Market Matters Blog

FDA Inspections on the Rise to Ensure Facilities are FSMA Compliant

Mary Kennedy
By  Mary Kennedy , DTN Basis Analyst
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The dates have passed for required facilities to comply with the FSMA "Sanitary Transportation of Human and Animal Food," but it is important for those facilities to be prepared for inspections. FDA inspections for FSMA related rules are being conducted at all businesses and will continue to increase. (DTN file photo)

The Food Safety Modernization Act (FSMA) includes a rule called the "Sanitary Transportation of Human and Animal Food," which was created to protect foods from farm to table by keeping them safe from contamination during transportation. National Grain and Feed Association (NGFA) Senior Vice President of Feed Services David Fairfield spoke at the Nebraska Grain and Feed Association winter meeting on Dec. 17 about FSMA inspections and reviewed the Sanitary Transportation rule, clarifying the requirements for ag related businesses.

As a reminder, the 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. According to the FDA, the requirements do not apply to transportation by ship or air because of limitations in the law. FDA's final rule largely exempts rail carriers and truckers from the rule's requirements unless the shipper and carrier have a written agreement (e.g., contractual arrangement) making the carrier or another party responsible, in whole or in part, for sanitary conditions during the transportation operation. The rule defines a "carrier" to mean "a person who physically moves food by rail or motor vehicle in commerce within the United States," excluding persons who transport food while operating as a parcel delivery service.

Exemptions from the Sanitary Transportation of Human and Animal Food rule include:

-- Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue.

-- Transportation activities performed by a farm.

-- Transportation of food that is transshipped through the United States to another country.

-- Transportation of food that is imported for future export and that is neither consumed or distributed in the United States.

-- 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 that is completely enclosed by a container except a food that requires temperature control for safety.

-- Transportation of live food animals, except molluscan shellfish.

"The most responsible party for enduring the safety of food transportation is the shipper," said Fairfield. "Shippers, loaders, carriers and receivers all need to comply." Fairfield also noted that many companies are asking about prior loads before loading an empty vehicle -- a good practice to follow.

Fairfield noted that while compliance dates have passed for this rule, FDA is inspecting more facilities than they have in the past. FDA inspections will encompass all the FSMA rules your facility is expected to comply with and can last four to five days. Fairfield also noted that FSMA compliance inspections are expected to increase in 2020.

"Facility managers should be familiar with the regulations and how they apply to their operation. They should train the appropriate employees, develop programs that demonstrate compliance, including record keeping and have an inspection plan in place," said Fairfield. "A comprehensive plan to prepare for an inspection should address the potential scope of the inspection, questions an FDA inspector may ask and guidelines on handling record requests."

Fairfield said it is very important for facilities to establish and maintain required records. "All of the FSMA rules have provisions that specifically require certain procedures and activities to be documented. The FDA has the right to access, review and copy any required record. Having all of these required records in place is essential for a facility to demonstrate compliance. Facilities should include in their inspection plans which records the investigator would be allowed to access and copy."

Below are links to the FSMA rules and a link to the NGFA guidance for FDA inspections.

Link to information about Sanitary Transportation of Human and Animal Food rule:…

Link to information about the FSMA:…

Link to NGFA guide "Rights and Obligations During FDA Inspections":…

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