The Sanitary Transportation of Food rule is the last of the core Food Safety Modernization Act (FSMA) rules to be published, and is hot of the press, with the finalization of the rule only happening at the end March.
There are a lot of definitions to the Sanitary Transportation of Food rule and it continues a theme we’ve seen throughout FSMA, which extends the network that is governed by the FDA to new areas of the supply chain.
Programs like HACCP and GMPs are new concepts in certain areas like transportation and animal food, which are corners of the industry that have not been directly regulated before. But FSMA is not applying new concepts here; it’s simply applying familiar concepts to an area that hasn’t had them prior.
At its core, the Sanitary Transportation of Food rule covers FDA-regulated food that is transported by ground, which is an interesting piece to this rule in that it will not apply to air and sea, but solely motor vehicles and rail travel.
The rule covers a number of parties:
But the real focus is on carriers because they are the parties supplying the equipment, the vehicles, and conducting the transportation activity. The rule is looking at loading to unloading, and even preloading in some cases if temperature control is involved.
The shippers are going to be responsible for requirements within this rule in a way as well. They are going to be the ones informing the carrier of the necessary elements that need to be put in place for their products, e.g. temperature controls, allergen controls, etc.
There is a back and forth between the shipper and the receiver when it comes to setting requirements to make sure risks are controlled, but the carrier is the one that ultimately needs to make sure these mitigation activities are occurring for the sanitary transportation of the food.
Each of the FSMA rules can really be broken down into three or four key concepts. And here, we can look at four key areas (broken out into five below to separate out vehicles and equipment).
The Sanitary Transportation of Food rule essentially establishes Good Transportation Practices (GTPs)—analogous to Good Manufacturing Practices (GMPs)—which are applicable to all transportation operations and sets forth obligations based on these GTP activities.
Vehicles and Equipment
When it comes to vehicles and equipment, the rule is going to sound very familiar to GMPs used in other areas of the supply chain. Similar to what is seen in manufacturing facilities with GMPs, GTPs will be in place to make sure that transportation vehicles and equipment are designed and maintained to ensure that they do not cause food to become unsafe.
GTPs will provide ways to ensure the equipment or vehicles being used are suitable, adequately cleanable (Can they be hosed down or sanitized in a way to ensure they are safe and clean for their intended use?), and capable of maintaining temperatures necessary for safe transportation of food.
As depicted in the image above, there is a separate concept for operations, which really speaks to the idea that there is a need to have an overarching supervisory role. The idea of the Sanitary Transportation of Food rule is not to just set up a few materials and then leave them in place, but rather to be an active and living program very similar to GMPs. There will need to be someone ensuring these transportation practices are active and functioning as expected.
One of the key concepts to every FSMA rule published thus far is ensuring that there is adequate training in place, as well as ensuring that there is common awareness of what the risks could potentially be for particular foods and/or shippers.
Training is going to be slightly different with this rule versus what has been established with HARPC in the Preventive Controls rules where you have training set at certain standards with definitions, etc. FDA is developing an online course to meet the general requirements of the rule, and it will set some ideas for what training should include. A good idea, however, would be to search for “training” in the comments section of the published rule to see FDA’s response to get a better idea on FDA’s direction.
FDA does acknowledge that there are cases where carriers do not perform any transportation activity that would affect the sanitary condition of the food and so there is no benefit to training. These cases need to involve an agreement—a written contract— between the shipper and carrier which indicates the reasoning behind not following GTPs. If no written contract is in place, it will be assumed that there is application of the rule, which then requires training to be in place.
The last key concept to GTPs is also a key concept to all FSMA rules—recordkeeping. Every area within the FSMA rules has a very strong emphasis on documentation. From how you’re identifying training practices to implementing operations to what the GTPs will be, all these core requirements must be documented and available upon inspection.
Risks over Quality
The overarching aim of the Sanitary Transportation of Food rule is on risks, not on quality. The rule is really focused on the general sanitation of transportation with items like proper refrigeration, adequate cleaning between loads, attention to allergen control and cross-contact, and the proper protection of food during transportation to prevent contamination.
The initial proposed rule required that the carrier maintain vehicles and transportation equipment in a condition that prevented food from becoming filthy, putrid, decomposed, or otherwise unfit for food. The proposed rule was a really long requirement that incorporated a lot of language from case law and from the regulations seen over the years, but was also a little more confusing.
What is seen in the final rule is that it’s a little more narrowed down to a requirement that essentially keeps food free from adulteration—including spoilage—and keeps it “fit” for its intended purpose.
Again, the rule is not focusing on risks that would affect quality, but more so focusing on risks that would impose a safety concern, and this rule is also making sure transporters are meeting that general definition of food remaining fit.
Good Transportation Practices
Good Transportation Practices (GTPs) are analogous to GMPs, and the transportation rule highlights this in a number of places where FDA uses the definition or mentions a requirement that is essentially the same to GMPs. The definitions of adequate, sanitary conditions, and temperature controls are mirrored from GMPs to the transportation rule, and there are a couple more that are also very similar.
This rule is more narrowly focused on GTPs because you’re not doing labeling and you’re not involved in manufacturing activities, but there are certain controls that you want to have in place as you would in manufacturing facilities as well.
Another way GTPs are analogous to GMPs is, like with GMPs, these are broad goals and definitions, and are not specific activities. This makes sense in a lot of ways because the FDA regulates a wide range of products—from shellfish to fresh juice to ready-to-eat foods—each having unique conditions and/or unique hazards. FDA wants to make sure that general sanitary conditions are met and temperature controls are met when needed, but it’s really up to you to identify what that temperature needs to be, or what that sanitary control needs to be.
Exclusions and Exemptions
As with all FSMA rules, there are exclusions and exemptions. This rule, however, probably has a few more as compared to the others just because of the nature of transportation and the fact that FDA is covering a new field.
If you’re transhipping and just using the U.S. as a port to go to another country, i.e. coming in from Europe through the LAX port to head to Asia, since you’re not actually using the U.S. for sales and marketing, that particular shipment will be exempt from the rule.
If you’re only exporting food, getting the food to the port for export will be covered by the rule, but from export out will be exempt.
There are also requirements for meeting the definition of a “farm” for this rule, which is a theme throughout FSMA. If you meet the definition of a farm and if you’re doing transportation performed by a farm then you’re going to be excluded from the rule.
Live food animals and byproducts that don’t have further processing will also be excluded.
Indirect food additives are also excluded. For example, if you’re only transporting clam shell containers for food, you’re not going to be part of the rule
There is also a revenue exclusion/exemption for companies bringing in under $500,000 in annual sales for food that is completely enclosed in a container, but food that requires a temperature control is still covered.
The aim with exemptions and exclusions is to document your justification with the exemption/exclusion definition and how that definition applies to your operation. And in some ways, as your operations change, you want to make sure that you’re coming back to that document to make sure that you haven’t added something to your operation that then changes the your exemption/exclusion. Revenue change is a perfect example of this. Or maybe you have a new customer that is asking for food not to be shipped in an enclosed container, or maybe it’s food that is in a container which also requires temperature control.
You want to always be aware of where those thresholds are so that if something changes, you know what you need to do with that change. Exemptions and exclusions are not just an easy out. You want to make sure you’re always justifying the why.
FDA and USDA Jurisdiction
Food regulations in the U.S. utilize a dual jurisdiction in which the USDA regulates meat, poultry, and has a bit of a shared jurisdiction on eggs, and then the FDA regulates everything else.
The transportation rule initially indicated that the FDA would be covering everything (meat, produce, etc.), but has had to clarify this in the final rule. For example, if you are transporting soup products with a chicken noodle soup and a cream of mushroom soup, this is a dual jurisdiction situation—you have one soup falling under FDA and one falling under USDA.
With this rule, if there is a presentation of jurisdiction, then the rule will apply. In the example listed above, the transportation will apply to you.
There are a few waivers in the rule that are different from the exclusions. These are a little more technical in nature compared to the exclusions. So far there are only two waivers issued, but FDA has stated it would consider additional waivers and will publish them as they are issued in the federal register.
FSMA rules can be complex and confusing at times, but when broken down into familiar concepts, you can make the regulations more easily digestible.
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