FSMA — The 7 Rules

This is an online informational session on the seven FSMA Rules. The session is intended to introduce and clarify what FSMA entails. Because sections were abbreviated for these presentations, the information provided is only an overview and should not be relied upon as a substitute for reading the final rule, or obtaining legal advice, or as a summary of all regulatory requirements. Every company must conduct its own detailed review of the final rule. No certificates of completion will be issued after reading these modules.

The modules below briefly give a background of the law and cover some of the highlights of the final rules in six modules (Module II covers two rules):

Module I. Produce Safety

As of January 26, 2018, larger farms must comply with the FSMA Produce Safety Rule that establishes science-based standards for the growing, harvesting, packing, and holding of fruits and vegetables for human consumption. Compliance dates are staggered based on farm size, with small farms complying by 2019 and very small farms in 2020.

Dr. Samir Assar, Director of CFSAN Division of Produce Safety, explained in a conversation what is occurring and what may be expected to occur, including enforcement discretion, the On Farm Readiness Review, Produce Safety Network, the Produce International Partnership, and others.

Guidance for Industry: Policy Regarding Certain Entities Subject to GMP, Preventive Controls, Produce Safety, and FSVP

Module II (2 rules). cGMP and Preventive Controls for Human Food

Guidance for Industry: Policy Regarding Certain Entities Subject to GMP, Preventive Controls, Produce Safety, and FSVP

You may access a public version  of the Participant Manual used in the Preventive Controls for Human Food course.

Module III. Foreign Supplier Verification Program (FSVP)

What do importers need to know? Q&A

What do manufacturers/processors covered by the Preventive Control Supply-Chain need to know about FSVP? By FDA

Compliance Dates for the Final Rule on FSVP for Importers of Food for Humans and Animals

As of August 20, 2019, the FDA has listed 143 companies as FSVP Importers in Hawaii. If you are listed, the FDA may pay you a visit for FSVP Compliance. The FDA will update the list quarterly.

Guidance for Industry: Compliance with Providing An Acceptable Unique Facility Identifier for the FSVP regulations

Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the FSVP regulation

The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program that offers an expedited review and import entry of human and animal foods for participating importers. There are eligibility criteria and an annual user fee for eligible importers. The FDA published a list of importers subject to the FSVP regulation. The list identifies FSVP importers that may not be the same as the “importers of record.”

FSMA Final Rule: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What you Need to Know About the FDA Regulation; Small Entity Compliance Guide

Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR 112 or the Preventive Controls Requirements in part 117 or 507

Guidance for Industry: Policy Regarding Certain Entities Subject to GMP, Preventive Controls, Produce Safety, and FSVP

Draft Guidance: Chapter 15: Supply-Chain Program for Human Food Products

Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities

To help FSVP Importers identify FSVP records that they should develop and maintain to meet FSVP regulations, the U.S. FDA published a list of required records.

Module IV. Accredited Third-Party Certification Program

The Accredited Third-Party Certification is a voluntary program that FDA uses to recognize accreditation bodies that will accredit certification bodies that, in turn, will conduct food safety audits and issue certifications of foreign food facilities. Key Facts about the Accredited Third-Party Certification Program and a public registry of recognized accreditation bodies are posted on the FDA website. Accreditation bodies are recognized under the program for 5 years as authorities to accredit certification bodies that my conduct food safety audits pertaining to the following regulations: Current Good Manufacturing Practice (GMP), Hazard Analysis and Risk Based Preventive Controls for Human Food and Current GMP, and Hazard Analysis and Risk Based Preventive Controls for Animal Food.  A registry of the accredited third-party certification bodies is also on the FDA website.

These certifications may be used by foreign food facilities (1) to establish their eligibility for participation in the fee-based Voluntary Qualified Importer Program (VQIP) that offers expedited review and entry of food into the U.S. Simplistically, VQIP is similar to the TSA Precheck program. FDA consumer safety officers Doriliz De Leon and Amelia Tetterton explain the benefits of the VQIP.

“In rare and specific circumstances,” the certifications may also be used (2) to provide documentation to the FDA that the food entering the U.S. offers the same level of public health protection as those required of U.S. foods.

Module V. Sanitary Transportation of Human and Animal Food

The U.S. FDA free online training course for carriers was published on September 21, 2017 and is available for immediate use.

Waivers from Requirements of the Sanitary Transportation of Human and Animal Food Rule were also published.

Guidance for Industry: Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation. Small Entity Compliance Guide

Module VI. Intentional Adulteration

The final FDA food defense regulation to prevent intentional adulteration of the food supply was released on May 26, 2016. Domestic and foreign food facilities registered with the U.S. FDA are required to complete and maintain a written food defense plan. Mitigation strategies need to be identified, monitoring and corrective actions established, evaluations conducted to demonstrate that the system is working, personnel appropriately trained, and records maintained.

The Food Defense 101 course, updated by the FDA in partnership with the Food Safety Preventive Controls Alliance (FSPCA) Intentional Adulteration Subcommittee, is available for awareness training in food defense. It is recommended that food industry managers use the course for their front-line employees.

Compliance Dates

For compliance dates, please consult the FSPCA reference sheets in English and in Spanish.

Food Facility Registration

As part of FSMA implementation, the Food Facility Registration  rule was finalized on July 14, 2016.  A summary of the requirements is included. FDA also issued a Guidance for small entities on what to know about this regulation, with steps on how to register.

Please consult Upcoming Events on the right hand margin of this website for scheduled courses.