IKE Scenario 12-02: 9 CFR 416.2 (a) Grounds and Pest Control Under the Sanitation Performance Standards (SPS) - July 26, 2002
The latest several IKE scenarios are designed to illustrate the SSOP requirements as delineated in parts 9 CFR 416.12 through 416.16. To that end we have shown that the SSOP requirements are key components of the food safety system instituted with the pathogen reduction methodologies. Another equally important and sometimes overlooked part of the overall strategy is the sanitation performance standards.
The sanitation performance standards are an integral part of the overall public health picture of a facility or a plant. They are used in conjunction with the SSOP and HACCP to determine the level of commitment to ensure that wholesome products are produced in a sanitary environment. The Sanitation Performance Standards carry as much regulatory weight and enforceability as any other part of our regulatory food safety system. The Rules of Practice in Part 500 of the Code of Federal Regulations are quite clear on this issue.
In this scenario we will be relating the Sanitation Performance Standards to the SSOP as well as the Rules of Practice in Part 500.
Sec. 416.2(a): Establishment Grounds and Facilities.
(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.
You are a relief GS-9 IIC in a small establishment that slaughters beef and processes miscellaneous beef cuts, ground beef and cooked sausages. The procedures scheduled for today include the 01C02 procedure, which is the review and observation of the establishment’s operational SSOP’s for the following four regulatory requirements:
Implementation of the establishment’s SSOP’s (§ 416.13)
Maintenance (routine evaluation of effectiveness) of the establishment’s SSOP’s (§ 416.14)
Corrective actions taken, when necessary (§ 416.15)
Compliance with the recordkeeping requirements (§ 416.16)
The establishment’s Sanitation Standard Operating Procedure (SSOP) states that the establishment will monitor twice daily employee product handling practices to assure that no products are adulterated or contaminated. You decide to verify this procedure by observing the quality assurance manager while she performs her monitoring procedure as outlined in the SSOP. You start out in the main processing room. You observe the quality assurance manager perform her procedure exactly as it is outlined in the SSOP. You observe no noncompliance with the SSOP procedure and no direct product contamination is found.
While walking back through the processing room you look into the door of the boiler room which leads into the processing room. You observe rodent droppings in the back corner of the room along the floor/wall juncture. The boiler room is adjacent to a production room. You stop the quality assurance manager who is ahead of you and show her the droppings. Production continues to take place in the room behind you. You ask her if the plant has a rodent control program and her reply is “yes”. She then explains the program. You identify the boiler room with a US Reject tag and tell the quality assurance manager why the regulatory action was taken in accordance with 9 CFR 500.2(b).
An inspection of the connecting processing room finds no evidence of rodent droppings. You head back to the government office and review the Noncompliance Records (NR) on file. There has been one NR issued for rodents in the past month. It was in a production area. The corrective action by the plant was to have the boiler room door replaced and sealed to prevent rodent entry. This was verified by the inspector as shown through his signature in block 16 of FSIS Form 5400-4, Noncompliance Record (NR).
At this point as a critical thinker, what would you do to ensure that all regulatory requirements are being met and how would you respond to the quality assurance manager?
The regulation states 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. Further that the establishments must have in place a pest management program to prevent the harborage and breeding of pests on the grounds and within establishment facilities. Evidence of rodents in a food-handling environment may be identified, in the professional judgement of the Inspector or Veterinary Medical Officer, as an insanitary condition. Under Part 500.2 (a)(1) regulatory control action can be taken for insanitary conditions. 9 CFR 416.6 also gives direction in this type of situation.
In order to determine if the evidence of rodents will affect product in this scenario, the inspector needed to consider the following conditions:
The door to the boiler room was replaced and sealed. This was verified on the NR on file.
No traffic or product passes through the boiler room what so ever. It is little used.
No evidence was found that rodents entered any production area and no product was affected.
The establishment is not in compliance with 416.2(a) and once the US Reject tag is applied, the establishment must make the situation acceptable in accordance with 416.6. The plant must take whatever actions are necessary to eliminate the rodents from their facility and stop them from entering the facility again. This may include reviewing their pest and rodent control program.
The Inspector would inform the plant management of the insanitary condition provisions of the regulations and the FSIS obligation to take a regulatory control action to protect the public health in these circumstances. The incident would be documented on a Noncompliance Record (NR) under the 06D01 procedure code with a product based trend indicator. Additionally, documentation would be added to the NR to reflect that this is a repetitive noncompliance featuring the same root cause. Further that the corrective actions were ineffective to prevent to the reoccurrence of the noncompliance. The inspector’s procedure schedule would be marked as “performed” for the 01C02 procedure and if a 06D01 procedure was not scheduled it would be written in and marked as “P” for “product based”.
NOTE: The pest control program does not have to be written or be in the SSOP program. This is at the discretion of the plant. The requirement is that they simply have a pest management program in place.
Part 500.2(a)(1) and 416.6 authorizes FSIS personnel to reject areas and
equipment for insanitary conditions.
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