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Seven Major FSMA Rules Now Final

June 1, 2016

Florida oranges picked and waiting to be shipped across the country. Photo credit: National Archives and Records Administration.

Florida oranges picked and waiting to be shipped across the country. Photo credit: National Archives and Records Administration.

The U.S. Food and Drug Administration (FDA) has recently finalized two of the remaining major rules required by the Food Safety Modernization Act (FSMA): one governing shippers, carriers, and any other entity involved in transporting food (the “Transport Rule”), and another overseeing intentional acts of adulteration in the food supply (the “Intentional Adulteration Rule”). These rules establish new, prevention-oriented requirements for points across the entire supply chain, and are the last of seven major rules (the previously finalized rules were for produce farms, facilities that process animal feed and human food, and imported food) FDA is expected to finalize under FSMA.

Sanitary Transport of Human and Animal Food Rule

The Transport Rule governs shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food. The rule requires said entities to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated (i.e., contaminated or unfit for human consumption).

NSAC provided narrow comments on this rule, primarily focused on avoiding the unintended regulation of farms and mitigating the burden on small food enterprises – particularly those selling through direct market channels.

The final Transport Rule applies only to the “transportation operations” of carriers, shippers, loaders, and receivers. These operations include activities associated with transportation that may affect the sanitary condition of food including cleaning, inspecting, maintaining, loading and unloading, and operating vehicles and transportation equipment.

Exemptions for Farms, Small Businesses

All transportation activities performed by a farm are exempt from the definition of “transportation operation”. The definition of “farm” under the Transport Rule is the same as the definition under the Produce and Preventive Controls Rule. Therefore, if your operation satisfies FDA’s definition of “farm”, this rule does not apply to your transportation activities, even if you’re serving in the role of shipper, loader, carrier, or receiver.

However, you may be subject to the Produce Rule provisions for growing and packing your produce, or to the Preventive Controls Rule if you’re doing value-added processing on your farm. Additionally, existing law would still hold a farm responsible for putting adulterated (contaminated) food into commerce, or holding food under unsanitary conditions that could result in adulteration, regardless of whether it is technically covered under the new FSMA rules.

Shippers, receivers, or carriers with less than $500,000 in average annual sales (calculated on a rolling three-year basis and adjusted for inflation) are considered “non-covered businesses” and are exempt from this rule.

Waivers for Food Establishments

Food establishments – when acting either as receivers, or as shippers or carriers in operations where food is transported from the establishment direct to the consumer – are eligible for a waiver from the requirements under the Transport Rule. The rule contains a process whereby such a business can request a waiver, and FDA will be providing additional information regarding the process soon.


For businesses that are subject to the rule, the requirements touch on four main areas: vehicles and equipment; transportation operations (e.g. temperature controls); training; and records. You can learn more via FDA’s website, including additional information on exemptions and waivers.

Mitigation Strategies to Protect Food Against Intentional Adulteration

The Intentional Adulteration Rule seeks to protect against intentional acts to harm the public through the food supply, including acts of terrorism. Covered facilities are required to include (and implement) a food defense plan as part of their overall food safety plan, which includes a vulnerability assessment and mitigation strategies.

This rule only applies to certain food facilities registered with the FDA. Given its scope, it is targeted toward the largest companies with the greatest distribution, and there are many exemptions.

“Very small businesses”, defined under this rule as those with less than $10 million in human food sales per year (averaged over three years and adjusted for inflation), are exempt. The rule also does not apply to farms, or to “farm mixed-type facilities” doing low-risk processing.

For information on exemptions from the rule and on requirements for covered facilities, including compliance timelines, visit FDA’s webpage.

Now What?

Now that FDA has finalized the major FSMA rules within the judicially-imposed deadlines, the work turns in earnest toward implementation. Part of the implementation process involves the issuance of guidance documents that interpret particular provisions of the rules. FDA is currently in the process of drafting many of these guidance documents for the various rules, and will be releasing them for public comment. We will keep you posted on guidance documents relevant to the sustainable agriculture community as they are released.

There are also a few remaining (but no less important) rules still waiting to be issued. One of these is the clarified definition of “retail food establishment. This final rule has been long anticipated by the local food community, as it provides critical clarity for direct marketing farms and food enterprises that could otherwise be inappropriately regulated under the facilities rule – the definition of this rule is key in determining whether or not farmers and small food enterprises are considered food facilities subject to the Preventive Controls Rule.

As an integral element of the Preventive Controls Rule and the Transport Rule, this rule to clarify the definition of retail food establishment should have been finalized at the same time as the rest of the standards in the aforementioned rules. FDA has now indicated that this rule should be finalized in June. We strongly hope there will be no further delays.

FDA is also slated to issue a proposed rule setting additional traceability requirements for “high-risk” foods. However, FDA has not yet determined what those high-risk foods are; the action on this issue to date has consisted of a draft risk assessment model. A proposed rule on this issue is likely in the coming years.

If you have questions about whether or how the FSMA rules apply to your farm or food business, start by taking a look at NSAC’s Am I Affected flowchart.

You can also submit questions or recommendations to FDA to ask questions about the rules’ impact on your particular operation. These questions are very useful to FDA because they help the agency to identify issues that require further explanation.

Categories: Food Safety

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