FSMA Rules – Round Two

Signed into law in 2011, the Food Safety of Modernization Act (FSMA) is the most sweeping change to the way food safety is regulated in the U.S. since the adoption of the Food Drug and Cosmetic act itself in 1938. Due to the sheer size and magnitude of this legislation, the FDA is taking time to get the rules correct.

Many of us in the food safety industry had been asking when we would see the next round of FSMA rules. Originally, the FDA had planned to issue the next round of rules in early summer 2014, but the deadlines were again extended. Finally, on September 19, the FDA issued four supplemental proposed rules:

  • Proposed Supplemental Rule for Produce Safety
  • Proposed Supplemental Rule for Preventive Controls for Human Food
  • Proposed Supplemental Rule for Preventive Controls for Animal Food
  • Proposed Supplemental Rule for Foreign Supplier Verification Programs (FSVP)

The proposed supplemental rules were issued to address specific concerns raised in comments that the FDA received in response to the original proposed rules. They do not replace the original proposed rules.

While it is impossible to determine the exact dates when the final proposed rules will be issued, we do know that there are court-mandated deadlines for the FDA to release the final proposed rules. These dates are as follows:

  • August 30, 2015 – Preventive Controls rules – both the human food and the animal food rules
  • October 31, 2015 – Produce Safety, Foreign Supplier Verification Program, Accreditation of Third-party Auditors
  • March 31, 2016 – Sanitary Transport
  • May 31, 2016 – Intentional Adulteration/Food Defense

While we wait for the final rules, there are some things you can – and should – be doing.

Be Prepared

First, make sure you are prepared by utilizing the proposed rules that have already been published. While the specific details of each final rule are still unknown, the proposed rules provide a solid direction and basis of the requirements. Most likely, your customers will begin holding you to the standards of the proposed rules before the FDA finalizes and enforces the final rules.

Focus on Minimizing Risk

Second, begin building a good case around how your company is considering potential hazards, as well as the programs you are implementing to minimize risk. It is already determined that the FSMA rules will require more testing, however, the programs and controls companies use to verify testing is also an important component.

Get Your Comments In

Lastly, let the FDA know what you think of this second round of proposed supplemental rules. You have been given until December 15, 2014 to comment, so take the opportunity to influence the final outcome.

For more information and updates on FSMA, visit their website.