Regulatory Compliance

Introduction to Regulatory Compliance

Maintaining regulatory compliance of 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.

News and Updates

FDA Update – March 20, 2018:
FDA has issued a new draft guidance to make it easier for companies to determine if they fit the small business definition of Food Safety Modernization Act’s (FSMA) Preventive Controls (PC) rules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.
You can review the draft document, here:

FDA Update – January 13, 2017:

As of January 13th, 2017, the Food and Drug Administration (FDA) announced the availability of a revised draft guidance entitled “Control of Listeria monocytogenes in Ready-To-Eat Foods.” The revised draft guidance is intended for any person who is subject to the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and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 The revised draft guidance is intended to help these entities comply with the requirements of the final regulation with respect to measures that can significantly minimize or prevent the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.

Preventive Controls for Human Food Rule


Consuming safe food is a basic human right and being in the food safety industry grants the opportunity to contribute to the strengthening of food safety requirements for all. 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. Click here to read the executive summary

In March, 2018, GFSI and the GFSI Certification Program Owners (CPO’s) worked with the Acheson Group (TAG) to provide an up-to-date comparison of the current versions of their program against the FSMA Human Foods Preventive Control Rule (HFPCR). SQFI released the SQF Code, edition 8 in March, 2017 and all audits after January 2, 2018 are required to use edition 8. Changes to edition 8 were based off the release of the GFSI requirements document, version 7.1, FSMA requirements as well as other food safety enhancements and stakeholder feedback.

Changes include a stand-alone

  • Quality Code,
  • added requirements for food fraud,
  • strengthened allergen programs and
  • stronger supply chain controls.

A summary of changes in edition 8 can be found here

In the 2015 comparison study that TAG conducted against the SQF Code, edition 7 and the draft FSMA requirements showed good alignment of V7 and FSMA. View the comparison study here. The results of this more recent comparative analysis indicate that the SQF Program is more closely aligned with both GFSI and FSMA requirements. The study states, “The SQF Program continues to be highly comparable to FSMA and SQF certified sites can be confident that they have a solid foundation in place for compliance to the FSMA Human Food Rule.”

Click here to read the entire analysis

Product Safety Rule

SQFI has lead the way in keeping pace with the changing regulatory requirements of the US Food Safety Modernization Act and how it compares with The SQF Program, which focuses on food safety.

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 Program 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.

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

The U.S. Food and Drug Administration has updated 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.

Resources, Links and FDA Fact Sheets