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FDA Releases Food Defense Tool for Help in Meeting FSMA Requirements

May 01, 2013

The Food and Drug Administration today released its Food Defense Plan Builder software program, which is designed to guide manufacturers through steps that will help them develop a proprietary food defense plan. Working with industry, FDA developed the voluntary tool to help companies meet new regulations required by the Food Safety Modernization Act.

“I have collaborated with FDA during the development of this tool and during a number of vulnerability assessments that the tool is based upon, and I believe FDA has done a great job with this effort,” said Clay Detlefsen, IDFA vice president of regulatory affairs.  “Industry focus groups reviewed the tool and they liked it, too.”

The software program provides new functionality for food defense planning and implementation and harnesses existing FDA tools and resources into a single application. These tools and resources include FDA’s food defense guidance documents, Vulnerability Assessment Software Tool and Mitigation Strategies Database.  

The software program will guide user through the following sections:

  • Company Information;
  • Broad Mitigation Strategies;
  • Vulnerability Assessment;
  • Focused Mitigation Strategies;
  • Emergency Contacts;
  • Action Plan; and
  • Supporting Documents.

FDA is required by the Food Modernization Act to issue a rule on food defense, and IDFA expects to see an Advance Notice of Proposed Rulemaking (ANPR) later this year that will solicit comments on drafting an effective food defense rule. The next steps will be a proposed rule and then a final rule, so the process will take some time, Detlefsen said.

FDA plans to host an all-day food defense workshop at IDFA’s International Dairy Show this November in Chicago. The workshop will review the key learnings from the vulnerability assessments and will allow attendees time for hands-on experience with the tool. 

For more information, contact Detlefsen at

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