Agricultural Law in the Spotlight – FSMA Regulatory Update

Written by M. Sean High—Staff Attorney

On January 17, 2017, the Center for Agricultural and Shale Law posted two new Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) guidance documents on the Center’s FSMA Library Guide.

The first document posted is entitled Guidance for Industry and FDA Staff: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.  The resource contains nonbinding recommendations regarding FDA’s “voluntary program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.”  According to FDA, “[t]hese requirements will help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program.”

The second document posted is entitled Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods.  According to FDA, the draft guidance is intended for those subject to regulation 21 CFR part 117, entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and for those “who manufacture, process, pack, or hold ready-to-eat (RTE) foods.” The document is not for implementation and is being distributed for comment purposes only. 

According to FDA the “guidance is not directed to processors of RTE foods that receive a listericidal control measure applied to the food in the final package, or applied to the food just prior to packaging in a system that adequately shields the product and food contact surfaces of the packaging from contamination from the food processing environment.” FDA stated that “the guidance also is not intended for food establishments that are not subject to part 117, such as farms.” 

The Center for Agricultural and Shale Law's FSMA Library Guide is intended to represent a collection of legal resources relating to FSMA and FDA food and safety regulations.  To view the FSMA Library Guide, please click here.