The second anniversary of the signing into law of the Food Safety Modernization Act (FSMA) was celebrated January 4 by the US Food and Drug Administration (FDA) with the long-delayed unveiling of the first proposed regulations affecting manufacturers and their upstream partners in the food chain.
Elements of FSMA went into effect in 2011, and FDA exercised its authority to suspend operations at facilities tied to a food contamination event in November, when Sunland Inc. was forced to cease peanut butter and peanut paste production until corrective actions were taken. (173,521 domestic facilities were listed in the FDA registry as of January 18, an increase of 16,000 in three years.) But January’s release of proposed rules for farm-level and food plant practices lays out what FDA describes as “the cornerstone of a prevention based, modern food safety system.” Additional rules for foreign supplier verification, preventive controls for animal food and accredited third-party verification are expected later this year.
FSMA’s essence is a shift to a science-driven, prevention-based approach to food contamination and away from a reactive mode. Under it, every registered food facility will be required to develop a written hazard analysis and risk-based controls plan, including documentation of any food safety events and the corrective steps taken to ensure they don’t happen again. Some regard FSMA as HACCP by another name, and although HACCP plans are in place at approximately 85 percent of US food manufacturing sites, FSMA compliance will require more detailed recordkeeping and active involvement by management.
Public comments are being accepted until May 16 on the agricultural and manufacturing rules. After that, FDA officials are expected to make modifications before the regulations are published in the Congressional Record. No timetable has been set, though most observers don’t expect the rule to be finalized until next year. A phased compliance period will follow, with the largest companies facing the earliest compliance deadline, likely in 2015.
Both rules are posted on FDA’s website. But patience and intestinal fortitude are prerequisites for reviewing them—the rules for manufacturers run almost 700 pages and read more like a legal brief than a Grisham thriller. For those who enjoy reading between the lines, there are a lot of lines to read. Haggling over interpretations and the finer points aside, there are only minor surprises for those who have tracked FSMA and positioned their organizations to comply without disrupting production.
Greg Flickinger, vice president-manufacturing & corporate engineering at Charlotte, NC-based Snyder’s-Lance Inc., has spent the last two years laying the groundwork for compliance at the company’s 10 manufacturing facilities. Though none of the proposals surprised him, Flickinger says the expectation of manufacturers’ ability to identify problems, solve them and prove the problem has been exorcised is higher than he expected.
Flickinger will share his thoughts and insights on FSMA compliance when he speaks April 15 at Food Engineering’s Food Automation & Manufacturing Conference in Naples, FL.
Visibly clean equipment and food contact surfaces had been the standard for snack food manufacturers like Snyder’s-Lance. However, FSMA will require machinery to be cleaned to a microbiological level. Current good manufacturing practices will be streamlined, with 21 GMPs being deleted, but those related to allergens stipulate that cross-contact, not contamination, must be addressed. That will require the removal of proteins, which are not susceptible to the heat treatments that kill bacteria.
“The ability to clean heritage equipment is top of mind for everyone,” says Flickinger. He has organized work teams to re-engineer and rebuild existing machines whenever possible to make them compliant. The process takes about a week. Capital constraints preclude all-new equipment, but as older machines are retired, he expects most OEMs will have servo-driven, tool-less options with angled surfaces and no unnecessary holes and other harborage points. In the meantime, “we may have to spend more time cleaning,” he shrugs.

Scientific rigor

Kurt E. Deibel, vice president-quality & food safety at Pittsburgh-based H.J. Heinz Co., provided an FSMA update at Food Engineering’s 2012 Food Automation & Manufacturing Conference, nine months before the manufacturing rules were revealed. Deibel compared FSMA’s scope to the Food, Drug and Cosmetic Act of 1938 and its predecessor, 1906’s Pure Food and Drug Act, a measure supported by company founder, Henry J. Heinz. His focus is on the preventive controls and inspection and compliance rules. Validating the effectiveness of a manufacturer’s processes is more complex than most people would think, Deibel said.
He used ketchup to illustrate his point. Heinz has not experienced a safety event with ketchup in 100 years, but that doesn’t mean the firm gets a free pass on validating its process. Qualified individuals were required to study the scientific literature to determine the pathogens of concern, collect data from all of a plant’s critical control points to assess their effectiveness and quantify the effectiveness of existing interventions. “It’s a lot more involved than people realize,” Deibel told his audience of food professionals. “Records contain the information you need to provide the level of validation that [FDA] is looking for,” though he cautioned against collecting inaccurate or unnecessary records that drown managers in data.
Those who have dissected the proposed rules are surprised by some of them. Robert Rogers, senior advisor-food safety & regulations for Mettler-Toledo Product Inspection in Columbus, OH, says the inclusion of radiological hazards to the contaminants manufacturers must guard against “raised a little bit of a flag.” Many inline quality assurance instruments, such as fill-level sensors and X-ray inspection machines, rely on technology that uses small amounts of radioactive material. However, the emerging consensus is that FDA is primarily concerned with raw materials contamination. The 2011 tsunami that caused a nuclear meltdown at three Japanese reactors raised the specter of soil contamination and compromised crops for centuries to come. Migratory birds are being monitored to detect radioactive transfers to North America.
Also unclear is how FDA’s risk-based hazard analysis and control differs from HACCP. Some suggest it’s simply semantics, though others believe FSMA rules are more stringent in some areas. Documentation requirements, though similar to those for HACCP, are more extensive, says Stephanie Lopez, vice president-food safety education, AIB International Inc., Manhattan, KS. The FSMA rule requires “detailed management of all control measures, not just CCPs,” she says. “The formalization of monitoring, verification and recordkeeping around all control measures will likely be the biggest change for manufacturers,” including those who voluntarily implemented HACCP.
Consultant Jennifer McEntire notes the “substantial detail” of FDA’s expectations in the more than 1,000 pages of rules released so far, and she is reserving judgment until rules on supplier verification, environmental monitoring and finished product testing are finalized. “There are dozens of areas where FDA wants comments,” says McEntire, senior director-food & import safety for the consultancy Leavitt Partners. She encourages food professionals to speak up about their questions, concerns and suggestions before the rules are finalized.
The key to compliance will be recordkeeping, she adds. That’s good news for software vendors, many of which anticipated an industry shift to electronic records and away from paper 10 years ago, when the Bioterrorism Act of 2002 went into effect. FSMA doesn’t require e-signatures on compliance documents, but Katie Beissel of Charlottesville, VA-based GE Intelligent Platforms believes the law will push more food companies away from paper and toward a database approach. To date, pressure from customers was a major factor for the switch, the global industrial manager-food & beverage suggests.
Before joining GE last year, Beissel was plant manager at a Washington state bakery. “Paper may work, but it opens you to risk,” she says. Whenever there is an upset in the process, operators must abandon documentation responsibilities and address the problem. If records are not automatically collected and maintained, that will result in record gaps that will be unacceptable under FSMA.
“Gaps in records, particularly those pertaining to preventive controls, will provide opportunities for issuing citations or even suspending registration,” effectively shutting down production, according to AIB’s Lopez.

Dueling regulators

Despite its sweep, FSMA does not directly impact food manufacturers regulated by agencies other than FDA. The Bureau of Alcohol, Tobacco and Firearms maintains authority in its jurisdiction, and the Commerce Department still holds sway over seafood processing. Congress wants closer cooperation between agencies, but turf wars are always a contentious reality.
However, some companies must answer to multiple agencies, and FSMA could produce confusion. The classic example is the plant that makes cheese pizzas under FDA supervision as well as pepperoni pizza. If more than 3 percent of the pizza’s weight is meat, the pepperoni line operates under the daily, watchful eye of FSIS inspectors, according to McEntire. As a practical matter, the processor might apply the same food safety rigor to both lines, inasmuch as inspections by FDA likely will be few and far between. FSMA specifies a gap of no more than three years between re-inspections. However, the 112th Congress did not allocate the funds necessary to recruit and train the battalions of inspectors needed to visit the more than 456,000 domestic and foreign facilities registered with FDA. Acute staffing shortages are largely responsible for the overdue release of the proposed rules.
The agency has made a point of taking a collaborative approach to rule-making, and industry observers give FDA positive grades in that regard. McEntire says the opportunities for input have been markedly different from the approach at FSIS. “Command and control always is the phrase people use when describing that agency,” she ruefully notes.
“The opportunity for input has been phenomenal,” seconds Flickinger of Snyder’s-Lance.
Heinz’s Deibel concurs that today’s FDA is more in tune with the needs of industry. He cites FDA’s response to last year’s discovery of the pesticide carbendazim in shipments of orange juice concentrate from Brazil. Eleven shipments were found to have chemical residues five to 11 times higher than the allowable 10 parts per billion. After consulting with EPA and human health authorities, the agency allowed the imports to land. The outcome demonstrates the new mood of “practicality” that exists at FDA, Deibel suggests.
Development of the rules for accredited third-party certification of facility inspectors also has been a collaborative effort. FDA has received input from a group called Food Safety Services Providers. “To date, input has been taken in a constructive manner,” AIB’s Lopez says.
Considerable work remains in building the infrastructure necessary to implement FSMA. The Illinois Institute of Technology was given a $1 million grant in 2011 to develop training materials for compliance trainers. A “qualified individual” must be on hand to manage the day-to-day execution of the food safety plan at every plant, and compliance trainers will be deployed to help food companies meet the requirement.
The devil is in FSMA’s details, and the spirit of cooperation will probably be strained before all the details are hammered out. Meeting the requirements will be challenging for small and mid-sized companies. Instead of waiting for enforcement to begin, Mettler-Toledo’s Rogers urges processors to begin restructuring their procedures and protocols now. “It’s a continuous improvement process,” he says. “We don’t have to reach the finish line today.” Waiting at the starting line, however, is not advised.

FSMA down on the farm

If the new food safety standards cause anxiety for some food and beverage processors, imagine the panic in agricultural circles. From tomatoes to spinach, foodborne illnesses tied to raw fruits and vegetables in recent years exposed the vulnerability of produce to bacterial contamination and led to the Standards for Produce Safety, one of two rules unveiled January 4, along with Preventive Controls for Human Food. It signals the beginning of an ongoing presence by FDA on the farm level, according to Jennifer McEntire of Leavitt Partners, Washington, DC.
The produce sector has taken strides in building a comprehensive track and trace system for recalls. FSMA’s focus, however, is preventing the need for recalls in the first place, and the science-based controls required at the farm level open a new world of monitoring and documentation. FSMA addresses five areas of risk: agricultural water, biological soil amendments, worker health and hygiene, domestic and wild animals, and equipment, tools and buildings. All five have been identified as sources of biological contamination in produce. Documented worker training and special precautions for sprouts also are outlined.
In a recent Produce Marketing Association webcast, PMA’s Bob Whitaker, chief science & technology officer, explained the law’s fundamentals and the steps farm operators will have to take to comply. For example, any water that will touch produce or food contact surfaces must be tested at the beginning of the season and every three months thereafter. “If there is reason to believe it is not safe, water can’t be used until it is treated,” said Whitaker. If analytical testing finds generic E. coli or any of 235 colony formers, the water is deemed unsafe.
The demarcation between farming and processing is somewhat vague, and the cutoff between regulated farming and local, small-scale growers who qualify for a limited exemption is a moving target. “Where the lines are drawn becomes really important” as the proposals move toward a final rule, Whitaker says. Noting the extensive outreach FDA has done to get input, he adds, “FDA wants comments from our industries.” Both farmers and processors are encouraged to submit complaints, comments and suggestions by May 16.
For more information:
Stephanie Lopez, AIB International Inc., 253-315-4511,
Katie Beissel, GE Intelligent Platforms, 434-978-5000
Jennifer McEntire, Leavitt Partners Global Food Safety Solutions, 301-551-3601,
Robert Rogers, Mettler-Toledo, 813-342-9138,