Tag Archives: Sanitary Transportation of Human and Animal Food

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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FSMA Checklist: Sanitary Transportation of Human and Animal Food Rule

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

The FSMA rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. Sanitary Transportation is one of seven foundational rules proposed under FSMA since January 2011 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

How much do you know about the Sanitary Transportation Rule? Test your smarts by taking the FSMA IQ Test hereSpecifically, the Sanitary Transportation rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers. It applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicles. Additionally, it impacts shippers in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico) or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the United States, if that food will be consumed or distributed in the United States. These requirements took effect April 2017 for shippers, carriers and receivers subject to the rule.

As the FSMA rules move to enforcement status, food companies must prepare to best respond to requirements and to develop programs for compliance, including Sanitary Transportation. This requires companies to document specific verification steps to satisfy regulations and meet food safety transportation requirements.

Self-Diagnostic Assessment Tool
The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing Sanitary Transportation Requirements. To complete your own assessment, review and compare your programs to the questions in Table I.

FSMA Sanitary Transportation rule
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its Sanitary Transportation of Human and Animal Foods programs, as required under FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate systems in place to comply with FSMA Sanitary Transportation of Human and Animal Food requirements or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider regarding their Sanitary Transportation programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

Randy Fields, Repositrak
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Sanitary Transportation Rule: Ignore at Your Own Peril

By Randy Fields
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Randy Fields, Repositrak

FDA posted the FSMA rule on the Sanitary Transportation of Human and Animal Food in April. The majority of retailers, wholesalers, suppliers and carriers will have one year to comply with this new rule. The sanitary transportation rule sets out to prevent practices that would introduce contamination risk during the transportation of food through the supply chain.

For retailers, wholesalers, suppliers and carriers, the final rule is really the sleeper regulation among the new FSMA laws. You probably have your HAACP plans and preventative control procedures in place, but do you have the necessary documents in place with your carriers to meet the FDA’s requirements?  And, are those documents easily accessible?

Under FSMA, you must address all FDA record inquiries within 24 hours, and these inquiries can go back two years, plus 12 months beyond the expiration of related service agreements. Failure to respond to an FDA records inquiry is considered a “prohibited act” and can land you in hot water with both the FDA and Department of Justice, which acknowledged they will enforce FSMA through civil and criminal penalties. That’s a game changer.

You are now required to ensure that transportation equipment does not cause the food it is carrying to become unsafe. You must also maintain adequate temperatures throughout your portion of the supply chain and prevent cross contamination. And, you must train your personnel in sanitary practices. All of these factors—processes and procedures, agreements and formal training of personnel—must be documented and made available to the FDA. Put simply, compliance with FSMA is proven through documentation because according to the FDA, if it is not documented, it did not happen!

So what’s the best way to comply with the new rules? Having the information on paper in filing cabinets simply won’t do. Can you imagine searching for specific confirmation that an employee received the proper training in a bank of file cabinets? Even with an efficient system, that could be like looking for a needle in a haystack. Collecting the information in spreadsheets is only slightly better, as it simply digitizes the disorganization.

Retailers, wholesalers, suppliers and carriers need to start their compliance process by reviewing and understanding all of the FSMA rules, guidance procedures and responsibilities. You ignore them at your own peril.

Then, consider automating your recording keeping system.  It is really the only way to efficiently collect and manage the documentation needed to comply with the new law.  When reviewing technology options, make sure you choose a system that is not only easy to use by frontline workers, but also provides sophisticated reporting and alerts to point out potential problems in real time. And, if possible, the solution should do more than just report on food safety activities. As long as you’re investing in a technology to meet FSMA requirements, you might as well implement a system that can potentially save money in other areas such as managing business or training documentation, new vendor approvals, or carrier optimization.

The bottom line is that the sanitary transportation rule will require that you devote additional resources to make the entire extended grocery channel more risk free for consumers and companies alike. And the best way to do that is to implement new technology that gives visibility to product transfers from point of production or processing to the point of purchase, and documents each step along the way.

Sanitary Transportation of Human and AnimalFood

Ready, Set, Train! Sanitary Transport Rule Is Here

By Holly Mockus
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Sanitary Transportation of Human and AnimalFood

The Sanitary Transportation of Human and Animal Food rule goes into effect June 6, 2016. Large businesses must comply by April 6, 2017; small businesses must comply by April 6, 2018. The rule governs the protection of food during transport, including the sanitation of transport vehicles and equipment, refrigeration of food for safety, and proper cleaning of bulk transport vehicles between loads. So you’ll need a game plan…but what should your game plan include?

  1. Read the rule—every word of it—to understand the reasoning behind the decisions made in crafting it and to get a glimpse into how it will be regulated and enforced.
  2. Review all of your processes, protocols, procedures, and contracts to ensure compliance with the rule, and outline responsibility for how you’ll manage the safe transportation of food.
  3. Close any gaps in your current programs to ensure you’ll meet the regulations well in advance of the compliance date.
  4. Kick the tires by conducting mock inspections. Find non-compliances and give yourself time to correct them, rather than wait for bad news during a real inspection.
  5. Confirm the accuracy of all your documentation on a regular basis. Documentation can be the difference between success and failure when it comes to proving that you’re doing the right things.
  6. Get all stakeholders on board to empower employees at all levels and drive culture change.
Sanitary Transportation of Human and AnimalFood
Establish a driver training program to ensure compliance with the Sanitary Transport rule. Image courtesy of Alchemy Systems (Click to enlarge)

Use Driver Training to Prepare

Drivers are the conductors of the food supply chain. They literally have loads of responsibilities, including maintaining the cold chain, meeting delivery requirements, practicing safe driving always, and meeting all Department of Transportation regulations and requirements. Whether transporting raw materials, packaging, work-in-progress, or finished goods, drivers are the people that keep food safe in transit. So how can you take advantage of your driver training program to ensure compliance with the Sanitary Transport rule?

  • A blended learning strategy, combining online and instructor-led training, has been shown to provide the best food safety training outcomes.
  • Use online lessons to introduce and reinforce knowledge of new FSMA regulations and food safety awareness topics. Digital lessons are economical, learner-paced, provide consistent messaging, and are accessible 24/7.
  • Use hands-on direct instruction for refreshers or for topics like proper vehicle inspections, reefer unit checks, cargo securement, etc.
  • Subject matter experts should conduct any instructor-led training using a skills check-off approach to document driver’s abilities and to ensure that drivers perform to standard.
  • Group and prioritize drivers for training based on their compliance history.
  • Use online lessons and safety messaging proactively to sustain driver compliance and performance.

Use online training at least quarterly, but use safety messaging monthly. Drivers, like all learners, need regular reminders in order to break old habits and form new ones. Communications programs can provide multi-touchpoints to reinforce new knowledge, shift behaviors, and help ensure compliance.

Put Your Game Plan Into Action

The Sanitary Transport Rule is a reality. Now is the time to put written procedures and protocols in place and make sure all stakeholders have a clear understanding of them. Determine precisely who has responsibility for compliance throughout the distribution channels. A blend of online and face-to-face training will ensure compliance, increase performance, and protect foods during transportation operations. The benefits far outweigh the cost.

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