A Primer on Food Safety

If you dispense food and beverage gases, you are no longer an industrial gas producer. You are a food processing plant. And there are consequences if you don’t know the rules.

Seven Elements of HarpC

2015 is shaping up to be a landmark year for the laws and regulations that ensure America’s food is safe to eat. We are on the eve of the most significant and comprehensive change in food safety regulations since WWII. By fall of this year, the Food and Drug Administration (FDA) is expected to release finalized regulations entitled “Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventative Controls for Human Food.” Publication of these long anticipated rules will be the dawn of a new era in U.S. food regulation and the culmination of more than one and a half decades of concerted effort by the United States government to modernize their approach to regulating the food industry. This article will examine the forces driving food safety changes, provide an overview of what these new regulations mean for independent welding and gas producers, and examine what further changes can be expected to follow this initial wave.

Background

The last couple of decades have witnessed media coverage highlighting a seemingly ever increasing number of safety-related problems in our food supply. Recalls of contaminated beef, chicken, lettuce, spinach and even peanut butter have appeared in our headlines and on our televisions. A less publicized fact is that many of these higher profile cases resulted in food executives being fined or jailed. But even regulators resorting to such extreme measures as prosecuting managers has failed to bring about sustainable improvements in the safety of the food we eat.

Very few of us appreciate the magnitude of the current problems with our food supply chain. Recent statistics from the Center for Disease Control (CDC) show that on an annual basis, 49 million (nearly 1 in 6) Americans report getting sick, nearly 130,000 people are hospitalized, and over 3,000 Americans die every year as a result of food they have eaten. The CDC further estimates that for every reported case, there are likely between 30 and 150 cases that go unreported. That is potentially over 7 billion cases of foodborne illness in the U.S. each year!

With this kind of data, pressure for meaningful food safety reforms had been building steadily. Ultimately all sides realized change was inevitable, and by the late 1990s U.S. regulators began debating the specific controls needed. In early 2011 Congress sent the Food Safety and Modernization Act (FSMA) to the President for signature. FSMA passed with nearly 3-1 margins in both houses. Equally important, this legislation was strongly backed by influential consumer advocate groups and food industry alliances. For food producers, FSMA is the new reality.

FDA characterizes FSMA as the most sweeping reform of U.S. Food Safety laws in over 70 years. Congressional legislators have completely rewritten the laws pertaining to food. FSMA establishes 102 basic requirements every food manufacturer must meet, and significantly expands FDA authority. For example, FSMA now applies to U.S. or foreign food manufacturers that ship and sell food in the U.S. Under FSMA, FDA gained new powers to issue mandatory recall orders and shut down processing plants deemed a health hazard.

Food Safety and Modernization Act Status

Since early 2011, FDA’s Center for Food Safety and Nutrition (CFSAN) has been hard at work developing regulations which they will use to enforce FSMA’s broad scope, covering everything from human food to animal feed, site registration, foreign facility inspections, import notifications, vendor approvals, third-party auditor credentials and food defense, and this is just a partial list. This process has required the agency to walk a very fine line. First and foremost, FDA has to satisfy both the U.S. Congress and consumer advocates that these new regulations actually will be effective and improve the safety of our food supply chain. Simultaneously, FDA is under consumer pressure to preserve the quality and variety of the foodstuffs currently available to U.S. consumers. Finally, the agency recognizes it is imperative to keep food affordable. After publishing a draft set of regulations in 2013, FDA spent a year collecting public comments and holding public hearings. The agency spent much of 2014 digesting that feedback, and in October 2014 issued an updated set of proposals focused on just a handful of issues. This likely signals the agency is close to the end of their rule development process. In early 2014 FDA settled a lawsuit with the Center for Food Safety, a consumer advocate group, and entered into a consent decree establishing August 30, 2015, as the release date for the Human Food Good Manufacturing Practice regulations. Most food safety pundits believe FDA will meet this date.

The very first element of FSMA to be fully implemented was food facility registration. In 2003, under the Bioterrorism Act, food firms were required to submit a one-time facility registration. Starting in 2012, food facility registration evolved into a biennial requirement. Every two years, on even years, between October 1 and December 31, every food processing facility must submit an electronic registration for every branch and store location where food or beverage gases are stored and/or filled.

Risk Based Approach

The centerpiece of FSMA is something called Hazard Analysis and Risk Based Preventative Controls, or HARPC (“Harp C”) for short. HARPC mandates conducting a risk assessment of each facility and each manufacturing process. For gases, this means a separate risk assessment for each food gas product and each production facility. The output of the risk assessment becomes a guide to develop and implement appropriate risk based controls. These controls come in three basic flavors. The first level is site, product, or process specific controls. These are directly linked to the risk assessment process and are often unique to the site, the food itself, or the manufacturing process. The next level is Operational Pre-requisite Programs (oPRP). These are controls deemed essential to maintaining an appropriate environment for safe food processing. These programs can include items such as Allergen Controls, Pest Controls, Chemical Management, site security and Sanitary Operations. The third level of risk based controls are Pre-requisite Programs (PRP), most of which are compliance elements mandated by FSMA, also referred to as Good Manufacturing Practices (GMP). These include programs such as product traceability, process documentation, product recall, housekeeping and management of change.

A key element of controlling risk, especially in the gases industry, is qualifying your supply of bulk or cylinder gases. HARPC allows a distributor to rely on the controls their bulk supplier has in place to manage risks. The caveat is that the supplier’s controls have to be the appropriate spot in the supply chain to effectively manage that specific risk. To make this strategy work hinges on the distributor having documented verification that the supplier controls are adequate and fully implemented. For food and beverage gas products, most but not all of the potential product contaminants are controlled during the bulk manufacturing process. Therefore, in the gases industry, bulk vendor qualification and verification of their risk mitigation controls will be essential. FDA rules will require firms to take this qualification process way beyond simply receiving a Certificate of Analysis with the product shipment.

Another area FSMA addresses is defending our food. The Food Defense rules in FSMA focus on safeguarding against intentional contamination, which today is a very real threat. During the risk assessment process, a company must consider intentional sources of contamination. A couple of the obvious intentional threat sources come from outside agents looking to create panic, disgruntled employees seeking to address perceived wrongs, and extortionists targeting high profile customers for financial gain. Companies need to consider the various threats and attack modes, how to counter or deter them, and how to detect them if they occur. Once you have considered all this, you end up determining the Threat Assessment Critical Control Points (TACCP). Typical TACCP controls can range from facility security to tamper-indicating covers on containers, and need to be detailed as part of the food safety plan.

By now many reading this article are thinking about the massive amount of effort this risk based approach will take. While there is no denying that conducting a risk assessment that will pass FDA muster takes time, effort and resources, our experience, based on all the food safety risk assessments we have done to date, is that when done properly the risk assessment also identifies opportunities to eliminate steps that do not contribute to managing food safety. Firms that invest the effort in executing an adequate risk assessment end up with a solid documented justification for them focusing down onto what is truly important for controlling food safety.

Food Safety Plan

The risk assessment, the risk based controls, and the pre-requisite programs all become elements in a food safety plan. Essentially this plan is the sum total of the risk assessment, the risk based controls and your procedures, work instructions, quality systems, company policies, and any forms or technical information you need to comply with FSMA and HARPC. Your food safety plan also identifies your process Critical Control Points and Critical Limits as determined during the risk assessment. Finally the food safety plan outlines how compliance will be verified and monitored.

FSMA mandates that this plan then needs to be approved by a “Qualified Individual” or QI. Becoming a QI requires meeting specific credential requirements set by FDA, expected to be published later this year. There is considerably more to meeting FDA Qualified Individual requirements than having that title printed on your business card. QI credential requirements are anticipated to include formal training and experience in conducting risk assessments, developing and implementing food safety plans, and conducting food safety audits and food safety plan verifications. FDA anticipates smaller firms may not want to undergo the expense and effort of having an employee achieve and maintain a QI status, so a specific provision in FSMA states that the Qualified Individual is not required to be an employee of the firm, and companies can choose to rely on outside sources of expertise for that function. One of the first steps many smaller firms are likely to undertake is identifying who will be their QI to get their guidance and input as they develop their food safety plan.

Once an approved food safety plan is in place, the firm has to verify and validate the plan. Under FSMA the term validate is used differently than the definition used under FDA drug regulations. Validation for food facilities entails adequate and effective risk based controls and a full implemented food safety plan. In some cases scientific studies may need to be performed. For example, at facilities where bacterial or microbial contamination is a potential concern, the validation process may need to include data from scientific studies or laboratory testing that confirms the control measures for that hazard are effective. These validation activities must be signed off by a QI.

Who Is Regulated?

The FDA Food Code defines a Food Processing Facility as…“a commercial operation that manufactures, packages, labels, or stores food for human consumption, and provides food for sale.”

Unlike medical gases where you have to “manipulate molecules” to be FDA regulated, under FSMA, independent gas distributors only have to store food or beverage grade gases to fall under FDA authority. However, FSMA does offer a degree of leniency for smaller processors and farms.

“Large firms”
are defined as having more than 500 employees, and receive no leeway under FSMA and have just 12 months from the date the final regulations are released to fully implement FSMA.

Small farms are generally exempt from most of the HARPC requirements. This small farm provision, known as the Tester-Hagan Amendment, was one of the key compromises in getting FSMA through Congress. In order to be designated as a small farm, they must meet both of the following criteria: First, over a contiguous three-year span, they have average annual sales of less than $500,000 adjusted for inflation. Second, more than 50 percent of their sales must be direct to consumers, restaurants or grocery stores less than 275 miles distant and in the same state.

“Small businesses” are defined as having less than 500 employees and more than $1M in annual sales of food products of all kinds. FDA does not offer any exemptions to this size company, but they do get 24 months to implement these new regulations once the final rules are published.

A “very small business” is a firm that sells less than $1M annually in all food products. Very small businesses are not exempt from FSMA. They are required to implement what FDA euphemistically calls “modified controls.” At this point these modified controls have a strong resemblance to the full set of controls, and FDA is still collecting public comments on this issue. Many consumer advocates and members of Congress view the very small business accommodation as a potential loop hole in FSMA, and FDA is under a lot of pressure to close that loop hole. We anticipate the definition of modified controls to undergo more changes as FDA further clarifies what they expect. Very small businesses must electronically certify their status to FDA within 90 days of the publication of the final rule, and have 36 months to implement the modified controls after the final rule is published.

Evolving Food Supply Chain

FSMA and HARPC are just one element of the evolution in food safety taking place in the U.S. and globally. As HARPC moves toward implementation, food producers and national chain restaurants are also focusing on upgrading the food safety related aspects of their business. To these companies it is not only about keeping their food safe or complying with changing U.S. and international laws. Food companies in the 21st century, especially those that are household brand names, focus on brand protection and reputation management, and the safety of their products is a key component of that focus. Consider the recent plight of spinach in the U.S. In 2006 there was an incident of E coli involving fresh spinach across 26 states that sickened 200 people and killed three. Spinach is a food high in nutritional value and one of the best low cost sources of nutrition available to consumers. But as a result of this one incident, the nationwide sales of all spinach products plummeted. It was not until the 2014 harvest season that producers saw sales of spinach once again even begin to approach 2005 levels. This clearly illustrates the devastating impact to a product across all U.S. markets resulting from a single lapse of food safety in the supply chain.

As food producers and chain restaurants began upgrading their food safety processes, they quickly realized the need to understand and monitor the controls their suppliers of raw products and ingredients had in place. This resulted in a fundamental shift in the business practices of food companies to understand how risks are managed at all levels of their supply chain. It has developed into a very powerful force that today is driving food safety practices ever deeper into the food supply chain. For example, Walmart in 2008 established minimum food safety program criteria which all their suppliers are now required to meet. McDonalds, a recognized industry leader in food safety, recently embarked on a campaign to have their suppliers of beverage carbonation gases meet the stringent food safety requirements in the McDonald’s Supplier Quality Expectation (QSE). The QSE spells out in detail the food safety related programs and business activities a supplier must meet to be an approved McDonald’s vendor. In order to be added to the McDonald’s approved vendor list, beverage gas firms must pass a stringent audit to verify their compliance with this QSE and then undergo annual third-party audits to assure ongoing compliance. While the gases industry may view this type of vendor approval process as groundbreaking, that same practice is well on the way to becoming the accepted method for doing business throughout the rest of the food supply chain.

We foresee that this food safety “push” from customers down to vendors will continue to gain momentum in the coming months and years. We expect more restaurant chains and food producers to begin implementing their own supplier approval programs for food and beverage gases. Again, this is not just about those companies complying with new federal food safety rules. These businesses are looking to ensure their brands and trademarks have adequate protection from any potential hazards their suppliers could introduce into their product manufacturing and distribution processes. At some point in the near future, GAWDA members should expect their food and beverage customers of all types coming to see how you manage food safety. Many of those customers will be well prepared in their understanding of what effective food safety programs look like and bring with them some sophisticated expectations.

The Next Steps

Food and beverage gas firms need to begin preparing themselves for FSMA and HARPC. Even firms that may qualify as very small businesses are not exempt. In my opinion some of these very small gases firms likely will face a compliance paradox. As a very small business, FDA may not require them to meet the entire gamut of FSMA requirements, but in order to conduct business with many of their current or future food and beverage customers or compete with larger firms, they may find themselves having to comply with customer vendor requirements that encompass all of FSMA and more. The good news is that independent distributors who currently fill medical gases already understand how to meet some core FSMA compliance elements. Many of the programs and business tools they use to comply with FDA drug regulations can readily be adapted to FSMA compliance.

Over the next 9-18 months, FDA will be focused on completing the bulk of FSMA program development and move into the implementation phase. The agency can be expected to seriously focus on site inspection and compliance, and there are changes on the horizon aimed squarely at enhancing FDA’s ability to conduct the number of site inspections soon to be needed.

Early last year FDA Commissioner Hamburg announced the output of a working group formed to study ways of making FDA site inspectional processes more efficient. Currently FDA has five regions and 20 district offices. Within an FDA district, inspectors are tasked with auditing all the regulated companies in that territory, from drugs to devices, food and more. FDA appears poised to re-organize their regulatory and compliance activities around well-defined commodity-based and vertically integrated regulatory programs. FDA has identified six core groups, which include Drugs, Devices, Food and Feed, Biological Products, Bio Research and Tobacco. Each of these core groups would have specific goals and objectives along with individual budgets to support their plans. The ultimate aim of this effort is to better focus FDA site inspectional resources onto agency priorities. Under this scheme, inspectors would focus on a specific industry group vs. today’s method of inspectors who focus on auditing all the companies in a specific territory. In their 2016 budget proposal, FDA has requested an additional $25 million to retrain over 2,000 inspectors, compliance officers and other food safety staff to make them more proficient auditors. They also have requested $33 million to train state and local food inspectors. Medical gas plant managers who today complain about the inexperience of government auditors and having to “train” government inspectors in the gases business every time one shows up could come to remember those days with nostalgia.

For 2015, FDA is operating a food safety budget of $1.124 billion, an increase of $224 million over 2014. While less than the $268 million increase FDA initially sought, this amount was viewed as a clear victory for food safety funding. However, this is just the down payment for what is soon to come. FDA is already developing future budget forecasts and discussing with Congress how to fund food safety in the years to come, especially future site inspections. The initial 2016 FDA budget request asks for a further $109.5 million to implement FSMA, with more than half of that earmarked toward inspections. We don’t see federal coffers stretching enough to provide all the money FDA will eventually need to implement and manage FSMA. The food industry has to be prepared for the eventuality our government may move in the direction of alternative funding methods. One of those mechanisms that repeatedly surfaces in discussions is user fees. Recently another type of funding proposal made headlines. In January 2015, Senator Charles Schumer (D-NY) wrote FDA urging them to begin levying significant fines on non-compliant food facilities, and then use those funds to underwrite site inspectional activities. Senator Schumer was instrumental in getting FSMA through Congress, so when he speaks FDA listens. Unlike DOT and OSHA, the FDA has never had the authority to issue fines directly, so that is something that would likely take additional Congressional action to enact.

Overview of FSCMA Impact

Summary

FSMA represents a sea change in our country’s approach to food safety governance and food industry regulation. 2015 marks the beginning of a multi-year effort to implement the most sweeping set of regulatory changes most will see in their entire business career. Every food and beverage gas producer will need to do a risk reward analysis of their business portfolio. Those who decide to stay in the food and beverage gas business will be required to invest some amount of time, effort and resource into their existing programs and business practices. Not only is food safety soon to be the law of the land, but our food and beverage industry customers are coming to expect it as a condition of doing business with them.

Recently an influential executive of a very large food producer made an observation on the welding and gases industry that I think pretty well sums up the situation for independent producers. He commented that today independent gas producers view themselves as industrial gas companies who also sell a food and/or beverage grade of gases. He went on to comment that those gas firms seeking success in the food industry of tomorrow will need to change that paradigm and begin to view themselves as food producers making gas-based food products.

Welding and gas firms that resist adopting FSMA and HARCP into their business will end up finding themselves seriously challenged in trying to participate in the food and beverage gas market of the future. Food and beverage gas firms looking to chart a successful course in the markets of the future will embrace the coming changes and facilitate their organization becoming fluent in the new language of food safety.

Gases and Welding Distributors Association
“Having recently upgraded to a new spec gas plant with a high-tech computerized fill system, I like the tightening of the regulations. We’re familiar with the paperwork from our work with medical gases, and all of Butler Gas cylinders are already barcoded. At this point, we’re like everybody else, listening to vendors, CGA and other experts tell us what to do. That’s why we belong to GAWDA—for information and help.”
Jack Butler, President
Butler Gas Products (Pittsburgh, PA)
“All of our cylinders are tracked with barcodes. We developed a Food Grade Manual with each cylinder so labeled, and added lot numbers for traceability. Our CO2 food grade product also meets beverage specifications if so needed by customers. Certificates of analysis are provided on request. Whether CO2, liquid nitrogen or beer gas, every cylinder has a lot number. We now have four different sets of procedures to follow: food grade, medical, ISO 17025 for our lab, and our internal quality manual. They complement each other but are distinctly different. There is more paperwork to do, adding time and expense to the process.”
Tom Martin, President
Middlesex Gases & Technologies (Everett, MA)
“Carbonic Systems, Inc. is no longer in the gas business; we’re in the food processing business, and I have to look differently at my business. We’ll be spending money on consulting services and upgrading processes. I’ve never felt the need to use barcodes on my cylinders but will be adding them along with lot and batch numbers to comply with the traceability requirements. If a delivery has 10 cylinders, manually entering the numbers is not reasonable. So we are looking at a new computer system, scanner, barcodes, all of which will be purchased. On the plus side, the Homeland Security Act required we put a number of security systems in place after 9/11. From what I’ve read, the FDA regulation will require a security allowance, and since we’ve already done it for DOT, there is one less thing to worry about.”
Bob Finnie, President
Carbonic Systems, Inc. (Grand Rapids, MI)
“To become compliant, food and beverage gases require a new program, and there are costs coming from setting up the program, employee training, documentation of that training, preparation for audits, perhaps the purchase of additional software, even getting and keeping the filling area up to standard, one that is more stringent than an industrial situation. And these costs will be ongoing. In the end, the rising cost in the supply chain of beverage gas will roll down hill, all the way to the person buying a beer in a bar.”
Tom Biedermann, Vice President
Airweld, Inc. (Farmingdale, NY)
“Customers have not yet asked for certification. They trust that they will receive the grade they are supposed to be getting. All of Metro Welding Supply’s medical gases have barcodes on the cylinders and we are doing the same with beverage gases. More customers are requesting larger CO2 deliveries. GAWDA’s online gas seminars are helpful and I would advise distributors just getting into the product to seek professional advice and follow the guidelines. Training will be necessary.”
Frank Doran, Operations Manager
Metro Welding Supply (Detroit, MI)
“We lot number and test our loads. Larger breweries require purification certification for each load that is delivered. The supplier provides the certification, and we do periodical, random checks in our own lab. All of our customers are receiving food grade. We’ve been ready for the upcoming changes for a while.”
Ben Sadowski, PurCO2 Division Manager
Mississippi Welding Supply Company (Winona, MN)
Bob Yeoman Meet the Author
Bob Yeoman is president & CEO of B&R Compliance Associates in Lehigh Valley, Pennsylvania, and www.brcompliance.com.