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  5. Key Changes in the FSMA Final Rule on Sanitary Transportation of Human and Animal Food
  1. Food Safety Modernization Act (FSMA)

Key Changes in the FSMA Final Rule on Sanitary Transportation of Human and Animal Food

Back to FSMA Final Rule on Sanitary Transportation of Human and Animal Food

The proposed rule opened for public comment on February 5, 2014. The FDA made changes throughout the rule in response to public comments, as it has for the other FSMA rules that have become final in the last seven months. The agency’s goal is protecting public health while making each rule as feasible for companies as possible.

  • In keeping with the overarching food safety goal of FSMA, this rule now solely focuses on practices that create safety risks, rather than on those that affect its quality but don’t necessarily make it dangerous to consume.
    • There are provisions in the Federal Food, Drug, and Cosmetic (FD&C) Act that cover spoilage and other forms of adulteration, including during transportation.
  • The definition of “transportation operations” has been changed to exclude:
    • Transport of foods completely enclosed by a container (except for food that requires temperature control). The original proposal specified that the enclosed foods must be shelf-stable (safely stored at room temperature in a sealed container).
    • All transportation activities performed by a farm. Under the proposed rule, only the transportation of foods that are raw agricultural commodities would have been excluded.
      • The diversity of farms and their transportation operations make it difficult to develop regulations that would be broadly suitable. Instead, the FDA is considering providing guidance on good farm transportation practices.
      • Farms are still subject, however, to FD&C Act’s provisions that prohibit the holding of food under insanitary conditions.
    • Transport of human food byproducts for use as animal food without further processing, i.e., those sold directly to farmers to be fed to livestock. These do not include byproducts that are transported to facilities to be manufactured into feed or pet food.
    • Transport of food contact substances, which include coatings, plastics, paper, adhesives, as well as colorants, antimicrobials, and antioxidants found in packaging.
    • Transport of live food animals, except for molluscan shellfish (such as oysters, clams, mussels and scallops). The original proposal excluded all live food animals, including molluscan shellfish.
  • Another change is particularly important to rail carriers. Commenters raised concerns that rail operators often do not own, prepare or operate equipment, e.g, refrigeration units, in the railcars they transport, and do not have the ability to ensure that certain requirements such as temperature control and sanitary conditions, are met. The shipper or loader, and not the rail carrier, has generally assumed responsibilities, such as inspecting a railcar, to ensure that it is suitable. Shippers will continue to hold primary responsibility for sanitary conditions of transport under this rule unless the carrier has entered into a written agreement with the shipper to assume this responsibility.
    • By contrast, motor carriers generally own their vehicles and are directly involved with sanitation during transportation operations.
  • “Loaders” have been added as a covered party. A loader is a person who physically loads food onto a motor or rail vehicle.
    • Before loading a food not completely enclosed by a container, the loader must determine that the transportation equipment is in appropriate sanitary condition.
    • Before loading a food requiring temperature control, the loader must determine that each mechanically refrigerated cold storage compartment is adequately prepared for refrigerated transportation, including precooling, if necessary.
  • The final rule clarifies that the intended use of the vehicle or equipment (e.g., transporting animal feed versus human food) and the production stage of the food being transported (e.g., raw materials versus finished products) are relevant in determining the applicable sanitary transportation requirements.
  • Requirements for the use of a temperature indicating or recording device during transport have been replaced with a more flexible approach. The shipper and carrier can agree to a temperature monitoring mechanism for foods that require temperature control for safety.
    • The original proposal specified that a compartment must be equipped with a thermometer, temperature measuring device, or temperature recording device.
    • The agency agreed with commenters that there are a number of effective ways for ensuring temperature control that parties subject to this rule should be able to use.
    • The agency also agreed with commenters that carriers need to demonstrate they maintained requested temperature conditions only upon request, rather than as a requirement for every shipment, as previously proposed.
  • Primary responsibility for determining appropriate transportation operations now rests with the shipper, who may rely on contractual agreements to assign some of these responsibilities to other parties.
    • Shippers must develop and implement written procedures to ensure that equipment and vehicles are in appropriate sanitary condition.
    • Shippers of food transported in bulk must develop and implement written procedures to ensure that a previous cargo does not make food unsafe.
    • And shippers of food that require temperature control for safety must also develop and implement written procedures to ensure that food is transported under adequate temperature control.
  • If a covered person or company at any point in the transportation chain becomes aware of a possible failure of temperature control or any other condition that may render a food unsafe, that food must not be sold or distributed until a determination of safety is made.
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