New Mexico Slaughterhouses

Code:  03C02
Violation:  417.3(a)(1), 417.4(a), 417.4(a)(2) (ii), 417.5(a)(2)

Citation:

On 3/7/12, at approximately 1115 Hours MST, while performing routine HACCP and SSOP review and observation verification tasks in the small processing room, SPHV observed the following noncompliance. Upon entering the small processing room, SPHV observed the wall mounted, non-digital, thermometer on the South wall, approximately six feet from the floor, to read forty-eight degrees Fahrenheit (F). SPHV observed four employees to be processing intact cuts of raw beef product into small pieces (similar to shavings) and inch cubes using knives on three tables in the room. Using a USDA provided digital probe thermometer, SPHV performed an organoleptic reading of the one inch cubed beef on the table along the South wall. The temperature reading both in the pile of approximately twenty- five pounds of product and in individual cubes read forty-six point eight (46.8) degrees F. SPHV then re-sanitized the thermometer in the company provided dilute chlorine solution and collected a reading in an approximate one pound cut of beef on top in a plastic lug resting on the table along the East wall. The reading was forty-five point five (45.5) degrees F. SPHV observed no recordkeeping documents in the processing room and exited the processing room, traveled to the front of the facility, and asked which company employee was in charge of CCPs for the day. reported he was and he provided SPHV with the pre-operational and operational SSOP records for the day. SPHV reviewed the records and observed the temperature of the room had been recorded as degrees F during pre- operational sanitation. reported he had not yet taken the product CCPs for the day and retrieved the infra- red thermometer. SPHV explained that the USDA thermometer had read temperatures exceeding the company limits of degrees F and the temperature readings needed to be verified with a company calibrated thermometer. Using the infra-red thermometer, and SPHV observed a temperature of forty-five point five (45.5) degrees F for the cubed beef on the South wall table, and forty-seven degrees (47) F for two of the seven packaged, not sealed, bags of beef pieces. ‘ reading of the beef cuts in the lug on the East table read forty- three point five F. SPHV verbally informed of the noncompliance stating the product temperatures had exceeded critical limits and that USDA had noted the deviation, not the company. SPHV placed USDA Retain Tag number B38742707 on the breaking sawits stainless cutting tablewas being used to hold the seven bags of beef pieces, approximately ten pounds per bag. stated the company would be freezing the product, and SPHV explained the product would be retained until corrective actions were met and product disposition had been made. While SPHV remained in the processing room, exited the processing room and immediately returned with Mr. Rick De Los Santos. Using a company probe thermometer, Mr. Rick De Los Santos, , and SPHV observed a temperature reading of forty-five point two (45.2) degrees F for the inch cubed beef. Mr. Rick De Los Santos asked SPHV what the agency reading had been, and SPHV reported the USDA and infra-red findings as above to Mr. Rick De Los Santos. Mr. Rick De Los Santos instructed the processing employees and

Regulation:

417.3(a)(1)  Corrective actions: The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure the cause of the deviation is identified and eliminated.

417.4(a)  Validation, Verification, Reassessment: Every establishment shall validate the HACCP plan’s adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented.

417.4(a)(2)  Ongoing verification activities. Ongoing verification activities include, but are not limited to: (i) The calibration of process-monitoring instruments; (ii) Direct observations of monitoring activities and corrective actions; and (iii) The review of records generated and maintained in accordance with § 417.5(a)(3) of this part

417.5(a)(2)  The establishment shall maintain the following records documenting the establishment’s HACCP plan: The written HACCP plan, including decision making documents associated with the selection and development of CCP’s and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

Code:  01B02
Violation:  416.13(a), 416.13(c), 416.16(a)

Citation:

On 3/1/12, at approximately 0805 hours MST, while performing routine pre-operational sanitation verification inspection activities of the slaughter area, SPHV observed the following non-compliance. [newline][newline]Prior to entering the slaughter area, SPHV reviewed the pre-operational sanitation monitoring record dated 3/1/12. The record indicated two areas had been rejected and re-cleaned and sanitized. One of those areas was the carcass wash stand noted to have pieces of fat. [newline][newline]During review and observation of the carcass wash walls which face the carcass wash stand, SPHV visually observed a strip of reddish brown discoloration on the stainless steel panel immediately next to the white glass board panel. This linear strip of discoloration was approximately four inches wide and extended from approximately six and one half feet from the floor to approximately three feet from the floor. SPHV ran her finger through the discoloration and observed a streaking pattern on the wall where her finger had traveled, as well as transfer of the reddish brown material, rust, to her finger. SPHV pointed the rust areas out to the accompanying sanitation employee who indicated the rust would be removed. [newline][newline]SPHV also observed intermittent patches of rust residue on the exterior hinges of the hot box door. These areas were also pointed out by SPHV to the sanitation employee. [newline][newline]The sanitation employee immediately scrubbed the rust areas of the carcass wash walls and door hinges with a green scrub pad and then sprayed the areas with a hose. SPHV observed some rust staining had remained on the stainless steel walls, and upon digital inspection, observed no rust residue on her finger or streaking on the walls. SPHV observed all other areas of the slaughter area to be acceptable and the room was released for operations.[newline][newline]Immediately prior to antemortem inspection at 0815 hours, SPHV verbally notified of the above noncompliance stated he would have corrective actions performed and SPHV reported the sanitation employee had already performed corrective actions and the room had been released. [newline][newline]The above represents noncompliance with 9 CFR 416.13(a), 416.13(c), and 416.16(a), requiring establishments to implement, monitor, and record establishment pre-operational sanitation operations, respectively. [newline][newline]A search for previous noncompliance records issued for the same cause in the last ninety days revealed: NR#s YJL5311110302N-1 (11/2/11), YJL0012125808N-1, (12/8/11), YJL0910123013N-1 (12/13/11), YJL0710120729N-1 (12/29/11), YJL5510013305N-1 (1/5/12).

Regulation:

416.13(a)  Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.16(a)  Each official establishment shall maintain daily records sufficient to document the implementation and monitoring of the Sanitation SOP’s and any corrective actions taken. The establishment employee(s) specified in the Sanitation SOP’s as being responsible for the implementation and monitoring of the procedure(s) specified in the Sanitation SOP’s shall authenticate these records with his or her initials and the date.

Code:  03B02
Violation:  417.2(b), 417.5(a)(3)

Citation:

On 2/29/2012, at approximately 1100 hours MST, while performing routine record and pre-shipment review as part of a routine Non-intact HACCP taskinitiated on 2/28/2012, SPHV observed the following noncompliance. Upon review of the available records in one of the front company office desks and in the ‘Ground’ binder, SPHV could not locate a record for critical control point (CCP) ‘4B’, , taken on product produced 2/28/2012. SPHV did observe the intact product CCP4B to have been recorded degrees F by on 2/28/2012. SPHV immediately asked who had been responsible for CCPs yesterday and verbally reported had taken the CCPs yesterday. SPHV then immediately asked for the CCP records for the ground beef product. reported he had only taken and recorded the CCPs for the intact product. SPHV explained to the company must also take the temperature of any ground beef product produced at least once each day per the company plan. SPHV verbally notified of the noncompliance and stated a USDA Retain Tag would be placed on all of the ground beef product packaged yesterday, 2/28/12,and a noncompliance record would be generated. SPHV informed corrective actions would be needed in the disposition of the product. Immediately after providing notification of the noncompliance, SPHV entered the large freezer storage area and identified the packaged ground beef product produced on 2/28/12, as the product pallet was labeled with asheet of white copy paper with a date of ‘2/28/2012’ written in large black numbers. The ground product was packaged in clear vacuum sealed packages, pounds each, and stored five packages per product box bottom on a pallet. SPHV counted six box bottoms with five packages each, and one single vacuum sealed package in a seventh box bottom, approximating a total of pounds of ground beef produced 2/28/2012. SPHV placed USDA Retain Tag #B38742706 on the top of the product on the pallet. The above represents noncompliance with 9 CFR 417.2(b)(1) requiring development and implementation of the establishment’s written HACCP plan and 417.5 (a)(3) requiring establishments to maintain records documenting the monitoring of CCPs. A search for noncompliance records issued for the same cause in the last ninety days revealed none.

Regulation:

417.2(b)  The HACCP plan. (1) Every establishment shall develop and implement a written HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph (a) of this section, including products in the following processing categories: (i) Slaughter—all species. (ii) Raw product—ground. (iii) Raw product—not ground. (iv) Thermally processed—commercially sterile. (v) Not heat treated—shelf stable. (vi) Heat treated—shelf stable. (vii) Fully cooked—not shelf stable. (viii) Heat treated but not fully cooked—not shelf stable. (ix) Product with secondary inhibitors—not shelf stable.

417.5(a)(3)  The establishment shall maintain the following records documenting the establishment’s HACCP plan: Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

Code:  04C02
Violation:  313.1, 313.2

Citation:

On 2/24/12, at approximately 0810 Hours MST, while performing routine antemortem livestock inspection for antemortem handling, prod use, and slips and falls, SPHV observed the following noncompliance. [newline][newline][newline][newline]SPHV observed a company employee climb over the rails to stand inside and on the rails of the most East pen with a cement floor, on the immediate south side of the loading chute to knocking. Inside the pen were three beef cows the employee was trying to move West into the pen with the wire floor so that the animals could then be moved back East into the loading chute up the ramp into the knocking chute. The employee was observed to be moving slowly and holding one yellow, electric prod. SPHV observed the employee touch one cow with the prod (not with the electric) in the dorsal rump area. SPHV observed that cow and the two others all try to move from the East pen with a cement floor to the wire floor pen through the open gates. As each cow moved to the different pen, she slipped on the wet cement and completely fell on the cement flooring, landing one her sternum and abdomen, then immediately stood and moved forward into the wire pen area. None of the cows were observed by SPHV have sustained any injuries or lameness following their slips and falls. SPHV noted the moisture on the cement in the pen was from the water tub and recent bovine excrement. [newline][newline][newline][newline]SPHV immediately informed slaughter QC, of the non-compliance. SPHV explained to a non-compliance record would be issued for this non-egregious event due the following circumstance: no other animals were in the East pen or would need to moved through the pen for slaughter, the cows which had fallen were able to immediately stand and move forward, and the cows had not slipped and fallen as a result of being excessively moved by the company employee. Additionally, SPHV explained to a USDA reject tag would not be placed on the East pen so as not interfere with the construction activity for the facility upgrades, including new footing, which were ongoing in that area and not to put any other animals in the East pen. verbally agreed the company would move the remaining animals in such a manner that would not require the use of the East pen. [newline][newline][newline][newline]The above represents noncompliance with 9 CFR 313.1(b) and 313.2 (a) (HATS Category VII) which require establishments to provide adequate footing in their livestock facilities to prevent slips and falls, causing discomfort to the livestock during movement to the knocking area, respectively. A search for noncompliance records issued for the same cause in the last ninety days revealed none.

Regulation:

313.1  Livestock pens, driveways and Ramps: (a) 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.

313.2  Handling of Livestock: Driving of livestock from the unloading ramps to the holding pens and from the holding pens to the stunning area shall be done with a minimum of excitement and discomfort to the animals. Livestock shall not be forced to move faster than a normal walking speed.

Code:  01C02
Violation:  416.13(b), 416.13(c), 416.4(a), 416.5(a)

Citation:

On 1/30/12, at approximately 1000 hours MST, while performing routine record and pre-shipment review verification in the establishment office, SPHV observed the following noncompliance. While reviewing inspected slaughter and processing HACCP records and pre-shipment reviews in the office facing the dry storage area, SPHV observed an employee donned in a white processing frock and blue nitrile gloves retrieve a rectangular brown cardboard box from the dry storage shelves and walk back towards the large processing room. SPHV followed the processing employee to observe the handling of the box and its contents. From the windows in the processing doors, SPHV observed the employee carry the box through the processing doors, across the processing room, and through another set of swinging doors leading to an area between the loading dock, large freezer, and processing room. The employee re-emerged into the processing room within ninety seconds of exiting and was observed carrying clear, plastic product packaging bags in both hands while still wearing the frock and blue nitrile gloves. SPHV observed the employee place these bags on the table at one end of the centrally located processing table belt, which was covered with a green, plastic, combo liner. As SPHV was not wearing a frock, hairnet, or hardhat, she immediately retrieved and donned those items, entered the processing area, observed the bags on the end of the table with several employees continuing to process beef carcasses on the same table, and placed USDA Rejected tag number B40742751 on the packaging bags and B40742752 on the table in the immediate area of the bags. On the table, SPHV also observed approximately ten pounds of boneless beef trim approximately six inches from the plastic bags, as well as three carcass quarters several feet away. SPHV immediately verbally informed Mr , already present in the processing room, of the noncompliance. stated the sanitation issue would be addressed. The plastic bags were removed and placed in a white plastic lug. SPHV observed spray the green plastic liner at the end of the table where the bags had been and the ten pounds of trim with SPHV verbally explained to controls microbial outgrowth and is not considered a sanitizing agent. then sanitized the green plastic liner with dilute bleach solution. also sanitized the outer most two plastic packaging bags with the dilute bleach solution. SPHV removed the rejected tags and released the table and its contentsand the plastic bags. No product was directly affected; however, ten pounds of boneless beef trim was in close proximity to the insanitary conditions created. The above represents noncompliance with 9 CFR 416.5(a) which requires employees to adhere to hygienic practices to prevent insanitary conditions and 9 CFR 416.4(a) which requires all food contact surfaces to be maintained in a sanitary condition. As the above occurred during production, there is also noncompliance with 9 CFR parts 416.13(b) and(c) which require establishments to implement and monitor SSOPs, respectively. A search for noncompliance records issued for the same cause within the last ninety days revealed none.

Regulation:

416.13(b)  Implementation of SOP’s: Each official establishment shall conduct all other procedures in the Sanitation SOP’s at the frequencies specified.

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.4(a)  All food-contact surfaces, including food-contact surfaces of utensils and equipment, must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

416.5(a)  Cleanliness. 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.

Code:  01B02
Violation:  416.13(a), 416.13(c), 416.15(b), 416.16(a)

Citation:

On 1/5/2012, at approximately 0830 MST, while performing routine pre-operational sanitation verification review and observation of the large processing room, Front Line Supervisor (FLS) and Intermittent Inspector observed the following noncompliance. [newline][newline]While performing visual inspection of the central, motorized, rolling processing table belt, FLS observed numerous cuts, cracks, and gouges in the belt. Upon further investigation, using her finger nail and clean paper towel, FLS digitally removed superficial residue and red to brown meat particles from many of the deeper cracks and gouges. As the rolling belt was rotated by the sanitation employee, FLS was able to extract meat particles and residue from cracks and gouges as they were exposed. On the horizontal, stainless steel, support rod of the belt closet to the entrances door, a piece of fat was observed, approximately one to two inches in size, between the underside of the top section of belt and the rod. [newline][newline]FLS and Intermittent observed no other insanitary conditions and verbally informed the sanitation monitor, Mr , the rolling table was rejected. The company elected to re-clean and re-sanitize the table and belt. [newline][newline]At approximately 0915 hours, Mr. verbally informed FLS and SPHV the rolling table was ready for sanitation verification. Upon review of the table, both FLS and SPHV observed brown meat particles and residue in several of the deepest gouges, which were extractable using a paper towel. At approximately 0935 hours, after time spent individually cleaning and sanitizing each location of persistent meat and residue as they were indicated by FSIS, Mr. Rick De Los Santos, owner, informed the processing employees to cease sanitation. Mr. De Los Santos instructed the employees to cover the rolling belt with the green , plastic liners used for the large combo bins. Mr. De Los Santos unplugged the rolling table and stated the belt would not be used until the company was able to repair or replace the belt. Mr. De Los Santos explained the company would use the clean combo liners as barrier and not mobilize the belt. [newline][newline]The table belt was observed by SPHV at approximately 0945 hours to be covered with a clean, green, plastic combo liner and the table was released for use. [newline][newline]The above represents noncompliance with 9 CFR 416.13(a), 416.13(c), and 416.16(a) requiring establishments to implement, monitor, and record monitored findings of pre-operational sanitation procedures. As the company’s initial corrective actions to restore sanitary conditions by means of re-cleaning and re-sanitizing the rolling belt were ineffective, there is also noncompliance with 9 CFR 416. 15(b), requiring establishments to implement corrective actions and restore sanitary conditions. [newline][newline]A search for noncompliance records (NR) issued in the last ninety days for the same cause revealed: : NR#YJL5311110302N-1 (11/2), #YJL0012125808N-1 (12/8), #YJL0910123013N-1 (12/13), #YJL0710120729N (12/29) all issued for presentation of insanitary conditions during pre-operational sanitation verification review and observation with corresponding implementation, monitoring, and recordkeeping noncompliance. Additionally, #YJL0710120729N also documents noncompliance with 9CFR 416.15(b) failure of corrective actions to restore sanitary conditions.

Regulation:

416.13(a)  Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.15(b)  Corrective actions include procedures to ensure appropriate disposition of product(s) that may be contaminated, restore sanitary conditions, and prevent the recurrence of direct contamination or adulteration of product(s), including appropriate reevaluation and modification of the Sanitation SOP’s and the procedures specified therein or appropriate improvements in the execution of the Sanitation SOP’s or the procedures specified therein.

416.16(a)  Each official establishment shall maintain daily records sufficient to document the implementation and monitoring of the Sanitation SOP’s and any corrective actions taken. The establishment employee(s) specified in the Sanitation SOP’s as being responsible for the implementation and monitoring of the procedure(s) specified in the Sanitation SOP’s shall authenticate these records with his or her initials and the date.

Code:  04B04
Violation:  317.16

Citation:

On 12/30/11, at approximately 1605 hours MST, while verifying cessation of inspected processing productionin the large processing room due to end of duty hours (1600), SPHV observed the following noncompliance. At 1605 hours SPHV observed in the large processing various labeled and unlabeled red meat products in various stages of production and packaging not yet stored following production. SPHV noted a pallet of approximately twenty brown product boxes with generically approved inspected labels for various cuts of red intact meat stacked near the entry of the room. On the cutting board side of the rolling table near the freezer access, SPHV observed two full lugs of ground beef product and a half sheet of notebook paper stating, “CUSTOM”. On the rolling table’s opposite side cutting table, SPHV observed approximately five, clear, unsealed vacuum packs of red meat strips, mostly fat, and two to three vacuum sealed packages of this same intact product. Two additional vacuum packages of this intact product were observed in the vacuum sealing machine. One unsealed vacuum package of intact product was resting immediately adjacent to the lugs of ground product. None of the intact product in vacuum packages was observed to have identification or labeling. On a pallet within approximately two and one half to three (2.5-3) feet of both the opened, unlabeled raw intact product and vacuum sealing machine, SPHV observed approximately sixteen brown product boxes and one sealed, clear, vacuum packaged (approximately ten pounds) ground beef stacked on a pallet with the ground beef package resting on the boxes; none of this product was labeled. Throughout the inspected production day, SPHV had observed the inspected labeled product boxes to have been placed in the observed location and the pallet of unlabeled boxed product to have been assembled during processing of inspected ground beef. SPHV had also observed two lugs of ground product stacked on a stainless steel rolling tier rack with half sheets of paper identifying the tier rack product as custom exempt. During the observations made at 1605, two company employees were in the processing room, one handling ground product and one vacuum sealing the intact product. The employee handling the intact product selected the unsealed package of intact adjacent to the lugs and aligned it in the vacuum machine for sealing. Mr. De Los Santos had entered the processing room shortly after SPHV SPHV verbally stated that the production needed to be finished as it was after 1600 hours. Mr. De Los Santos stated the two lugs of ground product were custom exempt and pointed to the half sheet of paper stating the product had been identified all day as such. SPHV acknowledged observing the custom ground product earlier stated there must be separation of time and space between inspected and custom product and all custom prepared product must be labeled as such. SPHV stated that she had observed the employee move a package of intact product which had been adjacent to the ground product and place it in the vacuum machine. Mr. De Los Santos reported the intact product was fat. SPHV asked what the company intentions were for the fat and Mr. De Los Santos reported that fat was for his own personal use for ground product. SPHV explained that all custom prepared product must be labeled as such and that immediately next the this now claimed custom product was a pallet of unlabeled ground product. SPHV a

Regulation:

317.16  Labeling and containers of custom prepared products: Products that are custom prepared under § 303.1(a)(2) of this subchapter must be packaged immediately after preparation and must be labeled (in lieu of information otherwise required by this part 317) with the words ‘‘Not For Sale’’ in lettering not less than three-eighth inch in height. Such exempted custom prepared products or their containers may bear additional labeling provided such labeling is not false or misleading.

Code:  01B02
Violation:  416.1, 416.13(a), 416.13(c), 416.15(b), 416.16(a), 416.4(b)

Citation:

On 12/29/2011, at approximately 0815 hours MST, while performing routine pre-operational sanitation inspection verification of the large processing room, SPHV observed the following noncompliance. Prior to entering the processing room for review and observation, SPHV reviewed the 12/29/11 pre-operational sanitation monitoring record and observed all areas had been indicated as monitored and verified as acceptable. Upon review of the centrally located, rolling processing table, SPHV observed pieces of red meat particles, ranging from one half to three centimeters long, accumulating on andaround three of the four stainless steel table legs and feet. Additional pieces of red meat particles were observed on the floor immediately around the table and stuck to the drain, along three of the four walls, and on the cooler door latch. The floor in the far corner under and around the grinding machine was extremely slick with residue as determined by SPHV shoes sliding easily over the floor surface. SPHV observed a wooden paint stir stick with dried white paint covering two thirds of the stick resting on the “curb” portion of the wall on the hinge side of the cooler door. SPHV also observed a very rusted curved, approximately two feet length of metal stripping resting on the lower stainless steel support of the grinding machine. who was following SPHV during the review, immediate removed these to items. SPHV had pointed out all of the described defects as above to during the review and upon exiting of the processing room, informed Mr. De Los Santos of the noncompliance and that the processing room was rejected. The room was immediately re-cleaned and sanitized and presented to SPHV at approximately 0830 for verification. SPHV again observed various pieces of red meat particles on the floor of the processing room and pointed those out to Mr. De Los Santos. SPHV directly observed the remaining particles manually removed and those surfaces re-cleaned and sanitized. The room was released for production. No product was affected. The above represents noncompliance with 9 CFR 416.1 requiring establishments to operate in a manner to prevent insanitary conditions and 416.4(b) requiring establishments to clean and sanitize nonfood contact surfaces as often as needed to prevent insanitary conditions. Because the establishment’s written pre-operational sanitation procedures for the processing room specify nonfood contact surfaces of all processing tables will be reviewed by the Processing QC, rejected if insanitary, and re-cleaned and sanitized prior to notifying the Inspector In Charge of completion, there is noncompliance with 9 CFR 416.13(a) and (c) requiring establishments to implement pre-operational sanitation procedures prior to the start of operations and monitor those procedures, respectively and 416.16(a) requiring recordkeeping of the monitoring and implementation of SSOPs. Because the establishment presented the room for verification following corrective action sanitation and continued insanitary conditions were observed by SPHV there is noncompliance with 9 CFR 416.15(b) requiring establishments to take appropriate corrective actions after FSIS determines a failure in implementation or monitoring of SSOPs and those corrective actions are effective in restoring sanitary conditions and again with 416.13(a) and (c) as the company failed to successfully implement and monitor, respectively, the

Regulation:

416.1  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.

416.13(a)  Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.15(b)  Corrective actions include procedures to ensure appropriate disposition of product(s) that may be contaminated, restore sanitary conditions, and prevent the recurrence of direct contamination or adulteration of product(s), including appropriate reevaluation and modification of the Sanitation SOP’s and the procedures specified therein or appropriate improvements in the execution of the Sanitation SOP’s or the procedures specified therein.

416.16(a)  Each official establishment shall maintain daily records sufficient to document the implementation and monitoring of the Sanitation SOP’s and any corrective actions taken. The establishment employee(s) specified in the Sanitation SOP’s as being responsible for the implementation and monitoring of the procedure(s) specified in the Sanitation SOP’s shall authenticate these records with his or her initials and the date.

416.4(b)  Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

Code:  01D01
Violation:  416.1, 416.3(a)

Citation:

On 12/28/2011, at approximately 1530 hours MST, while washing her hands at the hand sink in the large processing room prior to entry into the storage cooler to release retained product, SPHV observed the following noncompliance. [newline][newline]SPHV observed the hand saw used to cut hanging carcasses into large sections for processing hanging on a nonfood contact surface. The saw was hung by hooking the connected curved portion of the blade (“nose”) opposite the handle over the cooler door securing latch mounted on the door frame, approximately six feet from the floor. [newline][newline]SPHV immediately verbally notified the processing QC by means of pointing to the hanging saw, and the QC promptly removed the saw and sanitized it in the hot water sterilizer before hanging it on the designated equipment hook. SPHV also verbally notified Mr. Rick De Los Santos, who was in the loading area preparing a shipment of product. [newline][newline]Mr. De Los Santos immediately verbally instructed all employees present in the processing area to use only the equipment hooks for hanging product equipment. As SPHV had exited the processing area and cooler at approximately 1525 hours, during which she had observed the saw to have been hung on the equipment hooks, and there was not a discernable increase in the amount of product on the boning table to indicate the saw had been used; no product was affected regarding the use of the hand saw following the contact with a nonfood contact surface. [newline][newline]The above represents noncompliance with 9 CFR 416.1 requiring establishments to operate in a manner to prevent the creation of insanitary conditions and 416.3(a) requiring establishments to maintain equipment and utensils in a sanitary condition. A search for previous noncompliance records issued in the last ninety days revealed none.

Regulation:

416.1  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.

416.3(a)  Equipment and utensils used for processing or otherwise handling edible product or ingredients must be of such material and construction to facilitate thorough cleaning and to ensure that their use will not cause the adulteration of product during processing, handling, or storage. Equipment and utensils must be maintained in sanitary condition so as not to adulterate product.

Code:  01D01
Violation:  416.1, 416.4(d)

Citation:

On 12/27/2011, at approximately 0750 MST, while retrieving tissues for residue testing from the storage cooler, SPHV observed the following noncompliance. Upon retrieval of the tissues from the bottom shelf of the two shelf, stainless steel, rolling cart, SPHV observed one plastic lug full of large, beef cuts of product stored on the top shelf of the stainless steel cart (approximately two and one half feet tall) to be uncovered. This cart is used for USDA supplies and not maintained as a food contact surface. A white half sheet of paper on a cut of meat in the lug identified the product as “CUSTOM”. was in the cooler area and SPHV pointed to the uncovered product and stated there was noncompliance. SPHV reviewed the other lugs stored in the cooler to verify product storage protection methods and observed the top lug of beef cuts in a rolling stainless steel tier rack was also not covered. Sheets of paper affixed to the sides of the plastic lugs stored on the tier rack claimed all product to be custom exempt. As SPHV was retrieving thetissues from the cooler prior to company pre-operational sanitation or handling of any product for the day, the uncovered product was stored at least one night without adequate protection. The above represents noncompliance with 9 CFR 416.1 requiring all establishments to operate in a manner to prevent insanitary conditions and product adulteration and 416.4(d) requiring establishments to protect product during storage. A search for previous noncompliance records issued for the same cause in the last ninety days revealed none.

Regulation:

416.1  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.

416.4(d)  Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments.

Code:  01B02
Violation:  416.1, 416.13(a), 416.13(c), 416.16(a), 416.2(b)(1) , 416.2(b)(2)

Citation:

On 12/13/11, at approximately 0745 hours MST, while performing a routine pre-operational sanitation review and observation verification of the slaughter floor, SPHV observed the following noncompliance. Prior to observing the slaughter floor, SPHV reviewed the pre-operational sanitation monitoring record and noted the monitor had indicated some areas had been rejected, re-cleaned and sanitized, with no product affected. The landing area was indicated as “acceptable”. Upon review of the slaughter floor landing area, the area where the cattle roll out of the knocking chute following knocking, SPHV observed the third tier of the wall immediately adjacent to the chute to be generally covered in a black/brown colored substance in a splatter pattern. SPHV ran her finger through the substance, smearing it easily and identifying it as fecal and dirt matter. From the floor upwards, the first two tiers of this wall were observed to be comprised stainless steel, approximately three and a half (3.5) feet long by two and a half (2.5) feet tall and 3.5 feet long by one and half (1.5) tall. The third tier was observed to be white glass board 3.5 by 2.5 feet and was affected by the fecal dirt matter. Additionally, the glass board tier was observed to be broken via indentation approximately twelve inches in diameter at the bottom middle edge. The wood wall frame support and exterior wall were visible through the indentation defect. Another indentation in the glass board of approximately the same size was observed approximately twelve inches above the first, although the second indentation was only completely penetrated at the bottom most part of the indentation and the remaining board was still intact with cracking. SPHV verbally notified and physically pointed out the noncompliance to the sanitation monitor. The sanitation monitor re-cleaned the damaged glass board and verbally notified of the need for repair. Mr. De Los Santos placed a small piece of new glass board behind the lowest indentation, sliding the small piece up behind the larger piece. The right corner of the small piece of the glass board also covered the broken section of the upper indentation. SPHV verified the temporary solution and verbally explained to Mr. De Los Santos that this “repair” was only acceptable for this day’s production as the indentations would continue to accumulate moisture and organic particulates and debris which would also affect the small glass board; i.e. because the repair cannot be thoroughly sanitized, it is not suitable for more than a one time use. SPHV verified sanitation of the glass board and placement of the small patch of glass board and released the kill floor for operation. No product was affected. As the company includes the review of non-food contact surfaces (landing area) in their written pre-operational sanitation monitoring program (written SSOP), the above represents noncompliance with 9 CFR 416.13(a) which requires those procedures identified in the written SSOP as pre-operational sanitation to occur prior to the start of operations, 416.13(c) the monitoring of those procedures and 416.16(a) recordkeeping of the monitoring and implementation of the SSOP. Additionally, the broken and damaged glass board represents noncompliance with 9 CFR 416.1 requiring establishments to operate under and maintain sanitary conditions and 416.2(b)(1) and (2) requiring structures, rooms, and compartments must be maintained in sound construction and good repair to

Regulation:

416.1  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.

416.13(a)  Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.16(a)  Each official establishment shall maintain daily records sufficient to document the implementation and monitoring of the Sanitation SOP’s and any corrective actions taken. The establishment employee(s) specified in the Sanitation SOP’s as being responsible for the implementation and monitoring of the procedure(s) specified in the Sanitation SOP’s shall authenticate these records with his or her initials and the date.

416.2(b)(1)  Establishment buildings, including their structures, rooms, and compartments must be of sound construction, be kept in good repair, and be of sufficient size to allow for processing, handling, and storage of product in a manner that does not result in product adulteration or the creation of insanitary conditions.

416.2(b)(2)  Walls, floors, and ceilings within establishments must be built of durable materials impervious to moisture and be cleaned and sanitized as necessary to prevent adulteration of product or the creation of insanitary conditions.

Code:  01B02
Violation:  416.13(a), 416.13(c), 416.15(b), 416.16(a)

Citation:

On 12/8/11, at approximately 0815 hours MST, while performing routine pre-operational sanitation inspection verification in the large processing room, SPHV observed the following non-compliance. Prior to entering the processing room, SPHV reviewed the pre-operational sanitation monitoring record for 12/8/11. The record indicated the sanitation monitor had accepted all areas and a separate employee verified the findings. On review and observation of the centrally located, rolling processing table, SPHV observed numerous small pieces of red meat particles (one half to three centimeters) and debris on the stainless steel table legs and lower support bar. SPHV also observed small pieces (one to five millimeters) of tan dried debris generally disseminated on the rolling table surface. SPHV used a fingernail to scrape at one of the pieces of tan debris at the far end of the table and observed the debris to lift off and SPHV identified it as protein and fat residue. SPHV rejected the central processing table and observed all other areas in the processing room to be acceptable. The sanitation monitor immediately re-cleaned and sanitized the table. SPHV reviewed the table and observed the table food and nonfood contact surfaces to be clean and sanitary. Following release of the processing table, SPHV verbally notified Mr. Rick De Los Santos, owner, of the above noncompliance. No product was affected. The above represents noncompliance with 9 CFR 416.13(a) and (c) which requires pre-operational sanitation procedures to occur prior to the start of operations and the monitoring of implementation and 416.16(a) requiring establishments to maintain records documenting sanitation procedure implementation, monitoring, and corrective actions. As search for noncompliance records (NR) issued in the last ninety days for the same cause revealed NR# YJL531110302N issued on 11/2/11 for meat and protein residue observed during FSIS pre-operational sanitation verification in the large processing room. The written response plant further planned actions provided by the company include having a separate employee re-inspect the large processing room to verify the sanitation monitor’s findings and corrective actions. The failure of the verification employee to monitor and implement necessary corrective actions is in noncompliance with the above sited noncompliance and 9 CFR 416.15(b) which requires establishment evaluation of sanitation procedures and further preventive measures to prevent re-occurrence.

Regulation:

416.13(a)  Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.15(b)  Corrective actions include procedures to ensure appropriate disposition of product(s) that may be contaminated, restore sanitary conditions, and prevent the recurrence of direct contamination or adulteration of product(s), including appropriate reevaluation and modification of the Sanitation SOP’s and the procedures specified therein or appropriate improvements in the execution of the Sanitation SOP’s or the procedures specified therein.

416.16(a)  Each official establishment shall maintain daily records sufficient to document the implementation and monitoring of the Sanitation SOP’s and any corrective actions taken. The establishment employee(s) specified in the Sanitation SOP’s as being responsible for the implementation and monitoring of the procedure(s) specified in the Sanitation SOP’s shall authenticate these records with his or her initials and the date.

Code:  04C02
Violation:  313.1, 313.2

Citation:

On 11/30/11, at approximately 1015 hours MST, the following noncompliance was observed by Intermittent Inspector and verified by SPHV at approximately 1018 hours. At approximately 1015 MST, Intermittent Inspector reported to SPHV that she had observed an adult dairy cow being held in the side chute on the cement ramp to have a rear leg caught on the lowest rung of the metal piping chute side. Intermittent explained to SPHV the cow was being held there because the handheld usually used was not working and the company was obtaining the correct knocking firearm (no attempts were made to use the This animal had been lead into the knocking chute at approximately 1000 hours and Inspector was conducting a visual antemortem assessment of the cow given the amount of time lapsed since entry into the chute. SPHV informed Intermittent to tag the knocking area while SPHV investigated the cow in the side chute. Intermittent placed USDA Reject Tag#B40248214 in the knocking area immediately after the last cow which had been knocked was shackled and hoisted. At approximately 1018 hours MST, SPHV observed one adult dairy cow being held in the side chute along the east wall of the building, on the cement ramp. The cow was facing south toward the kill floor entrance, was approximately half way up the ramp, and had her left rear hoof caught on the lower level of the two tiered metal piping side of the chute (piping abuts the exterior wall of the facility). SPHV did not observe the animal to be in distress or vocalizing, only in discomfort as she was unable to remove her hoof from the piping tier, which was approximately eighteen to twenty-four inches off the ground, after repeated attempts. As SPHV was returning into the facility via the front entrance at approximately 1020 MST, Intermittent and Mr. Rick De Los Santos exited the facility through the kill floor and released the cow. Mr. De Los Santos and Intermittent met SPHV in the USDA office and Mr. De Los Santos verbally reported the cow had been able to walk forward, dislodging her hoof, once the chute door was opened; Intermittent verified this report. The above represents noncompliance with 9 CFR 313.1(a) requiring livestock pens, driveways and ramps to be maintained in good repair to prevent injury or pain to animals and that any unnecessary openings where heads, feet, or legs of an animal could be injured shall be repaired and 9 CFR 313.2 (a) requiring driving of livestock from holding pens to stunning area shall be done with minimum excitement and discomfort (HATS Category IV). As Mr. De Los Santos immediately enabled the cow to dislodge her hoof and exit the shoot, and the noncompliance was determined as not egregious, no further enforcement actions are required. A search for noncompliance records issued for the same cause in the last ninety days revealed none.

Regulation:

313.1  Livestock pens, driveways and Ramps: (a) 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.

313.2  Handling of Livestock: Driving of livestock from the unloading ramps to the holding pens and from the holding pens to the stunning area shall be done with a minimum of excitement and discomfort to the animals. Livestock shall not be forced to move faster than a normal walking speed.

Code:  01D01
Violation:  416.1, 416.2(d)

Citation:

On 11/25/11, at approximately 1000 Hours MST, while performing a routine SPS ventilation verification task, SPHV observed the following noncompliance in the large storage freezer. [newline][newline]After sliding the freezer access door open, SPHV observed a heavy build up of white ice shavings extending from the top of the door frame along the vertically hanging plastic curtain flaps approximately twelve inches toward the floor. The build up of ice condensate was observed to span the right half to two thirds of the overall width of the plastic curtain barrier. The metal freezer door slides right to left and is approximately ten feet in width and height. On observation of the freezer floor, SPHV noted there was a very minor, thin, streaking of ice extending from the entrance into the freezer for approximately four feet. The size and pattern of the streaking indicates the floor ice/condensate is a result the wheels of the pallet jack tracking the condensate from the entry further into the freezer. SPHV did not observe any ice or condensate on any other non- food contact or food contact surfaces, including product and packaging, in the freezer or facility, aside from the previously described entryway and floor buildup. [newline][newline]As Mr. De Los Santos, owner, was unavailable 11/25, SPHV could not verify until 11/28 the ice condensate issue was not previously identified by the establishment as an item on the plant improvement plan (PIP). On 11/28, at approximately 0945 hours, SPHV asked Mr. De Los Santos if there had been any recent additions to the PIP and Mr. De Los Santos reported there had not been and a company assessment would be made today. SPHV verbally notified Mr. De Los Santos of the ice condensate noncompliance. [newline][newline]The above represents noncompliance with 9 CFR 416.1 requiring establishment to operate in a manner to prevent insanitary conditions and 416.2(d) requiring establishments to provide adequate ventilation to prevent the formation of insanitary conditions as a result of condensation. [newline][newline]No product was affected; however, continued development and tracking of ice condensate into the freezer storage could result in direct product contamination due to these insanitary conditions. [newline][newline]A search for noncompliance records issue for the same cause within the last ninety days revealed none.

Regulation:

416.1  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.

416.2(d)  Ventilation: Ventilation adequate to control odors, vapors, and condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions must be provided.

Code:  01D01
Violation:  416.1, 416.2(a)

Citation:

On 11/22/11, at approximately 0815 MST, while speaking with Intermittent Inspector in the USDA office, SPHV observed a dark gray/black coated mouse moving along the USDA restroom door, located within the office, toward the hand sink and the metal bait box located on the floor underneath the sink (North West corner of the office). Approximately fifteen minutes later, 0830, SPHV observed the mouse moving from the bait box, under the USDA restroom door, and into the lavatory. The USDA office is located approximately five feet north and on the opposite side of the hallway from the loose swinging door entrance to the smaller processing room, in which custom exempt operations had already commenced. SPHV verbally notified Mr. Rick De Los Santos, owner, of the continued presence of mice inside the establishment at approximately 0830. Spring loaded, food baited, wire traps and additional rodenticide pellets were placed by the company in the USDA office and restroom at approximately 0900. The above represents noncompliance with 9 CFR 416.1 requiring establishments to operate in a manner to prevent insanitary conditions and 416.2(a) requiring the establishment maintain sanitary conditions and prevent the creation of insanitary conditions due to pests or vermin, as well as have in place a pest control program to prevent the harborage and breeding of pests. No product was affected. A search of noncompliance records issued for the same cause in the last ninety days revealed noncompliance record number YJL011011451N/1 was issued 11/14/11 for observation of rodent activity in the company hot box. The establishment has not provided a written or electronically written response to this noncompliance record and it remains open.

Regulation:

416.1  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.

416.2(a)  Grounds and pest control: The grounds about an establishment must be maintained to prevent conditions that could lead to insanitary conditions, adulteration of product, or interfere with inspection by FSIS program employees. Establishments must have in place a pest management program to prevent the harborage and breeding of pests on the grounds and within establishment facilities. Pest control substances used must be safe and effective under the conditions of use and not be applied or stored in a manner that will result in the adulteration of product or the creation of insanitary conditions.

Code:  01D01
Violation:  416.1, 416.2(a)

Citation:

On 11/14/11, at approximately 0745 MST, while in the hot box performing routine verification of USDA retained product from 11/10/11 slaughter and determination of whether cheek meat product for a FSIS directed sample would be available, SPHV observed the following noncompliance While reviewing the slaughter product storage trays for identification of available sampling product, SPHV observed a dark shadow dart along the edge of the hot box cement “curb”, approximately four inches above the floor, away from the tiered product trays. SPHV shifted position to look along the wall of the hot box toward the kill floor access door and noted one, medium sized, dark grey/black coated mouse scamper along the “curb”, to the floor, and under the door leading to the kill floor even though there is no excessive gap between the door and the floor. On the product trays, SPHV observed two sets of USDA retained tongue and cheek meat (MPD57275871 and 57275872) on the most bottom tray (approximately six inches from the floor) and was unable to observe if additional product was held on the upper most tiered trays. SPHV also noted approximately ten to fifteen cattle carcasses hanging on the rail system in the hot box. SPHV immediately placed USDA Retain and Reject tags on the hot box access doors; #B40248222 leading from the cooler and B40248221 leading from the kill floor. At approximately 0815, before performing routine pre-operational sanitation verification, SPHV verbally notified the processing sanitation verifier of the above noncompliance. The above represents noncompliance with 9 CFR 416.1 requiring establishments to operate in a manner to prevent insanitary conditions and product adulteration and 416.2(a) requiring the establishment to maintain sanitary conditions and prevent the creation of insanitary conditions or product adulteration due to pests or vermin, as well as have in place a pest control program to prevent the harborage and breeding of pests. Any product held on the hot box product trays meets the standards for product adulteration as defined in 9 CFR 301.2(4) as products held in insanitary conditions. Observation by SPHV of the mouse in such proximity of product trays represents insanitary conditions with product adulteration. The hanging hot box carcass product has also been held in insanitary conditions. A search for noncompliance records issued for the same cause in the last ninety days revealed none.

Regulation:

416.1  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.

416.2(a)  Grounds and pest control: The grounds about an establishment must be maintained to prevent conditions that could lead to insanitary conditions, adulteration of product, or interfere with inspection by FSIS program employees. Establishments must have in place a pest management program to prevent the harborage and breeding of pests on the grounds and within establishment facilities. Pest control substances used must be safe and effective under the conditions of use and not be applied or stored in a manner that will result in the adulteration of product or the creation of insanitary conditions.

Code:  01B02
Violation:  416.13(a), 416.13(c), 416.15(b), 416.16(a)

Citation:

On 11/2/11, at approximately 0825 MST, while performing routine pre-operational sanitation verification in the large processing room, SPHV and Intermittent Inspector (IPP) observed the following noncompliance. IPP observed numerous particles of pink meat and protein residue from previous day’s production on the handle and blade of the hand saw, three red meat particles along the long edge of the central processing rolling table facing the sink, and multiple, small red blood droplets and residue particles along the exterior hood and sides of the vacuum packer. SPHV observed additional debris inside the vacuum packer on the product package surface each time the processing employee moved the vacuum hood left to right and observed the interior surface of the hood to be generally covered with dried blood and particle residue. The saw and table represent direct food contact surfaces. While the vacuum packer comes in direct contact with the product packaging, the exterior of the machine comes in direct contact with frock fronts during operation and frock fronts are in direct contact with product throughout processing. Additionally, the packaged product to be sealed is placed in the machine with the packaging not sealed (open) and thus debris from the inside of the hood could contaminate product prior to sealing of the packaging. Prior to initiating pre-operational sanitation verification, SPHV reviewed the 11/2/11 processing pre-operational sanitation monitoring record and had observed the monitor recorded the rolling table and breaking saw had been rejected, re-cleaned, and sanitized with no product affected. All areas were indicated as acceptable prior to IPP review. SPHV verbally informed the processing employee the room was rejected for processing operations. SPHV immediately verbally notified Mr. Rick De Los Santos of the noncompliance. The room was re- cleaned and sanitized and re-presented to IPP for pre-operational sanitation verification at 0840 hours MST. IPP verified implementation, monitoring, and record keeping of the processing pre-operational sanitation and the room and released the room for processing operations. The above represents noncompliance with 9 CFR 416.13 parts (a) and (c), and 416.16 (a) which requires pre-operational sanitation to be implemented, monitored, and recorded, respectively. Additionally there is noncompliance with 416.15

Regulation:

416.13(a)  Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.15(b)  Corrective actions include procedures to ensure appropriate disposition of product(s) that may be contaminated, restore sanitary conditions, and prevent the recurrence of direct contamination or adulteration of product(s), including appropriate reevaluation and modification of the Sanitation SOP’s and the procedures specified therein or appropriate improvements in the execution of the Sanitation SOP’s or the procedures specified therein.

416.16(a)  Each official establishment shall maintain daily records sufficient to document the implementation and monitoring of the Sanitation SOP’s and any corrective actions taken. The establishment employee(s) specified in the Sanitation SOP’s as being responsible for the implementation and monitoring of the procedure(s) specified in the Sanitation SOP’s shall authenticate these records with his or her initials and the date.

Code:  04C02
Violation:  313.2

Citation:

On 10/25/11, at approximately 1540 hours MST, following the conclusion of slaughter activities. while verifying the denaturing of a antemortem condemned animal and performing routine humane handling of livestock water and feed accessiblity (HAT Catagory III), SPHV observed the following noncompliance. SPHV observed one, single, dairy cow to be held in a rectangular pen, approximately ten by twenty feet, with no source of available water provided. SPHV verbally notified the employees outside and water was provided in a black plastic round tub immediately. SPHV observed the cow to be standing, in good condition for a dairy cull animal and not outwardly dehydrated. Upon receipt of the water, the cow did not appear overly thirsty, just curious. SPHV observed the remaining animals (cattle) held in various other pens to all have a source of water available. SPHV verbally notified Mr. Rick De Los Santos of the noncompliance immediately upon entering the facility. Mr. De Los Santos reported the cow was one of two which had arrived in the late afternoon for slaughter (the other was slaughtered). As slaughter was completed for the day and the employees immediately provided available water, no additional regulatory control action was taken. The above represents noncompliance with 9 CFR 313.2(e) requiring all animals in holding pens to have access to water. A search for noncompliance records issued within the last ninety days revealed none.

Regulation:

313.2  Handling of Livestock: Driving of livestock from the unloading ramps to the holding pens and from the holding pens to the stunning area shall be done with a minimum of excitement and discomfort to the animals. Livestock shall not be forced to move faster than a normal walking speed.

Code:  01C02
Violation:  416.4(d)

Citation:

On 10/19/11, at approximately 0805 hours, while performing a pre-operational sanitation verification task, the processing QC wanted to demonstrate to SPHV the product retained 10/18/11 for exceeding critical temperature limits (NR # YJL42151053) had been frozen. During entrance into the larger product storage freezer, SPHV observed the following non-compliance. SPHV observed seventeen boxes of boneless beef trim product stored uncovered in the freezer and the product was not in any additional packaging, just resting in the open box bottoms. The boxes were either resting on pallets or other boxes of covered product on pallets. Five boxes aligned in a two by three pattern rectangle had two lids resting across the box bottom top edges, but not completely covered or sealed. The observed uncovered boneless beef trim was the same product already retained with USDA Retain Tag # B40248238 on 10/18/11. SPHV also observed two large lined combo bins with exposed bob veal carcasses protruding from the open, semi-covered tops. The above represents noncompliance with 9 CFR 416.4(d) requiring product to be protected during storage. SPHV immediately verbally notified the processing QC and of the noncompliance and placed USDA Retain Tag # B40248237 on the handle of the large freezer. A search for noncompliance records issued in the last ninety days revealed NR# YJL1609095419N-1 issued 9/19/11; storing edible product in the storage cooler uncovered.

Regulation:

416.4(d)  Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments.

Code:  03C02
Violation:  417.5(a)(3)

Citation:

On 10/18/2011, at approximately 1415 hours MST, while conducting routine raw intact HACCP, net weight, and general labeling verification tasks in the inspected processing room, the following noncompliance was observed. SPHV observed a pallet with twenty six (26) boxes of product stacked and had observed three of those boxes being weighed to sixty (60) pounds each and a processing employee preparing labels “BONELESS BEEF TRIM” with “60) written into the net weight space and then applied. Approximately forty (40) pounds of product remained un-packaged. SPHV asked the processing QC for the temperature recording record (CCP 3, 3B, 4B, freezer temperatures) and the processing QC reported he had not taken any temperatures. SPHV sought Mr. Rick De Los Santos, HACCP coordinator and owner, who is responsible for the CCPs, and observed him to be unavailable. SPHV returned to the processing room, sanitized the USDA digital thermomotor and inserted it into an approximately five pound piece of beef trim. The digital readout read forty- six point nine (46.9) degrees Fahrenheit (F). The upper critical limit for product temperature CCP 4B, according to the written HACCP plan, is degrees F. Because a USDA thermomotor was used, SPHV then sanitized and inserted an available, non-digital company thermomotor. The reading of this thermomotor was fifty (50) degrees F after several minutes. SPHV informed the processing QC not to disrupt the product or thermomotors. SPHV left the processing room and immediately requested Mr. Rick De Los Santos, now available, to come and observe the temperature readings. Mr. De Los Santos observed the readings and moved the thermomotors for additional readings: forty-seven point one (47.1) and forty-six point eight (46.8, forty-six point one (46.1). After the additional reading were still above maximum value, SPHV asked what the last recorded CCP reading had been. The written frequency for product temperature is at least during packaging. Mr. De Los Santos reported he had not taken a temperature CCP yet today and that they occur during packaging. SPHV pointed to the remaining approximate forty (forty) pounds of un-packaged product and stated that there was not really any more opportunities for CCP 4B. CCP 4B, product temperature was not monitored by the company at the designated frequency and when reviewed by SPHV the temperature exceeded the critical limit and is in noncompliance with 9 CFR 417.5(a)(3). SPHV observed the storage temperature (CCP 3B) to be at degrees F and within the critical limit. Mr. De Los Santos reported the morning product surface temperature (CCP 3) to have been within critical limits at degrees F. SPHV stated the entire lot of boneless beef produced today would be retained as there was not a previous CCP 4B value within critical limits prior to deviation. The product would be retained until appropriate corrective actions and product disposition was presented by the company. SPHV retained the approximate sixteen hundred (1600) pounds of boneless beef trim in twenty-seven boxes with USDA Retain Tag# B40248238. Each box had “236” written in black permanent marker in the top right corner indicating a specific owner. Mr. De Los Santos reported the product would be moved back into the cooler and product temperature would be taken every thirty minutes or so until it was within critical limits. A search for

Regulation:

417.5(a)(3)  The establishment shall maintain the following records documenting the establishment’s HACCP plan: Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

Code:  01C02
Violation:  416.2(b)(4) , 416.4(b), 416.4(d)

Citation:

On 8/12/11, at approximately 1530 hours MST, Intermittent Inspector directly observed processing employee Mr. drag a blue, plastic, fifty gallon barrel marked “INEDIBLE” through the hotbox containing hanging product on the wall perpendicular to the slaughter door entrance and a rolling tiered rack with two trays of product along the wall perpendicular to the cooler door entrance. Inspector reported her observation to SPHV and stated the barrel contained inedible material, was uncovered, and very full with material hanging over the side. The above represents noncompliance with 9 CFR 416.2(b)(4), 416.4(b), and 416.4(d) which require the separation of handling inedible product from edible by time or space, non-food contact surfaces be cleaned and sanitized as needed, and product to be protected from adulteration during storage. Moving uncovered, exposed inedible product through the space containing uncovered edible product by grabbing the inedible container/material interface creates an insanitary storage condition and potential product adulteration. SPHV and Intermittent immediately tagged the doors to the hotbox with USDA Rejected Tag#B40248230 on the cooler access point and #B40248231 on the slaughter floor access point. SPHV also immediately notified owner and HACCP coordinator Mr. Rick De Los Santos of the noncompliance observation and rejection of the hotbox. Mr. De Los Santos immediately reviewed the hotbox and directed the sanitation of the affected areas of the hotbox with hot water and chlorine bleach rinsing. SPHV observed the product in the hotbox to have been sufficiently far enough away from the doors to prevent direct contact with the inedible barrel and its contents and Inspector confirmed no direct contact was observed. SPHV was notified by a company employee the hotbox had been cleaned and sanitized and SPHV conducted a review, verifying the floors, ceilings, walls were clean and sanitary. SPHV also observed the product in the hotbox to have been undisturbed. The tags were removed at 1545 hours MST. A search for noncompliance records issued for the same cause in the last ninety days yielded none. No product was directly affected.

Regulation:

416.2(b)(4)  Establishment grounds and facilities: Rooms or compartments in which edible product is processed, handled, or stored must be separate and distinct from rooms or compartments in which inedible product is processed, handled, or stored, to the extent necessary to prevent product adulteration and the creation of insanitary conditions.

416.4(b)  Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

416.4(d)  Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments.

Code:  01D01
Violation:  314.4, 416.1

Citation:

On 9/20/2011, while performing pre-operation sanitation verification of the slaughter floor at approximately 0800 hours MST, SPHV and Intermittent Inspector detected a severe, strong, sour odor immediately upon entering the kill floor. SPHV verbally questioned the sanitation monitor, where the source of the malodor was stemming from. reported the odor was stemming from the inedible bone stored overnight in the viscera room/antechamber located behind the kill floor. SPHV stated there was noncompliance for the creation of insanitary conditions. [newline][newline]SPHV visually observed eight, plastic, fifty gallon drum barrels stored in the viscera antechamber; one white, three black, and four blue, all clearly marked “INEDIBLE” and full of bones and other red meat trim. SPHV noted the sour odor was intensified in this area, supporting the inedible materials as the source of the malodor. [newline][newline]SPHV also verbally notified Mr. Rick De Los Santos, owner, of the noncompliance, explaining 9 CFR 314.4 requires the control of odors from inedible products and that inspected slaughter activities would not begin until the inedible material was properly disposed of and the odor dissipated. The above also represents noncompliance with 9 CFR 416.1 requiring facilities to operate in a manner to prevent insanitary conditions. Production of product in an environment with a strong malodor could lead to product adulteration and unwholesomeness. [newline][newline]A search for noncompliance records issued for the same cause in the last ninety days revealed none.

Regulation:

314.4  Tanks, fertilizer driers, and other equipment used in the preparation of inedible product must be operated in a manner that will suppress odors incident to such preparation which could adulterate edible product or create insanitary conditions.

416.1  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.

Code:  01C02
Violation:  416.4(d)

Citation:

On 9/19/11. at approximately 0739 hours MST, while retrieving residue sampling supplies and tissues from the storage cooler, SPHV observed the following noncompliance. The one stainless steal rolling product bin located in the storage cooler contained approximately eighty pounds of raw boneless beef trim stored uncovered. Also in this bin, directly contacting product, a brown product empty box bottom was resting diagonally on its bottom and side. As SPHV was this first person to enter the product cooler on 9/19/11, the product had been stored at least one night uncovered, with the brown cardboard box bottom directly contacting product. SPHV observed the stainless steal bin and product box bottom to otherwise be in good sanitary condition. On brief inspection, SPHV observed the product to appear wholesome and not further contaminated aside from the box. The above ceiling was not observed by SPHV to have condensation and the floor around the product was not observed to have no visible debris aside from blood and product particles. The above represents noncompliance with 9 CFR 416.4(d) which requires product to be protected during storage. SPHV placed a USDA Retain tag number B40248242 on the stainless steal product bin and immediately verbally notified of the noncompliance. A search of noncompliance records issued within the last ninety days for the same cause revealed none.

Regulation:

416.4(d)  Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments.

Code:  03C02
Violation:  318.1(a), 318.2(d)

Citation:

On 9/16/11, at approximately 1300 hours, while conducting routine processing production observation, SPHV observed approximately seventy-five pounds of bovine cheek meat to be displayed on the inspected processing table. SPHV then investigated into the product storage cooler and observed the cheek meat retained with carcass MPD47726466 for residue confirmation was not evident on the meat tray; only the tongue and carcass remained in the cooler. The tongue and carcass halves were each tagged. The company stores retained cheek meat adjacent to the corresponding tagged tongue on the plastic meat trays. SPHV immediately verbally notified Mr. Rick De Los Santos, owner, the retained cheek meat which SPHV had observed to be present earlier in the morning was now absent. Mr. De Los Santos immediately questioned the processing employees in front of SPHV One employee reported the cheek meat retained with the tongue had been used to complete the last ten pound bag of vacuum sealed product. Mr. De Los Santos verbally explained to the processing employees that no retained product can be removed without USDA first removing the retain tags and releasing the product and the company was also going to be “written up” for doing so. SPHV also explained to Mr. De Los Santos only the ten pounds of bagged cheek meat were to be retained instead of the entire lot because the employee was able to immediate discern where the retained product had been packaged. Mr. De Los Santos repeated this concept to the employees and further stated the entire lot could thrown out if the retained product ended up being condemned. SPHV placed USDA Retain Tag number B40248206 on the bagged cheek meat in a plastic lug containing approximately five pounds of additional cheek meat which may have been from carcass MPD47726466. The plastic lug was placed in the freezer. [newline][newline]Because the company processes product slaughtered at the same facility, the above represents noncompliance with 9 CFR 318.1(a) where only inspected and passed product may enter the processing facility and 318.2(d) only FSIS employees are to remove USDA retain tags. [newline][newline]Mr. De Los Santos verbally reported to SPHV in the future, any non-carcass product retained for laboratory testing with be thrown out by the company to prevent confusion and accidental packaging. [newline][newline]A search for similar noncompliance records issued for the same cause in the last ninety-days revealed none.

Regulation:

318.1(a)  Products and other articles entering official establishments: (a) Except as otherwise provided in paragraphs (g) and (h) of this section or § 318.12, no product shall be brought into an official establishment unless it has been prepared only in an official establishment and previously inspected and passed by a Program employee, and is identified by an official inspection legend as so inspected and passed. Notwithstanding the foregoing provisions of this subparagraph, product imported in accordance with part 327 of this subchapter and not prepared in the United States outside an official establishment, may enter any official establishment subject in other respects to the same restrictions as apply to domestic product. Products received in an official establishment during the Program employees absence shall be identified and maintained in a manner acceptable to such employee. Product entering any official establishment shall not be used or prepared thereat until it has been reinspected in accordance with § 318.2. Any product originally prepared at any official establishment may not be returned into any part of such establishment, except the receiving area approved under § 318.3, until it has been reinspected by the inspector:

318.2(d)  Reinspection, retention, and disposal of meat and poultry products at official establishments: (d) A U.S. retained tag shall be placed by a Program employee at the time of reinspection at any official establishment on all products which are suspected on such reinspection of being adulterated or misbranded, and such products shall be held for further inspection. Such tags shall be removed only by authorized Program employees. When further inspection is made, if the product is found to be adulterated, all official inspection legends or other official marks for which the product is found to be ineligible under the regulations in this subchapter, shall be removed or defaced and the product will be subject to condemnation and disposal in accordance with part 314 of this subchapter, except that a determination regarding adulteration may be deferred if a product has become soiled or unclean by falling on the floor or in any other accidental way or if the product is affected with any other condition which the inspector deems capable of correction, in which case the product shall be cleaned (including trimming if necessary) or otherwise handled in a manner approved by the inspector to assure that it will not be adulterated or misbranded and shall then be presented for reinspection and disposal in accordance with this section. If upon final inspection, the product is found to be neither adulterated nor misbranded, the inspector shall remove the U.S. retained tag. If a product is found upon reinspection to be misbranded, it shall be held under a U.S. retained tag, or a U.S. detention tag as provided in part 329 of this subchapter, pending correction of the misbranding or issuance of an order under section 7 of the Act to withhold from use the labeling or container of the product, or the institution of a judicial seizure action under section 403 of Act or other appropriate action. The inspector shall make a complete record of each transaction under this paragraph and shall report his action to the area supervisor.

Code:  01C02
Violation:  416.3(a)

Citation:

On 9/1/11, while conducting routine operational sanitation review and observation of the processing and cooler storage areas, SPHV observed the following noncompliance at approximately 1130 hours MST. Upon entering the cooler through the processing area, SPHV observed a handsaw resting blade side down on the USDA gray, plastic storage tote used for storing KIS test packages. USDA does not routinely clean or sanitize this container as a food contact surface. The container is maintained in a condition only to prevent the creation of insanitary conditions in the cooler storage area. SPHV picked up the saw by the handle, entered the processing area, and asked one of the two processing employees what the saw was being used for. The employee reported the saw was used to cut carcasses. SPHV explained the gray tote is not a food contact surface, nor maintained as such, and therefore it is a noncompliance to rest equipment used on edible product without recleaning and sanitizing the equipment. The employee asked where the saw could be hung and SPHV stated on any clean and sanitized food contact surface. The employee reached to hang the saw on a carcass and SPHV stopped him before the saw touched the carcass. SPHV explained the saw must be recleaned and sanitized before it can be used on product or other food contact surfaces without contaminating the product or surface. SPHV asked how many of the carcasses had been cut that day with the saw. The employee reported that all of the carcasses had been cut with that saw. The above describes noncompliance with 9 CFR 416.a(1) requiring equipment to be maintained in a clean and sanitary manner to prevent contamination, and 416.13(b) and (c) implementation and monitoring of plant implementation of SSOPs (Sanitation Standard Operating Procedures), respectively. SPHV immediately moved to the kill floor to verbally notify of the noncompliance as Mr. Rick De Los Santos was not in the facility. SPHV verbally explained the situation to and stated that product was considered affected because the employee responses did not indicate the saw had been handled in a sanitary manner during production prior to the observations made by SPHV suggested the product be held in a large combo bin in order for Mr. Rick De Los Santos to be able to make decisions regarding the product. asked if all product needed to be retained, and SPHV replied all product produced thus far today will need to be retained because it has been commingled with those parts cut by the saw and that all food contact surfaces and equipment will need to be recleaned and sanitize before unaffected product may be processed in that same area. then immediately left the kill floor to provide instructions to the two processing employees. SPHV directly observed the raw intact product produced on 9/1/11 to be placed into clean and sanitary stainless steel carts and covered with combo liner and placed the following USDA “US RETAINED” tags on the carts: #B40 -248248, -248249, and B38742756. SPHV also observed the recleaning and sanitizing of all food contact surfaces and equipment in the processing area. [newline]At 1240 hours, verbally informed SPHV of the following information derived from requesting details from the processing employees regarding saw usage. The employee reported they had used th

Regulation:

416.3(a)  Equipment and utensils used for processing or otherwise handling edible product or ingredients must be of such material and construction to facilitate thorough cleaning and to ensure that their use will not cause the adulteration of product during processing, handling, or storage. Equipment and utensils must be maintained in sanitary condition so as not to adulterate product.

Code:  06B01
Violation:  303.1(b)(4) , 416.3(c)

Citation:

[newline]On 7/25/2011, at approximately 0735 hours, while retrieving tissue samples for residue sampling from the cooler, SPHV observed the following noncompliance.[newline]In a stainless steel rectangular lug resting atop a stainless steel product cart, ground beef product was evident without any covering to protect the product during storage. As SPHV was the first person to enter the cooler, FSIS or company, by default the product was stored overnight without a cover. Because SPHV observed the uncovered product to be ground beef and the establishment does not produce inspected ground product, Custom Exempt noncompliance was observed. [newline]SPHV verbally informed there is a noncompliance for having uncovered product in the cooler and not identifying the product as “Not For Sale”. stated he would contact Mr. Rick De Los Santos (on medical leave) for instructions on how to respond to the noncompliance record and to get information on the product. reported to SPHV on 7/26/2011 the ground product had been left by Mr. Rick De Los Santos on Saturday 7/23/11 for an establishment partner to visually observe the product as being unwholesome before the product was to be tanked.[newline]With the information reported by to SPHV on 7/26/11, the Custom Exempt noncompliance is with 9 CFR 416.3(c) and 303.1(4)(b) , which require inedible product containers to be clearly marked and conspicuous and inedible product to be properly denatured. [newline]No noncompliance records have been issued in the last ninety days for the same cause.

Regulation:

303.1(b)(4)  Exceptions: (4) Articles capable of use as human food, resulting from the exempted custom slaughter or other preparation of products shall be promptly denatured or otherwise identified in accordance with § 325.13 of this subchapter and not removed from the establishment where the custom operations are conducted until so identified, unless they are delivered to the owner of the articles for use in accordance with paragraph (a)(2) of this section.

416.3(c)  Receptacles used for storing inedible material must be of such material and construction that their use will not result in the adulteration of any edible product or in the creation of insanitary conditions. Such receptacles must not be used for storing any edible product and must bear conspicuous and distinctive marking to identify permitted uses.

Code:  03C02
Violation:  417.5(a)(1), 417.5(a)(2)

Citation:

[newline]On 6/30/2011, at 1415 hours MST, while retrieving FSIS sampling supplies, SPHV observed the following noncompliance in the processing area. [newline]SPHV observed four product boxes not belonging to Establishment 07299. Upon further investigation, SPHV identified three covered boxes and one empty box bottom lined with clear plastic with blood residue. These boxes were located next to the central processing table and the white lids had labels stating “Beef” “Eye of Round” and a label with a USDA mark of inspection with “Est. 7041B”. Two of the covered boxes were on a wooden pallet and SPHV placed USDA Retain Tag #B38742766 (net weight sixty-nine and sixty-four hundredths (69.64) pounds) and B38742770 (net weight sixty-nine and fifty-four hundredths (69.64) pounds) on each lid. The third covered box was on the floor in a shallow puddle and SPHV removed the retain tag placed after observing the contents of the box to be the discarded clear plastic wrappings from eye of rounds previously opened. The empty box bottom was also on the floor but was immediately next to/under the central processing table.[newline]SPHV observed the central processing table to have approximately thirty five (35) unwrapped, eye of rounds, stacked neatly on the cutting board, representing approximately one hundred to one hundred fifty (100-150) pounds of product. The table was tagged by SPHV with USDA Retain Tag# B38742767.[newline]On the processing table adjacent to the exit near the freezer, SPHV observed approximately thirty (30) pounds of beef trim and placed USDA Retain Tag #B3874771 on the table. [newline]At the end of the central processing table, SPHV noted the official scale was in use with an establishment box bottom containing beef trim. The scale read twenty seven (27) pounds and SPHV placed USDA Retain Tag# B38742768 on the scale. Next to the scale, a wooden pallet with seventeen (17) boxes of covered product stacked neatly was observed. SPHV placed USDA Retain Tag# B3874769 on one of the top boxes. These boxes had no markings on them (typical of processing to weigh sixty pounds of beef trim in each and then affix labels at the end of production).[newline]After placement of USDA retain tags, SPHV made inquiries to the processing floor QC about the observations noted above. The floor QC reported to SPHV the eye of rounds on the table were from a different establishment and were being trimmed and added to company product. SPHV verbally informed the QC processing activities were not to be conducted until further notice by FSIS. SPHV also verbally notified the slaughter QC as Mr. Rick De Los Santos was unavailable while knocking animals for slaughter.[newline]SPHV contact Denver Deputy District Manager Anna Gallegos for further guidance and was instructed to retain all of the product involved and verbally communicated with Mr. Rick De Los Santos on the need for a written response by the company to be sent to Ms. Gallegos via fax.[newline][newline]Two company processing employees re-boxed the opened beef eye of rounds, table beef trim, and beef trim on the scale separately. SPHV identified each with the original USDA Retain Tags and green USDA Laboratory seals. The seals had “rounds” written in by SPHV on boxes containing the eye of round. These boxes were stacked on a wooden pallet. The seventeen boxes of covered product were then stacked on top of the re-boxed product and SPHV used the original USDA

Regulation:

417.5(a)(1)  The establishment shall maintain the following records documenting the establishment’s HACCP plan: (1) The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation.

417.5(a)(2)  The establishment shall maintain the following records documenting the establishment’s HACCP plan: The written HACCP plan, including decision making documents associated with the selection and development of CCP’s and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

Code:  06B01
Violation:  303.1(a)(2) (ii), 303.1(a)(2) (iii)

Citation:

On 6/22/2011,while conducting a routine net weight task, SPHV observed the following noncompliance,[newline][newline]Two unopened boxes of beef product in “IBP” manufacturer boxes were observed at 1530 hours MST by SPHV in the processing room, on the free standing processing table, near the packaging area. SPHV immediately sought out Mr. Rick De Los Santos to inquire why product inspected at another facility was in the processing area during inspected processing procedures. Mr. De Los Santos reported the boxes of IBP beef were to be used to make hamburger. [newline][newline]Establishment 07299 does not produce inspected non-intact product, therefore the presence of the IBP beef in the inspected processing area during production, without a label stating “Not for Sale” or “Custom” is in noncompliance with 9 CFR 303.1(a)(2)(ii) and 303(1(a)(2)(iii) requiring custom products to be kept sperate from inspected product and marked “Not for Sale”.[newline]As the boxes of IBP beef were not opened, no inspected product was affected.[newline]A search for noncompliance records issued in the last ninety days for similar cause revealed none.

Regulation:

303.1(a)(2)  Exceptions: (2) The custom slaughter by any person of cattle, sheep, swine, or goats delivered by the owner thereof for such slaughter, and the preparation by such slaughterer and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such livestock, exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and employees; nor to the custom preparation by any person of carcasses, parts thereof, meat or meat food products derived from the slaughter by any individual of cattle, sheep, swine, or goats of his own raising or from game animals, delivered by the owner thereof for such custom preparation, and transportation in commerce of such custom prepared articles, exclusively for use in the household of such owner, by him and members of his household and his nonpaying guests and employees: Provided, That the following requirements are met by such custom operator

303.1(a)(2)  Exceptions: (2) The custom slaughter by any person of cattle, sheep, swine, or goats delivered by the owner thereof for such slaughter, and the preparation by such slaughterer and transportation in commerce of the carcasses, parts thereof, meat and meat food products of such livestock, exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and employees; nor to the custom preparation by any person of carcasses, parts thereof, meat or meat food products derived from the slaughter by any individual of cattle, sheep, swine, or goats of his own raising or from game animals, delivered by the owner thereof for such custom preparation, and transportation in commerce of such custom prepared articles, exclusively for use in the household of such owner, by him and members of his household and his nonpaying guests and employees: Provided, That the following requirements are met by such custom operator

Code:  03J02
Violation:  417.2(c)(4), 417.5(a)(3), 417.5(b), 417.5(c)

Citation:

During a review of Slaughter HACCP records from 5/1/11-5/24/11 the following regulatory non-compliances were identified:[newline][newline]1. Time not indicated when HACCP monitoring check was performed: [newline][newline]For the monitoring of CCP 1 ) on 5/3, 5/4, and 5/5 there were entries indicating checks were performed that were acceptable for tongues/cheek meat. These entries included the initials of the responsible employee and the result (i.e acceptable) but they lacked the time when the checks were performed. [newline][newline]2. Monitoring checks not performed and/or recorded at frequency stipulated by written Slaughter HACCP plan: [newline][newline]There is supposed to be at least one monitoring check per production day for CCP-1 ( ) on the Variety Meats (includes head meat/cheek meat/hearts). On 5/20 there was no event recorded for the Variety Meats. [newline][newline]For CCP-2 ) there is supposed to be at least one monitoring check performed each production day for the Variety Meats. There were no entries found documenting monitoring of the Variety Meats for this CCP for the slaughter dates of 5/9, 5/10, 5/11, 5/12, 5/13, 5/17, 5/18, 5/19, 5/20 and 5/24. [newline][newline]3. That the above indicated HACCP records were incomplete was missed by the individual performing the preshipment review.

Regulation:

417.2(c)(4)  List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits.

417.5(a)(3)  The establishment shall maintain the following records documenting the establishment’s HACCP plan: Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

417.5(b)  Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry.

417.5(c)  Prior to shipping product, the establishment shall review the records associated with the production of that product, documented in accordance with this section, to ensure completeness, including the determination that all critical limits were met and, if appropriate, corrective actions were taken, including the proper disposition of product. Where practicable, this review shall be conducted, dated, and signed by an individual who did not produce the record(s), preferably by someone trained in accordance with § 417.7 of this part, or the responsible establishment official.

Code:  01B02
Violation:  416.13(c), 416.15(b)

Citation:

On 5/20/2011, while conducting a routine pre-operation sanitation review and observation task in Processing Area #2, SPHV noted the following noncompliance. The centrally located processing table contained white, firm, approimately one by one half (1 x 0.5) centimeter pieces of material, possibly fat, along the outside surfaces of the table rollers, smeared fat residue along the far end metal bar between the rolling belt and cutting boards extending approximately eight (8) centimeters, and a quarter (0.25) square inch piece of red meat on the lower horizontal metal table leg. These findings are in noncompliance with 9 CFR 416.13 which requires monitoring of the implementation of the SSOP.[newline][newline]No product was affected. [newline][newline]Intermittent observed the recleaning and sanitizing of the table involved and verified the effectiveness of said actions. [newline][newline]Preventive measures from the previous noncompliance record to prevent future reoccurrence by retraining the sanitation employee were ineffective and thus in non- compliance with 9 CFR 415.15(b).[newline][newline]Two similar cause noncompliance records have been issued in the last ninety days; 4/12/11 (#YJL5709040312N) and 4/21/11 (YJL4813040821N) and will be linked.

Regulation:

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.15(b)  Corrective actions include procedures to ensure appropriate disposition of product(s) that may be contaminated, restore sanitary conditions, and prevent the recurrence of direct contamination or adulteration of product(s), including appropriate reevaluation and modification of the Sanitation SOP’s and the procedures specified therein or appropriate improvements in the execution of the Sanitation SOP’s or the procedures specified therein.

Code:  01B02
Violation:  416.13(c), 416.15(b)

Citation:

On 4/21/2011, at 08:15, while conducting a routine preoperational sanitation review and observation procedure, SPHV noted the following noncompliance:[newline][newline]The cutting boards located on the central table in Processing Area #2 had numerous pieces of meat particles and residue smudges, predominately on the lateral edges. This is noncompliance with 9 CFR 416.13(c), monitoring of implementation of SSOP procedures.[newline][newline]The present employee immediately recleaned and sanitized the cutting boards. SPHV directly observed these corrective actions, verified the effectiveness, and released the table for use.[newline][newline]No product was affected.[newline][newline]A similar non-compliance record was issued 4/12/11 (#YJL5709040312N) for the same cause; meat particles on the central table. Because the preventive measures stated by the establishment to prevent reoccurrence (consultation with sanitation employees) were in effective, there is also noncompliance with 9 CFR 416.15(b).[newline]This noncompliance record will be linked to YJL5709040312N.

Regulation:

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.15(b)  Corrective actions include procedures to ensure appropriate disposition of product(s) that may be contaminated, restore sanitary conditions, and prevent the recurrence of direct contamination or adulteration of product(s), including appropriate reevaluation and modification of the Sanitation SOP’s and the procedures specified therein or appropriate improvements in the execution of the Sanitation SOP’s or the procedures specified therein.

Code:  01B02
Violation:  416.13(c)

Citation:

[newline]On 4/12/2011, at 0830, during a routine pre-operational sanitation verification procedure of “Processing Room #2”, SPHV observed the following noncompliance.[newline][newline]Meat particles ranging in size from one eighth (1/8) to one fourth (1/4) inch from the previous day’s production were generally disseminated along both lengthwise sides of the metal trim boarding the centralized rolling table. This is in noncompliance with 9 CFR 416.13(c) requiring monitoring of SSOP implementation. The remaining areas observed to be effectively clean and sanitized.[newline][newline]The present employee immediate re-cleaned and re-sanitized the affected areas. SPHV directly observed these corrective actions and verified they were effective. The table was released for use.[newline][newline]SPHV verbally notified a different employee, Mr. of the noncompliance. At approximately 0840, SPHV verbally notified Mr. Ricardo De Los Santos of the noncompliance. Mr. De Los Santos verbally stated he would speak with the pre-operational sanitation employees regarding this noncompliance and areas affected.[newline][newline]No product was affected and no other noncompliance records have been issued in the last ninety (90) days for the same cause.

Regulation:

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

Code:  01C02
Violation:  416.13(c), 416.4(d)

Citation:

At approximately 07:50 hours, while retrieving USDA controlled tissue samples for residue testing from the cooler, SPHV observed an Establishment # 07299 carcass, establishment tagged #413, stamped “USDA Condemned” hanging in the cooler on the same rail as edible carcasses bearing the mark of inspection. The carcass was slaughtered 2/18/11 and condemned 2/23/11 for Epithelioma following pathology testing. USDA had notified management and stamped the carcass “Condemned” 2/23/2011. The establishment was unable to cut down the carcass at that time due to the stocking density in the cooler and had requested to delay removal until product could be moved. The request was granted; however, the establishment did not contact USDA for later removal. This is non-compliance with 9 CFR 416.4(d) requiring facilities to protect product during storage. Storing condemned, and therefore inedible, product with edible product creates insanitary conditions directly affecting product and food safety. This is also in non-compliance with 9 CFR 416.13(c) which requires the establishment to monitor daily the implementation of the SSOPs which do include the storage cooler. SPHV immediately hung a USDA “Reject” tag, numbered #B38742366 on the cooler handle located on the door in the processing room. At 08:08 hours, SPHV verbally notified the Processing QC of the non-compliance as no other employees were available when the non-compliance was first directly observed at 07:50. Both parties directly observed the hanging condemned carcass at 08:08 hours. At 08:30 hours, the Processing QC requested reinspection after removal and denaturing of the condemned carcass. SPHV verified the carcass was removed and denatured. SPHV also reinspected the carcasses which were adjacent to the condemned carcass. No inspected and passed product was affected and the cooler was released. A search for previous non-compliance records issued within the last ninety days for the same cause revealed none.

Regulation:

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.4(d)  Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments.

Code:  06D01
Violation:  416.4(b)

Citation:

At approximately 8:10 hours, while performing a scheduled 01B02 procedure on the slaughter floor carcass wash station, SPHV A. and Intermittent Inspector observed copious amounts of animal fat pieces and residue, as well as opaque water, in the tank used to warm the container containing . This is in non-compliance with 9 CFR 416.4(b), Sanitary Operations, requiring non-food contact surfaces to be cleaned and sanitized as frequently as needed to prevent the creation of insanitary conditions and product adulteration. USDA Reject tag number #B38742476 was placed around the warming tank by SPHV Mr. De Los Santo was immediately notified verbally of the non- compliance and regulatory control action taken by SPHV Mr. De Los Santos reported immediate corrective actions would occur. At 08:25 hours, SPHV directly observed the cleaning and sanitizing of the container with bleach. The warming tank water was drained; the tank was cleaned with antimicrobial soap, rinsed, repeated twice, and refilled. SPHV visually and digitally inspected the tank for residual residue and detected none. The tank was refilled and SPHV observed the water to be transparent and released the tank for use. While the warming tank water is not a direct food contact surface, the spray container resting submerged in the water is removed during application of the to each carcass and other variety meat. Not only could the spray container come in direct contact with product during application, the employee’s hands touching the spray container may also directly contact carcasses and other products during and post application of the resulting in product contamination. No product was directly affected and a search of similar non-compliance records (NRs) within the last 90 days resulted in a finding of no similar NRs.

Regulation:

416.4(b)  Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

Code:  04C02
Violation:  313.15

Citation:

At approximately 8:00 hours, while performing veterinary antemortem assessment and knocking observation of a non- ambulatory disabled cow in the establishment’s holding pen, SPHV witnessed the following Human Handling non- compliance. The employee placed the handheld against the cow’s forehead and discharged. The mechanism’s remained lodged in the cow’s skull following discharge, leaving the entire apparatus adhered to the cow. The employee was unable to manually extract the by pulling on the gun, or using a mechanical tool (pliers) to retract the cylinder. The cow was not rendered unconscious with the discharge. This is in non-compliance with 9 CFR 313.15 (a)(1) and (3) requiring the to provide immediate and complete unconsciousness with minimal excitement and discomfort to the animal. The employee ran into the establishment to retrieve a but returned without it stating there were no available. A time period of approximately 3 minutes had elapsed. The employee, joined by a second employee, continued to attempt to remove the from the cow’s forehead by manual extraction until Mr. Rick De Los Santos appeared in the holding pen with the and Mr. De Los Santos three (3) into the cow’s skull from behind, just proximal to the foramen magnum area. The first appeared to render the cow unconscious. SPHV remained onsite to witness denaturing, during which time a third employee was able to extract the Before the USDA Reject Tag “B38742684” could be placed around the the four cows previously passed on antemortem inspection had been knocked for slaughter. SPHV orally notified Mr. De Los Santos the Reject Tag numbered above had been applied to the and non-compliance would be issued. A search for previous non-compliance records for the same cause generated zero records for the last 90 days.

Regulation:

313.15  Mechanical; captive bolt: The slaughtering of sheep, swine, goats, calves, cattle, horses, mules, and other equines by using captive bolt stunners and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.

Code:  01B02
Violation:  416.13(c)

Citation:

At approximately 7:45 hours, while performing the FSIS review and observation of pre-operational sanitation monitoring and implementation activities on the kill floor, SPHV observed approximately 3 small pieces (approximately 1-2 cm linear) of debris from the green scrub pads used to clean equipment in the wheel of the split saw. The aforementioned is in non- compliance with 9 CFR 416.13(c) which requires the establishment to monitor the implementation of SSOPs for cleaning and sanitizing food contact surfaces. SPHV informed the slaughter floor designee assigned to pre-operational sanitation for 10/29/2010 of the non-compliance. The establishment designee immediately removed the debris using the spray hose. No product was involved and a search of similar cause NRs in the last 90 days revealed: Previous Ineffective Plant Actions: Ineffective retraining of employees per NR: 15-2010 dated 8/11/2010 and NR: 26-2010 dated 10/25/2010 both for residue particles observed during FSIS pre-operational sanitation review and observation. Further continued non-compliance may result in addition regulatory or administrative action per 9 CFR 500.4

Regulation:

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

Code:  01B02
Violation:  416.13(c)

Citation:

At approximately 8:45 hours, while performing the FSIS review and observation of pre-operational sanitation monitoring and implementation activities on the kill floor, SPHV observed as small piece (approximately 1 cm linear) of residual debris in the bottom of an edible lug bin on the bottom of the stack of two bins. The aforementioned is in non-compliance with 9 CFR 416.13(c) which the establishment to monitor the implementation of SSOPs for cleaning and sanitizing food contact surfaces. SPHV informed the slaughter floor designee assigned to pre-operational sanitation for 10/25/2010 of the non- compliance. The establishment designee immediately removed the lug from the area for re-cleaning and sanitizing. SPHV was represented with the newly sanitized and debris free lug. No product was involved and a search of similar cause NRs in the last 90 days revealed: Previous Ineffective Plant Actions: Ineffective retraining of employees per NR: 15-2010 dated 8/11/2010 for residue particles observed during FSIS pre-operational sanitation review and observation. Further continued non-compliance may result in additional regulatory or administrative action per 9 CFR 500.4

Regulation:

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

Code:  06D01
Violation:  416.2(a), 416.2(b)(3)

Citation:

At approximately 14:00 hours, while performing inspection slaughter floor activities, SPHV and Intermittent Inspector observed 2 medium sized, gray with head/neck dark coloring similar to a pigeon, birds fly down the ventilation opening in the ceiling above the hoist area into the kill floor. Production stopped immediately and Mr. Rick De Los Santos was immediately notified by plant personnel of the birds. Mr. De Los Santos asked if he could wrap the four (4) carcasses prior to removal of the birds in order to protect product while removing the birds. SPHV agreed as the birds had not flown past the trolley rail or to the dressing stations. The plastic used to wrap the carcasses was that used to line the combo bins for processed product. The carcasses in question were in various stages of dressing procedures: one forth hide removal of hindquarter, one half hide removal of hindquarter and ventral abdomen, full hide removal – no evisceration, and full hide removal – evisceration for inspection. The establishment removed the birds via spraying of a hose only in the direction of the exterior wall where the door was opened to allow the birds to exit. Neither bird had migrated any further into the production areas. Prior to the plastic removal, the walls were sprayed, and establishment personnel observed for any fly activity which may have resulted from the external door being opened. No other animals were to be slaughter 10/20/2010, thus the hoisting area would no longer be in use. Mr. De Los Santos thought the birds may have entered in the space between the roof and the ceiling and were sealed in after foam had been applied to the exterior building near the roof, or had entered where some of the exterior foam had crumbled away. Mr. De Los Santos said he would promptly insert chicken wire where some of the foam had been removed to prevent further admittance of birds. Upon assessment of the exterior facilities, Mr. De Los Santos believed the birds most likely entered through a loose piece of sheet metal. While no product was directly affected in this instance, there is a high probability direct product or product surface contamination could occur should pests and vermin continue to have access to a means of entry into the establishment. This is in non-compliance with 9 CFR 416.2(a) and 416.2 (b)(3) which requires the establishment to have a pest management program to prevent harborage of pests on the grounds and within the establishment and floors, ceilings, windows, and other outside openings to be constructed and maintained to prevent entrance of vermin. Past Similar NRs – Previous Ineffective Plant Actions: verbal corrective action to seal openings to prevent access to vermin was ineffective This NR will be linked with NR: 24-2010 dated 10/20/2010.

Regulation:

416.2(a)  Grounds and pest control: The grounds about an establishment must be maintained to prevent conditions that could lead to insanitary conditions, adulteration of product, or interfere with inspection by FSIS program employees. Establishments must have in place a pest management program to prevent the harborage and breeding of pests on the grounds and within establishment facilities. Pest control substances used must be safe and effective under the conditions of use and not be applied or stored in a manner that will result in the adulteration of product or the creation of insanitary conditions.

416.2(b)(3)  Walls, floors, ceilings, doors, windows, and other outside openings must be constructed and maintained to prevent the entrance of vermin, such as flies, rats, and mice.

Code:  06D01
Violation:  416.1, 416.2(a), 416.2(b)(3)

Citation:

At 1120 hours on 10/20/2010 while performing a scheduled 06D01 SPS (Sanitary Dressing Procedure) there were several (4 or more) flying insects (flies) on the plants kill floor located on the north side of the facility that will create insanitary conditions and adulterate product if not properly corrected. The flies were present at the evisceration station, at the carcass splitting saw area and were also present at the final trim station located on the east end of the kill floor. There was no observation of flies directly contacting beef carcasses being processed however there is a high probability that direct contamination of product and product contact surfaces will occur. Mr. , was immediately notified of the presence of flying insects in the areas referenced and that corrective actions should be taken in a timely manner to prevent possibility of creation of insanitary conditions and direct product contamination. Mr. immediately instructed a plant employee to take the necessary action to eliminate the flies that were present on the kill floor and to ensure that all openings to the outside were properly sealed to prevent further entry of flies on the kill floor. The plant pest control program states that . On observation of the outside premises and grounds on the west side of the facility there were numerous (too many to count) flies swarming in and around the livestock holding pens and the livestock chute entrance to the stunning area on slaughter floor. Mr. informed CSI that the outside areas had been treated at the start of operations today. Mr. further stated that he would contact the plant manager regarding additional actions to be accomplished to correct the problem. Upon review of the plant operational sanitation monitoring record dated 10/20/2010 there were no entries addressing the noncompliance. There is noncompliance with 9 CFR 416.1 which requires establishments be operated and maintained in a manner sufficient to prevent creation of insanitary conditions. There is also noncompliance with 416.2 (a) which requires establishment to have a pest control management program in place to prevent harborage and breeding of pests on the grounds and within the establishment. Finally, there is noncompliance with 9 CFR 416.2

Regulation:

416.1  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.

416.2(a)  Grounds and pest control: The grounds about an establishment must be maintained to prevent conditions that could lead to insanitary conditions, adulteration of product, or interfere with inspection by FSIS program employees. Establishments must have in place a pest management program to prevent the harborage and breeding of pests on the grounds and within establishment facilities. Pest control substances used must be safe and effective under the conditions of use and not be applied or stored in a manner that will result in the adulteration of product or the creation of insanitary conditions.

416.2(b)(3)  Walls, floors, ceilings, doors, windows, and other outside openings must be constructed and maintained to prevent the entrance of vermin, such as flies, rats, and mice.

Code:  01B02
Violation:  416.13(c), 416.2(e), 416.4(b)

Citation:

On 10/01/2010 at approximately 0800 hours, CSI accompanied by SPHV/IIC Dr performed a scheduled 01B02 pre-operational sanitation procedure in the plant’s boning/fabrication room located in the approximate center of the facility adjacent to the carcass holding cooler. On observation of the stainless steel product contact boning table, located on the east side of the fabrication room there was protein/fat residue on the product contact surface in an area approximately 12 inches in diameter form prior operations. The protein/fat residue extended down from the table top (product contact surface) to sides of the processing table (non-product contact surface) and was also present on the undersides of the processing table. In addition, on observation of the fabrication table located on the west side of the processing room, there was again evidence of fat protein residues on the product contact surface in various locations. Upon observation of the undersides of the processing table, there was extensive food protein residue and buildup on all of the understructures of the table that can create an insanitary condition. There was no product present in the room at the time of the pre-op procedure and a regulatory control action was taken with US Reject Tag numbers B39578434 and B39578433. The processing tables referenced were rejected from use pending plant corrective actions. There is non compliance with 9 CFR 416.13 (c) for the plant failure to properly implement and monitor the written procedures as written in the plant Pre-operational Sanitation SOP. In addition, there is noncompliance with 9 CFR 416.4

Regulation:

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.2(e)  Establishment grounds and facilities: Plumbing. Plumbing systems must be installed and maintained to: (1) Carry sufficient quantities of water to required locations throughout the establishment; (2) Properly convey sewage and liquid disposable waste from the establishment; (3) Prevent adulteration of product, water supplies, equipment, and utensils and prevent the creation of insanitary conditions throughout the establishment; (4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; (5) Prevent back-flow conditions in and cross-connection between piping systems that discharge waste water or sewage and piping systems that carry water for product manufacturing; and (6) Prevent the backup of sewer gases.

416.4(b)  Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

Code:  03C02
Violation:  417.2(a)(1), 417.4(a)(2) (ii), 417.5(a)(1), 417.5(a)(2)

Citation:

While conducting the 2010 Comprehensive Food Safety Assessment of establishment 07299, EIAOs and reviewed the Processing HACCP system and observed the following HACCP non-compliances: The processing hazard analysis does not include the step of Fabrication of Beef Trimmings/Beef Primals; however, this step is included in the flow diagram. This omission from the hazard analysis is in non-compliance with 9 CFR 417.2 (a)(1), requiring all official establishments to conduct a hazard analysis which include all food safety hazards reasonably likely to occur. The CCP-4B” records on July 13 and 29, 2010 lacked a record of direct observation verification for either week. This is a non- compliance with 9 CFR 417.4 (a)(2)(ii), requiring establishments validate the HACCP plan adequacy and verify implementation and ongoing verification activities include direct observation and monitoring and corrective actions. The system lacked documentation to support either the monitoring or verification procedures and frequencies listed in the HACCP plan. This is a non-compliance with 9 CFR 417.5(a)(2), requiring establishments to maintain records of supporting documentation. Although the establishment did have supporting documentation for the testing methodology of E. coli 0157:H7, the establishment was unable to provide written procedures for sample collection for E. coli 0157:H7 validation testing. This is in non-compliance with 9 CFR 417.5 (a)(1) requiring establishments to maintain a written hazard analysis as prescribed in 9 CFR 417.2(a). None of these non-compliances involved product and no other similar non-compliance records have been issued in the last 90 days.

Regulation:

417.2(a)(1)  Hazard Analysis: Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reason- able possibility that it will occur in the particular type of product being processed, in the absence of those controls.

417.4(a)(2)  Ongoing verification activities. Ongoing verification activities include, but are not limited to: (i) The calibration of process-monitoring instruments; (ii) Direct observations of monitoring activities and corrective actions; and (iii) The review of records generated and maintained in accordance with § 417.5(a)(3) of this part

417.5(a)(1)  The establishment shall maintain the following records documenting the establishment’s HACCP plan: (1) The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation.

417.5(a)(2)  The establishment shall maintain the following records documenting the establishment’s HACCP plan: The written HACCP plan, including decision making documents associated with the selection and development of CCP’s and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

Code:  01C02
Violation:  416.13(a), 416.13(c), 416.16(a)

Citation:

On August 10, 2010, while conducting a Comprehensive Food Safety Assessment, EIAOs and reviewed the “Form PR-1” records from May 1, 2010 through July 30, 2010, and made the following observations: 1) the pre-operational sanitation/processing room procedure lists that the processing room QC will check walls, floors, and any other equipment that will be used as an area to check for pre-operational sanitation; however this procedure is not listed nor checked on the “Form PR-1” record, and 2) the pre-operational processing procedure states, “Processing Room QC will record sterilizer temperature,” however, the sterilizer temperature was not recorded on May 3, 4, 5, 26, and 31, 2010, June 18, 2010, July 9 and 13, 2010. Observation 1) is in non-compliance with 9 CFR 416.13(a)(c), pre-operational procedures shall be conducted before start of operations and daily implementation monitoring of SSOP’s. Observation 2) is in non-compliance with 9 CFR 416.16 (a) which requires the designated establishment employee to monitor and implement the SSOP’s. There was no product involvement with these non-compliances and no other similar non-compliance records have been issued in the last 90 days.

Regulation:

416.13(a)  Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.16(a)  Each official establishment shall maintain daily records sufficient to document the implementation and monitoring of the Sanitation SOP’s and any corrective actions taken. The establishment employee(s) specified in the Sanitation SOP’s as being responsible for the implementation and monitoring of the procedure(s) specified in the Sanitation SOP’s shall authenticate these records with his or her initials and the date.

Code:  03J02
Violation:  417.2(a)(1), 417.3(a)(1), 417.3(a)(2), 417.3(a)(3), 417.3(a)(4), 417.4(a)(2) (ii)

Citation:

While conducting the 2010 Comprehensive Food Safety Assessment of establishment 07299, EIAOs and reviewed the Slaughter HACCP system and observed the following HACCP non-compliances: The following steps were not included in the hazard analysis but were addressed elsewhere in the HACCP system: 1) spray and put product in the cooler and 2) freeze variety meats. Steps 1) and 2) are both found in the flow diagram. Step 1), also corresponds to monitored CCP-2. Step 2) freeze varieties meats is being monitored and has freezer temperature records kept. These omissions from the hazard analysis are in non-compliance with 9 CFR 417.2 (a)(1), requiring all official establishments to conduct a hazard analysis which include all food safety hazards reasonably likely to occur. ” CCP-1 had no record of variety meat direct observation verification for either the week of June 3 or 16, 2010. This is a non- compliance with 9 CFR 417.4 (a)(2)(ii), requiring establishments to validate the HACCP plan adequacy and verify implementation and ongoing verification activities include direct observation and monitoring and corrective actions. Neither of the above non-compliances involved product. CCP-3 and CCP-3B records from May 4, 2010 through July 30, 2010 were reviewed and on the July 17, 2010 record to listed a product surface temperature of 42 F, a deviation from the critical limit of hours; however, the establishment did not take corrective action. This is a noncompliance with 9 CFR 417.3 (a)(1-4), requiring the establishment to ensure corrective actions identify the cause of the deviation, restore control of the CCP, identify measure to prevent reoccurrence, and no affected product injurious to health enters commerce. Although a deviation from a critical limit occurred and product was involved, the HACCP supporting documentation for the critical limit value is therefore the deviation to 42 F does not present a food safety concern. No other similar non-compliance records have been issued in the last 90 days for any of the above non-compliances.

Regulation:

417.2(a)(1)  Hazard Analysis: Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reason- able possibility that it will occur in the particular type of product being processed, in the absence of those controls.

417.3(a)(1)  Corrective actions: The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure the cause of the deviation is identified and eliminated.

417.3(a)(2)  Corrective actions: The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure the CCP will be under control after the corrective action is taken.

417.3(a)(3)  Corrective actions: The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure measures to prevent recurrence are established.

417.3(a)(4)  Corrective actions: The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure no product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce.

417.4(a)(2)  Ongoing verification activities. Ongoing verification activities include, but are not limited to: (i) The calibration of process-monitoring instruments; (ii) Direct observations of monitoring activities and corrective actions; and (iii) The review of records generated and maintained in accordance with § 417.5(a)(3) of this part

Code:  06D01
Violation:  416.2(b)(1)

Citation:

On August 17th 2010, EIAO’s and were conducting a Compressive Food Safety Assessment (FSA) at the establishment and found the following Sanitation Performance Standard (SPS) noncompliance with 9 CFR 416.2

Regulation:

416.2(b)(1)  Establishment buildings, including their structures, rooms, and compartments must be of sound construction, be kept in good repair, and be of sufficient size to allow for processing, handling, and storage of product in a manner that does not result in product adulteration or the creation of insanitary conditions.

Code:  03J02
Violation:  417.5(a)(2), 417.5(a)(3), 417.5(c)

Citation:

The following is a list of 03J HACCP recordkeeping noncompliance observed by EIAO’s and during review of the Slaughter HACCP system as part of a compressive FSA (Food Safety Assessment) at the establishment: Upon review of the records for CCP-2 from May 4th, 2010 through July 30th, 2010, the plant Quality Control person did not document on the ” on July 22, 2010 that the was acceptable per the written in the 03J Slaughter HACCP plan at CCP-2. This is a noncompliance with 9 CFR 417.5 (a) (3) which requires records documenting the monitoring of CCP’s and their critical limits as prescribed in the plant HACCP plan procedure. In addition, on review of the above log’s records on 05/04/2010 and 07/16/2010 for CCP-2 in the plant 03J HACCP plan, the plant failed to document the tag I.D. for variety meats (tongues and cheek meat) on the monitoring record as required. This is also a noncompliance with 9 CFR 417.5 (a) (3) which requires the monitoring and documenting of CCP’s and their critical limits as prescribed in the plant HACCP plan procedures. Finally, on observation of the aforementioned log records for CCP-2 for 07/16/2010, the plant failed to document the actual as required at CCP-2 by the plant 03J HACCP plan. The monitoring records only document that the is “ok” or “acceptable” and fails to document actual numerical values, temperatures or quantifiable values as required by 9 CFR 417.5 (a) (3). On review of the plant 03J plant HACCP plan at CCP-3B, regarding , it was found that the establishment does not state the frequency for the calibration of the official plant thermometer under the verification procedures; however, this calibration was stated under monitoring procedures in the HACCP plan. This is a noncompliance with 9 CFR 417.5 (a) (2) which requires frequency of monitoring and verification procedures be documented in the plant HACCP plan. In addition, it was observed that the plant does not have documents supporting the monitoring and verification procedures and frequencies for CCP’s written in the HACCP plan. This is a noncompliance with 9 CFR 417.5 (a) (2) due to the plants failure to maintain supporting documents on file supporting for both the monitoring and verification procedures and the frequency of those procedures to ensure that hazards are not reasonably likely to occur. Upon review of the establishment’s pre-shipment review records for 07/17/2010, it was noticed that the plant reviewer, Ricardo De Los Santos, failed to notice that there was a deviation to the critical limit for CCP-3 and CCP-3B regarding the surface temperature of the beef cheek and tongue meat. The written HACCP plan CCP critical limit states that . The monitoring record however for this date indicated that the surface temperature was hour cool down, which is a deviation of the critical limit for CCP-3 and 3B. There is non-compliance with 9 CFR 417.5 (c), as the plant failed to detect the deviation of the critical limit during the pre-shipment review and no corrective actions were taken per 9 CFR 417.3 (a) (1-4) as required. No product was involved with these non-compliances or similar NR’s issued for the same cause in the past 90 days.

Regulation:

417.5(a)(2)  The establishment shall maintain the following records documenting the establishment’s HACCP plan: The written HACCP plan, including decision making documents associated with the selection and development of CCP’s and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

417.5(a)(3)  The establishment shall maintain the following records documenting the establishment’s HACCP plan: Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

417.5(c)  Prior to shipping product, the establishment shall review the records associated with the production of that product, documented in accordance with this section, to ensure completeness, including the determination that all critical limits were met and, if appropriate, corrective actions were taken, including the proper disposition of product. Where practicable, this review shall be conducted, dated, and signed by an individual who did not produce the record(s), preferably by someone trained in accordance with § 417.7 of this part, or the responsible establishment official.

Code:  06D01
Violation:  416.2(b)(1) , 416.2(b)(2)

Citation:

On 09/17/2010, at 1020 hours CSI performed a scheduled 06D01 (Sanitary Performance Standards) procedure and found the following noncompliance. Upon observation of the fan guards on the overhead condenser unit located in the approximate center of the boning/fabrication room there is excessive rusting and flaking paint on the outside surface of the fan guards positioned directly over product contact equipment and exposed product flow areas. Mr. Ricardo De Los Santos the plant manager was notified that there is noncompliance with 9 CFR 416.2

Regulation:

416.2(b)(1)  Establishment buildings, including their structures, rooms, and compartments must be of sound construction, be kept in good repair, and be of sufficient size to allow for processing, handling, and storage of product in a manner that does not result in product adulteration or the creation of insanitary conditions.

416.2(b)(2)  Walls, floors, and ceilings within establishments must be built of durable materials impervious to moisture and be cleaned and sanitized as necessary to prevent adulteration of product or the creation of insanitary conditions.

Code:  06D01
Violation:  416.2(b)(2) , 416.4(d)

Citation:

On 08/19/2010 at approximately 1430 hours Ms. an EIAO detailed to perform a comprehensive FSA (Food Safety Assessment) at the establishment informed CSI that she had discovered water/condensate dripping from an overhead steel support beam in the plants product holding cooler. In addition there was condensation on the ceiling surface directly in front of the product freezer door entrance in the boning and fabrication room. Ms. accompanied CSI to the product holding cooler and processing room and observed the noncompliance’s. Upon observation of the overhead ceiling in the product holding cooler and ceiling surface in the processing room CSI observed that there was water/condensate dripping down onto the floor surface from a seam in an overhead beam approximately 12 feet from the east wall surface in the approximate center area of the product holding cooler. The water droplets were falling at a rate of approximately one droplet every 30 seconds. In addition there was beaded condensate located on the ceiling surface directly in front of the product holding freezer. Ms. advised CSI that there was no product stored directly under the areas where the water was falling form the overhead structures in the product holding cooler and condensate on the ceiling surface in the processing room at the time of the observation. CSI immediately notified Mr. Ricardo De Los Santos, plant manager, of the problems and a plant employee was instructed to position a barrier and a plant control to prevent the possibility of exposed product to enter or be stored in the area where the water leak was observed in the product holding cooler. In addition the condensate observed on the ceiling surface directly in front of the product holding freezer was wiped and dried by a plant employee. Mr. De Los Santos agreed that there was water leaking from the area referenced in the product holding cooler and condensation on the ceiling surface in the processing room. Mr. De Los Santos stated that necessary repairs and corrective actions would be accomplished in a timely manner. CSI informed Mr. De Los Santos that the area in the cooler and ceiling surface in the processing room should be properly maintained to prevent an insanitary condition or product contamination until repairs and corrective actions can be accomplished. A regulatory control action was not taken pending further evaluation and review of corrective and preventive actions to be accomplished. There was no direct product contamination noticed during the observation. Mr. De Los Santos was informed that there is noncompliance with 9 CFR 416.2

Regulation:

416.2(b)(2)  Walls, floors, and ceilings within establishments must be built of durable materials impervious to moisture and be cleaned and sanitized as necessary to prevent adulteration of product or the creation of insanitary conditions.

416.4(d)  Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments.

Code:  01B02
Violation:  416.13(c)

Citation:

On 08/11/2010 at approximately 0910 hours CSI performed an 01B02 (Pre-operational Sanitation) procedure to determine if cleaning and sanitizing of the food contact surfaces on the plants kill floor were accomplished per the plants written procedures in the Sanitation SOP per 9 CFR 416.13. The following noncompliance’s were found on conducting the pre- op procedure: On observation of the product contact surfaces of stainless steel beef tongue and cheek meat harvesting table located on the south wall adjacent to the entrance/exit to the kill floor CSI found that there were meat particles and protein residue approximately 1/32 to 1/8 inch in diameter on inside surfaces of the drain holes in various locations on the product contact table surface from prior harvesting activities. The beef check and beef tongue harvesting table was rejected from use with U.S. Reject Tag number B39578482. On observation of the carcass splitting saw located on the east end of the kill floor CSI observed that on the product contact inside surface directly below the large front wheel assembly in the area where the band saw blade is attached there was a green fiber material (Fibers from a green scouring pad used to clean the equipment) approximately 1 inch long by 1/8 inch wide wedged in the saw blade slot that could potentially cause direct product contamination. In addition at the far end of the splitting saw directly in the rear of the small wheel blade assembly there were food protein residues and meat and fat particles approximately 1/8 inch in diameter on the contact surfaces from prior carcass splitting activities. The carcass splitting saw was rejected with U.S. Reject Tag number B39578483. Mr. , was notified at approximately 0915 hours of the noncompliance’s and of regulatory control actions taken. Immediate re-cleaning and sanitizing of the harvesting table and carcass splitting saw was accomplished by the plant employees. At 0925 hours the harvesting table and carcass splitting saw were re-offered for pre-op inspection and found clean and sanitary and were released for operations. CSI contacted the plant manager, Mr. Ricardo De Los Santos, and informed him of the plants Sanitation SOP failure and that there is noncompliance for the plants failure to implement and monitor the written Sanitation procedures per 9 CFR 416.13 (c). Mr. De Los Santos stated that the plant employee’s responsible would be counseled and re-trained as necessary to ensure compliance. On observation of the KF-1 kill floor plant monitoring record at 1000 hour CSI found that the plant had addressed the corrective actions accomplished to ensure that the referenced equipment was clean and sanitary prior to operations. A search was conducted of NR’s issued to the facility in the past 90 days revealing no same cause NR’s. This NR is not linked for same cause.

Regulation:

416.13(c)  Implementation of SOP’s: Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

Code:  06D01
Violation:  416.2(d), 416.4(d)

Citation:

On 08/09/2010 at approximately 1045 hours CSI performed a 06D01 SPS (Sanitary Performance Standards) procedure. Upon observation of the facilities product holding cooler to determine if the sanitary conditions met the regulatory requirements of 9 CFR 416 the following noncompliance’s were observed: Upon observation of the overhead condenser units on the east and south walls of the product holding cooler there was beaded condensation present on the bottom surfaces of the overhead condenser units that could cause insanitary conditions. Upon further inspection there were three or four beef carcasses stored in the cooler directly under the condensation observed on the overhead condenser unit on the south wall in the holding cooler. There were no beef carcasses or exposed product stored in the vicinity of the overhead condenser unit on the east wall at the time of the observation. During the observation CSI observed no direct product contamination however the condition would cause direct product contamination if not corrected in a timely manner. Mr. Ricardo De Los Santos, the plant manager, was contacted at approximately 1050 hours and notified that there was noncompliance with 9 CFR 416.2 (d) which requires that ventilation in the facility be adequate to control condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions. In addition Mr. De Los Santos was notified that there was also noncompliance with 9 CFR 416.4 (d) regarding the beef carcasses stored directly under the overhead condenser unit on the south wall of the product holding cooler. Finally Mr. De Los Santos was notified that a regulatory control action was taken due to the establishment’s failure to protect product from contamination during storage with U.S. Reject tag number B38868269. Mr. De Los Santos immediately moved the beef carcasses that were stored directly under the overhead condenser unit on the south wall to an area in the center of the holding cooler to prevent the possibility of product contamination. In addition Mr. De Los Santos stated that there was maintenance being conducted on the refrigeration unit for the holding cooler and was ongoing at the present time. Finally Mr. De Los Santos stated that the beef carcasses stored in the cooler would be re-routed on the overhead railing system to avoid movement in the areas of the overhead condenser units until such time as corrective action can be accomplished. Mr. De Los Santos also stated that the bottom surfaces of the condenser units would be dried with a sponge mop as needed until such time as suitable drip pans could be installed to prevent condensate from falling and contaminating product stored in the holding cooler. CSI informed Mr. De Los Santos that the immediate corrective action would be acceptable pending final preventive repairs and corrections accomplished. The regulatory control action (U.S. Reject Tag) was removed at 1130 hours pending further review and evaluation. On observation of the written plant corrective action report at 1135 hours an entry of corrective actions was documented as discussed. This NR is not linked for same cause.

Regulation:

416.2(d)  Ventilation: Ventilation adequate to control odors, vapors, and condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions must be provided.

416.4(d)  Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments.

Code:  05A02
Violation:  310.25(a)

Citation:

On 07/22/2010 at approximately 1345 hours CSI performed a 05A02 ISP procedure to verify that the establishment was performing Generic E-coli testing per 9 CFR 310.25 (a) which requires that each official establishment that slaughters livestock must test for Escherichia coli Biotype 1. In addition the facility must test per the criteria set forth in 9 CFR 310.25 (a) (2) (v) (A). Finally the official establishment must maintain records that document analytic results in accordance with 9 CFR 310.25 (a) (4). Upon requesting the documentation of the required testing Mr. De Los Santos the plant manager informed CSI that the establishment had not conducted any generic E-coli tests due to economic reasons and that the facility had only conducted slaughter operations on three (3) or four (4) occasions. CSI informed Mr. De Los Santos that the facility was considered a low volume establishment and testing must be conducted starting the first full week in June and continue for 13 consecutive slaughter weeks per 9 CFR 310.25 (a) (2) (v) (A). CSI informed Mr. De Los Santos that failure to perform the generic E-coli testing and to document analytic records of the results is a noncompliance that could trigger suspension actions per the rules of practice (9 CFR 500) upon finding that an official establishment has failed one are more provisions of 9 CFR 310.25 (a). CSI informed Mr. De Los Santos that there is noncompliance and a noncompliance record (NR) would be issued to the establishment. In addition the Denver District Office supervisors would be contacted regarding the noncompliance for any additional actions in accordance with 9 CFR 500.4. Mr. De Los Santos stated that until recently he had contemplated shutting the facility down due to economic reasons however with the new partnership formed he advised that he will acquire the required testing supplies and begin testing for generic E-coli per the requirements of 9 CFR 310.25 (a) (2) (v) (A). There was no regulatory control action taken pending instructions from the Denver District Office.

Regulation:

310.25(a)  Contamination with Microorganisms: Each official establishment that slaughters livestock must test for Escherichia coli Biotype 1 (E.coli) Establishments that slaughter more than one type of livestock or both livestock and poultry, shall test the type of livestock or poultry slaughtered in the greatest number.