Endpoint Selection Homework

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University of Texas, San Antonio *

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3323

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Health Science

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May 13, 2024

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docx

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Homework Assignment 3 Now that you have some background on the toxicological profile of glyphosate, please complete the following review of emerging toxicity data. The goal of this assignment is to compare the existing federal record as it is found in the human health risk assessment published by the Environmental Protection Agency and those that are now emerging conducted by academic and private entities. EPA Glyphosate HHRA: https://www.regulations.gov/document/EPA-HQ-OPP-2009-0361-0068 Please fill out all parts of this assignment and submit the complete document to Blackboard. PART I: The Great Debate on Toxicity First, begin by reading the following article on the debate regarding the toxicity of glyphosate found here: https://www.frontiersin.org/articles/10.3389/fpubh.2017.00316/full According to the article, “the underestimation of the toxicity of a commercialized product is known to have devastating effects on public health. Although it has long been asserted by both industry and regulatory agencies that glyphosate is safe even at relatively high daily intake levels (for example, 1.75 mg/kg bw/day in the US), major gaps in its evaluation have been identified and need to be addressed in order to definitely conclude on its safety.” 1. Please compare this statement to the information provided in the human health risk assessment, specifically, page 12-14 regarding dietary risk exposures. What is your opinion on these data based on the comparative analysis? In comparison to the article, databases show evidence through multi-generational reproduction studies done on rats and rabbits. It shows that there are no acute dietary end points based on the study population. However, Glyphosate has a low toxicity via oral exposure, but it is considered safe of use for food and nonfood. I think the database needs to be on ongoing research to see how Glyphosate safety is an actual concern and its toxicity has affected many people in getting cancer through oral or incidental oral exposure. Databases need to be more factual and show a higher amount of evidence and not just animal studies to argue the continued use of glyphosate. 2. Please describe at least two reported biological hazard effects reported in the article that are not consistent with the information provided in the human health risk assessment for glyphosate. Please be specific. Remember, you can find a general listing of all the studies available for glyphosate in the appendix of the documents. According to the article in a most recent study, it revealed kidney and liver damage to its structure and function in which it was based on rats’ chronic ingestion of ultra-low dose of Glyphosate herbicide. Another biological hazard is that Glyphosate is linked with disturbance of gut microbiome, and it may lead to the NCGS disease since it is associated with imbalances in gut bacterial population. This can relate to where many NCGS patients do have a consistent problem of infertility, reproduction, and birth defects. 3. Please review the two documents as it relates to the cancer classification of glyphosate. Are these two classifications consistent? If not, why do you think there is a stark difference in the classifications? What is your regulatory recommendation moving forward as it relates to the considerations of data? In the regulatory data sheet acute cancer dietary risk assessment was not conducted. However, throughout the different epidemiological, animal carcinogenicity, and
genotoxicity studies it concluded that glyphosate classification is not likely to be cancerogenic to humans. In comparison to the article there was no proven linkage between glyphosate herbicide and certain rise of cancer such as breast cancer, although since the increased use of glyphosate in the past decade, there was a steep increase in cancer cases in related use of crops and material that are affected by glyphosate herbicide. Moving forward, I think from a cancer standpoint the regulatory database is correct on the risk and safety of glyphosate in relation to cancer. Nonetheless, ongoing studies need to be conducted in the future as environmental use of glycophytic herbicide in the United States is increasing daily. _____________________________________________________________________________________ PART II: Emerging Evidence of Glyphosate Toxicity Now that you have some background on the great debate of glyphosates toxicity between the regulatory agency, the public, and private industry, let’s take a look at the new data being published and compare that to the current assertions in the human health risk assessment. Begin by reviewing the following article: https://www.tandfonline.com/doi/full/10.1080/1547691X.2020.1804492 4. Focusing on the impacts of genotoxicity, mutagenicity, and digestive health, please identify how these reported effects differ from that of the toxicity profile in the human health risk assessment. Please remember to include specific data regarding these specific routes and study details. Please address each individually. In this article a study was conducted to examine the genotoxicity in association with glyphosate and GBHs. In results, it was observed that glyphosate is genotoxic with use of high concentration of in healthy and fibrosarcoma human cells. Compared to the regulatory data base studies in vivo and vitro evaluating mutagenicity and genotoxicity, the Federal Insecticide, Fungicide, and Rodenticide Scientific Advisory Panel (FIFRA SAP) concluded that glyphosate should be classified as “not likely to be carcinogenic to humans.” In the article it also discussed the effect of glyphosate and GBHs on non-immune cells similar to immune cells in evaluating genotoxicity and oxidative stress. The genotoxicity and oxidative stress were observed in studying bovine lymphocyte cultus with different concentrations of glyphosate which resulted in increasing dose-dependent chromosome aberrations and sister-chromatid exchanges. Even though GBHs, glyphosate, and AMPA pose a mild genotoxic hazard on environmentally- relevant concentrations, it can still be a long-term issue. For digestive health problems, a study showed that dairy cows that are highly exposed to glyphosate have changes in their rumen fungal composition compared to non-exposed cattle. Another study was demonstrated on mice with oral exposure to Roundup (highly glyphosate material). This study resulted specifically, in these hosts, there was a decreased ratio of firmicutes/bactericides, the balance of which is essential for host physiology. Then as both GBHs and glyphosate concentration increase as they highly damage the liver leading to mild liver lesions up to fibrosis. Compared to the database regulatory, 30 to 40 % was an estimated absorption from the GI tract for glyphosate through oral exposure.
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