The Point Person for FSMA Food Safety

One requirement of the new food safety law is the creations of a new position, the so-called “Qualified Individual.” He/she will be the point person to insure food manufacturing and processing plants, as well as shippers and importers, are operating with carefully drawn up preventive control-based food safety plans.

Who, exactly, is this qualified individual? What is he/she responsible for?

First, a bit of background. The new food safety law, known by the acronym FSMA, requires all food manufacturers and processors to conduct a detailed analysis of possible food contamination points throughout their facilities. From that analysis, a plant-wide food safety plan must be created in order for the facility to gain compliance with the law (or eventually face penalties). That plan must emphasize concrete, specific steps to prevent contamination at every step in the manufacturing process.

Someone has to manage all of these details, and that designee is the Qualified Individual (also called a Preventive Controls Qualified Individual, or PCQI). Some companies already have such a person, perhaps a food safety director or specialist. But others companies, especially smaller-sized operations, will have to create this job and fill it with either a current employee, a new hire, or by using an outside consultant.

Here is the position as described by the FDA:

A preventive controls qualified individual is someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system. The written food safety plan required of food facilities must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. And the preventive controls qualified individual is charged with overseeing the validation that preventive controls are capable of controlling identified hazards and the records review.

What about training? What’s required?

In advance of FSMA implementation, an industry-academic-government consortium called the Food Safety Preventive Controls Alliance (FSPCA) was established to translate the law’s many requirements into a comprehensive curriculum for those interested in (or assigned to) becoming a qualified individual. The requirements are set out here in Q and A form. However, the FDA has also enabled training to be much more flexible, as long as the curriculum meets the FSPCA’s standards. Food safety training, in fact, has spawned a cottage industry with courses available in many locations as well as online. Google “Preventive Controls Qualified Individual Training courses” and you will see listed numerous training courses available.

The Preventive Controls Qualified Individual isn’t the only person responsible for  a company’s food safety. FSMA also incorporates what is known as the “Park Doctrine” that makes a manufacturing company’s top executive directly responsible for food safety oversight. Additionally, the law requires that the food safety plan is shared with all employees through meetings, presentations and one-on-one sessions. Moreover, the plan must be revised and updated every three years.

All of this — the required food safety plan, preventive controls, qualified individual training and executive oversight — represents a sea change in government regulation of the food supply (for humans and animals). Food safety has long been a voluntary industry priority, but and the continuing scourage of deadly foodborne illness recalls and microbiological contaminations demonstrated that stronger protections were needed. FSMA is the result.

The new requirements also bring a new sensibility to food production and distribution. It is the awareness that food safety must be not just a management priority, but also an attitude that becomes ingrained and habitual at all levels of the massive global food supply chain. It heralds a culture of food safety which, if it truly takes hold in the industry, holds the promise of making food fatalities a thing of the past.

 

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

Is the nation’s new food safety law on Congress’s cutting block?

The 2016 election results have the food industry and regulators scrambling to determine whether – or which – government programs may be affected once President-elect Trump and a new, Republican-controlled Congress take office in January.

The short answer is that nearly every program and agency in the federal budget likely will come under review, as is always the case each fiscal year but even more so when there’s a new Administration. Donald Trump and the GOP strongly advocate cutting government spending, so it is a safe bet that the Congressional budget and appropriations committees will be focusing renewed attention on by eliminating or trimming existing programs and regulations.

How will funding for the new Food Safety Modernization Act (FSMA) fare? Right now, an educated guess will have to suffice; much depends upon appropriations choices for the U.S. Department of Agriculture, the parent agency of the Food and Drug Administration, which oversees FSMA implementation.

What we do know is that in outgoing President Obama’s final budget submission to Congress (which was declared “dead on arrival by House Republicans), the Administration sought a $25 million increase in FDA’s food safety budget to a total of $1.195 billion FY 2017. That’s down from the FY 2016 budget in which the FDA received a $1.5 billion outlay, which was higher due to FDA’s FSMA implementation.

Beyond the bare numbers, which are sure to change, the following are for possible food safety budget reductions:

  • Food safety inspections of domestic and foreign manufacturing plants. FSMA envisions a preventive-based approach to food safety that is backed by extensive and strengthened inspection procedures carried out by the agency itself and by state agriculture or public health agencies. The food industry prefers voluntary compliance, and it is possible Congress will delay stepped-up inspection and rely on industry self-compliance.
  • Compliance deadlines. Although FSMA is now fully implemented, the agency plans to emphasize education over enforcement until August 2017. For budget reasons, as well as ongoing industry challenges in achieving compliance, it may be tempting for Congress to push back the compliance deadline even more into the future.
  • Food safety research and testing. Over the past several budget cycles, the FDA and the Centers for Disease Control (CDC) have spearheaded the use of emerging microbiological technologies to more quickly pinpoint the sources of food-borne illnesses. Yet the GOP Congress has long been skeptical about government research, preferring privately funded activities, and the new Congress could take a red pen to food safety research expenditures.

Of course, there is an alternative case to be made that Congress will leave FDA funding mostly alone. Food illness outbreaks always generate headlines and, at times, huge negative publicity when there are fatalities or indications of industry malfeasance. Food safety’s importance to consumers may thus prompt legislators to refrain from sizable budget reductions. Still, with the federal deficit at record highs and a majority political party eager to bring federal spending under control, the budget for food safety regulation may be vulnerable to cutbacks when FSMA’s full impact will be just getting underway.

 

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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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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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