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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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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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 Challenge of Date Labeling

One of the food industry’s most vexing challenges is creating a food package date label that everyone understands.

The problem, and potential solutions, are well-documented; here’s a report from 2014 that I co-authored that spells out the issue in detail. In fact, a comprehensive (albet voluntary) model open dating regulation created by the National Conference of Weights & Measures has been available for some 40 years. But adoption of the model law has been slow and spotty and as yet, there is no national labeling law other than one for infant formula.

Food LabelClearly, a universally acceptable date label remains a frustratingly elusive goal, and no wonder. The manufacturer and retailer need a package code that would help them trace a product involved in a food safety recall. The retailer also needs a date code (“Sell By”) to insure proper inventory circulation. Consumers need something different altogether: a date that tells them if the items in their freezer or pantry shelf are still good — and safe — to eat. Balancing these complementary needs has been a difficult condundrum that, among other negative impacts, has resulted in the wasteful loss of tons of perfectly edible and safe food each year — food discarded at the manufacturing plant, the grocery store, the restaurant and cafeteria, and the home kitchen.

Now, efforts are underway once again to tackle the problem. Those efforts appear to coalesce around a handful of potentially realizable goals:

  • A uniform, national regulation requiring all packages sold to consumers to include an open (i.e., “Best if Used By) date;
  • A national regulation requiring packagers to imprint a coded label that shows the date of manufacture and the lot number for use in the event of a recall;
  • A concerted customer-directed public service program to inform the general public what, precisely, “Best if Used By” means. Such a program would include media public service advertising, social media and, perhaps, tags on products that require strict handling and storage methods to avoid contamination;

For these goals to be reached, Congress will need to understand the benefit of uniform open dating. Manufacturers will need to upgrade their packaging and labels to accomplish product uniformity, and end-users (you and me, and our friends and neighbors) will need to be informed about the critical relationship of open dating labels and proper product handling and storage.



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Tracking Food Contamination Outbreaks

There is dramatic evidence for consumers that food safety measures are increasingly sophisticated, which is a good thing.

With little public attention, several recent and related recalls of a variety of food items suspected of being contaminated with Listeria have been carried out regionally and nationally since March. That’s the bad news. The good news is that science was put to use to link the tainted products to a single food producer, CRF Frozen Foods, Inc. in Pasco, WA. This was accomplished in large part because state and federal regulators were able to connect reports on eight Listeria-infected people from California, Maryland, and Washington to vegetable products produced by CRF Frozen Foods using both epidemiological and laboratory evidence.

frozen-veg-aw-620x0The evidence began accumulating when, as part of a routine product sampling program, the Ohio Department of Agriculture collected packages of frozen vegetable products from a retail location and isolated Listeria monocytogenes from True Goodness by Meijer brand frozen organic white sweet cut corn and frozen organic petite green peas. Both products were produced by CRF Frozen Foods.

Based upon the positive findings in Ohio, CRF recalled 11 frozen vegetable products on April 22, because they were suspected of Listeria contamination. Further testing using genome sequencing to isolate Listeria in the frozen product clinched the case. The isolate was closely related genetically to bacterial isolates in the stool of people who had been ill after eating the contaminated product. On May 2, 2016, following a conversation with the Food and Drug Administration and the CDC, CRF Frozen Foods expanded its recall to include all of its frozen organic and traditional fruit and vegetable products manufactured or processed in CRF Frozen Foods’ Pasco facility since May 1, 2014. It also initiated a series of secondary food recalls from companies supplied by CRF, including Meijer, Kroger and ConAgra Foods. Approximately 358 consumer products sold under 42 separate brands were recalled.

Sophisticated Sleuthing

The importance of this laboratory sleuthing cannot be under-estimated. Until recently, state and federal regulators and health officials had a difficult time linking food illness outbreaks. They could do it, but it took weeks and sometimes months to determine whether contaminations originated with one supplier or brand. Advances in microbiology and genome sequencing give regulators highly effective tools to establish that contaminated products that infected people in scattered locations came from one source.

There’s another reason this series of related recalls is important. It demonstrates beyond question that the nation’s food supply chain is not only inextricably linked, but also — and because of those links — highly vulnerable to widespread outbreaks of food-borne illness. CRF Frozen Foods supplies not just retailers, but also national brand producers and downstream wholesalers.

Chasing down all these potential leads takes time, effort and staff resources that regulators simply don’t have. But with the advent of new scientific methodology, we are likely to see more quick action to prevent large-scale food illness outbreaks by getting suspect products off the shelves and out of homes as quickly as possible. Doing that — moving swiftly to control outbreaks — is very definitely a good thing.

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Training for FSMA: Who Does It and How?

One of the major, but often overlooked, challenges when sweeping new legislation is enacted involves training the people — managers, production supervisors and shift workers — who will be required to implement and execute the regulations.

Fortunately, the Food and Drug Administration (FDA) took several steps in anticipation of that challenge, as outlined in this blog:


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