---
kind: "range"
citation: "9 C.F.R. §§ 416.13–416.16"
title: "9"
from: "416.13"
to: "416.16"
count: 4
url: "https://uscodex.org/cfr/9/416.13..416.16"
---

# §416.13. Implementation of SOP's.

- (a) Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP's before the start of operations.
- (b) Each official establishment shall conduct all other procedures in the Sanitation SOP's at the frequencies specified.
- (c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP's.

# §416.14. Maintenance of Sanitation SOP's.


Each official establishment shall routinely evaluate the effectiveness of the Sanitation SOP's and the procedures therein in preventing direct contamination or adulteration of product(s) and shall revise both as necessary to keep them effective and current with respect to changes in facilities, equipment, utensils, operations, or personnel.


# §416.15. Corrective Actions.

- (a) Each official establishment shall take appropriate corrective action(s) when either the establishment or FSIS determines that the establishment's Sanitation SOP's or the procedures specified therein, or the implementation or maintenance of the Sanitation SOP's, may have failed to prevent direct contamination or adulteration of product(s).
- (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. Recordkeeping requirements.

- (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.
- (b) Records required by this part may be maintained on computers provided the establishment implements appropriate controls to ensure the integrity of the electronic data.
- (c) Records required by this part shall be maintained for at least 6 months and made available to FSIS. All such records shall be maintained at the official establishment for 48 hours following completion, after which they may be maintained off-site provided such records can be made available to FSIS within 24 hours of request.