News Feature | January 21, 2015

2015: The Year Of FDA Food Regulations

Sam Lewis

By Sam Lewis

2015 FDA Food Regulations

The FDA’s long-awaited, food-safety rules are under court order to be published this year. Here is what to expect from the agency as 2015 progresses.

The FDA faces a court-mandated order to publish three final rules of the Food Safety Modernization Act (FSMA). These three rules are among nearly 50 others that the FDA is scheduled to execute this year according to “Current Regulatory Plan and the Unified Agenda of Regulatory and Deregulatory Actions.” The agency has already published proposed rules regarding produce safety, foreign supplier verification, and preventive controls for human food. These three proposals garnered public comments counting it the thousands.

Related: What To Expect From The FDA & FSMA In 2015

The FDA responded to those rules with published revisions to the produce rule and allowed additional comments through December 15, 2014. From there, deadlines were set by federal court for final versions of the rules to be published. According to Michael Taylor, deputy director of food for FDA, the deadlines of final rules will be met.

Below are the court-ordered deadlines for five of FSMA’s rules:

  • Preventive Controls For Human Food — August 30, 2015
  • Preventive Controls For Animal Food — August 30, 2015
  • Produce Safety — October 31, 2015
  • Foreign Supplier Verification — October 31, 2015
  • Third-Party Accreditation — October 31, 2015

The rules to be published this year cover five of seven of FSMA’s pillars. The remaining two rules — Sanitary Transport and Intentional Adulteration of food — will be published in finality in March and May of 2016.

Related: Preventing The Intentional Adulteration Of Food—It’s More Than Food Defense

In addition to the mentioned rules, the FDA will be updating its food-facility registration requirements. These revisions will be in March. According to the rule’s official description, “This rule would amend FDA’s regulation for food-facility registration, including by requiring that food facilities submit registrations in an electronic format beginning in 2016, and by codifying the requirement that facilities renew their registrations with FDA every two years.” The description continues, “In addition, the rule would amend the definition of ‘retail food establishment,’ and would also require certain, additional information be submitted as part of food-facility registration.”

Finally, the FDA will need to address the rule regarding its procedures to determine which foods are generally recognized as safe (GRAS). Currently, there is a pending court order that would push the FDA to have a final rule for GRAS protocol in place by August, 2016.