The FDA Food Safety Modernization Act (FSMA)
Sanitary Transportation of Human and Animal Foods Rule
Important Dates: The earliest compliance date for most entities will be one (1) year after the final rule is published, on April 6, 2017.
Companies need safe and reliable solutions to ensure food safety and operational efficiencies in food processing. The following, issued by the FDA, outlines key information and dates.
The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The earliest compliance dates for some firms begin one year after publication of the final rule in the Federal Register.
The first FSMA deadline comes September 2016, when large companies (having 500 or more full-time equivalent employees) must comply with the preventive controls rules for human food. Small companies (fewer than 500 employees) will have until September 2017, and very small businesses (less than $1 million in average annual sales), until September 2018. Large companies dealing with animal food also have until September 2016 to implement the current Good Manufacturing Practices (GMP) requirements of that rule. In addition, FDA intends to implement “as soon as possible” the third-party auditor certification program for U.S. importing companies, regardless of size. That final rule was published in November 2015. The other FSMA rules have staggered deadlines, but companies will generally have between one and three years following publication to comply, depending on their number of employees or average annual sales volume.
This rule is one of seven foundational rules proposed since January 2013 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.
The rule builds on safeguards envisioned in the 2005 Sanitary Food Transportation Act (SFTA). Because of illness outbreaks resulting from human and animal food contaminated during transportation, and incidents and reports of unsanitary transportation practices, there have long been concerns about the need for regulations to ensure that foods are being transported in a safe manner.
The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.
Specifically, the FSMA rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training and waivers.1,2
The goal of every sanitation program is to rid the processing environment of bacteria and to prevent bacteria from entering the plant, whether it invades via people, insects/vermin, or equipment.
Manufacturing and processing facilities must also maintain risk-based supply chain programs for raw materials and ingredients and provide GMP education and training to their relevant employees.
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.
- Small Businesses – businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts would have to comply two years after the publication of the final rule.
- Other Businesses – a business that is not small and is not otherwise excluded from coverage would have to comply one year after the publication of the final rule.