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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