November 6, 2019
Public Health Assessments Regarding the Use of Glyphosate
Written by Chloe Marie – Research Specialist
Glyphosate is one of the most frequently used herbicides for weed and grass controls, especially in agriculture, and is almost exclusively produced by Monsanto, a Missouri-based multinational agricultural biotechnology company. It has been marketed under the brand Roundup from the mid-1970s onwards. Glyphosate was thrust into the spotlight in March 2015 when the International Agency for Research on Cancer (IARC) identified the herbicide as being carcinogenic to humans, resulting in extensive public concern in the United States as well as worldwide. Most governments, however, including the United States, have rejected this finding and have continued to act based upon the premise that glyphosate products are safe to use. The U.S. Environmental Protection Agency (EPA) has concluded that glyphosate does not pose an unreasonable risk to the health and safety of persons or to the environment based on a recent review of the herbicide. Despite the governmental actions supporting its usage, many individuals have brought legal actions against Monsanto alleging that they suffered significant health issues due to the negligence of Monsanto in the manufacturing of Roundup® products.
This article will provide a detailed overview of the IARC’s findings on the health risks of glyphosate as well as the EPA’s review and conclusion that glyphosate is a safe substance. In a subsequent article, we will address selected ongoing cases challenging the safety of Roundup® products in the states of California and Missouri.
These articles are intended to be companions to a recent article published by the National Agricultural Law Center that provides additional and further details on major regulatory and legal developments regarding glyphosate. The Center for Agricultural and Shale Law is a partner of the National Agricultural Law Center.
International Agency for Research on Cancer (IARC) Glyphosate Classification
The International Agency for Research on Cancer established the Monographs program in the 1970s following numerous requests for advice regarding the carcinogenicity of chemicals. This program includes the preparation of scientific evaluation about the potential carcinogenic risk of chemicals to humans and takes the form of a monograph. According to the Preamble to the IARC Monographs outlining all steps of the evaluation process, “[t]he Monographs assess the strength of the available evidence that an agent can cause cancer in humans, based on three streams of evidence: on cancer in humans … on cancer in experimental animals … and on mechanistic evidence.”
A Working Group comprised of 17 experts from around the world was asked to assess the carcinogenicity of five chemical agents, including glyphosate, and after an intensive year of discussions and preparations, they concluded in March 2015 that glyphosate is “probably carcinogenic to humans.”
IARC published and presented to the public a Monographs in July 2015 setting out the conclusions of the Working Group. IARC reiterated its findings that glyphosate must be classified as a human carcinogen and declared that “[i]n addition to limited evidence for the carcinogenicity of glyphosate in humans and sufficient evidence for the carcinogenicity of glyphosate in experimental animals, there is strong evidence that glyphosate can operate through two key characteristics of known human carcinogens, and that these can be operative in humans.”
In January 2018, IARC issued a response to criticisms of the Monographs and the glyphosate evaluation due to “unprecedented, coordinated efforts to undermine the evaluation, the program and the organization” regarding the glyphosate, and pointed to the agro-chemical industry and associated media outlets for harming the credibility of their 2015 Monographs.
According to IARC, said attacks “have taken place in the context of major financial interests relating to: a) the relicensing of glyphosate by the European Commission; b) hundreds of litigation cases in the USA brought by cancer patients against Monsanto, claiming that their malignancies were caused by glyphosate use; c) and the decision by the Californian Environmental Protection Agency to label glyphosate as a carcinogen.”
U.S. Environmental Protection Agency’s Glyphosate Registration Review
The U.S. Environmental Protection Agency (EPA) has registered glyphosate as a pesticide since 1974 and has an obligation to pursue a review process every 15 years to determine whether glyphosate, in light of new information, poses public health or environmental risks that may no longer be acceptable to the population. This review is called a “registration review” and must meet the statutory standard for registration laid out in section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
EPA is currently carrying out a registration review of glyphosate, which initially started in July 2009 under the docket EPA-HQ-OPP-2009-0361. In December 2009, EPA released a Final Work Plan considering what additional information and analyses may be needed by the agency to perform a full registration review of glyphosate. Interestingly, the document pointed out that the latest risk assessment handled in 1993 “did not include a complete endangered species determination for glyphosate” and that assessing the potential impacts of glyphosate on several species would be paramount in conducting an adequate ecological risk assessment for the registration review of glyphosate.
Even though it was stated that a final registration review decision should be made by 2015, it was not until February 2018 that EPA published a Preliminary Ecological Risk Assessment for Glyphosate and a Human Health Draft Risk Assessment. In May of this year, EPA then issued a Proposed Interim Registration Review decision.
In a Press Release dated April 30, 2019, EPA continues to assert its conclusion that “there are no risks to public health when glyphosate is used in accordance with its current label and that glyphosate is not a carcinogen” before adding that the “agency’s scientific findings on human health risk are consistent with the conclusions of science reviews by many other countries and other federal agencies.” Interestingly though, EPA did identify many ecological risks associated with the spraying of glyphosate.
Soon after, on May 6, 2019, EPA issued a notice of availability of the agency’s proposed interim registration review decision for glyphosate. In order to mitigate the ecological risks, EPA proposed to implement spray drift management measures “to reduce off-site exposure to non-target wildlife” and weed resistance management labeling “to preserve glyphosate as a valuable tool for growers.” In addition, EPA made a commitment to prepare a listed species assessment and perform an endocrine screening for the glyphosate before completing the registration review process. The comment period for EPA’s interim registration review decision ended on September 3, 2019.
References:
Glyphosate Final Work Plan (FWP) Registration Review Case No. 0178 (December 2009)
This material is based upon work supported by the National Agricultural Library, Agricultural Research Service, U.S. Department of Agriculture.
