audit led us to conduct an evaluation of FSIS' assessment of the equivalence of the Canadian food safety inspection system, which we issued in December 2005.
The then FSIS Administrator and the Under Secretary for Food Safety had identified concerns with the Canadian inspection system in late 2003. Our audit determined that FSIS did not fully address the issues raised by USDA officials in a timely manner. For example, in July 2003 FSIS found that Canadian inspection officials were not enforcing certain pathogen reduction and HACCP system regulations. These same types of concerns were identified again in June 2005.
At the time of our audit, FSIS did not have protocols for evaluating deficiencies in a foreign country's inspection system which could be used to question the system's equivalence to U.S. standards. In addition, FSIS had not instituted compensating controls (such as increased port-of-entry testing) to strengthen public health protections while
7
deficiencies were present. During the period of January 2003–May 2005, 4.4 billion pounds of Canadian processed product entered the U.S., even though FSIS officials questioned the equivalence of the Canadian inspection system.
FSIS agreed with OIG's five recommendations, which included implementing protocols to determine which deficiencies would lead FSIS to question whether a foreign country's inspection system is equivalent to the U.S. system. In response to the report, FSIS committed to develop these protocols by March 2006 and to implement them immediately thereafter.
Oversight of FSIS Recalls
For the past several years we have testified about our continuing work regarding adulterated beef product recalls. In July 2004, a Pennsylvania firm initiated a recall of approximately 170,000 pounds of ground beef patties because of mislabeling. Approximately one-fourth of this product was made, in part, from beef trim from Canada which was not eligible for import to the U.S., following the detection of a Canadian cow with BSE. In May 2005, we reported on the adequacy of FSIS' effectiveness checks and the agency's oversight of the recall. Overall, we concluded that FSIS had strengthened its procedures regarding the agency's oversight of recalls. However, we noted that FSIS personnel did not determine the amount of product purchased by firms on 26 of the 58 completed effectiveness checks. This resulted in reduced assurance that mislabeled product was completely retrieved from distribution. Agency officials concurred with the firms' assertions that the product had been removed from the marketplace. In response to
8
our recommendations, FSIS agreed to provide more specific direction to its personnel on identifying and evaluating the amount of product purchased.
The Subcommittee has been interested in OIG's investigation of a Pennsylvania company's recall of meat products. This remains an ongoing civil fraud investigation and we will be pleased to provide information on its resolution to the Subcommittee upon its conclusion.
snip...
III. Management of USDA's Public Resources
GIPSA's Management and Oversight of the Packers and Stockyards Programs (P&SP)
The Grain Inspection, Packers and Stockyards Administration (GIPSA) has regulatory authority within USDA to ensure a productive and competitive global marketplace for agricultural products such as livestock and poultry. In response to a Congressional
26
request in April 2005, we initiated an audit to evaluate GIPSA's management and oversight of P&SP to ensure anti-competitive and unfair practices in the livestock and poultry markets were accurately and effectively examined, reported, and resolved.
We concluded that GIPSA had not established an adequate control structure and environment to oversee and manage its investigative activities for P&SP. We found that P&SP had difficulties defining and tracking investigations, planning and conducting anti-competitive investigations, and making agency policy. Also, GIPSA did not fully implement agreed upon corrective actions in response to prior OIG and GAO findings. For example, P&SP did not effectively integrate economists into its investigations.
GIPSA agreed with the report's 10 recommendations. Based on its written response, the agency has completed corrective action on four recommendations and is working to complete actions on the remaining ones by September 2006. The new leadership at GIPSA has committed to take significant corrective actions to address the issues identified in OIG's report.
Implementing Research Misconduct Policies in USDA Agencies
In December 2000, the Executive Office of the President, Office of Science and Technology Policy (OSTP), issued the Federal Policy on Research Misconduct to govern all federally funded research and proposals submitted for research funding. OSTP allowed Federal agencies 1 year to implement the Government-wide policy, which included requirements to establish sound processes for identifying, adjudicating, and
27
taking potential administrative actions against research misconduct. In light of USDA's large investment in research – $2.1 billion in FY 2004 – OIG assessed the Department's compliance with OSTP's policy.
In our report issued on March 31, 2005, we determined that the Department had not implemented OSTP's requirements. Except for the Forest Service, USDA agencies were operating under a patchwork of policies. Seven USDA agencies with FY 2004 research appropriations totaling an estimated $733 million did not have official research misconduct policies. Some USDA agencies had not issued policies applicable to extramural research misconduct.
The Department generally concurred with our recommendations and agreed that a centralized oversight body for research misconduct within USDA would be established in the Office of the Undersecretary for Research, Education, and Economics. In December 2005, USDA provided OIG with information describing administrative measures which, if implemented, would substantially address our concerns.
snip...
http://appropriations.house.gov/_files/FongTestimony.pdf
TSS
