12. Animal Food Safety Compliance Policy Guides
FDA issues guidance to its staff in the form of a compliance policy guide (CPG). The primary purpose of a CPG is to explain FDA's policy on regulatory issues related to the statutes and regulations that FDA is responsible for implementing. CPGs advise FDA field inspection and compliance personnel as to FDA's standards and procedures to be applied when determining industry compliance with our regulatory requirements. FDA issues CPGs in accordance with its regulation for good guidance practices in SEC 10.115 and makes the CPGs available to the public, thereby providing regulated industry with additional insight into how the Agency interprets the statutes and regulations it is responsible for implementing for purposes of assessing compliance with the Agency's regulatory requirements. In general, FDA's animal food safety CPGs are relatively focused in scope. For example, the Agency has issued a CPG regarding Salmonella contamination in all food for animals (Ref. 14), and a CPG that sets forth the criteria that are to be used by FDA personnel to determine whether to take action on animal foods containing aflatoxins (Ref. 15).
B. The Food and Drug Administration Amendments Act of 2007
On September 27, 2007, the FDAAA (21 U.S.C. 2102) was signed into law (Pub. L. 110-85). Section 1002(a) of Title X (Food Safety) of the FDAAA requires the Secretary of Health and Human Services (HHS), in consultation with relevant stakeholder groups, including the Association of American Feed Control Officials (AAFCO), veterinary medical associations, animal health organizations, and pet food manufacturers, to issue new regulations establishing, among other things, processing standards for pet foods. A public meeting that included representatives for the previously mentioned stakeholders was held May 13, 2008, after publication of a notice in the Federal Register on April 21, 2008 (73 FR 21357).
Neither the FDAAA, nor its legislative history, described what Congress meant by "processing standards" for pet food. In many instances the same ingredients and manufacturing processes are used to produce animal food for both non-food-producing animals, including pets, and food-producing animals. FDA determined that it would not be feasible to implement or enforce processing standards that only applied to one segment of the industry (i.e., pet food.)
The proposed rule for process control standards that the Agency was developing (see the discussion in section II.A.1) included all animal food. After FDAAA was signed into law, a discussion of FDAAA and the requirements for processing standards for pet food was added to the preamble of the proposed rule for process controls standards to clarify that the proposed rule would satisfy these requirements for pet food. After FSMA was enacted, the Agency decided to issue one rule that would satisfy the mandate of section 1002(a) of FDAAA and section 103 of FSMA.
C. FDA Food Safety Modernization Act
1. Requirements for Food Facilities
FSMA was signed into law by the President on January 4, 2011 (Pub. L. 111-353). Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418 (21 U.S.C. 350g) with the same name. Many of the provisions in section 103 of FSMA that are relevant to this rulemaking are codified in section 418 of the FD&C Act.