Blowing the Whistle on Dangerous Food

The new national food safety law extends whistleblower protections to employees who uncover food safety problems at their workplace. This is the first time such protection has applied to food safety issues, according to an analysis by the national law firm Thompson Coburn LLP.

food-production-workersWith little fanfare, the whistleblower provisions took effect immediately upon FSMA’s passage in 2011. The rules cover companies in food manufacturing, processing, packing, distribution, holding, importation and transportation. (Whistleblower complaints actually are managed for the FDA by the Occupational Health & Safety Administration (OSHA), which manages whistleblower actions for more than 20 federal departments). In its first three years, 144 food industry whistleblower complaints were submitted.

The protections afforded whistleblowers are straightforward: employers are prohibited from firing or discriminating against any employee who speaks up about potential or ongoing safety issues, whether publicly or privately. FSMA’s Section 402 specifically prohibits employer actions such as termination or demotion, and also protects workers from any form of reprisal that might dissuade other employees from engaging in similar activity.

Section 402 is especially relevant to food scientists and technologists, who have the scientific training in food contamination and are the individuals typically assigned to oversee food safety protocols for manufacturers, notes the Canadian-based International Union of Food Science and Technology (UoFST). Protection from reprisals against these employees is especially important, UoFST notes. This may become more of an issue in the future as larger food manufacturers bring on trained microbiologists and researchers to help pinpoint food safety vulnerabilities.

What about importers? Do these whistleblower provisions apply to overseas workers in the same way that FSMA’s safety rules directly impact foreign exporters and manufacturers whose products are sold in the U.S.?

The answer is the proverbial “it depends.” The UoFST points out that whistleblower protections outside the U.S. are uneven in effectiveness. The United Kingdom prohibits retaliation against whistleblowers under its Public Interest Disclosure Act (1998). Japan and South Africa both have dedicated legislation on whistleblower protection. But, writes Gerald Moy, a retired World Health Organization executive, many whistleblower laws worldwide are limited in scope to anticorruption. Other countries may not have the regulatory infrastructure in place to handle such complaints.

By contrast, Moy notes, the inclusion of these protections in the U.S. food safety law is another demonstration of the government’s commitment to head off food safety problems before they lead to costly recalls, consumer illness (or death) and negative news reports of “unsafe” food.

The FDA wants the industry to become prevention-oriented, but instead of purely voluntary compliance, the agency has written tough new rules into the new law requiring a host of procedures to insure safe food production and holding management personally responsible for any violations.

So, in answer to what happens next at the bakery, here’s a checklist for employers under FSMA:

  1. Make certain food safety training has been implemented throughout the organization as part of an overall management food safety system;
  2. Train supervisors to deal promptly with complaints, “shop talk” or rumors of potential food safety problems;
  3. Maintain records of logged complaints and follow-up actions;
  4. Resist the temptation to punish or criticize any employee who spots a problem.

With FSMA now the law of the land, and food-borne illness prevention the guiding regulatory goal, food manufacturs just might want to reward employees who speak up with a bonus check for a job well done.

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FSMA and the Challenges for Small Business

FSMA BUSINESS COMPLIANCE DATES

April 30, 2017 — food safety verification for companies exporting product or ingredients to American-based small businesses;

August 30, 2017 — companies with fewer than 500 full-time employees;

August 30, 2018 — companies with annual sales of less than $1 million (for animal products, $2.5 million)

The big compliance date has come and gone, and food manufacturers and their suppliers are now subject to the Food Safety Modernization Act (FSMA).

Yet in many ways, the September 2016 deadline was only the start of a new countdown to compliance for small and and very small food companies and their suppliers, domestic and foreign.

Let’s take a look by examining what “compliance” actually means to the Food and Drug Administration, the agency that governs the food industry and manages FSMA:

  • ENFORCEMENT. Although FSMA is in effect for large-scale, multinational food companies, the FDA has offered industry a grace period in which education will take precedence over enforcement. Essentially, regulators are allowing manufacturers and their suppliers an extended period of time to implement the new safety law’s many requirements without fear of citation, license revocation or a mandated food recall. However — and this is a big caveat — the FDA will crack down on “egregious” FSMA violations, defined as activities that demonstrate that a food company is willfully failing to comply with the new law.
  • SMALL BUSINESS DEADLINES. The FDA’s rules offer a helping hand to small businesses in the food industry by extending compliance deadlines for nearly a year – to August 30, 2017. What constitutes a small business? Generally, the FDA says, a small business is one with less than 500 full time equivalent employees. There is also a “very small” business category, with a somewhat different definition: a company with average annual sales of less than $1 million, including the market value of inventory on hand. (For producers of animal food, the cutoff for compliance is annual sales of $2.5 million).
  • IMPORTERS. How to insure compliance for food importers is one of the trickiest aspects of FSMA. The overall intent of the law is clear: the United States wants foreign-based suppliers of food items or ingredients to be held to the same safety standards as American-based firms. Yet the various rules governing what the FDA calls the Foreign Supplier Verification Program (FSVP) have differing compliance dates tied to the size of the importing company, where it is domiciled, and what it is shipping to the U.S. Suffice it to say that if a small American company is importing food items from overseas, it must verify the foreign supplier’s compliance with FSMA standards by April 30, 2017.
  • TRAINING & ASSISTANCE. A baked-in assumption in FDA’s rules is that large manufacturers will already have been close to compliance, but that smaller firms many not possess the budget, personnel or access to training to meet FSMA’s tough new safety standards. One solution is the Food Safety Preventive Controls Alliance, comprised of government, industry and academic advisors who can assist small businesses understand FSMA’s requirements and schedules through seminars, distance learning and online and printed materials.

American manufacturing is by and large driven by small business. Of some 252,000 manufacturers of all types in 2013, according to the National Association of Manufacturers, the vast majority employed fewer than 500 people, the cutoff point for FDA compliance next year, not this year.

What these numbers suggest is that reaching the thousands upon thousands of employees and persuading them to make food safety a personal responsibility will take time, effort and patience. Thankfully, the FDA has recognized the scope of the task, and is rolling out FSMA compliance in a way that helps every business adjust to the new law.

 

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A Safer Food Supply?

Will the nation’s food supply be safer under FSMA?

The new Food Safety Modernization Act, or FSMA, which takes full effect in September, has a multitude of goals, but foremost of these is insuring that the nation’s food supply (human and animal) is safe – safer than it already is. Will the new law do that?

That was certainly the motivation for passage of FSMA in 2011. Congress recognized that the vast American food supply from farm to table was very safe, but also persistently vulnerable to microbiological contamination, accidents, and terrorist threats. FSMA addresses these dangers directly and indirectly. Here are three of the primary goals behind the new food safety regulations.

  1. Responding to the new realities of a global food chain. America’s food supply throughout much of its history has been largely self-contained: American growers, ranchers and manufacturers accounted for the vast majority of food items available to consumers. But it was never 100% domestic: Coffee from Africa and Central America; winter produce from Mexico; Canadian wheat, spice from Southeast Asia. As the consumer palate has become more varied and reflective of diverse cultures, our food supply is incredibly global in scale. FSMA is intended to insure that all food items and ingredients coming from overseas are subject to stringent safety protocols.
  1. foodmfgPlacing more aggressive regulations on suppliers, not just manufacturers. If the world’s food supply were envisioned as an iceberg, the portion above the water line would represent manufacturers, processors, and retailers. The portion of the iceberg below water – by far the largest segment – would represent the thousands upon thousands of suppliers that play a pivotal but often overlooked role in food safety. It’s a supply chain that is both widespread and granular in scope: it includes makers of conveyor equipment, as well as suppliers of lubricants for that equipment.
  1. Preventing food safety issues rather than relying upon government intervention only when there’s a problem, is at the very heart of FSMA, and one that should have the most immediate and beneficial impact on food safety over time. That’s because, for the first time, food manufacturers and processors, along with their supply chain partners, have clear direction in preventing food contamination by creating and maintaining a food safe environment up and down the supply line. One requirement alone – having in place a comprehensive food safety plan – is perhaps the single most significant of all of FSMA’s many regulations.

Of course, maintaining a 100 percent safe food supply is literally impossible. But as an aspirational goal, FSMA represents forward thinking on the part of the government and the food industry, both of which have an obvious, vested interest in producing and selling products that are as safe as they can possibly be.

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Time for a FSMA Checklist

Full compliance with the Food Safety Modernization Act just a few months away. Is the food industry ready?

Here’s what food manufacturers need to do:

  • Hazard Analysis — the first compliance step required of all but the smallest food manufacturers is a thorough analysis of any potential food safety problems in production plants and shipping areas. Remember, under the new FMSA, the core idea underlying regulatory oversight is prevention of food safety problems. The obvious place to start is in the production facility. Included in the hazard review are “foreseeable hazards,” which are possible trouble spots for contamination that must be dealt with. Here’s a link to hazard analysis implementation.
  • Food Safety Plan — after the hazard analysis, this is the logical next step for manufacturers, but also the requirement that will take up the most time to implement properly. FSMA requires manufacturers to lay out a step-by-step risk-based preventive control plans that identifies real and possible food contamination weaknesses, and what will be done to mitigate or address the problems. Additionally, FSMA requires that the appropriate production line employees be given thorough food safety training, with regular review sessions. A plan’s food safety plan also must include a specific recall procedure in the event one is needed. This requirement is especially important because food contamination events can create serious, even deadly, public health emergencies. How well affected product can be tracked back to the source, and how quickly it can be removed from sale, is an essential component of the new food safety law.

food-processing-industry-image-4697FSMA also applies to suppliers in the long and complex food chain. As an example, food production lines convey thousands of pounds of raw food ingredients every day. The machines that control the manufacturing process need regular maintenance to keep them in good running order. Maintenance is performed by employees assigned to the task, and these workers use lubricants that are specifically formulated for food production. The lubricants must be “food grade;” that is, they cannot be potentially harmful to food being produced. FSMA requires that suppliers of these lubricants also perform a hazard analysis in their production facilities, and then create their own food safety and recall plans — just in case. (The website you are reading was created by a leading lubricants maker, CRC Industries, Inc. to help their customers and others with FSMA compliance).

  • Management Oversight — Perhaps the most controversial requirement of FSMA is a strengthened emphasis, backed by the force of possible legal action, on top management oversight of food safety.  While this feature has long been assumed by the Food and Drug Administration (FDA), the responsibility has been codified in the new food safety law. Top executives, including the CEO, can be held liable for food safety violations within their companies; using the so-called Park Doctrine, the FDA and the Department of Justice can mount civil and criminal actions against corporate executives whose companies become involved in a food safety crisis, even if the executives argue that they didn’t know about the safety problems and expected underlings to handle such matters.

The Food Safety Modernization Act is a watershed standard in food safety responsibility. The emphasis on prevention requires a higher level of vigilance for food manufacturers, their suppliers, as well as the companies that transport food products to warehouses and stores. It could reasonably be said that under FSMA, there can’t be enough food safety, which is a standard that could positively guide food production for years to come.

 

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What Is a Foreseeable Hazard?

With an emphasis on prevention, the Food Safety Modernization Act (FSMA) directs manufacturers and suppliers along the food chain to identify “foreseeable hazards” in their operations as they prepare mandatory food safety plans. But nowhere is that term defined. So what is a foreseeable hazard?

The answer is, there is no clear answer. Dictionaries aren’t much help because they repeat the word in their definition. Yet there is some agreement around the notion that something is foreseeable when it is predictable and will probably last a long time.

food-processing.ashxSuch vagueness is often a problem with new regulations (which are the end result of years of revisions, give-and-take, and compromises between regulators and the industries to be covered), but in the case of the new food safety law, a foreseeable hazard sounds like, walks like and talks like what you would uncover as a problem in analyzing your production operations. Such problems – hazards – must be identified in advance of production and preventative controls put in place to eliminate the problem, a process, by the way, that must be undertaken every three years.

In the Federal Register, the FDA says this: “A facility subject to the (FSMA) rule must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed . . .”

A Maryland-based consulting company, FDAImports, established a website, harpc.com on perhaps the key provision of the new food safety law, Hazard Analysis and Risk-Based Preventive Controls, or HARPC. But even this website skirts around foreseeable hazards, although noting in clear language that (quoting):

“HARPC requires virtually every food manufacturer, packer, bottler and storage facility to identify food safety and adulteration risks associated with their foods and processes, to implement controls to minimize the risks, to verify that the controls are working, and to design and implement corrective actions to address any deviations from the controls that might arise. 

So what we are left with is a kind of working definition that directs the food industry to uncover and deal with areas in their production facility that will, or might, pose food safety risks, and take steps to eliminate them. They might be places where water is sprayed on raw food, or a hard-to-reach nook in a piece of machinery where listeria could grow. It could be a non-food grade lubricant on bread pans, or a production worker with hepatitis.

Whatever the precise definition, FSMA is going to require a great deal of new work and oversight by companies regulated by the FDA. Undoubtedly, the major food manufacturers and processors will have the budgets and people to insure compliance. The smaller companies, however, may be hard-pressed to manage the new regulations. Budgets will have to be created and people assigned to food safety management. Training will become essential to help workers and managers identify potential risks in the production process, so that a comprehensive food safety plan (another FSMA requirement) can be drafted and implemented.

Clearly, there will be growing pains associated with FSMA’s rollout. Defining terms, always a challenge, will most likely be settled through a combination of administrative decision-making, compliance challenges, and even legal action.

For now, though, anyone responsible for food safety ought to become very familiar with the term “foreseeable hazard.” It very well could be something that may end up helping save lives.

 

 

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