October 27, 2016

FDA Extends FSMA Compliance Dates

The FDA is setting the first major compliance dates for the Food Safety Modernization Act of 2011 for large food facilities. The agency also issued a final rule that “extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules.” The final rule addresses technical issues and aligns compliance dates across the four rules.


Human food companies, other than small and very small businesses, need to come into compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule by September 19, 2016. This rule creates new requirements for the production of human food in three ways.

First, certain domestic and foreign facilities must implement hazard analysis and risk-based preventive controls, including maintaining a food safety plan, performing a hazard analysis, issuing corrective actions, having a recall plan, and instituting preventive controls. The rule also modernizes FDA’s current good manufacturing practice (CGMP) regulations, which were last updated in 1986. And third, the rule clarifies the scope of exemption for “farms”, affecting those subject to existing regulations and new requirements for record keeping and registration.

Animal food companies other than small and very small businesses will need to come into compliance with Current Good Manufacturing Practices for Food for Animals rule by September 19, 2016, and with preventive controls by September 18, 2017. Contaminated animal food can threaten human health by direct contact, or by contact with animals who have eaten the food and may or may not be sick.

The rule creates new CGMP regulations for establishments that are required to register with FDA as a food “facility”. It also creates new requirements to implement and establish hazard analysis and risk-based preventive controls for food for animals. Just as with human food manufacturers, these facilities must maintain a food plan, perform hazard analysis, and institute preventive controls.

The changes in today’s final rule affect compliance dates in certain provisions in these four rules: the two CGMP and Preventive Controls rules for human and animal food, the Foreign Supplier Verification Program, and Produce Safety. Manufacturers will have more time to meet requirements, related to assurances their customers must provide, along with more time for importers of food contact substances and time for FDA to resolve issues.

Public comment will be allowed on the draft guidance starting August 24, 2016. the FDA will release more chapters of the draft guidance for public comment as they are completed. All chapters of this draft guidance will be released by early 2018.


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