IKE Scenario 13-02: 9 CFR 416.2 (b) Construction under the Sanitation Performance Standards-  August 13, 2002

In the last IKE scenario we featured rodent contamination in a non-production-related area. The relief inspector took a regulatory control action, ensured no product was affected, determined that the plant had a rodent control program and documented the findings of the repetitive noncompliance on a noncompliance record. This scenario is a continuation of scenario 12-02. In this IKE scenario the same relief inspector returns and is assigned to the same plant one month later.

The latest IKE presentations have been put forward to reiterate the importance of the Sanitation Performance Standards (SPS). The SPS 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 is 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.

416.2(b) Construction

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.

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.

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.

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.

You are a relief GS-9 IIC once again assigned to a small establishment that slaughters beef and processes miscellaneous beef cuts, ground beef and cooked sausages. The procedures scheduled for today include the 06D01 procedure. This includes the review and observation of the establishment’s facilities, equipment and records to verify compliance with regulatory requirements.

You haven’t been back to the plant in a month since you observed the rodent droppings in the boiler room. Before you go out in the plant to perform the procedures scheduled for today, you review the noncompliance records (NR) on file. You see six NR’s on file:

the old NR on rodents

an NR issued for condensation leading to direct product contamination

an NR issued for condensation leading to direct product contamination

an NR issued for holes in walls around pipes behind the smokehouse

an NR issued for a door with gaps leading to the outside and a hole in the processing room wall leading to the outside.

and your rodent NR issued for the droppings in the boiler room.

You also check to see if the NR that you had issued to the plant concerning the rodent droppings was answered. The corrective action was to clean and sanitize the area. The plant took appropriate corrective actions and the Inspector-In-Charge had verified this by signature in block 16 of FSIS Form 5400-4, Noncompliance Record (NR). Closing the filing cabinet, you walk out into the plant to perform your 06D01 verifications.

The plant has already started production and the main processing room. As you walk past the tables you observe the ceiling above the cooked sausage unloading area. Walking back through the processing room you walk past the smokehouse and observe rodent droppings in the cold, solidified fat on three dirty cook racks waiting to be washed. A closer observation of the area revealed holes in the wall as the water pipe exited the wall and rodent droppings on the pipe directly over the sausage-stuffing table feeding the stuffer.

The inspector issues a US Reject tag in accordance with 9 CFR 500.2(a)(1) for insanitary conditions due to the evidence of rodent infestation. The tag is affixed to the main door of the processing room. The room is rejected and all equipment and utensils contained therein for use. Additionally the inspector issues and affixes a US Retained tag under 9 CFR 500.2 (a)(2) to the affected sausage product manufactured in the insanitary environment. This was done as the rodent droppings were found over product preparation areas and on product preparation equipment. The inspector informs plant management of the control actions under 9 CFR 500.2(b). The plant opted to condemn the sausage and all affected product. The entire processing room and all adjacent rooms were cleaned and sanitized according to the firm’s SSOP procedure. The entire day’s production is lost to cleaning procedures. The next morning the firm performs a routine pre-operational inspection. No other action has been taken. The quality assurance manager then asks you if the firm can begin production.

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 that the 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. 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 judgment 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.

The establishment is not in compliance with 416.2(b)(3) and once the US Reject tag is applied, the establishment must make the situation acceptable in accordance with 416.6. The establishment’s pest and rodent control program is not effective. The plant must take whatever actions are necessary to eliminate the rodents from their facility and stop them from entering the facility again. Until assurances are given in the form of meaningful preventive measures that an effective rodent control program is in place the regulatory control action must remain in place. This is a repetitive noncompliance and the inspector linked it to the other noncompliance records on file.

The Inspector would inform plant management of the regulatory requirement for an effective pest and rodent control program per 416.2 (a) and the firm’s responsibility to maintain their facilities under 416.2 (b). The inspector issues a noncompliance record under the procedure code 01C02 with a “monitoring” trend indicator. Notification must be made that this is a repetitive noncompliance and reference the other NR’s on file. This includes the language that the corrective actions have been ineffective to prevent the reoccurrence of the noncompliance. In addition, as noted in the scenario the inspector did observed holes in the wall as the water pipe exited the wall. Consequently, this also should be documented on the “NR.” The inspector would record the 06D01 procedure as “performed” on the schedule.

The 01C02 procedure code is utilized in this scenario in lieu of the 06D01 procedure code due to the insanitary conditions caused by the rodent droppings. There was exposed product in the area and heavy traffic flow continually through this processing room. Because of the rodent droppings, the history of rodents in the facility, the proximity of rodent droppings to processing activities and product, the inspector in her professional judgment rightfully found that the use of the 01C02 procedure code was justified in lieu of the 06D01 procedure code in the scenario.

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.

 

For IKE related questions, send mail to ike@fsis.usda.gov. For all other general questions, send to Tech Center address listed below.