Monsanto Co. is taking legal action to prevent what they called a “flawed listing” of the herbicide glyphosate under California’s Proposition 65 (Prop 65), which requires the state to maintain a “list of chemicals known to the state of California to cause cancer.”
Monsanto said the listing of glyphosate would be “flawed and baseless because glyphosate does not cause cancer, as has been concluded by the U.S. EPA (Environmental Protection Agency), the European Food Safety Authority (EFSA) and pesticide regulators around the world.” It said the listing would violate the California and U.S. constitutions because the state would be ceding the basis of its regulatory authority to an unelected and non-transparent foreign body that is not under the oversight or control of any federal or state government entity.
Monsanto filed the suit against the California Office of Environmental Health Hazard Assessment (OEHHA) in California’s Fresno Superior Court.
Indeed, OEHHA, the very state agency that has announced its intention to add glyphosate to the Prop 65 list, determined in 2007 — after conducting a rigorous and science-based assessment — that glyphosate was unlikely to cause cancer. In striking contrast, OEHHA now interprets Prop 65 to require the agency to accept the erroneous classification of glyphosate as a “probable carcinogen” by an ad hoc working group of the International Agency for Research on Cancer (IARC), based in Lyon, France, as the sole basis for the proposed listing. This interpretation of Prop 65 is unconstitutional, Monsanto said.
Moreover, IARC’s own governing documents specifically disavow any policy- or law-making role for its classifications, and it does not intend its classifications to carry the force of law. As stated in IARC’s preamble, “These evaluations represent only one part of the body of information on which public health decisions may be based. … Therefore, no recommendation is given with regard to regulation or legislation, which are the responsibility of individual governments or other international organizations.”
“Glyphosate does not cause cancer, so listing glyphosate under California’s Prop 65 is not warranted scientifically and would cause unwarranted concern for consumers,” said Dr. Phil Miller, vice president of regulatory affairs at Monsanto. “Based on the overwhelming weight of evidence, regulatory agencies have concluded for more than 40 years that glyphosate can be used safely. The conclusion from the IARC meeting in France was erroneous, non-transparent and based on selectively interpreted data. We are bringing this challenge forward because this intention to list is contrary to science.”
Regulatory agencies around the globe - such as EPA and EFSA - evaluate pesticides, including glyphosate, using thorough and robust risk assessments based on internationally recognized toxicological principles. As required by law, these evaluations consider all relevant scientific data to arrive at a conclusion about whether a pesticide could be carcinogenic. A routine EPA registration review on glyphosate opened in 2009 and remains underway.
Since the initial announcement of the IARC meeting’s classification in March 2015, multiple regulatory bodies have publicly affirmed that glyphosate does not cause cancer.
In reference to 55 epidemiological studies EPA evaluated in 2014, Carissa Cryan, EPA chemical review manager, said, “Our review concluded that this body of research does not provide evidence to show that glyphosate causes cancer, and it does not warrant any change in EPA’s cancer classification for glyphosate.”
EFSA, in its conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate, said, “Glyphosate did not present genotoxic potential, and no evidence of carcinogenicity was observed in rats or mice.”
In 2014, the Canadian Pest Management Regulatory Authority said, “In consideration of the strength and limitations of the large body of information on glyphosate, … the overall weight of evidence indicates that glyphosate is unlikely to pose a human cancer risk. This is consistent with all other pesticide regulatory authorities worldwide, including the most recent ongoing comprehensive re-evaluation by Germany.”
These regulatory conclusions are consistent with OEHHA’s own assessment of glyphosate from 2007, which found: “Based on the weight of the evidence, glyphosate is judged unlikely to pose a cancer hazard to humans.”
Monsanto added that the members of the ad hoc IARC working group were hand-picked and conducted their assessment in a non-transparent process that is not accountable to the laws or governments of the U.S. or the state of California. Unlike regulatory risk assessments, the IARC classification process followed non-standard procedures and selectively included and interpreted only a subset of the data actually available on glyphosate.
“The IARC classification of glyphosate is inconsistent with the findings of regulatory bodies in the United States and around the world, and it is not a sound basis for any regulatory action,” Miller said. “Glyphosate is an efficient, effective and safe tool for weed control in fields, along roadways and in other environments. We urge the state of California to uphold its own science-based conclusion about glyphosate reached in 2007 and the conclusions of the U.S. EPA and all other pesticide regulators.”