On January 21, 2005, the Boulder District Office issued a Notice of Intended Enforcement (NOIE) to Establishment P-6164A.

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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 CERTIFIED RETURN RECEIPT REQUESTED & FACSIMILE January 28, 2005 (b) (6) Foster Poultry Farms, Est. P-6164A 1700 South 13 th Avenue Kelso, Washington Dear Mr. (b) (6) This letter serves as official notification of suspension of the assignment of inspectors at your Establishment P-6164A, Foster Poultry Farms, Kelso, Washington. This suspension is based on concerns identified during a Comprehensive Food Safety Assessment with your Sanitation Performance Standards (SPS), Sanitation Standard Operating Procedures (SSOP) and Pathogen Reduction/ Hazard Analysis Critical Control Points (HACCP) and other food safety hazards. On January 21, 2005, the Boulder District Office issued a Notice of Intended Enforcement (NOIE) to Establishment P-6164A. On January 26, 2005, you provided the Boulder District Office with a facsimile of your proposed corrective actions, followed by a overnight delivery on January 27, 2005 containing documentation supporting your response to the Notice of Intended Enforcement (NOIE), which you outlined measures to bring your firm into regulatory compliance. FSIS carefully reviewed your responses and determined that the establishment s proposed actions and commitments were inadequate. Additionally, you did not fully address the deficiencies as outlined in the Notice of Intended Enforcement. We are requesting that your firm provide specific corrective actions and timelines on the following concerns: Standard Sanitation Operational Procedures (9 CFR 416), Hazard Analysis and Critical Control Points (9 CFR 417), Sanitation Performance Standards (9 CFR ), 9 CFR , 9 CFR and addressing the multiple Salmonella Set failures. The following is a list of issues or items which require clarification: Category #1 of the NOIE- Salmonella Heidelberg Illnesses Associated with Est. P-6164A Product On January 21, 2005, the Boulder District Office issued a Notice of Intended Enforcement (NOIE) to Est. P-6164A. The NOIE was divided into six separate categories, to assist establishment representatives in eliciting responses and explanations. In the General Manager s

2 Foster Poultry Farms, Est. P- 6164A, Notice of Suspension ( )15-05-S005 Page 2 reply, the first category, Salmonella Heidelberg Illnesses Associated with Est. P-6164A Product was not addressed in the company s letter, dated January 27, Mr. (b) (6) issued two statements in an effort to solidify Foster Poultry Farms opposition to the agency s position at this particular facility: Relative to Salmonella performance, S. Heidelberg in and of itself is not a specific regulatory organism and therefore is not targeted specifically for control in the industry. Foster Farms has been focusing on reducing Salmonella as a regulatory entity and not specific sero-types. The background for these statements, at least partly, do not account for the Salmonella persistence or the persistence of certain serotypes, including S. Heidelberg, in Foster Farm s poultry operation. Additionally, the establishment does not indicate how it will further evaluate its food safety system and effectively quantify food-related microbiological health risks attributable to the Salmonella bacteria. The epidemiological data and Salmonella test results of plant and FSIS associated with Establishment P-6164A s efforts also overshadow Food Safety and Inspection Services mandates for major reductions in the incidence of foodborne illness attributable to meat, poultry and egg products. The agency reiterates that it has clearly expressed and continues to express that there is sufficient epidemiological information linked to S. Heidelberg to believe Est. P-6164A is implicated in foodborne outbreaks in seven states over the past year, Category #2 of the NOIE- Positive Salmonella Analyses of Est. P-6164A Product Outlined FSIS Salmonella Test Results, Foster Poultry Farms, Est. P-6164A Salmonella Test Results, and Public Health Salmonella Testing Results. Further, it outlined the Salmonella Set failures, as well as Salmonella Heidelberg sample linkage involving illnesses. The firm responded by stating that Foster Farms has taken and will continue to take numerous actions both at the farm level, as well as specific activities in the facility that will be discussed in further detail to address their in-house Salmonella results, as well as those of FSIS. Further, the firm notes that Salmonella Heidelberg in and of itself, is not a specific regulatory organism and therefore is not targeted specifically for control in the industry. The response only provided timelines; there is no mention of Salmonella Testing. The firm has a history of continuously producing product containing S. Heidelberg. Plant, FSIS, and Oregon State Health records indicate the presence of Salmonella dating back to Many of the results identify Salmonella Heidelberg since Additionally, the Oregon State Health Dept. informed the firm about S. Heidelberg showing that they were aware that the State was also testing their product and also coming up positive with S. Heidelberg. The firm has no validation data or data to show the control or the reduction of Salmonella since was implemented. The firm did conduct a carcass rinse study between 12/13 through 12/20 and showed a decrease from 50% to 31.6%. A new carcass rinse study was to be initiated on 01/10/05; however, no results have been presented thus far. The establishment s documentation indicates that the plant is not meeting the Salmonella performance standard of 20%.

3 Foster Poultry Farms, Est. P- 6164A, Notice of Suspension ( )15-05-S005 Page 3 Category #3 of the NOIE- Failure to comply with HACCP regulatory Requirements (9 CFR 417) 9 CFR Hazard Analysis and HACCP Plan: The plant s response letter provides a re-assessment date of February 25, 2005, for the processing HACCP plans and Hazard Analyses. This date is unacceptable as the establishment wants to continue to produce products under HACCP plans that do not meet regulatory requirements. The injection process fails to recognize that Salmonella is a hazard in the process. The H/A for Slaughter has been changed to address Salmonella instead of Salmonella growth, but in doing so there were other changes made that affect the H/A. Specifically, the new H/A eliminated all CPs that were being used and now refers to the SSOP program for cross contamination of equipment. In reviewing the new SSOP program it states that. As contamination does occur with the evisceration of carcasses and equipment does get contaminated, there was no supporting documentation or rationale to explain that is sufficient in controlling cross contamination issues. There was also no frequency or procedures given for the monitoring of the. The first step in the new Slaughter H/A identifies that Salmonella is reasonably likely to occur on the surface of birds and in the intestinal tract at the receiving and live hanging step. The new Slaughter H/A at venting, evisceration,, crop removal, lung removal, neck, etc. and all other steps up to the final wash cabinet states there is no hazard reasonably likely to occur in the process. The final wash step in the H/A states that yes, there is a hazard for Salmonella and E. coli and justifies this by stating that this process is designed to remove visible fecal and reduce the level of Salmonella and E. coli. The statement made by the company on page 3, of the NOIE response letter that the 5% and 10% performance standards are only for machine performance is incorrect as the machine performance does affect contamination in the process. Since the H/A at the receiving step identifies Salmonella both on the outside and inside of the birds, to then state there is no hazard through these various evisceration steps is illogical as bird carcass contamination does occur based on plant and FSIS documentation. These hazards do exist but may or may not be controlled at a later step as indicated by the final wash cabinet justification. The plant s response still does not address the lack of scientific and/or supporting documentation for the level of being used at the current levels and only addresses the 90 day validation period for the new CCPs implemented in Slaughter for the use of Without the initial validation and decision making documents to support the Hazard Analysis for the selection of CCPs and critical limits as outlined in 9 CFR and 417.5(a)(2) FSIS could not perform the initial validation on this process to determine if the levels of being used by the establishment was effective in controlling Salmonella. Further, the validation period to 90 days should be reconsidered because P- 6164A HACCP plan has continually failed to prevent conditions resulting in a food safety hazard. This should extend to all of P-6164A s HACCP plans. The Establishment s Slaughter HACCP plan, is not clear as to where CCPs 4B and 5B have been implemented within the process.

4 Foster Poultry Farms, Est. P- 6164A, Notice of Suspension ( )15-05-S005 Page 4 For clarification the plant s response states that the validation of the new CCPs will be completed within the 90 days provided by 304.3(c). This regulation states that before producing new products an establishment must conduct a hazard analysis and develop a HACCP plan then validate the plan within the 90 days as quoted by the establishment. The plant is not introducing new product but adjusting process controls. The plant s response did not address the issue of reassessments based on Salmonella results. The establishment s reassessment team considered the possibility of cross contamination associated with the injection process and concluded the following: The practices and equipment described in the NOIE are common in the industry and have not been attributable to any known cross contamination. The temperature of the marinade is maintained below growth of Salmonella. (b) ( degrees Fahrenheit, which prevents the There are no regulatory Salmonella performance standards for this type of process and the finished product is labeled with the safe food handling statement. We agree with the plant s statements; however the poor sanitary dressing procedures and inadequate Hazard Analysis have a detrimental effect on the marinade process by introducing a food safety hazard reasonably likely to occur in arriving birds to the interior musculature of the product. The letter failed to address physical introduction of Salmonella to inner meat surfaces. The letter failed to address marinade becoming contaminated or acting as a holding media for Salmonella bacteria as this marinade is injected into the carcasses and parts. The supporting documentation provided does not state where the temperature of the marinade is taken, and according to the brine temperature chart submitted by the plant, the temperature is only taken once a week. The establishment needs to provide justification for frequency. The establishment needs to also provide justification for choice and or placement of CP or CCP. The plant s response only addresses a temperature of F. Although there is no performance standard for Salmonella in injected birds, the PPIA (21 USC 451 ET Seq) states health and welfare of consumers must be protected by assuring meat and poultry products be wholesome, not adulterated etc. The establishment has not addressed hazards associated with their injection needles in their marinating process as to biological hazards, nor have they provided any procedures for the cleaning of these needles in their GMPs, SSOPs. No Hazard Analysis or HACCP plan was provided for evaluation. Additional CCPs for the use of that when validated, will demonstrate the further reduction of Salmonella on product used in the injection process. The processing HACCP plan and Hazard Analysis, for Injected product was not presented. The Slaughter HACCP plan has a date for validation of March 6, 2005, for this plant. Whole

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11 Foster Poultry Farms, Est. P- 6164A, Notice of Suspension ( )15-05-S005 Page 11 Establishment states that the microbiological performance indicates that history for their establishment supports that the SSOP program relative to pre-op is functioning as intended. Establishment has not addressed operational sanitation for which the continuous machine rinse is in conjunction with the evisceration process step. Only pre-op is addressed in the firms statement. Operational sanitation was not addressed in P-6164A s response for their evisceration process and cross contamination deficiencies. 9 CFR 416.5(a) (b) Employee Hygiene: Establishment states all new hires receive general GMP instructions during initial orientation, which is documented in their personnel file. The supervisor or trainer provides additional GMP training to the new employee prior to them being assigned work responsibilities and that this training is documented. Provide documentation of personnel that have been trained. Establishment fails to address the reassessment of training materials and the method of administering this training or ways to prevent the recurrence of deficiencies associated with employee hygiene. List the differences in the referenced training that will make it an effective tool to educate and prevent the reoccurrence of deficiencies associated with employee hygiene. Provide a copy of the old training materials, as well as the new training materials. Establishment states all employees will receive refresher GMP training between March 1, 2005 and April 30, 2005 and that it will be documented. Given the continued sanitation non-compliances, the dates given for training are not acceptable. The training should occur more expeditiously. Establishment has not addressed the issue of the retraining of employees which has been a repetitive answer on establishment documentation and non-compliance reports generated by FSIS personnel. Category #5 of the NOIE- 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 written SSOP for pre-op and operational sanitation appeared vague in the selection process for equipment and/or areas that will be monitored prior to and during operations. The written SSOP program only describes a rinse down at lunch break for the processing/packaging room. It could not be determined from the written SSOP plan if this rinse down at lunch applied to the lunch period on first shift or second shift, or both. As this

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14 Foster Poultry Farms, Est. P- 6164A, Notice of Suspension ( )15-05-S005 Page 14 A review of the SSOP sheet addressing the reassessment of the program does not reveal any entry that indicates that the firm reacted to repetitious NR findings or items brought up at the weekly meetings. The firm response only addresses their findings (trends) and fails to address the findings of the USDA staff. 9 CFR Corrective Actions: As indicated by the linkage of the NR s 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) NR s issued for insanitary employee practices that resulted in cross contamination of product. There were thirteen (13) NR s written for grease smears and rail dust on broiler carcasses. There were seven (7) NR s for cross contamination as a result of contamination from trailing intestines on the evisceration line as a result of the machine not functioning properly. Additional NR s were written for a variety of sanitation non-compliances. From the date of December 9, 2004, to December 28, 2004, five additional operational sanitation NR s have been written and are documented on NR s 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. The establishment advised that as of January 17, 2005, any SSOP documents that reference counseling of employees as a preventative measure is being documented. Firm s response fails to address this section of the NOIE. The firm does not address the repetitive NR s or the ineffective corrective/preventive measures. PBIS Reader information revels that from 09/01/04 to 12/27/04 a total of 44 NR s in the 01B01 & 02 and 01C01 & 2 categories were written. From 12/28/2004 (the start of the assessment) to 01/26/2005 a total of 24 NR s in these categories have been documented. Noncompliance reports in these categories still appear to be numerous. Repetitive entries of statements relating to counseling of the employee have been ineffective in preventing the re-occurring of those types of deficiencies. There is no mention of re-evaluation of the training program. Neither does the firm propose increased monitoring during operations. The operational sanitation portion of the SSOP only addresses the monitoring of the break time rinse down. There does not appear to be a clearly identified section addressing the observation of employee s habits and over all area condition by the QC personnel or designee during operation other than at break times. The SSOP describes the sanitation procedures but does not address the monitoring (or frequencies) to be preformed by the monitoring individuals.

15 Foster Poultry Farms, Est. P- 6164A, Notice of Suspension ( )15-05-S005 Page 15 9 CFR Recordkeeping Requirements: The establishment was not generating a record of any training or counseling of employees as reflected in response to numerous NR s documented relating to unsanitary conditions or practices. The establishment has not supplied any documentation of training or counseling. Category #6 of the NOIE- Failure to comply with Poultry Products Inspection requirements (9 CFR and 9 CFR ) 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 helpers. 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. Establishment states, trimmers and inspector helpers will be retrained on proper disposition of gib pac with attached intestines by February 1, Retraining of personnel has been a repetitive answer given by the firm in answering NR s of all causes. It would appear that the retraining of personnel has not been effective as a corrective/preventive measure. Plant has not considered correcting improper presentation. Answer provided by Establishment: There has been no USDA documentation to indicate that fecal material has become airborne or that product contact surfaces have become contaminated by airborne fecal material. Although this comment is true, as far as NR s are concerned, the proper removal of long pieces of viscera at the machine from the gib pacs will avoid the inspectors trimmers having to remove the long pieces while the viscera is in a shackle above or in close proximity to the opened carcass(es). The firm s answer does not address the preventing of the long viscera at the machine rather only states the retraining of personnel to remove them after the machine. Establishment responded, carcass presentation deficiencies i.e. missing and non-uniform viscera, fecal and ingesta matter, are allowed as part of the FPS standards and the cited NR s are random deviations in the process and are not indicative on insanitary conditions or operating in noncompliance of

16 Foster Poultry Farms, Est. P- 6164A, Notice of Suspension ( )15-05-S005 Page 16 Finished Products Standards (FPS) (CFR ) is a process control program for other consumer protection and quality factors in poultry slaughter. At the pre-chill location carcasses are sampled for trim and processing non-conformances. Examples of trim non-conformances are; compound fracture, untrimmed short hock, sores, scabs, etc. Examples of processing nonconformances include oil glands, intestine, extraneous material, crop, etc. At the post chill location extraneous material is a nonconformance. Currently FPS does not include feces and FPS is not a process control indication of sanitary dressing. The Agency s food safety standard for feces is zero (hence zero tolerance) and the standard is applied just prior to the chiller ( (e)). If feces is found on a FPS pre-chill verification check, (which is located just prior to the chiller) the finding is documented on an NR as a monitoring noncompliance and the establishment is required to meet the corrective actions of (a). Prior to the point where zero tolerance for feces standard is applied, the finding of feces is evaluated from a process control perspective. That is, the scope, degree, and amount (e.g. the number of carcasses affected) is taken into to account to determine whether sanitary dressing is in control. (This is not a zero tolerance standard.) Sanitary dressing may be part of an establishment s SSOP or another prerequisite program or not part of any program. Documentation of non-compliances by FSIS is according to how the plant handles sanitary dressing. The was designed to decrease contamination by separating the viscera from the carcass prior to USDA inspection. At inspection the viscera is present, but detached from the carcasses. In addition to a presentation check a no viscera check is performed (b) at the machine to assure that no more than % of carcasses are missing a viscera pack. (Standards for presentation and no-viscera are contained in the training package.) At on-line postmortem inspection, the on-line inspector inspects the inside, outside of the carcass and the viscera. If contamination is observed on or inside carcasses, the on-line inspector makes a disposition that the carcasses are hung for off-line reprocessing or are condemned (if carcasses are contaminated to the extent the inspector cannot determine whether the carcasses are wholesome). If the establishment has an on-line reprocessing, the on-line inspector allows the carcasses contaminated with feces, inside or outside the carcass to go down line, except, if the carcasses are grossly contaminated; then they are hung-back for off-line reprocessing. (If carcasses are contaminated to the extent the inspector cannot determine whether the carcasses are wholesome, the carcass is condemned.) Off-line inspection personnel should evaluate whether sanitary dressing from a process control perspective is in control by observing operations along the slaughter line. This activity is separate from checking FPS and from checking zero tolerance. It is possible for a plant to meet zero tolerance standard, and not have sanitary dressing in control. Repetitious NR s, 12 involving this issue in the past four months concludes that the instances are not, random deviations in the process. NR dated 09/08/2004 has a missing viscera check failure and a retest failure. NR dated 09/09/2004 has a missing viscera check failure and a retest failure. This NR also documents a presentation failure and a retest failure. NR dated 9/13/04 has a missing viscera test failure. It also

17 Foster Poultry Farms, Est. P- 6164A, Notice of Suspension ( )15-05-S005 Page 17 documents a presentation failure and a retest failure. NR dated 11/1/04 has a missing viscera failure and a retest failure. NR dated 11/19/04 has a presentation test failure and a retest failure. NR dated 12/9/04 documents presentation test failures when done on several stands and retests failures on several stands. NR dated 01/06/2005 documents a presentation test failure and a retest failure. NR dated 01/11/2005 documents a failure in a missing viscera test and the subsequent retest failure. A NR dated 01/18/2005 documents a presentation test failure on several stands. These NR s are linked and also document ineffective corrective/preventive measures by the firm meant to avoid the recurrence of the failures. It appears that, when these defects or presentation issues arise, the firm is not able to respond in a manner timely enough to meet the ten minute retest time period. 9 CFR Contamination: Data collected from the eards pertaining to condemnation due to contaminated birds has been correlated to equipment malfunctions in the 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 to be made at the start of 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 approval, the leading problems seen with the used of the 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 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. Answer provided by Establishment: As previously stated the, performance standard referenced in the NOIE has been established for a system based on machine performance for the transfer of the gib pacs from the carcass to the pac shackle line. This is not designed to control Salmonella growth. In reassessing the hazard analysis we have deleted all references to Salmonella growth. The section of the NOIE referenced by the firm discusses the issue of contamination resulting in the condemnation of carcasses. The answer does not satisfy the question of grossly contaminated carcasses resulting in the condemnation of those carcasses. The new hazard analysis only refers to cross contamination of carcasses by the machinery. The hazard analysis does not address the gross contamination of the interior of the carcass due to the spillage of intestinal tract contents that were a result of machine error. Answer provided by Establishment: October 5, 2004 representatives from evaluated the performance of the system and made numerous modifications to the equipment. In addition, will conduct a re-evaluation on March 5, 2005 and Foster Farms has signed a long term service agreement to provide semi-annual servicing of the system and to be on call in case of gross machine malfunctions.

18 Foster Poultry Farms, Est. P- 6164A, Notice of Suspension ( )15-05-S005 Page 18 Although this appears to be a step in the right direction, other facts need to be examined. Fully half the NR s noted above involving presentation and missing viscera occurred after the service call by The first was less than a month (11/1/04) post service call. The NOIE alludes to, Inadequate equipment maintenance, substitution using other than 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. Missing viscera, poor presentation, and contaminated carcasses may not qualify as gross machine malfunctions referred to by the firm; therefore, will not be contacted. Annual or semi-annual service visits will not correct these items on a daily or flock by flock basis. The firm fails to address what action they will take to ensure the daily operation of the machinery to avoid gross contamination resulting in the condemnation of carcasses. As previously stated in the NOIE 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. The issues addressed above may not be all inclusive of all of the concerns in question and may be an issue with more than one program. Please provide a written response to the Boulder District Office addressing the issues identified above with further clarification. As a federally inspected establishment, you are expected to comply with all regulatory requirements concerning the preparation, sale, handling and transportation of meat and poultry products capable of use as human food from becoming adulterated or misbranded. The Poultry Products Inspection Act (PPIA) prescribes the legal requirements you are responsible for concerning this matter. Sanitation Performance Standards, SSOP, and HACCP noncompliance has continued it is apparent that the corrective actions and preventive measures taken in response to the NOIE were inadequate, ineffective and did not meet 9 CFR Parts 416 and 417. Furthermore, the suspension is being taken as provided by and according to 9 CFR 500.4, (Rules of Practice.) Furthermore repetitive SSOP non-compliance is a failure to maintain sanitary conditions in accordance with the PPIA, Section 7 (21 U.S.C. 456).

19 Foster Poultry Farms, Est. P- 6164A, Notice of Suspension ( )15-05-S005 Page 19 Based on these events, the FSIS Boulder District Office has concluded that a suspension at Est. P-6164A is warranted and will remain in effect until such time you provide adequate written assurances in an action plan outlining procedures you will implement. In order to reinstate the assignment of FSIS inspectors at Est. P-6164A, the following information must be provided in your written responses: 1. Identify what qualitative assessment process the plant used to determine the nature and cause associated with noncompliance with Sanitation Performance Standards your SSOP and HACCP plans, or other process deficiencies. 2. Identify what the assessment revealed as the likely cause of the problem, that is, the specific reasons the systems failed. 3. Specify the actions taken or planned to eliminate the identified causes of the SSOP and HACCP or other process deficiencies. 4. Describe the specific changes to be made to your SSOP and HACCP plan or other control plans. 5. Define the future monitoring activities that the plan will use to ensure that the changes are effectively implemented and appropriately executed, as well as identify actions to be taken if monitoring activities identify failures. You may appeal this action by contacting: Executive Associate for Regulatory Operations USDA, FSIS, FO Room 2130 South Building 1400 Independence Ave. SW Washington, D.C Telephone: (202) Facsimile: (202) In accordance with 9 CFR Part 500.5(d), you may request a hearing concerning this action by contacting: Director Evaluation and Enforcement Division Office of Program Evaluation, Enforcement and Review Food Safety and Inspection Service United States Department of Agriculture West End Court Building, Room 300 Washington, D.C Telephone: (202) Facsimile: (202)

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