Arsenic – Stakeholder recommendations regarding US EPA’s Toxicological Review of Inorganic Arsenic – Scoping and Planning
These recommendations are respectfully submitted to the US EPA and NAS Arsenic Toxicology Review Panel by the following: Dr Kathleen Burns and Dr Micheal Harbut
Our written comments submitted at the January 8-9 US EPA arsenic stakeholder meeting titled “Toxicological Review of Arsenic Must Include Consideration of Disproportionately High Rates of Cardiovascular Disease in African Americans” are being submitted with these recommendations. The following recommendations are brief summaries on issues we consider important to the arsenic risk assessment scope and planning. Most are also more broadly relevant to the IRIS evaluations of all hazardous chemicals. We make these recommendations based on our experience in toxicology, epidemiology, risk assessment, public health, and medicine, with the goal of obtaining more informative, public health-oriented, and scientifically current toxicological reviews from US EPA. We will provide additional technical information and citations related to these issues when we submit recommendations regarding technical aspects that are scheduled by US EPA to be addressed in the near future.
Recognition of the Use of EPA’s IRIS assessments worldwide & the implications for scope IRIS evaluations are used across the US and in other countries as a key source of information on qualitative and quantitative aspects of hazardous chemicals. They are relied upon by public health, occupational and environmental agencies, scientists and health professionals, and industry and advocates. Information that is not included regarding health may not be considered.
A common misconception is that IRIS files list all potential human health effects, which was neither the intent nor the actual content of such documents. However, the current use of IRIS files suggests that specific language and technical content could substantially improve the utility and appropriate use of IRIS assessments. This is especially true for arsenic, which is of high national and international concern. EPA’s arsenic assessment will inevitably be widely relied upon as being highly authoritative.
Inclusion of Information Explicit information on the types of information that are included and excluded should be offered upfront, with links to other sources for information that is not included (e.g., medical guidance, clinical testing for identified health problems, susceptibility aspects that aren’t covered). Since the sources of such information will be largely consistent across chemicals, this would impose a minimal time burden.
It is important that IRIS evaluations provide a scientifically complete picture of the range of adverse health effects and related science for all impacts that may be relevant to public health and regulatory actions. This should include discussions and citations for well-established adverse effects and a summary of emerging scientific evidence on likely or potentially relevant effects. In the specific case of arsenic, the rapid acceleration in the publication of epidemiological, toxicological, and mechanistic science has resulted in many new health concerns since 2000, especially in the last 5 years. It has also confirmed previously “suspected” effects and provided extensive supporting mechanistic and other evidence.
We expect the IRIS assessment will provide detail on a single or few sensitive noncancer endpoints for quantification (e.g., hypertension). Recent scientific evidence supports examination and discussion of the issue of when exposure occurs, and that should include an emphasis on protections required during particular life stages. For example, a review of the impacts of arsenic on early-life exposure by Boekelheide et al (2012) found an association with increased risk of cardiovascular disease later in life. The study authors suggest that their data and approaches can inform risk assessment and we recommend that this be carefully evaluated, with reliance on this and other information.
In addition to those health endpoints chosen for quantitative evaluation, it is important that the IRIS evaluation include discussions of other health effects and physiological perturbations with potential public health impacts (e.g., neurotoxicity, developmental harm, endocrine disruption, adverse impacts on male reproductive capacity). A general discussion of the ranges of exposure that may incur such effects, appropriately caveated, would be valuable to the public health and scientific communities, even in the absence of the ability to provide definitive quantification of exposure and outcome.
Acute exposure considerations & use of normative assumptions. In some cases, inclusion of acute toxicity information may be warranted. Due to the prevalence of arsenic and some other naturally occurring hazards, oral, inhalation and dermal exposure at elevated levels are possible, and may occur in individuals with considerable susceptibility (e.g., newborns, people with existing diseases related to those caused by arsenic, or other chemicals with toxic effects similar to those of arsenic). Toxicological reviews do not explicitly address exposure, but must consider it to determine if acute exposure effects are possible in highly exposed susceptible populations.
Reliance on the 95th percentile for exposure assessment must be revisited to address its potential for exclusion of substantial numbers of people. Normative assumptions and reliance on a “normal” distribution inherently ignore exposures of up to 5% of a population of over 300 million people, thereby “accepting” serious health risks to a very large number of people.
People highly exposed to waterborne contaminants are often in poorer communities. Infants who receive the least costly formula – powdered milk mixed with tap water – are in the highest exposure groups for water contaminants, as are infants with health problems, low birth weight, or who suffer dehydration due to common illnesses. They consume far more water in relation to their body weight than is accounted for in normative approaches to exposure and their consumption could incur acute toxicity at water contamination levels considered “acceptable” for a healthy adult. They easily exceed a reference dose calculated based on normative assumptions.
Likewise people who work in jobs involving manual labor or outdoor work or who lack air conditioning in hot climates consumer more water, but cannot elect to consume less water. They are placed in jeopardy by insufficient risk calculations and inadequately protective standards. We recommend that the IRIS assessments include: 1) explicit discussion of the range of exposures under plausible worst case scenarios, 2) discussion of the potential health effects that may occur as a result of those elevated exposures, and 3) directions on accessing appropriate health guidance if acute exposure is suspected.
Mixtures of Chemicals EPA has discussed and provided some guidance on this difficult problem. There are potentially an infinite number of combinations of chemicals. However, it is common to have multiple toxic heavy metals in soil, air, or water, due to their natural and anthropogenic sources (e.g., fuel combustion). Consequently, it is necessary to have specific guidance on methods to address the assessment of toxicity when multiple heavy metals and/or other hazardous chemicals are present in order to prevent underestimation of effects or insufficiently protective policies.
Consideration of the combination of toxic heavy metals that are likely to occur in combination with arsenic is especially important for noncarcinogenic effects because the current risk assessment paradigm does not easily adapt to consideration of mixtures. Most toxic heavy metals target the same organ systems, though their potency varies by organ and cell type, and the nature of the evidence varies (i.e., the outcomes being measured). In spite of the difficult, it is clear that a health-protective approach to this is essential. The combined exposures impacting the nervous system, liver, kidneys, and other organ systems at ostensibly “safe” levels may pose serious health risks.
We recommend that the IRIS assessment explicitly point out the need to evaluate concurrent exposures to other toxic heavy metals (and possibly other commonly encountered chemicals with similar target organs) when determining appropriate public policies and public health responses. EPA should quickly incorporate a simple mathematical model in IRIS assessments to assist users in making prudent public health judgments, due to the prevalence of multiple heavy metal contamination across the US.
Use of existing public health data to inform toxicological reviews. As noted in our submission for the January 8-9 meeting, health sciences are sophisticated in their elucidation of both at risk populations and the underlying mechanisms for those increased risks. Health statistics should be used to inform toxicological reviews and quantitative risk assessments when it suggests fundamental elevated-risk populations that are likely to be impacted by exposure to an agent. Epidemiological studies, health databases, and other sources documenting pre-existing elevated risks should be utilized to modify the qualitative evaluations of chemicals that are likely to exacerbate those risks. Morbidity distributions can be used to inform the likelihood of reaching an adverse tipping point and adjust estimates of safe exposure, rather than reliance on simplistic “safety factors”.
The extensive health documentation on cardiovascular disease in African Americans and the unequivocal literature on arsenic’s cardiovascular impacts make this chemical an ideal candidate for the development of such an approach (see citations and brief discussion in our January 8th submission to US EPA for the stakeholders meeting). We highly recommend work on this issue due to both the critical public health need and the strong potential for improving the quality and length of life among a substantial portion of the US population through high quality scientific work to develop a scientifically-based approach to the problem.
Database Review Considerable concern was raised by US EPA staff at the January 8-9 meeting regarding the extensive nature of the arsenic database on health and related scientific issues. The use of various systematics options was presented as “necessary”. Two days later the NAS had an excellent two day meeting: “Integrating Environmental Health Data to Advance Discovery”. The keynote and subsequent speakers emphasized the limited understanding we currently have of health and biology, the need to avoid over-simplification because so many fundamental dynamics are not understood, and some ways in which the challenge of extensive scientific data is being addressed. EPA and other staff spoke at the meeting, which covered epidemiology, toxicology, clinical medicine, and other issues. These fields and the meeting content were highly relevant to how the evaluation of arsenic is approached.
The juxtaposition of the approaches recommended by the two meetings could not be more strikingly different. We believe the second is far more appropriate when approaching a complex chemical such as arsenic. Many of the health hazards of arsenic that are well established were not being consider 20 years ago, and many new concerns are being substantiated by carefully designed experimental work. More advances are expected. Many connections across the evidence from different studies, fields of inquiry, and methods can be obtained through careful review of the health-related data on arsenic. It is onerous, and we have provided a compilation of most of the studies from 2012 in Appendix A. This was done to 1) illustrate the wide range of new information being generated and 2) emphasize the need for careful review.
Systematics as presented on January 8th by US EPA relied on key words and other tricks-of-the-trade that sound logical, but have limited value in accessing the breadth of relevant science. Investigation of chemical toxicity is an iterative process that requires considerable attention to detail, and the skills of well-trained toxicologists, epidemiologists, geneticists, and others to identify both the relevant information and make the connections between important related concepts. This simply cannot be done by a computer model, no matter how carefully designed.
Our group includes people charged with reviewing all of the chemical toxicity data for US EPA’s 500 Toxics Release Inventory Chemicals. Others carried out reviews of all of the published corporate and grey literature on chemicals comprising tens of thousands of pages. So we do not recommend a human versus computer selection of key papers without understanding the difficulty of the task. However, we believe that there is simply no replacement for well trained scientists’ selection of studies from the entire range of potentially relevant information.
Given the new arenas of knowledge in arsenic toxicity, especially at the subcellular level where new nomenclature is prevalent, it is very important to have scientists carrying out such work. If US EPA requires additional time to be careful and comprehensive, then that should be provided, since the quality of the science matters far more than the month in which the evaluation is completed.
Genotoxicity Although these recommendations are largely on scoping and planning, the issue of genotoxicity was raised at the January 8-9 meeting. Based on a review of the extensive scientific evidence available on inorganic arsenic, there is no doubt that arsenic is genotoxic. It may be that past US EPA concerns regarding the implications for IRIS cancer potency values impacted their evaluation of the science, enabling them to avoid a protection factor for early life exposures which is necessary in this case. A positive genotoxicity conclusion is therefore likely to result in a higher cancer potency estimate and lower public health exposure limits (e.g., drinking water standards). However, the scientific evidence is overwhelming at this point and should not be suppressed to achieve more politically palatable results. The implications of health science for policy should be deliberated outside of the IRIS process, after the best possible scientific evaluation is conducted.
We look forward to hearing what the NAS panel has to contribute regarding US EPA’s evaluation of arsenic and hope that our recommendations will be considered.
Disclosure: We did not receive any funding to develop these recommendations and have no financial conflicts of interest. We each have conducted scientific and/or medical work related to arsenic and the assessment of health risks over many years.
Appendix A. Health-relevant Studies of Arsenic Published in Peer Reviewed Journals in 2012.
This Appendix contains all potentially health-relevant publications that were retrieved during January 2013 from the National Library of Medicine via PubMed through a search with a single term: “arsenic”. All papers were printed or published via e-pub during 2012. Papers were excluded if they did not appear to be health related or focused primarily on the use of arsenic in cancer therapy, though the latter may be useful in IRIS evaluation. The wide ranging information on health and related scientific concepts that address arsenic’s toxicological actions are clear from a quick review of the paper topics.
In chronological order based on National Library of Medicine publication date.
Kunrath J, Gurzau E, Gurzau A, et al Blood pressure hyperreactivity: an early cardiovascular risk in normotensive men exposed to low-to-moderate inorganic arsenic in drinking water. J Hypertens. 2013 Feb;31(2):361-9.
Lamm SH, Robbins SA, Zhou C, et al. Bladder/lung cancer mortality in Blackfoot-disease (BFD)-endemic area villages with low (<150μg/L) well water arsenic levels – An exploration of the dose-response Poisson analysis. Regul Toxicol Pharmacol. 2013 Feb;65(1):147-56.
Yadav S, Anbalagan M, Shi Y, et al. Arsenic inhibits the adipogenic differentiation of mesenchymal stem cells by down-regulating peroxisome proliferator-activated receptor gamma and CCAAT enhancer-binding proteins. Toxicol In Vitro. 2013 Feb;27(1):211-9.
Stamatelos SK, Androulakis IP, Kong AN, et al A semi-mechanistic integrated toxicokinetic-toxicodynamic (TK/TD) model for arsenic(III) in hepatocytes. J Theor Biol. 2013 Jan 21;317:244-56.
Vitela-Rodriguez AV, Rangel-Mendez JR. Arsenic removal by modified activated carbons with iron hydro(oxide) nanoparticles. J Environ Manage. 2013 Jan 15;114:225-31.
Macoch M, Morzadec C, Fardel O, et al. Inorganic arsenic impairs differentiation and functions of human dendritic cells. Toxicol Appl Pharmacol. 2013 Jan 15;266(2):204-13.
Chung CJ, Huang CY, Pu YS, et al. The effect of cigarette smoke and arsenic exposure on urothelial carcinoma risk is modified by glutathione S-transferase M1 gene null genotype. Toxicol Appl Pharmacol 2013 Jan 15;266(2):254-9.
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 The IRIS assessments and toxicological reviews are not identical, but both are the subject of the ongoing meetings and deliberations. For simplicity, they are both referred to simply as “IRIS assessment” in these recommendations.
 Boekelheide K et al. 2012. Predicting Later-life Outcomes of Early-life Exposures. Environ Health Persp. 120(10):1353-1361.