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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Page 57
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Page 58
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
×
Page 59
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Page 60

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References Balshem, H., M. Helfand, H. J. Schünemann, A. D. Oxman, R. Kunz, J. Brozek, G. E. Vist, Y. Falck-Ytter, J. Meerpohl, and S. Norris. 2011. GRADE guidelines: 3. Rating the quality of evidence. Journal of Clinical Epidemiology 64(4):401–406. Bergeson, L. L. 2016. TSCA reform: Is it still in our future? Industrial Biotechnology 12(2):75–77. Bero, L., N. Chartres, J. Diong, A. Fabbri, D. Ghersi, J. Lam, A. Lau, S. McDonald, B. Mintzes, P. Sutton, J. L. Turton, and T. J. Woodruff. 2018. The risk of bias in observational studies of exposures (ROBINS-E) tool: Concerns arising from application to observational studies of exposures. Systematic Reviews 7(1):242. Booth, A., M. Clarke, G. Dooley, D. Ghersi, D. Moher, M. Petticrew, and L. Stewart. 2012. The nuts and bolts of PROSPERO: An international prospective register of systematic reviews. Systematic Reviews 1(1):1–9. Card, M. L., V. Gomez-Alvarez, W. H. Lee, D. G. Lynch, N. S. Orentas, M. T. Lee, E. M. Wong, and R. S. Boethling. 2017. History of EPI Suite™ and future perspectives on chemical property estimation in US Toxic Substances Control Act new chemical risk assessments. Environmental Science: Processes & Impacts 19(3):203–212. Cohen Hubal, E. A., J. J. Frank, R. Nachman, M. Angrish, N. C. Deziel, M. Fry, R. Tornero-Velez, A. Kraft, and E. Lavoie. 2020. Advancing systematic-review methodology in exposure science for environmental health decision making. Journal of Exposure Science and Environmental Epidemiology 30:906–916. Mayo-Bean, K., K. Moran-Bruce, J. V. Nabholz, W. M. Meylan, P. H. Howard, and L. Cassidy. 2017. Operation manual for the Ecological Structure-Activity Relationship Model (ECOSAR) class program.” Risk Assessment Division, U.S. Environmental Protection Agency, Washington, DC. EDF (Environmental Defense Fund). 2020. Comments on 1,4-Dioxane; Supplemental Analysis to the Draft Toxic Substances Control Act (TSCA) Risk Evaluation. http://blogs.edf.org/health/files/2020/12/EDF-Comments- on-14-dioxane-DRE-Supplement-FINAL-12-10-20.pdf, accessed November 13, 2020. Eick, S. M., D. E. Goin, N. Chartres, J. Lam, and T. J. Woodruff. 2020. Assessing risk of bias in human environmental epidemiology studies using three tools: Different conclusions from different tools. Systematic Reviews 9(1):249. EPA (U.S. Environmental Protection Agency). 1998. Guidelines for Ecological Risk Assessment. EPA/630/R- 95/002F. Federal Register 63(93):26846–26924. EPA. 2011. Exposure Factors Handbook 2011 Edition (Final Report). EPA/600/R-09/052F. U.S. Environmental Protection Agency, Washington, DC. EPA. 2012a. Benchmark Dose Technical Guidance. U.S. Environmental Protection Agency, Washington, DC. EPA. 2012b. Benchmark Dose Software (BMDS) Development and Maintenance Multitumor (MS Combo) Model. U.S. Environmental Protection Agency, Washington, DC. EPA. 2016. Weight of Evidence in Ecological Assessment. U.S. Environmental Protection Agency, Washington, DC. EPA. 2017a. Scope of the Risk Evaluation for Trichloroethylene. Office of Chemical Safety and Pollution Prevention, Washington, DC. EPA. 2017b. Scope of the Risk Evaluation for 1-Bromopropane. Office of Chemical Safety and Pollution Prevention, Washington, DC. EPA. 2017c. Strategy for Conducting Literature Searches for Trichloroethylene (TCE): Supplemental Document to the TSCA Scope Document CASRN: 79-01-6. Office of Chemical Safety and Pollution Prevention, Washington, DC. EPA. 2018a. Application of Systematic Review in TSCA Risk Evaluations. Office of Chemical Safety and Pollution Prevention, Washington, DC. EPA. 2018b. Problem Formulation of the Risk Evaluation for Trichloroethyene. Office of Chemical Safety and Pollution Prevention and Office of Pollution Prevention and Toxics, Washington, DC. EPA. 2019a. Final Risk Evaluation for 1,4-Dioxane. U.S. Environmental Protection Agency, Washington, DC. EPA. 2019b. Guidelines for Human Exposure Assessment. Risk Assessment Forum, U.S. Environmental Protection Agency, Washington, DC. EPA. 2019c. Integrated Science Assessment (ISA) for Particulate Matter. U.S. Environmental Protection Agency, Washington, DC. Prepublication Copy 57

The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations EPA. 2020a. Draft Risk Evaluation for Trichloroethylene. Office of Chemical Safety and Pollution Prevention, Washington, DC. EPA. 2020b. ECOTOX User Guide: ECOTOXicology Database System, Version 5.3. EPA. 2020c. Risk Evaluation for 1-Bromopropane (n-Propyl Bromide). Office of Chemical Safety and Pollution Prevention, Washington, DC. Etterson, M. 2020. Technical Manual: SSD Toolbox Version 1.0. EPA/600/R-19/104. U.S. Environmental Protection Agency, Office of Research and Development, Center for Computational Toxicology and Exposure, Great Lakes Toxicology and Ecology Division, Duluth, MN. Foster, E. D., and A. Deardorff. 2017. Open science framework (OSF). Journal of the Medical Library Association 105(2):203–206. Gartlehner, G., G. Wagner, L. Lux, L. Affengruber, A. Dobrescu, A. Kaminski-Hartenthaler, and M. Viswanathan. 2019. Assessing the accuracy of machine-assisted abstract screening with DistillerAI: A user study. Systematic Reviews 8(1):277. Greenland, S., and K. O’Rouke. 2001. On the bias produced by quality scores in meta-analysis, and a hierarchical view of proposed solutions. Biostatistics 2(4):463–471. Guyatt, G. H., A. D. Oxman, R. Kunz, J. Woodcock, J. Brozek, M. Helfand, P. Alonso-Coello, P. Glasziou, R. Jaeschke, and E. A. Akl. 2011. GRADE guidelines: 7. Rating the quality of evidence—inconsistency. Journal of Clinical Epidemiology 64(12):1294–1302. Herbison, P., J. Hay-Smith, and W. J. Gillespie. 2006. Adjustment of meta-analyses on the basis of quality scores should be abandoned. Journal of Clinical Epidemiology 59(12):1249–1256. Higgins, J. P., D. G. Altman, P. C. Gøtzsche, P. Jüni, D. Moher, A. D. Oxman, J. Savović, K. F. Schulz, L. Weeks, and J. A. Sterne. 2011. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 343:d5928. Higgins, J. P., J. Thomas, J. Chandler, M. Cumpston, T. Li, M. J. Page, and V. A. Welch. 2019. Cochrane Handbook for Systematic Reviews of Interventions. Chichester, UK: John Wiley & Sons. Hill, A. 1965. The environment and disease: Association or causation? Proceedings of the Royal Society of Medicine 58(5):295–300. Hooijmans, C. R., R. B. M. de Vries, M. Ritskes-Hoitinga, M. M. Rovers, M. M. Leeflang, J. IntHout, K. E. Wever, L. Hooft, H. de Beer, T. Kuijpers, M. R. Macleod, E. S. Sena, G. Ter Riet, R. L. Morgan, K. A. Thayer, A. A. Rooney, G. H. Guyatt, H. J. Schünemann, and M. W. Langendam. 2018. Facilitating healthcare decisions by assessing the certainty in the evidence from preclinical animal studies. PLoS One 13(1):e0187271. Howard, B. E., J. Phillips, K. Miller, A. Tandon, D. Mav, M. R. Shah, S. Holmgren, K. E. Pelch, V. Walker, A. A. Rooney, M. Macleod, R. R. Shah, and K. Thayer. 2016. SWIFT-Review: A text-mining workbench for systematic review. Systematic Reviews 5:87. Howard, B. E., J. Phillips, A. Tandon, A. Maharana, R. Elmore, D. Mav, A. Sedykh, K. Thayer, B. A. Merrick, and V. Walker. 2020. SWIFT-Active Screener: Accelerated document screening through active learning and integrated recall estimation. Environment International 138:105623. IOM (Institute of Medicine). 2011. Finding What Works in Health Care: Standards for Systematic Reviews. Washington, DC: The National Academies Press. Jüni, P., A. Witschi, R. Bloch, and M. Egger. 1999. The hazards of scoring the quality of clinical trials for meta- analysis. Journal of the American Medical Association 282(11):1054–1060. Kase, R., M. Korkaric, I. Werner, and M. Ågerstrand. 2016. Criteria for Reporting and Evaluating ecotoxicity Data (CRED): Comparison and perception of the Klimisch and CRED methods for evaluating reliability and relevance of ecotoxicity studies. Environmental Sciences Europe 28(1):1–14. Klimisch, H.-J., M. Andreae, and U. Tillmann. 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regulatory Toxicology and Pharmacology 25(1):1–5. Koustas, E., J. Lam, P. Sutton, P. I. Johnson, D. S. Atchley, S. Sen, K. A. Robinson, D. A. Axelrad, and T. J. Woodruff. 2014. The Navigation Guide—evidence-based medicine meets environmental health: Systematic review of nonhuman evidence for PFOA effects on fetal growth. Environmental Health Perspectives 122(10):1015–1027. Krnic Martinic, M., D. Pieper, A. Glatt, and L. Puljak. 2019. Definition of a systematic review used in overviews of systematic reviews, meta-epidemiological studies and textbooks. BMC Medical Research Methodology 19(1):203. Levac, D., H. Colquhoun, and K. K. O’Brien. 2010. Scoping studies: Advancing the methodology. Implementation Science 5(1):69. 58 Prepublication Copy

References Moermond, C. T., R. Kase, M. Korkaric, and M. Ågerstrand. 2016. CRED: Criteria for Reporting and Evaluating ecotoxicity Data. Environmental Toxicology and Chemistry 35(5):1297–1309. Moher, D., A. Liberati, J. Tetzlaff, and D. G. Altman. 2009. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Medicine 6(7):e1000097. Morgan, R. L., K. A. Thayer, L. Bero, N. Bruce, Y. Falck-Ytter, D. Ghersi, G. Guyatt, C. Hooijmans, M. Langendam, and D. Mandrioli. 2016. GRADE: Assessing the quality of evidence in environmental and occupational health. Environment International 92:611–616. Morgan, R. L., P. Whaley, K. A. Thayer, and H. J. Schünemann. 2018. Identifying the PECO: A framework for formulating good questions to explore the association of environmental and other exposures with health outcomes. Environment International 121(Pt 1):1027–1031. NASEM (National Academies of Sciences, Engineering, and Medicine). 2017a. Using 21st Century Science to Improve Risk-Related Evaluations. Washington, DC: The National Academies Press. NASEM. 2017b. Application of Systematic Review Methods in an Overall Strategy for Evaluating Low-Dose Toxicity from Endocrine Active Chemicals. Washington, DC: The National Academies Press. NASEM. 2018. Progress Toward Transforming the Integrated Risk Information System (IRIS) Program. Washington, DC: The National Academies Press. NASEM. 2019. Review of DOD’s Approach to Deriving an Occupational Exposure Level for Trichloroethylene. Washington, DC: The National Academies Press. NRC (National Research Council). 2009. Science and Decisions: Advancing Risk Assessment. Washington, DC: The National Academies Press. NRC. 2010. Review of the Environmental Protection Agency’s Draft IRIS Assessment of Tetrachloroethylene. Washington, DC: The National Academies Press. NRC. 2011. Review of the Environmental Protection Agency’s Draft IRIS Assessment of Formaldehyde. Washington, DC: The National Academies Press. NRC. 2014. Review of EPA’s Integrated Risk Information System (IRIS) Process. Washington, DC: The National Academies Press. OHAT (Office of Health Assessment and Translation). 2019. Handbook for Conducting a Literature-Based Health Assessment Using OHAT Approach for Systematic Review and Evidence Integration. https://ntp.niehs.nih. gov/ntp/ohat/pubs/handbookmarch2019_508.pdf, accessed November 13, 2020. Pega, F., S. L. Norris, C. Backes, L. A. Bero, A. Descatha, D. Gagliardi, L. Godderis, T. Loney, A. Modenese, R. L. Morgan, D. Pachito, M. B. S. Paulo, P. T. J. Scheepers, V. Schlünssen, D. Sgargi, E. K. Silbergeld, K. Sørensen, P. Sutton, T. Tenkate, D. Torreão Corrêa da Silva, Y. Ujita, E. van Deventer, T. J. Woodruff, and D. Mandrioli. 2020. RoB-SPEO: A tool for assessing risk of bias in studies estimating the prevalence of exposure to occupational risk factors from the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury. Environment International 135:105039. doi:10.1016/j.envint.2019.105039. Peters, M. D., C. M. Godfrey, H. Khalil, P. McInerney, D. Parker, and C. B. Soares. 2015. Guidance for conducting systematic scoping reviews. International Journal of Evidence-based Healthcare 13(3):141–146. Posthuma, L., G. W. Suter II, and T. P. Traas. 2001. Species Sensitivity Distributions in Ecotoxicology. Boca Raton, FL. CRC press. https://doi.org/10.1201/9781420032314. Rooney, A. A., A. L. Boyles, M. S. Wolfe, J. R. Bucher, and K. A. Thayer. 2014. Systematic review and evidence integration for literature-based environmental health science assessments. Environmental Health Perspectives 122(7):711–718. Schaefer, H. R., and J. L. Myers. 2017. Guidelines for performing systematic reviews in the development of toxicity factors. Regulatory Toxicology and Pharmacology 91:124–141. Shea, B. J., B. C. Reeves, G. Wells, M. Thuku, C. Hamel, J. Moran, D. Moher, P. Tugwell, V. Welch, E. Kristjansson, and D. A. Henry. 2017. AMSTAR 2: A critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ 358:j4008. Singla, V.I., P.M. Sutton, and T.J., Woodruff. 2019. The Environmental Protection Agency Toxic Substances Control Act systematic review method may curtail science used to inform policies, with profound implications for public health. American Journal of Public Health 109(7):982–984. Stephens, M. L., K. Betts, N. B. Beck, V. Cogliano, K. Dickersin, S. Fitzpatrick, J. Freeman, G. Gray, T. Hartung, J. McPartland, A. A. Rooney, R. W. Scherer, D. Verloo, and S. Hoffmann. 2016. The emergence of systematic review in toxicology. Toxicological Sciences 152(1):10–16. Suter, G., J. Nichols, E. Lavoie, and S. Cormier. 2020. Systematic review and weight of evidence are integral to ecological and human health assessments: They need an integrated framework. Integrated Environmental Assessment and Management 16(5):718–728. Prepublication Copy 59

The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations Van der Mierden, S., K. Tsaioun, A. Bleich, and C. H. Leenaars. 2019. Software tools for literature screening in systematic reviews in biomedical research. Altex 36(3):508–517. Villeneuve, D. L., D. Crump, N. Garcia-Reyero, M. Hecker, T. H, Hutchinson, C. A. LaLone, B. Landesmann, T. Lettieri, S. Munn, M. Nepelska, and M. A. Ottinger. 2014a. Adverse outcome pathway (AOP) development I: Strategies and principles. Toxicological Sciences 142(2):312–320. Villeneuve, D. L., D. Crump, N. Garcia-Reyero, M. Hecker, T. H. Hutchinson, C. A. LaLone, B. Landesmann, T. Lettieri, S. Munn, M. Nepelska, and M. A. Ottinger. 2014b. Adverse outcome pathway development II: Best practices. Toxicological Sciences 142(2):321–330. Wang, Z., G. W. Walker, D. C. G. Muir, and K. Nagatani-Yoshida. 2020. Toward a global understanding of chemical pollution: A first comprehensive analysis of national and regional chemical inventories. Environmental Science & Technology 54(5):2575–2584. Whaley, P., C. Halsall, M. Ågerstrand, E. Aiassa, D. Benford, G. Bilotta, D. Coggon, C. Collins, C. Dempsey, R. Duarte-Davidson, R. FitzGerald, M. Galay-Burgos, D. Gee, S. Hoffmann, J. Lam, T. Lasserson, L. Levy, S. Lipworth, S. M. Ross, O. Martin, C. Meads, M. Meyer-Baron, J. Miller, C. Pease, A. Rooney, A. Sapiets, G. Stewart, and D. Taylor. 2016. Implementing systematic review techniques in chemical risk assessment: Challenges, opportunities and recommendations. Environment International 92-93:556–564. doi: 10.1016/j.envint.2015.11.002. Whaley, P., E. Aiassa, C. Beausoleil, A. Beronius, G. Bilotta, A. Boobis, R. de Vries, A. Hanberg, S. Hoffmann, N. Hunt, C. F. Kwiatkowski, J. Lam, S. Lipworth, O. Martin, N. Randall, L. Rhomberg, A. A. Rooney, H. J. Schunemann, D. Wikoff, T. Wolffe, and C. Halsall. 2020. Recommendations for the conduct of systematic reviews in toxicology and environmental health research (COSTER). Environment International 143:105926. Woodruff, T. J., and P. Sutton. 2014. The Navigation Guide systematic review methodology: A rigorous and transparent method for translating environmental health science into better health outcomes. Environmental Health Perspectives 122(10):1007–1014. 60 Prepublication Copy

Next: Appendix A: Biographical Information on the Members of the Committee to Review EPA's TSCA Systematic Review Guidance Document »
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Systematic review - a scientific investigation that focuses on a specific question and uses explicit, prespecified scientific methods to identify, select, assess, and summarize the findings of similar but separate studies - has become the foundation for assessing evidence to be used for decision making in a variety of health contexts, including health care and public health.

At the request of the Environmental Protection Agency (EPA), this publication reviews EPA's 2018 guidance document Application of Systematic Review in TSCA (Toxic Substances and Control Act) Risk Evaluations and associated materials to determine whether the process is comprehensive, workable, objective, and transparent.

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