Abstract
Chemical exposures from consumer products are a major concern in modern society. To address the need for accurate health risk estimation, particularly for chronic chemical hazards that may be less evident such as those contained in consumer products, this study reports on the development of the Population Attributable Risk Screening Tool (PAR Tool) Version 1.0. The PAR Tool was designed for the use of professional staff at the Consumer Product Safety Commission (CPSC), and assumes some prior knowledge of chemical risk assessment. This tool provides reasonable estimates of potential acute and chronic health impacts and mortality resulting from exposure to chemicals in consumer products. The PAR Tool provides the ability to integrate diverse data sources, including consumer product composition, user exposures, chemical toxicity data, consumer use patterns, and other pertinent factors to estimate the Population Attributable Risk associated with exposures to chemical components in consumer products. By generating PAR estimates on a chemical-by-chemical basis, the tool will assist the CPSC in assessing potential health risks and prioritizing efforts for risk reduction. Output from the tool provides an estimate of the number of specific health outcomes that may occur in the population of users of a specific consumer product. Interim steps produce exposure percentiles that are used along with dose–response data for a selected chemical and exposure pathway to calculate the proportion of the population at risk. The output is an estimated number of cases of an adverse health effect or mortality in a product user population potentially related to exposures to a single chemical in a product. These results are based primarily on user inputs, and the rationale for selection of these inputs is documented. All inputs and calculations within the PAR Tool are traceable and based on accepted practices and resources. The ongoing development of the PAR Tool aims to enhance its functionalities, incorporating features such as uncertainty analysis, increased automation, and user support. For example, future iterations may allow CPSC users to analyze multiple chemicals and health endpoints simultaneously and introduce sensitivity analysis capabilities for exposure and toxicity parameters. Ultimately, the PAR Tool represents a valuable advancement in comprehending product risks related to consumer product exposure, contributing to enhanced consumer protection and improved health outcomes.
Similar content being viewed by others
Notes
A BMD is a dose or concentration that produces a change in the response rate of an adverse effect.
The POD is the lowest dose or concentration level in an experiment that deviates from a normal response.
References
Agency for Toxic Substances and Disease Registry (ATSDR) (1999) Toxicological Profile for Formaldehyde. July 1999
Andersen ME, Krewski D (2009) Toxicity testing in the 21st century: bringing the vision to life. Toxicol Sci 107(2):324–330
Arnot JA, Brown TN, Wania F, Breivik K, McLachlan MS (2012) Prioritizing chemicals and data requirements for screening-level exposure and risk assessment. Environ Health Perspect 120:1565–1570
ATSDR (2023a) Toxicity profiles (https://www.atsdr.cdc.gov/toxprofiledocs/index.html)
ATSDR (2023b) Minimal risk levels (https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx)
Aurisano N, Jolliet O, Chiu WA, Judson R, Jang S, Unnikrishnan A, Kosnik MB, Fantke P (2023) Probabilistic points of departure and reference doses for characterizing human noncancer and developmental/reproductive effects for 10,145 chemicals. Environ Health Perspect 131:3
Bailar III, JC, Bailer, AJ (1999) Risk assessment-the mother of all uncertainties: disciplinary perspectives on uncertainty in risk assessment. Annals New York Academy of Sciences 895(1):273–285
Ballentine ML, Kennedy AJ, May LR, Shih WS, Patel R, Kavastha V, Price CL, Chappell MA, Gust KA, Rycroft TE, Laird JG (2023) Safe and rapid development of advanced materials: a research case study for safe development of nanoenabled environmental sensors. US Army Corps of Engineers, Engineer Research and Development Center, ERDC/EL SR-23-1, March 2023
Banzhaf H (2022) The value of statistical life: a meta-analysis of meta-analyses. J Benefit Cost Anal 13(2):182–197
Bhat VS, Meek ME, Valcke M, English C, Boobis A, Brown R (2017) Evolution of chemical-specific adjustment factors (CSAF) based on recent international experience; increasing utility and facilitating regulatory acceptance. Crit Rev Toxicol 47:9
Borgert CJ, Fuentes C, Burgoon LD (2021) Principles of dose-setting in toxicology studies: the importance of kinetics for ensuring human safety. Arch Toxicol 95(12):3651–64
Bruinen De Bruin Y, Hakkinen P, Lahaniatis M et al (2007) Risk management measures for chemicals in consumer products: documentation, assessment, and communication across the supply chain. J Expo Sci Environ Epidemiol 17(Suppl 1):S55–S66
Buckley TJ, Egeghy PP, Isaacs K, Richard AM, Ring C, Sayre RR, Sobus JR, Thomas RS, Ulrich EM, Wambaugh JF, Williams AJ (2023) Cutting-edge computational chemical exposure research at the US environmental protection agency. Environment International 108097.
Chemical and Products Database (CPDat) (2023) (https://comptox.epa.gov/dashboard; https://www.epa.gov/chemical-research/chemical-and-products-database-cpdat; https://www.nature.com/articles/sdata2018125)
Cohen Hubal EA, Reif DM, Slover R, Mullikin A, Little JC (2020) Children’s environmental health: a systems approach for anticipating impacts from chemicals. Int J Environ Res Public Health 17(22):8337
Consumer Product Safety Commission (CPSC) (2023) (https://www.cpsc.gov/)
CPID (Consumer Product Information Database) (2023) (https://www.whatsinproducts.com/; https://www.whatsinproducts.com/contents/about_cpid/1)
EFSA (2022) EFSA Scientific Committee (2022) Guidance on the use of the benchmark dose approach in risk assessment. EFSA J 20(10):7584
Environmental Protection Agency (EPA) (2012) benchmark dose technical guidance. Risk assessment forum, U.S. Environmental Protection Agency Washington, DC, EPA/100/R-12/001, June 2012
EPA (2023a) SHEDS database (https://www.epa.gov/chemical-research/stochastic-human-exposure-and-dose-simulation-sheds)
EPA (2023b) IRIS database (https://www.epa.gov/iris)
EPA (2023c) Benchmark Dose website (https://www.epa.gov/bmds)
EPA (2023d) Consolidated Human Activity Database (CHAD) (https://www.epa.gov/healthresearch/consolidated-human-activity-database-chad-use-human-exposure-and-health-studies-and)
European Chemicals Agency (2017) Guidance on biocidal products regulation: Volume III human health—Assessment & evaluation (Parts B+C) pp. 1–436
European Food Safety Authority Scientific Committee (EFSA) (2009) Guidance of the scientific committee on use of the benchmark dose approach in risk assessment. EFSA J 1150:1–72
Hao N, Sun P, Zhao W, Li X (2023) Application of a developed triple-classification machine learning model for carcinogenic prediction of hazardous organic chemicals to the US, EU, and WHO based on Chinese database. Ecotoxicol Environ Saf 255:114806
Isaacs KK, Glen WG, Egeghy P, Goldsmith MR, Smith L, Vallero D, Brooks R, Grulke CM, Ozkaynak H (2014) SHEDS-HT: an integrated probabilistic exposure model for prioritizing exposures to chemicals with near-field and dietary sources. Environ Sci Technol 48(21):12750–12759
Jensen SM, Kluxen FM, Ritz C (2019) A review of recent advances in benchmark dose methodology. Risk Anal 39(10):2295–2315
Jolliet O, Huang L, Hou P, Fantke P (2021) High throughput risk and impact screening of chemicals in consumer products. Risk Anal 41(4):627–644
Krewski D, Andersen ME, Tyshenko MG, Krishnan K, Hartung T, Boekelheide K, Wambaugh JF, Jones D, Whelan M, Thomas R, Yauk C (2020) Toxicity testing in the 21st century: progress in the past decade and future perspectives. Arch Toxicol 94:1–58
Li D, Suh S (2019) Health risks of chemicals in consumer products: a review. Environ Int 123:580–587
National Research Council (NRC) (2009) Science and decisions: advancing risk assessment. The National Academies Press, Washington, DC
National Research Council (1994). Science and judgment in risk assessment
Rusch G, Clary JJ, Rinehart WE, Bolte HF (1983) A 26 week inhalation toxicity study with formaldehyde in the monkey, rat and hamster. Toxicol Appl Pharmacol 68:329–343
Schaefer HR, Myers JL (2017) Guidelines for performing systematic reviews in the development of toxicity factors. Regul Toxicol Pharmacol 91:124–141
Sussman RG, Naumann BD, Pfister T, Sehner C, CSeaman, PA Weideman, (2016) A harmonization effort for acceptable daily exposure derivation—considerations for application of adjustment factors. Regul Toxicol Pharmacol 79(1):S57–S66
Thomas RS, Philbert MA, Auerbach SS, Wetmore BA, Devito MJ, Cote I, Rowlands JC, Whelan MP, Hays SM, Andersen ME, Meek ME (2013) Incorporating new technologies into toxicity testing and risk assessment: moving from 21st century vision to a data-driven framework. Toxicol Sci 136(1):4–18
Thomas RS, Bahadori T, Buckley TJ, Cowden J et al (2019) The next generation blueprint of computational toxicology at the US environmental protection agency. Toxicol Sci 169(2):317–332
U.S. Army Corps of Engineers (USACE) (2023) PAR Tool User Manual, Unpublished
Varshavsky JR, Rayasam SDG, Sass JB et al (2023) Current practice and recommendations for advancing how human variability and susceptibility are considered in chemical risk assessment. Environ Health 21(Suppl 1):133
Viscusi WK, Aldy JE (2003) The value of a statistical life: a critical review of market estimates throughout the world. J Risk Uncertain 27:5–76
Wetmore BA, Wambaugh JF, Ferguson SS, Sochaski MA, Rotroff DM, Freeman K, Clewell HJ III, Dix DJ, Andersen ME, Houck KA, Allen B (2012) Integration of dosimetry, exposure, and high-throughput screening data in chemical toxicity assessment. Toxicol Sci 125(1):157–174
Woodruff TJ, Rayasam SD, Axelrad DA, Koman PD, Chartres N, Bennett DH, Birnbaum LS, Brown P, Carignan CC, Cooper C, Cranor CF (2023) A science-based agenda for health-protective chemical assessments and decisions: overview and consensus statement. Environ Health 21(Suppl 1):132
World Health Organization (WHO) (2020) Principles and methods for the risk assessment of chemicals in food. Environmental health criteria 240. Chapter 5 Dose–response assessment and derivation of health-based guidance values. Second edition
Funding
This work was funded by the U.S. Consumer Product Safety Commission.
Author information
Authors and Affiliations
Contributions
AR, KK, JD, CC, wrote the main manuscript text and AR and KK prepared the figures. All authors reviewed the manuscript.
Corresponding author
Ethics declarations
Conflict of interests
The authors have no relevant financial or non-financial interests to disclose.
Rights and permissions
About this article
Cite this article
Rosenstein, A.B., Thomas, T., Linkov, I. et al. Development of a population attributable risk screening tool to estimate health consequences of consumer product exposure. Environ Syst Decis (2024). https://doi.org/10.1007/s10669-024-09970-1
Accepted:
Published:
DOI: https://doi.org/10.1007/s10669-024-09970-1