Md. Code Regs. 10.15.04.08

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.15.04.08 - Hazard Analysis and Risk-Based Preventive Controls

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.

Md. Code Regs. 10.15.04.08

Regulations .08 adopted effective November 22, 2004 (31:23 Md. R. 1652)
Regulation .08A amended effective May 4, 2009 (36:9 Md. R. 651)
Regulation .08A amended effective March 5, 2012 (39:4 Md. R. 337); adopted effective 51:15 Md. R. 708, eff. 8/5/2024.