(b) (6) January 21, Copy Hand Delivered & Original Sent via Federal Express

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1 United States Food Safety Boulder District Office of Field Operations Department of and Inspection 665 South Broadway, Suite B. Agriculture Service Boulder, Colorado (b) (6) Foster Poultry Farms; Est. P-6164A 1700 South 13 th Avenue Kelso, Washington January 21, 2005 Copy Hand Delivered & Original Sent via Federal Express NOTICE OF INTENDED ENFORCEMENT This serves as official notification by the Food Safety and Inspection Service (FSIS) of our intent to withhold the marks of inspection and suspend the assignment of FSIS inspection program personnel at Foster Poultry Farms, Establishment P-6164A, 1700 South 13 th Avenue; Kelso, Washington. Background and Authority: The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) provide that it is essential in the public interest that the health and welfare of consumers be protected by assuring that meat and poultry products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged. These Acts give FSIS the authority, as designated by the Secretary of the Department of Agriculture, to prescribe rules and regulations describing sanitation requirements for inspected establishments. They also provide FSIS program personnel the authority to refuse to allow meat or meat food products, or poultry products, to be labeled, marked, stamped, or tagged as inspected and passed and to prevent the entry of products into commerce when the sanitary conditions of any such establishment are such that products are adulterated and provide definitions for the term adulterated. Furthermore, the Acts provide FSIS the authority to appoint inspectors from time to time to examine and inspect products, including the sanitary conditions of facilities. They also give FSIS program personnel the right to examine and inspect all carcasses and parts of carcasses that are further treated and prepared and the right to access and examine and copy establishment records. When the sanitary conditions of a facility are not properly maintained, FSIS can refuse to render inspection and indefinitely withdraw inspection from an establishment provided the establishment is afforded the right to an administrative hearing. Under the authorities of the Act, FSIS has prescribed rules and regulations required for establishments producing meat and poultry products, including the requirements pertaining to Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) (9 CFR Parts 416 and Part 417) and other matters. FSIS has also developed Rules of Practice regarding enforcement (9 CFR Part 500). FSIS FORM (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES

2 Foster Poultry Farms, Est. P- 6164A, Notice of Intended Enforcement ( )15-05-N002 Page 2 The Rules of Practice describe the types of enforcement action that FSIS may take and include procedures for withholding the marks of inspection and/or suspending the assignment of inspectors, with or without prior notification, and for filing a complaint to withdraw a grant of Federal inspection. Findings and Basis for the Action: On December 27, 2004, a comprehensive Food Safety Assessment (FSA) was initiated regarding the food safety systems at Establishment P-6164A. The assessment was initiated after receiving information that numerous Salmonella enterica serovar Heidelberg illnesses occurred in Washington, Oregon, and other states during the summer and fall of 2004, and because some of the persons who became ill reported to have consumed chicken produced by Establishment P- 6164A. On December 15, 2004, shortly before the FSA began, FSIS notified the establishment that results of FSIS Salmonella testing ongoing in the plant since November 2004, indicated that the establishment was likely to fail the sample set. The FSA team members were Enforcement Investigations and Analysis Officers (EIAOs), (b) (7)(C), and Dr. James Adams, Deputy District Manager of the Boulder District Office. The findings are presented below in six different categories: 1) S. Heidelberg illnesses Associated with Est. P-6164A Product, 2) Positive Salmonella Analyses of Est. P-6164A Product, 3) Failure to Comply with HACCP Regulatory Requirements (9 CFR Part 417), 4) Failure to Comply with Sanitation Performance Standards (SPS) Regulatory Requirements (9 CFR Part to 416.5), 5) Failure to Comply with Sanitation Standard Operating Procedures (SSOPs) (9 CFR Part to ), and 6) Failure to Comply with Poultry Products Inspection Regulatory Requirements (9 CFR Part 381). The findings demonstrate that poultry product at Est. P-6164A has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health, as defined in Section (g)(4) of the Poultry Products Inspection Act. The findings are the basis for this Notice of Intended Enforcement. 1) S. Heidelberg Illnesses Associated with Est. P-6164A Product On December 9, 2004, the Washington state epidemiologist notified the Foodborne Disease Investigations Branch, HHSD, OPHS, FSIS, of a Salmonella Heidelberg outbreak following a November 20 th, 2004 party. There were four (4) culture-confirmed cases of Salmonella Heidelberg infections and three (3) probable cases, with all 7 illnesses possibly related to chicken purchased from P- 6164A and consumed at the party. The Pulsed-Field Gel Electrophoresis (PFGE) pattern for the four (4) confirmed illnesses was JF6X This was a new pattern to the PulseNet database; since this was a new/rare pattern the second enzyme digest was not needed for identification or discrimination. The Washington state laboratory tested for Salmonella an unused intact sample of chicken associated with the party purchase. The Washington State laboratory reported that Salmonella species were found, however, they were unable to determine the serotype or PFGE pattern of the isolates from this product sample. FSIS FORM (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES

3 Foster Poultry Farms, Est. P- 6164A, Notice of Intended Enforcement ( )15-05-N002 Page 3 In 2004, there were 16 cases of salmonellosis (Salmonella Heidelberg) documented in Oregon, with PFGE pattern combination JF6X /JF6A This was a new two enzyme PFGE pattern combination for Oregon, and it is a relatively uncommon pattern combination in the national database, representing approximately 5% of Salmonella Heidelberg patterns. Date of illness onsets ranged from June to September, Epidemiological interviews revealed that two (2) persons reported consumption of product from P-6164A and two (2) other individuals consumed chicken of unknown source prior to illness onset. Also, one of the illnesses occurring in September was in an employee working at a grower facility for Foster Poultry Farms; per State health officials, the majority of birds from that grower facility go to P6164A. Additionally, Washington State had seventeen (17) cases of Salmonella Heidelberg matching the same PFGE pattern combination, JF6X /JF6A Seven (7) of these patients had known poultry exposure, unknown source. The illness PFGE pattern combination, JF6X /JF6A , matched one retail sample of chicken collected and tested by the State of Oregon, produced by 6164A. In summary, isolates from the 16 ill individuals in Oregon, the 17 ill individuals in Washington, and the one retail poultry sample from P6164A were all found to be indistinguishable by two enzyme PFGE analysis. Pattern combination, JF6X /JF6A , differs by one band from the most common Salmonella Heidelberg pattern combination in the national database, JF6X /JF6A , representing 55% of Salmonella Heidelberg patterns. Also during 2004, there were multiple Salmonella Heidelberg illnesses in Oregon and Washington with PFGE pattern combinations JF6X /JF6A and JF6X /JF6A These pattern combinations are relatively uncommon with (b) (4) JF6X /JF6A and JF6X /JF6A representing and 7% respectively in the PulseNet S. Heidelberg database. On visual inspection these two PFGE patterns were found to differ by a single band and were grouped together for epidemiologic evaluation purposes. A November 2004 PulseNet spreadsheet for these two related PFGE pattern combinations lists twenty (20) human cases distributed in six (6) states. The lab received date for the samples ranged from June through September Two enzyme PFGE pattern combinations were reported for ten (10) of twenty (20) human cases; five cases in Washington, four in Oregon, and one in Hawaii. The lab received date for the samples ranged from June through July The spreadsheet also included pattern identifiers for six (6) isolates from P- 6164A poultry samples collected by Oregon State officials at retail stores. These six (6) poultry isolates had PFGE pattern combinations JF6X /JF6A or JF6X /JF6A The lab received date for the samples ranged from May through September The state officials are re-interviewing the patients for potential poultry contact. Pulsed-field gel electrophoresis (PFGE) analysis is a molecular subtyping method that allows for the discrimination of bacterial isolates through the characterization of molecular proteins or nucleic acids. PulseNet, the Molecular Subtyping Network for Foodborne Bacterial Disease Surveillance, compares PFGE patterns from bacterial isolates obtained from human specimens and food and environmental samples. Clustering of isolates by PFGE pattern can assist epidemiologic investigators focused on the identification of a common source. 2) Positive Salmonella Analyses of Est. P-6164A Product During the assessment, FSIS and plant records were reviewed regarding Salmonella testing for broilers and ground poultry. FSIS FORM (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES

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5 Foster Poultry Farms, Est. P- 6164A, Notice of Intended Enforcement ( )15-05-N002 Page 5 Public Health Salmonella Testing Results: Oregon State s public health officials reported that nine (9) retail samples produced by P-6164A, Foster Poultry Farms, were collected and tested, all were positive for Salmonella Heidelberg. Seven (7) retail samples were collected for the National Antimicrobial Resistance Monitoring System (NARMS) Retail Study. Six (6) of these NARMS samples were positive for Salmonella Heidelberg with PFGE pattern combination. JF6X /JF6A and one NARMS sample was positive for Salmonella Heidelberg with PFGE pattern JF6X (no second enzyme was reported). The other two retail samples of raw intact chicken products, with freeze by dates of 10/6/04 and 10/17/04, were collected by the Oregon State epidemiologist at Costco in October, Both samples tested positive for Salmonella Heidelberg; one with PFGE pattern combination JF6X /JF6A and the other with JF6X /JF6A In addition, six human isolates and two chicken isolates were submitted for antimicrobial susceptibility. Salmonella enterica serovar Heidelberg is demonstrating increasing resistance to antimicrobial agents. One chicken isolate was resistant to Gentamycin and Streptomycin and the second isolate was inhibited by Streptomycin. None of the human isolates have demonstrated antimicrobial resistance. Salmonella Heidelberg Sample Linkage: As a result of the current Salmonella HACCP A-set sampling results provided by OPHS, the following conclusions may be drawn relating to the results to date: 1.) Eight (8) of fifteen (15) Salmonella isolates were serotype Heidelberg; 2.) Five (5) of the eight (8) Heidelberg match one of the three patterns previously identified in human illnesses in the States of Oregon and Washington. 3.) These results show that establishment P-6164A has had a problem with Salmonella Heidelberg, specifically with product PFGE patterns matching patterns found in human illnesses isolates from Oregon and Washington. 3) Failure to Comply with HACCP Regulatory Requirements ( 9 CFR Part 417) The findings below support that the establishment s HACCP plans are inadequate because they do not meet the requirements of 9 CFR Part CFR Hazard Analysis and HACCP Plan: The S. Heidelberg illnesses associated with Est. P-6164A product described above, plus the history of Salmonella positive samples of Est. P-6164A product also described above, clearly show that Salmonella is a hazard reasonably likely to occur before, during, and after entry into the establishment. The Hazard Analysis does not address Salmonella as a hazard reasonably likely to occur, and therefore fails to comply with 9 CFR 417.2(a). The Hazard Analysis only addresses Salmonella growth; to only address Salmonella growth is illogical if the Hazard Analysis does not in the first place address Salmonella as a hazard reasonably likely to occur. FSIS FORM (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES

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11 Foster Poultry Farms, Est. P- 6164A, Notice of Intended Enforcement ( )15-05-N002 Page 11 Three (3) 06D01 NRs were written from 10/1/2004, through 1/1/2005, documenting noncompliance with requirements. One NR number , dated 10/11/2004 documents non-compliance due to an exposed cloth band-aid on the finger of an employee handling soaker pads and product trays. On 12/13/2004, NR number documents, a piece of 12" x 24"cardboard was observed folded in half with one half of it inside a tub in direct contact with raw chicken livers, the NR indicates that the entire tub of chicken livers was rendered by the company. On 12/16/2004, NR number , documents an evisceration lead person was observed by Consumer Safety Inspector (CSI) (b) (7)(C) dumping a barrel of condemned product in the condemned room. The employee then returned to the evisceration department and washed her hands but did not change her smock or put on an apron prior to returning to the main evisceration line to perform a presentation test. The main line was stopped and the product contacted by the employee was immediately rendered. The employee was counseled on proper product handling practices. Numerous NRs have been documented by FSIS personnel from June, 2004 through the present which continually demonstrate the plant employees did not understand or practice good hygiene or follow the establishment GMPs. There is no evidence or documentation of employee training or oversight by establishment supervision. Other specific references are covered under SSOP. 5) Failure to Comply with Sanitation Standard Operating Procedures (9 CFR ) 9 CFR Development of SSOP The written SSOP does address the pre-operational procedures and the cleaning of food contact surfaces in both the evisceration and processing departments, and describes the daily activities that are conducted for pre-operational and operational sanitation inspections. However, the SSOP checklist used to monitor and verify the effectiveness of cleaning does not identify all equipment used by the plant. Therefore, the random selection approach that is described in the SSOP for equipment cannot be achieved, as all equipment is not considered when the establishment selects equipment to monitor and verify Maintenance of the SSOP Records reviewed revealed that SSOP re-evaluations are not being effectively conducted to address the deficiencies documented on FSIS NRs and weekly meeting notes as well as establishment QC records. As indicated by the linkage of the NRs and the recurring non-compliances, the establishment has failed to implement effective preventive measures in response to a food contact deficiency. In addition, the establishment has repeatedly failed to recognize and address the continual SSOP operational deficiencies involving insanitary practices and/or product cross contamination. For instance, from July, 2004, there were fourteen (14) NRs issued for unsanitary employee practices that resulted in cross contamination of product. There were thirteen (13) NRs written for grease smears and rail dust on broiler carcasses. There were seven (7) NRs for cross contamination as a result of contamination from trailing intestines on the evisceration line as a result of the PGI machine not functioning properly. Additional NR s were written for a variety of sanitation non-compliances. FSIS FORM (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES

12 Foster Poultry Farms, Est. P- 6164A, Notice of Intended Enforcement ( )15-05-N002 Page 12 From the date of December 9, 2004, to December 28, 2004, five additional operational sanitation NR s have been written and are documented on NRs 197 dated 12/06/04 for potential cross contamination; 201, dated 12/08/04, for potential cross contamination; 204, dated 12/13/04, for insanitary practices; 207, dated 12/17/04 and 211, dated 12/28/04, also for insanitary practices. During the month of August, 2004, direct product contamination was documented as repetitive NRs. Corrective actions during the time period did not address the issues of contamination in addressing adequate control and preventive measures. Additionally, the establishment stated in their response to the NRs after re-evaluation no changes or modifications were necessary to the SSOP Corrective Actions. Counseling of employees is being used and documented as a preventive measure in response to a food contact deficiency. However, the establishment could not provide any documentation to support the preventive measures of counseling the employee and monitoring the employee is actually being performed, or preventing reoccurrence Recordkeeping requirements. The establishment is conducting monitoring and verification and recording deficiencies on the days when deficiencies occur. However, the establishment does not generate records on the days when no deficiencies are found. Therefore, the establishment is not maintaining daily records as required. In addition, on numerous occasions when responding to noncompliance records the establishment s response has been employees have been counseled or trained. However, the establishment does not have any SSOP records to support that such counseling or training did in fact take place. 6) Failure to Comply with Poultry Products Inspection Requirements (9 CFR Part 381) 9 CFR Post-mortem Inspection, when required, extent, traditional, streamlined Inspection System (SIS), New Line Speed (NELS), Inspection System and the New Turkey Inspection (NTI) System; rate of inspection. Missing viscera, improper dispositions and inadequate presentations have been documented in both NR's and weekly plant meeting notes. The weekly meeting notes for 8/20/2004, 9/1/2004, 10/14/2004, 10/21/2004, 11/17/2004 and 12/8/2004 all indicate problems with plant trimmers/inspector s helper. According to the FSIS in-plant personnel, there is an on-going practice where the plant employees fail to drop giblet packs with intestines causing grossly contaminated viscera. When the intestines are pulled off viscera pacs in an unsanitary manner, fecal material becomes air-borne, causing cross-contamination of carcasses and equipment. Carcass presentation deficiencies, i.e. missing and non-uniform viscera, fecal and ingesta matter, were noted under procedure 06D02 in twelve NRs (130, 135, 146, 155, 156,159, 166, 174, 188, 203, and ) from 9/9/2004 to present. 9 CFR Contamination FSIS FORM (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES

13 Foster Poultry Farms, Est. P- 6164A, Notice of Intended Enforcement ( )15-05-N002 Page 13 Data collected from the eards pertaining to condemnation due to contaminated birds has been correlated to equipment malfunctions in the (b) (4) system. Maintenance personnel are responsible for adjusting equipment at the start of operation based on daily production records stating the origin of bird, lot size, age and weight of birds. The equipment adjustment made during operations is not documented. The findings of the in-plant FSIS personnel and observation of the FSA team is not consistent with the establishment s conclusion that the system is under control. After start up, the leading problems seen with the used of the (b) (4) system resulted from failure to maintain process control as evidenced by failing the No Viscera standard and failure to ensure synchronization of the viscera with the corresponding carcass. Inadequate equipment maintenance, substitution using other than (b) (4) compatible equipment, failure to adjust the equipment based on bird size, and attempts to process lots with birds of dissimilar size which exceeded the inherent system capacity to accommodate the range of sizes resulted in loss of process control. Summary FSIS Salmonella Performance Standard testing and plant Salmonella testing have identified a recurring presence of S. Heidelberg in your product. The most recent FSIS Performance Standard testing found eight of fifteen Salmonella isolates from the current A set sampling results were Heidelberg. Five of the eight Heidelberg match one of the three PFGE patterns previously identified in human illnesses in the States of Oregon and Washington including some people who have purchased or consumed your product. Given the low occurrence of this specific pathogen, the illness it has caused, and it s occurrence in your product, there is sufficient reason to believe that product produced by Foster Poultry Farms, Establishment P-6164A has borne this added poisonous substance at a level that has caused product to be injurious to health, and that the sanitary conditions, detailed above, under which product has been produced at Foster Poultry Farms, Establishment P-6164A, have not been adequate to ensure that product that is not injurious to health is produced. The District concludes poultry product in this establishment has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health, as defined in Section (g)(4) of the PPIA. In accordance with 9 CFR Part (Rules of Practice), FSIS is notifying you of our intent to withhold the marks of inspection and suspend the assignment of inspectors at your facility. Please provide this office with a written response concerning this notice of intended enforcement (NOIE) within three (3) working days from the date of receipt of this letter. We will determine further action, if any, based on your response. If you have any questions regarding this matter, you may call the Boulder District Office at Sincerely, (b) (7)(C) District Manager Boulder District FSIS FORM (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES

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