The landscape is changing for commercial bakers and snack manufacturers as the Food Safety Modernization Act grants the Food and Drug Administration a wider reach. Will the act shift the responsibility for food safety of imported foods to the importer? And do all companies have the expertise they need to handle preventative measures?


According to the Centers for Disease Control and Prevention (CDC), about 48 million Americans (one in six) get sick, 128,000 are hospitalized and 3,000 die each year from foodborne illnesses. In response, President Obama signed the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA), which grants the FDA wider control over preventing food-safety breaches, rather than reacting to them after the damage has been done.


Prevention challenges

The act’s proposed rule for preventive controls, which focuses on preventing problems at the plant that can cause illness on the plate, requires domestic and foreign manufacturers, processors and warehouses to have written plans that identify hazards, specify the steps they will take to eliminate or minimize those hazards, outline monitoring and recording procedures and specify what actions will be taken should a problem arise. Hazards can include anything from sanitation concerns to food allergens.

The FDA stipulates that a “qualified” individual is required to prepare this food-safety plan. To be considered qualified, the preparer must either successfully complete standardized training or rack up years of job experience. To its credit, the FDA will prepare and help disseminate a standardized training curriculum to help businesses comply with this rule; however, the proposal is complicated and industry buy-in varies.

Gale Prince, president of SAGE Food Safety LLC, Cincinnati, and a 46-year food-safety industry veteran, foresees many issues with this proposal. First, creating a food-safety plan is not only incredibly time-consuming, it also requires scientific expertise that many companies may not have on staff. “There’s a limited supply of qualified individuals to handle what’s expected by the proposed regulations,” he says. “Just reading the proposed regulations is taxing for some companies.”

The least of Prince’s concerns are large firms that have the staff and resources to wade through and comply with the regulations. Midsize bakers and manufacturers may have limited technical expertise and time to implement a plan, but can still seek outside help at a cost, he reasons. But the smaller firms run the biggest risk of caving under the weight of these reforms. “The extensive requirement spelled out in the proposed preventative controls regulations will be an economic disaster to many of this group who will not be able to comply with the requirements,” he says.


Importance of imports

Yet another layer of preventative consideration comes with imports. For many American manufacturers, importing ingredients has been a way to cut costs. In fact, according to Australian food packaging supplier tna, as much as 15% of the entire U.S. supply chain is imported.

It is Prince’s belief that companies that embraced this shift relied on the (sometimes incorrect) assumption that food-safety standards were equal around the world—and if not, that the FDA would catch the problem at the ports. “Unfortunately, U.S. Customs and the FDA only look at a very small portion of the total food imports,” he explains. “The FSMA will clearly shift the responsibility for food safety to the importer.”

This means that all food imported into the U.S. must meet standards for safety, including food additives, food colors, heavy metals, drug residue and pesticides, Prince says. It’s up to the importer to ensure that the preventative controls are in place before the food is imported by visiting the plant or reviewing proper documentation. “This will have a major impact on the food importing business,” he says, “Again, there are currently very few food scientists employed with importing firms.”

While staffing remains a clear challenge, time is also of the essence, points out Susan Hancock, vice president of learning and communications at AIB International, Manhattan, Kan. “Under the current situation, importers may not even know who the foreign manufacturer is,” she says. “In addition to identifying foreign suppliers and confirming their compliance to FDA regulations, some foreign suppliers may need to attain certification to qualify for export to the U.S.”


Prepare now

The first compliance date is set for one year from when FSMA rules are published in the Federal Register, which doesn’t leave much room for error. But there’s a lot that companies can be doing now to prepare.

First, Prince says, companies should familiarize themselves with every step in their supply chain. “Too many times, major food-safety recalls have resulted from a one-time purchase of an ingredient from a new supplier without an approval process,” he says, noting that ingredient buyers and quality-control staff must work together going forward to achieve safety goals. Prince also recommends that all food plant management read and understand the FDA’s Good Manufacturing Practices as a starting point and hold training sessions with staff to enhance current safety programs.

“There’s much that facilities can be doing right now, such as completing vulnerability assessments, enhancing the training of their teams, conducting supplier reviews, establishing an environmental monitoring program and validating kill steps to be prepared for when the final rules are published,” agrees Hancock. To that end, AIB International has added seminars on the act and supplier verification for companies interested in expanding their preparedness. “In addition, under the direction of our director of microbiology, we are offering environmental monitoring consulting and kill step validation consulting,” she adds.

Equipment, other upgrades

Another option is to enhance existing equipment with food-safety upgrades. Tna offers integrative solutions like its hyper-detect metal detector, which can detect stainless-steel and non-ferrous and ferrous materials even at high speeds; intelli-scan 2 date-code assurance system; and intelli-read 3 bar-code scanning system.

Companies without an on-staff food-safety professional can start looking into third-party options. “Third parties bring a fresh set of eyes focused on food-safety programs to look at programs and operations,” says Prince. “The auditor should bring a wealth of food-safety knowledge from their experience in auditing food firms all over the country. If the auditor doesn’t add anything to their program, they should find a new auditor.”


Changing food-safety paradigm

“There’s no need to recreate the wheel,” agrees Lee Sanders, senior vice president of government relations and public affairs at the American Bakers Association (ABA). “Third-party certification can be a positive opportunity for the industry. There are good plans and procedures in place using any of those approved through the Global Food Safety Initiative (GFSI) standard.” But, she stresses, it’s important for the FDA to allow sufficient time after the preventative control rule is approved, so manufacturers can include their importing practices as part of their overall safety plan.

In the meantime, the ABA is assisting its members in prioritizing and responding to the FDA on the issues impacting the baking industry directly, as well as educating the FDA on current industry practices and historically proven approaches that can be effective as part of FSMA integration.

“The ABA has emphasized to the FDA that in all of the FSMA-related proposals, it will be essential to keep the final rules as straightforward and simple as possible, so that all manufacturers, both large and small, can grasp the key requirements and comply,” concludes Sanders. In turn, she says, “companies and their staff need to be vigilant in their food-safety efforts remembering that the FDA has changed the food-safety paradigm. With inspections, the FDA’s focus now is to make sure that there are systems always in place.”

Sidebar 1

FSMA: Just the facts

Spanning more than 1,000 pages, the Food Safety Modernization Act (FMSA) covers a lot of ground. According to the Food and Drug Adminstration’s (FDA) FMSA website,, here are the basics:


Prevention: For the first time, the FDA will require science-based, preventative controls across the supply chain. While the FDA will develop safety standards and regulations protecting against the intentional adulteration of food, the onus is on food manufacturers to implement a written preventative plan, from evaluating hazards to specifying how their facilities will address them.


Inspection and compliance: The FSMA provides the FDA with the power to inspect high-risk facilities every three years and grants the FDA access to manufacturer records like food-safety plans and evaluations. The FSMA also directs the FDA to establish a laboratory accreditation program for those that will be testing foods.


Response: If problems are detected, the FDA can issue a mandatory recall, detain products and suspend a facility’s registration, which prevents it from distributing food.


Imports: Under the FSMA, the onus is solely on importers to verify the safety of ingredients obtained from foreign suppliers. The act establishes a third-party verification program for compliance to U.S. food-safety standards, and the FDA can require that high-risk foods be accompanied by third-party verification. The FDA can also refuse a food’s entry into the U.S. if it’s denied access by the foreign facility or country.


Sidebar 2:

FDA recall power: What does it mean?

Despite the Food Safety Modernization Act’s focus on prevention, it also enables the Food and Drug Administration (FDA) to issue mandatory product recalls, taking these decisions out of the hands of manufacturers. But in practice, the act will change very little in the supply chain for commercial bakers and snack food manufacturers that have been prioritizing safety from the start. “Although recalls have been previously considered voluntary, they were at times initiated by the FDA,” says Susan Hancock at AIB International. “Many manufacturers already conduct a voluntary recall when approached by the FDA because it is in their best interest to avoid receiving civil penalties or negative publicity.”

Gale Prince at SAGE Food Safety LLC agrees that the mandatory recall statute will have a negligible effect on the number of food recalls overall. “I believe even since this part of the act went into effect, the FDA may have only used it once in three years,” he says, noting that the vast majority of food recalls have been conducted voluntarily. “I look at it as a food-safety neutral part of the act.”