The Alphabet Soup of Food Safety (Part I)

FSMA. FSSC22000. GFSI. HAACP. SQF. Stop! My head hurts.

This is the likely reaction of anyone performing a deep dive into the intricacies of the world’s food safety standards. But understanding the acronyms of the various entities involved in food safety is well worth the time and effort if you are a food manufacturer or supplier. Why? Because the safety standards – a mix of voluntary, industry-led guidelines and government mandated regulations – will likely play an important, perhaps even decisive role in your business going forward.

What follows is the first of a two-part blog on helping food manufacturers and their suppliers – here and abroad – understand the key organizations and programs involved in safeguarding the global food supply.

Ready? Let’s jump in . . .

FSMA — This is the Food Safety Modernization Act of 2011 passed by Congress and signed into law by former President Barack Obama. It is watershed legislation because of its dramatic shift in focus from dealing with foodborne illness outbreaks after they occur to preventing them (as much as possible) from happening in the first place.

The rules and procedures in FSMA took regulators from the Food and Drug Administration more than five years to draw up and finalize. Much of the work (as this post demonstrates) was based upon already existing food safety procedures and guidelines. Implementation is now underway using compliance timetables generally related to the size of companies. FSMA applies to farmers and growers (but not cattle ranchers), manufacturers and processors, as well as shippers. Its provisions also apply to companies that http://www.sqfi.comimport food into the U.S.  Food, under FSMA, is both for humans and animals.

(In the U.S., government agencies and academia have teamed up to create the Food Safety Preventive Controls Alliance (FSPCA) to help train companies on how to meet FSMA’s regulations).

HAACPHazard Analysis and Critical Control Point (HACCP) is an internationally accepted management program for reducing potentially dangerous hazards in food. HAACP forms the basis of the new food safety act as well as voluntary food safety certification programs.

A HACCP System requires that potential hazards be identified and controlled at specific points in the manufacturing, storing and distribution process along the global food chain. This includes biological, chemical or physical hazards. Any company involved in the manufacturing, processing or handling of food products can use HACCP to minimize or eliminate food safety issues from occurring. (The language in FSMA refers to “preventive controls,” which largely build upon HAACP principles).

GFSIThe Global Food Safety Initiative is a Paris-based association of major food companies that promulgates food safety protocols (or “schemes) for food companies.  It was formed in 2000 in response to a series of serious food safety crises. GFSI is a voluntary organization. Industry-led committees and workgroups formulate schemes, which serve as benchmarks for companies that want to gain GFSI certification. Although it has a global reach, GFSI’s schemes have been adopted more internationally than in the U.S.

SQFThe Safe Food Quality Institute is a standard-setting, voluntary organization for the food industry, with a focus on U.S. based food retailers. The SQF Program is recognized by the Global Food Safety Initiative (GFSI) as a Food Safety Management Systems Certification program (see more below).

ISO The International Organization for Standards, based in Geneva, Switzerland, is an independent, non-governmental organization of some 163 national standard setting bodies. The standards, many thousands in all, cover a wide range of industries (including the human and animal food industry) through “best practice” specifications for products, services and systems. The standards are voluntary – they don’t carry the force of law – and are based on consensus of relevant national standard setting bodies.

Importantly, ISO itself does not provide certification that a company has met its standards; this is done by external certification bodies (such as SQF). Once certified, a company can promote its compliance with the ISO standard.

FSSC 22000 – This is a Food Safety Management System (FSMS) Certification Scheme. Certification is granted to retailers, manufacturers, suppliers and others when the companies have implemented prevention-based hazard food safety controls and a third-party auditor has audited the system to verify that it complies with its requirements.

FSSC 22000 is a certification program recognized by GFSI. In April, 2017, it issued its 15,000th certificate.

Whew! That’s a lot of information to absorb. The point is that taken as a whole, these organizations are all about establishing and maintaining worldwide food safety standards. In Part II, we’ll show you how these organizations compare to, and differ from, regulatory efforts via the new American food safety law, and why that law is both evolutionary and revolutionary in its scope and intent.

 

 

 

 

 

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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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