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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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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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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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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FSMA Ushers In New Era of Shared Food Safety Responsibility

The new Food Safety Modernization Act of 2011 is finally here.

As of this weekend, large scale food manufacturing operations in the U.S. and abroad must be in compliance with the sweeping new law, known by its acronym FSMA. This follows five years of regulation writing and review by the Food and Drug Administration, many revisions, deletions and additions, and enough controversies to last a lifetime.

The slow process from enactment to implementation is hardly surprising in view of the scope of the new law and the huge, sprawling industry it oversees. According to the Department of Labor’s Bureau of Labor Statistics, food manufacturing in the U.S. alone consists of 32,200 processing plants and employs 1.5 million people, not even counting agricultural workers, grocery store employees or restaurants!

Following is an overview of the new law and what it means for the food industry, and food safety.


FSMA covers human and animal food production from harvest through distribution. Foods imported from overseas are now covered, as well. However, meat, poultry and seafood products are excluded because they are regulated by separate agencies within the Department of Agriculture (FDA’s parent agency). Also excluded are supermarkets and restaurants, which are regulated by state and local statutes.

frozen-veg-aw-620x0The new law’s focus is squarely on manufacturing and that sector’s vast supplier network. The rationale for this focus is that most food safety outbreaks are the result of breakdowns in the production and distribution of products. Despite the universal belief that America’s food supply is the safest in the world, each year around 48 million Americans become sick due to a foodborne illness. Some 3,000 die as a result, according to the Centers for Disease Control and Prevention.

Under old food safety regulations, first enacted in 1937, the FDA exerted a largely passive role, reacting to food illness outbreaks after the fact, and working with the industry to encourage voluntary recalls when needed.

With FSMA, that approach is changing dramatically.


The basic concept underlying the new food safety law is proactive prevention. Under FSMA, regulated companies must undertake a series of internal measures to meet compliance standards and avoid contaminations. Responsibility for food safety falls more than ever on the shoulders of the firms that make and distribute our food.

The key provisions are as follows (directly from FDA’s website):

  • Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. Final rule issued: Sept. 10, 2015.
  • Preventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals. Final rule issued: Sept. 10, 2015.
  • Produce Safety: Establishes science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. Final rule issued: Nov. 13, 2015.
  • Foreign Supplier Verification Program: Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers. Final rule issued: Nov. 13, 2015.
  • Third Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. Final rule issued: Nov. 13, 2015.
  • Sanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food. Final rule issued: Apr. 5, 2016.
  • Intentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm. Final rule deadline was May 31, 2016.

These provisions, however, don’t offer a full reckoning of what’s required to insure business compliance. For example, putting in place preventive controls for human (or animal) food will require manufacturers to have conducted a thorough hazard analysis of their facilities to identify trouble spots (hard-to-clean equipment, leaky roofs, etc.), from which a plant specific Food Safety Plan must be created. That plan requires a training requirement for the relevant employees in each facility. Moreover, the plans must be reviewed and updated every 2-3 years, and they also are subject to 24-hour notice by FDA inspectors.

During FSMA’s rollout, much concern was expressed about the ability of companies to meet these requirements, especially smaller-sized suppliers with limited budgets. There are different deadlines for these smaller businesses, but by September 2017, all manufacturing in the U.S. must be in FSMA compliance.


No company likes being subject to a food recall. They are costly, they cause tremendous internal upheaval, and they can sabotage a company’s brands and overall reputation.

To encourage compliance, FSMA takes the threat of recalls a step further by holding company executives directly responsible for food safety breakdowns. Under the so-called Park Doctrine, the Department of Justice is able to extend civil and criminal liabilities to executives who fail to actively manage food safety practices in their organization. As SAGE Food Safety Consultants reported in April, the significance of the Park Doctrine can not be understated. The doctrine means that businesses that food products for humans and animals now have an affirmative duty to ensure the safety of their products.

However, given the scope of the new requirements, the FDA’s initial post-compliance strategy is to emphasize industry education over regulatory enforcement. This is a stance SAGE Food Safety Consultants supports. Experience tells us that no matter how long the lead time, many organizations procrastinate or operate in a state of virtual denial that they will be subject to the new laws. Additionally, FSMA’s requirements are very complicated, and in places, contradictory. That’s why FDA in August began issuing “guidance” documents for manufacturers on various parts of the new law, beginning with what’s expected in the area of preventive controls. Other guidance reports will be issued periodically to assist companies in understanding their regulatory obligations. A few weeks ago, additionally,

Does this mean that there’s a grace period for the industry to attain compliance? No. The FDA has made it clear that it will take enforcement action against egregious food safety violations under existing regulatory law.


FDA’s budget for carrying out these myriad duties is still under discussion. According to latest figures, Congress has recommended an increase of $103 million in funding for the FDA (including user fee revenue) for Fiscal Year 2017, of which some $40.2 million has been set aside for increased food safety regulation. By Washington standards, that’s a paltry amount and hardly adequate for the FDA to implement industry oversight.

As an acknowledgement of limited budgets, the FDA has built into FSMA provisions that envision a larger regulatory role for state health departments and third-dairyinspector.ashxparty inspection services. FSMA also imposes new user fees for such things as re-inspection of facilities following non-compliance findings, and for a voluntary qualified importer program.

It also has created an “enhanced partnership” program under FSMA to build capacity for food safety compliance. According to the National Council of State Legislatures (NCSL), these are some of the most important collaborations FSMA envisions:

  • State and local capacity building: FSMA directs the FDA to implement strategies that bolster food safety and food defense capabilities of state and local food and health agencies;
  • Foreign capacity building: FDA must create and implement plans to to address food safety training of foreign governments, as well as technical and scientific initiatives to enhance bilateral cooperation for exporters, such as electronic data sharing, and the sharing of the latest laboratory techniques;
  • Reliance on inspections by other agencies: FDA is explicitly authorized to rely on inspections of other Federal, state and local agencies to meet its increased inspection mandate for domestic facilities. FDA also is encouraged to enter into interagency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.


 Given the current number of food recalls, foodborne illnesses, and the changing dynamics of the food supply, it goes without saying that decades-old food safety regulations needed updating. With FSMA, prevention has taken center stage and, along with it, heightened responsibility placed on business to treat preventive food safety programs as a top management priority.

The FDA still seeks (and prefers) voluntary cooperation on the part of the food industry, but it is backing that position with a tough new standard that makes food safety vigilance mandatory. FSMA provides the agency with new enforcement tools such as mandatory recall authority and the ability to withdraw facility registration so a firm would not be able to receive, process or ship food products. While the FDA will encourage compliance through education, it will also, under the Park Doctrine, hold food company executives personally responsible for preventable safety breakdowns.

It is all but certain that food recalls will continue to plague the industry going forward. Even so, FSMA is important if for no other reason than that embedded in the law is an essential food safety goals: bringing business and government into close alignment on the basic premise that food safety  is now an over-arching industry — shared — responsibility.









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