FDA Seeks Comments on Food Facility Preventive Controls for FSMA

Comments are due August 22, 2011.

FSMA Requires Food Facilities to Evaluate Hazards, Have Preventive Controls

The FSMA requires the owner, operator, or agent in charge of a facility required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 USC 350d) to take certain actions, including: (i) the evaluation of hazards that could affect food manufactured, processed, packed, or held by the facility, and (ii) the identification and (iii) implementation of preventive controls to significantly minimize or prevent the occurrence of such hazards. A written plan must be prepared to describe the procedures used by the facility to comply.

FDA to Consider Industry Best Practices in Developing Guidance for Facilities

FDA must issue guidance with respect to hazard analysis and preventive controls in order to help facilities meet these FSMA requirements. FDA plans to base its guidance, where appropriate, on the best practices identified by the food and feed industries.

Seeks Input for Specific Foods and Methods of Control

FDA seeks input on the following with respect to specific types of food or feed and specific methods in their manufacture, processing, packing, or holding:

• Conducting a hazard analysis to determine the hazards associated with specific human food or animal food/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 food/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/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/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/feed including feed ingredients.
• Preventive control approaches and practices (e.g., for validation, supplier controls) that are practical for small and very small businesses to implement.

(See ITT’s Online Archives or 05/23/11 news, 11052306, for BP summary of FDA stating that prevention would be the focus of many FSMA rules, inspections, etc.

See ITT’s Online Archives or 05/18/11 news, 11051808, for BP summary of FDA stating that foreign food facility inspections would increase and inspectors would especially be looking at implementation of preventive controls.

See ITT’s Online Archives or 01/04/11 and 03/07/11 news, 11010426 and 11030720, for BP summary of the FSMA and an FDA overview of it, including the preventive controls provisions.)

FDA contact - Jenny Scott 301--436--2166

(FR Pub 05/23/11, D/N FDA--2011--N--0002)