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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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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Small Businesses Catch a FSMA Compliance Break

The nation’s new food safety law took effect for a substantial chunk of the vast food industry in mid-September. But the Food and Drug Administration, rightly concerned that smaller sized manufacturers might not have the resources to comply with the complicated new regs, has given that segment a break by putting off compliance for another year, until August. 30, 2017. (There’s even another year added for really small businesses, those with less than a $1 million in annual sales, counting inventory).

In the meantime, and again due to the complicated nature of the law, the FDA has explained that in the first few months following enactment, it will emphasize education in the details of compliance, rather than enforcement of the regs. But manufacturers beware: the agency adds that “egregious” violations of the new standards will be dealt with severely, including the possibility of a mandated recall. That threat alone ought to spur compliance; a major Class I recall can cost a brand millions of dollars in returned or destroyed product, plus incaluable damage to the copany’s reputation.

For additional information, here’s a link to a blog by CRC Industries, Inc., (a food industry supplier of machine lubricants).  The site that has become a “must visit” source for businesses of all sizes in the food manufacturing industry:

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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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FSMA Gets Tough on 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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Is FSMA Really Necessary?

As the Food Safety Modernization Act of 2011 was being considered by Congress (and even after its passage) many in the food chain questioned the need for the new regulations. Voluntary efforts, it was argued, would be much more efficient and less costly than bureaucratically imposed requirements.

The Act, known by its FSMA acronym, is now law, and implementation is underway. But is FSMA really necessary? Read more at:

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