Jeff Van Pelt was actively involved with the Grocery Manufacturers Association when a lot of the early FSMA regulations were just kicking in. At the time, it was the GMA pushing for the law, because tainted food was costing the industry billions of dollars in recalls, lost sales and legal expenses. Meanwhile, food and beverage manufacturers weren’t happy with the onslaught of new regulations.

Now, as the industry principal of food & beverage at OSIsoft, Van Pelt says he has noticed a shift in how processors are approaching the Food Safety Modernization Act.

“I’ve seen the manufacturing community work more closely with the FDA—more closely than I thought they would—and I think it’s for the benefit of the consumer,” Van Pelt says. “Back in 2011, it wasn’t a case of collaboration, it was, ‘Here comes the government pushing paperwork down our throat.’ But they realized ultimately this process is going to benefit them in relation to protecting their brands.”

Specifically, he points to trends like clean labels and source of origin identification, as well as organic and non-GMO ingredients.

“A lot of things consumers are asking for is what FSMA is asking [processors] to do as well,” Van Pelt explains. “A lot of the work [processors] did is actually providing them brand benefit when they go out to the market place.”

It’s been about six years now since President Barack Obama signed the measure into law on Jan. 4, 2011 with the hope of protecting public health and strengthening the food safety system.

And Charles M. Breen, an independent advisor, FSMA, for the EAS Consulting Group, agrees that in the long run, the regulations have been and are a net good for the industry.

“I’m very glad we have FSMA,” he says. “It will take time for many of the benefits of FSMA to be realized, but it will offer consumers significant improvements in food safety. Likewise, FSMA will protect responsible food manufacturers from those who cut corners and destroy consumer demand for a particular food, although this protection is not without effort and cost to food growers and manufacturers.”

And that brings up the problem many in the industry face: Even as food and beverage manufacturers are learning to look on the bright side of FSMA, new regulations keep taking effect, and they all require more than just a good outlook to comply with them.

“Food companies are learning that food safety and Foreign Supplier Verification Program [FSVP] plans have to be flexible,” Breen explains. “Companies should remain open to frequent updates and revisions. FSMA compliance is not going to be one and done. Compliance, and how to efficiently achieve and document [it], will be a learning process for food firms and FDA.”

Most of the early deadlines focused on things like creating a plan, infrastructure improvements and documentation. But the next wave of deadlines will focus on the full supply chain, prevention and food defense, Van Pelt says.

“Those are things like having the ability to predict when something’s going to go wrong,” he explains.

OSIsoft’s products can help prevent problems because the data it captures can tell the plant workers if something is running out of order or if a temperature is not quite right before an issue occurs.

“It’s really about digitizing the supply chain,” Van Pelt says.

One of the major changes many companies have made, due to FSMA, is moving from spreadsheet documentation to specialty software.

“The initial things that food and beverage companies were required to do were probably more people and processes intensive than technology intensive. You could document that, ‘Yes, I have a plan in place,’” Van Pelt says. “2017 was the first year of compliance—the increase in FDA audits, documentation.”

A company like OSIsoft can help food and beverage manufacturers by providing insights into operations, such as by grabbing data from ovens, air conditioners, the chemical sensors inside big distillation vats, etc. This data delivers a comprehensive picture of the plant.

“We help clients get out of going through an FDA audit with spreadsheets,” Van Pelt says. “You can imagine the difference [of] having something ready to report vs. having to go through spreadsheets.”

Having this data also benefits small and medium-sized businesses worried about costs, because it comes from sensors the factory already has.

Another company that helps processors digitize in response to FSMA is Plex, which offers the Plex Manufacturing Cloud that provides a unified system of record for manufacturers.

Gerry Gray, director of product management for Plex Systems, concedes that meeting FSMA regulations can be cumbersome and time consuming. And the whole process can be compounded for companies that don’t have a central repository for all their operating data.

“A paper-based approach or legacy software system creates huge headaches,” Gray says. “One of the best solutions for FSMA compliance is to take the opportunity to digitize and automate operations, so you have a comprehensive system of record for running the business—and clear visibility into core requirements, like quality management and supply chain activity.”

And Gray agrees that there are often unforeseen benefits to FSMA compliance.

“Leveraging a connected operation not only helps manufacturers improve quality and efficiency through their entire supply chain, the visibility into their operations effectively becomes part of the foundation for FSMA compliance,” Gray says.

For example, Plex worked with the Sanders Candy Company to set up its system in the plant so that it could better respond to FSMA regulations. Since then, the confectioner has improved its SQF-certified level from 1 to 3 in the three years and improved mock recall times from four hours to 15 minutes.

To tackle all parts of FSMA, a great help can be to team up with companies like EAS Consulting Group, which has a consultant team made up of former FDA officials, as well as USDA and food industry experts. The EAS consultants will conduct audits, perform gap analyses or mock FDA inspections and design regulatory compliance and food safety programs.

Breen says he does everything from helping processors prepare facility-specific food safety and Foreign Supplier Verification Program plans to advising firms on what ready-to-eat (RTE) means. He’s also represented companies before the FDA in dealing with food recalls, responded to FDA lists of objectionable conditions (483s) and helped importers demonstrate to the FDA that a shipment should be permitted entry when initially detained by FDA.

“As a consultant, I’ve found myself helping companies understand FDA expectations in regulatory matters,” he says. “FDA does try to make clear what must be accomplished, but cannot say how to get there. Having sat on the FDA side of the table as long as I did allows me to expand and clarify what FDA wants and to offer advice on actions that I have seen that satisfy the agency. I translate government-speak for companies.”

Another company that helps processors see the bigger picture is Registrar Corp., a consulting firm that helps companies in the food and beverage industry comply with FDA regulations.

Russell Statman, Registrar’s executive director, says the company even offers something called the FSMA Compliance Wizard, which is a free tool to help food facilities, importers and farms determine their possible requirements under FSMA.

“Requirements under FSMA involve many nuances depending on the size of a business, its functions, the types of food it handles and even its location,” Statman says. “Most FSMA rules offer modified requirements and a longer compliance period for small and very small businesses. FSMA Wizard users answer a series of questions about the facility in question and the Wizard returns an individualized report of possible requirements.”

The company also created an FDA Compliance Monitor, which helps importers and manufacturers/processors meet requirements under FSMA, as both parties must monitor and document their suppliers’ FDA compliance history.

“The FDA Compliance Monitor monitors suppliers for FDA import alerts, warning letters, import refusals and inspection classifications,” Statman explains. “Without this tool, covered parties need to routinely search for each of their suppliers individually in each of FDA’s applicable online databases. The FDA Compliance Monitor streamlines this process by aggregating all necessary data into a simple report and stores the information in an archive.”

FDA tries to help

For its part, FDA has recently released a new software tool that helps processors create a food safety plan specific to their facilities in an effort to help them meet upcoming deadlines.

The Food Safety Plan Builder (FSPB) is a free software application developed by FDA that businesses can download from the agency’s website to guide them, step by step, through the creation of a food safety plan, as required by FSMA.

Users are taken through a series of sections in the application that prompt them to answer questions and/or fill in information specific to their business and facility, says Jenny Scott, MS, a senior advisor in the Office of Food Safety within the FDA’s Center for Food Safety and Applied Nutrition. The questions help identify potential hazards and the preventive controls to have in place to address those hazards.

“For example, a hazard could be an allergen, like peanuts, and the preventive control could be ensuring that the allergen is properly labeled on the finished product,” Scott explains in an FDA blog post. “Another preventive control could be to ensure that the equipment used to process a peanut-containing product is properly cleaned after use to prevent the allergen from contaminating any products that are subsequently processed on the equipment.”

Once all the tabs have been completed, the file may be saved or printed, and the firm will have a food safety plan to use in its operations and to provide when FDA conducts an inspection. FDA says it will not track or monitor use of the Food Safety Plan Builder, nor will it have access to any content or documents developed using this tool.

Scott emphasizes that while use of FDA’s tool is optional, food safety plans are obviously not.

“Right now, the Centers for Disease Control and Prevention estimates that roughly 48 million people get sick, 128,000 are hospitalized, and about 3,000 people die from foodborne illness each year in the United States,” she explains. “In many cases, these illnesses can be avoided by preventing contaminants from reaching food and by stopping contaminated food from reaching consumers—exactly what these food safety plans aim to do.”

Even with tools like that, though, many companies find it difficult to translate the regulations into practice.

Biggest challenges

Breen says many of the problems processors face are somewhat related to the newness of the regulations.

“Even FDA is learning what it means for regulated companies to comply,” he explains. “The agency’s advice is for food firms to make a good faith effort to comply and keep learning as FDA continues to publish guidance documents.”

As for specific issues, Breen says he’s seen far too many recalls for undeclared allergens.

“This is straightforward and easy for FDA to document, but is really a food safety plan failure,” he says. “Food manufacturers need to step up their game to better manage suppliers, allergens, labels, equipment clean-out and the training of employees. With both FDA and the food processing industry now operating in a preventive mode, I am hoping that the number of FDA allergen enforcement actions will start decreasing, so no undeclared allergens reach the marketplace.”

He also says companies seem to be struggling with equipment repairs.

“The correct and hygienic repair using metal welds is an ongoing problem,” Breen says. “I would like to see equipment designers reach out to obtain input from line workers and sanitation crews before finalizing their equipment designs. Their insights could help make the next generation of food processing equipment easier to clean, maintain and repair.”

Statman says when it comes to writing and implementing food safety plans, one common challenge is the lack of adequately trained or experienced food safety personnel who can write the plan as a PCQI.

“To overcome this, a facility may hire a trained professional or obtain PCQI training for existing personnel,” he says, adding that there are a variety of PCQI training classes through the FSPCA.

Another common challenge Statman sees relates to manufacturers and processors outside the United States—the language barrier.

“Food safety plans aren’t technically required to be in English, but they must be written so that any US importers of the relevant product understand it,” Statman explains.

He recommends processors hire a third party to develop food safety plans. And while that can often be seen as something too expensive to do, outsourcing the work often costs less than PCQI training or the salary of a food safety professional.

“Translation of such long, technical documents can also be quite expensive and is subject to error,” Statman says. “Having food safety plans done by an experienced third party also ensures that the plans will be done correctly.”

There’s no doubt that when FSMA was first signed into law, processors were worried about how they would keep up with all the regulations and the seemingly never-ending deadlines. But six years in, food and beverage companies are well on their way.

And really, as Statman points out, FSMS does help everyone.

“It’s a good law,” he says. “Particularly for those who eat food.”

For more information:

EAS Consulting Group, www.easconsultinggroup.com

OSIsoft, www.osisoft.com

Plex Systems, www.plex.com

Registrar Corp., http://www.registrarcorp.com,
www.fsmawizard.com, www.fdamonitor.com