FDA extends compliance dates for some FSMA provisions
AFIA says move is welcomed, but ‘very late’
Animal feed companies other than small and very small businesses will need to come into compliance with Current Good Manufacturing Practices (CGMPs) under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule by September 19, 2016, and with preventive controls by September 18, 2017. Human food companies other than small and very small businesses will need to come into compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule by September 19, 2016.
The two CGMP and preventive controls rules – along with the five other foundational rules that will be implemented over the next several years to strengthen FDA oversight of produce, imported foods, sanitary transportation and intentional adulteration – will create the preventive and risk-based food safety system mandated by FSMA and reduce foodborne illness.
The changes in the final rule affect the compliance dates for certain provisions in these four rules: the two CGMP and Preventive Controls rules for human food and animal feed, Foreign Supplier Verification Programs (FSVP), and produce safety. The changes include providing more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions to align compliance dates for various other food operations or provide time for FDA to resolve specified issues. The rule also clarifies the time frame for agricultural water testing.
AFIA: Move ‘very welcomed, but very late’
The American Feed Industry Association (AFIA) said it welcomes the release of the draft guidance document, ‘Current Good Manufacturing Practice Requirements for Food for Animals,’ but that it comes “very late.”
“Historically, guidance of this type is used both by industry and FDA field staff to determine the requirements of specific rules; clearly this was not the case here,” AFIA said in a statement. “The compliance date for firms with more than 500 employees is Sept. 19 – less than one month away – for CGMP compliance. Industry needs adequate time to review this document and determine if their facilities are in compliance with FDA’s interpretation of this rule as explained in this document. The tardy nature of the guidance makes this task near impossible to achieve.
“We urge FDA to be more timely in its release of these important documents and to use regulatory discretion in inspections for several months to come as firms match their facilities’ CGMPs to the agency’s expectations.”
A draft guidance that is available for public comment involves five chapters of what will be multi-chapter guidance designed to help businesses comply with the CGMP and Preventive Controls for Human Food Rule. The draft guidance explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls and includes a discussion about establishing a food safety plan. FDA will release additional chapters of the draft guidance for public comment as they are completed. The agency plans on releasing all chapters of this draft guidance by early 2018.