Sorting through the FDA Food Safety Modernization Act (FSMA) Final Rules can be a time consuming and confusing task. We’ve put together our FSMA Resource page to help you understand the legal and regulatory complexities of FSMA while alleviating some of the pain points our stakeholders are struggling with regarding implementation and execution.
FDA has issued a new draft guidance to make it easier for companies to determine if they fit the small business definition of Food Safety Modernization Act’s (FSMA) Preventive Controls (PC) rules for human and animal foods.
As of January 13th, 2017, the Food and Drug Administration (FDA) announced the availability of a revised draft guidance entitled “Control of Listeria monocytogenes in Ready-To-Eat Foods.”The revised draft guidance is intended for any person who is subject to the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and who manufactures, processes, packs, or holds ready-to-eat (RTE) foods. The revised draft guidance is intended to help these entities comply with the requirements of the final regulation with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes.
Consuming safe food is a basic human right we all have and being in the food safety industry gives us all the opportunity to contribute to the strengthening of food safety requirements. According to the FDA, the “Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years…” We at SQFI realize the importance of this reform and have taken the necessary steps to create additional resources that will assist our stakeholders strengthen their food safety programs and meet the robust requirements of the FSMA PC rule. In response to FSMA, SQFI has developed a voluntary Preventive Controls audit checklist and guidance document for stakeholders to use as a guide for identifying the necessary steps to bridge any gaps between a company’s SQF Program and the PC rule.
It is important to note, however, that using these documents does not guarantee compliance – nor does it absolve the supplier from ensuring that they meet all aspects of the FSMA Preventive Controls Rule for Human Food. While this checklist is voluntary and will not be scored, it is a valuable tool to help suppliers identify and understand any differences between the SQF Program and the PC rule. We will be having a webinar to go over these documents and how to implement them on September 27, 2016. Check www.sqfi.com/events for more details and to register.
In addition to the PC checklist, SQFI contracted The Acheson Group (TAG) to compare the elements of SQF Level 2 Certification (specifically Modules 2 and 11) to the FDA FSMA Final Rule requirements. The analysis examined the two major aspects of the Final Rule: the new preventive controls requirements that industry must comply with in order to implement the requirements of Section 103 of FSMA, and the updated current Good Manufacturing Practices (cGMPs) (current 21 C.F.R. Part 110 now re-designated as Part 117).
As the food industry looks to protect consumers, customers, and their brand as well as successfully be in compliant with the final new rules, TAG’s analysis indicates that being SQF Level 2 certified is a very robust, strong advantage to fulfilling FSMA requirements.
FSMA Final Preventive Control for Human Food Rule-Comparison with FMI Positions and Supplemental Proposed and Proposed Rules – Click here to see the comparison.
Recognizing the suspected parallels between GFSI and the Produce Safety Rule, questions related to the comparability of these requirements and the practices and processes already in place on farms and packing houses certified to a GFSI benchmarked scheme have understandably arisen. As a result, SQF contracted with The Acheson Group, LLC (TAG) to compare the elements of SQF Level 2 (specifically Module 7) to the FDA Final Produce Safety Rule. Further SQF understands that produce growers and packinghouses have historically followed Good Agricultural Practices guidance to control food safety risks on the farm. As such, our analysis examined two major requirements as they relate to the produce industry: the Produce Safety Rule that industry must comply with in order to implement the requirements of Section 105 of FSMA. Click here to read the analysis and learn more.
In response to FSMA, SQFI has developed a voluntary Produce Safety Rule audit checklist and guidance document for stakeholders to use as a guide for identifying the necessary steps to bridge any gaps between a company’s SQF Program and the Produce rule.
Please click here to read some notes of clarification for questions regarding FDA’s Sanitary Transportation waivers released the week of April 3, 2017.
As of May 11th, the FDA has released a constituent update on FSVP.
The U.S. Food and Drug Administration has updated FDA.gov to include updated fact sheets, and new guidance as a resource for importers subject to the FSVP rule, which makes them responsible for verifying that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.
Fact Chart: Am I Subject to FSVP?
Accredited Third-Party Certification Rule: More information coming soon!
The FDA has provided factsheets and flowcharts on the FSMA webpage for each rule. These documents are an entry point to understanding who is covered under each rule.