Two extension agents examine corn crop in the field
Updated: March 30, 2021

Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA) is sweeping legislation designed to protect the American public by focusing on preventing illness rather than responding to outbreaks after people are already sick. The Act was passed in 2010.

FSMS amends the Food, Drug and Cosmetic Act (FDCA) and gives FDA the authority to mandate preventive-based controls across the food supply chain.  Not only does this include U.S. food facilities  but also provides for  a greater oversight of the millions of food products entering the United States from other countries every year as well.

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

1) Preventive Controls

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

“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

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

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

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)

Preventive Rule

For most producers the most applicable section of FSMA is the Preventive Controls (aka Preventive Rule). Determining whether the Preventive Rule applies to you is based on whether you qualify as a “facility” or “farm” as its defined by FDA.  If you are a “facility” you must register with the FDA and will be subject to the proposed Preventive Rule.  A “facility” is defined as “any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States.”(21 CFR 1 § 227(b)(2)).  If you are a “farm” or retail food establishment you generally are not subject to the Preventive Rule.  For example, farmers’ markets, community supported agriculture programs (CSA), and other direct-to-consumer sale structures come under the definition of retail food establishment and are not subject to the Preventive Rule. 

As noted above, the Preventive Rule is split into two main parts and because of this, coverage under these two parts must be determined separately since certain facilities may be subject to one and not the other. 

1) Requirements For Hazard Analysis and Risk-Based Preventive Controls (HARPC)

2) Good Manufacturing Practice (GMP) Requirements. In reference to the GMPs, if you operate a facility you are generally subject to the requirements.  The only facilities FDA has excluded from GMPs are warehouses and grain elevators that store raw agricultural commodities intended for further processing. This includes both fruits and vegetables.

For further information on the Preventive Rule, visit the FDA website.

For Producers and Processors, Start Here:

The summary of requirements presented here is for reference only and may not be inclusive of a processor’s full responsibilities.

  • Do you grow, harvest, pack, or hold (store) fruits or vegetables? If yes, you may be affected by the Produce Rule.
  • Do you process, manufacture, pack, or hold (store) human food? If yes, you may be affected by the Preventive Controls Rule.
  • Do you BOTH grow, harvest, pack, or hold (store) fruits or vegetables AND process, manufacture, pack, or hold (store) human food? If yes, you may be affected by BOTH the Produce Rule and the Preventive Controls Rule.
  • Are you a food hub, CSA farm, on-farm processor, or direct marketer? We also have special guidance available for these operations.

Download the National Sustainable Agriculture Coalition “Am I Affected?” flowchart to help determine if your business may be subject to the proposed Produce or Preventive Controls Rules!

Produce Rule – Are You Affected?

Farms are likely to fall into one of four categories: 1) exempt from the Produce Rule, 2) subject to less extensive modified requirements under the Produce Rule, 3) subject to full requirements of the Produce Rule but with extended time to come into compliance, or 4) subject to full requirements of the Produce Rule without extended compliance time.