type: other

jurisdiction: US

text: b' U.S. Department of Agriculture\n\n Office of Inspector General\n Midwest Region\n\n\n\n\n Audit Report\n Review of Pathogen Reduction\nEnforcement Program Sampling Procedures\n\n\n\n\n Report No. 24601- 0007-Ch\n September 2006\n\x0c UNITED STATES DEPARTMENT OF AGRICULTURE\n OFFICE OF INSPECTOR GENERAL\n\n Washington D.C. 20250\n\n\n\n\nDATE: September 28, 2006\n\nREPLY TO\nATTN OF: 24601-0007-Ch\n\nTO: Barbara J. Masters, D.V.M\n Administrator\n Food Safety and Inspection Service\n\nATTN: William C. Smith\n Assistant Administrator\n Office of Program Evaluation, Enforcement and Review\n\nFROM: Robert W. Young /s/\n Assistant Inspector General\n for Audit\n\nSUBJECT: Review of Pathogen Reduction Enforcement Program Sampling Procedures\n\n\nThis report presents the results of our audit of the Food Safety and Inspection Service\xe2\x80\x99s (FSIS)\npathogen reduction efforts. Our audit evaluated the effectiveness of FSIS\xe2\x80\x99 process for scheduling\nand conducting microbiological testing of meat and poultry products.\n\nThe FSIS response to the official draft report is included in exhibit D with excerpts and the\nOffice of Inspector General\xe2\x80\x99s position incorporated into the Findings and Recommendations\nsections of the report. Based on the response, we have reached management decisions on\nRecommendations 1, 2, 3, 4 and 6. Please follow your agency\xe2\x80\x99s internal procedures in\nforwarding documentation for final action to the Office of the Chief Financial Officer.\n\nManagement decision has not been reached for Recommendation 5. Management decision can\nbe reached on this recommendation once you have provided the additional information outlined\nin the report section, OIG Position.\n\nIn accordance with Departmental Regulation 1720-1, please provide a reply within 60 days\ndescribing the corrective action taken and planned, including timeframes for their\nimplementation. Please note that the regulation requires that management decisions be reached\non all recommendations within a maximum of 6 months from report issuance.\n\nWe appreciate the courtesies and cooperation extended to the auditors by your staff during the\naudit.\n\nAttachment\n\x0cExecutive Summary\nReview of Pathogen Reduction Enforcement Program Sampling Procedures\n(Audit Report No. 24601-0007-Ch)\n\nResults in Brief The Pathogen Reduction Enforcement Program (PREP) is a database and\n monitoring system maintained by FSIS\xe2\x80\x99 Office of Public Health and Science\n (OPHS). The system is used to support FSIS\xe2\x80\x99 pathogen reduction efforts by\n scheduling microbiological product sampling at FSIS-inspected meat and\n poultry establishments, and generating automated reports that allow FSIS\n managers to monitor both the sampling process and the results of laboratory\n tests. PREP supports the science-based Hazard Analysis and Critical Control\n Point (HACCP) system as a tool for preventing and controlling\n contamination through Salmonella testing. In addition, it is used to identify\n selected products for testing of the adulterants E. coli O157:H7 and Listeria\n monocytogenes. The PREP system became operational in 2001, and has been\n a valuable tool in FSIS\xe2\x80\x99 pathogen reduction efforts.\n\n We found that in the testing programs for the adulterants E. coli 0157:H7 and\n Listeria monocytogenes, FSIS had developed procedures to transfer\n establishment data from the Performance Based Inspection System (PBIS)1 to\n PREP (two separate systems), and was selecting the identified establishments\n for testing within reasonable timeframes. However, we found that controls\n still need to be materially strengthened within the Salmonella testing program\n to ensure that all establishments are included as required in microbiological\n testing programs. We found a significant number of establishments that were\n excluded from the Salmonella sampling database because of ineffective\n controls to identify eligible establishments and also because district office\n personnel did not fully understand the process for including the\n establishments in the database. At the district we visited, 28 percent of the\n establishments that should have been subject to Salmonella testing were\n excluded from the sampling database. This problem was particularly\n apparent at establishments inspected under Federal-State Cooperative\n Programs (Talmadge-Aiken establishments) in the one State we visited. The\n State supervisors responsible for program oversight at these establishments\n were not provided with the eligibility reports that could have allowed them to\n identify establishments that needed to be included in the sampling database.\n\n\n\n\n1\n \xe2\x80\x9cThe Performance Based Inspection System (PBIS) was implemented in 1989 to provide a method of scheduling inspection tasks and recording their\n results. Each establishment has a PBIS establishment profile, maintained by the FSIS inspector, which identifies the species slaughtered and/or\n processed as well as other key data pertaining to the establishment.\xe2\x80\x9d\n USDA/OIG-A/24601-0007-Ch Page i\n\x0c Although the 2002 ConAgra recall highlighted the risks of exempting\n establishments from microbiological testing by FSIS field laboratories, we\n noted that some establishments continue to be excluded from product testing.\n Specifically, we found that because of the time needed to collect and test the\n required number of samples to complete a sampling set under the PR/HACCP\n Salmonella testing program, establishments whose slaughter or processing\n activity falls below a specific threshold are not subject to product testing.\n Likewise, establishments that produce non-intact beef products that do not\n meet the standard of identity of Section 9, Code of Federal Regulations\n (CFR) 319.15 (a), (b), or (c) such as raw ground beef sausages and meatballs,\n are excluded from testing. Agency officials stated that their policy was based\n on their assessment of the risk factors involved in different types of ground\n beef products, including the expectation that consumers are more likely to\n fully cook these products than tested products such as bulk ground beef and\n hamburger patties. However, the agency could not provide documentation to\n support these determinations. As a result, there is a reduced level of\n assurance that products from establishments which produce such products\n will be free of this pathogen.\n\nRecommendations\nIn Brief We recommended that FSIS strengthen its procedures to ensure that all\n establishments subject to Salmonella testing are identified. In addition, we\n recommended that modifications be made to the PBIS to allow PREP to draw\n establishment information directly from that system rather than depending on\n manual updates. We also recommended that FSIS develop a risk assessment\n to support its policy for excluding low-volume establishments from\n Salmonella testing or conduct testing in all plants, and that the agency obtain\n scientific advice to evaluate whether its policy of not testing certain raw\n ground beef products for E. coli O157:H7 contamination should be\n continued.\n\nAgency Response In their response dated September 26, 2006, FSIS officials generally agreed\n with the findings and recommendations contained in this report. We have\n incorporated applicable portions of FSIS\xe2\x80\x99 response, along with our position,\n in the Findings and Recommendations section of this report. The agency\xe2\x80\x99s\n response is included in its entirety as exhibit D of the report.\n\nOIG Position We agree with FSIS officials\xe2\x80\x99 response to the recommendations and have\n reached management decisions on Recommendations 1, 2, 3, 4, and 6.\n Management decision has not been reached for Recommendation 5.\n Management decision can be reached on this recommendation once we\n receive the information specified in the OIG Position section for this\n recommendation.\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page ii\n\x0cAbbreviations Used in This Report\n\nAMR Advanced Meat Recovery (Systems)\neADRS Electronic Animal Disposition Reporting System\nE. coli O157:H7 Escherichia coli O157:H7\nFSIS Food Safety and Inspection Service\nHACCP Hazard Analysis and Critical Control Point (System)\nIPPS In-Plant Performance System\nIT Information Technology\nOFO Office of Field Operations\nOPHS Office of Public Health and Science\nOPPED Office of Policy, Program and Employee Development\nPBIS Performance Based Inspection System\nPREP Pathogen Reduction Enforcement Program\nPR/HACCP Pathogen Reduction/Hazard Analysis and Critical Control Point (System)\nRTE Ready-to-Eat\n\n\n\n\n USDA/OIG-A/24601-0007-Ch Page iii\n\x0cTable of Contents\nExecutive Summary .................................................................................................................................i\n\nAbbreviations Used in This Report ......................................................................................................iii\n\nBackground and Objectives ................................................................................................................... 1\n\nFindings and Recommendations............................................................................................................ 4\n\n Section 1. Microbiological Testing Programs Do Not Include All Required Establishments..... 4\n\n Finding 1 Salmonella Testing Frame Significantly Understated............................................. 5\n Recommendation 1 .......................................................................................... 8\n Recommendation 2 .......................................................................................... 8\n Recommendation 3 .......................................................................................... 9\n Finding 2 In At Least One District, Talmadge-Aiken Establishments Were Excluded\n From PR/HACCP Salmonella Sampling............................................................... 10\n Recommendation 4 ........................................................................................ 11\n\n Section 2. Some Establishments and Products Are Excluded From FSIS Microbiological\n Testing ....................................................................................................................... 13\n\n Finding 3 FSIS Excludes Small and Low-Volume Establishments From Its Salmonella\n Testing Program .................................................................................................... 13\n Recommendation 5 ........................................................................................ 15\n Finding 4 Some Raw Ground Beef Products Are Excluded From E. coli O157:H7\n Testing................................................................................................................... 16\n Recommendation 6 ........................................................................................ 18\n\nScope and Methodology........................................................................................................................ 19\n\nExhibit A \xe2\x80\x93 Nationwide List of Establishments Potentially Excluded from PR/HACCP\n Salmonella Sampling Frame........................................................................................... 20\nExhibit B \xe2\x80\x93 District 50 Establishments Not Included In PR/HACCP Salmonella Sampling\n Frame................................................................................................................................ 21\nExhibit C \xe2\x80\x93 Potentially Eligible Establishments Not Included in Nationwide HACCP\n (HC01) Sampling Frame (Excluding District 50)......................................................... 22\nExhibit D \xe2\x80\x93 Agency Response to the Draft Report ............................................................................ 23\n\n\n\n\n USDA/OIG-A/24601-0007-Ch Page iv\n\x0cBackground and Objectives\nBackground The Food Safety and Inspection Service (FSIS) was established by the\n Secretary of Agriculture on June 17, 1981, to ensure that the Nation\xe2\x80\x99s\n commercial supply of meat, poultry, and egg products is safe, wholesome,\n and correctly labeled and packaged. Over 7,600 full-time FSIS inspectors\n monitor the slaughter and processing of meat and poultry products at\n approximately 6,000 establishments nationwide. FSIS inspectors take\n microbiological samples for the various testing programs based on\n instructions from FSIS\xe2\x80\x99 Office of Public Health and Science (OPHS), which\n manages the various testing programs within FSIS.\n\n In 1996, FSIS issued its landmark rule, Pathogen Reduction: Hazard Analysis\n and Critical Control Point (HACCP) System, which replaced the old method\n of inspection with a system based on science and laboratory diagnostics. The\n new science-based system was designed to improve food safety and make\n better use of agency resources. In addition, the final rule established\n pathogen reduction performance standards for Salmonella in raw meat and\n poultry products. To improve the effectiveness and efficiency of the\n laboratory testing programs, FSIS instituted the Pathogen Reduction\n Enforcement Program (PREP) system in 2001. The PREP system contains\n databases which record key information on all meat and poultry\n establishments subject to product testing under three different programs.\n\n \xe2\x80\xa2 The PR/HACCP Salmonella program supports the HACCP system by\n testing products for the presence of Salmonella. Salmonella was selected\n because it can be detected with modern microbiology techniques and is\n present in varying degrees in all major species. In addition, the health and\n safety concerns stemming from Salmonella contamination in products\n marketed to consumers have become of increasing concern to both the\n Department and the public. This testing is performed on all products for\n which Salmonella testing standards have been developed and incorporated\n into the regulations. These include both slaughtered and processed beef\n and chicken. In addition, there are standards for slaughtered swine and\n processed turkey. Product testing for Salmonella is performed in \xe2\x80\x9csets\xe2\x80\x9d of\n between 51 and 82 2 individual sample tests. As of November 2005, the\n PREP system recorded 1,481 establishments nationwide whose products\n were subject to Salmonella testing. In 2005 FSIS field laboratories tested\n 40,714 initial samples for Salmonella, with additional testing performed\n in cases where followup was required.\n\n \xe2\x80\xa2 The MT03 program tests raw ground beef products for the presence of the\n pathogen E. coli O157:H7. Since this pathogen is classed as an adulterant\n\n2\n 9 CFR 381.94 (b) (1), 9 CFR 310.25 (b) (1)\nUSDA/OIG-A/24601-0007-Ch Page 1\n\x0c and can cause serious illness or death if ingested with inadequately\n cooked product, a single confirmed positive test result is sufficient to\n warrant immediate action by FSIS, including the prompt recall of any\n product believed to be contaminated. For this testing program, the PREP\n system draws its \xe2\x80\x9csampling frame\xe2\x80\x9d of eligible establishments directly\n from the plant profiles which individual establishment inspectors maintain\n as part of the Performance-Based Inspection System (PBIS). As of\n February 2006, there were 1,653 establishments nationwide that were\n subject to E. coli O157:H7 testing, and during 2005 the field laboratories\n performed 10,976 tests.\n\n \xe2\x80\xa2 The Ready-To-Eat (RTE) sampling program tests processed meat and\n poultry products that can be eaten as-is by consumers without additional\n cooking. This testing program looks for the presence of Listeria\n monocytogenes, a dangerous pathogen which like E. coli O157:H7 is\n classified as an adulterant in meat and poultry products. Like the\n MT03 sampling frame, the RTE sampling frame is drawn directly from\n the PBIS Plant Profiles, which are electronically updated into PREP on a\n monthly basis. In February 2006, there were 2,434 establishments in the\n RTE sampling frame, and the agency performed 16,000 laboratory tests\n for Listeria monocytogenes in 2005.\n\n In addition to scheduling product tests, PREP also maintains information on\n test results and the disposition of product sampling requests. The system\n generates a number of standard reports that are provided to the district offices\n on a periodic basis to allow them to monitor various aspects of the testing\n programs. These reports include the Salmonella Performance Standards\n Testing Eligibility Report, which districts use to ensure the completeness of\n the manually-updated PR/HACCP Salmonella sampling frame, and the Non-\n Responder Report which lists establishments where FSIS inspectors have\n failed to respond to requests for product samples. The system also tracks\n other information, such as the last date that a particular establishment was\n scheduled for product testing or actually had a sample analyzed. Although\n not generated in report format on a routine basis, this information can be\n accessed through ad hoc reports by trained personnel such as those in FSIS\xe2\x80\x99\n Data Systems Management Division.\n\n Prior OIG audits, 3 performed before the PREP system became operational,\n disclosed that sampling frames were incomplete, and that as a result not all\n eligible establishments were in fact subject to testing. In addition, our earlier\n audit work disclosed that FSIS did not track instances in which FSIS\n establishment inspectors failed to respond to OPHS requests for product\n samples to be tested for Salmonella, E. coli O157:H7, or Listeria\n\n3\n Audit Report Nos. 24601-0001-CH, \xe2\x80\x9cLaboratory Testing of Meat and Poultry Products,\xe2\x80\x9d June 2000; and 24001-0004-AT, \xe2\x80\x9cFollowup Audit on the\n Inspector General\xe2\x80\x99s Food Safety Initiative of Fiscal Year 2000,\xe2\x80\x9d September 2004\nUSDA/OIG-A/24601-0007-Ch Page 2\n\x0c monocytogenes. In their responses to our earlier recommendations in this\n area, FSIS officials cited the PREP system as a major component in\n addressing the reported deficiencies.\n\nObjectives The objective of this audit was to evaluate the effectiveness of FSIS\xe2\x80\x99 process\n for scheduling and conducting microbiological testing of meat and poultry\n products. Specifically, we determined whether: (1) FSIS has effective\n controls to ensure that all eligible meat and poultry establishments are\n included in the appropriate sampling database; (2) changes in an\n establishment\xe2\x80\x99s operational status or type of product are timely reflected in\n the database; and (3) processes exist to ensure that all establishments are\n selected for testing within a reasonable amount of time.\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 3\n\x0cFindings and Recommendations\nSection 1. Microbiological Testing Programs Do Not Include All Required\nEstablishments\n\n Controls need to be materially strengthened to ensure that all required\n establishments are included in microbiological testing programs conducted by\n FSIS. We found a significant number of establishments that were excluded\n from the Salmonella sampling database maintained in the PREP system, due\n to ineffective controls and to a system for manual followup and input that was\n not fully understood by FSIS officials at the district office level. At one\n district, 28 percent of the establishments subject to Salmonella testing were\n not included in the database. This problem was particularly noticeable in\n State-inspected establishments that were subject to PREP testing under\n Federal-State Cooperative Agreements. A key tracking report was not\n provided to supervisors in these establishments until this situation was\n identified by our audit. On a nationwide basis, we identified a large number\n of establishments that may have been inadvertently left out of the sampling\n process.\n\n PREP is an information system that schedules samples and tracks test results\n of Salmonella sample sets for the Pathogen Reduction/Hazard Analysis and\n Critical Control Point (PR/HACCP) program. PREP also schedules samples\n for the MT03 (E. coli O157:H7) and RTE (Listeria monocytogenes) testing\n programs. OPHS provides microbiological, chemical, and toxicological\n expertise, leadership, and quality assurance and control for the agency.\n OPHS also manages laboratory activities including analyses of official\n samples obtained from meat and poultry establishments under a variety of\n testing programs. FSIS uses PREP to select establishments for product\n testing. The system contains separate listings of establishments, referred to as\n \xe2\x80\x9csampling frames,\xe2\x80\x9d which categorize establishments by the type of testing\n they are subject to. However, unlike the MT03 and RTE sampling frames\n which drew their information directly from the PBIS Plant Profiles\n maintained by the establishment inspectors, OPHS relied upon field\n inspectors to inform them of establishments needing to be tested under\n PR/HACCP Salmonella.\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 4\n\x0cFinding 1 Salmonella Testing Frame Significantly Understated\n\n Our review in one district found that the PREP sampling frame for\n PR/HACCP Salmonella, which identified 99 establishments as being eligible\n for testing, was understated by 39 establishments (28 percent). This occurred\n because FSIS had not established an automated control to assist in the\n identification of such establishments. Instead, they relied upon field\n inspectors and frontline supervisors to inform them of establishments which\n needed to be included in the sampling frame. However, personnel at the\n district level were not always aware of how the system was intended to work,\n or did not understand their role in it. As a result, the 39 establishments we\n identified were not being tested for Salmonella, thus reducing the assurance\n that FSIS would become aware of such contamination.\n\n On July 25, 1996, FSIS published its final rule on Pathogen Reduction and\n Hazard Analysis and Critical Control Point Systems (PR/HACCP), which\n established new requirements for all meat and poultry products to improve\n food safety. Under HACCP, all slaughter and processing establishments are\n required to adopt the HACCP process controls to prevent food safety hazards.\n To verify that HACCP systems are effective in controlling contamination of\n raw product with harmful bacteria, the rule sets pathogen reduction\n performance standards for Salmonella that establishments must meet if they\n produce certain kinds of products. Establishments affected by the Salmonella\n testing requirement \xe2\x80\x93 under which product samples are obtained by FSIS\n establishment inspectors and tested by FSIS field laboratories \xe2\x80\x93 include\n slaughtering establishments for cattle, swine, and (chicken) broilers, and also\n establishments that process raw ground beef, chicken, and turkey. As of June\n 2006, turkey slaughtering establishments were also incorporated into the\n sampling program to address public concerns over the safety of this product.\n\n Qualifying establishments are listed in a \xe2\x80\x9csampling frame\xe2\x80\x9d that is maintained\n by FSIS as an electronic database in its PREP system. FSIS uses this\n sampling frame each month to select the establishments whose products will\n be tested for Salmonella contamination. An establishment must be included\n in the sampling frame in order to be selected for testing. We found that,\n unlike the other two microbiological testing programs that FSIS operates\n (E. coli O157:H7 testing for raw ground beef and Listeria monocytogenes\n testing for Ready-to-Eat products), the PR/HACCP sampling frame is not\n automatically updated directly from PBIS. This is because the PBIS\n establishment profiles do not contain data on production levels and operating\n schedules (see Finding 3) that determines which establishments need to be\n tested. Instead, this sampling frame must be kept up-to-date manually and is\n dependent upon FSIS field personnel to identify the eligible establishments\n within their districts and report them for inclusion.\n\nUSDA/OIG-A/24601-0007-Ch Page 5\n\x0c Every 6 months, FSIS uses the PREP system to generate the Salmonella\n Performance Standards Testing Eligibility Report. This report is sent\n electronically to each frontline supervisor (responsible for visiting inspected\n establishments and overseeing the activities of FSIS inspectors) and district\n manager. It lists every establishment under the district\xe2\x80\x99s jurisdiction that, as\n of the date of the report, was included in the PR/HACCP Salmonella\n sampling frame.\n\n The instructions at the top of each report provide that:\n\n . . . District managers and inspection personnel should review\n plant production activities for all plants to determine if a plant is\n subject to Salmonella Performance Standard requirements for\n one or more classes of product. If you are aware that a plant\n under your jurisdiction is producing a product that is subject to\n Salmonella Performance Standard testing and the plant is not on\n this report, you must notify OPHS by sending a reply to this\n message in Outlook.\n\n The instructions also include the production thresholds below which an\n establishment is exempt from Salmonella testing (see Finding 2).\n\n The district analyst and the managers at the district office we visited stated\n that, based on their understanding, all of the PREP sampling frames were\n updated directly from the PBIS Plant Profile that each FSIS establishment\n inspector maintains on an ongoing basis. This profile contains information on\n the types of products (i.e., beef, chicken) and on the type of processes that\n each FSIS-inspected establishment uses (slaughter, grinding of raw product,\n processing of Ready-to-Eat products, etc.). Thus, district officials believed\n that a qualifying establishment would be automatically added to the sampling\n frame as long as the PBIS Plant Profile contained correct and complete\n information on the establishment\xe2\x80\x99s products and operations. District officials\n informed us that they instructed their frontline supervisors to ensure that\n establishment inspectors update the Plant Profiles in PBIS.\n\n However, as noted earlier, the PR/HACCP Salmonella sampling frame is not\n drawn directly from the PBIS Plant Profile because FSIS policy excludes any\n establishment that slaughters fewer than a certain number of animals or birds,\n or processes fewer than 26 days per year. This information is not contained\n in the PBIS Plant Profile. The district officials were not aware of this,\n however, until FSIS Headquarters officials informed them of the policy\n following our discussions. In interviews with the frontline supervisors, we\n found that some of them likewise believed that the sampling frame was\n updated automatically based on the Plant Profile and thus did not use the\n semiannual Salmonella Performance Standards Testing Eligibility Report.\n\nUSDA/OIG-A/24601-0007-Ch Page 6\n\x0c As of November 2005, the PR/HACCP sampling frame listed\n 1,481 establishments nationwide. To determine whether the sampling frame\n contained all of the qualifying establishments that needed to be tested for\n Salmonella, we obtained a PBIS listing of all FSIS-inspected establishments\n within the jurisdiction of the district we visited, and identified those whose\n products should have made them eligible for inclusion in the sampling frame.\n (Note that we relied on the accuracy of PBIS data, since performing tests of\n that system was not part of the scope of this audit.) For the slaughter\n establishments, we were able to eliminate those whose volume of activity\n (fewer than 500 red meat carcasses slaughtered on less than 100 days, or\n fewer than 20,000 birds) exempted them under FSIS policy using the\n Electronic Animal Disposition Reporting System (eADRS). No equivalent\n report existed for processing establishments, so we could not determine\n which of those did, or did not, qualify based on their level of activity. We\n found that a total of 174 establishments in the selected district appeared\n eligible for Salmonella testing; however, the sampling frame listed only 99 of\n these. We requested that the district review the remaining 75 establishments\n to determine whether they met the criteria that would require them to be\n tested for Salmonella.\n\n District officials responded that, as a result of their followup, they determined\n that 37 of the 75 establishments needed to be added to the sampling frame. In\n addition, the district identified 2 other establishments that needed to be added\n to the sampling frame, for a total of 39 (see exhibit B for a profile of these\n establishments). The remainder, all processing establishments, were\n determined ineligible because they operated fewer than the 26-days-per-year\n threshold or because their products were not covered under FSIS\xe2\x80\x99 testing\n standards.\n\n Because of this large discrepancy, we performed the same review for the\n remaining districts, and nationwide we found that, excluding the district\n already reviewed, the PR/HACCP sampling frame listed\n 1,382 establishments. Using PBIS and eADRS, we identified an additional\n 790 establishments (see exhibit A) that appeared eligible for the sampling\n program. Profiles of these establishments are presented in exhibit C. This\n information was provided to FSIS, so that any necessary followup could be\n performed. Although some of the 790 establishments will likely be excluded\n because their processing is too infrequent, it appears that the\n 1,481 establishments in the sampling frame nationwide (including the\n selected district) could be significantly understated.\n\n By contrast, we found that the other sampling frames \xe2\x80\x93 which did not rely on\n field personnel to identify establishments that needed to be included, but\n instead got their data from the Establishment Profiles in PBIS \xe2\x80\x93 did not have\n this deficiency. Although we recognize that additional data elements are\n needed to determine eligibility for this sampling frame as opposed to those\nUSDA/OIG-A/24601-0007-Ch Page 7\n\x0c for E. coli O157:H7 and Listeria monocytogenes testing, the number of\n excluded establishments noted above indicates that in the long term, FSIS\n needs to develop an automated means of identifying establishments for\n inclusion in the Salmonella sampling frame. This could, in part, be done by\n making better use of the information in eADRS. In the interim, agency\n officials need to take steps to ensure that district managers and frontline\n supervisors clearly understand their responsibilities for following up on the\n Salmonella Performance Standards Testing Eligibility Report and ensuring\n that all eligible establishments are reported to FSIS for inclusion in the\n sampling frame.\n\nRecommendation 1\n\n Issue guidance to more clearly state the responsibilities of field personnel in\n assuring the Salmonella sampling frame includes all establishments eligible\n for testing.\n\n Agency Response\n\n FSIS officials stated that the Office of Policy, Program, and Employee\n Development (OPPED) will develop an FSIS Notice that gives explicit\n instructions to District Managers to update the PREP Salmonella sampling\n frame. Eligibility requirements for the Salmonella sampling frame will be\n included and will reflect the recently published \xe2\x80\x9cFSIS Scheduling Criteria for\n Salmonella Sets in Raw Classes of Product\xe2\x80\x9d which outlines agency policy to\n allocate sampling within classes of raw product and is based on agency data\n of variability of process control at individual establishments. The expected\n completion date is December 2006.\n\n OIG Position\n\n We accept FSIS\xe2\x80\x99 management decision. Final action can be reached upon\n issuance of the proposed notice.\n\nRecommendation 2\n\n Modify PBIS to incorporate the codings necessary to identify establishments\n requiring Salmonella testing similar to those presently used for the E. coli\n O157:H7 and Listeria monocytogenes testing programs.\n\n Agency Response\n\n FSIS officials stated that the PBIS is being modified to update the Salmonella\n sampling frame. The response further stated that an FSIS notice has been\n drafted to inform the districts that they will no longer receive the eligibility\n report, and that the Salmonella sampling frame will be derived in part, from\nUSDA/OIG-A/24601-0007-Ch Page 8\n\x0c electronic PBIS data. Instructions are provided for identifying new\n establishments or establishments that begin making an eligible product, and\n getting them added to the frame. They expect this action to be completed in\n March 2007.\n\n OIG Position\n\n We accept FSIS\xe2\x80\x99 management decision. Final action can be reached upon\n completion of the modification and issuance of the notice.\n\nRecommendation 3\n\n Use eADRS to the extent necessary to ensure that all establishments eligible\n for Salmonella testing are included in the sampling frame.\n\n Agency Response\n\n FSIS officials stated that the frames will be derived, in part, from eADRS\n data. The agency began using eADRS data to identify establishments\n slaughtering species for which there is a performance standard or guideline in\n May 2005. They expect completion in March 2007.\n\n OIG Position\n\n We accept FSIS\xe2\x80\x99 management decision. Final action can be reached when this\n action is completed in conjunction with the PBIS modification.\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 9\n\x0cFinding 2 In At Least One District, Talmadge-Aiken Establishments Were\n Excluded From PR/HACCP Salmonella Sampling\n\n In our visit to one district, we found that establishments inspected by State\n employees under Federal-State Cooperative Agreements (Talmadge-Aiken\n establishments) were less likely than FSIS-inspected establishments to be\n included in the PR/HACCP testing program. This occurred because neither\n OPHS nor the Office of Field Operations (OFO) had provided specific\n guidance on how these establishments were to be covered under the existing\n system for identifying eligible establishments. As a result, we found a\n notable disparity in the number of slaughter establishments that were left out\n of the sampling frame. Prior to our review, only 31 percent of the Talmadge-\n Aiken establishments in the district had been included in the PR/HACCP\n Salmonella sampling frame, as compared to 81 percent of FSIS-inspected\n establishments.\n\n \xe2\x80\x9cTalmadge-Aiken plants,\xe2\x80\x9d are authorized under the Talmadge-Aiken Act of\n 1962. The approximately 350 meat and poultry establishments that operate\n under this program, located in 9 States, are considered Federally-inspected\n establishments but are in fact inspected by State employees. Unlike State-\n inspected establishments, these establishments can market their products\n interstate and are governed by FSIS regulations.\n\n The district office we visited (District 50) covers 3 States, one of which\n (Illinois) had 8 Talmadge-Aiken establishments listed in the PR/HACCP\n Salmonella sampling frame; these establishments represented about 8 percent\n of the 99 establishments in the sampling frame for this district. To determine\n whether establishments producing products subject to microbiological testing\n under the PR/HACCP Salmonella program were included in the sampling\n frame, we reviewed eADRS. This system allowed us to determine whether\n slaughter establishments produced a sufficient volume of product to be\n subject to testing under current FSIS policy. This review identified 10\n slaughter establishments that were not in the PR/HACCP Salmonella\n sampling frame, even though they qualified both in terms of the type of\n product produced and the level of production. Of these, 9 were Talmadge-\n Aiken establishments.\n\n At our request, the district office verified that 37 of the 75 establishments we\n questioned should have been included in the sampling frame. Of the\n 37 establishments, 16 were Talmadge-Aiken establishments. The district also\n identified two additional Talmadge-Aiken establishments that needed to be\n included in the sampling frame. Thus, of 26 Talmadge-Aiken establishments\n that should have been included in the PR/HACCP sampling frame,\n 18 (69 percent) had been omitted. By contrast, 19 percent (21 of 112) of the\n establishments inspected directly by FSIS were omitted.\nUSDA/OIG-A/24601-0007-Ch Page 10\n\x0c FSIS frontline supervisors, who are responsible for ensuring that eligible\n establishments are included in the Salmonella testing program, are provided\n the Salmonella Performance Standards Testing Eligibility Report in electronic\n format when it is issued twice a year. However, in our interview with the\n Illinois official who oversees inspection operations at the Talmadge-Aiken\n establishments, we found that he did not have access to FSIS\xe2\x80\x99 system and\n therefore did not get the report. As a result, the State supervisors who\n perform equivalent functions to the FSIS frontline supervisors did not have\n the necessary information to identify establishments that should have been\n placed in the sampling frame.\n\n We discussed this with an FSIS district official, who concurred that the State\n employees need to have access to this system in order to be effective in\n identifying establishments whose products need to be tested for Salmonella.\n As a result of our audit, the district office provided State supervisors with the\n necessary system access to receive the Salmonella Performance Standards\n Testing Eligibility Report and to electronically report establishments that\n need to be added, as FSIS frontline supervisors do. District management\n stated that they had not received any guidance from FSIS Headquarters on\n what procedures should be followed to ensure Talmadge-Aiken\n establishments are included in the sampling frame.\n\n An FSIS Headquarters official confirmed that FSIS has not provided\n guidance, saying that managers in each district were allowed to deal with the\n Talmadge-Aiken establishments in their own manner. However, the fact that\n District 50 had not implemented such a process until the time of our audit, as\n well as the large percentage of Talmadge-Aiken establishments that were not\n included in the sampling frame, indicates the need for FSIS Headquarters to\n provide written guidance to the districts to ensure these conditions are not\n occurring on a nationwide basis.\n\nRecommendation 4\n\n Provide written procedures to all district offices to ensure that processes for\n identifying establishments that need to be tested for Salmonella are applied to\n Talmadge-Aiken establishments.\n\n Agency Response\n\n FSIS officials stated that OPPED will develop an FSIS Notice that gives\n explicit instructions to District Managers to update the PREP Salmonella\n sampling frame. They expect this action to be completed in December 2006.\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 11\n\x0c OIG Position\n\n We accept FSIS\xe2\x80\x99 management decision. Final action can be reached upon\n issuance of the notice.\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 12\n\x0cSection 2. Some Establishments and Products Are Excluded From FSIS\nMicrobiological Testing\n\n Following the massive ConAgra recall of ground beef products in 2002, FSIS\n officials revoked an earlier policy that exempted some establishments which\n would otherwise have been subject to product testing for E. coli\n O157:H7 under the MT03 testing program. However, we noted that some\n exclusions continue to exist, and establishments that fall under these are not\n subject to product testing. FSIS could not provide scientific support and/or\n risk assessments to support these exclusions from testing. We found that\n because of the time needed to collect and test the required number of samples\n to complete a sampling set under the PR/HACCP Salmonella testing\n program, establishments whose slaughter or processing activity falls below a\n specific threshold are not subject to product testing. Likewise, establishments\n that produce non-intact beef products that do not meet the standard of identity\n of 9 CFR 319.15 (a), (b), or (c) are excluded from E. coli O157:H7 testing.\n FSIS officials stated that certain raw ground beef products are excluded\n because they involve less risk to the public. However, because of these\n exclusions, there is a reduced level of assurance that products produced at\n these establishments will be free of dangerous pathogens.\n\n\nFinding 3 FSIS Excludes Small and Low-Volume Establishments From Its\n Salmonella Testing Program\n\n The FSIS Salmonella testing program focuses on large establishments, those\n slaughtering more than 500 meat animals or 20,000 birds per year, and\n processing establishments that operate on 26 or more days per year. An FSIS\n official stated that these thresholds were set so that the sample sets required\n for Salmonella testing could be completed within a reasonable timeframe, but\n could not provide documentation of the specific factors that went into their\n determination. However, excluding smaller slaughter or processing\n establishments from its Salmonella testing program could also increase the\n risk that Salmonella contamination or sanitation problems at these smaller\n establishments could go undetected.\n\n FSIS, in its 1996 rule on Pathogen Reduction and Hazard Analysis and\n Critical Control Point Systems (PR/HACCP), established requirements\n intended to improve food safety at all meat and poultry slaughter and\n processing establishments. To ensure that the HACCP programs at each\n establishment are effective in maintaining acceptable sanitation standards and\n preventing the contamination of products by harmful microbiological\n organisms, FSIS created pathogen reduction performance standards for a\n number of commonly-marketed meat and poultry products including broilers\n (young chickens, Guineas, etc.), steers, heifers, bulls, cows, and hogs. Any\nUSDA/OIG-A/24601-0007-Ch Page 13\n\x0c establishment producing one of these products is required to submit product\n samples for Salmonella testing by one of the FSIS field laboratories.\n Salmonella was selected for this testing program because its presence is\n considered a sign of overall sanitation problems at an establishment, which\n could result in public health issues. Unlike E. coli O157:H7 or Listeria\n monocytogenes, however, a single positive test result for Salmonella is not\n considered as proof of a significant sanitation problem or a lack of process\n controls. Therefore, Salmonella testing is done in \xe2\x80\x9csets\xe2\x80\x9d of between 51 to\n 82 product samples. The regulations define the number of \xe2\x80\x9cpositive\xe2\x80\x9d\n Salmonella test results for each product that would warrant enforcement\n action by FSIS.\n\n However, because the time needed to complete the sampling \xe2\x80\x9csets\xe2\x80\x9d depended\n on the activity level of the establishment being tested \xe2\x80\x93 with establishments\n that seldom slaughter or process product taking longer because of product\n availability issues \xe2\x80\x93 FSIS established activity thresholds as part of its\n sampling eligibility determination for each establishment. As stated in the\n Salmonella Performance Standards Testing Eligibility Report that OPHS\n provides to each district twice a year, an \xe2\x80\x9cInfrequent Producer\xe2\x80\x9d is defined as a\n establishment that:\n\n \xee\xa0\xba Produces raw ground beef less than 26 times per year;\n \xee\xa0\xba Slaughters fewer than 500 red meat carcasses on less than\n 100 different days per year; or\n \xee\xa0\xba Slaughters fewer than 20,000 young chickens per year.\n\n An FSIS official stated that the 26-times-per-year threshold is interpreted as\n meaning 26 different days per year, and is applied to any non-slaughter\n operation (i.e., a processing establishment). The 500-per-year threshold also\n applies to hogs, and the 20,000-per-year threshold applies to any type of bird\n (except for turkeys, which were added to the program in June 2006 and are\n tested only if the establishment produces on 100 or more days per year)\n covered by the testing program. The official stated that if an establishment\n slaughters or processes less frequently than described in the standards, an\n excessive amount of time is required to collect the number of samples needed\n to complete a sample set. As a result, FSIS excluded such establishments\n from the testing program and concentrated its efforts on the larger and more\n frequently-operating establishments.\n\n However, FSIS officials could not provide us with any documentation\n supporting their determination of what establishments to exclude. Nor did\n they have studies that documented that the risk associated with products\n produced by smaller establishments was less than that of larger\n establishments. As a result, FSIS cannot demonstrate that HACCP systems\n operating at small or low-volume establishments are low-risk for pathogen\n contamination.\nUSDA/OIG-A/24601-0007-Ch Page 14\n\x0c Because the PBIS Plant Profiles do not contain data on an establishment\xe2\x80\x99s\n level of activity (see Finding 1), the number of establishments nationwide that\n would be excluded from the PR/HACCP Salmonella testing program cannot\n be precisely determined. However, in the district we visited, we found that\n out of 75 establishments we identified as potentially meeting FSIS criteria for\n sampling (based on the type of product shown as being produced per the\n PBIS Plant Profile), 12 (16 percent) were determined by the district to be\n infrequent producers and therefore exempt. Nationwide, we identified an\n additional 790 establishments (see exhibit A) that have not been included in\n the sampling frame for PR/HACCP Salmonella, so it is possible that a similar\n percentage of these would also be excluded under FSIS policy.\n\n Product produced in smaller establishments is consumed by a public knowing\n that FSIS conducts microbiological testing to ensure the wholesomeness and\n safety of meat and poultry food products. Therefore, FSIS needs to develop a\n risk assessment supporting its testing policy or conduct testing in all plants.\n\nRecommendation 5\n\n Develop a risk assessment to support the agency\xe2\x80\x99s policy in excluding\n establishments from Salmonella testing or conduct testing in all plants.\n\n Agency Response\n\n FSIS officials stated that product produced by plants not included in the\n Salmonella testing program represents a fraction of a percent of consumer\n exposure to Salmonella from raw meat and poultry. They believe consumer\n exposure is minimal from the establishments which are not tested and did not\n agree to perform a risk assessment. In the risk-based system approach that\n FSIS is developing, exposure of food safety hazards to the public is related to\n production volume and this is where they will place their emphasis.\n\n OIG Position\n\n We cannot reach management decision because FSIS officials have not\n provided support for their position that risk is based solely on production\n volume. In fact, FSIS\xe2\x80\x99 own data on non-compliance reports for sanitation\n demonstrate that, on average, small establishments have sanitation\n deficiencies at a rate comparable to larger establishments, the only difference\n being that less product is distributed to the public. To reach management\n decision, FSIS officials need to provide the recommended risk assessment or\n else provide for at least a minimal level of testing at smaller establishments.\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 15\n\x0cFinding 4 Some Raw Ground Beef Products Are Excluded From E. coli\n O157:H7 Testing\n\n Although FSIS\xe2\x80\x99 testing program for the pathogen E. coli O157:H7 is intended\n to ensure the safety of raw ground beef products marketed to the public, we\n found that some ground beef products such as meatballs and sausages are not\n tested because of an agency determination that they were of sufficiently low\n risk that testing was not warranted. As a result, there is reduced assurance\n that establishments that produce these products are free from contamination\n by E. coli O157:H7.\n\n When E. coli O157:H7 was declared an adulterant in raw ground beef\n products in 1994, FSIS began testing raw ground beef for this pathogen at\n slaughter and processing establishments. However, when the testing program\n was announced, the Texas Food Industry Association filed a case in Federal\n Court against the Secretary of Agriculture to prevent this testing. The\n plaintiffs, as noted in the court\xe2\x80\x99s ruling dated December 13, 1994, contended\n among other things that FSIS and USDA had exceeded their statutory\n authority in declaring E. coli O157:H7 an adulterant (as opposed to pathogens\n such as Salmonella, which are not classified as adulterants). This contention\n was based on the argument that \xe2\x80\x9cE. coli contaminated ground beef is not\n adulterated because it is only injurious to health if improperly cooked.\xe2\x80\x9d\n\n The court disagreed with this contention and ruled in the Department\xe2\x80\x99s favor,\n stating that:\n\n However, unlike other pathogens, it is not \xe2\x80\x9cproper\xe2\x80\x9d cooking but\n \xe2\x80\x9cthorough\xe2\x80\x9d cooking that is necessary to protect consumers from\n E. coli. The evidence submitted by defendants indicates that\n many Americans consider ground beef to be properly cooked\n rare, medium rare, or medium . . . therefore, E. coli is a\n substance that renders \xe2\x80\x9cinjurious to health\xe2\x80\x9d what many\n Americans believe to be properly cooked ground beef. Based\n on this evidence, the Court finds that E. coli fits the definition of\n an adulterant under the [Federal Meat Inspection] Act. 4\n\n During our audit, we noted that FSIS inspectors in numerous meat\n establishments repeatedly responded to OPHS requests for raw ground beef\n product samples under the MT03 (E. coli O157:H7) testing program with the\n code that showed that the product was not produced, even though their PBIS\n Plant Profiles continued to reflect raw ground beef HACCP processes from\n month to month. Our fieldwork included visits to establishments that were\n listed in the MT03 sampling frame, and we found that in some cases, the\n\n4\n Title 21 USC, Chapter 12, Meat Inspection, the Federal Meat Inspection Act of 1906.\nUSDA/OIG-A/24601-0007-Ch Page 16\n\x0c establishments were producing either \xe2\x80\x9cmixed\xe2\x80\x9d products containing raw\n ground pork as well as beef, raw ground beef products formed into meatballs,\n or other products clearly not intended for use as hamburgers or hamburger\n patties. The establishment inspectors and frontline supervisors stated that\n they had been instructed not to send in samples of such products.\n\n FSIS officials confirmed this, stating that the agency\xe2\x80\x99s policy was to limit the\n testing program to raw ground beef or veal products clearly intended for use\n as hamburger patties or which otherwise met the standard of 9 CFR\n 319.15 (a), (b), or (c). They stated that products such as raw ground beef\n meatballs and sausages, as well as raw ground beef used in mixed-meat or\n spiced products, were excluded. Officials stated that, among other factors,\n consumers were more likely to fully cook these products (as referenced in the\n Federal Court ruling) than would be the case with hamburgers or other\n products that might be made from bulk ground beef marketed to the public.\n\n Officials of the Data Systems Management Division stated that\n establishments producing \xe2\x80\x9cexcluded\xe2\x80\x9d raw ground beef products continued to\n appear in the MT03 sampling frame because PREP automatically identifies\n any establishment whose PBIS Plant Profile carries the code \xe2\x80\x9c03B Ground\n Beef\xe2\x80\x9d as eligible for testing. The 03B code cannot be removed because it is\n this code that signals PBIS to schedule tasks for the establishment inspectors\n related to ground beef production. They noted that it would be preferable to\n send extra testing kits than to take a chance on having PBIS fail to schedule\n these tasks, or to miss sending E. coli O157:H7 test kits to establishments that\n should be properly included in the testing program.\n\n Based in part on their discussions with OIG, FSIS\xe2\x80\x99 OPPED issued FSIS\n Notice 80-05 on December 5, 2005. This notice announced the addition of a\n \xe2\x80\x9ccheck box\xe2\x80\x9d to the PBIS Plant Profile, which would give the inspector the\n ability to identify whether an establishment\xe2\x80\x99s products met the standards of\n identity for E. coli O157:H7 testing under 9 CFR 319.15 (a), (b), or (c). 5\n Once this feature becomes fully operational, it would be necessary for an\n inspector to fill in the check box before PBIS would identify the\n establishment as subject to testing under the MT03 sampling frame. Any\n establishment for which this box is not checked would be disregarded by the\n system when it refreshes the MT03 sampling frame each month. The notice\n also restated the types of product that are to be included or excluded from the\n testing program. Products specifically excluded include \xe2\x80\x9cany raw ground\n beef mixed with other species (pork or poultry); raw product comprised only\n of beef from advanced meat recovery (AMR) systems; fresh beef sausage,\n Italian sausage, and other raw beef sausage products; and raw ground beef\n meatballs.\xe2\x80\x9d\n\n5\n Title 9-Animals And Animal Products, Chapter III-FSIS, Department of Agriculture, Part 319 Standards of Identity or Composition, Section 319.15\n Miscellaneous Products.\nUSDA/OIG-A/24601-0007-Ch Page 17\n\x0c The procedures, such as the \xe2\x80\x9ccheck box\xe2\x80\x9d feature mentioned in the FSIS\n notice, does not address the question of whether the products excluded under\n FSIS Notice 80-05 should be included in the E. coli O157:H7 testing\n program, or should continue to be excluded. FSIS officials were not able to\n provide us with any studies or test results to substantiate the agency\xe2\x80\x99s position\n that only certain raw ground beef products were of sufficient risk to warrant\n testing. Therefore, we believe that FSIS should perform scientific studies to\n determine whether the risk of E. coli O157:H7 outbreaks from non-\n hamburger or bulk ground beef products is sufficiently low as to warrant their\n continued exclusion from the testing program.\n\nRecommendation 6\n\n Perform scientific studies to determine whether the risk of E. coli\n O157:H7 outbreaks from excluded raw ground beef products is sufficiently\n low as to warrant their continued exclusion from the testing program.\n\n Agency Response\n\n According to their response, FSIS has sufficient science-based input from the\n National Advisory Committee on Microbiological Criteria for Foods to guide\n its approach to ensuring that the risk associated with E. coli O157:H7 in\n various ground beef components is being properly managed. Moreover, the\n agency has clearly articulated its intent to further assess proper controls for E.\n coli O157:H7 in source materials used to make ground beef, as well as for\n making other non-intact products (including meatballs and sausage products)\n in recent Federal Register documents. By early November 2006, FSIS\n expects to issue an FSIS Notice containing instructions for the routine testing\n of manufacturing trim in establishments that have been identified as suppliers\n impacted in positive tests for E. coli O157:H7. FSIS believes that this testing\n of manufacturing trim is a more science- and risk-based approach to ensuring\n that products made from beef are safe, rather than diverting limited resources\n for sampling non-ground beef end-products (e.g., sausage and meatballs).\n\n OIG Position\n\n We accept FSIS\xe2\x80\x99 management decision. Final action can be reached on the\n issuance of the notice.\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 18\n\x0cScope and Methodology\n We performed audit work at FSIS Headquarters in Washington D.C., and at\n the District 50 Office in Lombard, Illinois. We also visited 11 judgmentally-\n selected meat and poultry establishments located in Illinois. We performed\n our fieldwork from June 2005 through June 2006.\n\n At FSIS Headquarters, we held discussions with officials from OPHS, OFO,\n and the Information Technology (IT) staff. We reviewed both standard and\n ad hoc PREP reports to identify the controls and procedures in place to ensure\n that (1) meat and poultry establishments were properly identified for\n inclusion in the sampling frames for each testing program; (2) establishments\n were scheduled for sampling within reasonable timeframes; and, (3) district\n office personnel provided proper oversight of the process to collect scheduled\n samples.\n\n At the district office and selected establishments, we performed tests to\n evaluate the operation of these controls and processes at the field level. We\n reviewed PBIS Plant Profile information as well as the eADRS system on\n each establishment whose products appeared eligible for Salmonella testing,\n to identify establishments that may have been excluded; we provided this\n information to the district office for followup. Based on these results we\n obtained equivalent information for all establishments nationwide, and\n provided the results of our evaluation to OPHS for followup. We also held\n discussions with employees of the Illinois Department of Agriculture to\n evaluate controls over State-inspected establishments operating under\n Federal-State Cooperative Agreements. We reviewed data from PREP\n reports that tracked the disposition of sampling requests for this district and\n two others, to evaluate the effectiveness of FSIS\xe2\x80\x99 controls to ensure\n compliance by FSIS establishment inspectors. At the meat and poultry\n establishments, we observed operations and reviewed PBIS profile\n information to perform comparisons with data maintained in the PREP\n system. We did not, however, perform sufficient reviews of PBIS to\n comment on the accuracy of the establishment profile information.\n\n The audit was conducted in accordance with Government Auditing Standards\n issued by the Comptroller General of the United States.\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 19\n\x0cExhibit A \xe2\x80\x93 Nationwide List of Establishments Potentially Excluded from\nPR/HACCP Salmonella Sampling Frame\n Exhibit A \xe2\x80\x93 Page 1 of 1\n\n Salmonella Sampling Set\n Chicago District Office\n Questionable\n Sampling Set Estblshmts. Identified Estblshmts. Added\n per FSIS by OIG by District Percent Excluded\n 99 75 39 28%\n\n Remaining Districts\n Additional Estblshmts. Identified\n District Sampling Set per FSIS by OIG for Potential Inclusion\n\n 05 118 116\n 15 156 101\n 20 57 52\n 25 56 43\n 30 80 32\n 35 49 18\n 40 66 53\n 45 96 17\n 60 173 85\n 65 203 84\n 75 57 42\n 80 77 56\n 85 121 69\n 90 73 22\n\n Total 1,382 790\n\n\n Potentially Excluded\n Sampling Set Per FSIS of 1,382 x Rate of Exclusion 1.39 = 1,921\n No. Possibly Excluded \xe2\x80\x93 539\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 20\n\x0cExhibit B \xe2\x80\x93 District 50 Establishments Not Included In PR/HACCP Salmonella\nSampling Frame\n Exhibit B \xe2\x80\x93 Page 1 of 1\n\n\n\n Summary of 39 Establishments Questioned\n by Type of Establishment and Product\n\n\n Type of Establishment\n Processing 29\n Slaughter 5\n Combination 5\n Total 39\n\n\n Type of Product\n Ground Beef 27\n Ground Chicken 1\n Ground Turkey 1\n Slaughter \xe2\x80\x93 Hogs 2\n Slaughter \xe2\x80\x93 Steers/Heifers/Hogs 3\n Combo \xe2\x80\x93 Slaughter Steers/Heifers/Hogs/ 5\n Ground Beef\n Total 39\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 21\n\x0cExhibit C \xe2\x80\x93 Potentially Eligible Establishments Not Included in Nationwide\nHACCP (HC01) Sampling Frame (Excluding District 50)\n Exhibit C \xe2\x80\x93 Page 1 of 1\n\n Type of Establishment\n Processing 714\n Slaughter 40\n Combination 36\n Total 790\n\n\n Type of Product\n Ground Beef 530\n Ground Chicken 147\n Ground Turkey 37\n Slaughter \xe2\x80\x93 Chicken 12\n Slaughter \xe2\x80\x93 Chicken/ Guinea 3\n Slaughter \xe2\x80\x93 Dairy Cows/ Beef cows 1\n Slaughter \xe2\x80\x93 Hogs 6\n Slaughter \xe2\x80\x93 Steers 1\n Slaughter \xe2\x80\x93 Steers/ Heifers 6\n Slaughter \xe2\x80\x93 Steers/ Heifers/ Hogs 11\n Combo \xe2\x80\x93 Slaughter Chicken/ Ground Chicken 2\n Combo \xe2\x80\x93 Slaughter Hogs/ Ground Beef 1\n Combo \xe2\x80\x93 Slaughter Steers/ Ground Beef 1\n Combo \xe2\x80\x93 Slaughter Steers/ Heifers/ Ground Beef 2\n Combo \xe2\x80\x93 Slaughter Steers/ Heifers/ Hogs/\n 30\n Ground Beef\n Total 790\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 22\n\x0cExhibit D \xe2\x80\x93 Agency Response to the Draft Report\n Exhibit D \xe2\x80\x93 Page 1 of 5\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 23\n\x0cExhibit D \xe2\x80\x93 Agency Response to the Draft Report\n Exhibit D \xe2\x80\x93 Page 2 of 5\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 24\n\x0cExhibit D \xe2\x80\x93 Agency Response to the Draft Report\n Exhibit D \xe2\x80\x93 Page 3 of 5\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 25\n\x0cExhibit D \xe2\x80\x93 Agency Response to the Draft Report\n Exhibit D \xe2\x80\x93 Page 4 of 5\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 26\n\x0cExhibit D \xe2\x80\x93 Agency Response to the Draft Report\n Exhibit D \xe2\x80\x93 Page 5 of 5\n\n\n\n\nUSDA/OIG-A/24601-0007-Ch Page 27\n\x0c'


type: legislation

jurisdiction: EU

text:
 EUROPSKA KOMISIJA
 Bruxelles, 8.5.2017.
 COM(2017) 215 final
 2017/0092(NLE)
 Prijedlog
 ODLUKE VIJEĆA
 o utvrđivanju stajališta koje u ime Europske unije treba donijeti na godišnjoj konferenciji stranaka Konvencije o zaštiti i upravljanju resursima aljaške kolje u središnjem Beringovu moru te o stavljanju izvan snage Odluke 11724/12
 OBRAZLOŽENJE
 1.KONTEKST PRIJEDLOGA
 •Razlozi i ciljevi prijedloga
 Poljska je ugovorna stranka Konvencije o zaštiti i upravljanju resursima aljaške kolje u središnjem Beringovu moru (Konvencija o Beringovu moru). U skladu s člankom 6. stavkom 9. Akta o pristupanju
 1
 sporazumima o ribarstvu koje su nove države članice sklopile s trećim zemljama upravlja Unija i Unija bi trebala provoditi sve odluke donesene u okviru Konvencije.
 U okviru Konvencije o Beringovu moru godišnja konferencija stranaka odgovorna je za uspostavu međunarodnog sustava za upravljanje i optimalno korištenje resursima kolje na području primjene Konvencije te za njihovo očuvanje. Nastoji se i ponovno dovesti resurse kolje u Beringovu moru na razinu prinosa kojom bi se omogućio najveći održivi prinos te prikupiti i ispitati činjenične podatke o resursima kolje i drugim živim morskim resursima u Beringovu moru.
 U skladu s člankom 218. stavkom 9. Ugovora o funkcioniranju Europske unije, stajalište koje u ime Unije treba donijeti u regionalnim organizacijama za upravljanje ribarstvom kada su pozvane donositi akte koji proizvode pravne učinke, uz iznimku akata kojima se dopunjuje ili mijenja njihov institucijski okvir, mora biti doneseno odlukom Vijeća na prijedlog Komisije.
 Takvo stajalište u okviru RFMO-ova trenutačno se utvrđuje u skladu s dvostupanjskim pristupom. Odlukom Vijeća utvrđuju se vodeća načela i smjernice stajališta Unije na višegodišnjoj osnovi, uzimajući u obzir da se ono nakon toga usklađuje za svaki godišnji sastanak na temelju neslužbenih dokumenata Komisije o kojima će raspravljati radna skupina Vijeća.
 U pogledu Konvencije o Beringovu moru Odlukom Vijeća 11724/12 od 29. lipnja 2012. predviđa se revizija stajališta Unije prije godišnjeg sastanka 2016. Stoga se ovim prijedlogom nastoji utvrditi stajalište Unije u okviru Konvencije o Beringovu moru za razdoblje od 2017. do 2021. te na taj način zamijeniti Odluku Vijeća 11724/12 od 29. lipnja 2012., kojom je obuhvaćeno razdoblje od 2012. do 2016.
 •Dosljednost s postojećim odredbama politike u određenom području
 Revizijom se žele ugraditi načela i smjernice nove zajedničke ribarstvene politike (ZRP) kako je utvrđeno u Uredbi (EU) br. 1380/2013 Europskog parlamenta i Vijeća
 2
 , uzimajući u obzir i ciljeve Komunikacije Komisije o vanjskoj dimenziji ZRP-a
 3
 . Osim toga, stajalište Unije usklađeno je s Ugovorom iz Lisabona.
 Kao što je to slučaj s trenutačnim stajalištem, sljedeće stajalište sadržava opća načela i smjernice u mjeri u kojoj je to potrebno s obzirom na posebnosti Konvencije o Beringovu moru. Nadalje, na zahtjev država članica uvodi se standardni postupak za godišnje utvrđivanje stajališta Unije.
 Odlukom Vijeća 7277/16 od 11. travnja 2016. Republika Poljska dobila je ovlasti da u interesu Unije pregovara o izmjeni Konvencije o Beringovu moru kako bi Unija postala ugovorna stranka te Konvencije. Taj se mandat trenutačno provodi. Podrazumijeva se da će nakon prihvaćanja Unije kao punopravne ugovorne stranke Konvencije o Beringovu moru Republika Poljska povući svoje članstvo iz Konvencije.
 •Dosljednost u odnosu na druge politike Unije
 Nije primjenjivo
 2.PRAVNA OSNOVA, SUPSIDIJARNOST I PROPORCIONALNOST
 •Pravna osnova
 Sljedeća odluka temelji se na Ugovoru o funkcioniranju Europske unije, a posebno članku 43. stavku 2. u vezi s člankom 218. stavkom 9., kojim se predviđa da Vijeće na prijedlog Komisije donosi odluku o utvrđivanju stajališta koja u ime Unije treba donijeti tijelo osnovano na temelju sporazuma kada je to tijelo pozvano donositi akte koji proizvode pravne učinke. To se primjenjuje na stajalište koje u ime Unije treba donijeti Komisija na konferenciji stranaka Konvencije o Beringovu moru.
 Uredba (EU) br. 1380/2013 Europskog parlamenta i Vijeća pravna je osnova za utvrđivanje načela koja će se odraziti u ovom stajalištu.
 Sljedećom će se Odlukom zamijeniti Odluka Vijeća 11724/12 od 29. lipnja 2012., kojom je obuhvaćeno razdoblje od 2012. do 2016.
 •Supsidijarnost (za neisključivu nadležnost)
 Nije primjenjivo
 •Proporcionalnost
 Nije primjenjivo
 •Odabir instrumenta
 U skladu s člankom 218. stavkom 9. Ugovora o funkcioniranju Europske unije, stajalište koje u ime Unije treba donijeti u regionalnim organizacijama za upravljanje ribarstvom kada su pozvane donositi akte koji proizvode pravne učinke, uz iznimku akata kojima se dopunjuje ili mijenja njihov institucijski okvir, mora biti doneseno odlukom Vijeća na prijedlog Komisije.
 3.REZULTATI EX POST EVALUACIJA, SAVJETOVANJA S DIONICIMA I PROCJENE UČINAKA
 •Ex post evaluacija / provjera primjerenosti postojećeg zakonodavstva
 Nije primjenjivo
 •Savjetovanja s dionicima
 Nije primjenjivo
 •Prikupljanje i primjena stručnih znanja
 Nije primjenjivo
 •Procjena učinka
 Nije primjenjivo
 •Primjerenost propisa i pojednostavnjenje
 Nije primjenjivo
 •Temeljna prava
 Nije primjenjivo
 4.UTJECAJ NA PRORAČUN
 Nije primjenjivo
 5.OSTALI ELEMENTI
 •Planovi provedbe i mehanizmi praćenja, evaluacije i izvješćivanja
 Nije primjenjivo
 •Dokumenti s obrazloženjima (za direktive)
 Nije primjenjivo
 •Detaljno obrazloženje posebnih odredbi prijedloga
 Nije primjenjivo
 2017/0092 (NLE)
 Prijedlog
 ODLUKE VIJEĆA
 o utvrđivanju stajališta koje u ime Europske unije treba donijeti na godišnjoj konferenciji stranaka Konvencije o zaštiti i upravljanju resursima aljaške kolje u središnjem Beringovu moru te o stavljanju izvan snage Odluke 11724/12
 VIJEĆE EUROPSKE UNIJE,
 uzimajući u obzir Ugovor o funkcioniranju Europske unije, a posebno njegov članak 43. stavak 2. u vezi s člankom 218. stavkom 9.,
 uzimajući u obzir prijedlog Europske komisije,
 budući da:
 (1)Člankom 38. Ugovora o funkcioniranju Europske unije u vezi s njegovim člankom 39. stavkom 1. točkom (d) predviđa se da je jedan od ciljeva zajedničke ribarstvene politike osigurati dostupnost opskrbe.
 (2)Člankom 2. Uredbe (EU) br. 1380/2013 Europskog parlamenta i Vijeća
 4
 predviđa se da se zajedničkom ribarstvenom politikom osigurava da su aktivnosti u ribarstvu i akvakulturi dugoročno ekološki održive i da se njima upravlja na način koji je u skladu s ciljevima postizanja gospodarskih i društvenih koristi te koristi za zapošljavanje i doprinosa dostupnosti opskrbe hranom. Osim toga predviđa se da Unija primjenjuje predostrožni pristup upravljanju ribarstvom i nastoji osigurati da se iskorištavanjem živih morskih bioloških resursa obnavlja populacija ulovljenih vrsta i održava iznad razina koje mogu proizvesti najveći održivi prinos. Njome se predviđa i da Unija nastoji poduzimati mjere upravljanja i očuvanja koje se temelje na najboljim dostupnim znanstvenim savjetima, promicati ribolovne metode koje pridonose selektivnijem ribolovu i izbjegavanju te smanjenju, koliko je moguće, neželjenog ulova, baviti se ribolovom s manjim utjecajem na morski ekosustav i ribolovne resurse te postupno eliminirati odbačeni ulov. Osim toga, člankom 28. Uredbe (EU) br. 1380/2013 izričito se predviđa da Unija ta načela primjenjuje u svojoj vanjskoj politici.
 (3)Poljska je ugovorna stranka Konvencije o zaštiti i upravljanju resursima aljaške kolje u središnjem Beringovu moru (dalje u tekstu: „Konvencija o Beringovu moru”). Unija nije stranka te Konvencije. U skladu s člankom 6. stavkom 9. Akta o pristupanju
 5
 sporazumima o ribarstvu koje su nove države članice sklopile s trećim zemljama upravlja Unija i Unija bi trebala provoditi sve odluke donesene u okviru Konvencije.
 (4)Odlukom Vijeća 7277/16 od 11. travnja 2016. Republika Poljska dobila je ovlasti da u interesu Unije pregovara o izmjeni Konvencije o Beringovu moru kako bi Unija postala ugovorna stranka te Konvencije. Taj se mandat trenutačno provodi. Podrazumijeva se da će nakon prihvaćanja Unije kao punopravne ugovorne stranke Konvencije o Beringovu moru Republika Poljska povući svoje članstvo iz Konvencije.
 (5)Vijeće je 10. srpnja 2012. donijelo Odluku 11724/12 o utvrđivanju stajališta koje u ime Europske unije treba donijeti u okviru Konvencije o zaštiti i upravljanju resursima aljaške kolje u središnjem Beringovu moru.
 (6)Odlukom 11724/12 predviđa se da se u njoj utvrđeno stajalište treba revidirati najkasnije do godišnje konferencije stranaka Konvencije o Beringovu moru 2016. Stoga je primjereno staviti izvan snage Odluku 11724/12 i zamijeniti je novom odlukom.
 (7)Zbog promjenjive prirode resursa kolje na području primjene Konvencije o Beringovu moru i posljedične potrebe da se stajalištem Unije uzme u obzir novi razvoj događanja, uključujući statističke, biološke i druge podatke koji se predstavljaju prije ili tijekom godišnje konferencije stranaka, za godišnje utvrđivanje stajališta Unije potrebno je utvrditi postupke u skladu s načelom lojalne suradnje među institucijama Unije sadržanim u članku 13. stavku 2. UEU-a.
 (8)S obzirom na to da EU nije stranka Konvencije o Beringovu moru, na godišnjoj konferenciji stranaka Konvencije o Beringovu moru EU zastupa Republika Poljska. Stoga je ova je Odluka upućena Republici Poljskoj.
 (9)U skladu s člankom 218. i člankom 3. stavkom 1. UFEU-a nakon pristupanja EU-a Konvenciji o Beringovu moru na godišnjoj konferenciji stranaka Konvencije o Beringovu moru EU zastupa Komisija. Stoga se od tog trenutka ova Odluka upućuje Komisiji,
 DONIJELO JE OVU ODLUKU:
 Članak 1.
 Stajalište koje treba zauzeti Europska unija na godišnjoj konferenciji stranaka Konvencije o Beringovu moru kada je to tijelo pozvano donositi odluke koje imaju pravni učinak utvrđeno je u Prilogu I.
 Članak 2.
 Godišnje utvrđivanje stajališta Unije na godišnjoj konferenciji stranaka Konvencije o Beringovu moru provodi se u skladu s Prilogom II.
 Članak 3.
 1.
 Stajalište Unije utvrđeno u Prilogu I. Vijeće ocjenjuje i, ako je potrebno, revidira na prijedlog Komisije najkasnije do godišnje konferencije stranaka Konvencije o Beringovu moru 2022.
 2.
 U slučaju pristupanja EU-a Konvenciji o Beringovu moru stavak 1. ovog članka nastavlja se primjenjivati do kraja razdoblja predviđenog u tom stavku.
 Članak 4.
 Odluka 11724/12 stavlja se izvan snage.
 Članak 5.
 1.
 Ova je Odluka upućena Republici Poljskoj.
 2.
 U okolnostima predviđenima člankom 3. stavkom 2. ova Odluka upućuje se Europskoj komisiji, koja zastupa EU na konferenciji stranaka Konvencije o Beringovu moru.
 Sastavljeno u Bruxellesu
 Za Vijeće
 Predsjednik
 (1)
 SL L 236, 23.9.2003., str. 33.
 (2)
 Uredba (EU) br. 1380/2013 Europskog parlamenta i Vijeća o zajedničkoj ribarstvenoj politici, izmjeni uredaba Vijeća (EZ) br. 1954/2003 i (EZ) br. 1224/2009 i stavljanju izvan snage uredaba (EZ) br. 2371/2002 i (EZ) br. 639/2004 i Odluke Vijeća 2004/585/EZ (SL L 354, 28.12.2013., str. 22.).
 (3)
 COM(2011)424, 13.7.2011.
 (4)
 Uredba (EU) br. 1380/2013 Europskog parlamenta i Vijeća o zajedničkoj ribarstvenoj politici, izmjeni uredaba Vijeća (EZ) br. 1954/2003 i (EZ) br. 1224/2009 i stavljanju izvan snage uredaba (EZ) br. 2371/2002 i (EZ) br. 639/2004 i Odluke Vijeća 2004/585/EZ (SL L 354, 28.12.2013., str. 22.).
 (5)
 Akt o uvjetima pristupanja Češke Republike, Republike Estonije, Republike Cipra, Republike Latvije, Republike Litve, Republike Mađarske, Republike Malte, Republike Poljske, Republike Slovenije i Slovačke Republike i prilagodbama ugovora na kojima se temelji Europska unija (SL L 236, 23.9.2003., str. 33.).
 ---documentbreak---
 EUROPSKA KOMISIJA
 Bruxelles, 8.5.2017.
 COM(2017) 215 final
 PRILOZI
 Prijedlogu ODLUKE VIJEĆA
 o utvrđivanju stajališta koje u ime Europske unije treba donijeti na godišnjoj konferenciji stranaka Konvencije o zaštiti i upravljanju resursima aljaške kolje u središnjem Beringovu moru te o stavljanju izvan snage Odluke 11724/12
 PRILOG I.
 Stajalište Unije na godišnjoj konferenciji stranaka Konvencije o Beringovu moru
 (1)Načela
 Unija u okviru Konvencije o Beringovu moru:
 a)
 osigurava da su mjere donesene unutar godišnje konferencije stranaka Konvencije o Beringovu moru u skladu s ciljevima i načelima Unije utvrđenima u okviru zajedničke ribarstvene politike, posebno primjenom predostrožnog pristupa i s pomoću ciljeva povezanih s najvećim održivim prinosom kako je utvrđeno člankom 2. stavkom 2. uredbe (EU) br. 1380/2013, kako bi se promicala primjena pristupa upravljanju ribarstvom temeljenog na ekosustavu kojim se ograničava utjecaj ribolovnih aktivnosti na okoliš, kako bi se u navjećoj mogućoj mjeri izbjegao i smanjio neželjeni ulov i postupno eliminirao odbačeni ulov te kako bi se na najmanju moguću mjeru smanjio utjecaj ribolovnih aktivnosti na morski ekološki sustav, te promicanjem gospodarski održivog i konkurentnog ribolova Unije, kako bi se osigurao primjeren životni standard onima koji ovise o ribolovnim aktivnostima vodeći računa o interesima potrošača;
 b)
 osigurava da su mjere donesene u okviru godišnje konferencije stranaka Konvencije o Beringovu moru u skladu s ciljevima Konvencije o Beringovu moru;
 c)
 osigurava da su mjere donesene u okviru godišnje konferencije stranaka Konvencije o Beringovu moru usklađene s međunarodnim pravom, a posebno s odredbama Konvencije UN-a o pravu mora, Sporazuma UN-a o očuvanju i upravljanju pograničnim ribljim stokovima i vrlo migratornim ribljim stokovima, Sporazuma o promicanju usklađivanja ribarskih plovila na otvorenom moru s međunarodnim mjerama za očuvanje i upravljanje i Sporazuma o mjerama države luke Organizacije za hranu i poljoprivredu iz 2009.
 d)
 promiče stajališta koja su dosljedna s onima koja su zauzeta u okviru drugih regionalnih organizacija za upravljanje ribarstvom i, prema potrebi, s regionalnim konvencijama o moru na istom području;
 e)
 nastoji ostvariti sinergiju s politikom koju Unija provodi kao dio svojih bilateralnih odnosa u području ribarstva s trećim zemljama i osigurava usklađenost s njezinim drugim politikama, posebno s onima koje se odnose na vanjske odnose, okoliš, trgovinu, razvoj, istraživanje i inovacije te s drugima;
 f)
 osigurava poštovanje međunarodnih obveza Unije;
 g)
 slijedi Zaključke Vijeća od 19. ožujka 2012. o Komunikaciji o vanjskoj dimenziji zajedničke ribarstvene politike
 1
 ;
 h)
 nastoji na temelju istih načela i standarda koji se primjenjuju u okviru prava Unije stvoriti ujednačene uvjete za flotu Unije na području primjene Konvencije te promicati ujednačenu provedbu rezolucija i preporuka.
 (2)Smjernice
 Unija prema potrebi nastoji podupirati donošenje sljedećih mjera od strane godišnje konferencije stranaka Konvencije o Beringovu moru:
 a)
 mjere za očuvanje ribolovnih resursa i upravljanje njima na području primjene Konvencije o Beringovu moru koje se temelje na najboljim dostupnim znanstvenim savjetima, uključujući ukupni dopušteni ulov (TAC-ovi) i kvote za resurse aljaške kolje regulirane u okviru Konvencije o Beringovu moru. Prema potrebi, razmotrit će se posebne mjere za stokove koji su izloženi prelovu kako bi se omogućila obnova stokova;
 b)
 mjere praćenja, kontrole i nadzora na području primjene Konvencije o Beringovu moru kako bi se povećala učinkovitost mjera kontrole i usklađenost s mjerama donesenima u okviru Konvencije o Beringovu moru;
 c)
 jačanje mjera za sprečavanje nezakonitih, neprijavljenih i nereguliranih ribolovnih aktivnosti, odvraćanje od njih i njihovo zaustavljanje na području primjene Konvencije o Beringovu moru;
 d)
 zaštitne mjere za osjetljive morske ekosustave na području primjene Konvencije o Beringovu moru u skladu s rezolucijama Opće skupštine UN-a;
 e)
 razvoj zajedničkih pristupa s ostalim regionalnim organizacijama za upravljanje ribarstvom;
 f)
 dodatne tehničke mjere utemeljene na savjetima Znanstvenog i tehničkog odbora osnovanog u okviru Konvencije o Beringovu moru.
 PRILOG II.
 Godišnje utvrđivanje stajališta Unije koje treba zauzeti
 na godišnjoj konferenciji stranaka Konvencije o Beringovu moru
 Prije svake godišnje konferencije stranaka Konvencije o Beringovu moru poduzimaju se potrebni koraci kako bi se osiguralo da se stajalištem koje se izražava u ime Unije uzimaju u obzir najnoviji statistički, biološki i drugi relevantni podaci dostavljeni Europskoj komisiji, u skladu s načelima i smjernicama određenima u Prilogu I.
 U tu svrhu i na temelju tih podataka Europska komisija Vijeću ili njegovim pripremnim tijelima prije svakoga godišnjeg sastanka Konvencije o Beringovu moru pravovremeno dostavlja pisani dokument u kojem se utvrđuju detalji prijedloga utvrđivanja stajališta Unije za raspravu i prihvaćanje.
 Ako tijekom daljnjih sastanaka, uključujući sastanke na licu mjesta, nije moguće postići dogovor kako bi se stajalištem Unije uzeli u obzir novi elementi, pitanje se upućuje Vijeću ili njegovim pripremnim tijelima.
 (1)
 vidi dok. 7086/12 PECHE 66


type: wikipedia

text:
Andrea Fappani (né en 1977) est un cavalier nord-américain d'origine italienne, « chuchoteur » (horse whisperer en anglais) et éthologue, vivant à Rio Verde en Arizona. Il est surtout connu pour ses résultats équestres en reining et grâce à ses méthodes d'enseignement à distance, qui démocratise cette discipline en Europe.
 Activités de « chuchoteur »
 Pédagogue, Andrea Fappani a participé à la construction d'une diffusion de la culture des horse whisperers grâce à une série de DVD.
 Reining Breeder Classic 2007
 Le cavalier américain Andrea Fappani a obtenu le score le plus élevé depuis les de la NRHA, avec 236,5. Le cheval qu'il montait se nomme Custom Legend, le fils de Crome. Andrea Fappani a monté trois chevaux en finale de ce NRBC avec un bras en écharpe à la suite d'un accident. Il n'a pas pu monter ces chevaux pendant les trois semaines précédant le show. Selon lui, c'est grâce au fabuleux travail de son assistant entraîneur, Arno Honstetter, que cette victoire est arrivée
 Acteur
 Il a fait plusieurs apparitions dans des séries americaines en lien avec l'équitation. Il était, par exemple, dans Yellowstone (série télévisée) en 2018 puis dans The last cow-boy en 2019 .
 Notes et références
 Voir aussi
 Articles connexes
 Chuchoteur
 Éthologie
 Reining
 Liens externes
 Vidéo de l'exploit européen pendant le Reining Breeder Classic 2007
 Biographie officielle de Andrea Fappani
 Ensemble d'interviews pendant le Reining Breeder Classic 2007.
 Cavalier américain
 Équitation éthologique
 Naissance en 1977


text:
 1103 (MCIII) a fost un an obișnuit al calendarului iulian.
 Evenimente
 10 martie: Se încheie pactul de la Dover dintre regele Henric I Beauclerc al Angliei și contele Robert al II-lea de Flandra, îndreptat împotriva lui Robert I Courteheuse, ducele Normandiei.
 24 aprilie: După ce a întreprins numeroase expediții în insulele Hebride, Orkney, Man și în Țara Galilor, regele Magnus al III-lea al Norvegiei moare în timpul campaniei din Irlanda, în Ulster; regatul Norvegiei trece în stăpânirea celor trei fii ai săi, care domnesc în comun.
 27 aprilie: Episcopul Anselm de Canterbury este silit să plece în exil, ca urmare a neînțelegerilor cu regele Henric I al Angliei.
 10 iulie: Regele Eric I al Danemarcei moare în Cipru, în timpul unui pelerinaj către Ierusalim; soția și fiica sa continuă călătoria.
 Nesatate
 mai: Bohemund I de Tarent, principele Antiohiei, este eliberat din captivitatea turcilor danișmenizi, pentru 100.000 de dinari ca răscumpărare; după ce revine la Antiohia și plătește musulmanilor suma datorată, Bohemund pleacă în Europa.
 Congres al cnejilor din Rusia, pentru a stabili apărarea comună dinspre zona stepei.
 Cu sprijin bizantin, Raymond de Saint-Gilles, conte de Tripoli, construiește "Qalaat Saint-Gilles", fortăreață destinată protejării Tripoli dinspre uscat.
 Este consemnat principatul selgiucid din Erzurum.
 Henric al IV-lea oferă protecție evreilor, care în schimb îi asigură plata unui impozit special.
 Orașul scandinav Lund devine sediu episcopal, sub oblăduirea papei Pascal al II-lea.
 Puternice inundații în regiunea Goa din India.
 Arte, științe, literatură și filozofie
 Arhitectul și omul de stat chinez Li Jie publică Yingzao Fashi (Modele de construcție), un tratat de arhitectură chinezească.
 Prima atestatre a folosirii busolei de către chinezi, pentru orientarea în largul mării.
 Înscăunări
 24 aprilie: Sigurd I Jorsalfare (până la 1130), Oystein (Eystein) I Magnusson (1103-1123) și Olaf al IV-lea Magnusson (1103-1115), în comun regi ai Norvegiei.
 Amedeo al III-lea, conte de Savoia și de Maurienne.
 Nașteri
 24 februarie: Toba, împărat al Japoniei (d. 1156).
 Alphonse I, conte de Toulouse (d. 1148).
 Andre de Montbar, mare maestru al Ordinului Templierilor (d. 1156)
 Harald al IV-lea, rege al Norvegiei (d. 1136).
 Decese
 23 februarie: Constantin I, rege al Armeniei (n.c. 1035)
 23 martie: Eudes I, duce de Burgundia (n. 1058)
 1 mai: Janah al-Dawla, emir de Homs (n. ?)
 10 iulie: Eric I al Danemarcei, rege al Danemarcei (n. 1060)
 24 august: Magnus al III-lea al Norvegiei (n. 1073)
 14 octombrie: Umberto al II-lea, conte de Savoia (n. 1065)
 Gabriel din Melitene, conducător armean (n. 1055)
 Rabinul Isaac Alfasi, savant și jurist evreu din Maroc (n. ?)
 Vezi și
 Listă de conducători de stat din 1103
 1103


text:
 14.7.2017
 HU
 Az Európai Unió Hivatalos Lapja
 L 183/1
 A BIZOTTSÁG (EU) 2017/1266 VÉGREHAJTÁSI RENDELETE
 (2017. július 11.)
 az egyes árucikkeknek a Kombinált Nómenklatúra szerinti besorolásáról szóló 2494/96/EK rendelet hatályon kívül helyezéséről
 AZ EURÓPAI BIZOTTSÁG,
 tekintettel az Európai Unió működéséről szóló szerződésre,
 tekintettel az Uniós Vámkódex létrehozásáról szóló, 2013. október 9-i 952/2013/EU európai parlamenti és tanácsi rendeletre (1) és különösen annak 57. cikke (4) bekezdésére és 58. cikke (2) bekezdésére,
 mivel:
 (1)
 A 2658/87/EGK tanácsi rendelet (2) mellékletét képező Kombinált Nómenklatúra (a továbbiakban: KN) egységes alkalmazása érdekében intézkedéseket szükséges elfogadni egyes árucikkek besorolásáról.
 (2)
 A 2494/96/EK bizottsági rendeletben (3) a „polietilén-tereftalátból készült, 10 mikrométer vastagságot meg nem haladó, hőfestékkel bevont fólia, amely[et] 62 cm széles tekercsként forgalmaznak”, a Kombinált Nómenklatúra 3215 vámtarifaszáma alá került besorolásra mint „Nyomdafesték, írótinta vagy tus és más tinta, koncentrátumban vagy szilárd alakban is”. A termék 3215 vámtarifaszám alá történő besorolása a Kombinált Nómenklatúra értelmezésének 3.b) általános szabályán alapult, de az indoklás nem tér ki részletesen a 3.b) általános szabály alkalmazásakor fontolóra veendő lehetséges vámtarifaszámokra. Hiányoznak különösen a 9612 vámtarifaszám kizárására vonatkozó indokok; ez alá a vámtarifaszám alá tartozik a bélyegzőpárna mellett az „írógép- vagy hasonló szalag, tintával vagy más anyaggal – lenyomat készítésére – átitatva, orsón vagy kazettában is”.
 (3)
 A 2494/96/EK rendelet az úgynevezett „óriás tekercsekre” vonatkozik, amelyek nem használatra kész termékek, hanem meglehetősen hosszú tekercsek, amelyek csak a gyártási folyamat egy további lépése után helyezhetők be írógépbe vagy hasonló gépbe. Ez az információ nem szerepel a 2494/96/EK rendelet mellékletében található termékleírásban, és az információ hiánya a tintával átitatott, használatra kész szalagok helytelen tarifális besorolásához vezethet. Azokat a tintával átitatott szalagokat, amelyek használatra készek, a 9612 vámtarifaszám alá kell besorolni.
 (4)
 mivel a 2494/96/EK rendelet tárgyát képező termék már nem érhető el a piacon, a rendeletre a továbbiakban már nincs szükség. A piacon jelenleg elérhető, tintával átitatott szalagok többsége – még az igen széles és hosszú szalagok többsége is – közvetlenül használható írógépbe vagy hasonló gépbe helyezve anélkül, hogy egy további lépésre lenne szükség a gyártási folyamatban. Emellett a 9612 10 10 – 9612 10 80 KN-alszámokra („szalag”) vonatkozó magyarázat kerül majd megfogalmazásra, hogy iránymutatást nyújtson a tintával átitatott szalagok tarifális besorolására vonatkozóan.
 (5)
 Következésképpen a tintával átitatott szalagok tarifális besorolása közötti lehetséges eltérések kiküszöbölése és a Kombinált Nómenklatúra Unión belüli egységes alkalmazásának biztosítása érdekében a 2494/96/EK rendeletet hatályon kívül kell helyezni.
 (6)
 Az e rendeletben előírt intézkedések összhangban vannak a Vámkódexbizottság véleményével,
 ELFOGADTA EZT A RENDELETET:
 1. cikk
 A 2494/96/EK rendelet hatályát veszti.
 2. cikk
 Ez a rendelet az Európai Unió Hivatalos Lapjában való kihirdetését követő huszadik napon lép hatályba.
 Ez a rendelet teljes egészében kötelező és közvetlenül alkalmazandó valamennyi tagállamban.
 Kelt Brüsszelben, 2017. július 11-én.
 a Bizottság részéről,
 az elnök nevében,
 Stephen QUEST
 főigazgató
 Adóügyi és Vámuniós Főigazgatóság
 (1) HL L 269., 2013.10.10., 1. o.
 (2) A Tanács 2658/87/EGK rendelete (1987. július 23.) a vám- és a statisztikai nómenklatúráról, valamint a Közös Vámtarifáról (HL L 256., 1987.9.7., 1. o.).
 (3) A Bizottság 2494/96/EK rendelete (1996. december 23.) egyes árucikkeknek a Kombinált Nómenklatúra szerinti besorolásáról (HL L 338., 1996.12.28., 38. o.).


text:
Saská Kamenice ( [ˈkɛmnɪt͡s], 1953–1990 , ) je třetím největším městem německé spolkové země Sasko. Saská Kamenice je nezávislým městem nepříslušným k žádnému okresu. Leží na severním úpatí Krušných hor a má obyvatel.
 Etymologie
 Město Kamenice je pojmenováno podle řeky Kamenice (Kamenice, přítok řeky Cvikovské Muldy), která jím protéká. Původnější je slovanský (lužickosrbský) název znamenající kamenný potok. Od 10. května 1953 do 31. května 1990 se město jmenovalo Karl-Marx-Stadt podle Karla Marxe.
 Historie
 Na místě dnešního města se nacházelo slovanské sídliště Kamienica. První zmínky o užití názvu Saská Kamenice pocházejí z roku 1143, kdy zde byl postaven benediktinský klášter, kolem kterého se celé sídlo začalo rychle rozrůstat. Asi v roce 1170 se Fridrich I. Barbarossa zaručil, aby byla městu udělena práva svobodného říšského města. V roce 1307 se město stalo součástí Míšeňského markrabství, předchůdce dnešního Saska. V dobách středověku byla Saská Kamenice centrem textilní výroby a obchodu. Více než třetina obyvatel pracovala v oděvnictví. Začátkem 19. století se město stalo významným průmyslovým centrem, mnohdy nazývaným
 saský Manchester, pro své silně průmyslové zaměření. V roce 1913 dosáhla populace Saské Kamenice 320 000, což bylo na tehdejší dobu velmi ojedinělé, větších měst bylo jen několik.
 Během druhé světové války byla Saská Kamenice centrem vojenské výroby a ve zdejší firmě Astra-Werke AG pracovalo také 500 vězňů (žen) z koncentračního tábora Flossenbürg. Vzhledem ke zde situované průmyslové výrobě bylo město během února a března 1945 mnohokrát bombardováno Spojenci. Následkem těchto náletů byla velká část města poničena, což se během následné poválečné rekonstrukce podepsalo na vzhledu výstavbou panelových sídlišť. Mnoho poničených památek bylo opraveno za doby NDR, některé však až po znovusjednocení Německa
 Následkem druhé světové války a následných demolicí některých budov poválečným režimem vzniklo ve městě mnoho nezastavěných volných ploch, které se po sjednocení Německa jevily jako lukrativní místo pro vznik nové zástavby. Některé části města se záhy proměnily ve staveniště, srovnatelné snad jen s výstavbou v 90. letech na Postupimském náměstí v Berlíně. Byly postaveny nové budovy, jako jsou např. nákupní centrum Kaufhof, nebo galerie ve věži Roter Turm.
 Dle zprávy BBC z roku 2006 má Saská Kamenice nejnižší porodnost na světě.
 Památky
 Čtvrť Kaßberg v historickém centru města, je jednou z největších secesních čtvrtí v Německu.
 Historická budova staré radnice s historickým portálem z 15. století.
 Zámek na místě dřívějšího benediktinského kláštera.
 Roter Turm, věž z přelomu 12. a 13. století, jež byla součástí městských hradeb.
 Technische Universität, technická univerzita, studuje zde přes 10 000 studentů.
 Památník Karla Marxe, busta Karla Marxe od Lva Kerbela.
 Kulturkaufhaus Tietz, nová nákupní galerie v centru města.
 Průmyslové muzeum, které je na seznamu památek mezinárodního sdružení Evropská cesta průmyslového dědictví.
 Museum Gunzenhauser, muzeum a galerie moderního umění, jedno z nejvýznamnějších v Německu. Bylo otevřeno v roce 2007 a obsahuje přes 2 459 děl od 270 autorů. Díla byla nasbírána Alfredem Gunzenhauserem.
 Hrad Rabenstein, nejmenší hrad v Sasku.
 Průmysl
 Saská Kamenice je největším městem v metropolitní oblasti Chemnitz-Zwickau, a je jednou z nejvýznamnějších oblastí v bývalém Východním Německu z hlediska hospodářství. Od roku 2000 vykazuje město velmi vysoký růst HDP, a patří tak v Německu mezi deset ekonomicky nejrychleji rostoucích měst. Základními zdroji příjmů města jsou služby a průmyslová výroba, jako je metalurgie a strojírenství.
 Doprava
 Město protínají dvě dálnice, A4 (z Erfurtu do Drážďan) a A72 (z Hofu do Lipska, která je zatím postavena jen z části). Tyto dvě dálnice se křižují na severozápad od města.
 Ve městě je provozována tramvajová (28,7 km) a autobusová (326,08 km) městská doprava a je zde také systém příměstských železnic (16,3 km). Tuto dopravu provozuje akciová společnost Chemnitzer Verkehrs. Městská doprava je v provozu i v noci.
 Nedaleko jihozápadního okraje města leží letiště Chemnitz-Jahnsdorf, jehož plocha byla rozšířena přelomu 20. a 21. století. Zhruba 30 km severozápadně od Chemnitz se nachází letiště Altenburg-Nobitz, provozované irskou leteckou společností Ryanair.
 Sport
 V Saské Kamenici jsou dva významné fotbalové kluby Chemnitzer FC a VfB Fortuna Chemnitz, který byl prvním klubem Michaela Ballacka. Město má také hokejový klub ERC Chemnitz e.V.
 Nedaleko Saské Kamenice se nachází motocyklový okruh Sachsenring, na kterém je pořádána každoročně velká cena mistrovství světa motocyklů MotoGP
 Osobnosti
 Georgius Agricola (1494–1555), německý učenec, otec mineralogie
 Max Littmann (1862–1931), architekt
 Karl Schmidt-Rottluff (1884–1976), malíř
 Paul Oswald Ahnert (1897–1989), astronom
 Helmut Schelsky (1912–1984), sociolog a filozof
 Stefan Heym (1913–2001), spisovatel
 Frei Paul Otto (1925–2015), architekt
 Klaus Wunderlich (1931–1997), hudebník
 Valerij Bykovskij (1934-2019), sovětský důstojník a kosmonaut ruské národnosti, čestný občan Saské Kamenice
 Sigmund Jähn (* 1937), vojenský letec a kosmonaut z tehdejší NDR
 Helga Lindnerová (* 1951), plavkyně, stříbrná medaile na letních olympijských hrách v roce 1968
 Katarina Wittová (* 1965), krasobruslařka
 Ingo Steuer (* 1966), krasobruslař
 Sylke Ottová (* 1969), sáňkařka
 Silke Kleinová (* 1971), překladatelka a tlumočnice, od listopadu 2009 jako první Němka starostka Zpěváckého spolku Hlahol v Praze
 Frank Rost (* 1973), fotbalový brankář Hamburger SV
 Mandy Wötzelová (* 1973), krasobruslařka
 Michael Ballack (* 1976), fotbalista
 Anja Mittagová (* 1985), fotbalistka, mistryně světa 2007
 Partnerská města
 Galerie
 Reference
 Externí odkazy
 Města v Sasku
 Svatojakubská cesta v Německu
 Přejmenovaná sídla v Německu
 Svobodná říšská města


type: caselaw

text:
 19.9.2016
 CS
 Úřední věstník Evropské unie
 C 343/45
 Žaloba podaná dne 29. července 2016 – sheepworld v. EUIPO (Beste Mama)
 (Věc T-422/16)
 (2016/C 343/61)
 Jednací jazyk: němčina
 Účastníci řízení
 Žalobkyně: sheepworld AG (Ursensollen, Německo) (zástupce: S. von Rüden, advokát)
 Žalovaný: Úřad Evropské unie pro duševní vlastnictví (EUIPO)
 Údaje týkající se řízení před EUIPO
 Sporná ochranná známka: Slovní ochranná známka Evropské unie „Beste Mama“ – Přihláška č. 14 169 304
 Napadené rozhodnutí: Rozhodnutí čtvrtého odvolacího senátu EUIPO ze dne 13. května 2016, ve věci R 95/2016–4
 Návrhová žádání
 Žalobkyně navrhuje, aby Tribunál:
 —
 napadené rozhodnutí zrušil;
 —
 uložil EUIPO náhradu nákladů řízení, včetně nákladů řízení před odvolacím senátem.
 Dovolávanýžalobní důvod
 —
 Porušení čl. 7 odst. 1 písm. b) nařízení č. 207/2009.