The year of implementation for the Food Safety and Modernization Act of 2011 is halfway through, and most businesses only have seven more months before they must be compliant with Rule No. 6 — that of sanitary transportation — also called “the sleeper rule” for two reasons: because of its ability to directly or indirectly affect every player along the entire supply line, and because the majority of its exemptions and applications are buried beneath a mountain of definitions and vague terminology.

“(Who has to comply) isn’t defined by who you are in the food industry, in terms of manufacturers or packers or if you hold food,” says Hilary Thesmar, PhD, RD, CFS, and vice-president of food safety programs at the Food Marketing Institute. “It’s shippers, loaders, receivers and carriers, and anybody engaged in the transportation operations of food, and applies to intrastate and interstate transportation as well.”

Going in, it’s important to know the four definitions the FDA has outlined so that you might better understand which — if not all — apply to your business:

  •  A shipper is a person, manufacturer or freight broker who arranges for the transportation of food in the US by one or more carriers sequentially.  “So the shipper is the person who arranges for the shipment of the food,” Thesmar says, “and they actually have quite a lot of responsibility in this rule.”
  • A carrier is the person or company who physically moves food by rail or motor vehicle within the US, but it doesn’t include those who transport food while operating as a parcel delivery service. “So UPS, the mail service and FedEx are exempt from this seemingly, but it does include third-party transportation companies that are operating on behalf of the food industry,” Thesmar says.
  • A loader is a person that loads food into a motor or rail vehicle during transportation operations.
  • A receiver is any person who receives food at any point in the US after transportation, whether or not that person represents the final point of receipt for the food.

The rule applies to motor and rail transportation, but not to ships or air cargo. “It does have a caveat though,” Thesmar says. “If it arrives to the US on a ship and then that container is put on a truck to be transported, or on a train, then it is under the rule. While it’s on the ship, it’s not, but once it gets on a truck or train inside the United States, then it’s covered under this rule.”

“You must consider the type of business you have, because in a lot of cases, (a business will) fall under more than one heading here,” adds Jorge Hernandez, chief food safety officer for Wholesome International.

“For example, most of the larger distribution centers and companies will have warehouses, so you have to comply with (multiple regulations in accordance with each role within that warehouse). That will be important as we go about requirements for compliance, and also the deadlines for compliance. Because each rule has different deadlines, you will have to be compliant with some before others.”

Hernandez also says it’s critical that everyone within a business read the preamble to the rule, when it does and does not apply to a given role, and be sure that they understand when, where and why documentation is necessary for compliance.

Applications and exemptions

“(The rule) doesn’t just have a nice chart that says it applies to this and it doesn’t apply to that,” Thesmar says, noting that further FDA guidance is expected. “It’s kind of buried in the preamble, and especially in the definitions and the actual codified language of what is covered and not covered.”

The rule applies to foods that are temperature controlled for safety (TCS) in order to prevent growth of pathogens that may carry foodborne illnesses, as well as food that is not completely enclosed by a container. The latter has caused a flurry of discussion on what actually applies as being completely covered when it comes to packaging, and the FDA has followed up with further guidance on the issue. By and large, this stipulation applies to foods like produce that are shipped in bulk bins.

“It doesn’t include any packaged food item,” Thesmar clarifies. “It’s easier to say what’s out than what’s in, so ‘food not completely enclosed by a container’ is not packaged food that’s completely enclosed by the package, but (unpackaged) food not completely enclosed by the container (it’s shipped in). Produce is the perfect example for this.”

And just as the rule doesn’t have a chart explaining what does and doesn’t apply, neither does it have one for what is and isn’t exempt. The exemptions, she says, are also primarily found in the definitions section of the rule.

“It’s also kind of buried,” Thesmar says, “but the exemptions include foods regulated exclusively by USDA and food that is completely enclosed by a container that’s not TCS. So that’s going to be your canned food, cereal boxes, crackers, those kinds of things.”

Also exempt are compressed food gases, human food byproducts that are to be used as animal food without further processing, those substances that contact food without altering the food itself, and live food animals — the only exception to the last being molluscan shellfish.

“Interpretation is going to be a big part of it too,” Thesmar says, “so I think we’ll learn a lot over the next couple of years about whether things are in the rule or out of the rule. I think that it’s safer probably to put (a given product) in the rule and include it rather than assuming it’s exempt.”

Even if you discover that you aren’t exempt at some point down the road, there is at least one way for some along the supply chain to make their workload a little lighter when it comes to documentation.

“I know that exemptions were requested and were not given,” Thesmar says, “but the FDA did come back and say that written procedures can be rewritten for shippers, receivers, loaders and carriers who are under the same ownership or operational control of a single legal entity.

“So when one company is performing all of those roles, (the FDA) realize that having written standard operating procedures for how you handle the shipping, avoid contamination, and control for temperature — all of the things that are required within the rule — could suffice for your documentation of compliance.”


But just like all legislation of this magnitude has bureaucratic tangles to unwind, it also has shortcuts for those whom common sense has deemed worthy of a waiver.

“Now the good news,” Thesmar says laughing. “A little bit of relief — there was some talk of waivers in the preamble and the codified language. And the specific mentions of waivers were for PMOs, Grade-A milk, milk products, and also for retail stores as receivers. So the retail store is actually under the jurisdiction of the USDA’s Food Code, and direct-to-consumer transportation is also under the waiver of a retail store. The FDA is planning to issue a final rule just on waivers, but there’s also a way to petition for a waiver if (your procedures are considered) low-risk. So there’s a way to get a waiver on things that are outside of retail stores and pasteurized milk ordinates by petitioning the FDA.”

There’s also a little more leeway on the deadline for making all of these changes, she says.

“Most companies have to be in full compliance with these rules by April 6, 2017, though small businesses that are either non-motor carriers with less than 500 full-time equivalents or motor carriers with less than $27.5 million in annual receipts get one more year on top of that.”

And if you’re still confused on whether or not a certain aspect of the rule applies to your business, you can go online and actually ask the FDA about your circumstances directly.

“The FDA has a technical assistance network where you can ask questions about any of the FSMA rules directly to them,” Thesmar says. “I can tell you though, they’re not quick — the wait time is probably about a month. So you do get an official answer from the FDA, which is really nice, but you do have to wait a little bit for it.”

What to expect

 “The impact of the rule depends on what kind of company you are,” Thesmar says. “So for retailers and wholesalers, communication with the carriers is going to be key — avoiding contaminating the product and then implementing increased procedures and records are going to be your main impact.” Manufacturers can expect more of the same, she says, as they have the possibility of occupying all of the defined roles at once. Shippers and carriers are going to have more responsibility than the loaders or receivers, she says, but those are the things that you need to look at depending on your place within the supply chain.

“The records you’re going to see are written agreements between parties and written standard operating procedures,” she says. “These could be what you already have, or they could be new standard operating procedures that you’ve put in place. The key difference that we’ve seen is that (documentation) must be kept for 12 months beyond when the procedures are in use. So your ‘to-do list,’ to check it off in terms of what you need to do based on what kind of company you are — retail distribution center, wholesaler, manufacturer — (should first be) to identify your role in transportation, and then put the appropriate procedures, training and recordkeeping in place.”