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FDA Publishes Draft Approach to Identifying High-Risk Foods

The Food Safety Modernization Act (FSMA) requires the U.S. Food and Drug Administration (FDA) to designate high-risk foods and to establish recordkeeping requirements for those foods.  On February 4, 2014, FDA published a draft approach as its first step toward meeting the requirement.

FDA plans to use the following factors to determine whether a food should be designated as high-risk:

  • The known risks of the food
  • The food’s history of foodborne illness outbreaks and the severity
  • The food’s risk for microbiological or chemical contamination
  • The food’s manufacturing process
  • The likelihood that consuming the food would result in a foodborne illness
  • The likely severity of a foodborne illness attributed to the food

FDA is considering a semi-quantitative risk model that would be data-driven and comprehensive, flexible enough to be adapted to a number of different hazards, and applicable to a wide variety of foods.  The agency will consider comments, data received from stakeholders, and other input, and adjust its approach accordingly.   The draft approach is now open for comments.  The comment period will close on April 7, 2014.

Registrar Corp is an FDA compliance firm that helps food and beverage companies comply with FDA regulations.  Registrar Corp offers a variety of food safety services, including FDA inspection assistance and Food Defense Plan development and review.  If you require assistance or have questions regarding FDA’s draft approach, contact Registrar Corp at +1-757-224-0177 or through the 24/7 Live Help service: http://www.registrarcorp.com/livehelp.