FSMA: How to Avoid the Compliance Cops

FSMA: How to Avoid the Compliance Cops

HALT! Be on the lookout for the Food Safety Modernization Act, which will impact all food shippers and carriers. We rounded up some expert advice, because if you don’t know the new rules, whatcha gonna do when they come for you?

Preparing for FSMA: A Proactive Approach Reduces Unnecessary Waste and Litigation

Christopher J. Lalak | Associate, Benesch, Friedlander, Coplan & Aronoff LLP
[email protected] | 216-363-4557


Playing by the Rules
Affiliated Foods Midwest Finds Compliance in the Cloud

Implementation of the Food Safety Modernization Act (FSMA) has been anything but speedy. The FSMA, which was signed into law in 2011, authorizes the Food and Drug Administration (FDA) to implement regulations geared toward food safety, and has no true impact until these underlying regulations become effective.

Now that two of the final regulations are finally released, and the FDA’s Sanitary Transportation Rule is set to be released in a few months, all segments of the food supply chain should take a proactive approach to preparing for the regulations—the FDA’s lack of urgency notwithstanding. This is particularly true for shippers.

Under the FDA’s forthcoming Sanitary Transportation Rule, for example, shippers are responsible for identifying the requirements for all temperature-controlled food, as well as setting the sanitation and vehicle maintenance requirements for carriers.

The Letter of the Law

The proposed rule is unforgiving, and demands strict adherence to these shipper-defined requirements to keep the food from becoming “adulterated” within the meaning of the Food, Drug, and Cosmetic Act, and thus becoming unfit for consumption. Given the FDA’s approach, it is easy to see how needless waste could occur if shippers are not careful in their approach to setting temperature requirements.

Consider a truckload shipment of yogurt to be transported from a shipper’s facility. Assume that the shipper, pursuant to the Sanitary Transportation Rule, designates that the yogurt is to be maintained at 35 degrees throughout transport. After being loaded onto a carrier’s trailer, however, normal fluctuations during transport cause the temperature inside the refrigerated trailer to rise to 36 degrees before returning to 35 degrees.

Despite the fact that the yogurt is still perfectly safe following this brief deviation from the designated temperature setting, the entire shipment is nevertheless “adulterated.” A receiving facility cannot accept it, and it can’t be salvaged or sold on the secondary market. It is a complete waste, and will likely lead to costly and time-consuming claims litigation, and the unnecessary disposal of perfectly good product.

The good news is that shippers can avoid this scenario by planning at the outset, and by setting thoughtful temperature requirements for the product in question.

In the above scenario, if the shipper set parameters for the yogurt shipment that specified a desired temperature of 35 degrees throughout shipment, but further specified that the food is not to be considered unsafe or adulterated until it reaches a certain temperature, or is exposed to a certain temperature for a certain length of time, undue risk of needless waste could be mitigated while still preserving concerns about product quality.

The same analysis applies to vehicle maintenance and sanitation requirements. Here, too, shipper-set guidelines govern shipment. And here, too, thoughtful requirements in addition to proactive discussions with carriers about their plans will help make compliance as painless as possible.

Although the final rule is not yet released, it is coming. Many analysts suggest that the final rule will be substantially similar to the proposed rule; indeed, some predict as high as 95 percent similar. Bottom line: The rule is not likely to change much, and delaying preparations for compliance is equally unlikely to prove beneficial to shippers.

How FSMA Impacts Inbound Food Transportation

John Ryan | President, Sanitary Cold Chain
[email protected] | 808-469-0046

The Rule on the Sanitary Transportation of Human and Animal Foods impacts shippers, carriers, and receivers of food that is transported by truck or rail with the intention of being consumed within the United States.

Don’t let the exclusion of air or containership freight fool you. Once food is offloaded from a plane or a ship, it almost always goes on a truck for transportation. Hence, it is covered by the rules.

Many companies now have less than one year to change their processes, procedures, and documentation systems or risk prosecution for non-compliance under the food transportation rules. Bulk foods and those “not completely enclosed by a container” that require sanitary and temperature-controlled transportation are in the FDA’s bullseye.

FSMA and other food import rules call for registration, certification, and prior notice for all non-U.S. farms, carriers, and shippers intending to import food into the United States. Documentation regarding planning, implementation, verification, and validation of controls designed to prevent food contamination during transportation is required. Inbound shipments that arrive without documented compliance allow the FDA to seize, hold, and destroy them.

Under the new rules, members of the food supply chain share liability for the food produced, processed, packed, and transported. The FDA has successfully prosecuted several company officials for knowingly transporting contaminated cantaloupes across state lines.

With food imports continuing to increase because of extended supply chains and U.S. consumer preferences, companies that purchase and import foods must immediately begin to upgrade their food transportation systems. As the Sanitary Transportation Rules imply, these companies must develop, document, and prove they established container and trailer sanitation processes through preventive standards for cleaning and sanitation testing.

Similarly, data regarding required temperature controls for transported perishables must be available for FDA or food safety audits. Taken together, the FDA considers container sanitation and temperature monitoring to be preventive food safety transporter controls.

So, what should shippers, carriers and receivers do? Basically, shippers of perishable food that is partially exposed to the environment are required to provide carriers with written sanitation and temperature control requirements for the transport of their foods. The carrier is expected to comply with those requirements, and offer documentation.

Carriers should pre-cool containers and trailers used to transport perishable foods according to the shippers’ temperature specifications.

Both the shipper and carrier must maintain written procedures detailing sanitation and temperature processes. There must be proof that the procedures are followed (verification) and cover requirements for preventive control over potential hazards (validation), meaning that the container or trailer should be washed and sometimes sanitized to remove residue or contaminants.

The Outer Limits

There should also be clearly stated upper and lower temperature limits that need to be maintained during transportation, as evidenced by data from a temperature monitoring and reporting system that the shipper, carrier, and receiver can share. Ideally, the reporting provides some kind of alert when the temperature goes beyond the established limits. Of course, the safe transportation of the type of food carried is critical.

With the FDA partnering with Customs and Border Protection and Homeland Security to control imported foods at U.S. ports, inbound shippers, carriers, and receivers need to cooperate to assure they comply with new food transportation rules. Companies need to assure that their supply chain partners are in agreement and in control of food transportation processes. Current food safety audit standards need to expand to include load, unload, and in-transit operations, and must cover all tools and equipment involved in those processes.

5 Ways to Manage Supplier Quality to Ensure FSMA Compliance

Brandon Henning | Director of Industry Solutions, Sparta Systems
[email protected] | 609-807-5373

Today’s food and beverage manufacturers are under more pressure than ever to effectively manage the quality of ingredients and materials across the supply chain. On top of that, new regulations are being put into law, forcing them to not only have supplier and importer quality management procedures in place, but also to prove that the supplier quality regimen for suppliers and importers—especially for high-risk ingredients—is executed.

FSMA requires manufacturers to demonstrate that they know which supplier sites are providing ingredients and materials to which manufacturing sites, and that those supplier sites are meeting the quality programs put in place via the manufacturer’s supplier quality management program.

Companies may be forced via FSMA to audit every supplier site based on risk, as well as ensure that all required documents are on file for every supplier site. Communicating with suppliers via email, fax, and paper makes it virtually impossible for manufacturers to comply with new regulations, and will add such a high cost to quality that most companies will see a drop in top-line revenue due to the hit product margins will take.

Here are five steps to implementing a supplier quality management program that supports FSMA compliance, takes the complexity out of managing supplier quality, and allows you to put a program in place that has sustainable business benefits.

1. Establish a supplier foundation.

Create a single repository of all the suppliers you work with, the supplier sites where your ingredients or materials are sourced from, and the class of ingredient or material those suppliers provide. Use this repository to leverage your newfound knowledge of who your suppliers are and to put an effective audit program in place.

With a workflow-based tool, ensure that your audit programs and any follow-ups are being executed in a timely manner, and if they are not, that all parties involved are notified.

2. Put an effective supplier onboarding capability in place.

When on-boarding multiple suppliers at the same time, initial top-level questionnaires and risk assessments can help ensure you meet FSMA regulations for supplier and ingredient onboarding. No matter the reason, being able to quickly onboard new suppliers creates significant impact on your company’s ability to contain cost and grow revenue.

3. Better manage the ingredients you are actually sourcing from your suppliers.

Once you have a deeper understanding of your suppliers, you can effectively communicate ingredient specifications’ changes driven either by you as a manufacturer, or the supplier, to ensure that you are never producing with the wrong ingredient specification. This step allows quality to play a huge role in both the reduction of cost of goods sold and the cost of quality, while further enabling effective risk and change management, as well as FSMA compliance.

4. Integrate incident management.

Putting a quality management system in place allows you to truly understand the impact that the ingredients and materials sourced from your suppliers has on complaints from the market and on internal quality incidents.

Streamlining communication makes suppliers want to work with you to resolve issues affecting your product quality as quickly as possible. This leads to reduced raw material cost and variability, improved yield, and increased supply chain reliability.

5. Implement real-time performance management.

You now have all the information required to put a true supplier performance management system in place, with all of the key performance indicators you require. A supplier performance management system allows you to focus on which of your suppliers or internal manufacturing sites are having the most trouble meeting your quality goals. This drives continuous supplier quality improvement, grows operational productivity, reduces costs, and increases the performance of new product introductions.

Developing a Track-and-Trace Strategy that Keeps Regulators—and Customers—Happy

Bill Tomasi | Vice President, Product Management, IBS
[email protected] | 262-520-0800

Track and trace has long been an important part of doing business in the perishable food industry. FSMA ups the ante by putting formal requirements around the process.

Track and trace is not just about meeting regulatory requirements; it’s also about brand preservation. Should a product be recalled, your company must be able to figure out its location quickly, concisely, and in an organized manner. Anything less could severely damage your brand—a company’s single most valuable asset.

The key to mitigating risk is swift, clear access to data about your products—where the components came from and where the finished product has gone. That’s where an effective track-and-trace strategy comes in.

Here are three ways to ensure your track-and-trace strategy protects your brand during a crisis.

  1. Invest in a system that automatically gathers information and easily creates reports. When a recall goes into effect, a company needs to act fast. The response becomes more complicated when dealing with products that contain multiple components from different suppliers. A company could hire 10 new employees to tackle the new FSMA data-gathering and reporting requirements. But imagine trying to dig through file cabinets to figure out exactly which shipments of frozen quiche contain contaminated E coli spinach.An automated solution is more accurate and cost-efficient. When a track-and-trace strategy functions as it’s supposed to, it collects information from every step in the process: what treatments organic farmers used on their crops; when components entered and left the manufacturing facility; and where the finished product is going.

    A warehouse management system easily fulfills this goal by recording and monitoring information about products during each step of the supply chain. The system keeps all the data in one place, and provides an integrated platform among suppliers, manufacturers, and distributors. This helps streamline response not just during a recall, but also during normal operations.

  2. Establish standardized processes. As soon as a company receives a request for information under the FSMA, the clock starts ticking. Instead of winging it when it’s time to produce data, spend time now establishing protocols for responding to such requests. Think about how to gather and mine the data; which employees are authorized to access and compile it; and how to meet the requirement for delivering the data electronically. Enacting standardized, corporate procedures is as important as the data itself in ensuring that your track-and-trace strategy works when you really need it.
  3. Validate the data. What good is a report if you can’t trust the data that’s in it? Conduct spot audits to make sure that the right information is collected, and that it is 100-percent correct. When a company automates a track-and-trace strategy, it puts a lot of trust in it—especially when bringing a new supplier online. Conducting spot audits guarantees that it is capturing information that’s as close to perfect as possible.

When talking about track and trace, FSMA compliance is on the table, and brand protection is at stake. But by weaving together automated data collection, standardized response processes, and thorough validation procedures , shippers have the tools they need to protect their future, and handle recalls effectively and intelligently.

Playing by the Rules

The FDA’s proposed rule on Sanitary Transportation of Human and Animal Food, required by the Food Safety Modernization Act, would establish criteria for sanitary food transportation.

Specifically, the proposed rule would establish requirements for:

  • Vehicles and transportation equipment: Designing and maintaining vehicles and equipment to ensure they don’t contaminate the food that they transport.
  • Transportation operations: The measures taken during transportation, such as adequate temperature controls and separating food from non-food items in the same load, to ensure food is not contaminated.
  • Information exchange: Procedures for shippers, carriers, and receivers to exchange information about prior cargos, cleaning of transportation equipment, and temperature control.
  • Training: Carrier personnel need to understand sanitary transportation practices and document the training.
  • Records: Carriers and shippers need to maintain written procedures and records related to transportation equipment cleaning, prior cargos, and temperature control.
  • Waivers: FDA procedures to waive any of these requirements if it determines that the waiver will not result in transporting food under unsafe conditions.

*Source: fda.gov. The FDA recommends consulting the proposed rule for specific requirements.


Affiliated Foods Midwest Finds Compliance in the Cloud

With the signing of FSMA in 2011, wholesaler and retailer executives are now legally responsible for supply chain safety. In addition, FSMA’s focus on prevention and seven new rules require retailers and wholesalers to collect, manage, and store multiple documents from each vendor for compliance. These documents must be accessible upon FDA request within 24 hours and two years back. Importantly, senior executives are now responsible for the compliance of their supply chain with FSMA.

At the Food Safety Consortium held near Chicago in November 2015, Affiliated Foods Midwest (AFM), a member-owned cooperative that serves independent grocers throughout a 15-state area, related how it prepared for FSMA compliance and decided to move away from its “home-built” and “highly manual” compliance system, which stored both soft and hard copies of vendor documents. With FSMA rules focused on documenting preventive measures, AFM leadership assessed the company’s gaps and determined they needed to be more proactive.

At the start of its undertaking, about 30 percent of vendors were non-compliant with the three records required: Certificates of Liability with specified limits, Hold Harmless forms, and W-9s.

“We knew compliance built on trust was not enough and wanted more business documents and regulatory records collected,” said John Grimes, director of safety for AFM. “We also needed to increase compliance, and be more proactive, so we were looking to automate our systems.”

AFM decided to adopt the cloud-based Compliance Management System from ReposiTrak, a provider of solutions to help companies comply with regulatory requirements, to proactively manage both business-related documents and FSMA-related records. Once implemented, ReposiTrak reduced vendor non-compliance by 60 percent in the first 90 days through proactive alerts and automated exception reporting.

“With our prior system I could find a requested document within 24 hours, but with ReposiTrak, I can pull it up and instantly share it with an FDA agent even before they have a chance to leave my office,” Grimes said.

Document management at AFM is now more proactive than reactive. The ReposiTrak system automatically sends alerts to Grimes and the vendor when documents are missing, when insurance limits are too low, or when a document is due to expire. ReposiTrak’s system enables AFM to proactively manage more documents by vendor than in the past.