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Food Safety Modernization Act Final Rules; The Final Countdown

August 12, 2015

By: Samantha Cooper, Manager, Food Safety and Quality Assurance

The FDA Food Safety Modernization Act (FSMA) has been described as the most sweeping reform of our food safety laws in more than 70 years, shifting the focus from responding to safety issues to preventing them from occurring.

FSMA was signed into law in 2011, and its new requirements affect nearly all members of the food industry including suppliers, producers, importers, distributors, manufactures, and transporters.

Of the seven proposed rules released by FDA starting in 2013, The Preventive Controls for Human Food and the Preventive Controls for Animal Food final rules are scheduled to be published as final rules on August 30. For those who have been living and breathing FSMA for the last four years, a few more weeks to wait to finally see these long-awaited rules could not come sooner.

Implementation of these two rules will keep FSMA followers and all affected facilities busy until October 31, 2015, when the Produce Safety, Foreign Supplier Verification Program, and 3rd Party Accreditation and Certification final rules are set to be published. Thus, after a four-year wait, the food industry will have five of the FSMA final rules delivered within a span of only two months.

The Human Food Preventive Controls proposed rule modernizes existing current Good Manufacturing Practices (cGMPs) and requires that each facility, except for those exempt from the rule, develop and implement a written food safety plan. This rule covers most facilities that manufacturer, process, pack, or hold food for consumption in the United States. Similarly, the Animal Food Preventive Controls rule establishes food safety requirements for facilities that manufacture, process, pack, or hold animal food; requiring covered facilities to implement cGMPs and develop and implement preventive controls as part of a food safety plan.  In addition, the Preventive Controls for Animal Food rule includes CGMPs for human food manufacturers supplying by-products to animal food supply chain.

During the rule making process, FDA was receptive to stakeholder input on developing final rules that reflect a flexible, risk and science-based approach to managing food safety. GMA participated extensively in this process, submitting over 1,000 pages of comments on the proposed regulations. For an overview of FSMA and to view GMA’s comments, visit the GMA FSMA webpage.

As we get closer to August 30, the food industry will be eager to see how this modern food safety reform will be implemented and how FSMA will change the regulatory landscape of the food industry and improve public health.


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Filed under: Product Safety

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