Jan. 5, 2018 – -On January 5, 2017 the U.S. Food & Drug Administration (FDA) announced the Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs.

The FDA announcement outlines that it will exercise enforcement discretion for certain provisions in four of the rules that implement the FDA FSMA. This means that during the enforcement discretion period, the agency does not intend to enforce these provisions as they currently apply to certain entities or activities. FDA had previously extended the compliance dates for many of the provisions, but is now exercising discretion.

The Almond Alliance, assisted by the Memorandum Of Agreement with the Almond Board of California, is analyzing the full impact of the Guidance and will have further advice and details in the coming weeks. Currently, we can provide the following key points:

1) FDA will exercise discretion for the written assurance provisions in all four FSMA rules-including the  Produce Safety Rule. FDA intends to continue to exercise such discretion while it engages in continued rule-making on this issue.

2) FDA will exercise enforcement discretion for facilities that would qualify as secondary activities farms except for the ownership of the facility.  In particular, FDA’s exercise of enforcement discretion applies to any operation (not located on a primary production farm) that is dedicated to harvesting, packing, and/or holding raw agricultural commodities (RACs), as well as facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells.  FDA specifically provides “facilities engaged in nut hulling/shelling operations” (i.e., hullers and shellers) as an example of the type of facility likely to fall within this category.  Accordingly, practically speaking hullers/shellers will have neither preventive controls nor GMP obligations if they fall under the Preventive Controls rule.  In the longer term, FDA will initiate a rule-making that could change the way the requirements in the Preventive Controls rule apply to facilities that conduct activities similar to those that occur on farms.

The links to the guidance, Constituent Update, and fact-sheet related to this announcement are included below for your reference.

FR Notice

Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs

Constituent Update

Factsheet

Contact Andrea York, Manager of Government Relations, for further information ayork@almondalliance.org