Benson William H, Gallagher Kathryn, McClintock J Thomas
Office of the Science Advisor, U.S. Environmental Protection Agency, Washington, DC 20460, USA.
Environ Mol Mutagen. 2007 Jun;48(5):359-62. doi: 10.1002/em.20302.
Genomics is expected to have significant implications for risk assessment and regulatory decision making. Since 2002, the U.S. Environmental Protection Agency (EPA) has undertaken a number of cross-agency activities to further prepare itself to receive, interpret, and apply genomics information for risk assessment and regulatory purposes. These activities include: (1) the issuance of an Interim Genomics Policy on the use of genomics information in risk assessments and decision making, (2) the release of the 2004 Genomics White Paper, which outlines potential applications and implications of genomics for EPA, and (3) the recent release of the external review draft of the Interim Guidance on Microarray-Based Assays, which outlines data submission, quality, analysis, management, and training considerations for such data. This manuscript discusses these activities and more recent follow-up activities with the aim of further communicating these efforts to the broader scientific and stakeholder community.
基因组学预计将对风险评估和监管决策产生重大影响。自2002年以来，美国环境保护局（EPA）开展了多项跨部门活动，以便更好地接收、解读和应用基因组学信息用于风险评估和监管目的。这些活动包括：（1）发布关于在风险评估和决策中使用基因组学信息的《基因组学临时政策》；（2）发布2004年《基因组学白皮书》，概述基因组学对EPA的潜在应用和影响；（3）最近发布了基于微阵列分析的临时指南外部审查草案，其中概述了此类数据的数据提交、质量、分析、管理和培训方面的注意事项。本手稿讨论了这些活动以及最近的后续活动，目的是向更广泛的科学界和利益相关者群体进一步传达这些努力。
