commissary INSIDER - September 2016 - 8

KEY CONSIDERATIONS FOR SANITARY TRANSPORTATION * Applies to shippers, carriers, loaders and receivers * Covers food transported Interstate as well as Intrastate * Focuses on temperature control and avoiding contamination of products * All records must be kept for 12 months beyond procedures are in use SOURCE: FMI 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 8 * SEPTEMBER 2016 * 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 commissary INSIDER 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."

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