It’s not exactly the fight of the century, but by European regulatory standards, it’s some pretty unusual fisticuffs.
This fight brings in two contenders for evaluating the safety of food in Europe. In one corner, there’s the World Health Organization’s International Agency for Research on Cancer (IARC). This agency is not a regulator, but combs through existing research studies to determine the hazard posed by a certain product, crop or activity. In the other corner, there’s the European Food Safety Authority (EFSA). This agency is a regulator, for the European Union. It will also look at hazards, but also assess the actual risks of exposure to food products or crops.
When the EFSA’s executive director, Bernhard Url, accused a group of scientists of conducting “Facebook science” because they publicly signed a letter protesting EFSA’s determination that the herbicide glyphosate was not a probable carcinogen, the anti-GMO community howled.
Specifically, the EFSA concluded that:
The substance is unlikely to be genotoxic (i.e. damaging to DNA) or to pose a carcinogenic threat to humans. Glyphosate is not proposed to be classified as carcinogenic under the EU regulation for classification, labelling and packaging of chemical substances. In particular, all the Member State experts but one agreed that neither the epidemiological data (i.e. on humans) nor the evidence from animal studies demonstrated causality between exposure to glyphosate and the development of cancer in humans.
The EFSA decision directly contradicted the determination of “probable carcinogen” made by IARC, which for 50 years has evaluated hazards, or the capacity for a number of substances and activities to cause cancer. The same anti-GMO groups that hailed the IARC decision also condemned EFSA’s. Franziska Achterberg, food policy director at Greenpeace EU, wrote that:
“This conclusion clashed head-on with the assessment of the world’s most reputable cancer agency. This is good news for pesticides companies, but bad news for everybody else. If the EU continues to follow this “regular, stringent process” we can expect that about every pesticide will be deemed safe.”
But further investigation shows that IARC, one of the oldest agencies charged with evaluating cancer hazards, has its self been infiltrated by the interests of non-government organizations. The organizations actively oppose the so-called genetic modification of food and have engaged in lobbying and other activities that, instead of providing unbiased information to protect the public, have served to use their definition of the “precautionary principle” to further their agendas. In addition, this subversion of IARC’s original purpose — coupled with the evolution of regulatory agencies charge with risk-assessment of environmental chemicals many countries over recent decades — has led some experts to question IARC’s continued existence.
What did EFSA say?
In November of 2015, EFSA, the regulatory agency responsible for food and agricultural safety in Europe, issued a report concluding that glyphosate, the world’s most widely used herbicide was “unlikely” to cause cancer in humans and could safely be used at higher exposure levels than those currently allowed in Europe.
After 96 scientists, including some members of the IARC committees that concluded that glyphosate was a “probable” cancer hazard, wrote their protest letter to the EU Health Commissioner against EFSA, Url responded with this:
You leave the area of science, and you enter the area of lobbying and campaigning… For me this is the first sign of the Facebook Age of science. You have a scientific assessment, you put it on Facebook and you count how many people like it.
This unusually public and provocative exchange revealed a significant differences in approach between EFSA, European member states’ health and safety risk agencies, and IARC.
First and foremost, IARC is not a regulatory agency, and is tasked only with identifying and evaluating hazards. As such, it considers only the possibility that any amount of a substance or activity might be connected to cancer. In contrast to EFSA and other risk assessment bodies, it does not evaluate actual risk associated with a hazard. Unfortunately, this distinction is lost on many people, including some regulators (e.g., California and France), who have subsequently made regulatory decisions restricting glyphosate and other substances on the basis of IARC evaluations.
Second, IARC today only looks at what is considered “peer reviewed” published scientific reports, conducts no independent research of its own, and has member scientists who are only permitted to review what’s been given them by their committee chair and IARC Secretariat. EFSA, like other agencies such as the US EPA or the German Federal Institute for Risk Assessment (BfR), will also evaluate publicly available data from other sources—including the extensive data packages generated by companies in support of a product registrations—which are not considered “peer reviewed.”
Reinvention of IARC reviews
Reviewing how IARC conducts its reviews over the past 10 years shows how the WHO agency has departed from the way that most regulatory agencies work.
IARC monographs are created by working groups or committees, which consist of about 20 scientific experts from about 10 countries. The members and chairs are all selected by the IARC Secretariat staff and are tasked with reaching a consensus on both the conclusions that they reach and the specific chemicals, activities, or other environmental phenomena to include in their evaluations. Since 1971, IARC has reviewed more than 900 agents and has only deemed on compound as “not carcinogenic”; over 400 have been classified as “possibly,” “probably” or “carcinogenic.”
In 2005, a committee was set up to overhaul the approach IARC used to evaluate potential carcinogens and report on them in its monographs. According to the report of that committee, IARC tabled the possibility of using quantitative risk assessment in their evaluations of possible hazards, and set up the rules on what could be selected. It also ruled out the use of any studies that were not published (unless they were accepted for publication), and ultimately allowed studies like the highly criticized and now retracted rat/tumor study by Gilles-Éric Séralini to be included in the monograph on glyphosate.
A 2014 committee report on hazard versus risk assessment guidelines for review committees set the stage for strict hazard assessments that excluded huge amounts of available and scientifically valid information. In this report, the committee concluded that:
…charging a Monograph Working Group to address broader issues of QRC (quantitative risk management) would divert the Working Group from its established main purpose and reduce the effectiveness of the current Monographs Programme. There is clearly a need for better information on the global burden of cancer, and for information that would be useful in developing and monitoring interventions to reduce this burden. If IARC wishes to pursue QRC to the point of developing risk estimates, combining these risks with exposures and predicting cancer burden, additional resources will need to be committed by the Agency to accomplish this goal.
The same year, then, a third committee established the substances, elements, and activities that would be reviewed by IARC for cancer hazard potential. Glyphosate, atrazine (which already had been studied under older guidelines) and GMOs were listed, but cannabis and water pipe-inhaled tobacco were not.
Who is Christopher Portier?
What did these committees have in common? Besides creating a very different environment for evaluation, they were all chaired by the same person: Christopher Portier, who was listed as retired from the National Center for Environmental Health at the US Centers for Disease Control and Prevention (CDC).
Not disclosed at the time was that Portier also was senior consulting scientist with the Environmental Defense Fund (EDF), a group that has actively campaigned (and lobbied government agencies) against the use of GMOs, glyphosate, and other pesticides associated with genetically modified crops. Interestingly, when Portier retired from the CDC in 2013, he began working with (and drawing a salary from) the EDF. IARC disclosed Portier’s EDF affiliation, including salary, in 2015. Before then, however, IARC listed Portier only as employed by, or retired from, the National Center for Environmental Health. While a senior scientist at EDF, in 2014 Portier’s affiliation with IARC is noted in a paper protesting the retraction of the discredited paper on rat tumors and glyphosate by Gilles-Éric Séralini.
An IARC committee chair wields a great deal of power over his or her committees. The chair, working with the Secretariat that appointed him or her, helps select the topics for evaluation and can set the rules for what scientific information will be evaluated and what must be excluded.
Portier, IARC, and EFSA continue to use an interpretation of what’s often called the “precautionary principle” as a regulatory and hazard assessment standard. The Precautionary Principle originated in the late sixties as governments began grappling with air pollution, and other relatively new hazards, and dictates that new technology was, in essence, “harmful until proven safe.” The European Commission stresses that the “precautionary principle may only be invoked in the event of a potential risk and that it can never justify arbitrary decisions,” but also has argued that “states have the right to adopt a precautionary approach when dealing with GMOs.” The use of this definition of the precautionary principle in regulatory decision making not only differentiates the EU from other industrial nations, it has opened the door for environmental and anti-GMO advocates (which include the EDF) to lobby for laws tightening or preventing approval of GM crops and certain chemicals that are approved elsewhere.
Andrew Porterfield is a writer, editor and communications consultant for academic institutions, companies and non-profits in the life sciences. He is based in Camarillo, California. Follow @AMPorterfield on Twitter.