On August 24, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule (81 Fed. Reg. 57,784) that extends and clarifies the compliance dates for certain provisions in four of the foundational rules implementing the Food Safety Modernization Act (FSMA). These changes are intended to address concerns about the practicality of compliance with certain provisions, better align compliance dates across the rules, and address technical issues.

Customer Provisions: FDA is extending the compliance dates with respect to "customer provisions" that apply when a manufacturer/processor identifies a hazard requiring a preventive control, does not control the identified hazard, and relies on an entity in its distribution chain to address the hazard. On March 23, 2016, FDA met with the Grocery Manufacturers Association (GMA) at GMA's request. GMA provided examples of product distribution chains that would require vastly more written assurances than anticipated by FDA.

After considering the information presented by GMA, FDA concluded that compliance with the requirements for written assurance by the initial compliance date of September 19, 2016, may not be feasible, and the Agency elected to extend the compliance dates for 2 years for the written assurance requirements in § 117.136 (for human food) and § 507.36 (for animal food) and the related rules while FDA considers the best approach to address feasibility concerns. As a result of the extension, the compliance date for certain associated requirements that are contingent on the specified delayed provisions are also delayed. The revised compliance dates for written assurances for businesses that are not small or very small are as follows:

  • Human Food Written Assurance Requirements: September 19, 2018
  • Animal Food Written Assurance Requirements: September 19, 2019
  • FSVP Written Assurance Requirements: The latest date of May 28, 2019 or, for importers of food from a foreign supplier subject to the preventive controls regulation for human food, the preventive controls or CGMP requirements for animal foods, or the produce safety regulation, 30 months after the previously-announced compliance dates for the relevant regulations.
  • Produce Safety Written Assurance Requirements: January 28, 2019 for businesses relying on the exemption in § 112.2(b) for sprouts that would otherwise be subject to subpart M; January 27, 2020 for businesses relying on the exemption in § 112.2(b) for all other produce that would otherwise be covered.

The compliance dates for written assurances for businesses that are small or very small are also extended by 2 years.

Facilities Solely Engaged in Packing/Holding Produce RACs: FDA is extending the date for facilities that are solely engaged in packing and/or holding activities on produce raw agricultural commodities (RACs) to comply with the preventive controls requirements for human food in part 117 or for animal food in part 507, as applicable. FDA is extending the compliance dates by approximately 16 months to match the compliance dates for businesses in the same size categories in the produce safety regulation. This change is intended to provide facilities that are solely engaged in packing and/or holding activities on produce RACs the same time to understand the applicable provisions of the produce safety regulation as farms that conduct similar packing and holding activities, and to enable such facilities to develop a food safety plan that builds on the requirements of the produce safety regulation. The revised compliance date for human food facilities that are not small or very small businesses is January 26, 2018. The revised compliance dates for animal food facilities that are not small or very small businesses are January 26, 2018 for CGMPs and January 28, 2019 for preventive controls. The compliance dates for businesses that are small or very small are also extended by approximately 16 months.
Operations under "Common Ownership" with Primary Production Farms: 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 "secondary activities farms" (i.e., the operation is not owned by the primary production farm). FDA is extending the compliance dates by approximately 16 months to match the compliance dates for businesses in the same size categories in the produce safety regulation. The extension is applicable only if: (1) the operation is not located on a primary production farm; (2) the operation is devoted to harvesting, packing, and/or holding of RACs (including operations that hull, shell, and/or dry nuts without additional manufacturing); 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. The revised compliance date for human food facilities that are not small or very small businesses is January 26, 2018. The revised compliance dates for animal food facilities that are not small or very small businesses are January 26, 2018 for CGMPs and January 28, 2019 for preventive controls. The compliance dates for businesses that are small or very small are also extended by approximately 16 months.

Facilities that Color RACs: FDA is extending the compliance dates for facilities that would qualify as farms if they did not color RACs by approximately 16 months to match the compliance dates for businesses in the same size categories in the produce safety regulation. The change is intended to give FDA additional time to consider whether future rulemaking to modify the "farm" definition is appropriate. As the term "farm" is currently defined, treating RACs to manipulate ripening, packaging RACs, and labeling RACs are manufacturing/processing activities that do not transform a RAC into a processed food, and therefore do not trigger the registration requirement and application of the human food preventive controls requirements in part 117. In contrast, coloring RAC, which is also a manufacturing/processing activity that does not transform a RAC into a processed food, does trigger such requirements (unless another exemption applies). The revised compliance date for human food facilities that are not small or very small businesses is January 26, 2018. The compliance dates for businesses that are small or very small are also extended by approximately 16 months.

Cotton Ginning Facilities: FDA is extending the compliance dates for animal food preventive controls requirements for facilities subject to part 507 that solely engage in the ginning of cotton by approximately 16 months to match the other extension dates that relate to the "farm" definition. Ginning cotton does not transform a RAC into a processed food but results in component RACs, some of which (e.g., cotton seed) are used for animal food, which generally triggers the food facility registration requirement and application of the animal food preventive controls requirements in part 507. The cotton industry expressed concern that the part 507 rule does not apply to the vast majority of cotton ginners that are part of a farm, while it does apply to the minority of cotton ginners that do not meet the "farm" definition, despite the fact that both types of operations perform the same activities. The change is intended to give FDA additional time to consider whether and how FDA should address these concerns. The revised compliance date for animal food facilities that are not small or very small businesses is January 28, 2019. The compliance dates for businesses that are small or very small are also extended by approximately 16 months.

Foreign Supplier Verification for Food Contact Substances: FDA is extending the compliance dates for verification activities under the FSVP regulation for food contact substances by 2 years. In June, FDA met with industry representatives at industry's request, and the Agency was informed that the supply chain associated with imported substances used to manufacture food contact substances is highly complex and very different from other foods subject to the FSVP regulation, and that any hazards associated with food contact substances are already adequately addressed through the food additive petition and food contact substance notification processes. After considering the information presented by the industry representatives, FDA determined that compliance with the requirement to conduct verification activities under the FSVP regulation for food contact substances by May 30, 2017, might not be feasible. Accordingly, FDA is extending the applicable compliance date so that it can consider how best to address the feasibility concerns. The earliest revised compliance date is May 28, 2019.

Grade "A" Milk and Milk Products: For Grade "A" milk and milk products covered by National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO), FDA is extending the date for compliance with the modernized CGMPs until September 17, 2018. This extension will align the compliance date for the Grade "A" milk and milk products covered by the PMO with respect to the modernized CGMPs with the compliance date for such products with respect to the principal provisions of the human preventive controls requirements.

Testing of Surface Water: FDA is clarifying the compliance date for covered farms that are required to sample and test untreated surface water in accordance with § 112.46(b)(1)(i)(A). The final rule clarifies that covered farms must begin sampling and testing, as applicable, no later than two years before the compliance date for the § 112.44(b) microbial quality criteria for such water. The farm has discretion under § 112.46(b)(1)(i)(A) as to both (1) the number of samples they include in their initial survey, provided that the total must be 20 or more samples; and (2) the time period over which samples are taken, provided that the period must be at least 2 years and no more than 4 years.