Living in and through a pandemic, we’ve all adjusted a bit. We don’t shop as much. When we do, many of the things we used to buy in person are purchased online. We don’t go out to eat as often.

Many things we want or purchase are delivered to us. Other things we get by using the drive-thru.

Drive-thrus and online retailing are great ideas and can truly help the economy locally and nationally. After a couple minutes of shopping and placing an order, we get the satisfaction of our confirmation email and news that whatever we bought is on the way.

Of course, it isn’t always perfect. After receiving a delivery, I’ve realized I was shipped the wrong item. After getting my take-out meal, I have found that the entire order wasn’t included. Both of these examples would be failures if this was a food safety or quality program.

That got me thinking, are we managing our quality programs using the same drive-thru thought process? Are we taking a minute to order, expecting that in a few more minutes we’ll have the best output from our quality programs delivered to us? Or are we actively managing quality and food safety programs to achieve the best possible outcomes, without failures?

In training classes I am blessed to provide, I like to use a beehive diagram to represent all the quality and food safety programs that are needed or managed in a food plant. Look at a honeycomb: Notice how all those hexagonal openings fit so well together? Notice how they are all interconnected? Notice that if one cell is removed, several others are affected?

I think of the honeycomb as the home for all those quality and food safety programs that we have to manage. Imagine that each cell is a single unique quality program: environmental monitoring, net weight, preventive maintenance, allergens, pest control, process control, product quality, package quality, quality certifications, microbial testing, quality culture and so many more. How many cells of quality does your beehive have?

Now, imagine that you have to do all that program management using a drive-thru methodology.

Can you do it?

Of course not. It’s impossible to just drive-thru and get what you want. UberEats and DoorDash can’t deliver your high-quality allergen management plan. You can’t drive to the pick-up window and be handed your successful process control program. Quality management takes active hands-on approaches; it requires that you be there.

Successful quality and food safety management programs take time and skill to build. There are lots of jobs in a beehive, but just like the architect or nurse bees, quality management means getting out there to work with the other bees and assure the hive is growing in the right direction and will support the overall goals of the hive/company.

You have to be on the processing and assembly line. You have to observe actions taken by all those worker bees, forager bees and repair bees, then you have to react to those actions to assure that product quality (the honeycomb) meets the expectations and results in goodness for the entire hive. Each cell contributes to the success of the other cells and the result is your consistent and high-quality finished product.

Bottom line: In a world now dominated by drive-thru windows and drive-by deliveries, don’t let your quality and food safety programs become a matter of convenience instead of deliberate actions. Bee sure you’re there and appropriately directing, reviewing and (most importantly) correcting things in a timely manner to have a successful hive.

The United States food industry is on the clock. By 2050, less than three decades from now, the European Union will become climate neutral. At least, that’s the plan. If U.S. businesses are going to compete, they have to forge a greener path.

The aim of climate neutrality is completely offsetting the footprint of a product. The Intergovernmental Panel on Climate Change, a multi-national authority of science experts housed in Switzerland, explained that such “a carbon offset is a reduction in emissions of carbon dioxide or other greenhouse gases made in order to compensate for an emission made elsewhere.” Simply put, what goes in, has to be recycled. Thus, a climate neutral product emits no pollution and everything that goes into production reaps some sort of benefit.

The United Nations initiative Climate Neutral Now calls for urgent action from businesses and governments to realize the main goal of the Paris Agreement, to limit global warming to well below 2 degrees Celsius. President Joe Biden also announced his administration’s attention to the matter in one of his first Executive Orders.

Realistically, the EU planning to be climate neutral by 2050 leaves U.S. businesses very little time to compete. Unless the pressures from within the market go far beyond existing schemes of corporate social responsibility, the greening of the EU’s economy will leave resource-intensive production in the U.S. in the dark.

According to the European Commission (EC), a whopping 94% of Europeans prioritize their food’s environmental impact. One of the many pieces of supporting evidence is the “Farm to Fork Strategy,” in which the EC, the EU’s executive branch, “recognizes the inextricable links between healthy people, healthy societies and a healthy planet.”

The circularity of food, production and the environment is at the center of the climate neutrality conversation. If current food waste trends continue until 2050, the “global demand for resources will almost triple to 130 billion tons annually, which would overuse the Earth’s capacity by more than 400%,” according to JP Morgan. In addition, the many aspects of the U.N.’s Sustainable Development Goals give hold to the need to achieve carbon neutrality because, according to the U.N., “70% of the Earth’s population’s livelihoods depend directly on a healthy planet.” Thus, exploiting resources is poor planning. Maximizing resources to achieve climate neutrality, in contrast, is smart planning. Smart planning, in turn, translates into economic efficiencies and financial advantages. Investing in sustainable strategies that help offset environmental footprints of products is prudent for future bottom lines. For instance, “[a]chieving the 2 degrees Celsius Paris Agreement target could save $54.1 trillion for a global expenditure of $22.1 trillion,” according to the U.N. In a circular economy, this money could be reinvested to achieve better and more sustainable goals.

A healthy economy rests on healthy competition. With the new strategies in the EU, “healthy” is undergoing an overhaul that includes environmental integrity and public health.

Further, the COVID-19 pandemic has underlined the importance of a robust and resilient food system that functions in all circumstances. It has also made us acutely aware of the interrelations between our health, ecosystems, supply chains, consumption patterns and planetary boundaries. And it is possible for companies to make the pivot. Emanuel Faber, CEO of Danone, told McKinsey & Co. in 2016 that embracing the circular economic model for the dairy producer is “turning something that is a challenge today into something that will have value tomorrow.” Danone is working on redesigning their “products to optimize material use and eliminate waste.” Some of the strategies involve consumers and optimize formal Extended Producer Responsibility (EPR) and Deposit Return Scheme (DRS) systems, which are on par to meet the EU’s expected 2025 target of 90% collection for beverage bottles. By the end of 2022, Danone’s polyethylene terephthalate (PET) bottles will be bio-plastic.

Biden’s new executive order on making climate change a priority is a first step. But once the Circular Economy Action Plan passes into EU law, unsustainably produced products from the U.S. may not be fit for the EU market.

The EU’s proactive action plan might bring an economic upswing and increase efficiencies for many sectors, including food. While the EU is aware of this, the new administration in the U.S. may have an uphill battle making the necessary level of resource efficiency the new norm.

Even before the Food Safety Modernization Act (FSMA) was signed into law on Jan. 4, 2011, the Food and Drug Administration (FDA) was preparing. In fact, when Michael Taylor was appointed as FDA’s senior advisor to the commissioner in 2009 (then deputy commissioner for foods and veterinary medicine in 2010), he accepted the position with the expectation that FSMA would be passed “sooner rather than later,” and it would become the central mission of FDA’s food program. “So a lot was going on to prepare well before the law was enacted,” said Taylor, who now co-chairs the board of directors of STOP Foodborne Illness.

FSMA called for a mindset shift, one that required a fundamental change in FDA’s approach to food safety, he said. It shifted the traditional system of inspect/enforce/react to a system based on the central aspiration to prevent foodborne illness. This not only meant a different set of rules, but also a different way of looking at the mission to protect public health, he said.

Additionally, Taylor said, the spinach E. coli outbreak of 2006, which had been instrumental in catalyzing the politics of getting FSMA enacted, had shifted some elements of the produce industry from resistance to regulation into a mode of wanting regulation. “So when I came in, the agency was already thinking about how to regulate produce safety even without FSMA. So FDA started developing a produce safety rule even before FSMA was enacted.”

Once FSMA was enacted, FDA prioritized the top seven rules it felt to be most important to finish quickly. The goal was to meet the dozens of statutory deadlines as fully as possible, but, Taylor said, “we were really quite explicit at the time that meeting all the deadlines was not doable. That was just not remotely possible, but we wanted to move as quickly as we could on the major rules.”

So FDA set up working groups for each rule with representatives from different areas of FDA. “It took the rulemaking completely out of the normal sequential drafting and review process that typically occurs at FDA — and helps make rulemaking a lengthy process — and brought all the elements that go into rulemaking into one integrated set of committees,” he said. “It was a daunting task with an incredible list of deliverables. And that work still goes on.”

Produce Safety Rule.

There was a strong consensus from the manufactured foods sector at the time FSMA was enacted that the new preventive controls framework was the right way to go. In the produce sector, there was less clarity and unity around both the need for and manner of regulation, Taylor said. Trying to move a sector that had no federal regulation for food safety (other than for pesticide residues) to being under a comprehensive preventive regime generated a lot of questions and concerns. Not only were (and are) there vast regional differences on farms in terms of food safety problems, agricultural systems and scale of production, but there was, he said, “a politically powerful sustainable ag community that initially just wanted to be left alone.”

So Taylor invested a great deal of time in outreach, visiting farms and meeting with farmers in more than half the states, hearing from a wide range of people in different settings. From the visits, he made the decision to repropose the produce safety rule, despite the time pressure FDA was under. Realizing there were ways to improve the rule, he said, “that decision helped make the rule better. It also showed we were listening and trying to get it as right as we could.”

Even with all the work that was done, Taylor said, “when I look back, I realize we didn’t know as much as we needed to know on produce safety. So, while the produce rule has some very sound elements, we didn’t come up with all of the right regulatory strategies to be successful.”

For example, FSMA identifies, and the rule addresses, key vectors of contamination (such as animals, water, worker hygiene and soil amendments), but, due to the great diversity of produce operations across the country, the rule necessarily leaves the risk assessment and intervention decisions in particular situations largely to the grower. This framework can work in a lot of settings, but is not working for leafy greens, he said, as this sector often involves very large-scale production in the vicinity of animal agriculture, which has contributed to numerous illness outbreaks, despite FSMA’s prevention mandate. “The proximity of dairy and cattle operations to leafy green fields is an unsolved food safety problem that requires business and policy decisions that are probably beyond the reach of the Produce Safety Rule to compel in its current form,” Taylor said.

“FSMA creates a very solid, very appropriate prevention framework for most of the food system, and it is having a tremendously positive impact in manufacturing,” he said. “But the produce sector illustrates that we’re not there yet in terms of the food system as a whole and having the right set of policies and strategies for food safety.”

“When I look back, I realize we didn’t know as much as we needed to know on produce safety.”Michael Taylor, Former Deputy Commissioner for Foods and Veterinary Medicine

Traceability.

One rule that Taylor chose not to prioritize — and was publicly open about — was traceability (Section 204). As written by Congress, the section specifically precludes FDA mandating true real-time full-value chain tracing. It is more about restricting what FDA can do for traceability then about empowering FDA to act. “That remains a critical issue today,” Taylor said. FDA did the best it could in its recently proposed rule, he said, “but the fundamental conceptual flaw is that FSMA continues to treat traceback as an investigation that FDA does rather than making it an obligation of the industry to provide timely and accurate traceback information.”

So, once the Centers for Disease Control and Prevention identifies the food vehicle it believes associated with an outbreak, FDA will still have to do its “persistent shoe-leather investigation” up the chain, searching for the documents and disparate records that can lead it to the source, and only then hope to contain the outbreak and discover the cause. “It is a step-by-step, time-consuming investigation,” Taylor said.

Because of the statutory limitations in Section 204 of FSMA, Taylor saw it as less important to prioritize the traceability rulemaking as he felt it would not make as much contribution to public health as other required rules. “I think traceability remains an open issue, particularly for sectors like fresh produce items grown outdoors that are inherently high risk,” Taylor added. “We still haven’t solved traceability. And FDA alone can’t solve it under current law.” If there were a clear business commitment in industry to solve it, the proposed rule might help, he said. “But for reasons that I continue not to understand, there has not been sufficient will across the produce value chain to fix the traceability problem.”

Funding.

Another barrier to FSMA’s success that continues today is lack of adequate funding. Despite the amount of time Taylor and others spent working with the budget process within the administration and with Congress, FSMA implementation remains funded at about half of what the Congressional Budget Office estimated would be needed. “We were creating entirely new produce safety regulatory programs, entirely new importer regulatory programs, brand new inspection frequency mandates, including a massive foreign inspection mandate — and you can’t just do that out of thin air,” he said. “Congress and the administration have fallen far short of funding FSMA to the level that is needed to implement the law successfully. That’s a huge remaining issue.”

Developing and implementing the rules of FSMA was a tremendous learning experience and took a lot of effort by a lot of people at FDA and across the food industry. But the most memorable part of it all for Taylor were the farm visits, the farmer discussions and the many interactions with a wide range of other food system stakeholders. “That was the most educational and gratifying part of the experience for me,” he said.

FSMA’s Preventive Controls for Human Food Rule (PC Rule) was the first to be proposed — in January 2013. Two years later in September 2015, it (along with the Animal Foods rule) was the first to be finalized with compliance dates beginning a year following finalization.

Food businesses with thorough HACCP plans were well prepared for the new rule as, in many ways, the PC Rule was FDA’s way of updating and regulating HACCP, said Sabra Senior Director of Global Quality and Safety Rob Mommsen. But a lot of small companies did not have HACCP because they weren’t required to. Now they have to have a written Food Safety Plan (FSP), so for those who didn’t have HACCP, the PC Rule is difficult, he said.

HACCP AND THE PC RULE.

The primary difference between HACCP and the PC Rule is that HACCP is based on a hazard analysis that identifies and sets controls for activities or areas specified as critical control points. It’s not unusual for a HACCP plan to have a single CCP, he said. “That is all that is needed,” Mommsen added, explaining that other parameters are deemed as important for food safety, but don’t need to be listed as CCPs.

But, Mommsen said, “With the PC Rule, everything in the plant needs a preventive control.” And everything needs to be written out in a Food Safety Plan (FSP). “In my opinion, and many others agree, the preventive controls rule is no different than HACCP, except it has many, many more steps.”

For example, processors cannot simply base the FSP on what they know to be the inherent bacteria of their products and ingredient, they must reference FDA’s catalog for the associated hazards the agency has identified. Then, Mommsen explained, “You have to write how you control for it to not happen. And if it does happen, how you will control it.” For Sabra, Mommsen had to look up three dozen ingredients for the FDA-listed associated hazards, then justify why they weren’t a problem or how they are controlled.

“In my opinion ... the preventive controls rule is no different than HACCP, except it has many, many more steps.” Rob Mommsen, Sabra Senior Director of Global Quality and Safety

This means that while the company’s HACCP plans used to be about 10 pages — including a flow diagram, FSMA’s required FSP now needs to be 60 pages to meet the rule’s Hazard Analysis and Risk-Based Preventive Controls requirements. The problem with this, he said, is that the program required by the PC Rule does control hazards such as microbial load, but “a PC at a metal detector doesn’t prevent anything; it just tells you if anything is falling apart.”

Sabra had a thorough HACCP plan, so “forming that into a PC plan took only a couple months,” he said. “But what we weren’t prepared for was the FDA saying, ‘It’s not really what we were looking for.’ So, initially, we had to do a lot of rewrites.”

The industry began to take it in stride that FDA would come in and find something. “The lion’s share was getting over that hump; but now 99% of us are over the hump.” In fact, he said proudly, “On our last inspection, FDA found nothing, not even verbal.”

FINALLY HERE.

With all that, Mommsen sees FSMA and the PC Rule as having a lot of positives. “Both are risk based; they got that right,” he said. “FSMA brought with it some teeth for food safety. USDA has FSIS; FDA never had that until September of 2015.”

Other areas Mommsen sees as positives of FSMA and the PC Rule (“which I use interchangeably because you really can’t separate them,” he said) are:

• Mandated Recalls. FDA can now force companies to recall foods. “That is a very good thing. Though they get it wrong once in a while; I get that.”
• The Reportable Food Registry. “If I feel there is a possibility of a food safety issue with any of my suppliers, I can fill out a form anonymously that triggers an FDA investigation. No one liked that except me.”
• Allergens. For HACCP, allergens had to be identified and labeled; for PC, they have to be controlled. “I thought HACCP was a little light on allergens; the PC Rule is a little overkill, but it’s needed.”

There are a lot of people who don’t like the PC Rule because of the tedium, and there are certainly areas in which Mommsen is in agreement. “But I think FSMA was a good thing,” he said. “It was a long time coming, but at least it’s here now.”