To better protect our nation’s infrastructure from external threats, President Barack Obama signed the Food Safety Modernization Act (FSMA) into law in January 2011. The FDA, given the authority to better protect public health by strengthening our food safety system, now mandates a system based on science that addresses the hazards from the farm to your table. 

Since 2011, the FDA developed seven final rules that focus on preventing contamination throughout the entire food supply chain. Compliance Dates for these rules vary. The general compliance deadline was September 18, 2016; the small business (less than 500 employees) deadline was September 30, 2017; and the very small business (annual food sales below the applicable limit) deadline was September 18, 2018.

Rule 7, covering mitigation strategies against the intentional adulteration of food, had a compliance deadline of July 26, 2019 for large companies, and has upcoming deadlines of July 27, 2020 and July 26, 2021 for small and very small companies, respectively.

Learn how the LobbyGuard Visitor Management system works

LobbyGuard systems enable comprehensive background screening, full regulatory compliance, and real-time global line of sight to all visitors across a client’s facilities.

Understand FSMA’s Seven Rules to Prepare for Compliance Audits

Is your facility ready for an audit? Audits begin in March 2020 for intentional adulteration compliance.

These audits assess your facility and confirm you are following preventive practices to keep your food safe.  Below, we review the seven rules and talk about how you can ensure your compliance. Not every rule applies to each facility, so it is important to understand the rules themselves and confirm which ones apply to you. Many of the rules have variances and exemptions.


Rule One: Produce Safety

Focused on reducing the risk of contamination of produce, this rule establishes minimum standards to safely grow, harvest, package, and hold fruits and vegetables. This rule puts the responsibility on farmers, who must ensure their produce is protected by testing their water quality; training their employees on required health and hygiene practices; ensuring facilities, equipment, and tools are properly cleaned and sanitized, and more.

Rule Two: Controls for Human Food

FSMA requires food facilities to have a written food safety plan that includes hazard analysis, preventive controls, and management of these controls.

Rule Three: Controls for Animal Food

This rule is like the Controls for Human Food Rule and requires facilities that create animal products to have an animal  food safety plan with hazard analysis, preventive controls, and management of these controls.

Rule Four: Foreign Supplier Verification Programs (FSVP)

This rule was established to ensure foreign suppliers meet the same safety standards as US suppliers. Food importers are required to perform multiple risk-based activities to confirm their food meets FDA requirements, such as evaluating suppliers by looking at their safety history and processes and completing hazard identification and evaluation.

Rule Five: Accredited Third-Party Certification

This rule is a voluntary program to accredit third-party vendors for food safety audits. These accredited auditors can issue certifications to foreign facilities. Certified foreign facilities are eligible for the Voluntary Qualified Importer Program, which accelerates the import process. The FDA may also require certification to verify certain food safety issues.

Rule Six: Transportation of Human and Animal Food

This rule, which applies to shippers, receivers, loaders, and carriers who move both ingredients and finished food products by motor or rail vehicle, is focused on preventing contamination of food during transportation. The rule includes requirements such as maintaining adequate temperature controls during transport.

Rule Seven: Prevention of Intentional Adulteration

This rule requires food manufacturers to assess their facilities, determine how they can reduce the risk of intentional adulteration—that is, the purposeful introduction of substances with the intention of contaminating an ingredient or food product in order to cause widespread economic or physical harm. Generally speaking, the intentional adulteration of food is an attack on the safety of the food supply. The most common culprits are disgruntled employees seeking revenge on their employer or co-workers, food fraudsters seeking some sort of economic gain, or terrorists. After settling on preventive strategies, food manufacturers must implement the strategies and then confirm that their chosen strategies are working.


Are You Fully Prepared for FSMA Compliance?

Becoming FSMA compliant may seem like a daunting task, but with the proper resources, tools, and training, your organization can establish a FSMA-compliant program. Following are a few ways your company can help prepare itself for and achieve compliance.

Develop a Comprehensive Food Safety Plan

Rules Two and Three require food facilities to have a written food safety plan that ensures the safety of food during manufacturing, processing, packing, and holding. Your food safety plan must include hazard analysis, preventive controls, methods to monitor your procedures, corrective action processes, and procedures to verify that your chosen methods are working.  

Ensure Your Team Is Properly Trained

Everyone in your food facility is responsible for preventing foodborne illnesses and contamination. Employ qualified and trained employees to prepare your facility’s food safety plan. Start by establishing roles and assigning tasks for each part of the safety plan’s implementation, verification, validation, and correction. Seek food safety certification for your employees from recognized certification organizations.

Perform a Hazard Analysis

A main component of FSMA compliance is performing a hazard analysis on your facility. An analysis looks at many hazards: biological, chemical, physical, those that may occur naturally or unintentionally, and also those that may be intentionally introduced, including acts of terrorism. Other potential hazards can include residual pesticides, parasites, allergens, and decomposition.

Choose Reliable Preventive Controls & Monitor Their Effectiveness

One of the main steps in preventing foodborne illnesses and being compliant with FMSA is to develop reliable preventive controls and confirm that your controls are working.

Using Technology to Ensure FSMA Compliance

One widely-recognized reliable control that will prove fundamental to both your facility security and food defense is the use of a visitor management system that can track precisely who is accessing your facility and what their intentions are. FSMA requires that you maintain precise details of each and every visitorLobbyGuard Visitor Management systems are user-friendly, scalable solutions that integrate seamlessly with your existing data network and give your company complete, real-time line of sight to every visitor to your facility. LobbyGuard systems identify your visitors by scanning a photo ID; perform background checks by screening the person against various databases including banned lists and locally customized green-light/red-light lists; notify your employee escort of the visitor’s arrival; print an official temporary visitor badge that includes key authorization information; and automatically create a complete, permanent record of the visit. Records are easily accessed for on-demand reports for to ensure both FSMA compliance and FDA audit readiness, For more information on LobbyGuard Visitor Management solutions, call 866-905-6229 or contact [email protected]

Learn how the LobbyGuard Visitor Management system works

LobbyGuard systems enable comprehensive background screening, full regulatory compliance, and real-time global line of sight to all visitors across a client’s facilities.