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FDA Utilizing Discretionary Policy to Begin Enforcement of Certain FSMA Requirements

The Food and Drug Administration (FDA) is continuing to explain and inform importers on how they can expect to fulfill the new requirements of the Food Modernization Safety Act (FSMA). The Government Agency announced it plans to implement specific provisions of the FSMA rules with discretion by initially only enforcing four of the seven provisions of the act. Although the FDA announced an extension for the compliance dates for many of the stipulations of the FSMA, the organization chose to exercise enforcement discretion, and it will remain in place until the FDA decides on further actions on these issues.

The FDA is allowing some more time to install all the new changes or find better approaches to implement them. During this discretionary period, the FDA intention is not to enforce these provisions to the appropriate entities or undertakings. The enforcement discretion pertains to specific clauses in rules for the Foreign Supplier Verification Programs (FSVP), Preventive Controls for Human Food (PC Human Food), Preventive Controls for Food for Animals (PC Animal Food), and Produce Safety.

The enforcement discretion relates to:

  • facilities that would be farms except for certain factors and activities
  • written assurances provisions in all four rules related to the control of identified hazards or microorganisms that are a potential risk to public health
  • the animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food
  • FSVP requirements for importers of food contact substances

For more information regarding the FSMA, please visit the link to the FDA below or contact OCEANAIR compliance at (781) 286-2700 or compliance@oceanair.net.

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