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 “Reasonable Belief?”

As the new Food Safety Act (FSMA) is being implemented, the food manufacturing industry is confronting an expanded array of compliance regulations, most notably in record-keeping requirements.

As food manufacturers would undoubtedly agree, federal record-keeping regulations are plentiful and costly. But under the Food & Drug Administration’s intent to prevent as much as possible food illness outbreaks, companies are required to put in place written food safety plans that include food products that are “reasonably likely” to be adulterated. That’s not all. The FDA can also request records of products for which there is a “reasonable probability” that the items could cause serious adverse health consequences or death to humans or animals.

Once either of these circumstances is met (in the opinion of the agency), the FDA may request “all existing records” needed to help the agency in determining whether (quoting from the FDA’s website): “the circumstances, which gave rise to the records request, exist.”

If your head hurts after reading that, you are probably not alone. And, regrettably, the FDA hasn’t been able so far to clarify just what this means. It does offer up this explanation: “reasonable belief” is a determination that will be made on a case-by-case basis. That leaves manufacturers with the disagreeable duty of maintaining lots of new records on production just in case the FDA comes calling.

In FDA’s defense, expanded record keeping is in large part a response to what has long been a significant challenge: tracing a recalled product – one that threatens public health – back along its production and distribution path. Congress directed that traceability be baked into the new food safety act, and one manifestation of that inclusion is the requirement for manufacturers and suppliers to maintain more comprehensive records.

Not unexpectedly, the record keeping requirements have generated criticism as being either too vague, on the one hand, and too detailed, on the other. The records can be kept electronically or in print, but they must be instantly available within 24 hours notice, for example. Also, the records need to be updated every two years. One law firm that represents manufacturers posed this dystopian possibility: “FSMA expands the conditions under which the FDA has access to company records containing sensitive product-related information, (and it also has the ability) to publicize agency findings, suggesting that particular products and companies may be linked to foodborne disease outbreaks or other public health risks.”

Others are more sanguine. Former FDA and USDA Medical Officer David Acheson summarized the record-keeping requirements as a precautionary duty for the industry: “My main message on recordkeeping is that it is really important to do it right. I say this because the FDA view is that if you can’t produce the records you didn’t do it. I think this could be an Achilles heel for many facilities in that they do the right thing but don’t keep the records, and that will not be acceptable to the regulators. As noted above, keep in mind that your records will demonstrate to FDA that you know what you are doing, that you are taking a risk-based approach, and that you are compliant with the new rules.”

As Acheson suggests, the FDA expects that companies will take seriously their obligation to minimize risks inherent in food manufacturing and do all in their power to prevent contaminated product from reaching the market.

That’s a reasonable belief, certainly, and a welcomed one for consumers.


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.