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Introduction to the Food Safety Modernization Act (FSMA)

Updated: Jul 9, 2020

By Ashley Ellixson

Green field (Photo by Edwin Remsberg).

The Center for Disease Control and Prevention (CDC) estimated in 2011 that 48 million people (or 1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year of foodborne diseases. While these are startling numbers, this is a largely preventable issue according to the Food and Drug Administration (FDA). As a result of this issue, Congress passed the Food Safety Modernization Act (FSMA) in December 2010.

Pumpkins and squash sold at a market (Photo by Edwin Remsberg).

What is FSMA? In short, it is legislation amending the Food, Drug and Cosmetic Act (FDCA) and giving FDA the authority to mandate preventive-based controls across the food supply chain. Not only does this include U.S. food facilities but a greater oversight of the millions of food products entering the United States from other countries every year as well.

Today I will briefly go over the major elements of FSMA and over the next few weeks, dive further into each topic in order to shed some light on each element. Please feel free to email me at on areas that you would like to see further discussion.

The major elements of the FSMA can be separated into five key areas:

  1. Preventive Controls

    1. With the FSMA, FDA now has the legislative mandate to put in place preventive measures to ensure a safe food supply.

  2. Inspection and Compliance

    1. “The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food; thus, the law specifies how often FDA should inspect food producers. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches” (FDA).

  3. Imported Food Safety

    1. FDA has new tools to safeguard that imported foods meet U.S. standards and are safe for U.S. consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety. FDA will be able to verify qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards. (FDA)

  4. Response

    1. FDA will have mandatory recall authority for all food products as a result of the FMSA. According to FDA, it does not expect to use this authority often since the food industry largely honors its requests for voluntary recalls. (FDA)

  5. Enhanced Partnerships

    1. Since the FSMA guides FDA to improve training of state, local, territorial, and tribal food safety officials, a strengthening collaboration among all food safety agencies is expected to improve in order to achieve the legislations health goals. (FDA)

Squash in a box (Photo by Edwin Remsberg).

In the next blog post I will discuss in more detail which entities are affected by the FSMA. On a side note, the comment period for the Draft Environmental Impact Statement ends March 13, 2015. The Draft Environmental Impact Statement “assesses the environmental (including human) and related socioeconomic impacts for those provisions that FDA has determined may significantly affect the quality of the human environment (hereinafter referred to as ‘potentially significant provisions’), and alternatives to those provisions. It also assesses the No Action Alternative, which is made up of baseline agricultural practices, regulations, and industry programs, as well as background environmental conditions” (FDA EIS).

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