21 CFR 123.11: Sanitation control procedures

Requires fish and seafood processors to monitor eight key sanitation areas (water safety, surfaces, cross-contamination, hygiene facilities, pests, etc.), correct deficiencies promptly, keep records, and ideally maintain a written plant-specific sanitation SOP.

Part 123, Fish and Fishery Products · Subpart A, General Provisions

How FDA words it

The opening lines investigators use most when they cite 123.11, from the 483s we hold.

You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food.Most used

Your sanitation control records do not accurately document the conditions or practices observed at your firm.123.11(b)

Recent 483s citing 123.11

See all 483s citing 123.11

The regulation text

§ 123.11 Sanitation control procedures.

(a)Sanitation SOP. Each processor should have and implement a written sanitation standard operating procedure (herein referred to as SSOP) or similar document that is specific to each location where fish and fishery products are produced. The SSOP should specify how the processor will meet those sanitation conditions and practices that are to be monitored in accordance with paragraph (b) of this section.

(b)Sanitation monitoring. Each processor shall monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices specified in part 110 of this chapter and in subpart B of part 117 of this chapter that are both appropriate to the plant and the food being processed and relate to the following:

(1)Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;

(2)Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;

(3)Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product;

(4)Maintenance of hand washing, hand sanitizing, and toilet facilities;

(5)Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;

(6)Proper labeling, storage, and use of toxic compounds;

(7)Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and

(8)Exclusion of pests from the food plant.

The processor shall correct in a timely manner, those conditions and practices that are not met.

(c)Sanitation control records. Each processor shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by paragraph (b) of this section. These records are subject to the requirements of § 123.9.

(d)Relationship to HACCP plan. Sanitation controls may be included in the HACCP plan, required by § 123.6(b). However, to the extent that they are monitored in accordance with paragraph (b) of this section they need not be included in the HACCP plan, and vice versa.

[60 FR 65197, Dec. 18, 1995, as amended at 80 FR 56167, Sept. 17, 2015]

Questions

What does 21 CFR 123.11 require?

How do FDA investigators word a 123.11 observation?

The most common opening is: “You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food.”

Which sections are cited alongside 123.11?

In the same 483s, investigators most often also cite 123.6 (Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan), 123.7 (Corrective actions), 123.8 (Verification), 110.80 (Processes and controls).