Prichystalova Radka, Fini Jean-Baptiste, Trasande Leonardo, Bellanger Martine, Demeneix Barbara, Maxim Laura
Institut des Sciences de la Communication (UMS 3665), CNRS (Centre National de la Recherche Scientifique)/Université Paris Sorbonne/UPMC (Université Pierre et Marie Curie), 20 rue Berbier du Mets, 75013, Paris, France.
Sorbonne Universités, CNRS UMR 7221, RDDM, Muséum d'Histoire Naturelle, F-75005, Paris, France.
Environ Health. 2017 Jun 9;16(1):55. doi: 10.1186/s12940-017-0265-x.
Socioeconomic analysis is currently used in the Europe Union as part of the regulatory process in Regulation Registration, Evaluation and Authorisation of Chemicals (REACH), with the aim of assessing and managing risks from dangerous chemicals. The political impact of the socio-economic analysis is potentially high in the authorisation and restriction procedures, however, current socio-economic analysis dossiers submitted under REACH are very heterogeneous in terms of methodology used and quality. Furthermore, the economic literature is not very helpful for regulatory purposes, as most published calculations of health costs associated with chemical exposures use epidemiological studies as input data, but such studies are rarely available for most substances. The quasi-totality of the data used in the REACH dossiers comes from toxicological studies.
This paper assesses the use of the integrated probabilistic risk assessment, based on toxicological data, for the calculation of health costs associated with endocrine disrupting effects of triclosan. The results are compared with those obtained using the population attributable fraction, based on epidemiological data.
The results based on the integrated probabilistic risk assessment indicated that 4894 men could have reproductive deficits based on the decreased vas deferens weights observed in rats, 0 cases of changed T levels, and 0 cases of girls with early pubertal development. The results obtained with the Population Attributable Fraction method showed 7,199,228 cases of obesity per year, 281,923 girls per year with early pubertal development and 88,957 to 303,759 cases per year with increased total T hormone levels. The economic costs associated with increased BMI due to TCS exposure could be calculated. Direct health costs were estimated at €5.8 billion per year.
The two methods give very different results for the same effects. The choice of a toxicological-based or an epidemiological-based method in the socio-economic analysis will therefore significantly impact the estimated health costs and consequently the political risk management decision. Additional work should be done for understanding the reasons of these significant differences.
社会经济分析目前在欧盟被用作《化学品注册、评估、授权和限制法规》(REACH)监管程序的一部分,目的是评估和管理危险化学品带来的风险。社会经济分析在授权和限制程序中的政治影响可能很大,然而,目前根据REACH提交的社会经济分析档案在使用的方法和质量方面非常参差不齐。此外,经济文献对监管目的帮助不大,因为大多数已发表的与化学物质暴露相关的健康成本计算使用流行病学研究作为输入数据,但对于大多数物质来说,此类研究很少可得。REACH档案中使用的数据几乎全部来自毒理学研究。
本文评估基于毒理学数据的综合概率风险评估用于计算与三氯生内分泌干扰效应相关的健康成本的情况。将结果与使用基于流行病学数据的人群归因分数法获得的结果进行比较。
基于综合概率风险评估的结果表明,基于在大鼠中观察到的输精管重量下降,4894名男性可能出现生殖缺陷,睾酮水平改变的病例为0例,青春期早熟女孩的病例为0例。使用人群归因分数法获得的结果显示,每年有7199228例肥胖病例,每年有281923名青春期早熟女孩,每年有88957至303759例总睾酮激素水平升高的病例。可以计算出因接触三氯生导致体重指数增加相关的经济成本。直接健康成本估计为每年58亿欧元。
对于相同的影响,这两种方法给出的结果截然不同。因此,在社会经济分析中选择基于毒理学的方法还是基于流行病学的方法将对估计的健康成本产生重大影响,进而影响政治风险管理决策。应该开展更多工作来理解这些显著差异的原因。