Food

Compliance Date Extensions and Clarifications for FSMA Final Rules

General information on compliance dates for FSMA final rules is available on each rule page. The following is a summary of changes announced in the Final Rule: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules that impacts provisions in these four rules:

Extending compliance dates for certain provisions concerning written customer assurances  

  • All four rules contain “customer provisions” for modified requirements (or, in the case of the Produce Safety rule, an exemption) when food safety controls are applied downstream and certain conditions are satisfied. For example, the customer provisions in some of the rules allow a manufacturer/processor that does not control a hazard requiring a preventive control to rely on its customer to control the hazard.
  • The manufacturer/processor must disclose in documents accompanying the food that it is not processed to control the hazard and must obtain a written assurance from the customer that the customer will manufacture the food in accordance with applicable food safety requirements or sell only to someone that agrees to do so.
  • This final rule provides entities with an additional two years to comply with the customer assurance requirements while FDA considers the best approach to address feasibility concerns. The compliance dates for these requirements are different for each rule, with the earliest date being September 19, 2018 for large human food facilities.

Extending compliance dates for facilities that only pack and/or hold raw agricultural commodities that are produce and/or nut hulls and shells

  • Compliance dates for facilities that are covered by the two Preventive Controls rules for human and animal food, including CGMPs, and are solely engaged in packing and/or holding produce raw agricultural commodities (for example, some packing houses) are extended to align with the compliance dates for farms conducting similar activities under the Produce Safety rule.
  • This extension includes facilities that hull, shell, pack and/or hold nuts.
  • The earliest compliance date is January 26, 2018.

Extending compliance dates for certain facilities that would qualify as secondary activities farms except for the ownership of the facility

  • The FDA is extending the compliance dates for operations that would be secondary activities farms except that they do not meet the ownership criterion in the definition of a secondary activities farm.
  • For example, some operations that might otherwise qualify as secondary activities farms own the primary production farm, rather than being owned by the primary production farm as currently required. Or they are not owned by (and do not own) the primary production farm but are majority owned by the same entity as the primary production farm.
  • The extension is applicable only to an operation satisfying all of the following requirements: (1) the operation is not located on a primary production farm; (2) the operation is devoted to harvesting, packing, and/or holding of raw agricultural commodities; and (3) the operation is under common ownership with the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested packed, and/or held by the operation.
  • FDA is considering future rulemaking to modify the definition of a farm in order to address ownership issues.
  • The earliest compliance date is January 26, 2018.

Extending compliance dates for facilities coloring raw agricultural commodities 

  • Compliance dates for facilities that color raw agricultural commodities are being extended for 16 months to align with the Produce Safety rule. Currently coloring is considered a manufacturing/processing activity that requires food facility registration and is subject to the CGMP and Preventive Controls for Human Food rule.
  • FDA is considering future rulemaking to modify the definition of a farm in order to address “coloring” activities.
  • The earliest compliance date is January 26, 2018.

Extending compliance dates for cotton ginning facilities under animal food rule 

  • Off-farm facilities solely engaged in cotton ginning that provide products (for example, cotton seed and lint) without further processing for use as animal food now have an additional 16 months to comply with applicable requirements in the CGMP and Preventive Controls for Animal Food rule.
  • The earliest compliance date is January 28, 2019.

Extending compliance dates for food contact substances under FSVP rule 

  • Importers subject to the FSVP rule have an additional two years to meet the requirements of this rule for the importation of food contact substances. (A food contact substance is any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if the substance is not intended to have any technical effect on the food.)
  • The agency will consider how best to address feasibility concerns for the application of FSVP to these substances. In doing so, the FDA noted the relatively rare occurrence of significant safety concerns associated with the manufacture of food contact substances and the agency’s existing, extensive premarket approval and review processes for these substances provide some assurances regarding safety during this time.
  • The earliest compliance date is May 28, 2019.

Extending CGMP compliance date for Grade “A” milk products 

  • This final rule extends the compliance date for National Conference on Interstate Milk Shipments (NCIMS) facilities producing Grade “A” milk and milk products to comply with CGMPs under the CGMP and Preventive Controls for Human Food rule.
  • Originally, these facilities had different compliance dates for the CGMPs and the preventive control requirements.
  • This change will create a single compliance date, September 17, 2018, for facilities producing Grade “A” milk products to comply with all requirements.

Clarifying agricultural water testing compliance timeframe

  • The FDA is clarifying that farms subject to the Produce Safety rule have discretion in how they sample agricultural water to develop a microbial quality profile. They are allowed discretion as to both the number of samples they take in their initial survey, provided that the total is 20 or more samples. And they are allowed discretion as to the time period over which such samples are taken, provided that it is at least two years and no more than four years.
  • The rule provides examples of approaches that farms may consider when collecting water samples and how they relate to compliance dates for the water-related requirements of the Produce Safety rule.

Page Last Updated: 08/23/2016
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