Comment Deadline Approaching for Proposed HARPC FSMA Amendment

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After receiving over 20,000 comments, the U.S. Food and Drug Administration (FDA) recently amended several previously proposed rules for the Food Safety Modernization Act (FSMA), including the Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food rule. To address food safety from the beginning, the proposed HARPC rule requires preventative measures be taken at food processing facilities. While the FDA is currently accepting comments on the update, the December 15 deadline is rapidly approaching.

To prevent hazards, the proposed HARPC rule requires that, when appropriate, human food facilities test both products and the food facility’s environment, in addition to implementing certain supplier controls. Food facility operators must prepare and implement a food safety plan, including various documentation such as a written hazard analysis.

The hazard analysis should identify and evaluate reasonable foreseeable hazards to determine if there are any “significant hazards” or “a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis, establish controls to significantly minimize or prevent the hazard in a food.” In the originally proposed rule, this was described as a “hazard reasonably likely to occur” but commenters argued it was confusing.

The HARPC rule also requires operators:

  • Identify and implement preventive controls to minimize or prevent hazards

  • Establish a written recall plan for food with a hazard

  • Monitor the preventive controls frequently

  • Prepare and implement written corrective action procedures that must be taken if preventive controls are not properly implemented

  • Take appropriate corrective action in the event of an unanticipated problem if a preventive control is not properly implemented and a specific corrective action procedure has not been established

  • Conduct certain verification activities

  • Establish and maintain certain records

Key Revisions

The revisions to the HARPC rule are said to be more flexible and less burdensome in key areas. The FDA highlights the following updates:

  • Definition of a very small business proposed at less than $1 million in sales

  • Withdrawal of qualified exemptions process further clarified

  • Product testing, environmental monitoring, supplier controls proposed

  • Economically motivated adulteration language proposed

Before issuing the final FSMA rules in 2015, the FDA will consider comments on the original proposed rules in addition to comments on these revisions. Remember, the deadline to comment on these specific proposed amendments is December 15. You can submit your comments here.


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