FDA Seeks More Input On Food Facility Preventative Control Guidelines


The U.S. Food and Drug Administration (FDA) reopened the public comment period for seeking guidance on establishing preventative controls for registered human food, animal food and animal feed facilities.

In May 2011, the FDA sought comments on best practices for hazard analysis and preventative controls for facilities that manufacture, process, pack or hold food for human or animal consumption. The agency said it reopened the comment period “in response to a request for an extension to allow interested persons additional time to submit comments.”

Information obtained from the comments will assist the FDA in the development of guidance on preventative controls for food facilities.

The FDA is specifically seeking comments in the following general categories with respect to human food, animal food or animal feed, including pet food:

• Conducting a hazard analysis to determine the hazards associated with specific human food, animal food, and animal feed and processes (e.g., the procedures used to determine potential hazards and to assess whether they are reasonably likely to occur);
• Implementing process controls (e.g., processes employed to prevent, eliminate, or reduce to acceptable levels the occurrence of any hazards that are reasonably likely to occur);
• Validating one or both of food and feed safety controls (e.g., information on procedures used to determine that control measures are capable of controlling the identified hazards);
• Implementing sanitation controls (e.g., procedures and practices utilized to minimize the risk of contamination) for human food and animal food and feed;
• Implementing supplier controls (e.g., procedures and practices used to ensure raw materials and ingredients are safe for their intended use);
• Allergen control (human food), including procedures to ensure that ingredients are accurately declared on the label, procedures to ensure the proper label is applied to the food, and procedures and practices to prevent the unintentional incorporation of a major food allergen into a food by cross contact during manufacturing, processing, and holding food;
• Environmental monitoring for Salmonella and for Listeria monocytogenes for specific types of food facilities (e.g., ready-to-eat food facilities, pet food facilities);
• Microbiological and other testing used to help ensure the safety of specific human food and animal food and feed;
• Specific biological, chemical, radiological, and physical hazards and controls for food types such as (but not limited to) spices nuts, ready-to-eat food, bakery products, fresh-cut produce, milk products, and medical food;
• Specific biological, chemical, radiological, and physical hazards and controls for animal food and feed including feed ingredients; and
• Preventive control approaches and practices (e.g. for validation, supplier controls) that are practical for small and very small business to implement.

Electronic comments can be submitted to www.regulations.gov, and written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2011-N-0238. The comment period will be open until Dec. 20, 2011.


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