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 “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.

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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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The Challenge of FSMA Transparency

UPDATE

The critical importance of food transparency was underscored by the results of a recent global survey on consumer attitudes about overall food safety. Bottom line, confidence in food safety has declined, and consumers look to manufacturers and retailers to be proactive in preventing food contaminations and recalls. Read about the survey results here:

 

The new Food Safety Modernization Act (FSMA) presents food manufacturers and their suppliers with a significant challenge: how to efficiently filter FSMA preventative controls down the food supply chain to encompass the thousands of suppliers and vendors that will have to create and manage their own food safety plans?

The answer lies in a key section of FSMA, which codifies in its regulations the concept of “supply chain transparency.” Under the new regulations drawn up by the Food and Drug Administration (FDA), a manufacturing/processing facility must have a risk-based supply chain program for those raw material and other ingredients for which it has identified a hazard requiring a supply-chain applied control. In other words, at every step along the food chain from farm to table, manufacturers and producers must be fully cognizant of the safety controls of their suppliers – and have the records to prove it.

Actually, transparency has been around for several years in business-to-business circles. A series of disastrous food recalls traced to suppliers who either didn’t know what they were doing, or intentionally sold adulterated, unsafe product, prompted businesses here and abroad to begin putting their suppliers on notice: unsafe practices will not be tolerated. Under FSMA, manufacturers are obliged to hold their suppliers to the same food safety standards they must follow.

(Transparency and another descriptor, traceability, are often used interchangeably, but have slightly different meanings. Traceability usually describes the technical ability to verify the identity, history, location or application of an item, while transparency is used when talking about broader collaborations among trading partners in the food chain).

For the FDA, supply chain transparency is part of the agency’s new operating model that emphasizes strengthened collaboration and improved information sharing and gathering among trading partners, data-driven risk analytics, and the smart allocation of resources for food safety management.

food mfg close upThere are many places along the manufacturing production line where unintentional food adulteration may accidentally occur. Water used to hose down equipment may contain harmful bacteria. The lubricants used to keep the machines running at peak efficiency might touch the product as it whizzes by. And so on.

Suppliers of material used in manufacturing, such as lubricants, are required under FSMA to demonstrate that their products are properly formulated, labeled, stored and used to prevent compromising food safety, and that only “food grade” lubricants are allowed in those parts of the manufacturing facility where the food is produced. Lubricant manufacturers also must document their processes so that if a food safety problem arises, preventative control records and product formulations are readily accessible should a problem arise.

Over time, transparency will become second nature for manufacturers and their many supply chain partners. For the time being, however, companies all along the food chain are quickly realizing that the new way of doing business to prevent food contaminations will require time, attention and management focus not just inside their own operations, but also up and down the supply chain.

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