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"By denying scientific principles, one may maintain any paradox." – Galileo Galilei

House Science Hearing Highlights Myriad of Troubling Issues with IARC Monographs Program

The House Science, Space and Technology Committee held a full committee hearing on Feb. 6 to examine the “scientific underpinnings, principles, and procedures” at the International Agency for Research on Cancer’s (IARC) Monographs Program.

Prompted by recent investigations by Reuters and Politico, which revealed efforts by IARC Monograph scientists to omit data and manipulate outcomes during its 2015 evaluation on glyphosate, the hearing highlighted the systemic transparency issues, conflicts of interest and flawed methodologies that have led lawmakers to consider pulling millions of dollars of funding from IARC. As Subcommittee Chairman Lamar Smith (R-Texas) discussed at the start of the hearing:

“The selective use of data and the lack of public disclosure raise questions as to why IARC should receive any government funding in the future.”

Despite the fact that U.S. taxpayers have provided $48 million to IARC since 1985, including $22 million to the Monographs program specifically, IARC refused repeated Congressional requests to provide a witness for the hearing.  IARC’s refusal to cooperate was not lost on lawmakers.

“When asked to provide a witness for this hearing, IARC director (Christopher) Wild refused to attend,” Smith said. “No doubt, he could not defend IARC’s glyphosate findings. … If there’s nothing to hide, then why the secrecy?”

Committee Vice Chairman Frank Lucas (R-Okla.) added:

“This committee has on several occasions attempted to gain a greater understanding of IARC’s decision-making process. Unfortunately, the committee’s simple request for IARC to provide a witness to testify on the Monograph program has been met with resistance.”


Risk vs. Hazard

Meanwhile, several witnesses shed needed light on the many troubling deficiencies of the Monographs program. One reoccurring issue that surfaced was IARC’s flawed and severely dated scientific methodologies and insistence on assessing cancer hazards over risks, all the while communicating to the public through its preamble that it assesses cancer risks.

Nearly every other reputable regulatory authority around the world, including the U.S. Environmental Protection Agency, Health Canada, the United Kingdom Committee on Carcinogenicity, and European Food Safety Authority conducts risk assessments, while IARC conducts hazard evaluations. A hazard evaluation identifies anything that has the potential to cause harm, while far more useful risk assessment determines the likelihood that a hazard will cause harm.

Witness Timothy Pastoor, toxicologist and CEO of Pastoor Science Communications LLC, correctly characterized hazard evaluations as “antiquated” and “irrelevant,” noting they provide “no context on risk.” Pastoor said in written and oral testimony before the Committee:

“The difference between the words ‘hazard’ and ‘risk’ is absolutely, crucially important… [Hazard] classification schemes defy common sense, and yet IARC has used this scheme for a half century. While cancer classification systems such as IARC’s may have served a useful purpose when they were created, they are irrelevant today as the telegraph or 8-track tape player. They provide little to no useful information and do more to confuse the public — and policy makers — than to protect public health.”

It is for this exact reason that the EPA’s Office of Pesticide Programs conducts risk assessments rather than hazard evaluations. As witness Anna Lowitt, senior science advisor in the EPA’s Office of Pesticide Programs, noted, EPA “considers exposure as a critical component of its cancer evaluation.”  Exposure and potency are not evaluated in IARC’s hazard evaluation.


Flawed Science and IARC’s review of Glyphosate

Witness Robert Tarone, a retired mathematical statistician at the National Cancer Institute and the former biostatistics director for the International Epidemiology Institute, argued that there isn’t even sufficient evidence that glyphosate is a cancer hazard, as IARC’s evaluation claims.

Tarone took specific issue with the “deliberations of the IARC glyphosate working group,” testifying that IARC’s determination that glyphosate is “probably carcinogenic to humans” hinged entirely on its “flawed and incomplete” evaluation of a pair of rodent studies that it determined provided “sufficient” evidence that glyphosate is carcinogenic to animals.

“Taken together these two studies provide no evidence whatsoever to support the conclusion that glyphosate causes renal tumors in male mice,” Tarone testified.


Flawed Scientific Methods: Dosage & Data Exclusion

Pastoor, Lowitt and Tarone also took issue with the fact that the Monographs Program fails to provide context on dosage — it uses studies that administer “incredibly high” dosages over an extended period of time.

Pastoor noted that “the dose makes the poison” — using the example that two aspirin tabs can relieve a headache, while a full bottle could kill you — and added that “many things that could cause cancer in extremely high does are harmless at levels like encountered by human beings. IARC simple ignores this essential fact.”

Tarone also testified that IARC ignored several studies that found no correlation between glyphosate and cancer.

“Such systemic exclusion of exculpatory evidence is inexcusable, particularly when it is practiced by an influential source such as the IARC Monograph Program,” Tarone said.


IARC’s Impact on the Public and Public Health

The consequences of IARC’s work was a big focus of the hearing. As Pastoor stated:

“Outdated science and flawed process are not without consequence. Declarations by the Monograph Program have sown unnecessary fears about useful and safe products and deflected enormous resources away from useful investments in public health…. Any agency whose evaluations are used to influence public health decisions must be transparent and fully accountable to the public,”  adding that the Monographs Program either needs to be “significantly reformed” or “abolished.”

The Campaign for Accuracy in Public Health Research (CAPHR) Coalition is dedicated to the reform of IARC’s Monographs Program for these very reasons, and has applauded the House Science Committee’s move to examine IARC’s severely flawed cancer hazard evaluation program.

“The CAPHR Coalition fully supports the House Science Committee’s review of the IARC Monographs Program. We have serious concerns with the Program’s lack of scientific integrity and transparency in developing Monographs. Our goal is to reform and update the IARC Monographs Program to bring it into the 21st century and restore public trust,” said Cal Dooley, President and CEO of the American Chemistry Council (ACC).

As Tarone noted, “What I believe right now is that the Monograph program appears to think they’re accountable to no one. So I do think that they need to show some accountability to somebody.”

Modernizing IARC’s Monographs Program process will help to strengthen the integrity of its conclusion, and is especially urgent following several recent revelations of data suppression and manipulated outcomes in its cancer hazard evaluations.