title: Difficulties in establishing regulations for engineered nanomaterials and considerations for policy makers: avoiding an unbalance between benefits and risks.
abstract: Current evidence of engineered nanomaterials' (ENM) toxicity has led to a latent concern about hazards for both humans and the environment. For this reason, some efforts have been made to suggest frameworks or other guidance to regulate ENM handling; however, the real exposure risk to humans has not been well established. The aims of this work were to analyze the difficulties in establishing regulations for ENM and to discuss some considerations that may be helpful for policy makers involved in the regulation of ENM. Difficulties in establishing regulations are based on the novel properties of ENM associated with cytotoxic effects, the insufficiency of standardized methods to test those effects and the lack of epidemiological evidence of ENM toxicity, especially in occupational settings. Nevertheless, we offer some suggestions for establishing regulations, which include frameworks oriented towards protecting personnel exposed to ENM without decreasing production. In addition, we propose an ENM data sheet to offer available information of ENM. Finally, ethical aspects should also be considered in developing ENM regulations because every person who is working around or consuming ENM has the right to be informed about the potential risk.
authors.affiliation: Unidad de Biomedicina, Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México, CP 54090, Estado de México, México.
authors.forename: Luis Guillermo
authors.initials: LG
authors.lastname: Garduño-Balderas
authors.affiliation: Unidad de Biomedicina, Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México, CP 54090, Estado de México, México.|Programa de Posgrado en Ciencias Biomédicas, Universidad Nacional Autónoma de México.
authors.forename: Ismael Manuel
authors.initials: IM
authors.lastname: Urrutia-Ortega
authors.affiliation: Unidad de Biomedicina, Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México, CP 54090, Estado de México, México.|Programa de Posgrado en Ciencias Biomédicas, Universidad Nacional Autónoma de México.
authors.forename: Estefany Ingrid
authors.initials: EI
authors.lastname: Medina-Reyes
authors.affiliation: Unidad de Biomedicina, Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México, CP 54090, Estado de México, México.
authors.forename: Yolanda Irasema
authors.initials: YI
authors.lastname: Chirino
mesh_terms: D002470:Cell Survival / Q000187:drug effects; D004781:Environmental Exposure / Q000009:adverse effects / Q000331:legislation & jurisprudence; D015340:Epidemiologic Research Design; D006801:Humans; D007878:Legislation as Topic / Q000639:trends*; D049329:Nanostructures; D016273:Occupational Exposure / Q000009:adverse effects / Q000331:legislation & jurisprudence / Q000517:prevention & control; D011640:Public Policy; D012306:Risk; D018570:Risk Assessment
keywords: engineered nanomaterials; ethical considerations; regulations; standardized methods; technical ENM data sheet