DeVito, 2017
DeVito, Michael, “Update on NTP Studies of Glyphosate,” Presented at the National Toxicology Program (NTP) Board of Scientific Counselors Meeting, December 7-8, 2017.
SUMMARY:
Not available. FULL TEXT
Bibliography Tag: policy and politics
Defarge et al., 2018
Defarge, N., Spiroux de Vendomois, J., & Seralini, G. E., “Toxicity of formulants and heavy metals in glyphosate-based herbicides and other pesticides,” Toxicology Reports, 2018, 5, 156-163. DOI: 10.1016/j.toxrep.2017.12.025.
ABSTRACT:
The major pesticides of the world are glyphosate-based herbicides (GBH), and their toxicity is highly debated. To understand their mode of action, the comparative herbicidal and toxicological effects of glyphosate (G) alone and 14 of its formulations were studied in this work, as a model for pesticides. GBH are mixtures of water, with commonly 36-48% G claimed as the active principle. As with other pesticides, 10-20% of GBH consist of chemical formulants. We previously identified these by mass spectrometry and found them to be mainly families of petroleum-based oxidized molecules, such as POEA, and other contaminants. We exposed plants and human cells to the components of formulations, both mixed and separately, and measured toxicity and human cellular endocrine disruption below the direct toxicity experimentally measured threshold. G was only slightly toxic on plants at the recommended dilutions in agriculture, in contrast with the general belief. In the short term, the strong herbicidal and toxic properties of its formulations were exerted by the POEA formulant family alone. The toxic effects and endocrine disrupting properties of the formulations were mostly due to the formulants and not to G. In this work, we also identified by mass spectrometry the heavy metals arsenic, chromium, cobalt, lead and nickel, which are known to be toxic and endocrine disruptors, as contaminants in 22 pesticides, including 11 G-based ones. This could also explain some of the adverse effects of the pesticides. In in vivo chronic regulatory experiments that are used to establish the acceptable daily intakes of pesticides, G or other declared active ingredients in pesticides are assessed alone, without the formulants. Considering these new data, this assessment method appears insufficient to ensure safety. These results, taken together, shed a new light on the toxicity of these major herbicides and of pesticides in general. FULL TEXT
Davoren and Schiestl, 2018
Davoren, Michael J, & Schiestl, Robert H., “Glyphosate-based herbicides and cancer risk: a post-IARC decision review of potential mechanisms, policy and avenues of research,” Carcinogenesis, 2018, 39:10, 1207-1215. DOI:10.1093/carcin/bgy105.
ABSTRACT:
Since its initial sales in the 1970s, the herbicide glyphosate attained widespread use in modern agriculture, becoming the most commercially successful and widely used herbicide of all time as of 2016. Despite a primary mechanism that targets a pathway absent from animal cells and regulatory studies showing safety margins orders of magnitude better than many other, more directly toxic herbicides, the safety status of glyphosate has recently been brought into question by a slow accumulation of studies suggesting more subtle health risks, especially when considered in combination with the surfactants it is usually applied with. Current, official views of respected international regulatory and health bodies remain divided on glyphosate’s status as a human carcinogen, but the 2015 International Agency for Research on Cancer decision to reclassify the compound as Category 2A (probably carcinogenic to humans) marked a sea change in the scientific community’s consensus view. The goal of this review is to consider the state of science regarding glyphosate’s potential as a human carcinogen and genotoxin, with particular focus on studies suggesting mechanisms that would go largely undetected in traditional toxicology studies, such as microbiome disruption and endocrine mimicry at very low concentrations. FULL TEXT
Clausing et al., 2018
Clausing, P., Robinson, C., & Burtscher-Schaden, H., “Pesticides and public health: an analysis of the regulatory approach to assessing the carcinogenicity of glyphosate in the European Union,” Journal of Epidemiology and Community Health, 2018, 72(8), 668-672, DOI:10.1136/jech-2017-209776.
ABSTRACT:
The present paper scrutinises the European authorities’ assessment of the carcinogenic hazard posed by glyphosate based on Regulation (EC) 1272/2008. We use the authorities’ own criteria as a benchmark to analyse their weight of evidence (WoE) approach. Therefore, our analysis goes beyond the comparison of the assessments made by the European Food Safety Authority and the International Agency for Research on Cancer published by others. We show that not classifying glyphosate as a carcinogen by the European authorities, including the European Chemicals Agency, appears to be not consistent with, and in some instances, a direct violation of the applicable guidance and guideline documents. In particular, we criticise an arbitrary attenuation by the authorities of the power of statistical analyses; their disregard of existing dose-response relationships; their unjustified claim that the doses used in the mouse carcinogenicity studies were too high and their contention that the carcinogenic effects were not reproducible by focusing on quantitative and neglecting qualitative reproducibility. Further aspects incorrectly used were historical control data, multisite responses and progression of lesions to malignancy. Contrary to the authorities’ evaluations, proper application of statistical methods and WoE criteria inevitably leads to the conclusion that glyphosate is ‘probably carcinogenic’ (corresponding to category 1B in the European Union). FULL TEXT
Benbrook, 2019
Benbrook, Charles M., “How did the US EPA and IARC reach diametrically opposed conclusions on the genotoxicity of glyphosate-based herbicides?,” Environmental Sciences Europe, 2019, 31(1), DOI:10.1186/s12302-018-0184-7.
ABSTRACT:
BACKGROUND: The US EPA considers glyphosate as “not likely to be carcinogenic to humans.” The International Agency for Research on Cancer (IARC) has classified glyphosate as “probably carcinogenic to humans (Group 2A).” EPA asserts that there is no convincing evidence that “glyphosate induces mutations in vivo via the oral route.” IARC concludes there is “strong evidence” that exposure to glyphosate is genotoxic through at least two mechanisms known to be associated with human carcinogens (DNA damage, oxidative stress). Why and how did EPA and IARC reach such different conclusions?
RESULTS: A total of 52 genotoxicity assays done by registrants were cited by the EPA in its 2016 evaluation of technical glyphosate, and another 52 assays appeared in the public literature. Of these, one regulatory assay (2%) and 35 published assays (67%) reported positive evidence of a genotoxic response. In the case of formulated, glyphosatebased herbicides (GBHs), 43 regulatory assays were cited by EPA, plus 65 assays published in peer-reviewed journals. Of these, none of the regulatory, and 49 published assays (75%) reported evidence of a genotoxic response following exposure to a GBH. IARC considered a total of 118 genotoxicity assays in six core tables on glyphosate technical, GBHs, and aminomethylphosphonic acid (AMPA), glyphosate’s primary metabolite. EPA’s analysis encompassed 51 of these 118 assays (43%). In addition, IARC analyzed another 81 assays exploring other possible genotoxic mechanisms (mostly related to sex hormones and oxidative stress), of which 62 (77%) reported positive results. IARC placed considerable weight on three positive GBH studies in exposed human populations, whereas EPA placed little or no weight on them.
CONCLUSIONS: EPA and IARC reached diametrically opposed conclusions on glyphosate genotoxicity for three primary reasons: (1) in the core tables compiled by EPA and IARC, the EPA relied mostly on registrant-commissioned, unpublished regulatory studies, 99% of which were negative, while IARC relied mostly on peer-reviewed studies of which 70% were positive (83 of 118); (2) EPA’s evaluation was largely based on data from studies on technical glyphosate, whereas IARC’s review placed heavy weight on the results of formulated GBH and AMPA assays; (3) EPA’s evaluation was focused on typical, general population dietary exposures assuming legal, food-crop uses, and did not take into account, nor address generally higher occupational exposures and risks. IARC’s assessment encompassed data from typical dietary, occupational, and elevated exposure scenarios. More research is needed on real-world exposures to the chemicals within formulated GBHs and the biological fate and consequences of such exposures. FULL TEXT
Benbrook, 2018
Benbrook, Charles, “Why Regulators Lost Track and Control of Pesticide Risks: Lessons From the Case of Glyphosate-Based Herbicides and Genetically Engineered-Crop Technology,” Current Environmental Health Reports, 5:3, 387-395, 2018, DOI:10.1007/s40572-018-0207-y.
ABSTRACT:
PURPOSE OF REVIEW: The approval of genetically engineered (GE) crops in the late 1990s triggered dramatic changes in corn, soybean, and cotton pest management systems, as well as complex, novel regulatory challenges. Lessons learned are reviewed and solutions described.
RECENT FINDINGS: Government-imposed resistance management provisions can work and adapt to changing circumstances, but within the private sector, pressures to gain and hold market share have thus far trumped the widely recognized need for resistance management. Risks arising from the use of formulated pesticides often exceed by a wide margin those in regulatory risk assessments based on data derived from studies on nearly 100% pure active ingredients.
SUMMARY: Innovative policy changes are needed in four problem areas: excessive faith in the accuracy of pre-market risk assessments and regulatory thresholds; post-approval monitoring of actual impacts; risk arising from formulated pesticides, rather than just pure active ingredient; challenges inherent in assessing and mitigating the combined impacts of all GE traits and associated pesticides on agroecosystems, as opposed to each trait or pesticide alone; and, tools to deal with failing pest management systems. FULL TEXT
Richmond, 2018
Richmond, Martha E., “Glyphosate: A review of its global use, environmental impact, and potential health effects on humans and other species,” Journal of Environmental Studies and Sciences, Published online 09/28/2018, doi:10.1007/s13412-018-0517-2.
ABSTRACT:
Glyphosate, [N-(phosphonomethyl) glycine], was synthesized in 1950 and patented as a chemical chelator, capable of binding metals such as calcium, magnesium, and manganese. Glyphosate’s ability to bind to manganese was later found to inhibit an enzyme used by plants and bacteria for biosynthesis ofthree amino acids found in all proteins, and the commercial value ofthis property led to the development and marketing of glyphosate as a broad-spectrum herbicide. In 1974, the Monsanto Chemical Company introduced the herbicide as Roundup™, a formulation of glyphosate and adjuvants. Roundup™ was originally used for weed control in specific farming and landscaping operations and around power lines and train tracks. Following introduction of Roundup Ready™ seeds, in the 1990s, glyphosate use increased significantly. Although Monsanto’s patent on glyphosate expired in 2002, the widespread and growing use ofRoundup Ready™ seed globally and competitive glyphosate marketing by other chemical companies have led to glyphosate’s significant increase in the environment. Concerns about potential adverse effects have also grown. While, at present, many regulatory agencies have determined that there is little risk of adverse health effects to the general public or to farmworkers using proper handling techniques, the International Agency for Research on Cancer (IARC) assessing hazard data on glyphosate identified it in 2016 as a category 2A carcinogen (likely to cause human cancer). Response to this classification has been divided: The agribusiness industry has been forceful in its opposition, while other experts support IARC’s classification. The following article examines these issues. It also examines the basis for regulatory decisions, controversies involved, and questions of environmental justice that may or may not be addressed as glyphosate continues to be used. FULL TEXT
Landrigan and Belpoggi, 2018
Landrigan, P. J., and Belpoggi, F.,”The need for independent research on the health effects of glyphosate-based herbicides,” Environmental Health, 17(1), 51, 2018, doi:10.1186/s12940-018-0392-z.
ABSTRACT:
BACKGROUND: Glyphosate, formulated as Roundup, is the world’s most widely used herbicide. Glyphosate is used extensively on genetically modified (GM) food crops designed to tolerate the herbicide, and global use is increasing rapidly. Two recent reviews of glyphosate’s health hazards report conflicting results. An independent review by the International Agency for Research on Cancer (IARC) found that glyphosate is a “probable human carcinogen”. A review by the European Food Safety Agency (EFSA) found no evidence of carcinogenic hazard. These differing findings have produced regulatory uncertainty.
REGULATORY ACTIONS: Reflecting this regulatory uncertainty, the European Commission on November 27 2017, extended authorization for glyphosate for another 5 years, while the European Parliament opposed this decision and issued a call that pesticide approvals be based on peer-reviewed studies by independent scientists rather than on the current system that relies on proprietary industry studies.
RAMAZZINI INSTITUTE RESPONSE: The Ramazzini Institute has initiated a pilot study of glyphosate’s health hazards that will be followed by an integrated experimental research project. This evaluation will be independent of industry support and entirely sponsored by worldwide crowdfunding. The aim of the Ramazzini Institute project is to explore comprehensively the effects of exposures to glyphosate-based herbicides at current real-world levels on several toxicological endpoints, including carcinogenicity, long-term toxicity, neurotoxicity, endocrine disrupting effects, prenatal developmental toxicity, the microbiome and multi-generational effects. FULL TEXT
Neff, 2018
Lisa Neff, “Farmers, conservationists challenge Trump’s EPA, Monsanto over crop-damaging pesticide,” The Wisconsin Gazette, February 13, 2018.
SUMMARY:
Wisconsin Gazette describes the suit against the EPA and Monsanto, which was initiated by five agricultural and environmental watchdog organizations: the Center for Biological Diversity, Center for Food Safety, Earthjustice, National Family Farm Coalition, and Pesticide Action Network. The lawsuit alleges that many critics warned that dicamba was likely to drift when applied during the hot summer months, but did little to address these concerns, instead bowing to pressure from Monsanto to conditionally approve the new formulations. Court documents also claim that EPA recognized the potential negative impact from dicamba to hundreds of endangered species that would be exposed, but did not follow Endangered Species Act requirements to seek guidance on protective measures from the appropriate federal wildlife agencies. “That the EPA would indulge in this kind of recklessness and junk science to appease Monsanto is shocking,” said Paul Achitoff, attorney with Earthjustice, in a statement. FULL TEXT
Hettinger, 2018
Johnathan Hettinger, “EPA eased herbicide regulations following Monsanto research, records show,” St. Louis Post-Dispatch, March 1, 2018.
SUMMARY:
Reports on a document review investigation that reveals that Monsanto’s own science played a key role in how the use restrictions for the new dicamba formulations for use with Xtend crops were set. EPA had originally proposed a larger, more comprehensive, all-direction buffer for all of the new dicamba formulations, the first to be approved for post-emergent use over growing crops. Then, Monsanto submitted updated research on dicamba drift that, according to the company, demonstrated little to no volatility. EPA was apparently convinced, since it reduced the buffer to just 110 ft on the downwind side of fields on which the herbicide is applied — a big difference. This story reports that Monsanto research used to justify this was conducted in Georgia and Texas, two states that have had only modest problems with dicamba drift and crop damage, likely due to local weather conditions. FULL TEXT