BIG BEEF MEAT INSPECTION REPORTS. These inspection reports were obtained by the Kansas City Star under the federal Freedom of Information Act.

Transcription

1 BIG BEEF MEAT INSPECTION REPORTS These inspection reports were obtained by the Kansas City Star under the federal Freedom of Information Act.

2 00003L M Swift Beef Company /09/ C (c), 416.2(a) On July 9, 2010, at approximately 1430 hours, while on a tour of the slaughter department, I, was notified by Dr. that he was observing some gnats on a few lamb carcasses at the final inspection rail. At about 1443 hours after I had performed a HACCP check in the Offal department, I performed a review and observation of scheduled PBIS procedure 01C02 just after the final inspection rail. I noticed on three of seven carcasses, two gnats on one carcass and four to five gnats on two other carcasses. Regulatory control was taken by CSI by stopping the production line while the gnats were trimmed off. No USDA tag was required. This is in violation of Regulations 416.1, 416.4(d), and (c). I immediately notified Mr. QA Superintendent, that gnats (b)(6)(b)(7)( were being observed on the carcasses. Mr. also observed the gnats. I verbally (b)(6)(b)(7)( notified Mr. that a noncompliance report would be written. Mr. verbal preventive measure to CSI was that he would have someone spray the roof and plant exterior for gnats. SSOP records stated that the door was left open on the north dock allowing the gnats to get into the Kill Floor. He also stated that the QA department will monitor all doors to make sure they are kept closed. The Plant's SSOP revision date January 13, 2005, States under "General Product Handling" (b) (4) Regulation (c) states that, "Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP's." This noncompliance is not being linked to any other NR.

3 00003L M Swift Beef Company /09/ J (a)(3), 417.2(c)(4), J02 Slaughter: At approximately 1450 hours on July 10, 2010, I, CSI notified Ms. (QA Tech) that I wanted to perform a CCP-1 zero tolerance check on Lamb heads. Companies HACCP Plan, CCP-1 states (b) (4) As I was performing the scheduled PBIS 03J02 on a box of Lamb heads after the scale, I observed the following deficiencies: two pieces of straw, one 1/8"x1/4" and another 1/8"x1/8" on the tenth head of a 10 head check, on the back of the skull next to (b)(6)(b)(7)( (b)(6)(b where the head is severed. About 1452 hours I verbally notified Ms. Mr. (QA Superintendent), and Mr. (Slaughter Superintendent) who were all observing while I conducted inspection on Lamb heads, that fibrous plant like material was found, which they also observed, and that a noncompliance report would be written. This is in violation of Regulations 9 CFR 417.2(c) (4), , 416.4(d), and Corrective action taken by the company was: To Head take out the head and trim off the contamination. Preventive measure taken by plant management was: Contamination was shown to the Offal trimmer and both trimmers on the head table. No immediate USDA regulatory control tag was placed on the product already boxed because an additional two box check, in accordance with plants written procedures, was immediately performed by USDA on the product produced. The twenty heads checked (10 per box) were found acceptable. The establishment's variety meats HACCP Plan dated August 13, 2009 failed to identify and meet the Zero Tolerance standards for visible fecal/ingesta material as stated on the Critical Limit for CCP-1. This noncompliance is being linked to NR#0005 dated 05/06/2010. Companies corrective and preventive measures to NR#0005 were: Corrective: "Plant management notified, nine boxes of heads were retained to be reworked and reinspected. The heads were reinspected and released by USDA inspector at 1300 hours."preventive: "The viscera side supervisor and Slaughter manager counseled the employees responsible for inspecting the heads prior to packaging them and the employees that harvest and wash the heads."the establishment's corrective actions as per regulation 9 CFR for NR #0005 were either not implement or were not followed resulting in today's noncompliance. This document serves as written notification that your failure to comply with regulatory requirements could result in additional regulatory or administrative action.

4 00003L M Swift Beef Company /13/ B (c), 416.3(a) (b)(6)(b At approximately 0613 hours on 08/13/2010, I CSI asked Ms. (QA tech) in the Slaughter department if the department was ready for USDA (b)(6)(b)(7 pre-operational inspection. Ms. stated that the department was ready for inspection. While performing part of scheduled PBIS 01B02, (inspecting equipment on one or more areas of the department to ensure that pre-operational inspection procedures implemented by the company before the start of operations were effective in preventing direct contamination or other adulteration of product(s)), I observed the following deficiencies: (1.) In the casing room, I observed that the vacuum tanks (one small and one big) for the Steam Vac's used on lambs in the slaughter department had not been cleaned. (2.) Casing flusher equipment, three or four separate pieces, were really rusty and were not being cleaned. This flusher equipment has not been used for quite some time and the employees in the casing room were storing their aprons and other miscellaneous work garments in them. This is in violation of regulations 9 CFR (c), 9 CFR 416.3(a), and regulation 9 CFR Deficiencies were not on product contact surfaces. Regulatory control action was taken by CSI by applying USDA tag # B to the equipment until it was cleaned. All deficiencies observed were cleaned by the cleaning contract company before operations. Re-inspection was performed by Mr. (QA Superintendent), and then it was released to me (b)(6)(b)(7)( for verification. Mr. was verbally notified by CSI that there would be a noncompliance report written. No product was involved. Establishment's SSOP revision dated December 13, 2005 page 3 and USDA requirements were not met. Additionally, the pre-operational SSOP states that(b) (4) This noncompliance is not being linked to any other NR.

5 00003L M Swift Beef Company /05/ D (e), (a) On October 5, 2010 at approximately 1020 hours while an investigation was initiated concerning an and incident with (Pet Food) that had occurred at another establishment with product (50 pound boxes of inedible lamb livers) that were salvaged by establishment 3L and transported by Darling International Inc. out of (b)(6)(b Denver, Colorado. (b) (4) Investigator Ms. Dr. (QA manager), and CSI observed where the Pet Food was collected/salvaged, where the product is denatured, and where it was labeled. While observing stored Pet Food product in the freezer, it was noticed that the Pet Food containers that had been salvaged on previous days were not labeled with the term "Not Intended for Human Food "anywhere on the container. The containers were labeled "INEDIBLE" in letters not less than 2 inches high. The Species, product name, product code, and weight were on a separate label, on the container. This is in violation of 9 CFR regulation (e)(3). Unscheduled PBIS 06D01 was then performed. Mr. was verbally notified by CSI when we had returned back to the office that a non-compliance report would be written. No official control (tag) was required. The Establishments SOP, dated 11/15/2004, does address the collection procedures only that the company will take when harvesting inedible products. Products having the physical characteristics of a product fit for human food as per regulation (e)(3) must be denatured as per regulation (b)(6)(b)(7)( (a)(6) unless shipped under a numbered permit. Mr. had some labels "Not Intended for Human Food" printed and placed on the containers as per USDA Requirements. This non-compliance report is not being linked to any other NR.

6 00003L M Swift Beef Company /13/ J (c)(4), (b)(6)(b)(7) Variety Meats - At approximately 1352 hours on Oct. 13, 2010, I, CSI notified Ms. (QA Tech) that I was going to perform a scheduled check on Variety Meats CCP-1 (zero tolerance check on 10 Lamb Heads). As I was performing the scheduled PBIS 03J02 on a 10 Head check, I observed the following deficiencies: A strand of Hair on the 3rd head, a piece of plant like material (grass/straw), 1/2" long on the 5th head "outside left cheek". (b)(6)(b)(7)( Ms. was observing while I performed inspection on the 10 Heads. She also observed the fibrous plant like material that was found. I immediately verbally (b)(6)(b)(7)( notified Ms. that a noncompliance report would be written. This is in violation of Regulations 9 CFR 417.2(c)(4), , 416.4(d). Corrective actions taken by the company were: The two Heads identified with contamination were trimmed. Both heads were presented back to me for re-inspection, released. Preventive measure taken by plant management was: Ms. (Supervisor) will go back to the wool side to monitor and work with the "Nose Roller" employee. She will also have the wool side supervisor monitor and work with the new employee opening heads. They will monitor for two days. No immediate USDA regulatory control tag was needed by CSI At (b)(6)(b)(7)( 1419 hours I was informed by Ms. that the corrective and further planned (b)(6)(b)(7)( action had been implemented. Ms. performed the verification check on an additional 10 heads because I was on the line; one of our inspectors went home (b)(6)(b)(7)( sick. Ms. said that the heads were found acceptable. Company's Variety Meats HACCP Plan (dated Aug. 13, 2009), on CCP-1 states(b) (4). The Establishment's HACCP Plan failed to identify and meet the Zero Tolerance standards for visible fecal/ingesta material as stated on the Critical Limit for CCP-1. This noncompliance is not being linked to any other NR. The last NR issued on a zero tolerance failure on Lamb Heads was July

7 00003L M Swift Beef Company /23/ B (c), 416.4(a) (b)(6)(b)(7 At approximately 0614 hours on 11/23/2010, I CSI asked Ms. (QA tech) in the Shipping department if the department was ready for USDA (b)(6)(b) pre-operational inspection. Ms. stated that the department was ready for inspection. While performing part of scheduled PBIS 01B02, (inspecting equipment on one or more areas of the department to ensure that pre-operational inspection procedures implemented by the company before the start of operations were effective in preventing direct contamination or other adulteration of product(s)). While I was performing pre-operational inspection I observed the following deficiencies: (1.) Oil droplets on dogs and bolts, on the shipping dock chain. (2.) The "Expando Belt" was observed with two pieces of fat (1/2"x1/2"). (3.) White barrel used to store the tie-off twine, was observed with a 4"x4" piece of fat on the inside, and (4.) A Piece of meat/fat (5"x1/2") was observed on top of the light cover over the sales cooler trim stand. This is in violation of regulations 9 CFR (c), 9 CFR 416.3(a), and regulation 9 CFR Deficiencies two and three above were on product contact surfaces. Deficiencies one and four were potential for product contamination. I CSI did not have to apply a USDA tag to the department or equipment due to the immediate cleaning implemented by the (b)(6)(b) contract cleaning company before operations. Ms. was verbally notified by CSI that there would be a noncompliance report written. No product was involved. Establishment's SSOP revision dated December 13, 2005 page 3 and USDA requirements were not met. Additionally, the pre-operational SSOP states that (b) (4) linked to any other NR.. This noncompliance is not being

8 00003L M Swift Beef Company /24/ C (c), 416.2(d) 00003L M Swift Beef Company /20/ J (c)(4), At approx while performing a scheduled 01C02 operational sanitation procedure I (CSI observed that condensation had built up on the ceiling of hot box #2. On further investigation I noticed that condensation was dripping off of overhead structures, beams, and electrical conduit. I immediatley stopped the lamb carcass infeed chain to keep more carcasses from entering the area. I informed kill floor supervisor of the problem and he called QA Superintendent (b)(6)(b)(7)( to the hot box. Mr. also observed the condensation. After receiving a verbal corrective action plan of: (1) storing the remainder of that days kill in hot box #1, (2) having QA department retain 5 rails of lamb carcasses (approx carcasses) that were under the condensation (3) trimming identifiable contamination on the affected lamb carcasses, as stated in the SSOP, and spraying carcasses with lactic acid as they are moved to the sales cooler, I allowed (b)(6)(b)(7)( production to resume. I verbally notified Mr. at that time that this noncompliance would be documented. Condensation dripping over edible product violates 9CFR 416.2(d), (c) and the companies SSOP which address condensation on page 6 paragraph 3 dated A record check the next day showed that the noncompliance had been documented properly on the company SSOP log. This NR is not being linked to any other. At approx on I (CSI informed Ms. (QA Tech) that I was going to perform an unscheduled check on Variety Meats CCP -1 ( zero tolerance check on lamb heads). As I was performing the hands on check as part of an 03J02 procedure on 10 heads I observed a 1/4 inch by 1/2 inch area of ingesta (b)(6)(b)(7)( on the face of the 6th head inspected. Ms. observed the ingesta that was (b)(6)(b)(7)( found. I immediately verbally notified Ms. that ingesta on the head violated the company's HACCP plan CCP-1 (dated ) for zero tolerance. This also violates 9 CFR 417.2(c)(4), , and 416.4(d). Immediate corrective actions taken were to bring back all the heads from the last acceptable check ( box #0491 to box #0509). No retain tag required, all the heads were rewashed and trimmed in my presence. All heads were released at A record check showed all deficiencies and corrective action properly recorded. No preventive measures were given as the kill floor Superintendent and all supervisors had left the plant before offal packaging was complete. This NR is not being linked.

9 00003L M Swift Beef Company /03/ B (a), (c) At approx. 0725, QA Superintendent while waiting for the viscera side of the lamb kill floor to be ready for pre-op, asked me if I (CSI would start my scheduled preoperational sanitation inspection in the offal area. In the offal area I observed a fat buildup, from the previous days production, on the hooks on the edible offal product chain. There was a layer of hardened fat approx. 1 1/2 inch long on the inside curve of 5 out of 5 hooks. Using my thumbnail I could easily remove (b)(6)(b)(7)(c scrapings of the fat to show Mr. The hooks were immediately scrubbed with soap and water and rinsed. After I reinspected and released the hooks, the offal area was released at approx I then finished my preoperational inspection of the remainder of the kill floor and found no further noncompliance. The kill floor (b)(6)(b)(7)( was released at approx 0740 to production. I verbally notified Mr. that this noncompliance would be documented. This is a violation of 9CFR (c) and 416.4(a). This is also a violation of the companies preoperational sanitation SOP page 3 paragraph 8 dated This NR is not being linked L M Swift Beef Company /13/ A (a) On , at approximately 1230 hours, I, CSI was notified by (Shipping Superintendent) that China export certificate #MPA 54485, with approximately 810 containers, was ready to be checked. CSI was performing part of an unscheduled procedure 06A01, evaluation of product containers, to determine their eligibility for export and to determine if USDA-FSIS requirements were met as per 9 CFR 322.1(a). While inspecting the staged load, CSI noticed that the containers were stamped with the wrong export number on six hundred and fifteen (615) of the containers. The number on the containers was "015634"; the containers should have been stamped with export number "54485". This is in violation of Regulation 9 CFR 322.1(a) which requires that the container must be marked with the corresponding export certificate (b)(6)(b)(7)(c number. Mr. was notified of the noncompliance and he said he would make the correction and change to the correct number. I then verbally notified Mr. that a noncompliance report would be written. This noncompliance is not being linked to any other report within the previous ninety (90) days. (b)(6)(b)(7)(c

10 00003L M Swift Beef Company /01/ D , 416.2(b)(1), 416.4(b) On 9/01/2011 at approximately 1345 hours on the slaughter floor during operation, CSI observed numerous sheep pellets on the walkway of the clean side of the slaughter floor. CSI took regulatory control by stopping the line and tagging the walkway with tag no.b Supervisor immediately started cleaning the floor without even being told what the problem was. QA Tech was informed what the problem was that the pellets on the floor were creating an insanitary condition and she was asked to call QA Manager Mr. to the floor. The walkway was cleaned and (b)(6)(b)(7)( the tag was removed and production was allowed to continue. Mr. arrived on the floor and was told of the insanitary condition and was verbally notified that a non-compliance would be written. The establishment has been informed of this problem at weekly meetings since May 19, 2011; the reply was that they would look at this problem. At the August 25, 2011 meeting, the establishment said they would look at this before the next meeting. At the meeting on September 1, 2011 they still had not looked at the problem. This is a noncompliance with 9CFR 416.1, 9CFR 416.2(b) (1), and 9CFR 416.4(b). This non-compliance is not being linked to any other non-compliance L M Swift Beef Company /27/ D (a) At approximately 1400 hour's IIC Dr. and CSI entered the Offal Department and noticed that there was eight to ten fly's on the boxes and flying around. CSI went to the slaughter office where Slaughter Manager, QA Manager, and Engineering Manager, were asked to come to the Offal Department. All three were shown the flies. At this time fly swatters were used by plant employees to kill flies. This is in violation of 9 (b)(6)(b)(7)( CFR 416.2(a). Mr. was call to the government at approximately 1500 hours when he was informed that a NR would be issued. This problem of fly's in Offal has been addressed in the weekly NR exit meeting on several occasions and the establishment informed the IIC and CSI that fly strips would be hung daily to help prevent fly's in the department. On this day the fly strips were broken off and one was approximately two inches long and one of the other ones was approximately five inches long, and this was not effective in controlling flies. This NR is not being linked to any other NR.

11 00086K M Cargill Meat Solutions Corp /08/ A (a) During the Food Safety Assessment conducted at this establishment on June 14 through July 9, 2010, the following non-compliance was noted. During the observation portion of this FSA, it was observed that the laboratory technician was not following the written protocol for collecting these samples. Specifically, the establishment's Beef Microbiological Testing was reviewed and laboratory personnel were observed while sampling carcasses. During these observations, it was noted that the laboratory technician performing the task was not sponging the carcass in the correct order as specified in the establishment's SOP, USDA Surface Sponge Sampling (Carcasses). Specifically, the technician would first sample the inside round (should have been the rump), flank, and then brisket. This is contrary to the written procedure which calls for sampling the flank, brisket, and then the rump in that order. This is non-compliance with (a)(i) which states: "Collect samples in accordance with the sampling techniques, methodology, and frequency requirements in paragraph (a)(2) of this section". Food Safety Supervisor was notified of this non-compliance and stated that this issue would be addressed with the individual collecting the samples to prevent recurrence.

12 00086K M Cargill Meat Solutions Corp /08/ J (a)(1), 417.5(a)(1), 417.5(c), 417.2(a)(2) Several non-compliances with the record-keeping regulations were found during the FSA conducted June 14 through July 9, 2010 at this establishment. These are listed as the following: 1. BSE was not considered as a potential hazard associated with tonsillar material at some of the relevant steps within the Hazard Analysis. These steps are identified as #23 and #25. No consideration is made for this tonsillar material in light of any BSE hazards that may be associated with these steps. Step # 13 (Carcass Splitting) has not been analyzed for BSE hazards that may be present associated with this step. This establishment does not use a dedicated split saw for animals aged 30 months and older. Instead, it has elected to rinse and sanitize after splitting of these older animals; 2. In the "Carcass" and "Offal" Inspection process steps, the establishment states (b) (4) FSIS has a zero tolerance policy for visually identifiable feces, ingesta, and milk" with another indication that "FSIS Directive states, "that plant must address zero tolerance in the HACCP plan" Plant history has shown that there is the possibility of Presumptive results in tested offal product." The thought process clearly identifies the potential Biological hazards involved in these two steps, but has them categorized as Physical hazards. The contradiction is an indication that there are regulatory issues with this type of hazard analysis; 3. 4 issues that were found the Slaughter flow diagrams. The first issue shows packaging material flowing into the evisceration step when it is the pre-evisceration step that this material flows into. The second is with the Offal flow chart. It was found that fresh material is stored in plastic totes in the offal freezer until it can be brought back out into the packaging room for packaging into case ready packages. This circular movement is not depicted on this flow diagram. Third, no depiction of flow of edible tallow that is harvested out of the Slaughter plan into the Edible Rendering plan. Finally, in neither the Beef Slaughter nor the Offal flow chart, there is no direction that depicts where product that is either condemned or found to be otherwise unwholesome is directed; 4. The article used as support of the Lactic Acid Head Rinse Cabinet (SL4) and the Lactic Acid Offal Rinse Cabinet (SL5) does not support the use of lactic acid for the purposes intended. In this article, 'Interventions to reduce microbiological contamination on beef variety meats", (Delmore et al), no mention of the pathogens referenced in the hazard analysis, E. coli O157:H7 and Salmonella, are made in this article as being capable of being controlled. The decisions reached within the hazard analysis, that lactic acid used at these steps will be an effective organic acid at reducing pathogen loads, is wholly dependent upon this article. This article does not support that conclusion; and, 5. In reviewing the pre-shipment documents, it was noted that there were several

13 instances where the pre-shipment had not been signed as required of the regulations. Food Safety Coordinator was informed of the above.

14 00086K M Cargill Meat Solutions Corp /08/ F (a)(2), 417.5(c) During the Food Safety Assessment conducted at this establishment on June 14 through July 9, 2010, the following non-compliances were noted. The flow chart for this process category shows that this diagram has a mistake in the flow of material to inedible rendering. It is showing material destined for inedible rendering flowing back into the edible process at the (b) (4) Screen step. This appears to be more of a clerical error in the development of this diagram as there are no connections in this system to allow such flow at the steps identified. This is non-compliance with 9 CFR 417.2(a)(2), which states: "A flow chart describing the steps of each process and product flow in the establishment shall be prepared,.". In reviewing the pre-shipment documents, it was noted that there were several instances where the pre-shipment had not been signed as required of the regulations. HACCP Food Safety Coordinator was notified of the previously described non-compliances. He stated that these issues would be addressed with the appropriate staff members and within the HACCP plan in order to comply with regulatory requirements K M Cargill Meat Solutions Corp /08/ J (a)(1), 417.5(a)(3) During the Food Safety Assessment conducted at this establishment from June 14 through July 9, 2010, non-compliance was noted with the corrective actions associated with deviations that have occurred. This conclusion was reached by reviewing the last 60 days HACCP records. The deviations identified in this process category were all concerned with CCP SL2 (carcass zero tolerance). In each case, the establishment went to great lengths to describe what was done to bring the CCP back into compliance, actions to prevent the recurrence, and what was done to the product to prevent adulterated product from entering commerce. Yet, there is no mention as to any investigation into trying to determine that the cause of the deviation is identified and eliminated. The records reviewed that had corrective actions associated with these deviations show, on an almost a continuous basis, that the establishment did not meet 9 CFR 417.3(a)(1) which states that "The cause of the deviation is identified and eliminated". Further review resulted in the finding that the establishment failed to document the direct observation of corrective actions as required by 9 CFR (a) (3). These same omissions apply to the Raw Not Ground category as well in which the CCP FA1 failed to determine the cause of the deviation and document direct observation of the corrective actions. In all cases, the other three requirements contained within 9 CFR 417.3(a) have been met. HACCP Food Safety Coordinator was notified of this non-compliance and stated that the issue would be addressed with the appropriate staff in order to prevent recurrence.

15 00086K M Cargill Meat Solutions Corp /08/ B (c), (b), 416.3(a) On 28 June, 2010 at approximately 0500 hrs, while performing the preoperational observation phase of a comprehensive Food Safety Assessment, the assessing officials noted the following discrepancies: On the slaughter area of the facility, on the west side of the bung dropper stand which is in contact with the carcasses as they pass, the welds along the entire surface were rough and pitted. In the fabrication area of the facility, one of the production tables had two cutting boards that were worn nearly through creating deep scores with loose board materials that could have broken off during production. There were also several broken and pitted welds on product contact surfaces throughout the processing floor. The condition of these pieces of equipment could easily provide harborage areas for microorganisms and create an insanitary condition. The two cutting boards were immediately replaced and, according to Mr. Food Safety Superintendent, the welds would be addressed with maintenance immediately. Prior to the start of operations, condensation and hydraulic oil was observed on the structures over hanging carcasses. The hydraulic oil was not observed dropping, but, when the cleanup crew attempted to wipe the condensation from the bottom of the refrigeration unit, water was observed falling onto the carcasses. The QA personnel took control of the situation by retaining the carcasses for reconditioning. Review of the previous 60 days SSOP records resulted in the finding of 19 instances when a contact surface was identified during pre-operational sanitation and sanitary conditions were not restored in that the equipment contact surface was documented with the code 1 indicating it had been "Rinsed, reinspected, and (b) (4) according to the establishment's documented codes for Corrective Actions. The code (b) (4) was not used. This establishment has a scoring system for deficiencies that is used by the QA inspectors with 3 (b) (4) residue film. According to their written program, (b) (4). On 04 May 10, Area 10, a contact surface had a re-inspection code of (b) (4) no further corrective actions shown. The same occurred on 07 May 10 in Area 16. According to plant management, this was probably a documentation error where the numbers were transposed, but the proper documentation is paramount in food safety issues. Also, during review of the operational sanitation records for the previous 60 days, there were 6 instances where sanitation deficiencies were noted with incomplete corrective actions in that they did not cite preventive measures. These deficiencies were reported to Mr. Food Safety Superintendent who stated that they would be addressed with his staff to prevent the reoccurrence of these issues.

16 00086K M Cargill Meat Solutions Corp /08/ H (c)(7), 417.4(a)(2) (i), 417.4(a)(2) (ii) During the period of 14 Jun through 2 July, 2010, while performing a comprehensive Food Safety Assessment, the assessing officials noted noncompliance in the Plant Verification Activities. The HACCP plan did not address the calibration for the Metal Detector, which is a part of their process monitoring equipment. They also failed to address the direct observation of monitoring activities for their Critical Control Point that addresses the Disposition products that were found to be non-negative for the pathogen E. coli O157:H7 in Slaughter; Raw, Ground; and Raw, Not Ground process categories. These issues were reported to Mr. Food Safety Superintendent who stated that they would be addressed with his staff to prevent the reoccurrence of these issues K M Cargill Meat Solutions Corp /08/ H (a)(1), 417.2(a)(2), 417.5(c) During the period of 14 June through 2 July, 2010, while performing a comprehensive Food Safety Assessment, the assessing official observed several recordkeeping noncompliances. First, in the HACCP program for this process category, E. coli O157:H7 was identified in the receiving products step as being a potential Biological hazard that is reasonably likely to occur in the establishment's Decision-Making Documentation, but not in the actual Hazard Analysis. In light of the fact that both documents are used as their total Hazard Analysis, this presents a conflict that brings their analysis methodology into question and becomes a regulatory issue because there is no Critical Control Point if the hazard is reasonably likely to occur. The current use of the SSOP to support potential chemical hazards not being reasonably likely to occur is not supported in that the SSOP only addresses the use of approved cleaners and sanitizers, and does not reference the proper use of these chemicals other than the fact that pre-mixed; approved liquid sanitizers are used at a concentration that does not require a potable water rinse before operations. It does not address the testing of these solutions to assure the proper levels are being used. There was also no area in the flow diagram for this process that addressed the flow of contaminated or otherwise unwholesome product to inedible rendering. The Returned Product step shows all product flow going into the Outside Freezer/Distribution step, with no directional flow for condemned or damaged product going to inedible rendering. In reviewing the preshipment review documents it was also noted that during one week when the main reviewing individual was not present, the preshipment review had been documented, but not signed as required. This issue pertains to all of the establishment's process categories. These noncompliance issues were reported to Mr. Food Safety Superintendent, who stated these issues would be addressed with his staff to prevent their recurrence.

17 00086K M Cargill Meat Solutions Corp /08/ C (a)(1), 417.2(a)(2), 417.5(a)(3), 417.5(b), 417.5(c) From 14 Jun through 2 July, 2010, while performing a comprehensive food safety assessment, the assessing official identified several recordkeeping noncompliance issues associated with this process category. There is a regulatory issue in the Hazard Analysis page for the "Carcass Receiving" process step that states that (b) (4) This subsequent step is their Disposition CCP where presumptive positive product is found through testing and suspect product is either rendered to inedible or sent under controls to a federal establishment that will cook the product to lethality. In this step, the product is only sampled for E. coli O157:H7 and not for Salmonella, thusly not providing a control for an identified biological hazard found reasonably likely to occur. Another hazard analysis issue is in the "Trim Sortation" step where the Decision Document states(b) (4) Plant history has shown that there is possibility of presumptive positive results in tested combo trim.", yet there is no control measure cited. This process step is(b) (4) The establishment appears to be concerned with controlling the physical aspect of the fecal, milk, or ingesta issue while ignoring the pathogen aspect. This shows they have not adequately performed a Hazard Analysis. The current use of the SSOP to support potential chemical hazards not being reasonably likely to occur is not supported in that the SSOP only addresses the use of approved cleaners and sanitizers, and does not reference the proper use of these chemicals other than the fact that pre-mixed; approved liquid sanitizers are used at a concentration that does not require a potable water rinse before operations. It does not address the testing of these solutions to assure use at proper levels. There are also flow chart issues with this HACCP program in that there are no indicators showing that product that is contaminated or otherwise unfit are disposed of. The only exiting flow indicator shows all product going to Storage/Staging with no exiting point to an inedible rendering cited. Documentation of verification activities also presented noncompliance in that on 4/16/10, there was no time reported for the direct observation of monitoring, only the temperatures of 43.4 and 41.3, which were not found on the monitoring record for CCP FA-2. On 5/17/10, 5/26/10 and 6/2/10, the direct observation times of 1450, 1451, and 1433 respectively were reported, but corresponding monitoring times were not found on the CCP FA-1 monitoring records. While reviewing the preshipment review documents it was noted that

18 during one week, the preshipment review had been documented, but not signed as required. This noncompliance was also noted in the Slaughter; Raw, Ground; Heat Treated, Shelf Stable; and H 00086K M Cargill Meat Solutions Corp /13/ D On at approximately 5:20 p.m., I was monitoring the evisceration table for contamination. Of 25 viscera, 8 were contaminated with fecal, ingesta and/or bile. The fecal was seen coming from improperly wrapped bungs and ingesta was flowing from cut intestines and paunches. Involved were weasands, hearts and livers which were observed to be contaminated with the aforementioned contaminates. Also observed were approximately 5 carcasses with fecal contamination of the brisket, front shank, and midline as well as the outside and inside of the neck of these carcasses. On line inspection personnel condemned all affected edible products and the following individuals were notified of the deficiencies of proper dressing procedures and of the insanitary conditions being created: Kill Floor Superintendent, first shift Kill Floor Superintendent, Q.A. Supervisor, and second shift General Foreman, The Operational SSOP in force at this facility states, (b) (4) 9 CFR (a) states, under the heading of "Contamination of carcasses, organs, or other parts," "Carcasses, organs, and other parts shall be handled in a sanitary manner to prevent contamination with fecal material, urine, bile, hair, dirt, or foreign matter; however, if contamination occurs, it shall be promptly removed in a manner satisfactory to the inspector." Furthermore, 9 CFR states, under the heading "General rules", "Each official establishment must be operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to ensure that product is not adulterated." A similar Non-compliance Record, number , was issued on As of the date of this instrument, the previous Non-Compliance Record has not been answered by this establishment. The root cause of the non-compliance, in both records, is this establishment's ineffective implementation of sanitary dressing procedures. This document serves as written notification that your failure to comply with requirement(s) could result in additional regulatory or administrative action.

19 00086K M Cargill Meat Solutions Corp /19/ C (c) At approximately 2000 hrs I observed two combos of "off condition" Marrow bones on the old shipping dock. The regulatory control action was to tag combos with US retained tag number B and B Q. A. Specification Superintendant was notified. The operational Sanitation SOP in force, at this facility, states under the heading of "Faciltiy Sanitation" House keeping, trash pick-up, meat scrap pick-up is acceptable. 9 CFR states Each official establishment must be operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to ensure that product is not adulterated. 9 CFR (c) Each official establishment shall monitor daily the implementation of the procedures in the SanitationSOP's. This document serves as written notification that your failure to comply with regulatory requirement(s) could result in additional regulatory or administrative actions K M Cargill Meat Solutions Corp /09/ B (c), 416.3(b) On , a deviation was found to be non-complaint with establishment 86K SSOP plan. An electric well saw, used as a backup saw to a hydraulically driven saw for the separation of the brisket, did not meet the conditions of sanitation standards in the establishments written sanitation program. The saw in question was found with rust on the blade assembly and fat wedged in the blade and blade guide. The housing of the saw was covered with a film of gritty black grease, which could be transferred when touched. It is the responsibility of the establishment to have all equipment, which will be used during production, out at the time of pre-operational sanitation. Pre-operational sanitation starts at 0600 hrs.for the slaughter floor. At 0623 hrs.the saw, which is normally hanging or lying on the East side of the gut table, was not out for inspection. At 063 hrs. pre-operational sanitation had been completed and the saw was found on the East side of the gut table in the condition described above. The establishments written pre-operational sanitation states in part; (b) (4) A written procedure for monitoring states; (b) (4). CFR (b) states; Equipment and utensils must not be constructed, located, or operated in a manner that prevents FSIS inspection program employees from inspecting the equipment or utensils to determine whether they are in sanitary condition. CFR (c) states; each official establishment shall monitor daily the implementation of the procedures in the sanitation SOP's. This document serves as written notification that your failure to comply with regulatory requirement(s) could result in additional regulatory or administrative actions.

20 00086K M Cargill Meat Solutions Corp /24/ B At approximately 1500 hours hearts were observed being harvested and placed into their final packages, 60 pound boxes. The label on the boxes states, "Beef Hearts, Bone Removed (Frozen)". Approximately 80% of the hearts were observed to have approximately 4-5 inches of aorta attached to them. Also observed were small pieces of thymus gland approximately 1 inch in length. Mr. was notified and shown one of the excessively long aortas that was 5 inches long. Guidance received from the FSIS's Labeling and Program Delivery Division is as follows; "We believe that leaving a significant amount of aorta (4-5 inches) and in some cases the thymus gland requires a descriptive name so the label is not false or misleading". Based on the observations and this guidance a regulatory control action was initiated by instructing the QA Department to retain the entire day's production of hearts. This document serves as written notification that your failure to comply with regulatory requirement(s) may result in additional regulatory or administrative actions.

21 00086K M Cargill Meat Solutions Corp /02/ J (e) (1), 417.5(a)(1) On September 2, 2010 at approximately 10:20 p.m., inspection personnel identified a greater than 30 month of age head that had not been identified by this establishment. This identification was made after the head had been placed on the head chain and presented for inspection to FSIS personnel. A regulatory control action was immediately initiated by stopping the head chain and main chain. Kill floor superintendent, was notified of the non-compliance. Also involved was a >30 months of age carcass which this Establishment also failed to identify with blue flags and a #3 stamp. Blue ink was brought to the head inspection area and the head was then properly identified. The >30 month of age carcasses was also then stamped and identified. At that point control was relinquished and the main chain was restarted. This establishment has made the decision to identify those carcasses greater than 30 months of age by way of dentition in the absence of viable records of age. The pre-requisite program, "Segregation Process for greater than 30 month cattle carcasses", states: (b) (4) This pre-requisite program is also the foundation, in part, for the support made in this establishment's Hazard Analysis for the decision that BSE/SRM's are a hazard that is not likely reasonably to occur. Failure to properly identify those carcasses found to be greater than 30 month of age is non-compliance with 9 CFR (e)(1), which states, in part: "Establishment that slaughter cattle and establishments that process the carcasses or parts of cattle must develop, implement, and maintain written procedures for the removal, segregation, and disposition of specified risk materials." Furthermore, this establishment's supporting documentation is insufficient to support the decision in it's Hazard Analysis that SRM's are not reasonably likely to occur. Because of this insufficient support, this establishment is non-compliant with 9 CFR 417.5(a)(1) which states, "The establishment shall maintain the following records documenting the establishment's HACCP plan: The written hazard analysis prescribed in 417.2(a) of this part, including all supporting documentation;" This document serves as written notification that your failure to comply with regulatory requirement(s) could result in additional regulatory or administrative action.

22 00086K M Cargill Meat Solutions Corp /03/ D (e)(2), 416.2(f) On September 3, 2010 at approximately 1600 hrs Cargill Meat Solutions Quality Assurance department had rejected the use of the slaughter floor boot wash for backed up drains. At approximately 1800 hours I observed the area still rejected and proceeded to inspect the surrounding offices and lockerrooms. The QA office drain had a pool of water around it with a lactic acid spray bottle sitting in the backed up water and the nozzle and hose lying in the water. The QA "lab" had water in the drains with a material that looked like absorbant pellets in and around the drains. I notified my immediate Supervisor, who came and inspected the men's lockerroom. Slaughter General Foreman, was notified as well as the QA Supervisor, The drain in the toilet room had standing water that had drained out to the lockerroom and down the isles between the lockers. There was standing water with black sewage back-up in the shower room. We restricted use of the rooms by tagging them with FSIS retain tag numbers B and B The standing water was cleaned up and the floor of the rejected lockerroom was sprayed with bleach. We released the lockerroom and the Quality Assurance Department rejected and tagged the toilet and shower rooms. These conditions are a violation of the FSIS 9 CFR 416.2(e)(2) which states: "Plumbing. Plumbing systems must be installed and maintained to: (2) properly convey sewage and liquid disposable waste from the establishment. This document serves as written notification that your failure to comply with regulatory requirement(s) could result in additional regulatory or admisitrative action.

23 00086K M Cargill Meat Solutions Corp /08/ C (b), , (c) 9 CFR Agency Verification: FSIS shall verify the adequacy and effectiveness of the Sanitation SOP's and the procedures specified therein by determining that they meet the requirements of this part. Such verification may include(b)reviewing the daily records documenting the implementation of the Sanitation SOP's and the procedures specified therein and any corrective actions taken or required to be taken;(c)direct observation of the implementation of the Sanitation SOP's and the procedures specified therein and any corrective actions taken or required to be taken. Cargill Meat Solutions Sanitation SOP's requirements at the start up of each shift states: (b) (4). On September 8, 2010 I performed the required direct observation procedure. I observed the employees who work the hide on side come onto the floor through the doorway by the knife room but did not see a QA in the area performing the 10 employee audit as described above. I then went to the entrances to the hide off side and observed the employees entering the floor at the three doors to it. Again I did not see a Quality Assurance employee observe any of the slaughter employees enter the floor. At approximately 1800 hrs I performed the review of daily records, as prescribed by 9 CFR The document for the beginning of the shift for September 8, 2010 was completed and indicated that these procedures had been performed. Failure to perform the procedures in the Sanitation SOP's is a non-compliance with 9 CFR (b)(c) states: (b) each official establishment shall conduct all other procedures in the Sanitation SOP's at the frequencies specified. (c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP's. Cargill Meat Solutions Establishment 86K has changed its method of hand sanitizing and equipment cleaning and sanitizing. However, the Sanitation SOP's have not reflected these changes. 9 CFR states: Each official establishment shall routinely evaluate the effectiveness of the Sanitation SOP's and the procedures therein in preventing direct contamination or adulteration of product(s) and shall revise both as necessarey to keep them effective and current with respect to changes in facilities, equipment, utensils, operations, or personnel. This ducment serves as written notification that your failure to comply with regulatory requirement(s) could result in additional regulatory or administrative action.

24 00086K M Cargill Meat Solutions Corp /14/ C (c), 416.4(d) On September 14, 2010 at approximately 8:00 p.m., I was called to the viscera table by an online inspector. When I arrived at the table, I observed intestines, paunches, weasands, plucks and pieces of fat caught between the slats of the table. Also observed was ingesta and fecal which was not being cleaned from the surface of the table, resulting in contamination of hearts, liver and weasands. Also observed were dozens of paunches caught up in the brushes and framework under the table. This Establishment continued to run operations even though direct product contamination was being observed. I immediately initiated a control action by stopping production. Production was not allowed to resume until the insanitary condition was remedied. Sixty minutes of down time was incurred to clean up the insanitary condition. was notified that a Non- compliance Record would be forth coming. This Establishment's Sanitation SOP clearly states under facility sanitation: (b) (4) 9 CFR (c) states: "Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP's." Furthermore, non-compliance is found with 9CFR 416.4(d), which states: Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments. This document serves as written notification that your failure to comply with requirement(s) could result in additional regulatory or administrative action 00086K M Cargill Meat Solutions Corp /07/ C At approximately 0830 hours on October 7, 2010, while beginning truck unloading observations under HATS Category II, I observed a raised piece of metal over the north woven tire mat in unloading dock number two (2). The metal strip extended across the width of this northern most mat and presented a significant foot and leg injury potential to the cattle being unloaded on this dock. No cattle were present in this dock or being unloaded at the time of this observation. This is non-compliance with 9 CFR 313.1(a) which states: "Livestock pens, driveways and ramps shall be maintained in good repair. They shall be free from sharp or protruding objects which may, in the opinion of the inspector, cause injury or pain to the animals. Loose boards, splintered or broken planking, and unnecessary openings where the head, feet, or legs of an animal may be injured shall be repaired." I rejected unloading dock number two (2) with FSIS Reject Tag #B and secured the outside gate with a government lock until such time as repairs could be made. Mr. Technical Service Regulatory Affairs, was immediately notified of this non-compliance and that a Non-compliance Record would be issued.