subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "507"
part_subject: "CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS"
subpart_code: "C"
subpart_subject: "Hazard Analysis and Risk-Based Preventive Controls"
section_number: "507.49"
section_subject: "Verification of implementation and effectiveness."
cfr_reference: "21 CFR 507.49"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)You must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards. To do so, you must conduct activities that include the following, as appropriate to the facility, the animal food, and the nature of the preventive control and its role in the facility's food safety system:
(1)Calibration of process monitoring and verification instruments (or checking them for accuracy);
(2)Product testing for a pathogen (or appropriate indicator organism) or other hazard;
(3)Environmental monitoring, for an environmental pathogen or for an appropriate indicator organism, if contamination of an animal food with an environmental pathogen is a hazard requiring a preventive control, by collecting and testing environmental samples; and
(4)Review of the following records within the specified timeframes, by (or under the oversight of) a preventive controls qualified individual, to ensure the records are complete, the activities reflected in the records occurred in accordance with the food safety plan, the preventive controls are effective, and appropriate decisions were made about corrective actions:
(i)Monitoring and corrective action records within 7-working days after the records are created or within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 7-working days; and
(ii)Records of calibration, testing (e.g., product testing, environmental monitoring), and supplier and supply-chain verification activities, and other verification activities within a reasonable time after the records are created; and
(5)Other activities appropriate for verification of implementation and effectiveness.
(b)As appropriate to the facility, the food, the nature of the preventive control, and the role of the preventive control in the facility's food safety system, you must establish and implement written procedures for the following activities:
(1)The method and frequency of calibrating process monitoring instruments and verification instruments (or checking them for accuracy) as required by paragraph (a)(1) of this section;
(2)Product testing as required by paragraph (a)(2) of this section. Procedures for product testing must:
(iii)Identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring. The number and location of sampling sites must be adequate to determine whether preventive controls are effective;
(iv)Identify the timing and frequency for collecting and testing samples. The timing and frequency for collecting and testing samples must be adequate to determine whether preventive controls are effective;
(v)Identify the test(s) conducted, including the analytical method(s) used;
(vi)Identify the laboratory conducting the testing; and
(vii)Include the corrective action procedures required by § 507.42(a)(1)(ii).