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FDA Seeks Comments on Voluntary Submission of Facility Profiles

May 16, 2012

The Food and Drug Administration recently announced plans to modify the food facility registration process as a part of its implementation of the Food Safety Modernization Act. FDA wants companies to submit on a voluntary basis a "facility profile" with operational details about their plants so the agency can prepare for inspections in advance, reduce inspection times and create a database of products, hazards and preventive controls.

In a Federal Register notice published on Friday, FDA gave examples of the type of information the profile would gather, including the type of facility, products and hazards, and preventive control measures associated with those products. The profile also would ask about food safety training, facility size, operational schedule and number of employees.

FDA plans to use the information to determine whether a facility is high risk or non-high risk and to help determine inspection frequency for each type. The agency would use the searchable database when a problem occurred with certain foods or controls to target inspections to facilities at increased risk.

FDA is seeking comments on the profile plan and specifically requested information on four topics:

  • Whether the proposed collection of information is necessary for the proper performance of FDA's functions and whether the information gathered will have practical use;
  • Ways to enhance the quality, utility and clarity of the information;
  • Whether FDA's estimate of the burden of the proposed collection of information is accurate; and
  • Ways to minimize the burden of collecting information on respondents.

IDFA plans to submit comments before the comment period ends on July 10, 2012. Clay Detlefsen, IDFA vice president of regulatory affairs, encourages members to contact him at with comments to include.

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