FSMA Faq's

Food Safety Modernization Act (FSMA)

Frequently Asked Questions

U.S. Food & Drug Administration (FDA), Food, Guidance & Regulation, Food Safety Modernization Act (2018), Frequently Asked Questions, 

Retrieved From: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm

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1) How will the FDA implement and enforce this new rule?

As with the other FSMA rules, FDA is committed to developing training and technical assistance. Food industry training will be an important component of successful implementation of FSMA, as will be outreach to foreign trading partners. The agency will also use its partnerships with other Federal agencies (such as the U.S. Department of Transportation) and with state, local, and tribal entities to implement this rule.

FDA will carry out some inspections, and the Department of Transportation, under the 2005 SFTA, will also establish procedures for transportation safety inspections to be conducted by DOT or state personnel. FDA maintains its ability to take enforcement action when agency efforts to work with a company fail to achieve compliance, but promoting a strong food safety culture is FDA’s first priority.

2) As a loader, what are my responsibilities under the rule?

· Before loading food not completely enclosed by a container onto a vehicle or into transportation equipment, you must determine, considering, as appropriate, any specifications provided by the shipper, that the vehicle or transportation equipment is in appropriate sanitary condition for the transport of the food, for example, it is in adequate physical condition, and free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe during transportation. You may accomplish this by any appropriate means. (21 CFR 1.908(c)(1))

· Before loading food that requires temperature control for safety, you must verify, considering, as appropriate, specifications provided by the shipper, that each mechanically refrigerated cold storage compartment or container is adequately prepared for the transportation of such food, including that it has been properly pre-cooled, if necessary, and meets other sanitary conditions for food transportation. (21 CFR 1.908(c)(2))

3) As a receiver, what are my responsibilities under the rule?

Upon receipt of food that requires temperature control for safety under the conditions of shipment, you must take steps to adequately assess that the food was not subjected to significant temperature abuse, such as determining the food's temperature, the ambient temperature of the vehicle and its temperature setting, and conducting a sensory inspection, e.g., for off-odors. (21 CFR 1.908(d))

4) What are the specific requirements for carriers when a shipper-carrier agreement has been established?

When a shipper-carrier agreement has been established, the carrier is responsible for the following functions as applicable under the agreement:

· The carrier must ensure that vehicles and transportation equipment meet the shipper's specifications and are otherwise appropriate to prevent the food from becoming unsafe during the transportation operation. (21 CFR 1.908(e)(1))

· The carrier must, once the transportation operation is complete and if requested by the receiver, provide the operating temperature specified by the shipper, as discussed in Section V. B. 2, and, if requested by the shipper or receiver, demonstrate that it has maintained temperature conditions during the transportation operation consistent with the operating temperature. The demonstration may be accomplished by any appropriate means agreeable to the carrier and shipper, such as the carrier presenting measurements of the ambient temperature upon loading and unloading or time/temperature data taken during the shipment. (21 CFR 1.908(e)(2))

· Before offering a vehicle or transportation equipment with an auxiliary refrigeration unit for use for the transportation of food that requires temperature control for safety under the conditions of the shipment during transportation, the carrier must pre-cool each mechanically refrigerated cold storage compartment as specified by the shipper, as discussed in Section V. B. 2. (21 CFR 1.908(e)(3))

· If requested by the shipper, a carrier that offers a bulk vehicle for food transportation must provide information to the shipper that identifies the previous cargo transported in the vehicle. (21 CFR 1.908(e)(4))

· If requested by the shipper, a carrier that offers a bulk vehicle for food transportation must provide information to the shipper that describes the most recent cleaning of the bulk vehicle. (21 CFR 1.908(e)(5))

· A carrier must develop and implement written procedures subject to the records requirements discussed in Section VII that: 

o Specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and transportation equipment that the carrier provides for use in the transportation of food to maintain the vehicles and the transportation equipment in appropriate sanitary condition as required by 21 CFR 1.906(b);

o Describe how it will comply with the provisions for temperature control in 21 CFR 1.908(e)(2), and;

o Describe how it will comply with the provisions for the use of bulk vehicles in 21 CFR 1.908(e)(4) and (5).  (21 CFR 1.908(e)(6))

5) What requirements apply to vehicles and transportation equipment?

Vehicles and transportation equipment used in transportation operations must:

· Be designed and of such material and workmanship as to be suitable and adequately cleanable for their intended use to prevent the food they transport from becoming unsafe during transportation; (21 CFR 1.906(a))

· Be maintained in such a sanitary condition for their intended use as to prevent the food they transport from becoming unsafe during transportation; and (21 CFR 1.906(b))

· Be stored in a manner that prevents their harboring pests or becoming contaminated in any other manner that could result in food for which they will be used becoming unsafe during transportation. (21 CFR 1.906(d))

6) What am I required to do if I notice that food that requires temperature control has been transported in a way in which it could become unsafe, such as in very hot weather on a truck without a refrigeration unit? 

If a person subject to this rule becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, you must not sell or distribute the food and you must take appropriate action including, as necessary, communication with other parties to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe. (21 CFR 1.908(a)(6))

Therefore, if you are a receiver and your standard procedure is to reject a delivery if it shows an indication of severe temperature abuse or another serious problem, you must also take additional action such as calling the shipper or carrier and informing them of what you observed that may indicate that the food has become unsafe. It then becomes that person’s responsibility to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe. 

7) As a shipper, what are my responsibilities under this rule?

As a shipper, you must establish written procedures subject to the records requirements discussed in Section VII, that describe how you conduct your operations to ensure that food does not become unsafe during transportation. There are as many as 3 specific types of written procedures you must establish, depending upon the type of food you ship:

· In all cases, as a shipper, you must develop and implement written procedures adequate to ensure that vehicles and equipment used in your transportation operations are in appropriate sanitary condition for the transportation of the food, i.e., they will prevent the food from becoming unsafe during the transportation operation. You may perform the measures to implement these procedures yourself, or they may be accomplished by the carrier or another party subject to the rule under a written agreement subject to the records requirements discussed in Section VII.  (21 CFR 1.908(b)(3))

· If you ship food in bulk, you must also develop and implement written procedures adequate to ensure that a previous cargo does not make the food unsafe. You may perform the measures to implement these procedures yourself, or they may be accomplished by the carrier or another party subject to the rule under a written agreement subject to the records requirements discussed in Section VII.  (21 CFR 1.908(b)(4))

· If you ship food that requires temperature control for safety under the conditions of shipment you must also develop and implement written procedures to ensure that the food is transported under adequate temperature control. You may perform the measures to implement these procedures yourself, or they may be accomplished by the carrier or another party subject to the rule under a written agreement subject to the records requirements discussed in Section VII. These measures must include measures equivalent to those specified for carriers under 21 CFR 1.908(e)(1), (2) and (3) discussed in Section V. E.  (21 CFR 1.908(b)(2))

8) When Do I have to Comply with the Rule?

We encourage you to comply with the Sanitary Transportation rule as soon as possible. However, we are not requiring you to comply with the rule right away.