Risk, Evidence, Safety, & Activists
Risk, Evidence, Safety, & Activists

Risk, Evidence, Safety, & Activists

The following article was originally posted by the Genetic Literacy Project (GLP), on June 21, 2022. Click here to see Dr. Smyth’s original post. Thank you to GLP for allowing us to share this post with our audience!

From the Environmental Working Group to the Pesticide Action Network, food activists claim we face killer risks from chemicals. Here’s why scientists don’t agree

Ecoli in ready-to-eat salads? Salmonella in seafood? Spoiled ground beef? Listeria in vegetables? Pesticide traces in… everything?

Each year the Environmental Working Group puts out a “Dirty Dozen” list of produce that it claims has ‘toxic levels’ of chemical residues and poses health dangers to consumers. In releasing this year’s guide, EWG claimed:

More than 70 percent of non-organic fresh produce sold in the U.S. contains residues of potentially harmful pesticides….

Sounds scary, but it’s not scientifically accurate. EWG is mostly funded by the organic industry [read GLP’s profile of EWG], so it’s no surprise that it recommends organic food over conventional. Its analysis and conclusions are mostly scientific bunk.

Agricultural scientist Steve Savage recently addressed EWG’s misleading analysis, as have many health experts and scientists (herehereherehere) as the residue levels, even in its ‘dirtiest’ examples, are far below any level that any food agency anywhere in the world finds harmful.

But that doesn’t mean our food is always safe. Thousands of contaminated food products are recalled annually because of spoilage of one kind or another. Last year, for example, Tyson Foods recalled almost 8.5 million pounds of ready-to-eat chicken that showed traces of listeria. Every year, according to the Centers for Disease Control in the US (2015 reporting), 1 in 6 Americans get sick from contaminated food and 3,000 die from foodborne illness.

Organic foods, portrayed as a healthier alternative to conventional products by EWG and other activist groups, are generally safe but more problematic than conventional alternatives, say experts. This past April, for example, Alpine Fresh recalled packages of its Hippie Organics French green beans after they tested for listeria.

Independent researchers in Australia and New Zealand concluded in a 2021 study that “organic products are becoming less safe and … are recalled at a higher rate.” In a Canadian analysis, chemical residues were detected on nearly half of the organic produce tested. The U.S. Department of Agriculture estimates that foodborne illnesses cost the US more than $15.6 billion each year.

The growing contamination problem in organic food and the challenge of food safety raises questions among consumers. How does the global food safety assessment system work? How does it impact consumers and most importantly, how are the systems now in place adequate to protect food supply in countries like the US and Canada from chemicals and spoilage?

Safety concerns

The safety of products and food is so pervasive in modern societies that many of us assume that the systems providing safety have been around forever. The reality is that the current risk assessment frameworks came into existence less than 50 years ago. As knowledge and experience increased, food safety risk assessment frameworks have been continually refined and improved by incorporating new evidence.

As consumers and citizens, we have become more concerned about how products are produced, what ingredients or components were used, whether the products were adequately protected from spoilage, and how might we or the environment be impacted. Most often, safety is a back-of-mind item that we never prominently think about until we need it, like the brakes on our vehicle or the smoke alarms in our homes. Safety is something we rely on daily, yet the process to ensure products are safe can often be obscure, cloaked within thick regulatory documents and dense language.

Whether it’s the use of specific minerals or metals in the production of modern electronic equipment, the application of chemicals in the production of food, or the integrity of the supply change to prevent spoilage, consumers are growing more conscious of these processes and whether their family may be impacted.

Often, the only time that food safety systems receive much attention is when an unsafe product is detected and recalls are issued. This confirms that food safety systems are vigilant and rigorous in their efforts to continually monitor the products that are on store shelves. But what about the safety assessment that allowed these products to be first placed on the shelves? How has modern risk assessment evolved over the past 20 years?

How our integrated risk systems evolved

Modern risk analysis is often thought to have originated with Rachel Carson’s 1962 book Silent Spring, which highlighted the detrimental environmental effects of synthetic pesticides, particularly on birds. It stirred enormous controversy, in the public and in government. Many in society became concerned about the many unanalyzed technologies and products being introduced into our environment, economy and society.

The public outcry is generally credited with the founding of the US Environmental Protection Agency (EPA) in 1970 with an explicit mandate to regulate chemicals and other pollutants, protect human health and safeguard the natural environment—air, water, and land—upon which life depends. Although risk analysis was not yet a formally recognized process, the EPA completed its first risk assessment document in December 1975, and in 1976 issued its first directive on procedures and guidelines. In 1980, the EPA produced water quality criteria documents for 64 contaminants, the first EPA document which described the quantitative procedures used in their risk assessment.

The ’Red Book’ on risk assessment

The watershed development came In 1983 when the National Academy of Science published Risk Assessment in the Federal Government: Managing the Process commonly referred to as the ‘Red Book’. This publication was the first to lay out the context for a systemic, comprehensive process for risk analysis.

Under the Red Book paradigm, the assessment of risk is largely a science-driven process that quantitatively evaluates the probability of risk. As such, risk assessment is largely, removed from emotional factors that influence risk perception. Risk assessment flows logically from problem formulation through characterization of toxic effect or hazard and exposure analysis, ending in a risk conclusion.

The characterization process is repeatable: if any step yields unexplored concerns, the process loops back to develop or incorporate new science to refine the risk assessment. This process is done in stages, with different levels of potential hazards assessed proportionately. It is common for regulators to assess a risk assessment dossier and contact the submitter, requesting additional details and evidence, which is then assessed as part of the process once received by regulators.

Blue and Orange Books

Over time, the National Research Council expanded on its risk assessment principles into a series of subsequent reports, including Science and Judgment in Risk Assessment known as the ‘Blue Book’ and in 1996, the Orange Book shifted risk characterization from a science-driven enterprise to an ‘analytic-deliberative’ process. In essence, the process should be a “decision-driven activity, driven toward informing choices and solving problems.”

This requires a broad understanding of the harms or consequences of a technology or product on a defined population and requires participation by or representation of risk analysts, decision-makers and the affected population. Thus, public officials, natural and social scientists and interested and affected parties were now viewed as legitimate and important actors in the analysis, deliberations and learning and feedback stages.

How does the risk assessment process work?

In practical terms, the risk analysis framework can be divided into three distinct risk phases—assessment, management and communications. These specific domains are embedded in, informed by and have an influence on other parts of the development, commercialization, production, marketing and consumption of products and services, but they operate somewhat independently of the broader social concerns. At least partly due to the diverse nature of the three phases, they have emerged in different ways.

Risk assessment, as defined in the Red Book is

a scientifically-based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.

In the first instance, a hazard is defined as “biological, chemical, and physical agents capable of causing adverse … effects and which may be present…” Hazard identification involves examining whether the agent could cause an adverse effect and is informed by laboratory and field observations of adverse effects of similar agents.

Hazard characterization involves asking about the relationship between the dose of an agent and an adverse response in the environment, animals or humans. While no formal evaluation and decision flow from the assessment stage, the choices made and evidence gathered provide the context for the decision that would then be required in the risk management phase.

Risk management and communication

Codex Alimentarius asserts that risk management involves the “process of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures”. This happens inevitably in the social and political realm. Science cannot judge when a technology or product is ‘safe enough’—that is the role of the political system.

Different governments in different societies will have different views. Political systems decide when, where, and how to intervene in the private activities of individuals based on a wide range of philosophical, historical, social and institutional factors. Within the Organisation for Economic Co-operation and Development (OECD), most member states have developed explicit rules and institutions to analyze and control market access by numerous technologies and products to protect the environment, economy and society.

Management and communication of risk operate in two very different ways. Risk communication is defined by Codex as “the interactive exchange of information and opinions” “throughout the entire risk analysis process concerning risk“, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions. These communications, while important, often are not formally included in guidelines.

While the Orange Book made an explicit reference for enhanced two-way communications about technologies and products under risk assessment, it offered little direction on how the system should communicate its risk management decisions and maintain an ongoing dialogue with users and consumers of technologies and products once they are approved. Risk communications systems show that, despite the efforts of regulators, many risks have been socially amplified by ‘outrage’, resulting in wide divergences in the perceptions of risk between regulators and citizens. It is sometimes hard to measure outrage—sometimes it is evident in the marketplace and can often find its basis in misinformation.

The wisdom of rooting risk assessment methods on existing stocks of knowledge is that virtually all innovative products are simply refinements or enhancements of previous products. The risk assessment data of the previous product provides knowledge to the new products, which allows for the risk assessment focus to be on the unique differences. This process results in knowledge and evidence grounding risk assessments, ensuring that emotional sentiments have as minimal an impact as is possible.

Applying risk analysis to food

During the course of production, the food we consume can come in contact with a lot of things that can make us ill, or worse: kill us. Chemicals used to reduce insect and plant disease crop damage can be dangerous to human health if not managed properly.

When insects eat on crops that will soon be food options on our store shelves, they expose the food item to airborne toxins that can lead to cancer in humans. When chemicals are applied to fruits and vegetables to ensure insects don’t damage the crop, traces of the chemical can remain on the item when we purchase them in a store or farmers’ market. What confidence do we have that it is safe to consume a product that may contain chemical residues?

A simple way to remove chemical residues is to wash all fruits and vegetables, prior to using them. These crops are washed when harvested, removing most chemical residues, but some will remain and a 15-minute soak in water is able to remove the remaining residues. While we can adopt this practice in our own home, how do we know that other foods we consume are the same when it comes to chemical residues?

Much recent media coverage, not to mention misinformation spread by environmental activist groups like EWG, tend to portray chemical residues as extremely dangerous and something to be avoided at all costs. The reality is more nuanced: chemicals are a daily part of our life and food consumption. The concept of risk can be captured in the equation:

Risk = Hazard x Exposure

 

For a hazardous object or situation to become a risk, there must be exposure. For example, a wild and dangerous animal will always represent a hazard, but as long as it remains properly caged it will not represent a risk. X-rays are dangerous to human health, but when used for dental and medical purposes, our exposure is a fraction of a second and we rarely have x-rays, so the risk is very minimal. There can never be zero risk, so risk has to be assessed in ways that measure risk, not hazard (which is the potential for risk without considering exposure). The same principles apply to chemicals in our food.

Do chemical residues at vanishingly small levels pose dangers to humans as EWG and other food activists regularly claim? Advanced monitoring equipment can detect chemical residues in the parts per trillion or even one quadrillion—far tinier than evidence suggests would affect our health or safety. How small is one trillion? It would take a military jet flying at the speed of sound, reeling out a roll of dollar bills behind it, 14 years before it reeled out one trillion-dollar bills. In other words, not very much. But it sounds scary in an EWG press release on the ‘dangers of chemical in our food’. One part per trillion, measured in time, is the equivalent of one second in 31,500 years.

As part of the process to assess the risks of any chemical residue that might remain on our food products, experts assess how much of the chemical an individual would need to consume and in how much time, for this to be dangerous. Once the danger threshold is determined, regulatory agencies reduce this rate substantially to ensure that our exposure to the risk is far below this threshold.

As an example, the residues of a chemical used to control insects on apples may be dangerous to a person if they consumed 100 apples in a week. Expert scientists assess the toxicity evidence and determine the danger threshold, then set chemical application regulations such that a person could eat 300 apples a week without worry of harmful health effects from the chemical residues.

So, what about claims by the Environmental Working Group and other organic food activists that claim our food is laced with toxic chemicals? As professors Carl Winter and Josh Katz wrote in the Journal of Toxicology:

In summary, findings conclusively demonstrate that consumer exposures to the ten most frequently detected pesticides on EWG’s “Dirty Dozen” commodity list are at negligible levels and that the EWG methodology is insufficient to allow any meaningful rankings among commodities. 

No system operates perfectly and risk can never be zero. Errors in this method of risk assessment are exceedingly rare, given the reinforced nature of the system and that the method is globally applicable. Food safety experts routinely test food products to measure the levels of chemical residues to ensure that they are in line with existing standards and when a product is found to exceed the allowable limit, it is recalled from the market.

Over the past 50 years, a staggering amount of risk assessment evidence has been compiled and contributed to modern assessments. While risks are never able to be fully removed from the use or consumption of any product, the modern risk assessment framework provides a thorough assessment, erring on the side of caution, resulting in our food never have been safer.

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