scholarly journals Carcinogenicity assessment: technical and political challenges

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
F Madia ◽  
A Worth ◽  
M Whelan ◽  
R Corvi

Abstract The rising rates of cancer incidence and prevalence identified by the WHO are of serious concern. The scientific advances of the past twenty years have helped to describe major properties of the cancer disease, enabling therapies that are more sophisticated. It has become clear that the management of relevant risk factors can also significantly reduce cancer occurrence worldwide. Public health policy actions cannot be decoupled from environmental policy actions, since exposure to chemicals through air, soil, water and food can contribute to cancer as well as other chronic diseases. Furthermore, due to the increasing global trend of chemical production including novel compounds, chemical exposure patterns are foreseen to change, posing high demands on chemical safety assessment, and creating potential protection gaps. The safety assessment of carcinogenicity needs to evolve to keep pace with changes in the chemical environment and cancer epidemiology. The presentation focusses on EC-JRC recommendations and future strategies for carcinogenicity safety assessment. This also includes discussion on how the traditional data streams of regulatory toxicology, together with new available assessment methods can inform, along with indicators of public health status based on biomonitoring and clinical data, a more holistic human-relevant and impactful approach to carcinogenicity assessment and overall prevention of cancer disease.

2021 ◽  
pp. 126438
Author(s):  
Luana de Morais e Silva ◽  
Vinicius M. Alves ◽  
Edilma R.B. Dantas ◽  
Luciana Scotti ◽  
Wilton Silva Lopes ◽  
...  

2014 ◽  
Vol 36 (3) ◽  
pp. 19-25 ◽  
Author(s):  
Fiona Reynolds ◽  
Carl Westmoreland ◽  
Julia Fentem

New informatics capabilities and computational and mathematical modelling techniques, used in combination with highly sensitive molecular biology and mechanistic chemistry approaches, are transforming the way in which we assess the safety of chemicals and products. In recent years, good progress has been made in replacing some of the animal tests required for regulatory purposes with methods using cells and tissues in vitro. Nevertheless, big scientific challenges remain in developing relevant non-animal models able to predict the effects of chemicals which are absorbed systemically. The greatest breakthroughs in non-animal approaches for chemical safety assessment will most likely result from continued multi-disciplinary research investment in predictive (integrative and systems) biology. Some of our current research in this area is described in the present article.


2014 ◽  
Vol 4 (7) ◽  
pp. 2-13 ◽  
Author(s):  
Jack Caravanos ◽  
Lina Hernandez Gutierrez ◽  
Bret Ericson ◽  
Richard Fuller

Background. Although toxic waste sites have been well investigated in many developed countries, their prevalence and health impact have not been well documented in low and middle income countries where risks attributable to environmental pollution are generally higher than in developed nations. Methods. We compared the burden of disease from toxic waste sites expressed in disability-adjusted life-years (DALYs) with the same measurement for other threats in India, Indonesia and the Philippines. We used Blacksmith Institute for a Pure Earth's DALY estimates for chemical exposure at 373 toxic waste sites in the 3 countries and World Health Organization (WHO) DALY estimates for different health conditions in the same countries. Results. Chromium VI causes the majority of DALYs among chemicals in India, while lead does so in the Philippines and Indonesia. In India, exposure to chromium VI showed higher DALY estimates than health conditions such as multiple sclerosis, Parkinson's disease and various cancers. In Indonesia, exposure to chromium VI and lead presented higher DALYs than conditions such as upper respiratory infections. In the Philippines, lead had higher DALYs than most of the examined conditions, including malaria and human immunodeficiency virus (HIV)/AIDS. Conclusions. This study highlights that the burden of disease expressed in DALYs from toxic waste sites may be greater than previously recognized and greater than other well addressed public health threats. We call attention to the need for surveillance of toxic waste sites, epidemiological analysis of the associations between exposure to toxic chemicals and outcomes, and remediation of chemical contamination in India, Indonesia and the Philippines.


2021 ◽  
Vol 12 (1) ◽  
pp. 181-202
Author(s):  
Yogi Hale Hendlin

Faced with the non-optional acceptance of toxic chemical artifacts, the ubiquitous interweaving of chemicals in our social fabric oft en exists out of sight and out of mind. Yet, for many, toxic exposures signal life-changing or life-ending events, phantom threats that fail to appear as such until they become too late to mitigate. Assessments of toxicological risk consist of what Sheila Jasanoff calls “sociotechnical imaginaries,” arbitrations between calculated costs and benefits, known risks and scientifically wrought justifications of safety. Prevalent financial conflicts of interest and the socially determined hazards posed by chemical exposure suggest that chemical safety assessments and regulations are a form of postnormal science. Focusing on the histories of risk assessments of pesticides such as DDT, atrazine, PFAS, and glyphosate, this article critically reviews Michel Serres’s notion of “appropriation by contamination.”


2019 ◽  
Author(s):  
Vy Kim Nguyen ◽  
Adam Kahana ◽  
Julien Heidt ◽  
Katelyn Polemi ◽  
Jacob Kvasnicka ◽  
...  

AbstractBackgroundStark racial disparities in disease incidence among American women remains a persistent public health challenge. These disparities likely result from complex interactions between genetic, social, lifestyle, and environmental risk factors. The influence of environmental risk factors, such as chemical exposure, however, may be substantial and is poorly understood.ObjectivesWe quantitatively evaluated chemical-exposure disparities by race/ethnicity and age in United States (US) women by using biomarker data for 143 chemicals from the National Health and Nutrition Examination Survey (NHANES) 1999-2014.MethodsWe applied a series of survey-weighted, generalized linear models using data from the entire NHANES women population and age-group stratified subpopulations. The outcome was chemical biomarker concentration and the main predictor was race/ethnicity with adjustment for age, socioeconomic status, smoking habits, and NHANES cycle.ResultsThe highest disparities across non-Hispanic Black, Mexican American, Other Hispanic, and other race/multiracial women were observed for pesticides and their metabolites, including 2,5-dichlorophenol, o,p’-DDE, beta-hexachlorocyclohexane, and 2,4-dichlorophenol, along with personal care and consumer product compounds. The latter included parabens, monoethyl phthalate, and several metals, such as mercury and arsenic. Moreover, for Mexican American, Other Hispanic, and non-Hispanic black women, there were several exposure disparities that persisted across age groups, such as higher 2,4- and 2,5-dichlorophenol concentrations. Exposure differences for methyl and propyl parabens, however, were the starkest between non-Hispanic black and non-Hispanic white children with average differences exceeding 4 folds.DiscussionsWe systematically evaluated differences in chemical exposures across women of various race/ethnic groups and across age groups. Our findings could help inform chemical prioritization in designing epidemiological and toxicological studies. In addition, they could help guide public health interventions to reduce environmental and health disparities across populations.


2018 ◽  
Vol 2 ◽  
pp. 239784731880604
Author(s):  
April Neal-Kluever ◽  
Queenster Nartey ◽  
Jason Aungst ◽  
Federica Basso ◽  
Karen Davis-Bruno ◽  
...  

The US Food and Drug Administration (FDA) Division of Food Contact Notifications (DFCN) performs infant lifestage-specific exposure and safety assessments during the premarket review of FCNs proposed for use with infant formula or human milk. DFCN previously identified two protocols that may be best suited to support infant safety: the multigenerational developmental and reproductive toxicology (Gen-DART) protocol and the juvenile animal study (JAS) protocol. The Gen-DART protocol tests chemical exposure from prior to mating through one or two generations in rodents, while JAS protocols test a chemical during a specific developmental window. At FDA, Gen-DART studies are currently recommended to support the safety of food additives (FAs), including food contact substances, across lifestages (from conception through adulthood). JAS protocols are recommended in the nonclinical safety assessment of drugs seeking pediatric indications. To improve our recommendations regarding the use of either Gen-DART or JAS protocols for the infant safety assessment of food contact materials, we created a database of FDA-reviewed Gen-DART or JAS. Our database contains information from 41 Gen-DART studies (38 FAs) and 51 JAS (29 drugs). Both protocols can detect toxicity relevant to infant safety assessment, such as developmental toxicity in neurological, endocrine, reproductive, immunological, or skeletal systems. Selection of either protocol will depend on the amount of information available for the chemical under study. The Gen-DART protocol may be preferred when limited data on the mode of action or target organ of the chemical are available. However, if these data are available, a JAS may provide the best assessment of potential juvenile toxicity.


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