Policy and Politics - HH-RA.org

Bibliography Tag: policy and politics

Williams et al., 2000

Williams, G. M., Kroes, R., & Munro, I. C.; “Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, for humans;” Regulatory Toxicology and Pharmacology, 2000, 31(2 Pt 1), 117-165; DOI: 10.1006/rtph.1999.1371.

ABSTRACT:

Reviews on the safety of glyphosate and Roundup herbicide that have been conducted by several regulatory agencies and scientific institutions worldwide have concluded that there is no indication of any human health concern. Nevertheless, questions regarding their safety are periodically raised. This review was undertaken to produce a current and comprehensive safety evaluation and risk assessment for humans. It includes assessments of glyphosate, its major breakdown product [aminomethylphosphonic acid (AMPA)], its Roundup formulations, and the predominant surfactant [polyethoxylated tallow amine (POEA)] used in Roundup formulations worldwide. The studies evaluated in this review included those performed for regulatory purposes as well as published research reports. The oral absorption of glyphosate and AMPA is low, and both materials are eliminated essentially unmetabolized. Dermal penetration studies with Roundup showed very low absorption. Experimental evidence has shown that neither glyphosate nor AMPA bioaccumulates in any animal tissue. No significant toxicity occurred in acute, subchronic, and chronic studies. Direct ocular exposure to the concentrated Roundup formulation can result in transient irritation, while normal spray dilutions cause, at most, only minimal effects. The genotoxicity data for glyphosate and Roundup were assessed using a weight-of-evidence approach and standard evaluation criteria. There was no convincing evidence for direct DNA damage in vitro or in vivo, and it was concluded that Roundup and its components do not pose a risk for the production of heritable/somatic mutations in humans. Multiple lifetime feeding studies have failed to demonstrate any tumorigenic potential for glyphosate. Accordingly, it was concluded that glyphosate is noncarcinogenic. Glyphosate, AMPA, and POEA were not teratogenic or developmentally toxic. There were no effects on fertility or reproductive parameters in two multigeneration reproduction studies with glyphosate. Likewise there were no adverse effects in reproductive tissues from animals treated with glyphosate, AMPA, or POEA in chronic and/or subchronic studies. Results from standard studies with these materials also failed to show any effects indicative of endocrine modulation. Therefore, it is concluded that the use of Roundup herbicide does not result in adverse effects on development, reproduction, or endocrine systems in humans and other mammals. For purposes of risk assessment, no-observed-adverse-effect levels (NOAELs) were identified for all subchronic, chronic, developmental, and reproduction studies with glyphosate, AMPA, and POEA. Margins-of-exposure for chronic risk were calculated for each compound by dividing the lowest applicable NOAEL by worst-case estimates of chronic exposure. Acute risks were assessed by comparison of oral LD50 values to estimated maximum acute human exposure. It was concluded that, under present and expected conditions of use, Roundup herbicide does not pose a health risk to humans.

Boobis et al., 2008

Boobis, A. R., Ossendorp, B. C., Banasiak, U., Hamey, P. Y., Sebestyen, I., & Moretto, A.; “Cumulative risk assessment of pesticide residues in food;” Toxicology Letters, 2008, 180(2), 137-150; DOI: 10.1016/j.toxlet.2008.06.004.

ABSTRACT:

There is increasing need to address the potential risks of combined exposures to multiple residues from pesticides in the diet. The available evidence suggests that the main concern is from dose addition of those compounds that act by the same mode of action. The possibility of synergy needs to be addressed on a case-by-case basis, where there is a biologically plausible hypothesis that it may occur at the levels of residues occurring in the diet. Cumulative risk assessment is a resource-intense activity and hence a tiered approach to both toxicological evaluation and intake estimation is recommended, and the European Food Safety Authority (EFSA) has recently published such a proposal. Where assessments have already been undertaken by some other authority, full advantage should be taken of these, subject of course to considerations of quality and relevance. Inclusion of compounds in a cumulative assessment group (CAG) should be based on defined criteria, which allow for refinement in a tiered approach. These criteria should include chemical structure, mechanism of pesticidal action, target organ and toxic mode of action. A number of methods are available for cumulating toxicity. These are all inter-related, but some are mathematically more complex than others. The most useful methods, in increasing levels of complexity and refinement, are the hazard index, the reference point index, the Relative Potency Factor method and physiologically based toxicokinetic modelling, although this last method would only be considered should a highly refined assessment be necessary. Four possible exposure scenarios are of relevance for cumulative risk assessment, acute and chronic exposure in the context of maximum residue level (MRL)-setting, and in relation to exposures from the actual use patterns, respectively. Each can be addressed either deterministically or probabilistically. Strategies for dealing with residues below the limit of detection, limit of quantification or limit of reporting need to be agreed. A number of probabilistic models are available, but some of there are geographically constrained due to the underlying datasets used in their construction. Guidance on probabilistic modelling needs to be finalised. Cumulative risk assessments have been performed in a number of countries, on organophosphate insecticides alone (USA) or together with carbamates (UK, DK, NL), triazines, chloroacetanilides, carbamates alone (USA), and all pesticides (DE). All identifiable assumptions and uncertainties should be tabulated and evaluated, at least qualitatively. Those likely to have a major impact on the outcome of the assessment should be examined quantitatively. In cumulative risk assessment, it is necessary, as in other risk assessments, for risk managers to consider what level of risk would be considered “acceptable”, for example what percentile of the population should be below the reference value. Criteria for prioritising CAGs for cumulative risk assessment include frequency of detection in monitoring programmes, high usage, high exposure relative to the reference value, large number of compounds (e.g. five or more) in a group. FULL TEXT

Thacker, 2020

Thacker, Paul D, “Transparency and Conflicts in Science: History of Influence, Scandal, and Denial,” Chapter 1 in Integrity, Transparency and Corruption in Healthcare & Research on Health, 2020,Volume I (pp. 3-26), Springer Nature Singapore.

ABSTRACT:

Corporate finances influence many areas of science, originating with tobacco companies which hired public relations firms to protect their profits from research on the harms of smoking. Despite a large body of studies finding that money biases research, scientists and academic organizations fail to embrace the peer-reviewed research on corporate influence. In many instances, they reject the science and try to rationalize behavior, leading a cycle of scandal, followed by reform, followed by later scandal. Because corporate influence is so pervasive and often denied, policymakers must understand this history as well as the research on financial conflicts of interest to protect the public. FULL TEXT

Vineis, 2019

Vineis, P.; “Public Health and Independent Risk Assessment;” American Journal of Public Health, 2019, 109(7), 978-980; DOI: 10.2105/AJPH.2019.305142.

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Samet, 2019

Samet, J. M.; “Expert Review Under Attack: Glyphosate, Talc, and Cancer;” American Journal of Public Health, 2019, 109(7), 976-978; DOI: 10.2105/AJPH.2019.305131.

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Morabia, 2019

Morabia, A.; “Fighting Independent Risk Assessment of Talc and Glyphosate: Whose Benefit Is It Anyway?;” American Journal of Public Health, 2019, 109(7), 955-956; DOI: 10.2105/AJPH.2019.305144.

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Rodenberg, 2019

Rodenberg, H.; “Reliance, Not Responsibility: Relations Between Science and Industry;” American Journal of Public Health, 2019, 109(7), 980-981; DOI: 10.2105/AJPH.2019.305125.

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Schaden et al., 2020

Schaden, Helmut Burtscher, Clausing, Peter, & Van Scharen, Hans. “Factsheet: Dangerous Confidence in ‘Good Laboratory Practices,'” February 11, 2020, Corporate Europe Observatory and PAN Germany.

SUMMARY:

Our authorisation system for chemicals is based on the principle that manufacturers must prove, by means of scientifc studies, that their products do not pose unacceptable risks to public health and the environment. It is therefore also the responsibility of manufacturers to commission certifed contract laboratories to carry out the toxicological studies necessary for the approval procedure. As a guarantee against manipulation and falsifcation of these “regulatory” studies, regulatory authorities worldwide rely on the certifed standard of “Good Laboratory Practice” (GLP). This standard provides for strict documentation requirements and regular internal and external controls. However, the current fraud scandal involving a German contract laboratory certifed according to GLP, shows that this trust is unlikely to be justifed. According to reports, GLP studies have been manipulated and falsifed there since 2005.

Recent research now shows that LPT has also produced studies that were part of the study package for the EU-wide approval of glyphosate in December 2017: One in seven studies in this package, which was the basis to grant re-approval for glyphosate, came from LPT. These fndings are worrying in two ways: – On the one hand, there is the fundamental question of whether the risk assessments for medicines, pesticides and chemicals based on LPT studies can be trusted.
Even more worrying is the general realisation that laboratories, despite the supposedly “tamper-proof” GLP standard, are apparently able to falsify studies over years and decades without being noticed by the control authorities.

The classifcation of glyphosate as “non-carcinogenic” and “not genotoxic“o is based, among other things, on the European authorities’ full confdence in the GLP system. In the EU assessment proces GLP studies were automatically classifed as reliable; This in stark contrast with the numerous “non-GLP studies” from university research, peer reviewed and published, most of which reported evidence of a genotoxic effect and an increased risk of lymphatic cancer in users of glyphosate, were disqualifed by the authorities as “unreliable“.

The LPT counterfeiting scandal reveals the failure of a regulatory system, that places the commissioning and preparation of studies in the hands of industry. At the same time, it confrms the urgency of a fundamental reform of this system for identifying the risks of chemicals, as called for by the European coalition “Citizens for Science in Pesticide Regulation” in October 2018. FULL TEXT

Janssens and Stoks, 2017

Janssens, L., & Stoks, R.; “Stronger effects of Roundup than its active ingredient glyphosate in damselfly larvae;” Aquatic Toxicology, 2017, 193, 210-216; DOI: 10.1016/j.aquatox.2017.10.028.

ABSTRACT:

Pesticides are causing strong decreases in aquatic biodiversity at concentrations assumed safe by legislation. One reason for the failing risk assessment may be strong differences in the toxicity of the active ingredient of pesticides and their commercial formulations. Sublethal effects, especially those on behaviour, have been largely ignored in this context, yet can be equally important as lethal effects at the population and ecosystem levels. Here, we compared the toxicity of the herbicide Roundup and its active ingredient glyphosate on survival, but also on ecologically relevant sublethal traits (life history, behaviour and physiology) in damselfly larvae. Roundup was more toxic than glyphosate with negative effects on survival, behaviour and most of the physiological traits being present at lower concentrations (food intake, escape swimming speed) or even only present (survival, sugar and total energy content and muscle mass) following Roundup exposure. This confirms the toxicity of the surfactant POEA. Notably, also glyphosate was not harmless: a realistic concentration of 2mg/l resulted in reduced growth rate, escape swimming speed and fat content. Our results therefore indicate that the toxicity of Roundup cannot be fully attributed to its surfactant, thereby suggesting that also the new generation of glyphosate-based herbicides with other mixtures of surfactants likely will have adverse effects on non-target aquatic organisms. Ecotoxicological studies comparing the toxicity of active ingredients and their commercial formulations typically ignore behaviour while the here observed differential effects on behaviour likely will negatively impact damselfly populations. Our data highlight that risk assessment of pesticides ignoring sublethal effects may contribute to the negative effects of pesticides on aquatic biodiversity. FULL TEXT

Caiati et al., 2019

Caiati, C., Pollice, P., Favale, S., & Lepera, M. E.; “The Herbicide Glyphosate and Its Apparently Controversial Effect on Human Health: An Updated Clinical Perspective;” Endocrine, Metabolic, and Immune Disorders: Drug Targets, 2019; DOI: 10.2174/1871530319666191015191614.

ABSTRACT:

BACKGROUND: Glyphosate (G) is the most common weed-killer in the world. Every year tons and tons of G are applied on crop fields. G was first introduced in the mid 1970s and since then its usage has gradually increased to reach a peak since 2005. Now G usage is approximately 100 -fold what it was in 1970. Its impact on human health was considered benign at the beginning. But over the years, evidence of a pervasive negative effect of this pesticide on humans has been mounting. Nonetheless, G usage is allowed by government health control agencies (both in the United States and Europe), that rely upon the evidence produced by the G producer. However, the IARC (International Agency for Research on Cancer) in 2015 has stated that G is probable carcinogenic (class 2A), the second highest class in terms of risk.

OBJECTIVE: In this review, we explore the effect of G on human health, focusing in particular on more recent knowledge.

RESULTS: We have attempted to untangle the controversy about the dangers of the product for human beings in view of a very recent development, when the so -called Monsanto Papers, consisting of Emails and memos from Monsanto came to light, revealing a coordinated strategy to manipulate the debate about the safety of glyphosate to the company’s advantage.

CONCLUSIONS: The story of G is a recurrent one (see the tobacco story), that seriously jeopardizes the credibility of the scientific study in the modern era.

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