# COMAR Title 10 — Maryland Department of Health

## Subtitle 15 — Food

### Chapter 04 — Food and Drink Processing and Transportation

#### Regulation .08 Hazard Analysis and Risk-Based Preventive Controls.

*COMAR 10.15.04.08*

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.