FDA has published seven foundational rules to implement FSMA, and compliance dates are quickly approaching:
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
- Earliest compliance date: September 19, 2016
- Current Good Manufacturing Practice [CGMP], Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
- Earliest compliance date: September 18, 2016 (for CGMP)
- Earliest compliance date: January 26, 2017
- Earliest compliance date: May 28, 2017
- Accredited Third-Party Certification
- Sanitary Transportation of Human and Animal Food
- Mitigation Strategies to Protect Food Against Intentional Adulteration
An extension and clarification of compliance dates, published in today’s Federal Register, concerns the first four of these seven foundational rules. See generally The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules.
While the compliance dates for the four rules are not extended generally, specific aspects of the rules are extended, including:
- The compliance dates in all four rules for certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain;
- The compliance dates for Part 117 (human food) and Part 507 (animal feed) for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells, and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility;
- The compliance dates for Part 117 for certain facilities that color RACs;
- The compliance dates for Part 507 for facilities solely engaged in the ginning of cotton;
- The compliance dates for the FSVP regulation for importation of food contact substances; and
- The compliance date for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of Part 117.
FDA also clarifies how it interprets the compliance dates for certain provisions related to agricultural water testing in the Produce Safety regulation. See generally Compliance Date Extensions and Clarifications for FSMA Final Rules.
These extensions and clarifications are intended to facilitate responsible implementation of FSMA.