Prop 65 listing would be based solely on erroneous IARC classification, would contradict agency’s own 2007 assessment, and would defy scientific conclusions of U.S. EPA and regulators around the world
Monsanto Company is taking legal action to prevent 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.” The listing of glyphosate would be flawed and baseless because glyphosate does not cause cancer, as has been concluded by the U.S. EPA, the European Food Safety Authority (EFSA) and pesticide regulators around the world. 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 California Office of Environmental Health Hazard Assessment (OEHHA) today 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.
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 Phil Miller, Ph.D., 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 the U.S. 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 U.S. 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:
- U.S. EPA: “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.” U.S. EPA, Statement from Carissa Cryan, Chemical Review Manager, 2015 (in reference to 55 epidemiological studies evaluated by EPA in 2014). This conclusion was reiterated in testimony by EPA’s Deputy Director for Pesticide Programs, William Jordan, before the U.S. Senate Committee on Agriculture, Nutrition and Forestry on Oct. 21, 2015.
- European Food Safety Authority: “Glyphosate did not present genotoxic potential and no evidence of carcinogenicity was observed in rats or mice.” European Food Safety Authority, Conclusion on the Peer Review of the Pesticide Risk Assessment of the Active Substance Glyphosate, 2015.
- Canadian Pest Management Regulatory Authority: “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 world-wide, including the most recent ongoing comprehensive re-evaluation by Germany. …” Canadian Pest Management Regulatory Authority, Proposed Re-Evaluation Decision, PRVD2015-01, Glyphosate, 2015.
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.”
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 United States 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,” Dr. 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.”
More information on glyphosate is available here.
A copy of Monsanto’s complaint against the California Office of Environmental Health Hazard Assessment is available here http://www.monsanto.com/files/Documents/MONvOEHHA.pdf.