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FDA Releases Two Final Food Safety Rules: What You Need to Know

Food scientists at work in the labProgress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Food for Animals.

The final rule on Preventive Controls for Human Food creates and revises requirements for covered food facilities in three ways.  The final rule:

  1. Modernizes FDA’s current good manufacturing practice (cGMP) regulations, which govern the manufacturing, processing, packing, or holding of human food;
  2. Requires covered facilities to establish and implement hazard analysis and risk-based preventive controls for human food; and
  3. Clarifies the scope of the exemption for farms in FDA’s current food facility registration regulations and makes corresponding revisions to FDA’s current regulations for the establishment, maintenance, and availability of records.

The final rule on Preventive Controls for Animal Food establishes new requirements for the production of animal food by registered food facilities.  Specifically, the final rule:

  1. Creates new cGMP regulations that, for the first time, specifically address the manufacturing, processing, packing, and holding of food for animals; and
  2. Requires covered facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals.

These rules come in the midst of a long fight on Capitol Hill over funding for FDA and FSMA implementation and enforcement. To date, Congress has been unable to reach an agreement that would provide President Obama’s requested FDA budget increase of $109 million for FSMA implementation in FY2016. This budget uncertainty hampers FSMA implementation. In the Senate Agriculture’s September 16 hearing on FDA food safety efforts, Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine, stated: "There is no good outcome if we get the partial funding because something significant will have to give, whether it's in whole program areas, simply delaying or disrupting, or just doing everything inadequately…There will be hard choices.” FDA is also stuck in FSMA-related disputes with farmers, who have concerns about duplicative requirements with Department of Agriculture oversight, as well as with food safety groups that want the agency to require testing of more processed foods and produce under the law.

To continue its outreach and engagement with the regulated community on FSMA, FDA is hosting a series of three webinars on the two Preventive Controls final rules. The first webinar on September 15 focused on who is covered by the rules and the final definition of “farm.” The other two webinars, on September 16 & 17, will discuss the significant provisions of the Preventive Controls for Human Food and the Preventive Controls for Animal Food final rules, respectively. A public meeting about both Preventive Controls final rules will be held in Chicago on October 20, 2015.

These final rules and notices of the availability of the qualitative risk assessments will be published in the Federal Register on September 17, 2015 - an important date to keep in mind in order to accurately calculate compliance dates for your business as you work towards the new post-FSMA world.

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Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.