d. Proposed SEC 507.45(e)(3)--Revision of the food safety plan. Proposed SEC 507.45(e)(3) would require that the owner, operator, or agent in charge of a facility revise the written food safety plan if a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. Proposed SEC 507.45(e)(3) would implement section 418(i) of the FD&C Act, which requires that the written plan be revised "if . . . a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed." As discussed in section X.B of this document, the written hazard analysis is required even if the conclusion of the analysis is that there are no hazards reasonably likely to occur. It is also important to document that a reanalysis has been conducted even if no change has been made, as required by section 418(i) of the FD&C Act. Such documentation demonstrates that a facility has considered all relevant information on the safety of the products being produced, including new information that has become available since the last analysis, and determined that current procedures for implementing preventive controls are adequate to significantly minimize or prevent hazards that are reasonably likely to occur.
e. Proposed SEC 507.45(e)(4)--Requirement for a qualified individual. Proposed SEC 507.45(e)(4) would require that the reanalysis be performed, or overseen, by a qualified individual. Proposed SEC 507.45(e)(4) is consistent with proposed SEC 507.30(b) which would require that the food safety plan be developed by a qualified individual. The Agency tentatively concludes that the same qualifications are needed whether initially conducting a hazard analysis and establishing a food safety plan, or reanalyzing a hazard analysis and plan.
8. Proposed SEC 507.45(f)--Requirement for Records for Verification
Proposed SEC 507.45(f) would require that all verification activities taken in accordance with this section be documented in records and would implement section 418(g) of the FD&C Act.
H. Proposed SEC 507.48--Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Packaged Animal Food That Is Not Exposed to the Environment
1. Requirements of Section 418 of the FD&C Act
Briefly, as relevant to proposed SEC 507.48, specific provisions of section 418 of the FD&C Act require, in relevant part, that the owner, operator, or agent in charge of a facility:
* Identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility and develop a written analysis of the hazards (section 418(b) of the FD&C Act);
* Identify and implement preventive controls to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act (section 418(c) of the FD&C Act);
* Monitor the effectiveness of the preventive controls implemented under section 418 (c) of the FD&C Act to provide assurances that the outcomes described in section 418(c) shall be achieved (section 418(d) of the FD&C Act);
* Establish procedures to ensure that, if the preventive controls implemented under section 418(c) of the FD&C Act are not properly implemented or are found to be ineffective, appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; all affected food is evaluated for safety; and all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act (section 418(e) of the FD&C Act);
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