Adopting Global Food Safety Standards (Part II)

Suppose you are a manufacturer’s rep for a product that is needed by food processors facing the government’s new compliance standards under the Food Safety Modernization Act (FSMA). The client’s procurement manager tells you that his company already is compliant and has the certificate from something called FSC22000 to prove it. So why, he asks, do we even need new government regulations?

The question causes your head to spin:

  • Is the procurement manager correct, or is he smoking something?
  • What is FSC2200, anyway, and is it a substitute for FSMA?
  • Does my product meet the various food safety standards currently covering the food industry?
  • Can someone clear things up for me?

If this is you, or if you currently work in the food business, the chances are pretty good that you’ll face just these kinds of questions even as FSMA continues to roll out across America. How to make sense of the situation is the purpose of this post.

Voluntary versus Required

The first matter to keep straight in your mind is that there are many voluntary food safety certification programs and standards, but only one mandated law – FSMA. So, even if the company your work for has met those voluntary standards, your firm will still have to meet the new food law’s stringent regulations. But before you go off in a rage, it’s important to know that the voluntary safety standards by and large complement, and in some instances are incorporated into, FSMA.  So things may not be as onerous as you think.

Here’s why: the global food industry has taken clear leadership in creating food safety guidelines and standards for manufacturers, processors, suppliers in the food chain and food retailers around the world. These standards are rigorous, comprehensive and peer reviewed. They also are completely voluntary.

FSMA adds another layer of required compliance standards that in many ways reflect the industry’s standards. But it also adds record-keeping requirements that will force companies and their suppliers to maintain detailed records of preventive controls, safety reviews and inspections, and communications up and down the food chain.

Similarities and Differences

The food industry’s safety standards generally are organized into what are called “schemes.” Think of these as protocols or standards for the various procedures and practices of the global food chain. Example: temperature controls for perishable products. Each of the industry certification recommendations includes a set of established good manufacturing programs to insure that producers, shippers and retailers maintain constant and adequate temperatures to avoid food spoilage. So does FSMA, which also requires detailed record-keeping of temperatures for review by government inspectors.

Other similarities between industry voluntary standards and government regulations:

  • HAACP controls are prominent throughout all the food safety programs. FSMA’s are slightly different than the industry standards, but by and large, managing forseeable problems and dealing with them is a core concept underlying both the new government regulations and the industry programs;
  • Although different nomenclature is used, both the industry programs and FSMA emphasize the critical importance for companies to assign experienced food safety professionals to manage implementation and compliance efforts. The federal law calls these individuals “Preventive Control Qualified Individuals,” or PCQIs; the various voluntary industry programs also call for such individuals. Training for such designated individuals is widely available.
  • Food safety training is key to both the industry certification programs and the federal food safety law. The FDA has authorized dozens of training experts to conduct training seminars. Internet Google search lists numerous programs available for companies and individuals;
  • Perhaps the most significant difference between the voluntary programs and the government food safety law involves record-keeping. The industry programs lay out suggested actions a company should take to demonstrate proof of its compliance. FSMA, by contrast, requires companies to set up and maintain detailed compliance records that must be available on short notice for Food and Drug Administration inspectors. In fact, FSMA’s record-keeping requirements arguably are among the most contentious duties of the law.
  • One other difference is worth pointing out: the voluntary industry programs issue certification to those who pass muster. The FDA, on the other hand, does not certify manufacturers or suppliers as “certified” or “in compliance.” Practically speaking, this means that the industry certification can be used in advertising or marketing, but there is no such thing as FDA endorsement or certification.

It is important to note that as companies scramble to achieve compliance with FSMA, certification from a voluntary program can be especially helpful if for no other reason than to demonstrate to regulators that the company is serious about maintaining a high level of food safety protocols in its operation.

The voluntary standards are high-minded and tough. FSMA is tough and comprehensive. In the end, these standards are the most encouraging development in the long struggle to maintain a safe food supply.  The outcomes for consumers worldwide should result in fewer foodborne illness outbreaks and contaminations. That’s to everyone’s benefit.

 

 

 

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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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Is FSMA Under a Regulatory Freeze?

The answer is NO.

As the Trump Administration settles in, it is doing what all new administrations do almost as their first action: place a freeze on new or pending regulations left over from the previous occupant of the White House.

This is precisely what the Trump team did shortly after the inauguration. But, given the whirl of activities in Washington, it’s hardly surprising that companies impacted by the Food Safety Modernization Act (FSMA) might be wondering if — or whether — the new regulations may be delayed, canceled, or allowed to proceed.

Here’s a quick rundown of the situation:

  1. FSMA won’t be affected by the freeze. The food safety law was implemented nationwide last September, following five years of regulation-writing and industry comments. Since the law was published in the Federal Register (think of the Register as the official source document for all federal regulations), it is on the books and its provisions can’t be revoked or canceled without Congressional action — which no one is contemplating. (Besides which, removing existing regulations in the law requires a procedure that mirros the creation and passage of new laws, including hearings, comments, Congressional review and approval, plus White House endorsement).
  2. Pending deadlines for small and very small business compliance with FSMA also aren’t affected, since these were established in the basic food safety law. Ditto for the provisions covering the sanitary transportation of food and animal food products, foreign supplier verification and a host of others.

But — and it is a large “but,” FSMA compliance enforcement depends upon government funding for the Food and Drug Administration (as well as state health and inspection services), and this is a matter that remains very much up-in-the-air.

The FDA, many will recall, conveyed to the food industry that rather than go hard for immediate compliance with the law’s many requirements, it planned to take a more gradual approach, one that emphasized education and training. True compliance would begin a year after implementation (i.e., September, 2017). That’s when food manufacturers would have to show that they had a food safety plan up and running, among dozens of other requirements.

Still, compliance is a costly undertaking, and at this point, there is widespread uncertainty about the federal budget for the FDA (which is part of the Agriculture Department. As this space reported last year, the outgoing Obama Administration requested a modest increase in the FDA’s budget to help fund its FSMA regulatory activities. It’s unclear whether that request, in whole or in part, will make it through the Trump Administration’s budget team. If money isn’t allocated, or if enforcement budgets are slashed, then it’s fair to state that FSMA compliance will end up being a moot point.

Right now, industry observers are taking a wait-and-see attitude, while food manufacturers are moving ahead with implementation. No one wants to be caught flat-footed when FSMA compliance begins in earnest; the negative publicity could very definitely hurt a food brand’s reputation. So, cautious optimism appears to be the way to appraise FSMA’s future under the Trump Administration. Budgets could, of course, be trimmed or excised. But it is doubtful the White House or food manufacturers wants to be seen as soft on food safety.

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FSMA’s Record-Keeping Challenge

 

Of the many new requirements in the Food Safety Modernization Act, one of the most challenging is maintaining detailed records of compliance with the new law.

It’s a requirement that going to be especially difficult for small food manufacturers, those that typically do not operate with large administrative staffs. Even though small businesses (defined as those with less than 500 FTE employees) have until August 30, 2017 to achieve compliance, they still face a challenge: who are they going to tap to manage the array of records FSMA requires?

In fact, industry experts point out, FSMA requires that companies assign a management-level person to handle the record keeping, as well as an internal auditor to insure that the records are accurate and honest.

This will be no small assignment. FSMA’s record keeping regulations will require constant attention, for one thing, because the law says FDA inspectors can ask to review the records on just 24-hour notice. For another, once the August grace period ends and enforcement begins, operators who don’t meet the record keeping requirements could face costly fines.

The Food and Drug Administration (FDA) justifies the records maintenance requirement as being cost-effective in the long run. “We estimate that processed foods covered by this rulemaking are responsible for approximately 903,000 foodborne illnesses each year, at a total cost to the American public of approximately $2.2 billion,” FDA’s economic analysis of the rule explains.

Another wrinkle in FSMA is that the company’s records must be available whenever the FDA comes calling.  “Currently, the FDA only has broad records access in emergency situations when it uses authority granted by the Bioterrorism Act,” explained Maile Gradison Hermida, an Associate with the global law firm Hogan Lovells, in a 2015 Food Online blog post. “However, FSMA gives the FDA this broad records access every day, for routine inspections and without cause. The FDA will review records to assess whether you have the systems in place to make safe food and whether you are always following these programs.”

Through contractors, the FDA is offering training sessions to help companies understand the breadth of what they’ll need to keep track of: from hazard analyses to safety plans to documentation of suppliers and transporters. Still, there are common sense procedures that small and medium-sized manufacturers can implement early in 2017 (if they haven’t already been put in place):

  • Undertake a company-wide audit of existing record-keeping procedures, including how they are stored, who does the compilation, and what data might be located on cloud-based servers;
  • Assemble a FSMA compliance team that includes representatives of senior management (or ownership), operations, IT, accounting, legal and marketing. Its role would be to oversee all aspects of food safety implementation, including record-keeping and tracking. To assure efficiency, someone with the requisite experience in records handling should be designated as the team leader.
  • Invest in new technologies that will ease the record-keeping burden. Manufacturing software that monitors products throughout the manufacturing process should be a top priority. Cloud-based technology will not only provide a cost-effective way to store digital documents, but also offer an array of predictive analytics that can unearth potential production issues and also preempt alarm and failure events.

The enthusiastic buy-in of senior management to place food safety at the pinnacle of production is essential. In a very real sense, FSMA is a risk management tool intended to help companies in food production to protect their brands while maintaining product quality and safety.

Managing risk, after all, is a fundamental necessity for any business. Now, under FSMA, it can be the spur to efficient, profitable – and safe – performance.

 

 

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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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