Risk Assessment - HH-RA.org

Bibliography Tag: risk assessment

Benbrook et al., 2023

Benbrook C, Mesnage R, Sawyer W. “Genotoxicity Assays Published since 2016 Shed New Light on the Oncogenic Potential of Glyphosate-Based Herbicides.” Agrochemicals. 2023; 2(1):47-68. https://doi.org/10.3390/agrochemicals2010005

ABSTRACT:

Controversy over the oncogenicity of glyphosate-based herbicides (GBHs) persists seven years after a 2015 IARC Monograph classified glyphosate/GBHs as “probably carcinogenic” to humans. Most regulatory authorities have concluded that technical glyphosate poses little or no oncogenic risk via dietary exposure. The US EPA classified glyphosate as “not likely” to pose cancer risk in 1991, a decision reaffirmed in reports issued in 2017 and 2020. A Federal Circuit Court of Appeals in the US vacated EPA’s assessment of glyphosate human-health risks in 2022 and required EPA to revisit old and take into account new data in its forthcoming, possibly final glyphosate/GBH reregistration decision. Divergent assessments of GBH genotoxicity are the primary reason for differing conclusions regarding GBH oncogenic potential. We assessed whether assays published since completion of the EPA and IARC reviews shed new light on glyphosate/GBH genotoxicity. We found 94 such assays, 33 testing technical glyphosate (73% positive) and 61 on GBHs (95% positive). Seven of 7 in vivo human studies report positive results. In light of genotoxicity results published since 2015, the conclusion that GBHs pose no risk of cancer via a genotoxic mechanism is untenable. FULL TEXT

EPA, 2015b

Environmental Protection Agency, “Evaluation of the Carcinogenic Potential of Glyphosate Case No. 1071-83-6 .” Office of Chemical Safety and Pollution Prevention, October 1, 2015.

ABSTRACT:

On September 16, 2015, the Cancer Assessment Review Committee (CARC) of the Health
Effects Division, of the Office of Pesticide Programs evaluated the carcinogenic potential of
Glyphosate in accordance with the EPA ‘s Final Guidelines for Carcinogen Risk Assessment
(March, 2005). Attached please find the final Cancer Assessment Document.

FULL TEXT

Rezende et al., 2021

Rezende, E.C.N., Carneiro, F.M., de Moraes, J.B. et al. “Trends in science on glyphosate toxicity: a scientometric study.” Environmental Science and Pollution Research 28, 56432–56448 (2021). DOI: 10.1007/s11356-021-14556-4

ABSTRACT:

As part of the most used herbicides, glyphosate is the most successful ingredient of agrochemical companies. The main objective of this study was to demonstrate research trends related to the glyphosate toxicity and its main effects on human and environmental health. For this purpose, 443 articles published, from 1995 to 2020, on the platform Web of Science™ Thomson Reuters were selected. The main toxicity results related in literature are genotoxicity, cytotoxicity, and endocrine disruption. The environmental effects come mostly from the contamination of groundwater and soils. Several studies have concluded that herbicide concentrations right below the official safety limits induced toxic effects. The results presented a highlighted harmful effect of glyphosate on both human and environmental health. It has been observed that countries where publish the most about the glyphosate toxicity are great investors in large-scale agriculture. It is important to ponder that these countries are in a route of ecosystem exploitation that includes not only fauna and flora, but also human beings. Unfortunately, science does not provide concise data for these pesticide disapproval in the global consumer market. It is necessary to search sustainable global interest alternatives to increase agriculture production based on peoples’ food sovereignty. FULL TEXT

Aylward et al., 2010

Aylward, Lesa L., Morgan, Marsha K., Arbuckle, Tye E., Barr, Dana B., Burns, Carol J., Alexander, Bruce H., & Hays, Sean M.; “Biomonitoring data for 2,4-dichlorophenoxyacetic acid in the United States and Canada: Interpretation in a public health risk assessment context using biomonitoring equivalents;” Environmental Health Perspectives, 2010, 118, 177-181; DOI: 10.1289/ehp.0900970.

ABSTRACT:

BACKGROUND: Several extensive studies of exposure to 2,4-dichlorophenoxyacetic acid (2,4-D) using urinary concentrations in samples from the general population, farm applicators, and farm family members are now available. Reference doses (RfDs) exist for 2,4-D, and Biomonitoring Equivalents (BEs; concentrations in urine or plasma that are consistent with those RfDs) for 2,4-D have recently been derived and published.

OBJECTIVE: We reviewed the available biomonitoring data for 2,4-D from the United States and Canada and compared them with BE values to draw conclusions regarding the margin of safety for 2,4-D exposures within each population group.

DATA SOURCES: Data on urinary 2,4-D excretion in general and target populations from recent published studies are tabulated and the derivation of BE values for 2,4-D summarized.

DATA SYNTHESIS: The biomonitoring data indicate margins of safety (ratio of BE value to biomarker concentration) of approximately 200 at the central tendency and 50 at the extremes in the general population. Median exposures for applicators and their family members during periods of use appear to be well within acute exposure guidance values.

CONCLUSIONS: Biomonitoring data from these studies indicate that current exposures to 2,4-D are below applicable exposure guidance values. This review demonstrates the value of biomonitoring data in assessing population exposures in the context of existing risk assessments using the BE approach. Risk managers can use this approach to integrate the available biomonitoring data into an overall assessment of current risk management practices for 2,4-D.

FULL TEXT

Benbrook et al., 2021a

Benbrook, Charles, Perry, Melissa J., Belpoggi, Fiorella, Landrigan, Philip J., Perro, Michelle, Mandrioli, Daniele, Antoniou, Michael N., Winchester, Paul, & Mesnage, Robin; “Commentary: Novel strategies and new tools to curtail the health effects of pesticides;” Environmental Health, 2021, 20(1); DOI: 10.1186/s12940-021-00773-4.

ABSTRACT:

BACKGROUND: Flaws in the science supporting pesticide risk assessment and regulation stand in the way of progress in mitigating the human health impacts of pesticides. Critical problems include the scope of regulatory testing protocols, the near-total focus on pure active ingredients rather than formulated products, lack of publicly accessible information on co-formulants, excessive reliance on industry-supported studies coupled with reticence to incorporate published results in the risk assessment process, and failure to take advantage of new scientific opportunities and advances, e.g. biomonitoring and “omics” technologies.
RECOMMENDED ACTIONS: Problems in pesticide risk assessment are identified and linked to study design, data, and methodological shortcomings. Steps and strategies are presented that have potential to deepen scientific knowledge of pesticide toxicity, exposures, and risks.
We propose four solutions:
(1) End near-sole reliance in regulatory decision-making on industry-supported studies by supporting and relying more heavily on independent science, especially for core toxicology studies. The cost of conducting core toxicology studies at labs not affiliated with or funded directly by pesticide registrants should be covered via fees paid by manufacturers to public agencies.
(2) Regulators should place more weight on mechanistic data and low-dose studies within the range of contemporary exposures.
(3) Regulators, public health agencies, and funders should increase the share of exposure-assessment resources that produce direct measures of concentrations in bodily fluids and tissues. Human biomonitoring is vital in order to quickly identify rising exposures among vulnerable populations including applicators, pregnant women, and children.
(4) Scientific tools across disciplines can accelerate progress in risk assessments if integrated more effectively. New genetic and metabolomic markers of adverse health impacts and heritable epigenetic impacts are emerging and should be included more routinely in risk assessment to effectively prevent disease.
CONCLUSIONS: Preventing adverse public health outcomes triggered or made worse by exposure to pesticides will require changes in policy and risk assessment procedures, more science free of industry influence, and innovative strategies that blend traditional methods with new tools and mechanistic insights.

FULL TEXT

Messina and Goodis, 2020

Messina, Edward & Goodis, Mike; “Overview of EPA’s Pesticide Program”; Presented at the Farm, Ranch, and Rural Communities Committee Meeting; November 13, 2020. Environmental Protection Agency, 2020.

PRESENTATION OUTLINE

Background
Office of Pesticide Programs Structure and Responsibilities
Pesticide Legislation
Pesticide Registration and Registration Review Process
Risk Assessment, Risk Characterization, and Risk Management
Public Involvement
Collaboration with Domestic & International Partners
Updates on EPA Issues

FULL PRESENTATION

Mesnage et al., 2021B

Mesnage, R., Teixeira, M., Mandrioli, D., Falcioni, L., Ibragim, M., Ducarmon, Q. R., Zwittink, R. D., Amiel, C., Panoff, J. M., Bourne, E., Savage, E., Mein, C. A., Belpoggi, F., & Antoniou, M. N.; “Multi-omics phenotyping of the gut-liver axis reveals metabolic perturbations from a low-dose pesticide mixture in rats;” Communications Biology, 2021, 4(1), 471; DOI: 10.1038/s42003-021-01990-w.

ABSTRACT:

Health effects of pesticides are not always accurately detected using the current battery of regulatory toxicity tests. We compared standard histopathology and serum biochemistry measures and multi-omics analyses in a subchronic toxicity test of a mixture of six pesticides frequently detected in foodstuffs (azoxystrobin, boscalid, chlorpyrifos, glyphosate, imidacloprid and thiabendazole) in Sprague-Dawley rats. Analysis of water and feed consumption, body weight, histopathology and serum biochemistry showed little effect. Contrastingly, serum and caecum metabolomics revealed that nicotinamide and tryptophan metabolism were affected, which suggested activation of an oxidative stress response. This was not reflected by gut microbial community composition changes evaluated by shotgun metagenomics. Transcriptomics of the liver showed that 257 genes had their expression changed. Gene functions affected included the regulation of response to steroid hormones and the activation of stress response pathways. Genome-wide DNA methylation analysis of the same liver samples showed that 4,255 CpG sites were differentially methylated. Overall, we demonstrated that in-depth molecular profiling in laboratory animals exposed to low concentrations of pesticides allows the detection of metabolic perturbations that would remain undetected by standard regulatory biochemical measures and which could thus improve the predictability of health risks from exposure to chemical pollutants. FULL TEXT

Alavanja et al., 2004

Alavanja, M. C., Hoppin, J. A., & Kamel, F.; “Health effects of chronic pesticide exposure: cancer and neurotoxicity;” Annual review of public health, 2004, 25, 155-197; DOI: 10.1146/annurev.publhealth.25.101802.123020.

ABSTRACT:

Pesticides are widely used in agricultural and other settings, resulting in continuing human exposure. Epidemiologic studies indicate that, despite premarket animal testing, current exposures are associated with risks to human health. In this review, we describe the routes of pesticide exposures occurring today, and summarize and evaluate the epidemiologic studies of pesticide-related carcinogenicity and neurotoxicity in adults. Better understanding of the patterns of exposure, the underlying variability within the human population, and the links between the animal toxicology data and human health effects will improve the evaluation of the risks to human health posed by pesticides. Improving epidemiology studies and integrating this information with toxicology data will allow the human health risks of pesticide exposure to be more accurately judged by public health policy makers. FULL TEXT

Macfarlane et al., 2013

Macfarlane, E., Carey, R., Keegel, T., El-Zaemay, S., & Fritschi, L.; “Dermal exposure associated with occupational end use of pesticides and the role of protective measures;” Safety and Health at Work, 2013, 4(3), 136-141; DOI: 10.1016/j.shaw.2013.07.004.

ABSTRACT:

BACKGROUND: Occupational end users of pesticides may experience bodily absorption of the pesticide products they use, risking possible health effects. The purpose of this paper is to provide a guide for researchers, practitioners, and policy makers working in the field of agricultural health or other areas where occupational end use of pesticides and exposure issues are of interest.

METHODS: This paper characterizes the health effects of pesticide exposure, jobs associated with pesticide use, pesticide-related tasks, absorption of pesticides through the skin, and the use of personal protective equipment (PPE) for reducing exposure.

CONCLUSIONS: Although international and national efforts to reduce pesticide exposure through regulatory means should continue, it is difficult in the agricultural sector to implement engineering or system controls. It is clear that use of PPE does reduce dermal pesticide exposure but compliance among the majority of occupationally exposed pesticide end users appears to be poor. More research is needed on higher-order controls to reduce pesticide exposure and to understand the reasons for poor compliance with PPE and identify effective training methods.

FULL TEXT

Pisa et al., 2015

Pisa, L. W., Amaral-Rogers, V., Belzunces, L. P., Bonmatin, J. M., Downs, C. A., Goulson, D., Kreutzweiser, D. P., Krupke, C., Liess, M., McField, M., Morrissey, C. A., Noome, D. A., Settele, J., Simon-Delso, N., Stark, J. D., Van der Sluijs, J. P., Van Dyck, H., & Wiemers, M.; “Effects of neonicotinoids and fipronil on non-target invertebrates;” Environmental Science and Pollution Research International, 2015, 22(1), 68-102; DOI: 10.1007/s11356-014-3471-x.

ABSTRACT:

We assessed the state of knowledge regarding the effects of large-scale pollution with neonicotinoid insecticides and fipronil on non-target invertebrate species of terrestrial, freshwater and marine environments. A large section of the assessment is dedicated to the state of knowledge on sublethal effects on honeybees (Apis mellifera) because this important pollinator is the most studied non-target invertebrate species. Lepidoptera (butterflies and moths), Lumbricidae (earthworms), Apoidae sensu lato (bumblebees, solitary bees) and the section “other invertebrates” review available studies on the other terrestrial species. The sections on freshwater and marine species are rather short as little is known so far about the impact of neonicotinoid insecticides and fipronil on the diverse invertebrate fauna of these widely exposed habitats. For terrestrial and aquatic invertebrate species, the known effects of neonicotinoid pesticides and fipronil are described ranging from organismal toxicology and behavioural effects to population-level effects. For earthworms, freshwater and marine species, the relation of findings to regulatory risk assessment is described. Neonicotinoid insecticides exhibit very high toxicity to a wide range of invertebrates, particularly insects, and field-realistic exposure is likely to result in both lethal and a broad range of important sublethal impacts. There is a major knowledge gap regarding impacts on the grand majority of invertebrates, many of which perform essential roles enabling healthy ecosystem functioning. The data on the few non-target species on which field tests have been performed are limited by major flaws in the outdated test protocols. Despite large knowledge gaps and uncertainties, enough knowledge exists to conclude that existing levels of pollution with neonicotinoids and fipronil resulting from presently authorized uses frequently exceed the lowest observed adverse effect concentrations and are thus likely to have large-scale and wide ranging negative biological and ecological impacts on a wide range of non-target invertebrates in terrestrial, aquatic, marine and benthic habitats. FULL TEXT

Bibliography Index