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FDA Issues Final Rule on Sanitary Transportation of Human and Animal Food

Updated: Jul 9

By Ashley Ellixson

Small road past a farm (Photo by Edwin Remsberg).

This article first appeared in the April 26th Edition of the Delmarva Farmer.


If you have not heard of the Food Safety Modernization Act (FSMA) yet, you will likely be hearing about it more this year. We have also written posts on the blog! What is FSMA? In short, it is legislation amending the Food, Drug and Cosmetic Act (FDCA) and giving the Food and Drug Administration (FDA) the authority to mandate preventive-based controls across the food supply chain. Not only does this include the U.S. food supply but a greater oversight of the millions of food products entering the United States from other countries every year as well.


FSMA is comprised of seven foundational rules introduced in January 2013. Since then, there have been several proposed versions of each foundational rule, five of which were finalized in 2015. The finalized rules are:


  1. Preventive Controls For Human Foods

  2. Preventive Controls For Animal Foods

  3. Produce Safety Rule

  4. Foreign Supplier Verification Program

  5. Accreditation of Third-Party Certification

To add to the finalized foundation rules, on April 6, 2016, the FDA finalized the rule on Sanitary Transportation of Human and Animal Food. The seventh rule concentrates on mitigation strategies to protect food against intentional adulteration and is anticipated to be finalized later this year. All of these foundation rules making up FSMA are expected to work together within the food system to decrease foodborne illness and strengthen the U.S. food safety structure.


Today, I am going to look closer at the most recent finalized rule: Sanitary Transportation of Human and Animal Food, simplified on the FDA’s website (fda.gov). The website states that “[t]he rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.” The FSMA rule explicitly establishes requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers.


So who is covered by the rule and when must they be in compliance? With some exemptions (dictated in each foundation rule), the rule applies to shippers, receivers, loaders, and carriers who transport food in the United States (by rail or motor vehicle-not air) whether or not it is offered or enters into interstate commerce. Interstate commerce simply means that a product moves across state lines or from foreign commerce. This rule, which is different from the others, does not differ between products which travel solely within in the state from those which travel across state lines. This means that even if you operate in Delaware you are not exempt, though you could fall within an exception set out in the rule; more on that below. The rule does not apply to exporters who ship through the United States. For example, if I export melons from Mexico on trucks through the United States, with the end destination in Canada, the rule would not apply to me. However, U.S. companies which export food to foreign countries (food which will not be consumed or distributed in the U.S.) will be covered by the rule until the product reaches a port or border.

Other exemptions from the rule include:


· Shippers, receivers, or carriers engaged in food transportation operations with less than $500,000 in average annual revenue

· Transportation activities performed by a farm

· Transportation of compressed food gases (e.g. carbon dioxide, nitrogen, or oxygen authorized for use in food and beverage products), and food contact substances

· Transportation of human food byproducts transported for use as animal food without further processing

· Transportation of food which is completely enclosed by a container except foods requiring temperature control for safety

· Transportation of live food animals, except molluscan shellfish


The last exemption may concern those in the poultry industry specifically or those sending livestock to butcher. Be at ease in knowing live chickens or cattle in trailers transported to or from houses/processers will not be subject to this rule.


Compliance dates depend on which size of business you are. If you are a “small business” (businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts), you must comply two years after the publication of the final rule, or April 6, 2018. If you considered an “other business” (a business that is not small and is not otherwise excluded from coverage) you will have to comply one year after the publication of the final rule, or April 6, 2017.


This article is an overview of the Sanitary Transportation of Human and Animal Food. If you have further questions on how this rule may specifically relate to your business, please email me at aellix@umd.edu.


#FoodSafetyModernizationAct #FSMAseries #Foodsafety #FDA #FSMA #foodlaw

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