Bibliography Tag: policy and politics

Sheppard et al., 2020

Sheppard, L., McGrew, S., & Fenske, R. A.; “Flawed analysis of an intentional human dosing study and its impact on chlorpyrifos risk assessments;” Environment International, 2020, 143, 105905; DOI: 10.1016/j.envint.2020.105905.


In March 1972, Frederick Coulston and colleagues at the Albany Medical College reported results of an intentional chlorpyrifos dosing study to the study’s sponsor, Dow Chemical Company. Their report concluded that 0.03 mg/kg-day was the chronic no-observed-adverse-effect-level (NOAEL) for chlorpyrifos in humans. We demonstrate here that a proper analysis by the original statistical method should have found a lower NOAEL (0.014 mg/kg-day), and that use of statistical methods first available in 1982 would have shown that even the lowest dose in the study had a significant treatment effect. The original analysis, conducted by Dow-employed statisticians, did not undergo formal peer review; nevertheless, EPA cited the Coulston study as credible research and kept its reported NOAEL as a point of departure for risk assessments throughout much of the 1980’s and 1990’s. During that period, EPA allowed chlorpyrifos to be registered for multiple residential uses that were later cancelled to reduce potential health impacts to children and infants. Had appropriate analyses been employed in the evaluation of this study, it is likely that many of those registered uses of chlorpyrifos would not have been authorized by EPA. This work demonstrates that reliance by pesticide regulators on research results that have not been properly peer-reviewed may needlessly endanger the public. FULL TEXT

Qu et al., 2021

Qu, R. Y., He, B., Yang, J. F., Lin, H. Y., Yang, W. C., Wu, Q. Y., Li, Q. X., & Yang, G. F.; “Where are the New Herbicides?;” Pest Management Science, 2021; DOI: 10.1002/ps.6285.


Herbicide resistance has become one of the foremost problems in crop production worldwide. New herbicides are required to manage weeds that have evolved resistance to the existing herbicides. However, relatively few herbicides with new modes of action (MOAs) have been discovered in the past two decades. Therefore, the discovery of new herbicides (i.e., new chemical classes or MOAs) remains a primary but ongoing strategy to overcome herbicide resistance and ensure crop production. In this mini-review, starting with the inherent characteristics of the target proteins and the inhibitor structures, we propose two strategies for the rational design of new herbicides and one computational method for the risk evaluation of target mutation-conferred herbicide resistance. The information presented here may improve the utilization of known targets and inspire the discovery of herbicides with new targets. We believe that these strategies may trigger the sustainable development of herbicides in the future.

Klingelhöfer et al., 2020

Klingelhöfer, D., Braun, M., Brüggmann, D., & Groneberg, D. A.; “Glyphosate: How do ongoing controversies, market characteristics, and funding influence the global research landscape?;” Science of The Total Environment, 2020, 765, 144271; DOI: 10.1016/j.scitotenv.2020.144271.


Glyphosate is a systemic broad-spectrum herbicide that is by now the most extensively used herbicide in the world and has been the source for a still heated controversy about its harmful effects on human health and the environment. The different weighting of scientific studies has led to different attitudes in most countries towards appropriate handling and their regulatory authorities. Therefore, an in-depth analysis of the global research landscape on glyphosate is needed to provide the background for further decisions regarding appropriate and careful use, taking into account the different regional conditions. The present study is based on established bibliometric methodological tools and is extended by glyphosate-specific parameters. Chronological and geographical patterns are revealed to determine the incentives and intentions of international scientific efforts. Research output grew in line with the exponential growth in consumption, with the field of research becoming increasingly multidisciplinary and shifting towards environmental and medical disciplines. The countries with the highest herbicide use are also the leading countries in glyphosate research: USA, Brazil, Canada, China and Argentina. The link between publication output and market parameters is as evident as the association with national grants. The research interest of the manufacturing company Monsanto could be shown as the second largest publishing institution behind the US Department of Agriculture, which interest is underscored by its position among the otherwise government-funded organizations. Developing countries are generally underrepresented in glyphosate research, although the use of glyphosate is increasing dramatically. In conclusion, the incentives are strongly linked to market and agricultural interests, with the scientific infrastructure of the countries forming the basis for financing and conducting research. The existing international network is important and needs to be expanded and strengthened by including the lower economies in order to take into account all regional and social needs and aspects of glyphosate use.

Szekacs et al., 2018

Székács, András, Wilkinson, Martin G., Mader, Anneluise, & Appel, Bernd; “Environmental and food safety of spices and herbs along global food chains;” Food Control, 2018, 83, 1-6; DOI: 10.1016/j.foodcont.2017.06.033.


Spices and herbs, which are consumed in small quantities, but used in a wide range of foods and food products, represent a unique segment within the food sector. Moreover, being distributed as mostly in their dried, low water activity formats and associated with very complex distribution product chains, specific concerns as regards food safety apply to these particular commodities. To promote the capability of the food sector and the society to detect, respond to and prevent bio-threats, data generated from the EU FP7 project “Securing the spices and herbs commodity chains in Europe against deliberate, accidental or natural biological and chemical contamination” (SPICED) are presented thematically including: general considerations, issues of sampling, chemical and microbial contamination, and food chain and societal aspects. FULL TEXT

Attina et al., 2016

Attina, T. M., Hauser, R., Sathyanarayana, S., Hunt, P. A., Bourguignon, J. P., Myers, J. P., DiGangi, J., Zoeller, R. T., & Trasande, L.; “Exposure to endocrine-disrupting chemicals in the USA: a population-based disease burden and cost analysis;” Lancet Diabetes and Endocrinology, 2016, 4(12), 996-1003; DOI: 10.1016/S2213-8587(16)30275-3.


BACKGROUND: Endocrine-disrupting chemicals (EDCs) contribute to disease and dysfunction and incur high associated costs (>1% of the gross domestic product [GDP] in the European Union). Exposure to EDCs varies widely between the USA and Europe because of differences in regulations and, therefore, we aimed to quantify disease burdens and related economic costs to allow comparison.

METHODS: We used existing models for assessing epidemiological and toxicological studies to reach consensus on probabilities of causation for 15 exposure-response relations between substances and disorders. We used Monte Carlo methods to produce realistic probability ranges for costs across the exposure-response relation, taking into account uncertainties. Estimates were made based on population and costs in the USA in 2010. Costs for the European Union were converted to US$ (€1=$1·33).

FINDINGS: The disease costs of EDCs were much higher in the USA than in Europe ($340 billion [2·33% of GDP] vs $217 billion [1·28%]). The difference was driven mainly by intelligence quotient (IQ) points loss and intellectual disability due to polybrominated diphenyl ethers (11 million IQ points lost and 43 000 cases costing $266 billion in the USA vs 873 000 IQ points lost and 3290 cases costing $12·6 billion in the European Union). Accounting for probability of causation, in the European Union, organophosphate pesticides were the largest contributor to costs associated with EDC exposure ($121 billion), whereas in the USA costs due to pesticides were much lower ($42 billion).

INTERPRETATION: EDC exposure in the USA contributes to disease and dysfunction, with annual costs taking up more than 2% of the GDP. Differences from the European Union suggest the need for improved screening for chemical disruption to endocrine systems and proactive prevention.

Robinson et al., 2020

Robinson, Claire, Portier, Christopher J., ČAvoŠKi, Aleksandra, Mesnage, Robin, Roger, Apolline, Clausing, Peter, Whaley, Paul, Muilerman, Hans, & Lyssimachou, Angeliki; “Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions;” European Journal of Risk Regulation, 2020, 11(3), 450-480; DOI: 10.1017/err.2020.18.


The regulation of pesticides in the European Union (EU) relies on a network of hard law (legislation and implementing acts) and soft law (non-legally binding guidance documents and administrative and scientific practices). Both hard and soft laws govern how risk assessments are conducted, but a significant role is left to the latter. Europe’s pesticide regulation is one of the most stringent in the world. Its stated objectives are to ensure an independent, objective and transparent assessment of pesticides and achieve a high level of protection for health and environment. However, a growing body of evidence shows that pesticides that have passed through this process and are authorised for use may harm humans, animals and the environment. The authors of the current paper – experts in toxicology, law and policy – identified shortcomings in the authorisation process, focusing on the EU assessment of the pesticide active substance glyphosate. The shortcomings mostly consist of failures to implement the hard or soft laws. But in some instances the law itself is responsible, as some provisions can only fail to achieve its objectives. Ways to improve the system are proposed, requiring changes in hard and soft laws as well as in administrative and scientific practices. FULL TEXT

Powles and Gaines, 2017

Powles, Stephen B., & Gaines, Todd A.; “Exploring the Potential for a Regulatory Change to Encourage Diversity in Herbicide Use;” Weed Science, 2017, 64(SP1), 649-654; DOI: 10.1614/ws-d-15-00070.1.


An overreliance on herbicides in several important grain- and cotton-producing regions of the world has led to the widespread evolution of herbicide-resistant weed populations. Of particular concern are weed populations that exhibit simultaneous resistance to multiple herbicides (MHR). Too often, herbicides are the only tool used for weed control. We use the term herbicide-only syndrome (HOS) for this quasi-addiction to herbicides. Growers and their advisers focus on herbicide technology, unaware of or ignoring basic evolutionary principles or the necessary diversity provided by other methods of weed control. Diversity in weed control practices disrupts resistance evolution. Significant challenges exist to implementing diversity, including how to address information so that producers choose to alter existing behaviors (HOS) and take calculated risks by attempting new and more complex strategies. Herbicide resistance management in the long term will require creativity in many sectors, including roles for growers, industry, researchers, consultants, retailers, and regulators. There can be creativity in herbicide registration and regulation, as exemplified by the recent U.S. Environmental Protection Agency program that encourages herbicide registrants to register products in minor crops. We propose one idea for a regulatory incentive to enable herbicide registrants in jurisdictions such as the United States to receive an extended data exclusivity period in exchange for not developing one new herbicide in multiple crops used together in rotation, or for implementing stewardship practices such as robust mixtures or limitations on application frequency. This incentive would provide a mechanism to register herbicides in ways that help to ensure herbicide longevity. Approaches based only on market or financial incentives have contributed to the current situation of widespread MHR. Our suggestion for regulatory creativity is one way to provide both financial and biological benefits to the registering company and to the overall stakeholder community by incentivizing good resistance management. FULL TEXT

Boone et al., 2014

Boone, Michelle D., Bishop, Christine A., Boswell, Leigh A., Brodman, Robert D., Burger, Joanna, Davidson, Carlos, Gochfeld, Michael, Hoverman, Jason T., Neuman-Lee, Lorin A., Relyea, Rick A., Rohr, Jason R., Salice, Christopher, Semlitsch, Raymond D., Sparling, Donald, & Weir, Scott; “Pesticide Regulation amid the Influence of Industry;” BioScience, 2014, 64(10), 917-922; DOI: 10.1093/biosci/biu138.


Pesticide use results in the widespread distribution of chemical contaminants, which necessites regulatory agencies to assess the risks to environmental and human health. However, risk assessment is compromised when relatively few studies are used to determine impacts, particularly if most of the data used in an assessment are produced by a pesticide’s manufacturer, which constitutes a conflict of interest. Here, we present the shortcomings of the US Environmental Protection Agency’s pesticide risk assessment process, using the recent reassessment of atrazine’s impacts on amphibians as an example. We then offer solutions to improve the risk assessment process, which would reduce the potential for and perception of bias in a process that is crucial for environmental and human health. FULL TEXT

Benbrook, 2020

Benbrook, Charles; “Shining a Light on Glyphosate-Based Herbicide Hazard, Exposures and Risk: Role of Non-Hodgkin Lymphoma Litigation in the USA;” European Journal of Risk Regulation, 2020, 11(3), 498-519; DOI: 10.1017/err.2020.16.


Roundup, and other glyphosate-based herbicides, are the most heavily used pesticides in the history of the USA and globally. In March 2015, the International Agency for Research on Cancer (IARC) classified glyphosate as a “probable human carcinogen”. A portion of the 695,000 Americans then living in 2015 with non-Hodgkin lymphoma (NHL) became aware of IARC’s decision. Several thousand Roundup–NHL lawsuits had been filed by the end of 2017, rising to 18,400 by July 2019 and 42,000 by November 2019. Three cases have gone to trial, each won by the plaintiffs. The author has served as an expert witness for the plaintiffs in this litigation and has been compensated for his time spent. The impact of the litigation on the independent assessment of the science useful in determining whether glyphosate and glyphosate-based herbicide exposures are linked to NHL is reviewed, as is why the US Environmental Protection Agency (EPA) and IARC reached such different judgements regarding glyphosate human cancer hazard and risk. Two important “lessons learned” regarding the EPA versus IARC assessment of glyphosate cancer hazard and risk are highlighted. The first arises from differences in the magnitude of applicator risks from mostly dermal exposures to formulated glyphosate-based herbicides compared to just dietary exposures to technical glyphosate. The second relates to missed opportunities to markedly lower applicator exposures and risks with little or no impact on sales via reformulation, added warnings and worker safety provisions, company-driven stewardship programmes and greater determination by the EPA in the 1980s to compel Monsanto to add common-sense worker protection provisions onto Roundup labels (eg “wear gloves when applying this product”). Policy reforms designed to alleviate systemic problems with how pesticide hazards, exposures and risks are analysed, regulated and mitigated are described. FULL TEXT

Pellizzari et al., 2019

Pellizzari, E. D., Woodruff, T. J., Boyles, R. R., Kannan, K., Beamer, P. I., Buckley, J. P., Wang, A., Zhu, Y., & Bennett, D. H.; “Identifying and Prioritizing Chemicals with Uncertain Burden of Exposure: Opportunities for Biomonitoring and Health-Related Research;” Environmental Health Perspectives, 2019, 127(12), 126001; DOI: 10.1289/EHP5133.


BACKGROUND: The National Institutes of Health’s Environmental influences on Child Health Outcomes (ECHO) initiative aims to understand the impact of environmental factors on childhood disease. Over 40,000 chemicals are approved for commercial use. The challenge is to prioritize chemicals for biomonitoring that may present health risk concerns.

OBJECTIVES: Our aim was to prioritize chemicals that may elicit child health effects of interest to ECHO but that have not been biomonitored nationwide and to identify gaps needing additional research.

METHODS: We searched databases and the literature for chemicals in environmental media and in consumer products that were potentially toxic. We selected chemicals that were not measured in the National Health and Nutrition Examination Survey. From over 700 chemicals, we chose 155 chemicals and created eight chemical panels. For each chemical, we compiled biomonitoring and toxicity data, U.S. Environmental Protection Agency exposure predictions, and annual production usage. We also applied predictive modeling to estimate toxicity. Using these data, we recommended chemicals either for biomonitoring, to be deferred pending additional data, or as low priority for biomonitoring.

RESULTS: For the 155 chemicals, 97 were measured in food or water, 67 in air or house dust, and 52 in biospecimens. We found in vivo endocrine, developmental, reproductive, and neurotoxic effects for 61, 74, 47, and 32 chemicals, respectively. Eighty-six had data from high-throughput in vitro assays. Positive results for endocrine, developmental, neurotoxicity, and obesity were observed for 32, 11, 35, and 60 chemicals, respectively. Predictive modeling results suggested 90% are toxicants. Biomarkers were reported for 76 chemicals. Thirty-six were recommended for biomonitoring, 108 deferred pending additional research, and 11 as low priority for biomonitoring.

DISCUSSION: The 108 deferred chemicals included those lacking biomonitoring methods or toxicity data, representing an opportunity for future research. Our evaluation was, in general, limited by the large number of unmeasured or untested chemicals.  FULL TEXT