D. Verification of Sanitation Controls to Significantly Minimize or Prevent the Potential for an Environmental Pathogen To Contaminate Food
E. Role of Environmental Monitoring in Verifying the Implementation and Effectiveness of Sanitation Controls in Significantly Minimizing or Preventing the Potential for an Environmental Pathogen To Contaminate Food
F. The Role of Finished Product Testing in Verifying the Implementation and Effectiveness of Preventive Controls
II. The Role of Supplier Approval and Verification Programs in a Food Safety System
Purpose and Coverage of the Proposed Rule
The proposed rule would establish regulations regarding the manufacturing, processing, packing, or holding of animal food in two ways. First, it would create new current good manufacturing practice (CGMP) regulations that specifically address the manufacturing, processing, packing, and holding of animal food. Second, it would include new preventive control provisions intended to implement section 103 of the FDA Food Safety Modernization Act (FSMA) for animal food. In general, with some exceptions the new preventive control provisions would apply to animal food facilities that are required to register with
To put these changes in context, and to provide legal, regulatory, scientific, and technical information relevant to the new provisions, the Agency provides several sections of background. This background discusses the current approaches to animal food safety; summarizes the Food and Drug Administration Amendments Act of 2007 (FDAAA) as it applies to pet food; provides an overview of the provisions of FSMA applicable to this proposed rule; and describes a variety of hazards that have been associated with animal foods and animal food safety problems (including outbreaks of foodborne illness) that have resulted from these hazards. An Appendix also describes the role of testing as a verification measure in a food safety system and the role of supplier approval and verification programs in a food safety system.
Summary of the Major Provisions of the Proposed Rule
The proposed rule would establish certain CGMP provisions to ensure the safety and suitability of animal food. The implementation of these practices and procedures would protect against the contamination of animal food. The proposed CGMPs would establish procedures in areas such as buildings and facilities, design and layout, cleaning and maintenance, pest control, and personnel hygiene.
The proposed rule also would implement the requirements of section 103 of FSMA for animal food facilities that must register under section 415 of the FD&C Act (21 U.S.C. 350d) to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the proposed rule would establish requirements for:
* A written food safety plan;
* Hazard analysis;
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