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The Food Safety Modernization Act: The Final Rule

Posted - June 16, 2016

The Food Safety Modernization Act: The Final Rule

By: Pamela Johnston, Esq., Vice President, Legal and Risk

In part 1 of this blog post, I discussed the proposed Sanitary Transport of Human and Animal Food (STHAF) Rules. These rules establish criteria that will apply in determining whether food will be deemed adulterated because it has been transported or offered for transport under conditions that are not in compliance with the sanitary food transportation regulations. The final rules were published on April 6th, 2016 and there were some notable difference from the proposed rules.

Important Modifications in the Final Rule

Who is covered?

  • Shippers
  • Loaders (added in the final rule)
  • Truck Carriers
  • Rail Carriers
  • Exporters originating in US are covered until it reaches the port or border

Who is NOT covered?

  • Transshipments passing through the US (e.g., Canada to Mexico). Includes imported for later export.
  • Air & Ship (unless it’s a multimodal import that will include a truck)
  • Shippers, Receivers & Carriers with <$500K average annual revenue
  • Farm activities (prior rule was limited to raw agricultural products)
  • Compressed food gases and food contact substances
  • Human food byproducts for use as animal food without further processing (i.e., not en-route to pet food production)
  • Completely enclosed by a container, UNLESS it requires temperature control (prior rule was shelf stable and fully contained)
  • Non-molluscan shellfish live food animals (prior rule was ALL live animals).
  • Waived (typically when covered by another oversight body)
  • National Conference on Interstate Milk Shipments
  • Retail Food Program (i.e., delivery from grocery store or restaurant)

Key Requirements:

  • Vehicles and transportation equipment: Design and maintenance of vehicles and transportation equipment ensures that food that it transports won’t become unsafe. (E.g., must be capable of maintaining temperatures necessary for the safe transport of food).
  • Transportation operations: The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact, i.e., the unintentional incorporation of a food allergen.
  • Training: Training of carrier personnel in sanitary transportation practices and documentation of the training. (This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.)
  • Records: Maintenance of records of written procedures, agreements and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.

Other relevant points:

  • 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. Shipper and carrier can agree to a temperature monitoring mechanism for foods that require temperature control for safety.
  • 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, beyond thermometer or recording device.
  • 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.
  • 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.

For more information, the FDA has set up an assistance contact: FDA FSMA Food Safety Technical Assistance Network

Do you have other questions about the STHAF Final Rule?