It has been well established that the International Agency for Research on Cancer’s (IARC) research procedures need a major overhaul, but little is known about the negative policy implications that the small, France-based research outfit has on nearly 40 million Americans living half a world away. Examination into California’s Proposition 65 explains how IARC’s determinations are imported into the United States.
About Prop 65
The state of California enacted the Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Prop 65, after the ballot initiative passed in November 1986. The proposition was intended by its authors to protect Californians and the state’s drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to inform citizens about exposures to such chemicals.
While a laudable goal, the scientific approach behind Prop 65 is fundamentally flawed for several reasons, one of which is its reliance on IARC research. According to California’s Office of Environmental Health Hazard Assessment (OEHHA), the governing body behind Prop 65, anything IARC classifies as “possibly carcinogenic,” “probably carcinogenic,” or “carcinogenic” is fair game for listing on Prop 65.
There is a fundamental misalignment between the missions and scientific approaches of OEHHA and IARC, which has resounding and costly policy implications in California – and as we will discuss later – the United States at large. OEHHA’s mission is to protect public health and the environment by “scientific evaluation of risks posed by hazardous substances.” Meanwhile, IARC’s primary mission and research approach is to identify carcinogens by “evaluating cancer hazards.” And herein lies the conflict between IARC’s research approach and its influence on policy decisions in California.
Flawed Scientific Approach: Risks vs. Hazards and Why it Matters in Prop 65
There is a wide gulf between the evaluation of risk, and the identification of a hazard. A hazard is anything that has the potential to cause harm, whereas a risk is the likelihood that the hazard will cause harm. When scientists and policymakers carelessly substitute one for the other, public confusion gets compounded. As Reuters has pointed out:
“The public sometimes misunderstands what IARC means by its classifications. The agency says it assesses ‘hazard’ – the strength of evidence about whether a substance or activity can cause cancer in any way. It takes no account of typical levels of human exposure or consumption. So it is not measuring ‘risk’ or the likelihood of a person getting cancer from something.”
The Center for Accuracy in Public Health Research (CAPHR) has also documented the important differences between risks and hazards, noting that a risk assessment takes a known hazard and evaluates its impact in real-world applications. Risk assessments also take into account the following factors to determine the likelihood that any given hazard will actually pose a risk of harm.
Scientific Risk Assessments: Evaluation Criteria
Hazard assessments serve a scientific purpose as a screening tool for future risk assessments; however, conflating the two approaches under Prop 65 results in misclassifications and overregulation. As a result, nearly 80 substances are listed on Prop 65’s banned list because research by IARC has evaluated the potential of their harm, rather than the risk. The evaluation approach for this group is in stark contrast to the majority of other Prop 65-listed substances, which have been determined based on assessments of risk.
Unnecessary Alarm and Conflicting Guidance
Prop 65 and its IARC-backed listings have stirred up angst that negatively impacts Californians. Due to its poorly examined classification criteria, Prop 65’s carcinogen list includes nearly 1,000 agents, many of which are included in everyday products. For example, Prop 65 lists acrylamide — a chemical that naturally occurs in roasted coffee beans, cooked vegetables, and baked goods — as a carcinogen. The basis for the chemical’s listing on Prop 65 originated in IARC’s declaration that acrylamide was “probably carcinogenic,” another example of the foreign body’s assertions dictating domestic policy. Per the state regulation, all acrylamide products –like all Prop 65 substances– must contain a carcinogenic warning label to inform Californian consumers and discourage use.
Yet, the warning label does not only affect and influence the behaviors of Californians; many other Americans are indirectly impacted by Prop 65. Given the difficulty in ensuring unlabeled products with Prop 65-listed ingredients do not end up on store shelves in California, many manufacturers stamp the CA-required warning label on products destined for other states that do not have this requirement. This label causes unnecessary alarm and confusion for many other Americans, thus widening the reach of IARC’s bad science across our country.
Meanwhile, federal regulatory agencies say acrylamide is not harmful in the small doses typically found in table food. According to the U.S. Food and Drug Association (FDA), Americans should not stop eating foods that are fried, roasted or baked because of their acrylamide levels. In fact, acrylamide is “unlikely to have neurological, reproductive or developmental effects” in human foods,” reads FDA guidance. Lisa Halko, a Sacramento lawyer, expands upon Prop 65’s false-alarm warning labels versus the FDA’s approach: “There are better ways to get that information to people than putting a warning on just one theoretical risk. The U.S. Food and Drug Administration has more complete, better targeted information on possible risks.”
Halko raises an interesting point. Why should Californians be subjected to Prop 65’s alarmist notices, when federal regulatory organizations like the FDA have more complete information and appropriately communicated warnings about the risks in food? Acrylamide is just one example of how IARC’s carcinogen classifications conflate risks with hazards and negatively impact Californians.
Prop 65’s Money Trail
One might also wonder why OEHHA is willing to accept IARC’s hazard assessments as the law of the state without conducting its own risk evaluation. One clue might lie in the fact that the “citizen suit” provision included in Prop 65 has been a big moneymaker for powerful trial lawyers. This provision allows opportunistic lawyers to file lawsuits against any business in the country that sells products in the state. According to California Citizens Against Lawsuit Abuse, over 20,000 lawsuits have resulted in settlement payments totaling $500 million since 1986.
Additionally, between 2000 and 2010, businesses paid $142 million in Prop 65 settlements, including $89 million in attorney fees. These settlements tend to discriminate against small businesses that do not have the financial ability to defend lawsuits like larger corporations. As Art Torres, one of the authors of Prop 65 has admitted:
“Some of these small businesses have had to declare bankruptcy because of the lawsuits that were filed against them. Rather than having ‘gotcha’ lawsuits, we have to have a more reasonable approach for dealing with the issue.”
Prop 65 was intended to protect Californians from exposure to cancer-causing chemicals and products. Instead, it has turned into a cash cow for trial lawyers who have used IARC’s hazard assessments as reason to collect damages from businesses across the state.
By relying upon IARC classifications as a basis for listing agents to Prop 65, California’s OEHHA is going against its stated goal of evaluating and alerting consumers to risks. IARC’s influence on Prop 65 carcinogen lists creates unnecessary alarm for California consumers, and in some cases, contradicts federal regulatory guidance. Furthermore, Prop 65 Program has led trial lawyers and activists alike to seek financial gains at the cost of businesses small and large. In a world full of dangerous and potentially harmful substances, Prop 65 is blissfully ignorant to its own stated purpose. Prop 65 should focus on scientific consensus, rather than science for alarmism and profit.