Why Food Safety Plans must consider chemical hazards

By: Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant, Environmental Defense Fund

Since September 17, 2016, most facilities storing, processing, or manufacturing food are required to identify and, if necessary, control potential hazards in food under a Preventive Controls Rule promulgated by the Food and Drug Administration (FDA) pursuant to the FDA Food Safety Modernization Act of 2011 (FSMA). Some foods have had similar requirements in place for years. For example, fruit and vegetable juice processors have been required to have a Hazard Analysis and Critical Control Point (HACCP) Plan since the early 2000s.

Record numbers of consumers rate chemicals as their top food safety concern A Food Safety Plan required by FDA is an effective means to respond to this concern and proactively manage risks posed by chemicals instead of reacting to often preventable incidents.

The driving force behind the law and the rules has been reducing the hazard of pathogenic contamination in food. However, the Preventive Controls Rule defines a hazard broadly to include any chemical, whether a contaminant or an additive, that “has the potential to cause illness or injury.”

In this blog, we will explore how the requirements of the Preventive Controls Rule apply to chemical hazards using lead as an example. We chose lead because it is known to cause injury and clearly meets the definition of a hazard. It is well-established that there is no safe level of lead in the blood of children leading to lower IQ and academic achievement, and increases in attention related behaviors. We also know it is all too common in food that toddlers eat. And scientific evidence indicates that much of the lead in food gets into children’s blood.

Four potential sources of lead in the food supply chain

Lead can get into food in different ways including:

  • Absorption from contaminated soil into the roots, leaves, and, possibly, fruit. Soil may be contaminated from past use of lead arsenate pesticides or air deposition from burning leaded gasoline.
  • Contact with contaminated soil during production or harvesting. For example, soil may get into a head of lettuce or on an apple that falls to the ground.
  • Leaching from food handling equipment such as that made from brass or plastic that had lead intentionally added. Until 2014, brass used in drinking water applications could contain up to 8% lead and still be called lead-free. If such brass were used in pumps and valves in food production, leaching of lead into food may occur. Similarly, lead has also been used in PVC plastic as a stabilizer, although it has been phased out in U.S. and Europe. It is important to note that lead is not approved by FDA to be intentionally added to anything that contacts food. If any leaches into food from these sources, the lead would be considered an unapproved food additive. That would render the food adulterated and, therefore, illegal to sell. Note that a supplier’s claim that a material is “food grade” is no guarantee that its use is legal.
  • Contamination of food or food contact materials during processing such as lead from deteriorated paint in the building.

Elements of a Food Safety Plan

Under the Preventive Controls Rule, most facilities storing, processing or manufacturing food must have a written Food Safety Plan that consists of seven items:

  1. A hazard analysis to identify and evaluate known or reasonably foreseeable hazards;
  2. Preventive controls to ensure hazards are significantly minimized or prevented and food will not be adulterated;
  3. Risk-based supply chain program to protect raw materials and ingredients from hazards;
  4. Plan for recalls should they be necessary;
  5. Procedures to monitor preventive controls to assure they are consistently performed;
  6. Corrective action procedures if preventive controls are not properly implemented; and
  7. Verification procedures to validate that preventive controls are adequate and effective, other procedures are being followed, and plan is reevaluated at least once every three years.

The path forward

The FSMA food safety planning requirements put in place a systematic approach for food manufacturers to prevent food safety problems rather than react when they arise. This includes problems that can result from chemical hazards as well as pathogens. The goal is to ensure that consumers are not exposed to adulterated food, whether because it contains “any poisonous or deleterious substance which may render it injurious to health” or it contains an unapproved food or color additive.

A robust food safety plan for lead and other chemicals such as perchlorate would go a long way to protect children and pregnant women from unnecessary exposures to chemicals known to impair brain development, and the businesses from unnecessary risk.

What a Food Safety Plan would say for lead

To comply with the regulations and mitigate risk, the food manufacturer/processor’s written food safety plan is required to identify lead as a hazard if it is reasonably foreseeable that lead could get into food either as a contaminant or from its intentional addition to materials such as brass or plastic used in food handling equipment.

If the plan identifies lead as a hazard, the company must evaluate the risk by assessing (1) the severity of the illness or injury if the hazard were to occur, and (2) the probability that the hazard will occur in the absence of preventive controls. The plan must also develop and implement preventive controls to assure lead levels are significantly minimized or prevented and the food is not adulterated. The controls would likely include:

Next, the company must identify how the preventive controls would be monitored to spot implementation problems, explain how a recall would be conducted if lead were found to exceed the maximum amount identified in the plan or is present as an unapproved food additive, and describe what corrective action would be taken to prevent future recalls.

Finally, the food manufacturer/processor must reanalyze its Food Safety Plan at least every three years or when:

  1. There is a significant change in the activities conducted at the facility that creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard;
  2. The food manufacturer becomes aware of new information about potential hazards associated with the food;
  3. An unanticipated food safety problem occurs; or
  4. The food manufacturer finds the preventive control, combination of preventive controls, or the food safety plan as a whole is ineffective.

The Food Safety Plans are not made publicly available, but they must be made available to FDA on request or during an inspection. Potential downstream buyers and retailers most likely can obtain a copy through their own supply chain management programs.

The state of green business? Hopeful, puzzling… and pushing forward

I always look forward to the latest State of Green Business report from GreenBiz. It invigorates me and reminds me that there are a lot of talented people making sure that both business and the planet can thrive– a notion that I’m holding tight as the political atmosphere gets increasingly crazy.

I found two of the trends in the report of particular interest because they signal that smart business leaders are staying the course on climate.

Trend: Corporate Clean Energy Grows Up

The trend toward corporations transitioning to renewable energy has been gaining momentum for years. Today, twenty-two of the Fortune 100 have committed to procuring 100% of their energy from renewables, and 71 have a public target for sustainability or renewable energy.

“Business is a very important advocate for clean energy, because it speaks the language of hard economics,” points out Jim Walker, co-founder of The Climate Group. “It’s sending a strong signal to policymakers and the general public that this is the inevitable direction we’re going to move towards – a 100% clean energy economy.”

When innovative companies like Apple, Amazon, Unilever, and Google show leadership on renewable energy, their suppliers, customers, competitors, and the market respond. Microsoft, for example, is helping lead the way by purchasing 237 megawatts of capacity from projects in Wyoming and Kansas. And, Walmart, a long-time EDF partner, has also made a commitment to source 100% of its electricity from renewable energy. Currently at 25%, they’ve made significant progress on implementation.

With corporate leadership like this in place, it’s clear that business will continue to have an impact on the renewable energy revolution. The recent report from my EDF Climate Corps colleagues is proof of that: the solar power sector is growing quickly, and is a major source of jobs that are a.) impossible to outsource and, b.) available in all 50 states.

Trend – Companies Put Their Money Where Their Suppliers Are

According to the Business and Sustainable Development Commission, embedding sustainable business practices in the global food and agriculture industry could deliver $2.3 trillion annually.

“All stakeholders can share in the benefits: smallholder farmers improve their livelihoods; suppliers gain increased security of supply with improved quality; and we reduce volatility and uncertainty with a more secure and sustainable supply chain,” wrote Unilever CEO Paul Polman.

Elizabeth Sturcken, Managing Director, EDF+Business

When a corporation commits to reduce emissions in their supply chain, the results can be powerful.  We’re seeing this firsthand with our work with Walmart. EDF spent 10 years with Walmart to help drive sustainability across its global supply chain. The result? By the end of 2015, through leadership, innovation and a diverse range of projects, Walmart had exceeded its goal to reduce supply chain emissions eliminated 36 MMT of greenhouse gas from its supply chain. Now, they’ve committed to removing 1 Gigaton of emissions by 2030 – the equivalent of the total annual emissions of Germany.

Smithfield Foods is another company that EDF collaborated with in setting a goal to reduce absolute greenhouse gas emissions by 25% by 2025 across its upstream U.S. supply chain. EDF will continue to help Smithfield improve fertilizer efficiency and soil health, which will reduce nitrous oxide emissions from grain farms.

But to keep moving forward on these sustainability trends and others requires business to use its voice and influence to not backpedal on policies that are a win-win for our environment and our economy. We are at a crucial period where companies need to make the long-term economic case for policy, including the Clean Power Plan, Toxic Substances Control Act (TSCA) and ensuring the U.S remains part of the Paris Agreement.

Businesses will not go backwards on environmental protection. It’s bad for business and the environment. In fact, over 600 businesses have signed the Low Carbon USA letter calling on U.S. elected leaders to stay the course on environmental protection and climate leadership.  Now is the time for unlikely voices to step up and continue to press the case for action; the recent call for a carbon tax is probably most noteworthy because it was brought forth by Republican party faithfuls.

If there was one sentence in the State of Green Business report that captured the feeling of the moment it was this: “It’s hard to imagine a time more hopeful and horrifying for sustainable business.” At EDF, we’re not only hopeful but we’re committed: the economy and the planet can—and must–thrive together. Any conversation that suggests otherwise is a non-starter.

 

Now trending in global business: collective action on deforestation

edf-business-of-food-blog-graphic_shelton-grp_12-7-16With U.S. policy engagement on climate action in limbo, the rest of the world is marching forward. As major CEOs and political leaders gathered at the recent World Economic Forum (WEF) in Davos, Switzerland, clear support was shown for creative investment in clean energy, sustainable development and other climate change mitigation practices.

While many ideas were discussed, however, one topic emerged as both a driver of climate impact and an opportunity area for huge climate benefits: deforestation.

Two major initiatives around deforestation were launched at the WEF:

A fund to catalyze private investment in deforestation-free agriculture was announced by the Norwegian government, the Sustainable Trade Initiative (IDH), UN Environment, the Global Environmental Facility, and many other supporters. Their goal? To help fund sustainable intensification of agriculture in jurisdictions which are effectively working toward reducing deforestation. The fund will be operational by middle of 2017 and aims to protect over 5 million hectares of forest and peatlands through its projects by 2020. 

Norway pledged up to $100 million, with a capitalization goal of $400 million from other donors and private sector partners. The model aims to engage even more private sector financing, for a total investment of $1.6 billion by 2020. The Tropical Forest Alliance 2020 and major food giants like Carrefour, Marks & Spencer, Mars, Nestle and others are expressing support. Unilever is the first corporate leader to commit funding, with a pledge of $25 million over the next 5 years.

A plan to use big data to monitor and trace the raw materials in major corporations’ supply chains. Led by the World Resources Institute, the initiative has major support from food companies such as Bunge, Cargill, Walmart, and others, with a total combined value of $2.9 trillion.

The goal is to build a decision-support system to help companies track progress and real-time challenges associated with their deforestation commitments. The tool will enable corporations to make real-time decisions about geographies to prioritize in their deforestation reduction work, and get alerts when illegal activities are happening in those regions. While the tool is still in very early stages, the future could be bright.

Deforestation-free sourcing? There’s an app for that!

Deforestation_in_Panama

Two initiatives… powerful trends

So: what do these two initiatives—one helping to ensure that farming already-cleared land becomes more productive, and one helping companies shed light on the complex, murky labyrinth of their global supply chains—tell us about emerging trends in global climate leadership?

  1. Forests matter: Stakeholders understand the importance of forests for climate and supply chain stability. The impressive list of participants and lofty goals show that forests have become part of the main stage for how to address climate change globally. Deforestation contributes about 15% of greenhouse gas emissions annually, but can also be a major carbon sink if managed appropriately. Corporations understand that forests are vital for reducing reputational risk in product lines, ensuring stable weather patterns that can produce viable crops into the future, and increasing the resiliency of major geographic regions against drought and flooding. These new commitments indicate that action on forests as part of the climate dialogue are here to stay.
  1. Collective action is the right tool: Companies see the value in working collectively on effective solutions for deforestation reduction. Corporations know that there is significant risk in not engaging effectively on forests, both for the climate and for their supply chains. But the more challenging question to date has been: how? Over 350 companies have made public commitments to reduce deforestation related to major agricultural commodities in their supply chains. However, only one-third of these companies report on how they will reach these goals. These two new initiatives show the value of collective action between companies, non-profits,
    Katie Anderson, Project Manager, EDF+Business

    Katie Anderson, Project Manager, EDF+Business

    and governments to engage effectively in the multi-faceted challenge of deforestation-free sourcing. The days of working in silos, simply along supply chain boundaries, are no longer the most effective strategies. Working together provides new, creative solutions that can have an impact across entire regions rather than solely withinthe boundaries of sourcing relationships.

  1. There is still much to be done. While these initiatives are important signals of major trends within the deforestation space, they are still only in their infancy. Time will tell if the stakeholders engaged will be able to actualize the ambitious goals and creative thinking embedded in these ideas.

But, I’m optimistic. What emerged out of Davos tells me that the collective work of these major corporations can get us to where we need to go: productive, economically viable agricultural supply chains without destroying critical forest habitat upon which we all rely.

Will the U.S. join this trend toward collective action? The jury is still out on that one.

 

 

No “alternative facts” needed: leading on sustainability is smart business strategy

A Businessman is looking out the window in a modern panoramic meeting room in New York. The concept of the meeting of the Board of Director of the huge transnational corporation.

For the people who dedicate their lives to helping keep the planet livable, it’s hard to wrap one’s mind around our new weird, warped, post-election world. Every day seems to bring some new government official denying facts and science (aka reality), or doing unthinkable damage to the suddenly-less-venerable institutions they now lead.

As someone who has a 20-year track record of working side-by-side with the private sector to create positive environmental change, I can just imagine how anxious business executives must be feeling these days. The specter of a three a.m. tweet from the White House demanding that they run their company according to a Presidential whim, rather than the realities of the global marketplace (or the expectations of shareholders), can make for a lot of sleepless nights.

Unlike certain “business-executive-Presidents", however, real CEOs have to be fact-driven.

And the forward-thinking executives—the ones who are thinking hard about the long-term growth, profitability and resiliency of their companies—are well aware of the facts. They know that human-caused climate change is real, and carries with it huge costs. Executives selling food grown in rapidly changing landscapes and/or products dependent on materials from across the globe aren’t playing in a fantasy world where climate change is a “hoax invented by China.”

And they know that how we deal with climate change will determine whether we will be a driver or a destroyer of business value. As a peer-reviewed study in the journal Nature recently found (and the New York Times reported): "even if the world is able to stave off an increase in atmospheric temperatures of 2 degrees Celsius or 3.6 degrees Fahrenheit — a goal agreed to as part of the Paris deal — climate change could wipe out $1.7 trillion worth of global financial assets."

So, I’m hopeful that, at least in terms of sustainability, the rational decisions being made on Wall Street will act as a counter-balance to what appears to be erratic decisions coming out of Washington. Consider just a few of the recent announcements and actions of the private sector:

  • In just the past 3 months, Google, Microsoft, Pepsi, Smithfield Foods, Walmart and many others have continued to lead the way and prove what’s possible through bold, science-based goals, investments in clean energy and expanded efforts to drive down emissions in their operations and supply chains.
  • At the recent World Economic Forum (WEF) in Davos, Unilever CEO Paul Polman said “to make America great again, climate action is very logical. This is a very convincing story for job creation and economic growth.” My colleagues at EDF Climate Corps back this up with data; the sustainability sector is booming with jobs that 1.) can’t be outsourced, and 2.) are readily available in all fifty states.
  • A WEF report on the future of retail talks about “the golden age of the consumer” and the implications and opportunities that are created for sustainability by addressing how goods are delivered—what is called the “last mile of delivery”—and how products are packaged.
  • Commenting on that same report, Walmart CEO Doug McMillon pointed out that sustainability will impact retail in ways far beyond logistics and packaging: in this age of social media sharing, the push for transparency in supply chains will be customer-driven. McMillon knows that “retailers will only survive if their business creates shared value that benefits shareholders and society.”
  • Finally, in a recent op-ed entitled Why Walmart is doubling down on its commitment to climate change, Walmart board member Rob Walton, gave a simple answer: because it’s good for business! “We set [our climate goals] because we wanted to help address climate change and improve lives, while also strengthening our company and reducing expenses,” he said. “We thought it would be a win-win: good for society, and good for Walmart.  Eleven years later, that's exactly what we've seen.”

    Elizabeth Sturcken, Managing Director, EDF+Business

    Elizabeth Sturcken, Managing Director, EDF+Business

That’s a long list—and one that adds to the mounting evidence that corporate America “gets it”:

momentum for business leadership on sustainability is here to stay. Which is in no way surprising, because after my many years of working with business, I’ve seen firsthand the immense value creation that comes with moving forward—not backward—on environmental issues.

So, for all that has changed in these times of “alternative facts,” those who care about having a livable, thriving planet can feel confident that they have a powerful ally in business. Because when it comes to our climate, our health and our planet itself, if we’re not making progress, we’re losing.