Food Logistics Operations: How Does FSMA Apply?

At Safe Food Alliance we always strive to help the food industry understand and meet the requirements of both regulatory bodies and customers. It’s our feeling that currently, on the logistics side of the food industry, there are many companies that don’t fully understand the implications of the FDA’s new FSMA regulations (the Food Safety Modernization Act). So we’re writing this article in the hope that it will prove helpful in understanding these requirements.

Warehouses: How Does the Preventive Controls Rule Apply?

The rule applies to four activities: manufacturing, processing, packing, and holding of food. Warehouses are considered by FDA to conduct “holding” activities. Some warehouses will fall under the Preventive Controls rule, sometimes referred to as “HARPC”, if they store food that requires refrigeration or freezing for food safety reasons (not for quality reasons). If that’s the case, there are requirements to implement HACCP-like controls including a hazard analysis and monitoring of the cooling operations.

For any companies that fall under this category, we strongly encourage sending several employees to PCQI training, a training approved by FDA under this regulation. Safe Food Alliance believes that training is a critical first step to compliance with any food safety program. Our full schedule of upcoming training can be found on our events page; if you don’t see a training that works for you, let us know and we’ll try to set something up.

What Does the Sanitary Transportation rule require?

The rule applies to food shipped and consumed in the U.S. The rule focuses primarily on three situations:

  • Food commodities shipped in bulk
  • Packaged foods not fully enclosed in a container (such as boxes of produce, or food in plastic bags which have holes in them for breathability).
  • Foods which require temperature control for The rule doesn’t consider refrigeration for product quality, its focus is on the safety of food products.

The regulation defines four entities, and lays out the requirements in the rule based on these four types of activities. Many companies will fall under several of these categories, or potentially all of them.

  1. Shipper: The person who arranges for the transportation of the food.
    1. Must develop procedures to ensure that vehicles are in appropriate sanitary conditions, previous cargo does not affect the safety of products, and any temperature controls required for food safety are adhered to.
    2. Must have records demonstrating they’ve communicated any food safety related requirements to carries, such as temperature control, etc.
  2. Loader: Person conducting loading activities, loading products onto a transportation vehicle.
    1. Responsible for making sure the condition of the vehicle is acceptable for use (cleanliness, temperature, etc.)
  3. Carrier: Person which physically transports the food. Does not include parcel services such as UPS, Fedex, or the U.S. Postal Service.
    1. Responsible for developing SOPs (Standard Operating Procedures) for cleaning and inspection of vehicles or other activities as necessary for the safety of the food.
    2. If there is an agreement with the shipper that the carrier is responsible for sanitary conditions during shipping, the carrier must provide training to employees conducting relevant activities such as cleaning and sanitation of vehicles, etc. FDA will be providing a one-hour, web-based training to help meet these requirements. No news yet as to when it will be available.
  4. Receiver: Person who receives the food items, whether or not they are the final recipient.
    1. Responsible for assessing food upon receipt for any signs of temperature abuse or other concerns.

Who Isn’t Covered?

There’s a somewhat complex list of entities specifically exempted from the Sanitary Transportation rule:

  • Any foods fully enclosed in packaging, unless refrigeration is required for the safety of the food.
  • Human food by-products which will be used for animal food without further processing.
  • Farms which are shipping product are not covered by this rule; they’re covered by the Produce Safety rule.
  • Certain entities already covered by other regulations, such as retailers or operations which are solely regulated under USDA and not regulated under FDA.
  • Companies with less than $500,000 revenue, calculated on a 3-year average.
  • Any food trans-shipped through the U.S.; or food imports which won’t be consumed here, but are subsequently exported elsewhere, are not covered.
  • Live animals are not covered, except molluscan shellfish.
  • Compressed food gases and food contact substances.

We hope you found this article helpful. As further developments occur under the FSMA rules we will continue to keep our readers up to date. Please contact us with any questions you may have, or if you would like training or assistance.

Don’t forget to register for the Safe Food California Conference June 6-8, 2017 in Monterey, CA.