FSMA Deadlines Loom— And Some May Not Be Ready

It’s been over a year now since the publication of the first rules under FSMA (the Food Safety Modernization Act) by the U.S. FDA, and the industry has been discussing these game-changing regulations since well before their release. The first compliance dates, for the largest companies within the food industry, have already passed; this calendar year several more will pass.

…we find cause for concern as we observe some members of the food industry who may not be aware of the need to comply

The members of our team have watched and assisted with many companies’ plans as they worked to update their programs in order to meet these requirements, and in many cases the results we’ve observed have been excellent. We’re proud to work with so many outstanding members of the industry. Yet at the same time we find cause for concern as we observe some members of the food industry who may not be aware of the need to comply, or may not realize how close the compliance dates for their company are. As a result, we wanted distribute an update for our readers to ensure they have the information they need.

Below is an overview of the compliance dates for the various rules that have been issued by the FDA under FSMA. You’ll note that dates which the FDA refers to as “compliance dates” are, in effect, deadlines after which companies are expected to comply. We strongly recommend that companies start preparing now, if they have not done so already. It’s also important to note that the best first step to take is to be informed about what the rules require. For both the Preventive Controls rule and the Produce Safety rule, there are specific required training that has been approved by the FDA.

We can offer training on any of the rules you see below, whether you’re only looking for an hour of training, or something longer. Below are some webinars we will be offering later this spring you can sign up for. Also, one of the best opportunities you’ll find to get an update on these new requirements as well as other topics is at Safe Food California, our annual conference, which will be held this year on June 6th–8th in beautiful Monterey, CA. Check out the agenda— and join us there!

Upcoming Webinars

  • (Free!) FSMA Deadlines Update, and Q&A Session— May 5th
  • Produce Safety rule— May 19th
  • Foreign Supplier Verification and Sanitary Transportation Rules— May 26th

Safe Food Alliance is happy to play a role in assisting your company— whether you need training, consulting, an audit to verify or evaluate your existing programs, or if you just want to ask a question that’s got you stumped. You can subscribe to our newsletter for consistent updates or contact us with any specific questions.

Summary of Deadlines

Please consult the complete regulation for full details!

Preventive Controls Rule – Companies Which Manufacture, Process, Pack, or Hold Human Food

Company Size Compliance Date
>500 Employees Sept. 2016
<500 Employees Sept. 2017
< $1 Million sold or held Sept. 2018

Notes

For some companies which solely handle raw agricultural commodities (RACs), compliance dates have been extended to match the Produce Safety rule. Additionally, certain types of companies may have an exemption from the rule. These must be documented.

Foreign Supplier Verification Rule – Importers of Human Food, Including Brokers and Distributors

Company Type Compliance Date
Importers under Preventive Controls rule Refer to PC rule supply chain requirements (see table 54)
Importers buying RACs from a farm 6 months after supplier’s compliance date
Importers buying from companies under the Preventive Controls rule 6 months after supplier’s compliance date
All others 18 months after publication (May 2017)

Notes

This rule has heavy emphasis on documentation and records. Some extensions apply to specific things, including import of food-contact packaging.

Produce Safety Rule – Farms, including Nuts, Fruit, and other Produce

Company Size Main Compliance Date Water Analysis Compliance Date
<$250,000 January 2020 January 2022
<$500,000 January 2019 January 2021
All others January 2018 January 2020

Notes

Some exemptions may apply, and require certain documentation.

Sanitary Transportation Rule – Transport of Human and Animal Feed

Company Size Compliance Date
<500 employees or <$27.5 Million in annual receipts April 2018
All others April 2017

Notes

Certain exclusions apply, such as transport of RACs by a farm, and shelf-stable items which are fully enclosed in packaging.

Intentional Adulteration Rule – Facility Security Measures

Company Size Compliance Date
<$10 Million Processed, Packed, or Held without sale July 2021
<500 Employees July 2020
All Others July 2019

Notes

Applies primarily to facilities which manufacture, process, pack, or hold food. Supply chain risk is addressed under other rules.