The Alphabet Soup of Food Safety (Part I)

FSMA. FSSC22000. GFSI. HAACP. SQF. Stop! My head hurts.

This is the likely reaction of anyone performing a deep dive into the intricacies of the world’s food safety standards. But understanding the acronyms of the various entities involved in food safety is well worth the time and effort if you are a food manufacturer or supplier. Why? Because the safety standards – a mix of voluntary, industry-led guidelines and government mandated regulations – will likely play an important, perhaps even decisive role in your business going forward.

What follows is the first of a two-part blog on helping food manufacturers and their suppliers – here and abroad – understand the key organizations and programs involved in safeguarding the global food supply.

Ready? Let’s jump in . . .

FSMA — This is the Food Safety Modernization Act of 2011 passed by Congress and signed into law by former President Barack Obama. It is watershed legislation because of its dramatic shift in focus from dealing with foodborne illness outbreaks after they occur to preventing them (as much as possible) from happening in the first place.

The rules and procedures in FSMA took regulators from the Food and Drug Administration more than five years to draw up and finalize. Much of the work (as this post demonstrates) was based upon already existing food safety procedures and guidelines. Implementation is now underway using compliance timetables generally related to the size of companies. FSMA applies to farmers and growers (but not cattle ranchers), manufacturers and processors, as well as shippers. Its provisions also apply to companies that http://www.sqfi.comimport food into the U.S.  Food, under FSMA, is both for humans and animals.

(In the U.S., government agencies and academia have teamed up to create the Food Safety Preventive Controls Alliance (FSPCA) to help train companies on how to meet FSMA’s regulations).

HAACPHazard Analysis and Critical Control Point (HACCP) is an internationally accepted management program for reducing potentially dangerous hazards in food. HAACP forms the basis of the new food safety act as well as voluntary food safety certification programs.

A HACCP System requires that potential hazards be identified and controlled at specific points in the manufacturing, storing and distribution process along the global food chain. This includes biological, chemical or physical hazards. Any company involved in the manufacturing, processing or handling of food products can use HACCP to minimize or eliminate food safety issues from occurring. (The language in FSMA refers to “preventive controls,” which largely build upon HAACP principles).

GFSIThe Global Food Safety Initiative is a Paris-based association of major food companies that promulgates food safety protocols (or “schemes) for food companies.  It was formed in 2000 in response to a series of serious food safety crises. GFSI is a voluntary organization. Industry-led committees and workgroups formulate schemes, which serve as benchmarks for companies that want to gain GFSI certification. Although it has a global reach, GFSI’s schemes have been adopted more internationally than in the U.S.

SQFThe Safe Food Quality Institute is a standard-setting, voluntary organization for the food industry, with a focus on U.S. based food retailers. The SQF Program is recognized by the Global Food Safety Initiative (GFSI) as a Food Safety Management Systems Certification program (see more below).

ISO The International Organization for Standards, based in Geneva, Switzerland, is an independent, non-governmental organization of some 163 national standard setting bodies. The standards, many thousands in all, cover a wide range of industries (including the human and animal food industry) through “best practice” specifications for products, services and systems. The standards are voluntary – they don’t carry the force of law – and are based on consensus of relevant national standard setting bodies.

Importantly, ISO itself does not provide certification that a company has met its standards; this is done by external certification bodies (such as SQF). Once certified, a company can promote its compliance with the ISO standard.

FSSC 22000 – This is a Food Safety Management System (FSMS) Certification Scheme. Certification is granted to retailers, manufacturers, suppliers and others when the companies have implemented prevention-based hazard food safety controls and a third-party auditor has audited the system to verify that it complies with its requirements.

FSSC 22000 is a certification program recognized by GFSI. In April, 2017, it issued its 15,000th certificate.

Whew! That’s a lot of information to absorb. The point is that taken as a whole, these organizations are all about establishing and maintaining worldwide food safety standards. In Part II, we’ll show you how these organizations compare to, and differ from, regulatory efforts via the new American food safety law, and why that law is both evolutionary and revolutionary in its scope and intent.

 

 

 

 

 

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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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With New Administration, Where Does FSMA Stand Now?

The Food Safety Modernization Act (FSMA) went mostly into effect last fall. Where do things stand now with a new Administration in the White House?

It’s hard to know for certain, in part because the Food and Drug Administration (FDA) which oversees FSMA, is hanging in limbo without a new Commissioner in place. Plus, with all the other issues and policy differences on the front burner right now, food safety has pretty much been pushed into the deep background of White House priorities. For now, the timetable for rollout and compliance remains in effect (see compliance schedule chart).

Yet careful observers should be able to spot some indicators of what might happen in the months ahead.

For one thing, the newly-approved head of the Department of Health and Human Services, former Georgia Rep. Tom Price, is well-known for his strong views against government regulation. HHS oversees the FDA (a relationship often overlooked), and with the new Republican regime hustling to assemble a new federal budget, it would hardly be surprising if FDA’s already slim budget for FSMA enforcement were cut back some more. Reducing the FDA’s budget for inspectors would create obvious enforcement problems. State governments were allocated federal budget dollars to support local inspectors; these funds also might be reduced or eliminated.

For another, while the major chunks of the sweeping new food safety act have been implemented, compliance with the new regulations was postponed for a year last September, except in cases of gross violations by food manufacturers or transporters. Between now and August, FDA is committed to “educating” the industry on the law’s many and complex requirements. As a result, the new Administration simply might extend the compliance deadline even further into the future; in effect, turning FSMA into a voluntary set of guidelines, not federal law backed by severe fines and even imprisonment for violations.

Finally, compliance on the part of small manufacturers was specifically postponed to give them more time to figure out how to cover the costs of the law’s requirements, such as creating a food safety manager at each plant site. Thus, it would be easy for the Administration to either delay compliance by small companies even farther into the future, or to exempt them from FSMA altogether.

The interesting factor in this is the influence of the major manufacturers towards the new law. The big brands who churn out thousands of manufactured food products every day got on board with FSMA early on, figuring that a position opposing food safety standards was a non-starter, but also because most of the companies felt that food safety was, in fact, a growing concern as the global supply chain grew in size and complexity.

Experience has taught manufacturers (and retailers, which aren’t under FSMA) that food contamination outbreaks and widespread product recalls can have a serious negative impact on sales and brand reputation. FSMA’s entire approach to regulation is aimed at preventing outbreaks by instilling a “safety first” mantra at every link in the food supply channel.

All of these factors point to the conclusion that the Food Safety Modernization Act, like many federal regulations enacted during the previous eight years, could face delays in actual compliance. While that may please those who object to government involvement in business, it may distress others in the food industry who see the need for across-the-board standards that promote a safe food production and transportation environment.

 

 

 

 

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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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