On August 31, 2015, the U.S. Food and Drug Administration (FDA) announced it had submitted final versions of two of the long-awaited Food Safety Modernization Act (FSMA) regulations. The two regulations that have been finalized are:

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; and

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Animals

These two final regulations, commonly referred to as Preventative Control Rules for Human and Animal Food, are the central two pillars of FSMA. FDA announced last week that each has been submitted to the Federal Register for publication. Its announcement also cautioned that, “Documents submitted to the Federal Register can publish several days after they are submitted, with larger documents taking longer to process and display.” As of the writing of this article (September 8, 2015), the Federal Register had not yet processed and published these rules. The Federal Register website states that “This document [Human Food Rule] is unpublished, but on 09/17/2015 it is scheduled to be published and available on this page. Until then, you can download the pre-publication PDF version.”  

The date of submission of the two preventative control rules was in compliance with court-ordered deadlines. FSMA was signed into law by President Barack Obama on January 4, 2011. Following extensive delays, FDA found itself defending a lawsuit brought by the Center for Food Safety and the Center for Environmental Health. These consumer groups demanded that FDA issue the regulations required to implement the new food safety laws found in FSMA. After losing before the trial court, the FDA ultimately entered into a consent decree which set forth the following deadlines for issuing final regulations:

• Preventive Controls for Human Food by August 30, 2015

• Preventive Controls for Animal Food by August 30, 2015

• Produce Safety Standards by October 31, 2015

• Foreign Supplier Verification Program by October 31, 2015

• Accreditation of Third-Party Auditors by October 31, 2015

• Sanitary Transportation of Food by March 31, 2016

• Intentional Adulteration/Food Defense by May 31, 2016

Assuming continued compliance with this court-ordered schedule, FDA will have issued what it refers to as its seven primary pillars of food safety by spring of 2016. Other less central FSMA regulations have been and will continue to be published.

Following publication of each of these regulations, FDA will provide guidance documents. While not having the effect of law, a guidance represents FDA’s current thinking and interpretations of a particular regulation. In this instance, FDA has promised to publish guidance documents with recommendations for implementation of the new food safety laws. In the announcement on August 31, 2015, regarding the Preventive Control Rules, FDA stated, “The FDA is committed to sharing information about the final rules and how food facilities can comply as soon as we are able to do so. Please check back here for updates, which the agency will share as soon as the final rules are available via the Federal Register.”

Kathy Hardee, Esq., is co-chair of the Food & Agriculture Industry Group at Polsinelli, PC, which is composed of a team of attorneys from every legal practice area and who each have a focused background in the food industry.