Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 15 - FOOD
Chapter 10.15.04 - Food and Drink Processing and Transportation
Section 10.15.04.08 - Hazard Analysis and Risk-Based Preventive Controls

Universal Citation: MD Code Reg 10.15.04.08

Current through Register Vol. 51, No. 19, September 20, 2024

The person-in-charge:

A. Is exempt from this regulation if:

(1) They meet the definition of a qualified facility in 21 CFR § 117.3; or

(2) They meet the qualifications defined in:
(a)21 CFR §§ 117.5-117.8;

(b)21 CFR § 117.201;

(c)21 CFR §§ 117.251-117.287; and

(d)21 CFR § 117.315(a)(2);

B. Shall ensure that a food safety plan:

(1) Is prepared, implemented, and managed by one or more individuals qualified in preventative controls;

(2) Is signed and dated by the owner, operator, or agent in charge:
(a) Upon initial completion;

(b) When any modification takes place; and

(c) At least once every 3 years;

(3) Includes a written hazard analysis that identifies all known and reasonably likely to occur biological, chemical, and physical hazards associated with each type of food manufactured in the plant;

(4) Includes written procedures for:
(a) Preventive controls;

(b) Process controls with parameters and values;

(c) Allergen controls;

(d) Sanitation controls;

(e) Other controls necessary as identified in the hazard analysis;

(f) Monitoring and record keeping for each preventive control identified in the hazard analysis that include an adequate frequency to control the hazard;

(g) Corrective actions that:
(i) Identify and correct the problem;

(ii) Reduce the likelihood the problem will recur;

(iii) Evaluate all affected food for safety; and

(iv) Prevent all affected food from entering commerce;

(h) Verification activities that ensure that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards;

(i) Validation for process controls;

(j) A supply chain program that complies with 21 CFR §§ 117.405-117.475 if the receiving facility has identified a hazard requiring a supply-chain-applied control; and

(k) A recall plan for a food with a hazard requiring a preventive control, that includes:
(i) Maintaining accurate records to identify the initial distribution of the food;

(ii) Direct notification of the consignees of the food being recalled, including how to return or dispose of the affected food;

(iii) Public notification about any hazard presented by the food when appropriate to protect public health; and

(iv) Effectiveness checks to account for all products affected;

(5) Is implemented to prevent, eliminate, or reduce to an acceptable level, all identified hazards;

(6) Includes records that document implementation of:
(a) The food safety plan monitoring;

(b) Corrective actions; and

(c) Supply chain, verification, validation, and applicable training for the preventive controls qualified individual and the qualified auditor;

(7) Includes that records of monitoring and corrective actions are reviewed by a preventive controls qualified individual within 7 working days after the records are created, or within a reasonable time frame; and

(8) Includes that records of verification activities are reviewed within a reasonable time by a preventive controls qualified individual; and

C. Shall ensure that a processing plant complies with the 21 CFR §§ 117.136-117.137 and 117.335 if results of the hazard analysis determine the facility is not required to implement preventive controls for a food item.

Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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