Time for a FSMA Checklist

Full compliance with the Food Safety Modernization Act just a few months away. Is the food industry ready?

Here’s what food manufacturers need to do:

  • Hazard Analysis — the first compliance step required of all but the smallest food manufacturers is a thorough analysis of any potential food safety problems in production plants and shipping areas. Remember, under the new FMSA, the core idea underlying regulatory oversight is prevention of food safety problems. The obvious place to start is in the production facility. Included in the hazard review are “foreseeable hazards,” which are possible trouble spots for contamination that must be dealt with. Here’s a link to hazard analysis implementation.
  • Food Safety Plan — after the hazard analysis, this is the logical next step for manufacturers, but also the requirement that will take up the most time to implement properly. FSMA requires manufacturers to lay out a step-by-step risk-based preventive control plans that identifies real and possible food contamination weaknesses, and what will be done to mitigate or address the problems. Additionally, FSMA requires that the appropriate production line employees be given thorough food safety training, with regular review sessions. A plan’s food safety plan also must include a specific recall procedure in the event one is needed. This requirement is especially important because food contamination events can create serious, even deadly, public health emergencies. How well affected product can be tracked back to the source, and how quickly it can be removed from sale, is an essential component of the new food safety law.

food-processing-industry-image-4697FSMA also applies to suppliers in the long and complex food chain. As an example, food production lines convey thousands of pounds of raw food ingredients every day. The machines that control the manufacturing process need regular maintenance to keep them in good running order. Maintenance is performed by employees assigned to the task, and these workers use lubricants that are specifically formulated for food production. The lubricants must be “food grade;” that is, they cannot be potentially harmful to food being produced. FSMA requires that suppliers of these lubricants also perform a hazard analysis in their production facilities, and then create their own food safety and recall plans — just in case. (The website you are reading was created by a leading lubricants maker, CRC Industries, Inc. to help their customers and others with FSMA compliance).

  • Management Oversight — Perhaps the most controversial requirement of FSMA is a strengthened emphasis, backed by the force of possible legal action, on top management oversight of food safety.  While this feature has long been assumed by the Food and Drug Administration (FDA), the responsibility has been codified in the new food safety law. Top executives, including the CEO, can be held liable for food safety violations within their companies; using the so-called Park Doctrine, the FDA and the Department of Justice can mount civil and criminal actions against corporate executives whose companies become involved in a food safety crisis, even if the executives argue that they didn’t know about the safety problems and expected underlings to handle such matters.

The Food Safety Modernization Act is a watershed standard in food safety responsibility. The emphasis on prevention requires a higher level of vigilance for food manufacturers, their suppliers, as well as the companies that transport food products to warehouses and stores. It could reasonably be said that under FSMA, there can’t be enough food safety, which is a standard that could positively guide food production for years to come.



What Is a Foreseeable Hazard?

With an emphasis on prevention, the Food Safety Modernization Act (FSMA) directs manufacturers and suppliers along the food chain to identify “foreseeable hazards” in their operations as they prepare mandatory food safety plans. But nowhere is that term defined. So what is a foreseeable hazard?

The answer is, there is no clear answer. Dictionaries aren’t much help because they repeat the word in their definition. Yet there is some agreement around the notion that something is foreseeable when it is predictable and will probably last a long time.

food-processing.ashxSuch vagueness is often a problem with new regulations (which are the end result of years of revisions, give-and-take, and compromises between regulators and the industries to be covered), but in the case of the new food safety law, a foreseeable hazard sounds like, walks like and talks like what you would uncover as a problem in analyzing your production operations. Such problems – hazards – must be identified in advance of production and preventative controls put in place to eliminate the problem, a process, by the way, that must be undertaken every three years.

In the Federal Register, the FDA says this: “A facility subject to the (FSMA) rule must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed . . .”

A Maryland-based consulting company, FDAImports, established a website, harpc.com on perhaps the key provision of the new food safety law, Hazard Analysis and Risk-Based Preventive Controls, or HARPC. But even this website skirts around foreseeable hazards, although noting in clear language that (quoting):

“HARPC requires virtually every food manufacturer, packer, bottler and storage facility to identify food safety and adulteration risks associated with their foods and processes, to implement controls to minimize the risks, to verify that the controls are working, and to design and implement corrective actions to address any deviations from the controls that might arise. 

So what we are left with is a kind of working definition that directs the food industry to uncover and deal with areas in their production facility that will, or might, pose food safety risks, and take steps to eliminate them. They might be places where water is sprayed on raw food, or a hard-to-reach nook in a piece of machinery where listeria could grow. It could be a non-food grade lubricant on bread pans, or a production worker with hepatitis.

Whatever the precise definition, FSMA is going to require a great deal of new work and oversight by companies regulated by the FDA. Undoubtedly, the major food manufacturers and processors will have the budgets and people to insure compliance. The smaller companies, however, may be hard-pressed to manage the new regulations. Budgets will have to be created and people assigned to food safety management. Training will become essential to help workers and managers identify potential risks in the production process, so that a comprehensive food safety plan (another FSMA requirement) can be drafted and implemented.

Clearly, there will be growing pains associated with FSMA’s rollout. Defining terms, always a challenge, will most likely be settled through a combination of administrative decision-making, compliance challenges, and even legal action.

For now, though, anyone responsible for food safety ought to become very familiar with the term “foreseeable hazard.” It very well could be something that may end up helping save lives.




FSMA Training: Who Does It?

Among the first questions being asked about the new FSMA food safety rules is who’s going to handle training?

FSMA’s requirements for hazard analyses and detailed Preventative Control plans to minimize food contamination are but two of many substantial responsibilities for food companies and producers that will require extensive preparation and training. These rules extend beyond the companies themselves to the diffuse supplier segment of the food chain, where budgets for safety training traditionally have been limited.

With FSMA’s rollout continuing this year (the new regs for transporting human and animal food products were just released), training is becoming Priority #1 throughout the industry. Fortunately, FDA planned ahead on this aspect of FSMA, and the result is an alphabet soup lineup of alliances, partnerships and cooperative agreements involving government agencies, academia and the businesses themselves. Avoiding the pitfalls of “one size fits all,” the FDA is offering training by broad industry segment, as well as specific areas of the food chain, such as produce. There’s even an alliance devoted specifically to sprout safety.

For food manufacturers and processors, the key training alliance is The Food Safety Preventive Controls Alliance (FSPCA). Coordinated by the Illinois Institute of Technology’s Institute for Food Safety and Health, FSPCA is developing a standardized training and education program and technical information network to help the domestic and foreign food industry, including certain mixed-type facilities on farms, comply with the requirements of the Preventive Controls rules for human and animal food, as well as the forthcoming rule on Foreign Supplier Verification Programs (FSVP). This work includes developing:

  • Two separate standardized hazard analysis and preventive controls training courses and distance education modules—one for human food industry and regulatory personnel and another for animal food industry and regulatory personnel.
  • A training curriculum that addresses:
    • resources for and preliminary steps in developing a food safety plan,
    • types of hazards, conducting a hazard analysis, preventive controls for hazards,
    • monitoring preventive controls, verification and validation, and corrective actions/corrections,
    • recordkeeping, and regulatory requirements.
  • Two separate Train-the-Trainer courses for those interested in helping to train food facilities—one course for human food and another for animal food.
  • A module on the forthcoming FSVP rule for processors who import foods, and a full FSVP course for non-processor importers. The Alliance is also encouraging all importers to take the complete Preventive Controls training.

Alliance-developed materials will be publically available for use in training activities and as benchmarks for others developing equivalent curricula. In addition to these alliances, the FDA is supporting a variety of alternative training programs for specific industries or segments, as well as cooperative agreements, such as one with state departments of agriculture to help implement the industry’s new Produce Rule.

Much more information is available online. Companies wishing to get a head start on compliance are advised to ramp up their training programs (and budgets) ASAP.




FSMA’s Tough Stance Towards Food Company Executives

Earlier this month, Henry’s Farm, Inc., located in Woodford, Virginia, and its owner Soo C. Park, was put out of business after the U.S. Food and Drug Administration documented multiple violations of federal food safety laws and regulations. The resulting Federal consent decree prohibits Henry’s Farm, Inc. from receiving, processing, manufacturing, preparing, packing, holding and distributing ready-to-eat soybean and mung-bean sprouts. The U.S. Department of Justice  (DoJ) sought the consent decree on behalf of the FDA.

mungbig08While the government agencies have long sought to prosecute companies whose practices after food recalls, the tough action against Henry’s Farm reflects a higher level of government food safety oversight, an attitude embodied in the new Food Safety Modernization Act (FSMA). The consent decree was imposed even though there were no reported incidents of foodborne illness from Henry’s Farm’s sprouts.

For the food industry, the message couldn’t be clearer. Companies need to demonstrate a firm commitment to food safety in all facets of their operations, or face severe consequences. Put another way, it is too late to start your food safety program after the  U.S.Federal Marshals arrive to deliver court orders shutting down the business.  The FDA has the power to take action when there are concerns about potential health risks exist and the possibility of health.  With the cooperation of the Justice Department, the power to head off foodborne illness outbreaks enables the FDA to not only shut down an offending business, but also bring criminal charges.

“Insanitary conditions at food processing facilities can pose well-known risks to consumers, but such risks can be effectively mitigated if companies handling food take proper precautions,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to combat and deter conduct that leads to the distribution of adulterated food to consumers.”

In that regard, one of the tools the Justice Department may employ under FSMA is a standard of liability, called the Park Doctrine, which extends civil and criminal liabilities to executives who fail to actively monitor food safety practices. The standard derives from a Supreme Court case in 1975, in which a supermarket company executive, John Park, was fined and imprisoned for poor sanitation in some company warehouses. The executive argued that he had delegated responsibility for sanitation to others, but the Justices ruled that as the responsible executive, Park was culpable.  The resulting standard, called the Park Doctrine, lay fallow for years but now has been resurrected as new food safety rules take effect.

Its significance can’t be understated. One attorney, commenting on the Park Doctrine in 2009, summarized the decision this way: “Park was found guilty under the theory that people who manage businesses that make and sell products regulated by the FDA have an affirmative duty to ensure the safety of the products.”

Faced with the prospect of fines, pubic humiliation and even the closing down of the business, what can food executives do to avoid running afoul of FSMA?

The best course, industry sources agree, is to double down on food safety best practices in every aspect of food manufacturing and distribution. Senior management must support food safety efforts by providing a facility and equipment that is suitable for production and packaging of safe products.  They should also make sure that key management staff is trained and capable to oversee safe food production.  Companies should see to it that managers and supervisors be required to read the Park Doctrine as a way to emphasize that they bear a personal responsibility to insure a safe food production environment. By the same token, CEOs must fully commit to fostering and maintaining a safe food production environment.

Fortunately, FSMA lays out specific steps manufacturers can implement to create and maintain a safe production process. Each plant is required to undertake a hazard analysis of existing procedures, from which the companies must create a comprehensive Food Safety Plan that lays out in minute detail how every possible hazard is addressed. (See more details here and here).

In short, the FDA under FSMA is placing more responsibility for food safety squarely on those in charge. It is saying to executives: do your job and make food safety a top management priority. Or suffer the consequences.




FSMA and Hand Washing. Yes, Hand Washing

Embedded in the myriad rules and regulations of the Food Safety Modernization Act (FSMA) is a significant cultural shift in food manufacturing.

How so? The new law requires the food industry (and its many suppliers) to provide day-to-day management of all aspects of food safety, or suffer the consequences of government fines and public opprobrium. This represents a dramatic change from the largely voluntary approach of decades past amid a patchwork of vague, sometimes conflicting laws and regulations.

A perfect example of this transformation involves a simple procedure long associated with public health: hand washing. It’s long been standard practice (and a health code regulation) that employees working around or with food, whether in a restaurant, a growing field, or on a food manufacturing production line must wash their hands – thoroughly and regularly – while on the job.

handwashingPractically speaking, however, various studies over the years indicate that proper hand washing doesn’t occur as regularly or as thoroughly as needed or required. Even the ubiquitous hand sanitizer dispensers don’t offer the germ protection necessary to prevent contamination. Just as problematic is sketchy enforcement of hygiene. For food manufacturers and processors, hygienic requirements have always been nebulous. Many producers and processors have adopted the hand washing procedures outlined in the FDA Food Code or similar procedures. Yet the Food Code is only a set of recommendations and doesn’t carry the force of law.

With FSMA, these recommended procedures now become mandatory. Under FSMA’s required preventive controls,known by the acronym HARPC (Hazard Analysis and Risk-based Preventive Controls), manufacturers must create and maintain a thorough hygiene discipline throughout their facilities. Specifically, the new law says “management of covered facilities must ensure that all employees who manufacture, process, pack or hold food have the necessary education, training, and/or experience and ensure they receive training in the principles of food hygiene, food safety, and employee health and hygiene.” Such training includes thorough and regular briefings on proper hand washing protocols, as well as hand washing records available for FDA inspection.

Regulatory overkill? Perhaps. Hand washing seems like a such a small issue in the midst of a wholesale re-direction of food safety regulations under the Food Safety Modernization Act. Yet hand sanitation is a critical frontline technique to prevent the spread of harmful bacteria that can lead to outbreaks of Hepatitis and other illnesses. This has been the FDA’s intention for decades; now, with FSMA, proper hand washing carries the force of law.

That’s a clear cultural shift that will impact workers, managers, and manufacturers all along the food supply chain.