August 25, 2016

New FSMA Compliance Deadlines Impact Written Customer Assurances

In an August 23 action, the U.S. Food and Drug Administration (FDA) extended a range of compliance dates and clarified compliance obligations for provisions within four foundational rules set forth by the Food Safety Modernization Act (FSMA). The extensions will impact rule provisions related to human food, animal food, produce safety and foreign-supplier verification programs, allowing companies to delay their compliance obligations by up to two years.

Rules Affected

Following a strong response from industry stakeholders and trade associations raising concerns about the feasibility of meeting the original compliance deadlines of affected provisions, FDA (among other things) extended compliance dates across a range of specific operations (e.g., farms, packinghouses and importers) and products (e.g., milk, food contact substances). Notably, FDA has extended by two years implementation of its requirements for written customer assurances for the control of hazards, which have been a particular point of interest for food manufacturers.

Depending on size, manufacturers will now have two additional years to comply with requirements that they annually obtain written assurances that their customers “will manufacture the food in accordance with applicable food safety requirements or sell only to someone that agrees to do so” for foods not processed to control specified hazards. However, in the interim, manufacturers will still be required to disclose that the food is subject to uncontrolled hazards (FDA promises additional guidance on the disclosure requirement). FDA acknowledged that, in some cases, written assurances requirements currently proposed under FSMA “significantly exceed the current practices of even the largest facilities,” and could require “vastly more written assurances and consequently resources” than the agency anticipated. FDA will use the two year extension regarding customer assurances to consider the best approach to address these feasibility concerns.

The following rules are affected by FDA’s announcement:

  • Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food (Human Food)
  • Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Animal Food)
  • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP)
  • Standards for Growing Harvesting, Packing and Holding of Produce for Human Consumption (Produce Safety)

For a full view of the new deadlines affecting written assurances from customers, view FDA’s full table of extensions and affected provisions.

For a discussion summary of all affected provisions, read FDA’s summary of Compliance Date Extensions and Clarifications for FSMA Final Rules.

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