Sorting Out Food Safety Certification

An entire cottage industry has grown up around food safety training for manufacturers, retailers and suppliers. That’s a good thing, and it reflects a high degree of cooperation between government regulators and the private sector.

At the same time, however, there are many certification programs or “schemes,” which can create confusion over such fundamental issues as whether a certain program is voluntary or mandated by law.

Luckily, SAGE is on top of the issue. Below are links to two blog posts that cover food safety training standards in depth, and clarifies who is responsible. With the nation’s new food safety law, the Food Safety Modernization Act, or FSMA, rolling out implementation, it’s a perfect time for the food industry to become conversant with the many training programs and requirements of the new regulations.

The Alphabet Soup of Food Safety (Part I)

Adopting Global Food Safety Standards (Part II)

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FSMA’s Looming Funding Crisis

The Food Safety Modernization Act, now being implemented nationwide, represents a sweeping change in how the nation’s food supply is regulated. But paying for the costs of enforcing the new law is a looming crisis that could threaten food safety efforts.

A brief background: for years, food safety was a government priority only after-the-fact; that is, federal agencies typicaly took action after a costly and potentially dangerous food contamination issue had occurred. With the new legislation, known by its acronym “FSMA,” the focus has totally shifted to prevention and from government oversight to industry preventive controls. Food manufacturers and processors of human and animal food, shippers, and importers of food and food ingredients all must create and maintain a system of preventive controls to spot problems as they arise and deal with them or face severe fines and the threat of criminal action.


One aspect of the new law that hasn’t received much attention is the always consequential matter of who pays the costs of enforcement. While users fees collected by the FDA cover some of the expense, Congress envisions FSMA as a federal and state partnership to share inspection costs. The FDA simply has never had sufficient budget authority to fully fund inspection services. States have covered this gap by assigning inspectors from health departments to help oversee the vast food industry.

Two new factors are raising concerns about whether the FDA and state health departments will be up to the task of enforcing FSMA’s many new requirements.

One is the sheer size and scope of FSMA. It covers all domestic food manufacturers and processors, domestic produce suppliers, and importers of foodstuffs or ingredients. The second issue is budget authority under the Trump Administration. It is a matter of record that the White House opposes government regulations as needless interference with business. The unsettled question currently is how that attitude will translate into federal funding (or defunding) for existing programs already authorized and implemented.

At the federal level, the Trump Administration’s budget plans are highly fluid. Its first budget proposal would cut the budget of the Department of Health and Human Services (where the FDA is located) by some 15%. Further details have not been forthcoming but given the Administration’s many public comments about getting rid of government regulation, it’s certainly possible that monies earmarked for FSMA enforcement may be trimmed.

Recognizing this possibility, the National Association of State Departments of Agriculture (NASDA) have asked Congress for an additional $100 million annually for “sufficient funding” to implement FSMA inspections and oversight. Most of that money, if appropriated, would be earmarked for state-level inspection that would augment FDA enforcement activity.

Seeking additional federal dollars, given the prevailing anti-tax sentiment in Washington, may seem like a fool’s errand. But state budgets aren’t all in rosy shape, so governors may not have much choice. According to a new report by the Pew Charitable Trust, “the slow pace of tax revenue growth has left many states with little or no wiggle room in their budgets. Twenty-three states still collect less tax revenue than at their recession-era peaks, after adjusting for inflation, and most have a thinner financial cushion than they did before the last downturn. In addition, 16 states’ employment rates still clearly trail 2007 levels. Despite these challenges, personal income in all states has bounced back above pre-recession figures, though growth has fallen short of historic norms.”

Translated, that means states will be hard-pressed to increase food safety enforcement budgets, much less maintain previous spending for inspections and enforcement actions.

All of which leaves the fate of FSMA up in the air. There’s little indication that the food industry wants to turn back the food safety page — the general public would not like that scenario — but by the same token, lax enforcement resulting from budget cutbacks would put food safety more or less where it was — largely passive and reactive to food borne illness outbreaks.

That can’t be a good solution for anyone.

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The “Qualified Individual” for Food Safety Explained

One provision of the new food safety law requires manufacturers and processors to create a position, termed by the FDA as a “qualified individual” who will be responsible for maintaining food safety compliance at the plant and distribution levels.

Also known as the Preventive Controls Qualified Individual (PCQI), the position is laden with a wide range of responsibilities involving food safety protocols. It also requires rigorous training.

Here’s a recent blog on the subject . . .

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Examining the Fate of Federal Regulations on Food Safety Laws

The Trump Administration seems determined to reduce federal regulations on business. Will that goal impact the Food Safety Modernization Act (FSMA) and other regulations governing the nation’s food supply?

Right now, the outlook is uncertain. But there are some things we do know. Here’s a rundown of the current situation:

  • The seldom-used Congressional Review Act of 1996 has been resurrected by the Republican majority in the House of Representatives to evaluate executive actions put in place by the outgoing Obama White House in the closing two months of his incumbency. Although there are no significant FDA rules that fall under that timeframe, recent rules issued by the US Department of Agriculture are impacted, such as the Agricultural Marketing Service’s recent rule on livestock and poultry practices under the National Organic Program;
  • As of this writing, the post of FDA Commissioner has not been filled. Speculation has centered on candidates who are experienced in drug and pharmacy rules, not food safety. Confirmation of whomever is nominated will take months because the position requires Senate confirmation. Without a top executive running the FDA, it is highly doubtful the existing staff will do anything more than routine business;
  • For the moment, FSMA appears to be isolated from the Trump Administration’s regulation axe. However, “for the moment” is the operative phrase. There is still a chance (albeit slight) that the landmark food safety legislation might be subject to modification or even repeal.

The possibility exists because shortly after his inauguration, the President issued a series of related executive orders dealing with what his Administration asserts are needless and burdensome government regulations. One order directs each Federal agency to appoint a Regulatory Review Officer (RRO) and a corresponding Regulatory Review Task Force (RRTF).  Their overarching assignment is to look at all existing rules and laws under that agency’s control and calculate whether the costs of regulation outweigh benefits to affected consumers and businesses;

Theoretically, an FDA review task force could look at FSMA and conclude that in its scope and detail, it meets the Administration’s criteria for repeal, replacement or modification. However, no such action can happen without first seeking input from consumers, businesses and trade associations, much like the current comment period required by Federal law. Then, if there is still an intent to modify the food safety act, Congress would have to introduce new legislation and submit the proposal into the normal legislative process of committee hearings, public input, and so on.

Bottom line: Federal laws and regulations are perennial targets of criticism by both Republicans and Democrats. Revising or repealing them, however, is no quick or easy matter. As it relates to FSMA, the Trump Administration would have to argue that preventive rules to control food contamination and illness outbreaks — the heart of the law — are not worth the costs of the regulations to consumers.

In today’s world, where expensive foodborne illness recalls are all-too-common occurrences, that would likely be a difficult hard sell.


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Is a Food Safety Culture Possible?

In a presentation at a food safety conference recently, then-acting FDA Commissioner Stephen Ostroff observed that for the new food safety law to succeed, there needed to be a “food safety culture” throughout the global food chain.

Dr. Ostroff didn’t define what that culture was, but his meaning was clear: insuring a safe food supply is as much a matter of commitment and mind-set as it is regulations and procedures.

Now, with the new law largely in effect, do the people who harvest, manufacture, process, ship, sell and consume food possess a sensibility – a culture – in which safe food is a paramount concern?

food inspectorsThe short answer is that we will find out over time. There are promising initial trends. The Food Safety Modernization Act, better known as FSMA, has established a regulatory framework in which the prevention of food contamination along the supply chain is the dominant priority for the broad food industry. Also, advances in microbiology and genome sequencing are making it possible to quickly limit the spread of food-borne illnesses, saving untold number of people from serious illness or death

Those very same food consumers — families and households who enjoy the boundless productivity and quality of food products – are a big problem, perhaps the toughest challenge of all. Can individual consumers and by extension all consumers adopt a safe food culture? In a world in which a third of all food produced is thrown away every year, in part because they don’t understand the often confusing “best by” labels, it is clear that a prevailing awareness of food safety in the kitchen is at this point an aspirational goal.

A valid comparison is the transition in this country to a non-smoking environment. Smoking was a habit, but also an accepted social activity. To many, it was a coming-of-age ritual. Yet overtime, spurred by government research, the dangers of smoking became all too apparent, and the number of those who smokes began to gradually decline.

It was proven that smoking can kill. So, too, can food contamination. The Centers for Disease Control (CDC) estimated in 2016 that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases.

A brief overview of food safety-related issues shows how far we have come as a nation, and how still far we need to go in creating a safe food culture.

We know a great deal more about the causes of food contamination, how it spreads and how to contain outbreaks. Advances in microbiology and genetics enable epidemiologists and food safety inspectors to better track not only what causes food contamination outbreaks, but also how they spread.

We also are gaining new understanding of how to encourage safe food habits through research in the field of behavioral science – the discipline that examines why people act the way they do. For example, research over many years shows that people by and large learn to change their habits and preconceived notions from others – call them authority figures — whom they trust. A good example is the man in the white coat phenomenon: research reveals a behavioral trait called “enclothed cognition,” which is the tendency of people to more likely believe and trust those who wear symbolic clothing – the white coat of the scientist or doctor, or the officer in military garb.

How does this relate to food safety culture? One intriguing possibility is the tendency of people to adapt the behavior of others in certain situations, rather than exercising their own independent judgment. On the battlefield, for example, research has shown that what motivates soldiers to risk their live is the desire not to let down those fighting beside them. Firefighters are celebrated the world over for their incredible level of shared sacrifice. Could a desire to adopt safe food habits because others are doing so a possibility?

Listeria monocytogenes bacteria,  Courtesy James Archer



We are a long way from that ideal, clearly. After all, old habits die hard. And other research is not encouraging. Human error is widely accepted as perhaps the leading cause of serious unplanned events, which food-borne illness outbreaks surely are. Moreover, a dignificant percentage of food-related illness happens in the home via cross-contamination or insufficient temperature controls for perishables. Yet bringing a food safety consciousness into the home is an especially daunting task. Industry trade associations such as the Food Marketing Institute and the Grocery Manufacturers of America have spearheaded food safety information campaigns for decades but follow-up research indicates that the camapigns have had limited durable impact. Food retailers like Publix and Walmart are attempting to encourage a food safety culture in the home using gift cards and other incentives.

Yet there are also encouraging signs. Microbiology is a young science dating back to just the 1870s. Identified foodborne illness culprits, including Listeria, ecoli, norvoviruses and salmonella, weren’t even mentioned in school textbooks as recently as 50 years ago. The precursor of FSMA, the Hazard Analysis and Critical Control Point (HACCP) program, was developed for the NASA space program only in the 1960s and gradually spread to the food industry. The industry voluntary initiative on food safety, the GFSI, was assembled only within the past six years.

Scientific progress in food safety certainly is accelerating. Using sophisticated genome sequencing techniques, Listeria outbreaks can be detected when as few as two people have gotten sick, according to the CDC. The technique can isolate the precise cause of contamination, giving manufacturers, shippers and retailers (not to mention consumers) a head start in quarantining suspect product more quickly, thus lessening the chances of a serious public health crisis.

Where does this leave the nation and the safety of our now global food supply? FSMA holds the promise of substantially reducing food contamination, thus making our food safer. Its emphasis on prevention seems exactly right in emphasizing the food industry’s critical participation in advancing controls that reduce the chances of infection in the first place.

The concern now is that this progressive trend might be delayed or stopped altogether. Opposition to government oversight remains a hot political issue and, so far at least, it appears that the Trump Administration and Congress are looking for ways to lift burdensome government regulations, as FSMA surely is. It’s also true that food safety protocols are expensive and time-consuming. These are typically not issues for large manufacturers. But what of the small-scale processors; will they be able to afford the costs of maintaining a food safety regimen? Can plant managers instill in production line employees the critical necessity of the proper maintenance of machinery to avoid cross-contamination accidents? At this point, with FSMA still in its fledgling stage, it’s too soon to tell.

One thing is certain, however. The estimated 2,700 – 3,000 deaths each year of hundreds of consumers, and the severe illnesses others suffer, from eating dangerously contaminated food, should offer sufficient incentive to get food safety ingrained into the minds and actions of everyone who produces food and eats to live.

That ought to be an accepted benefit whether anyone happens to be wearing a white coat or not.

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FSMA Infographic

Anything as complex as the new Food Safety Modernization Act (FSMA) begs for a more simplified explanation.

A good case in point is the myriad deadlines for implementation and compliance of the law by who is directly affected: large, small and very small food manufacturers (and their forest of suppliers), foreign-based food importers, transportation companies and so on. The FDA has done yeoman’s work in publishing online information materials; the agency also has put on seminars and webinars and the food industry itself has committed time and resources for employee training on FSMA’s many details.

That said, the world of communication is growing steadily more visually-oriented. Most newspapers and magazines emphasize video and large-scale graphics to help explain the day’s events. And the online space is predicated on a rich visual environment (best evidenced, perhaps, in the vast array of cute puppy sites and posts). Note: mentioning puppies is a good reminder that animal food manufacturing also is covered by the food safety law.

Here (below) is a graphic we’ve produced to help explain just one facet of FSMA — its key deadlines for full implementation. It is by no means inclusive; to portray every implementation date would require a graphic that would have to be scrolled up and down. But this should give readers a quick glimpse of those dates that are crucial to the new law’s rollout.

It is also worth noting that the law’s implementation could be delayed because the FDA’s budget is cut back, or the new Administration decides to review existing federal regulations. Still, there’s every reason to believe that the nation’s food supply, already among the safest in the world, will become even safer in the years ahead.

For households and their pets.

FSMA Timeline

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Will the Federal Regulatory Freeze Halt FSMA?

The quick answer is “no.” Here’s why:

Every new Administration, Donald Trump’s being no exception, immediately calls a halt to pending federal regulations left over from the preceding White House occupants. Trump’s team imposed the freeze almost as its first official act.

But, even though such announcements generate losts of headlines, taking this action is more a pro forma exercise that, when you think about it, makes sense. Why would a new Administration want to move along potential new regulations that its predecessor wanted? Well, if they were of the same political party, you could see that happening. When the White House changes politically, it is expected that the new President will want to start with a clean slate; hence the regulatory freeze announcement.

As for the Food Safety Modernization Act (FSMA) the freeze doesn’t apply. For an explanation, read on here . . .


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The Challenges of FSMA Compliance

WIth the new Food Safety Modernization Act now largely implemented, food manufacturers are coming to grips with the law’s many new requirements. One of the most daunting is the provision mandating that companies keep detailed records of how they maintain compliance with the law, including inspection reports, equipment cleaning, personnel training and many others.

Here’s an overview of what the law requires along with suggestions on ways to manage the record-keeping challenge:

FSMA’s Record-Keeping Challenge


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FSMA’s Future with the New Congress

Government programs and regulations typically obtain budget authorization on a year-to-year basis, always subject to Congressional approval. When a new Administration takes over, however, it looks for ways to put its own stamp on government programs — canceling or cutting back on some, while expanding others.

So it is likely to be come January, when the new Trump Administration and the GOP-led Congress are sworn into office. At this point, it is anyone’s guess which current programs will evade the budget axe, which will receive new funding, and which will be amended, altered or remain untouched.

One such program of great importance to food consumers is the Food Safety Modernization Act of 2011 (known by its acronym FSMA), passed by a Democratic Administration and just now being implemented after five years of rule-making by the agency charged with the law’s implementation, the Food and Drug Administration (FDA).

It is too soon to tell what, if anything, might happen to FSMA, but here’s a link to a blog post on some possible outcomes:

Is the Nation’s New Food Safety Law on the Cutting Block?

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FSMA Supply Chain Disclosure Rules

A little noticed provision of the new Food Safety Modernization Act (FSMA) gives food companies some degree of relief from having to implement costly preventive food safety controls — as long as they disclose to their supply partners that their product may contain potentially dangerous food hazards that will have to be dealt with.

The provision went into effect earlier this year under Section 21 CFR 117.136 of the FSMA regulations. It allows a manufacturing or processing facility to sell product containing a known hazard to the next business in its distribution network as long as both companies, the sender and receiver, have written assurances from each other that the product will be handled to remove the hazard before it reaches the retail market.

(Note that the word “customer” is not synonymous with “consumer,” as in an end-use household. A customer in FSMA parlance is a supply chain partner that purchases a food product, processes it, and then moves it on through the distribution system).

A good example of how these provisions will work are items such as coffee or cocoa beans that would likely not be eaten without further processing. The first entity in the distribution that handles the beans would not be required to have a hazard control plan in place as long as it was selling the beans to a customer (say, a bean processor) that does have a preventive control plan to remove any potential health hazard.

In essence, the disclosure provisions incorporated in FSMA establishe interwoven and binding food safety checks and balances among various players in the food supply chain. The procedures apply to food products, food ingredients, and produce as well as to foreign suppliers importing food products or ingredients into the United States.

The critical component in this procedure is proper notification between suppliers and customers, according to the Food and Drug Administration. In its rule making, the FDA emphasized that a businesses adquately disclose known or potential food safety hazards in products.  Written documentation must accompany all food shipments. Additionally, the customer obtaining product with a hazard declaration must provide the supplier with written assurances that it has an established preventive control process to remove the hazard. These assurances — from supplier to customer and from customer to supplier — must be disclosed annually.

Bread productionBottom line: if you are a manufacturer or processor working with business partners who have given you written assurances that they have a preventive control plan in place, you can sell product to those partners as long as you have written assurances that the potential hazard will be eliminated before the food reaches the end-use consumer.

FDA requires the disclosure must be made in “documents accompanying the food in accordance with the practice of the trade.”  This allows for using a wide variety of types of documents that accompany the food, such as labels, labeling, bill of lading, shipment-specific certificates of analysis and other documents or papers associated with the shipments that the customer’s food safety manager is likely to see and read. However, contractual agreements, letters of guarantee, specifications or terms and conditions of use are not considered adequate since these documents are not applicable to particular shipments.

Importantly, the FDA is soliciting additional public comments on these customer notification provisions. After it goes through the comments, it will issue a “guidance” document intended to help businesses better understand their disclosure requirements.






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