May 14,2010. Mr. Edibey Kucukkarca, President E.N.A. Meat Packing, Inc. (Est /P-17778) 240 E. 5 th Street Paterson, NJ LETTER OF WARNING

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1 United States rood Safety Field Philadelphia District Department of and Inspection Operations Mellon Independence Agriculture Service 701 Market Street- Suite 4100A Philadelphia, P A May 14,2010 CERTIFIED-RETURNED RECEIPT REQUESTED Mr. Edibey Kucukkarca, President E.N.A. Meat Packing, Inc. (Est /P-17778) 240 E. 5 th Street Paterson, NJ LETTER OF WARNING Dear Mr. Kucukkarca: On September 21, 2009, the Food Safety and Inspection Service (FSIS) served an official Notice of Intended Enforcement (NO IE) to withhold the marks of inspection and suspend the assignment of inspection program personnel (IPP) at E.N.A. Meat Packing Inc., (Est /P 17778) located in Paterson, NJ, from products produced under your slaughter-beef, slaughtercalf with hide on, slaughter-iamb/goat/sheep HACCP plans. This decision was made in accordance with the Rules of Practice 9 CFR (a) (b) and (c). The notice was based on the findings of a Comprehensive Food Safety Assessment (CFSA), conducted by (b)(6),(b)(7)(c) (Ph. D), Enforcement and Investigation Analysis Officer (EIAO), who compiled documentation from August 17, 2009, through September 10, 2009, which identified and documented your failure to comply with the regulatory requirements pertaining to Hazard Analysis and Critical Control Point (HACCP) 9 CFR 417, and the Sanitation Performance Standards (SPS) 9 CFR 416. In accordance with FSIS' Rules of Practice, 9 CFR Parts (a) (b) and (c), FSIS notified you in writing of our intent to withhold the marks of inspection and suspend the assignment of inspectors at your facility. We afforded you an opportunity to demonstrate why an ineffective Sanitation Program, SSOP, and inadequate HACCP system determination should not be made, or submit a plan consisting ofcorrective actions that will ensure regulatory compliance of your food safety systems including Sanitation, HACCP, and SSOP. FSIS asked you to provide the Philadelphia District Office with a written response concerning the issues identified in the NOIE within three (3) working days from the day of receipt of the letter, and also advised you we would determine further action, if any, based on your response. On Friday September 25, 2009, you received the NOIE advising you to respond within three business days.

2 On October 2, 2009, the Philadelphia District Office received your contesting the basis for the proposed action relative to the Sanitation issues in which were addressed. On October 9, the Philadelphia District Office responded to your appeal and granted a portion of the appeal; the other issues remained in the NOIE, that needed to be addressed. On October 16, 2009, you submitted a letter to Dr. (b)(6),(b)(7)(c), (DVM), and Executive Associate for Regulatory Operation (EARO) Office of Field Operations (OFO), where you appealed the other issues in the NOIE. On October 22, 2009, after a review of your letter, Dr. (b)(6),(b)(7)(c) denied your appeal. He advised you in his response to provide the Philadelphia District Office a substantive written response to address all the non compliances and food safety concerns associated with the NOIE that had not been resolved. On November 12, 2009, your firm submitted a proposed written response to the NOIE. In those responses, you indicated a willingness to make all necessary corrective actions to meet the regulatory requirements of 9 CFR Part 416 and Part 417. These measures included, but were not limited to: (1) Reassess your slaughter HACCP plan for Beef, Calf with Hide, Lamb and Goat to correct all deficiencies to comply with 417. (2) Provide ongoing support for your food safety system where all the food safety hazards will be identified, and where all the preventive measures to control those hazards will be addressed, (3) Provide Personal Hygiene training program (GMP) for all your employees, and (4) Reevaluate your SSOP plans to meet all regulatory requirements, (5) Provide corrective actions to meet the Sanitation Performance Standards for the deficiencies documented by FSIS in the NOIE. On November 12, 2009, based on your response, FSIS made the decision to place the enforcement action in abeyance pending verification by FSIS Inspection Program Personnel (IPP) that the proposed actions have been effective. As part of the abeyance, FSIS developed a Verification Plan. This plan was designed to allow FSIS personnel to verify that you fully implemented the corrective actions proposed to your SPS, and HACCP plans and any additional supporting programs, and that these revisions and actions were effective in assuring ongoing regulatory compliance. During the abeyance period, FSIS personnel have verified your proposed corrective actions were effective. Regulatory requirements have now been met, and this incident is officially closed. Your plant personnel should continue to monitor operations to assure continued compliance to meet the SPS, and HACCP regulations to prevent failures from occurring in the future. Although the NOIE and subsequent abeyance are no longer in effect, please be advised that we consider violations of this type serious in nature. As a federally inspected establishment, you are expected to comply with 9 CFR Part 416 and 417 of the regulations and all other requirements concerning the preparation, sale, and transportation of meat and/or poultry products. Failure to comply with these requirements in the future could lead to the withholding or suspension of inspection or other appropriate action. We expect persons engaged 111 the handling of meat and/or poultry products to comply with all the regulatory requirements. We urge your voluntary compliance. 2

3 If you have any questions, please contact (b)(6),(b)(7)(c) (Ph.D), Enforcement Investigation and Analysis Officer (EIAO) at (215) 430 (b) (6) or (800) 637-(b) (6) ext. (b) (6) Sincerely, /s/ William Stewart, SEIAO for Mr. Jan T. Behney Philadelphia District Manager 3

4 cc: FO/Quarterly Enforcement Report Mr. Zygmunt Sala, Director, CID, FSIS, OPEER, Washington, DC Mr. James Borda, RM, FSIS, OPEER, Philadelphia, PA Me Jan T. Behney, DM, FSIS, OFO, Philadelphia District Office Me Paul Loulis, DDM, FSIS, OFO, Philadelphia District Office Ms. Susan Scarcia, DDM, FSIS, OFO, Philadelphia District Office (b) (6) (b) (6) (b) (6) (b) (6) (b)(6),(b)(7)(c) (b) (6) Est. File M/P SEIAO, FSIS, OFO, Philadelphia District Office, SEIAO, FSIS, OFO, Philadelphia District Office S, FSIS, OFO, Philaqelphia District Office retary (DM), FSIS, OFO, Philadelphia District Office O, Newark Circuit, FSIS, OFO, Philadelphia District Office, FLS, Newark Circuit, FSIS, OFO, Philadelphia District Office CSI-Relief; IIC, Newark Circuit, FSIS, OFO, OFO, Philadelphia District Office (Ph. D), EIAO, FSIS, OFO, Philadelphia District Office FSIS-OFO (b)(6),(b)(7)(c) (Ph. D):EIAO:EE:05/14/10 4

5 United States Food Safety Field Philadelphia District Department of and Inspection Operations Mellon Independence Center Agriculture Service 701 Market Street- Suite 4100A Philadelphia, P A Mr. Edibey Kucukkarca, President E.N.A. Meat Packing, Inc. (Est.17778) 240 E. 5 th Street Paterson, NJ NOTICE OF DEFERRAL Dear Mr. Kucukkarka, November 20, 2009 CERTIFIED-RETURN RECEIPT REQUESTED On September 21, 2009, the Food Safety and Inspection Service (FSIS) served an official Notice of Intended Enforcement (NO IE) to withhold the marks of inspection and suspend the assignment of inspection program personnel at E.N.A. Meat Packing Inc., (Est. l7778/p-17778), located at 240 E. 5 th Street in Paterson, NJ. This decision was made in accordance with the Rules of Practice 9 CFR (a) (b) and (c). This notice was based on the findings of a Comprehensive Food Safety Assessment, conducted by (b)(6),(b)(7)(c) (Ph.D), Enforcement Investigation, and Analysis Officer (ElAO), which documented your failure to comply with the regulatory requirements pertaining to Hazard Analysis and Critical Control Point (HACCP) 9 CFR Part 417 and Sanitation Standard Operating Procedures (SSOP) 9 CFR Part 416. In accordance with FSIS, Rules of Practice, 9 CFR Parts (a) (b) and (c), we notified you in writing of our intent to withhold the marks of inspection and suspend the assignment of inspectors at your facility. We afforded you an opportunity to demonstrate why an ineffective Sanitation Program, SSOP, and inadequate HACCP system determination should not be made, or submit a plan consisting ofcorrective actions that will ensure regulatory compliance of your food safety systems including Sanitation, HACCP, and SSOP are met. We asked you to provide the Philadelphia District Office with a written response concerning the issues identified in the NOIE within three (3) working days from the day ofreceipt of the letter, and we also advised you we would determine further action, if any, based on your response. On Friday September 25, 2009, you received the NOIE advising you to respond within three business days. On October 2, 2009, the Philadelphia District Office received your contesting the basis for the proposed action relative to the Sanitation issues in which I addressed.

6 On October 9, the Philadelphia District Office responded to your appeal. I granted a portion of the appeal; but on the other part, I found that the NOIE to your firm was supportable. On October 16, 2009, your establishment submitted a letter to Dr. (b)(6),(b)(7)(c) (DVM), Executive Associate for Regulatory Operation (Office of Field Operations), where you appealed the NOIE. On October 22, 2009, after a review of your letter, Dr. (b)(6),(b)(7)(c) denied your appeal. He advised you in his response to provide the Philadelphia District Office a substantive written response to address all the non compliances and food safety concerns associated with the NOIE that has not been resolved. On November 12, 2009, your firm submitted a proposed written response to the NOIE. In those responses, you indicated a willingness to make all necessary corrective actions to meet the regulatory requirements of 9 CFR Part 416 and Part 417. These measures included, but were not limited to: (1) Reassess the establishment's slaughter HACCP plan for Beef, Calf with Hide, Lamb and Goat to correct all deficiencies to comply with 417. (2) Provide on going support for the establishment's food safety system where all the food safety hazards will be identified, and where all the preventive measures to control those hazards will be addressed, (3) Provide Personal Hygiene training program (GMP) from all your employees, and (4) Reevaluate your SSOP plans to meet all regulatory requirements, (5) Provide corrective actions to meet the Sanitation Performance Standards for the deficiencies documented by FSIS in the NOIE by November 23, You provided written assurances that management is committed to achieving full compliance to all regulatory requirements and these written assurances appear to reflect your commitment for a more effective program. FSIS has carefully reviewed your responses and made a decision to defer an enforcement action based upon your immediate and proposed corrective measures. FSIS has created a Verification Plan and will monitor and verify that your proposed actions have been effectively implemented. FSIS personnel will continue to monitor your operations and provide you an opportunity to demonstrate that regulatory compliance has been achieved. A copy of the FSIS Verification Plan is attached to assist you in understanding the importance of the Agency's verification activities. This plan is designed to verify that your establishment fully implements the revisions to its plans and that these revisions are effective to assure continuous regulatory compliance. The plan identifies your corrective action written in your proposal, the relevant regulatory requirements, and the ISP code under which FSIS will conduct verification activity. The FSIS Verification Plan includes the expectation that you will meet all commitments identified in your corrective action plan within the specified time frames.

7 Please be advised that, as a federally inspected establishment, you are expected to comply with Title 9 of the Code of Federal Regulation (CFR) Part 417, Part 416 and all other requirements concerning the preparation, sale, and transportation of meat and/or poultry products. Failure to comply with these requirements or to effectively implement the corrective measures outlined in your written response may lead to withholding or suspension activities or other appropriate actions. Further questions should be directed to Mr. (b)(6),(b)(7)(c) Enforcement Investigation and Analysis Officer (EIAO) at: (215) 430-(b) (6) Sincerely, /s/ (Pau{P,. ou{is, (j)(j)9vf for Jan T. Behney District Manager Enclosure: The Food Safety and Inspection Service Verification Plan

8 cc: FO/Quarterly Enforcement Report Mr. Zygmunt Sala, Director, CJD, FSlS, OPEER, Washington, DC Mr. James 1. Borda, RM, FSlS, OPEER, Philadelphia, PA Mr. Jan T. Behney, OM, FSlS, OFO, Philadelphia District Office Ms. Susan G. Scarcia, DDM, FSlS, OFO, Philadelphia District Office \1r. Paul Loulis, DDM, FSlS, OFO, Philadelphia District Office (b)(6),(b)(7)(c) ElAO Supervisor, FSlS, OFO, Philadelphia District Office \(b)(6),(b)(7)(c) ElAO Supervisor, FSIS, OFO, Philadelphia District Office (b)(6),(b)(7)(c) (Ph.D), ElAO, FSlS, OFO, Philadelphia District Office (b) (6) VMO, Newark Circuit, OFO, Philadelphia District (b)(6),(b)(7)(c), FLS, Newark Circuit, OFO, Philadelphia District (b)(6),(b)(7)(c) CSl/IIC, FSIS, OFO, Philadelphia District Est. File FSIS: FO: (b)(6),(b)(7)(c):eiao:fd:11!20/09

9 E.N.A. Meat Packing Inc. Est. Ol7778/P Verification Plan November 20, 2009 Verification is defined as those activities, other than monitoring, that determine the validity of the food safety systems and these systems are operating in accordance to regulations. On September 21,2009, E.N.A Meat Packing Inc.; Inc. was issued a Notice of Intended Enforcement (NOIE) for failure to comply with part 9 CFR 417and part 9 CFR 416. This verification plan is designed to verify that the establishmcnt is implementing the prescribed corrections to the HACCP, SSOP and prerequisite plans in accordance with target dates shown on the to the NOIE. FSIS inspection personnel will perform the following procedures on a scheduled or IlnsC'.henllled basis. I ESTABLISHMENT ACTION PLANS The assigned CSIIIIC is to verify that management I REGULATION 9 CFR 417 ISP CODE 03J01 DUE DATE has reassessed the slaughter (Beef, Lamb, Goat) HACCP Plans, and has supporting documentation to support their decisions made in the HACCP plans where all the pathogens of concern are identified. The CSIIIIC is to veify that: At the processing step of "Receiving Live Animals", the establishment identifies all the pathogens of concern. At the processing steps of: the establishment identifies not only to identify the biological concerns that may arise in its food safety systems; but provides any supporting documentation for the decision made in its hazard analysis. The establishment's hazard analysis III place IS properly implemented and is effective in addressing all hazards; and that it has all the supporting documentation to verify and implement the decisions. made in the Hazard Analysis.. The establishment has adequate Supp011ing documentation of the decisions made in the hazard analysis. The establishment provides decision makmg and supporting documents for the frequencies of the I monitoring and verification of the Critical the CCPs in your HACCP plans.

10 2) QC CSIIIIC has 9 CFR DOI ) The assigned CSIIIIC is CSI has to 9CFR416.2(h)1 06DOI ) The assigned CSIIIIC is to verify that: in accrdance with 9CFR 416.2(h)1 9 CFR DOI ) The CSI IIIC is to verify that: The broken water pipe in the kill floor area is repaired in accordance with 9 CFR 416.2( e)(2) where by plumbing systems is installed and maintained to properly convey sewage and liquid disposablewaste from the establishment. 9 CFR 416.2(e)2 06DOI i in accordance with Sanitation Performance Standards. 7) The assigned CSIIIIC Also verify to make sure that the establishment displays sllch sign to educate its cllstomers per their response. 9 CFR DOI

11 , , ~--r ---~ , 9 CFR ) The CSVIIS is to! He/she is to verify that a log with the Sanitation *Verification procedures are to be performed as scheduled under PBIS unless indicated otherwise above or instructed differently by the Frontline Supervisor

12 United States Food Safety Field Philadelphia District Department of and Inspection Operations Mellon Independence Center Agriculture Service 701 Market Street- Suite 41 OOA Philadelphia, P A September 21,2009 CERTIFIED-RETURN RECEIPT REQUESTED tjilh~fs Mr. Edibey Kucukkarca, President lj~... -V1 ( E.N.A. Meat Packing, Inc. (Est ) 240 E. 5 th Street Paterson, NJ NOTICE OF INTENDED ENFORCEMENT Dear Mr. Kucukkarca, This serves as official notification by the Food Safety and Inspection Service (FSIS) of its intent to withhold the marks of inspection and suspend the assigrunent of inspection program personnel at E.N.A. Meat Packing [nc., (Est /P-I7778) located at 240 E. 5 th Street in Paterson, New Jersey. This action is taken in accordance with the rules ofpractice 9 CFR Part (a) (b) and (c). f5.ils:kground Authority The Federal Meat Inspection Act (FMIA) (21 U.S.c. 602 et seq.) and Poultry Products Inspection Act (PPIA) (21 U.S.c. 451 et seq.) provide that it is essential for 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 lules and regulations describing sanitation requirements for inspected establislul1ents. 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 tem1 "adulterated". Furthem10re, 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 establishment records. When the sanitary conditions of a facility are not properly maintained, FSIS can refuse inspection and indefinitely withdraw inspection from an establishment provided the establishment is afforded the right to an administrative hearing.

13 Under the authorities of these Acts, FSIS has prescribed rules and regulations required for establishments producing meat and poultry products, including the requirements pertaining to sanitation and Hazard Analysis and Critical Control Point (HACCP) (9 CFR Part 416 and Part 417) and other matters. FSIS has also developed Rules of Practice regarding enforcement (9 CFR Pali 500). The Rules of Practice describe the types of enforcement action that FSIS may take and include procedures for taking a withholding action and/or suspension, with or without prior notification and for filing a complaint to withdraw a Grant of Federal Inspection. Federal Meat Inspection Act (FMIA) 21 U.S.c. 608 provides Food Safety and Inspection Service (FSIS) program personnel the right to examine and inspect all carcasses and carcass parts that are treated and prepared, as well as the right to access and examine 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. Findings/Basis for Action A comprehensive food safety assessment was performed by (b)(6),(b)(7)(c) (Ph.D) Enforcement InvestigatiOn and Analysls 0fficer (EIAO), at your establishment from August 17, 2009, through September 03, The following information is provided to suppoli this Notification of Intended Enforcement (NO IE) for your facility. The decision to institute this action at your establishment is based on your failure to meet the regulatory requirements of the Sanitation Perfonnance Standards (SPS) 416.1, 416.2( e)(2), 416.2(h)(1), and 416.5(a)(b); Sanitation Standard Operating Procedures (SSOP): 9 CFR Pati , , , and ; the Hazard Analysis and Critical Control Point (HACCP) 9 CFR (a)(1), 417.5( a)(1 )(2). The following information is given to SUppOlt this action. Sanitation Perfonnance Standards (SPS) The regulatory requirements for Fsrs' Sanitation Performance Standards (SPS) require that official establishments must operate under sanitary conditions in a manner that ensures that product is not adulterated, and that does not interfere with FSIS inspection. Observations during the FSA lead to the detel1nination that your establishment has repetitive sanitation noncompliances, especially with regard to facilities/structures. You have failed to maintain sanitary conditions as required by the regulations. The facility SPS noncompliances could negatively affect public health by allowing product to be produced under insanitary conditions. If insanitary conditions persist, product produced at your establishment could be considered adulterated as defined by the FMIA. The following observations docllment your failures to meet the Sanitation Perf0l111ance Standards to ensure sanitary conditions are maintained in a manner sufficient to prevent product is not adulterated. 2

14 FSIS observed product being loaded 111to vehicles used to transpolt products from your establishment. The inside of the vehicles were not clean and a foul odor emanated from the vehicle(s). In this instance, you have failed to comply with the regulatory requirement of which states that if product is held under insanitary conditions, it may become adulterated. From August 17, 2009, thru September 03, 2009, plant personnel (employees) were observed going back and forth from the kill floor to the manager's office; and sitting outside during their breaks with their bloody garments on. Since the employees were observed wearing their gannents without coverings or removing them prior to exiting the slaughter floor, it's possible that environmental contaminants could have adhered and remained on the outside area of the gam1ents causing cross-contamination, due to the facts that employees re-enter the processing room with the same gannents they wore while they were sitting outside. In this instance: you failed to comply with the regulatory requirement 9 CFR (a) (b) where by: "All persons working in contact with product, food-contact surfaces, and product packaging materials must adhere to hygienic practices while on duty to prevent adulteration of product and the creation of insanitary conditions." "Clean gal111ents must be WOl11 at the start of each working day and ga1111ents must be changed during the day as necessary to prevent adulteration of product and the creation of insanitary condition" From August 17th to August 27th, 2009, the employees' break room locker was filled with two (2) weeks old used bloody stained coats emanating a foul odor. Yet the establishment's prerequisite program developed after the suspension of 03114/06, ensures that no food debris is left, and that rooms are cleaned and maintained in a sanitary manner to include procedures for monitoring conditions at a frequency of two (2) times per day. The establishment monitoring log record signed by QC manager (b) (6) ; and reviewed throughout the Food Safety Assessment, revealed no non compliance. Conclusion can be drawn that the establishment is not executing its program as written; and as intended since insanitary conditions still exist three years after the notice of suspension, as observed throughout the Food Safety Assessment. You have failed to comply with the regulatory requirement 9 CFR (h)(i) ad comply with your written program. The establishment's grounds and facilities are not maintained in a sound manner to prevent conditions that could lead to insanitary conditions and adulteration. On August 18, 2009, while perfol111ing the pre operation procedures, FSIS noticed broken (water pipe) ejecting water throughout the kill floor. On August 29, 2009, FSIS observed non-properly conveyed sewage in the basement whereby, filthy sewage waste was dripping and a foul odor was detected. Broken pipes in the establishment resulting in water dripping through the basement, coupled with the water from the sewage, this created an insanitary condition in the Westem part of the basement. This provides evidence that the establishmcnt does not, or can not provide adequate floor drainage in all its areas where floors are subject to flooding type cleaning, or where al operations release and discharge water, or other liquid waste on the

15 floor. You failed in this instance to comply with the regulatory requirement 9 CFR 416.2(e) (2); where by: plumbing must be installed and maintained to properly convey sewage and liquid disposable waste from the establishment. The outside premises (adjacent to E.N.A main building), the grounds between E.N.A, and the hides building are not well kept and maintained to prevent conditions that could lead to insanitary conditions, adulteration of the products. FSIS observed debris cluttering this area and observed two stainless steel bins which contained at least 6 chicken decomposing heads, each lying at the bottom of the container and attracting Hies. The perimeter of your facility is a harborage and breeding area which is not maintained 111 a sanitary manner sufficient to prevent the creation of insanitary conditions. On five (5) occasions, FSIS observed nies on the loading dock where carcasses are staged for shipping. Based on FSIS' finding observed and documented during the food safety assessment, it was detel1nined that the establishment failed to comply with its proposed corrective actions from the 2006 Notice of Suspension to maintain your facility and grounds to prevent conditions that could lead to insanitary conditions and adulteration of product. The establishment failed to design, execute and meet the Sanitation Performance Standards in accordance with 9 CFR Parts 416. Sanitary conditions are not being maintained within and outside the facility. The above are failures of your establishment to implement the Sanitation Perfol1nance Standards (SPS) CFR 416.1, and 416.2(e)(2), 416.6, (h)(1). Sanitation Standil.IcL" Operation Procedures (SSOP) The regulations for the Sanitation SOPs require that each official establishment shall develop, implement, and maintain written standard operating procedures for sanitation in accordance with the requirement of 9 CFR FSIS has detemlined you are not complying with the Sanitation SOPs Regulations of the USDA's Food Safety Inspection Service (FSIS) On August 17,18,19,20,24,25,26, 28,2009, as observed during the assessment, your retail customers were seen entering the processing rooms (coolers) with their street clothes on. Your SSOP has a procedure that requires designated coats to be WOl11 over street clothing prior to entering the cooler. Failure to comply with this procedure could create an insanitary condition since your customers did not comply with your SSOP procedure. During the preoperational inspection, FSIS observed a beef carcass (hind qum1er) dragging on the cooler Hoor. The establishment failed to take COITective action until after FSIS identified the non compliance. You failed to properly implement your establishment's own SSOP. 4

16 Hazard Analvsis and Critical Control Point (HACCP) 9CFR 417 Slaught. -Beef, Slaughter - Calf with Hide, Slaughter Lamb and Goat: (a) (1) (a) The comprehensive food safety assessoji::.pt identified your establishment's failure to provide supporting documentation for the decisions made within your hazard analysis for the Beef Slaughter, the Slaughter- Calf with Hide, and for the Slaughter of Lamb and Goat HACCP plans. You have not considered all the hazards associated with the following steps: At the processing step of "Receiving Live Animals", the establishment failed to identify the pathogens of concel11. At the processing steps of: "Holding Live Animals, Separation base on Age, Liver/Heart Branding, Tongue Removal, Branding and Rinsing Heads, Splitting carcasses in quarters, Testical I Pizzel Removal, Tactical Inspection, Packaging, Shipping, US.D.A. Retain in Chiller, First Trim, Final Trim, and Final wash", the establishment failed not only to identify the biological concems that may arise in its food safety systems; but also could not provide any supporting documentation for the decision made in its hazard analysis. The establishment's hazard analysis in place is not implemented properly; and may not be effective in addressing all hazards. it does not have the supporting documentation to verify the implementation referenced in the Hazard Analysis. This is a non compliance with 9 CFR 417.5(a) (1), for your establislunent failure to have adequate supporting documentation of the decisions made in the hazard analysis. The establishment failed to provide decision making and supporting documents for the frequencies of the monitoring and verification and the selection of the Critical Limits of the CCPs in your HACCP plans. The above illustrate the establishment's multiple failures in failing to comply with the regulatory requirments. Thus, the plant's food safety procedures in place may be ineffective in ensuring the safety of product produced at your establishment. Summa."v SSOP regulations require establishments to evaluate routinely the effectiveness of their SSOP in preventing the adulteration of their products. Your establishment has failed to perfonn such tasks to keep its SSOP effective according to Sanitary conditions arc not being maintained within your facility and meat products produced may ijecome adulterated, if it has been prepared, packed, or held under insanitary conditions, whereby it may have become contaminated with filth, or whereby it may have been rendered injuriolls to health as defined in Federal Meat Inspection Act (FMIA) 21 US.c. 60 I (m). The establishment's RACCP Plan in place is not implemented properly. It may not be effective in reducing the likely risk in the slaughter/processing environment. It does not have all the supporting documentation for the decisions made to verify the implementation referenced in tbe Hazard Analysis.

17 Additionally, your establishment failed to maintain the HACCP programs and the decision making documentations associated with those programs to demonstrate compliance with regulatory requirements. It failed to support the verification activities with decision making documents associated with your HACCP plans; it failed to effectively implement and evaluate the effectiveness of its SSOP procedures, and the Sanitation Perfonnance Standards. Therefore, products produced could become adulterated as defined in Federal Meat Inspection Act (FMIA) 21 U.S.c. 601(m)(4) ifit 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. Theses findings are consistent with a detennination that your HACCP plan may be inadequate based on the design and execution of the program as defined in 9 CFR Part Therefore, product produced could become adulterated if it has been prepared, packed, or held under unsanitary conditions whereby, it may have become contaminated with filth, or whereby, it may have been rendered injurious to health as defined in the Federal Meat Inspection Act (FMIA) 21 U.s.c. 601(m)(4). In accordance with FSIS' Rules of Practice 9 CFR Part 500.4(a) (b) (c), we are notifying you of our intent to withhold the marks of inspection and suspend the assignment of inspectors at your facility. Therefore, we are affording you an opportunity to demonstrate why an ineffective Sanitation program, SSOP and inadequate HACCP System determination should not be made, or submit a plan consisting of corrective actions that will ensure regulatory compliance of your food safety systems including Sanitation, HACCPand SSOP are met. Please provide this office with a written response conceming this Notice of Intended Enforcement (NOIE) within three (3) working days from the date of your receipt of this letter. We will detelllline further action, ifany, based on your response. If you have questions, or concerns regarding this matter, please feel free to contact (b)(6),(b)(7)(c) (b)(6),(b)(7)(c) (Ph.D), Enforcement Investigation Analysis Officer (EIAO), in the Philadelphia District Office at (b) (6) Ext. (b) (6) Sincerely, Susan G. Scarcia For Mr. Jan T. Behney Philadelphia District Manager 6

18 FO/Quarterly Enforcement Report Mr. Zygmunt Sala, Director, CID, FSIS, OPEER, Washington, DC Mr. James T. Borda, RM, FSIS, OPEER, Philadelphia, PA Mr. Jan T. Behney, OM, FSIS, OFO, Philadelphia District Office Ms. Susan G. Scarcia, DDM, FSIS, OFO, Philadelphia District Office Mr. Paul Loulis, DDM, FSIS, OFO, Philadelphia District Office (b) (6) (b)(6),(b)(7)(c) (b)(6),(b)(7)(c) (b)(6),(b)(7)(c) (b)(6),(b)(7)(c) Est. File - Ol7778/P CS, FSIS, OFO, Philadelphia District Office (Ph.D), EIAO, FSIS, OFO, Philadelphia District Office, SVMO, Newark Circuit, OFO, Philadelphia District, FLS, Newark Circuit, OFO, Philadelphia District CSI/IIC, FSIS, OFO, Philadelphia District 7