Proposed SEC 507.36(d)(2)(iv) would require that all corrective actions taken in accordance with proposed SEC 507.36(d)(2)(ii) be documented in records that would be subject to verification in accordance with proposed SEC 507.45(b)(2) and records review in accordance with proposed SEC 507.45(c)(1)(i) and (c)(2). The records that document corrective actions would be used to verify that appropriate decisions about corrective actions are being made and appropriate corrective actions are being taken.
7. Proposed SEC 507.36(d)(3)--Recall Plan
Proposed SEC 507.36(d)(3) would require that preventive controls include, as appropriate, a recall plan as would be required by proposed SEC 507.38. Proposed SEC 507.36(d)(3) would incorporate the statutory definition of "preventive controls" from section 418(o)(3)(E) of the FD&C Act, which establishes that preventive controls may include a recall plan. The Agency includes the details of the recall plan in proposed SEC 507.38 and discusses it in section X.D of this document.
8. Proposed SEC 507.36(d)(4)--Other Controls
Proposed SEC 507.36(d)(4) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include any other controls necessary to satisfy the requirements of proposed SEC 507.36(a), i.e., to significantly minimize or prevent hazards identified in the hazard analysis and to provide assurance that the animal food manufactured, processed, packed or held by such facility will not be adulterated under section 402 of the FD&C Act.
FDA notes that some of the controls listed in section 418(o) of the FD&C Act are not explicitly identified in proposed SEC 507.36. As discussed in section X.B, the Agency is not interpreting misbranding under section 403(w), major allergens, to apply to animal food. Therefore, the proposed preventive controls for animal food do not include allergen controls. In section X.K, the Agency requests comment on an environmental monitoring program (which section 418(o)(3)(C) of the FD&C Act indicates is one of the procedures, practices, and processes that preventive controls may include, and which section 418(f)(4) of the FD&C Act identifies as a verification activity.) In section X.L, the Agency also requests comment on a supplier approval and verification program as one of the procedures, practices, and processes that preventive controls my include (section 418(o)(3)(G)). In section IX.C, the Agency requests comment on supervisor, manager, and employee hygiene training. There is a full discussion on CGMPs in section IX of this document. Further, as discussed in section IX.A of this document, such controls are traditionally considered to be part of prerequisite programs, essential to effective preventive controls but often not part of them. FDA expects that compliance with those requirements in proposed part 507, subpart B will be sufficient. However, a facility may determine that in some circumstances it would be appropriate to include certain Current Good Manufacturing Practice provisions among their preventive controls (i.e., as "other controls" in proposed SEC 507.36(d)(4).
9. Proposed SEC 507.36(e)--Applicability of Monitoring, Corrective Actions, and Verification
Proposed SEC 507.36(e)(1)(i) through (iii) would specify that, except as provided by proposed SEC 507.36(e)(2), the preventive controls required under this section would be subject to monitoring as would be required by proposed SEC 507.39; corrective actions as would be required by proposed SEC 507.42; and verification as would be required by proposed SEC 507.45. Proposed SEC 507.36(e)(1)(i) through (iii) would restate the requirements of proposed SUBSEC 507.39, 507.42, and 507.45 to clearly communicate the applicability of proposed SUBSEC 507.39, 507.42, and 507.45 to the preventive controls that would be required under proposed SEC 507.36 and would establish no new requirements.
Most Popular Stories
- SpaceX's Satellite Launch Is 'Game-Changer'
- Reid Confident Congress to Pass Immigration Bill
- Maui Visitor Killed in Shark Attack
- Donors Abandon GOP Over Gun Stance
- Mexico: 'Extremely Dangerous' Radioactive Material Stolen
- CEOs More Optimistic About Economy, Hiring
- Climate Change Early Warning System Urged
- Private Sector Employment Surges by 215,000 Jobs
- Newtown 911 Tapes Being Released Today
- Wisconsin Gov. Campaign Aide Fired Over Tweets