“The Sleeper Rule,” also known as Rule No. 6 of the FSMA, is multilayered, and when it comes to training — and more importantly, documentation — what seems straightforward can quickly turn into a complex issue that demands miniscule attention to detail.
“There’s training required on this rule, and it’s all based on the carrier providing ‘adequate’ training to personnel engaged in transportation operations,” says Hilary Thesmar, PhD, RD, CFS, and vice-president of food safety programs at the Food Marketing Institute.
That training must abide by three basic requirements, she says. “It must include potential food safety problems that can occur, basic sanitary transportation practices and the responsibilities of the carrier. The training is required upon hiring and furthermore as needed, and then the training records require the date, type of training, and the name of the person trained, and then those become part of the official records that FDA has access to.”
Thankfully, the FDA is going to supply model training in the near future. The online training course that’s in development for carriers will be about an hour long, Thesmar says, and the FDA says that a guidance document is in the works as well, though there hasn’t been any set date for the completion of either.
But even then, these training requirements may put an additional burden on cooperating companies, warns Jorge Hernandez, chief food safety officer for Wholesome International.
“In my opinion this one is going to be a little bit of a challenge for companies when it comes to logistics,” he says, “because when you hire a carrier, you’re not only going to have to make sure that the carrier itself meets the regulations, but also if the person who’s going to be driving it needs the training, and if there is documentation to prove they have received it. It’s a little bit of a complexity that will have to be taken into consideration.”
And it’s likely the first of many complexities, as documentation is the cornerstone of proving compliance with the STR, and figuring out who is responsible for and holds what documents can only be sorted out with time and patience, as the industry as a whole endures the growing pains of such broad legislation. This is, after all, only one of the seven final rulings to come out of the FSMA. And unlike most legislation, all of this documentation must be kept on-hand and easily accessible to the FDA for much longer than most, and within 24 hours of its request.
“To summarize all of the records that are required, shippers and carriers both have specific records requirements, and there’s usually going to be a written agreement between the two,” Thesmar says. “If it’s a specific company, there’s going to be standard operating procedures in place, and those will become the defacto written agreement. All records must be kept for 12 months beyond when the procedures are in use, and that’s key — it’s not just ‘keep for 12 months’ — it’s 12 months beyond, so you have to keep them for one year past after you use them. And all records are required to be available to a ‘duly-authorized individual’ promptly upon oral or written request — that’s the specific language.
“Twelve months past the year the procedure was in use can be a pretty long period of time,” Hernandez agrees, “especially if you hire a third-party to do some of your business. So again, a complexity will have to be managed, documented, and available to the FDA within 24 hours, so this one is going to require some forward-thinking on the part of the industry.”