Food Defense

What is the background on the FSMA?

March 25, 2024 | 3 Min Read

According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the U.S. get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means 1 in 6 people in the U.S. get sick from contaminated food every 12 months. These statistics are important to take note of and address since the U.S. food supply also represents a huge economic asset, contributing almost $1 trillion to the national gross domestic product (GDP) each year.

Manufacturers have an important role to play in preventing foodborne illnesses through responsibilities outlined in the 2011 Food Safety Modernization Act (FSMA). The act overhauled regulations regarding food production and gave the Food and Drug Administration (FDA) more authority to oversee and enforce supply chains. The FSMA shifts the focus from responding to foodborne illnesses to preventing them and affects almost every business that must register with the FDA.

The FSMA was passed by Congress in December 2010 and signed into law by President Obama on January 4, 2011. However, it took the FDA several years to finalize what the FSMA regulations would look like in practice, which did not occur until 2015.

Compliance dates vary depending on the safety rule in question and the size of the operation. In a nutshell, large companies with more than 500 employees needed to achieve compliance in 2016, while small business with fewer than 500 employees were due in 2017. Very small businesses are defined by different sales thresholds depending on the rule, but most compliance dates for them were in 2018.

Ensuring that your traceability actions are proactive, not reactive, is critical to securing the movement of food materials in the supply chain. To effectively implement both of these requirements, you must have a dynamic system in place to ensure that the bulk ingredients unloaded at your facility were not adulterated in transit. The FDA is clear in FD.4 that it is the food production facility, not the carrier, that must take mitigation steps necessary to protect the cargo during transit.

Surelock Seals provides that system. We are your Out of The Box solution for food traceability and security, offering both handheld and stationary RFID reader options to fit your budget. Our RFID seals are attached to the trailer hatches after the bulk ingredient is loaded, and if tampered with in transit, they will be permanently destroyed, informing you of possible adulteration.

If you have questions regarding food traceability or the FSMA, check out this previous article on those topics.

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