FMSA - FDA Final Ruling
On March 31st the FDA submitted the final rule to the sanitary transportation of human and animal food to be published in the federal register. The rule was formally published on Wednesday, April 6 and will go into effect on June 6th 2016. Companies will have one year from this date to comply, and small businesses (<500 employees and $27,500,00 in annual receipts) will have 2 years to comply.
Several changes were made with the final ruling after gathering feedback from the industry. These changes include:
- Record Keeping
- The FDA clarified their position to request records on carrier’s procedures (SOP’s) that are in place to meet shipper/receiver requests. The FDA is not asking for temperature monitoring records for the past twelve months, just the fact that they have SOPs or guidelines in place on how to provide those records if requested.
- The proposed rule indicated a requirement for at least a half day of training for those handling food products. In the final ruling, the FDA states that the length of training will be left up to the shipper and carrier. FDA plans to provide a one hour web based training seminar on the basics of the rule and provide a certificate of completion.
- Adulteration/Claims Issues
- Initially the FDA proposed that if the temperature for the food product being shipped went outside the contractual range, the food would be deemed adulterated and rendering it useless. The FDA agreed to amend the language to state if a person notices an issue (temperature fluctuation, faulty device, etc) they must alert a qualified representative and the food held until a determination can be made on the safety.
- Temperature Monitoring
- In the previous ruling there was mention of a requirement for continuous monitoring of temperature readings, but the final rule has been modified to allow the shipper and the carrier to agree on temperature monitoring mechanism and the carrier is not required to demonstrate actual temperature records unless requested by the shipper. The FDA made this change because the submittal of records every delivery was unnecessary. This change does not preclude the shipper or receiver from contractually requiring the documentation.
- Increased Shipper Liability
- The final rule now places primary responsibility to the shipper to determine appropriate transportation operations (i.e. temp control for foods, relevant temp, proper clean out procedures, and whether previous cargo should be reported (no more 3 previous loads)). This shipper may assign some of this liability to the carrier through a contract.
- Additional Items
- The definition of a “shipper” has been modified to “anyone who arranges for the freight”. This change will have be impacts on manufacturers and brokers as they can now fall under the definition of a shipper.
- Parcel package carriers are exempt
- All transportation by a farm is exempted, not just raw agricultural commodities. The reason for this change is that many products fall under the FD&C Act.
- The exemption for very small businesses (under $500k in gross annual rev) still stands.
- Intra company shipments are not provided any relief and fall under all requirements of the STF
- The additional definition of a “loader” has been included. FDA included the loader in its covered entities to alleviate confusion for the LTL industry where part of the truck was being offloaded, and then reloaded without the shippers knowledge. The loader is now required to follow the STF requirements to ensure the food is moved safely (i.e. clean trailers, correct temp, equipment in good order, etc.)