The Food Safety Modernization Act (FSMA) is not yet an enforceable law. Anyone and everyone in the food industry is still waiting for the rulemaking process at the Food and Drug Administration (FDA) to work its way to completion.
Anticipation, however, is already running at full force. Bakers, formulators and everyone else along the line from ingredient to store shelf have long been dealing with questions and hurdles presented by FSMA. One of the biggest? How to deal with the coming onslaught of paperwork and records that will be required by the new regulations.
An illustration: Dan Herzog, vice-president of corporate compliance of food safety at Gonnella Baking Co., Schaumburg, IL, had some thoughts he wanted to share on this subject with Baking & Snack, but things kept getting in the way of a phone call. Most noticeable was a meeting. “Coincidentally, we are currently meeting with a training group specifically to help reduce the work and paper load expected from FSMA,” he said.
Quite a coincidence, indeed.
“We’re anticipating and experiencing already the ripple effect of the FSMA documentation increase,” Mr. Herzog said. “It equates to a lot of work. We’re investing in our future.”
FSMA has long been on the radars of formulators, bakers and just about everyone else in the industry. As the most sweeping reform of the nation’s food safety laws in more than a decade, FSMA was a hot topic well before President Barack Obama signed it into law in January 2011. It’s just that now, planning and implementation for these changes is well underway. Formulators and bakers now must decide how to handle the added work that is on the ever-nearing horizon.
“The main issues will be the additional time that will be required to make sure food safety is built into the finished product and having the additional resources available to accomplish this,” said Charlie Moon, vice-president of technical services/quality assurance/regulatory for Flowers Foods, Thomasville, GA. “The benefit of FSMA is that ingredients and all foods will be safer for consumers.”
Reactive out, preventive in
The biggest change FSMA has sent hurtling toward the industry is the departure from the country’s reactive tradition of food safety implementations. From the start of its rulemaking process, FDA emphasized the change to preventive controls.
Everyone from farmers to food processors will now bear significant responsibilities when it comes to contamination prevention. In the past, government inspectors have been relied on to catch tainted food after production and before it made its way into public consumption.
It will be the first time that comprehensive, science-based preventive controls will be required across the entire food chain.
“The primary challenge that food manufacturers will face under FSMA is that the burden of proof with regard to food safety lies with the manufacturer,” said Stephanie Lopez, vice-president for food safety services innovation at AIB International. “Evidence will need to be obtained to demonstrate that the product will be safe, and this evidence cannot be based solely on finished product testing. It must be based on proof that the combination of raw materials and process steps will continually result in safe food.”
That burden of proof, naturally, comes in the form of documentation. And product developers, in addition to providing proof of their preventable controls, must be sure the ingredients they are using can offer that same assurance and paper trail. As Ms. Lopez pointed out, formulators will continue to look for confirmation that the supplier has well-developed and implemented prerequisite programs and hazard analysis and risk-based preventive controls (HARPC), not just hazard analysis critical control points (HACCP), through audits or document review. The process will be much longer than teams are used to.
“The impending preventive controls and risk-based assessment of ingredients under FSMA will require that product development teams incorporate longer lead times into their process,” Mr. Moon said. “More time will be needed for product development teams to ensure mitigation of any ingredient-related food safety risks.
“The bottom line?” he asked and answered, “This will cause research and development teams to look long and hard before deciding to source an imported ingredient.”
Everything on record
Chengboey Lau, principal scientist for regulatory compliance/food safety at Mondelez International, Deerfield, IL, discussed FSMA at the Biscuit & Cracker Manufacturers’ Association technical conference in May. A portion of her thoughts emphasized record keeping.
Records must be kept onsite and must be made available promptly, especially in a food safety plant inspection or audit. When an inspector shows up to look at a plant, he or she wants to see a HACCP plan that makes sense, she emphasized.
“The industry has a big problem with this because one facility could have seven or eight HACCP plans,” Ms. Lau said. “What value does adding those into the facility profile give to an inspector? It doesn’t.”
She also pointed out that a record is anything that records thoughts. Even text messages and instant messages are considered records.
“In the case that there’s a recall and FDA is asking for specific information on your corrective action, all these records legally must be made available,” Ms. Lau said. “So you really want to educate your workforce on everything you write down. It has to make sense. Nobody’s going to remember what happened six months from now. It’s that piece of paper or record medium that you have to show the inspector to explain yourself.”
Auditing is already a way of life for formulators and ingredient handlers. As Mr. Herzog put it, “Everybody audits everybody these days. It’s just something that takes place.”
Customers of a bakery want to see documentation and standard operation procedures. The bakery wants to see the same from its suppliers. This focus on safety was key even before FSMA came into the mix, and when the rules become enforceable, it will only grow.
Even more documentation and planning will need to be in place. Mr. Moon said that could affect some vendors early on. “Some ingredients from smaller-sized vendors may be impacted since they will not immediately have the resources available to develop the required food safety, preventive control and record maintenance that will be required,” he said.
The same can be said for ingredient importers. If those companies can’t immediately provide the documented, preventive proof that its product will routinely be deemed safe, bakers will look for other options.
“Much of the burden for validating ingredient safety and verifying that preventive controls are in place will fall upon the importers,” Mr. Moon said. “For bakers, more thought will likely be given to procuring ingredients from a domestic source when possible.”
Ms. Lopez pointed out that this could affect some bakers greatly. “Some bakers may not be affected at all by import requirements under FSMA, and some may be significantly affected,” she said. “While the proposed rule has responsibilities for the importer of record, anyone further down the supply chain may be affected by a loss of suppliers or delays of shipments.”
The records and trails of paper aren’t just coming from amped-up operations procedures and new preventive measures. Ms. Lau pointed out that at the same time FDA inspections are increasing, they are also becoming more enforcement-oriented. In the past, the discovery of a minor infraction might result in a command from FDA to get it cleaned up and move on. Now, FDA is issuing more 483s — the documentation given to a firm’s management at the conclusion of an inspection when an investigator has observed any conditions that, in their judgment, may constitute violations.
“When you look at the FDA database from fiscal year 2013, which is the most available data right now, they have given 47% of their 483s to the food sector,” Ms. Lau said. “And that’s an increase in the past five years.”
When the company receives the 483, it has a set number of days to respond with corrective actions and a timeline of when they will take place. So the verbal commands from yesterday are now replaced with letters from FDA and documentation from the company on how the problem has been handled.
Everyone is dealing with and preparing for all of this in their own way, but Mr. Herzog pointed out that regardless of what direction you are going, the time is now.
“Certainly the time to begin to prepare for FDA’s proposed new regulations for food safety is now,” he said. “Companies should develop a strategic food safety plan, including continuous improvements and upgrades to current policy and programs. Food safety, legality and quality don’t happen by accident. They happen intentionally with training in place for preventive measures and sustainable practices.”
As far as the handling of the actual documentation — all those papers with all that legalese — one popular solution can be found in the sky, sort of. Companies are turning to the cloud as a way to manage their documents. TraceGains, Westminster, CO, said it promotes quality and safety within the food supply chain by offering a cloud-based, full-service supplier, compliance and regulatory document management solution. San Francisco-based iCiX offers a cloud application that enables businesses to manage risk along the supply chain.
“There is a learning curve, and there are a lot of people involved,” Mr. Herzog cautioned.
And perhaps the biggest solution that companies have deployed is the creation of new programs and departments. Mr. Herzog has been with Gonnella for 27 years, starting in production. Three years ago, he was promoted to his vice-president position in corporate compliance of food safety. “Up until a few years ago, we didn’t even have this department,” he said. “But with FSMA and the new initiatives that are out there and coming our way, there was a huge need to develop this department. And we’re not alone. This is new to a lot of baking companies out there.”
But in the end, he said, it’s all worth it. The added work and frustration and stress isn’t all for naught. It all results in safer products and higher consumer confidence.
“We have a corporate responsibility as food processors,” Mr. Herzog said. “We need to embrace these rules and regulations and make them work. It’s our obligation. We’re consumers as well. The responsibility is ours to move these forward. If not us, who?”