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Back to School Series - Part 2

Welcome to the second edition of Healthy Trailer’s Back to School series in recognition of Food Safety Education Month.

Our overall objective is to bring widespread acceptance and application of well-known food safety science and recognized protocols to food transportation. Or more specifically, to help people expand their food safety programs to include transportation.

Lesson 1 focused on the common roadblocks to learning, generally and specifically how it relates to food safety education.

Today we look at the specifics of the FDA’s Sanitary Transportation Rule, one of FSMA’s seven regulations that were implemented to keep our food supply chain safe.

We will answer these questions:

1) What is FSMA transportation, and what does the law require?

2) Why is this regulation included in FSMA?

3) Who are the people responsible for compliance, specifically within an organization?

4) How does a company actually comply with the Sanitary Transportation Rule?

History Lesson First

We feel it is important to point to the past and look at the lives of people who, intentionally or not, made contributions to the development of food education and food safety. But also as we did with Abraham Lincoln in Lesson 1, we will look beyond the contribution to the person’s purpose, to the ‘why’ that led them to their achievements. Today we study the contributions of Louis Pasteur.

Failure or Father?

I am a history major. This means that when I start looking for the ‘major’ events in someone’s life, it doesn’t take long before I have been pulled down the historical ‘rabbit hole’ and find myself a bit sidetracked with what others might say was mundane.

As it turns out, Pasteur was not an exceptionally good student in his early years (he probably hated Back to School conferences) and actually failed at least one year of school. While he showed artistic talent, the lure of science changed his academic trajectory.

Pasteur’s discoveries in microbiology were not a result of him determinedly focused on improving the world, but his research did contribute to the world’s happiness. One of his chemistry students asked Pastuer to figure out why his beetroot kept souring rather than becoming fine wine, which led to the process of ‘pasteurization.’

While this important lesson in microbiology was driven by commercial reasons, his studies in the field of infectious diseases was personal as two of his five children died of typhoid fever.

Lessons from Pasteur’s Passions

Words such as advancements, revolutionized, and revered are just a few of the descriptions that have been associated with Pasteur’s life and work. Today we use the term ‘pasteurize’ like it’s as old as science itself. He truly earned his title, the Father of Microbiology.

Our first lesson lies in an interesting fact about Pasteur’s work, however, is that his work began in a climate of confrontation and disagreement. Scientists in his day adhered to the theory of Spontaneous Generation that meant they believed that bacteria appeared out of nowhere, and that diseases always started inside the body.

The reluctance of the medical and scientific communities to accept Pasteur’s contributions meant delays in widespread application of his proven scientific discoveries.

Sometimes getting something right (for example, implementing legitimate safe food transportation protocols) means we have to take an honest look at what is wrong, challenge our assumptions and make critical changes.

What today, in food safety, are we resisting or rejecting as beneficial and essential? What science is available to us that would be worth the effort of working through our resistance so that we all benefit from knowing our transportation practices strengthen and protect our food supply chain?

Second, Pasteur’s work that ultimately ‘revolutionized’ winemaking started with a business purpose, not known health risk. Essentially, the producers of a product wanted to protect their investment. France’s wine and silk industries, both major contributors to the country’s economic fame and success, were improved if not saved by Pastuer’s contributions in microbiology.

The relevance of this fact to our food safety work today is that we often think of the application of science and protocols as a prevention step to safeguard health. The protection of people, through the protection of our food supply, is a fundamental purpose of our regulatory scheme.

But for all you out there in the vast world of food and beverage, from the producers to the retailers, how protected is your investment from either the ignorance or negligence of the companies who handle your product after it leaves your control?

The immense financial costs of creating, growing, processing, packing, shipping, marketing, selling, distributing…what are they worth to you and your company, and how are these investments at risk because the supply chain you are using has a weak, broken or perhaps missing link?

What is FSMA Transportation?

Here is a short list of comments from food and food transportation industry members:

It’s an ‘add on.’

It’s a suggestion.

It’s guidance.

It’s not required like the other six FSMA rules.

The FDA doesn’t inspect for transportation compliance.

No one has told us what ‘sanitary’ means.

What is ‘clean’ anyway?

We’ve found that most companies approach this particular FSMA rule as similar to how motorists interpret vehicle codes. It’s not mandatory, it’s more about general safety.

WHAT is FSMA transportation?

The most straightforward answer to the ‘what’ question is that it is one of the FDA’s seven food safety specific rules. We’ve included the text of the rule on our resource page. But we have also provided in this post a brief overview of what this rule requires.

Starting with the fact that FSMA transportation is a regulation shifts the discussion from “Do we have to?” to “How do we comply?” And the really good news is that compliance won’t require numerous changes to a company’s current transportation program.

WHY is safe food transportation part of FSMA?

The ‘why’ of FSMA is important because understanding its purpose shifts from the discussion about whether or not it requires compliance to purposeful and effective means of compliance.

It is critical to acknowledge that FSMA, at its core and as stated throughout all the rules, is part of our regulatory scheme because the safety of food is better ensured by being proactive rather than reactive. Prevent rather than respond.

This is FSMA--recognize the risks inherent in a particular activity that contribute to the safety of our food supply and mitigate against them. Transportation is comprised of numerous ‘activities’ that if ignored or are poorly managed can put food at risk.

In our upcoming Lesson 3, we will look at the science and the trailer environment to show how the consumers’ health and safety are at risk in food transport trailers. Understanding the role of science, applied with the ‘street smarts’ of transportation, will help us understand more of the ‘why’ behind competent FSMA transportation.

For now, we’ll share our approach to FSMA transportation. This is because we are hearing more industry members commenting about their concern about the cleanliness of the trailers, they are using to transport their products. Also, food safety professionals who specialize in the sanitation sciences and protocols are beginning to address concerns about transportation equipment and operations.

Voices from the Industry

Much has been written about this rule and its general application, particularly when the rule first was published and then again when it became enforceable. During this period of time, there was speculation about how detailed and onerous the regulations would be on the stakeholders who would be required to comply. This led to the release of explanations and recommendations, primarily presented in various food and transportation industry articles.

These articles are all great descriptions of the rule, the primary difference between them owing to the business purpose of the companies who published the information. For instance, the insurance post relates the FSMA requirements to risk, the information system providers will correlate their offerings to compliance documentation management, and so on. We’ve included a link to these resources on our website and encourage you to read through them to better assess the status of your current food safety compliance.

Also, several of these articles have good explanations about waivers, food that is covered by the rule, and other aspects of the rule.

Who is responsible for FSMA transportation compliance within the company?

People are the cornerstone of a good food safety plan. How they develop, implement, monitor and document the specifications not only determine the plan’s overall effectiveness and efficiency, but if the most unfortunate of situations occurs, such as being involved in a foodborne illness outbreak, the diligence and accountability of the people may mitigate possible severe outcomes.

We also suggest that the people who are responsible for compliance are team players. As obvious as this may be, we routinely find individuals in critical roles who negatively impact and influence the direction of food safety teams. Further, over the past year or so, an increasing number of food safety consultants are specifically noting that culture is foundational to quality food safety programs.

While you may not have a full team assigned to managing a transportation food safety plan, at a minimum, to comply with §1.908(a)(2) you should assign a ‘competent’ person to a supervisory position. This is the person who has been adequately trained in critical food safety areas, has transportation experience, and who will be responsible for demonstrating compliance.

We all know how challenging complying with food safety regulations can be, so it makes sense to have the right people in the right seats to ensure the highest level of food safety.

Paper (Documentation and Record Keeping)

A company can have an awesome food safety team that has developed and implemented a great set of protocols, but still be vulnerable to poor inspection results if the record keeping is not complete.

When I first started learning about food safety plans, a friend of mine invited me to her office and pulled out a binder that had everything organized, complete, and truly prepared for routine inspections. She mentioned that it wasn’t always easy to get people to meet her expectations, and sometimes they actually did not like her because she was inflexible about satisfying documentation requirements.

But the effort always paid off because inspection day was essentially worry free, she had good relationships with the inspectors, and most of the employees appreciated how her organization simplified their own work.

If a team member is pushing back on completing or producing records, either figure out where the process is going wrong, or suggest a different role for the person responsible. I wouldn’t like that job!


One of my favorite things to do in my work here at Healthy Trailer is to be onsite and talk to drivers. The most frequent and sometimes serious frustration that they mention (or vent about) is that they are given jobs to do, other than drive the truck, that seem either self-explanatory or uncomplicated, but in ‘practice’, circumstances make the job either impractical or cause delays.

This would be a good time to mention the FDA’s training video for truck drivers. I haven’t checked lately, so things may have changed, but the video is one hour in length and generally addresses food safety risks and how a driver should manage them.

I watched the video, and as I took notes, I couldn’t help but think of common transportation issues could make compliance difficult. My 25 years of truck brokering experience has taught me that if anything can go wrong, it will, and not during daylight hours or when the people who can best solve your problem are available. Maybe this is true for me because my work has been in the fresh produce industry where things happen fast.

We want drivers to make good decisions, and in the area of food safety, as you know, mistakes can be disastrous. Clear, complete protocols, if training is adequate, are an indispensable piece to defendable, repeatable food safety compliance.


We include Partners in our list of ‘must haves’ for the best food safety success because they can make or break your program.

Many of your partners may also be stakeholders identified in the FDA rule and should also be complying with the FSMA’s transportation requirements.

Who should be on this list? Suppliers, vendors, customers, service providers, or any other company that impacts or influences your food safety programs in ways that you may not notice, or if you do, because they are not part of your own organization, you don’t have control over how they affect your compliance.

Transportation vendors certainly can drain your resources, particularly time.

Here at Healthy Trailer, we’ve heard a number of shippers express frustration over the sanitary conditions of trailers brought in by drivers who assumed that the loading crew would load over the debris. The delay in waiting for the driver to get the trailer cleaned can alter shipping schedules, delivery dates, cost customers time and sometimes negatively impacts product supplies.

Some trucking vendors are stuck in uncomfortable situations with their customers over unclear transportation food safety expectations.

When the rule first became enforceable, carriers would call me and ask questions about how best to comply with specific contract obligations. My recommendation was to ask their customers for specifics on what their expectations were regarding contract terms. Also important was that these customers give the trucking company these expectations in writing.

Another example is the time I got a call from a worried, and frustrated dispatcher because one of his customers sent them to pick up freight at a dock that was ‘clearly’ unsanitary. That’s a Partner (customer) who has minimal food safety expectations.

Partner issues in FSMA transportation are complicated and create serious conflicts. The smaller the company, the harder it is for it to expect larger business partners to operate in compliance.

Practice and Closure

Look at the four areas of compliance and make a list of areas that would demonstrate your company’s compliance and those that are missing in your food safety plans. Decide one action item that would improve your plan in these areas, assign a person who will be responsible for its completion, specify the date it should be done, and follow up.

In closing, I find the challenge of finding like-minded partners the most difficult to accomplish. Remember Pasteur’s resolve to pursue what he thought was correct. You may need to take an unpopular position initially but evaluating the effect of their decisions and operations on the value of your product may lead you to better FSMA transportation compliance.

For further reading about Pasteur:

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