IKE Scenario 14-02: 9 CFR 416.2 (d) Ventilation under the Sanitation Performance Standards: August 23, 2002

In the last IKE scenario we featured rodent contamination in a production-related area. The relief inspector took a regulatory control action, all affected products were plant condemned, and documented the findings of this repetitive noncompliance on a noncompliance record. This scenario is a continuation of scenario 13-02. In this IKE scenario the same relief inspector returns and is assigned to the same plant one week 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(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.

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 were assigned to the plant last week where you observed the rodent droppings on solidified, cold fat on unclean cooking racks in the smokehouse. Before you go out in the plant to perform the procedures scheduled for today, you review the noncompliance records (NR) on file. You see seven relevant NR’s on file:

The original NR written on rodent activity.

A NR issued for condensation leading to direct product contamination.

A NR issued for condensation leading to direct product contamination.

A NR issued for holes in walls around pipes behind the smokehouse.

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

A NR issued for rodent droppings in the boiler room.

A NR issued for insanitary conditions due to rodents and contamination of product.

During your review of the noncompliance records, you notice a trend building of repetitive noncompliance pertaining to two separate issues: (a) rodent activity, and, (b) condensation involving product, product contact surfaces and production-related areas. Closing the filing cabinet, you walk out into the plant to perform your 06D01 verifications.

You walk over through the entrance of the processing room, and observe the area to determine if the ventilation is adequate to control odors, vapors, and condensation. As you proceed by the cooked sausage unloading area, you glance at the ceiling to observe if any condensation has formed as a result of unloading the hot, cooked product into the refrigerated processing room. No condensation is observed to have formed on overhead structures. However, upon further observation, a three-foot by two-foot area of beaded condensation is noted on the drop panel ceiling above a large unused vent in a wall. The area involved is in the corner of the processing room and from your knowledge of the plant, you know that no product or product contact equipment is stored or staged in this area. Additionally, the product flow is well away from this corner of the room. At the time of the observation there is no product or production related equipment stored under the hanging condensate.

You inform the quality assurance manager and inform her of the requirements of 9 CFR 416.4(d) which stipulates that ventilation must be adequate to control condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions. She states that the ceiling is not on a routine schedule to be cleaned. Additionally she informs you that there are no condensation elimination procedures included in the SSOP.

.

The inspector utilizes a US Reject tag in accordance with 9 CFR 500.2(a)(1) for insanitary conditions due to the evidence of beading condensation. The area is rejected for use. The inspector informs plant management of the control action under 9 CFR 500.2(b). The ceiling is wiped dry of condensation, and the affected area (wall and floor) is cleaned. Since this was a third occurrence in as many weeks, the quality assurance manager required a quality assurance inspector to monitor the area continuously the remainder of that production day as an interim preventive measure. The quality assurance manager states that a contractor will be contacted to install fans near the ceiling within the week. No other actions are pursued. 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 establishment was not in compliance with 416.4(d), which stipulates that ventilation must be adequate to control condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions. This is a repetitive noncompliance, third incident, with the same root cause.

The Inspector would inform plant management of the regulatory requirement for ventilation per 416.4 (d). A noncompliance record under the procedure code 06D01 with a “structural” trend indicator would be issued. A notification would be made that this is a repetitive noncompliance and reference the other two previous NR’s on condensation. This includes the language that the corrective actions have been ineffective to prevent the reoccurrence of the noncompliance.

The regulatory control action would be lifted after the immediate corrective action is taken as the plant has put in place an interim preventive measure and committed to a long term correction of the noncompliance through the installation of the fans.

 

NOTE: Measures to combat condensation do not have to be written in the SSOP program. This is at the discretion of the plant. Additionally, as this is an O6D01 noncompliance, the requirements of 9 CFR 416.15 or 416.16 do not apply. Therefore no written record of the action is mandated upon the plant by regulation. Preventive measures are not required, but inspection personnel may elect to maintain the regulatory control action already in place until preventive measures are addressed if in their professional judgement these actions are necessary to maintain sanitary conditions or meet other regulatory requirements.

Part 500.2(a)(1) and 416.6 authorizes FSIS personnel to reject areas and equipment for insanitary conditions.

REFERENCED REGULATIONS

9 CFR 416.4(d) 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.

 

9 CFR 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 necessary to prevent the creation of insanitary conditions and the adulteration of product.

9 CFR 416.6 When an FSIS program employee finds that any equipment, utensil, room, or compartment at an official establishment is insanitary or that its use could cause the adulteration of product, he will attach to it a ``U.S. Rejected'' tag. Equipment, utensils, rooms, or compartments so tagged cannot be used until made acceptable. Only an FSIS program employee may remove a ``U.S. Rejected'' tag.

9 CFR 500.2(a)(1) FSIS may take a regulatory control action because of insanitary condition or practices.

9 CFR 500.2(b) If a regulatory control action is taken, the program employee will immediately notify the establishment orally or in writing of the action and the basis for the action.



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