Jay Sjerven

After years of discussion, notice and preparation, the first two of seven rules establishing a new national risk-based food safety system as required under the Food Safety Modernization Act (FSMA) will be in force this month. Companies that manufacture food for human consumption, except for small and very small businesses, must be in compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule by Sept. 19. And animal food companies, other than small and very small businesses, must be in compliance with Current Good Manufacturing Practices (C.G.M.P.s) component of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule by Sept. 19, and with rule’s preventive control component by Sept. 18, 2017.

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule requires food facilities manufacturers to establish and implement a food safety regimen, including a written food safety plan, hazard analysis, preventive controls, monitoring, corrective 
actions and corrections, verification, a supply-chain program, a recall plan and associated recordkeeping.

This final rule was published in the Sept. 17, 2015, Federal Register. It has been the subject of scores of discussions, consultations and webinars held by food manufacturer associations and other stakeholders, and it was expected most if not all large companies are or shall be in compliance by Sept. 19. The compliance date for small food manufacturers is Sept. 18, 2017, and the compliance date for very small food manufacturers is Sept. 17, 2018.

While the F.D.A. asserted the major provisions of the FSMA rules taking effect this month are unchanged and will be implemented as planned, it issued a final rule published in the Federal Register on Aug. 24 that extends and clarifies the compliance dates for certain provisions in those two rules and in two other rules — Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. The latter two FSMA rules have compliance dates beginning in 2017.

Implementing FSMA
The law goes into effect Sept. 19 for some food and beverage companies.

The F.D.A. commented, “These changes are part of the F.D.A.’s continuing efforts to make the rules as practical as possible while still protecting public health. The final rule addresses technical issues and better aligns compliance dates across the four rules.”

One of the changes contained in the new final rule relates to compliance dates for “certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain.” This change applies to all four of the affected FSMA rules.

Each of the four FSMA rules have “customer provisions” that apply when a manufacturer/processor identifies a hazard requiring a preventive control but itself does not control the identified hazard and instead relies on an entity in its distribution chain to address the hazard.

The F.D.A. noted it met with representatives of the Grocery Manufacturers Association in March 2016 to discuss the “customer provisions.” The F.D.A. commented, “The G.M.A. provided examples of product distribution chains that would require vastly more written assurances and consequently resources to comply with the requirement than anticipated by F.D.A.” The F.D.A. added, “After considering the information presented by G.M.A., F.D.A. believes that the requirement for written assurances in the customer provisions (of part 117 of the human food rule) significantly exceeds the current practices of even the largest facilities; compliance by those facilities by Sept. 19, 2016, may not be feasible.” The F.D.A. concluded it was appropriate to extend the compliance date for the written assurance requirements under the customer provisions of the human food rule, and under the other rules as well, while the agency “considers the best approach to address feasibility concerns.”

This means the new compliance date for the provisions requiring written assurances in the customer provisions of the human food rule is moved from Sept. 16, 2016, for large food manufacturers to Sept. 19, 2018.

Another change related to the FSMA human food rule is an extension of compliance dates for certain provisions for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities 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.

In addition to the new final rule outlining the extended compliance dates for the specified provisions of the four affected FSMA final rules, the F.D.A. on Aug. 24 made available for public comment a draft guidance document that involves five chapters of what will be a multi-chapter guidance designed to help businesses comply with the C.G.M.P. and Preventive Controls for Human Food rule. The draft guidance explains the F.D.A.’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.

The F.D.A. said it 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.