FSMA and the Challenges for Small Business

FSMA BUSINESS COMPLIANCE DATES

April 30, 2017 — food safety verification for companies exporting product or ingredients to American-based small businesses;

August 30, 2017 — companies with fewer than 500 full-time employees;

August 30, 2018 — companies with annual sales of less than $1 million (for animal products, $2.5 million)

The big compliance date has come and gone, and food manufacturers and their suppliers are now subject to the Food Safety Modernization Act (FSMA).

Yet in many ways, the September 2016 deadline was only the start of a new countdown to compliance for small and and very small food companies and their suppliers, domestic and foreign.

Let’s take a look by examining what “compliance” actually means to the Food and Drug Administration, the agency that governs the food industry and manages FSMA:

  • ENFORCEMENT. Although FSMA is in effect for large-scale, multinational food companies, the FDA has offered industry a grace period in which education will take precedence over enforcement. Essentially, regulators are allowing manufacturers and their suppliers an extended period of time to implement the new safety law’s many requirements without fear of citation, license revocation or a mandated food recall. However — and this is a big caveat — the FDA will crack down on “egregious” FSMA violations, defined as activities that demonstrate that a food company is willfully failing to comply with the new law.
  • SMALL BUSINESS DEADLINES. The FDA’s rules offer a helping hand to small businesses in the food industry by extending compliance deadlines for nearly a year – to August 30, 2017. What constitutes a small business? Generally, the FDA says, a small business is one with less than 500 full time equivalent employees. There is also a “very small” business category, with a somewhat different definition: a company with average annual sales of less than $1 million, including the market value of inventory on hand. (For producers of animal food, the cutoff for compliance is annual sales of $2.5 million).
  • IMPORTERS. How to insure compliance for food importers is one of the trickiest aspects of FSMA. The overall intent of the law is clear: the United States wants foreign-based suppliers of food items or ingredients to be held to the same safety standards as American-based firms. Yet the various rules governing what the FDA calls the Foreign Supplier Verification Program (FSVP) have differing compliance dates tied to the size of the importing company, where it is domiciled, and what it is shipping to the U.S. Suffice it to say that if a small American company is importing food items from overseas, it must verify the foreign supplier’s compliance with FSMA standards by April 30, 2017.
  • TRAINING & ASSISTANCE. A baked-in assumption in FDA’s rules is that large manufacturers will already have been close to compliance, but that smaller firms many not possess the budget, personnel or access to training to meet FSMA’s tough new safety standards. One solution is the Food Safety Preventive Controls Alliance, comprised of government, industry and academic advisors who can assist small businesses understand FSMA’s requirements and schedules through seminars, distance learning and online and printed materials.

American manufacturing is by and large driven by small business. Of some 252,000 manufacturers of all types in 2013, according to the National Association of Manufacturers, the vast majority employed fewer than 500 people, the cutoff point for FDA compliance next year, not this year.

What these numbers suggest is that reaching the thousands upon thousands of employees and persuading them to make food safety a personal responsibility will take time, effort and patience. Thankfully, the FDA has recognized the scope of the task, and is rolling out FSMA compliance in a way that helps every business adjust to the new law.

 

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A Safer Food Supply?

Will the nation’s food supply be safer under FSMA?

The new Food Safety Modernization Act, or FSMA, which takes full effect in September, has a multitude of goals, but foremost of these is insuring that the nation’s food supply (human and animal) is safe – safer than it already is. Will the new law do that?

That was certainly the motivation for passage of FSMA in 2011. Congress recognized that the vast American food supply from farm to table was very safe, but also persistently vulnerable to microbiological contamination, accidents, and terrorist threats. FSMA addresses these dangers directly and indirectly. Here are three of the primary goals behind the new food safety regulations.

  1. Responding to the new realities of a global food chain. America’s food supply throughout much of its history has been largely self-contained: American growers, ranchers and manufacturers accounted for the vast majority of food items available to consumers. But it was never 100% domestic: Coffee from Africa and Central America; winter produce from Mexico; Canadian wheat, spice from Southeast Asia. As the consumer palate has become more varied and reflective of diverse cultures, our food supply is incredibly global in scale. FSMA is intended to insure that all food items and ingredients coming from overseas are subject to stringent safety protocols.
  1. foodmfgPlacing more aggressive regulations on suppliers, not just manufacturers. If the world’s food supply were envisioned as an iceberg, the portion above the water line would represent manufacturers, processors, and retailers. The portion of the iceberg below water – by far the largest segment – would represent the thousands upon thousands of suppliers that play a pivotal but often overlooked role in food safety. It’s a supply chain that is both widespread and granular in scope: it includes makers of conveyor equipment, as well as suppliers of lubricants for that equipment.
  1. Preventing food safety issues rather than relying upon government intervention only when there’s a problem, is at the very heart of FSMA, and one that should have the most immediate and beneficial impact on food safety over time. That’s because, for the first time, food manufacturers and processors, along with their supply chain partners, have clear direction in preventing food contamination by creating and maintaining a food safe environment up and down the supply line. One requirement alone – having in place a comprehensive food safety plan – is perhaps the single most significant of all of FSMA’s many regulations.

Of course, maintaining a 100 percent safe food supply is literally impossible. But as an aspirational goal, FSMA represents forward thinking on the part of the government and the food industry, both of which have an obvious, vested interest in producing and selling products that are as safe as they can possibly be.

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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.

 

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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.

 

 

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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.

 

 

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