Practical Risk Assessment and Management Issues Arising were we to Adopt Low-Dose Linearity for all Endpoints

Rhomberg, Lorenz R.
April 2011
Dose-Response;2011, Vol. 9 Issue 2, p144
Academic Journal
The 2009 National Research Council report, Science and Decisions, proposes harmonizing dose-response approaches for cancer and non-cancer endpoints, and for non-cancer quantitative risk assessment, this would usually take the form of a low-dose linear nothreshold dose-response curve. The soundness of this recommendation has been questioned, but I focus on its consequences if adopted, many of them apparently unintended. If most endpoints for most agents are assumed to have non-zero low-dose risks, then the critical-effect concept, choosing the one endpoint on which to calculate acceptable doses, loses its basis. All regulatory decisions, since they entail substituting some exposures (and their attendant risks) for others, become risk-risk trade-off decisions, and equity questions are raised since risk transfer is inevitably involved. A valid basis for estimating low-dose linear components is not evident, and upper-bound approaches fail to be reliably public health-protective owing to the risk trade-off decisions that need to be faced.


Related Articles

  • Science and Decisions: Advancing Toxicology to Advance Risk Assessment. Rodricks, Joseph V.; Levy, Jonathan I. // Toxicological Sciences;Jan2013, Vol. 131 Issue 1, p1 

    In 2009, the National Research Council (NRC) released the latest in a series of advisory reports on human health risk assessment, titled Science and Decisions: Advancing Risk Assessment. This wide-ranging report made a number of recommendations related to risk assessment practice at the U.S....

  • Risk Characterization: A Bridge to Informed Decision Making1. Ohanian, Edward V.; Moore, John A.; Fowle, John R.; Omenn, Gilbert S.; Lewis, Steven C.; Gray, George M.; North, D. Warner // Fundamental & Applied Toxicology;1997, Vol. 39 Issue 2, p81 

    Regulatory decisions should be made in the most expert and informed way since they are precipitated by real and perceived threats to human health, under the glare of public scrutiny. In 1994, the National Research Council (NRC) reported that the U.S. Environmental Protection Agency's (USEPA's)...

  • Dose-Response Modeling of Etoposide-Induced DNA Damage Response. Li, Zhenhong; Sun, Bin; Clewell, Rebecca A.; Adeleye, Yeyejide; Andersen, Melvin E.; Zhang, Qiang // Toxicological Sciences;Feb2014, Vol. 137 Issue 2, p371 

    The 2007 National Research Council Report “Toxicity Testing in the 21st Century: A Vision and A Strategy” recommended an integrated, toxicity pathway–oriented approach for chemical testing. As an integral component of the recommendation, computational dose-response modeling of...

  • Testing the Dose-Response Specification in Epidemiology: Public Health and Policy Consequences for Lead. Rothenberg, Stephen J.; Rothenberg, Jesse C. // Environmental Health Perspectives;Sep2005, Vol. 113 Issue 9, p1190 

    Statistical evaluation of the dose-response function in lead epidemiology is rarely attempted. Economic evaluation of health benefits of lead reduction usually assumes a linear dose-response function, regardless of the outcome measure used. We reanalyzed a previously published study, an...

  • Dose-Response Analyses of the Carcinogenic Effects of Trichloroethylene in Experimental Animals. Rhomberg, Lorenz R. // Environmental Health Perspectives Supplements;May2000 Supplement 2, Vol. 108, p343 

    Discusses approaches to dose-response analysis of the low-dose potency of trichloroethylene (TCE) in humans. How TCE causes liver, lung and kidney tumors in mice; Methods for carcinogen risk assessment from the United States Environmental Protection Agency (EPA); Human potency projects under...

  • Life-Span Exposure to Low Doses of Aspartame Beginning during Prenatal Life Increases Cancer Effects in Rats. Soffritti, Morando; Belpoggi, Fiorella; Tibaldi, Eva; Esposti, Davide Degli; Lauriola, Michelina // Environmental Health Perspectives;Sep2007, Vol. 115 Issue 9, p1293 

    BACKGROUND: In a previous study conducted at the Cesare Mahoni Cancer Research Center of the European Ramazzini Foundation (CMCRC/ERF), we demonstrated for the first time that aspartame (APM) is a multipotent carcinogenic agent when various doses are administered with feed to Sprague-Dawley rats...

  • A Weight-of-Evidence Analysis of the Cancer Dose-Response Characteristics of 2,3,7,8-Tetrachlorodibenzodioxin (TCDD). Popp, James A.; Crouch, Edmund; McConnell, Ernest E. // Toxicological Sciences;Feb2006, Vol. 89 Issue 2, p361 

    Cancer risk assessment for TCDD and other compounds must focus on the cancer dose-response relationship and corresponding potency for the range of human doses before it can have relevance to the human exposure environment. Major differences of opinion exist over whether the dose-response curve...

  • Occupational cancer in Britain. Chen, Yiqun; Osman, John // British Journal of Cancer;6/19/2012 Supplement, Vol. 107, pS104 

    Although only a relatively small proportion of cancer is attributable to occupational exposure to carcinogenic agents, the estimated number of deaths due to occupational cancer is high when compared to other deaths due to work-related ill health and injury. However, risk from occupational...

  • Tea consumption and the risk of five major cancers: a dose--response meta-analysis of prospective studies. Feifei Yu; Zhichao Jin; Hong Jiang; Chun Xiang; Jianyuan Tang; Tuo Li; Jia He // BMC Cancer;2014, Vol. 14 Issue 1, p1 

    Background: We conducted a dose--response meta-analysis of prospective studies to summarize evidence of the association between tea consumption and the risk of breast, colorectal, liver, prostate, and stomach cancer. Methods: We searched PubMed and two other databases. Prospective studies that...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics