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A. Definitions. For purposes of this section, the following definition shall apply:

1. Facility” shall include any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing).

B. The United States Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) 2017 Food Code (Food Code) Sections 1-201, 3-401.14, 3-501.14, 3-501.15, 3-501.16, 3-501.17, and 3-501.19, and accompanying annex, including such chapters, appendices, annexes and comprehensive HHS/FDA Food Code amendments that may be amended and published from time to time shall be the governing law of the Osage Nation.

C. If a facility that is solely engaged in the storage of unexposed packaged food stores any such refrigerated packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens the facility must conduct the following activities as appropriate to ensure the effectiveness of the temperature controls:

1. Establish and implement temperature controls adequate to significantly minimize or prevent the growth of or toxin production by pathogens;

2. Monitor the temperature controls with adequate frequency to provide assurance that the temperature controls are consistently performed;

3. If there is a loss of temperature control that may impact the safety of such refrigerated packaged food, take appropriate corrective actions to:

a. Correct the problem and reduce the likelihood that the problem will recur;

b. Evaluate all affected food for safety; and

c. Prevent the food from entering commerce, if you cannot ensure the affected food is not adulterated under Section 402 of the Federal Food, Drug, and Cosmetic Act;

4. Verify that temperature controls are consistently implemented by:

a. Calibrating temperature monitoring and recording devices (or checking them for accuracy);

b. Reviewing records of calibration within a reasonable time after the records are created; and

c. Reviewing records of monitoring and corrective actions taken to correct a problem with the control of temperature within seven working days after the records are created or within a reasonable time frame; provided, that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a time frame that exceeds seven working days;

5. Establish and maintain the following records:

a. Records (whether affirmative records demonstrating temperature is controlled or exception records demonstrating loss of temperature control) documenting the monitoring of temperature controls for any such refrigerated packaged food;

b. Records of corrective actions taken when there is a loss of temperature control that may impact the safety of any such refrigerated packaged food; and

c. Records documenting verification activities.

D. Penalties.

1. Any person who violates a provision of this title shall be imprisoned for not more than one year or fined not more than One Thousand Dollars ($1,000.00), or both.

2. Notwithstanding the provisions of paragraph (D)(1) of this section, if any person commits such a violation after a conviction under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than Ten Thousand Dollars ($10,000.00), or both. ONCA 21-40, eff. Apr. 28, 2021.