PREPARATION OF THE REPORT ON CARCINOGENS

该合同的目的是为国家毒理学计划（NTP）的危害识别活动提供支持，这些活动旨在预防因环境暴露于化学或物理制剂而引起的疾病或不良影响。该合同的具体任务是协助编写《致癌物报告》和审查可能列入和从《致癌物报告》中除名的物质（即候选物质）所用的背景文件。RoC是国会授权的文件，列出了已知或合理预期为人类致癌物的试剂，物质，混合物或暴露情况（以下简称物质）。这是一个汇编，物质概况？，每一份都简要说明了特定物质的致癌性、接触情况和监管信息。2008年，康斯特拉集团提供了支持，以更新目前列于《第11次致癌物年度报告》（2004年）中的一些物质概况的信息，为《第12次致癌物年度报告》的出版做准备。大约有200个配置文件需要更新，因此这是一项持续的任务。 候选物质通过严格的审查程序进行评估，包括由不同科学委员会进行的连续审查。为响应最近颁布的管理和预算办公室同行审查准则，对《规则》的审查程序进行了修订，修订后的程序于2007年4月公布。根据修订后的审查程序，每份背景文件将由一个专家小组进行同行审查，该专家小组由国家结核病规划根据《联邦咨询委员会法》和卫生与公众服务部的指导方针和条例挑选的具有相关专长和知识的公共和私营部门的科学家组成。(The专家小组还建议将其列入《中华人民共和国清单》）。修改了合同的工作说明书，以支持NTP为召开专家小组会议提供行政支持。2008年，召开了三次专家小组会议，审查了5种候选物质。 背景文件是应用标准和就候选物质在《中华人民共和国规则》中的列入地位提出建议所使用的主要科学资源。它还可作为一种资源，用于编写《中华人民共和国规则》中公布的物质简介。候选物质的背景文件提供了以下方面的数据：（1）使用和生产，（2）暴露，包括来自环境来源、一般人群和工作场所的暴露，以及（3）来自公开的同行评审文献的人类流行病学、动物、遗传毒性和机理研究。背景文件由Constella集团、NTP员工或专家顾问撰写。在专家小组进行同行审查之前，对这些报告进行内部审查，并将其放在国家结核控制规划网站上征求公众意见（见http：//ntp.niehs.nih.gov/go/29679）。Constella为上述专家小组会议上经过同行审查的5份背景文件草案提供了支持。Constella还根据专家小组的同行审评意见，为最后确定5份背景文件提供了支持，这些文件已张贴在NTP网站上。 关键词肿瘤;危险识别;国会授权;（美国）国家毒理学计划;卫生与公众服务部;暴露;法规;人类癌症研究;动物癌症研究;遗传毒性;生物学机制

The goal of this contract is to provide support of National Toxicology Program (NTP) hazard identification activities targeted toward the prevention of diseases or adverse effects caused by environmental exposure to chemical or physical agents. The specific task of this contract is to procure assistance in preparing the Report on Carcinogens (RoC) and the background documents used in the review of substances under consideration for possible listing and delisting in the RoC (that is candidate substances). The RoC is a congressionally mandated document that lists agents, substances, mixtures or exposure circumstances (here-after referred to as substances) that are known or reasonably anticipated to be human carcinogens. It is a compilation of ¿substance profiles¿, each of which contains a brief description of the carcinogenicity, exposure and regulatory information for a specific substance, for all listed human carcinogens. In 2008, Constella Group provided support to update the information for some of the substance profiles that are currently listed in the 11th Annual Report on Carcinogens (2004) in preparation for the publication of the 12th Annual Report on Carcinogens. There are approximately 200 profiles that need to be updated, so this is an ongoing task. Candidate substances are evaluated by a rigorous review process, consisting of sequential reviews by distinct scientific committees. The review process for the RoC was revised in response to the recently enacted Office of Management and Budget peer review guidelines and the revised process was released in April 2007. Under the revised review process, each background document will be peer review by an expert panel composed of scientists from public and private sectors with relevant expertise and knowledge selected by the NTP in accordance with the Federal Advisory Committee Act and HHS guidelines and regulations. (The expert panel also makes a recommendation for listing in the RoC). The statement of work of the contract was modified to support NTP in providing administrative support for convening the expert panel meetings. In 2008, three expert panel meetings were convened reviewing 5 candidate substances. The background document is the primary scientific resource used for applying the criteria and making a recommendation on listing status of the candidate substance in the RoC. It also serves as a resource that can be used in preparing the substance profile published in the RoC. The background document for a candidate substance presents data on (1) use and production, (2) exposure including from environmental sources, within the general population and in the workplace, and (3) human epidemiology, animal, genotoxicity and mechanistic studies from the publicly available peer-reviewed literature. The background documents are written by Constella Group, NTP Staff or expert consultants. They are reviewed internally before they undergo peer review by the expert panels and are place on the NTP website for public comments (See (http://ntp.niehs.nih.gov/go/29679). Constella provided support for 5 draft background documents that were peer-reviewed in the expert panel meeting mentioned above. Constella also provided support for finalizing the 5 background documents based on the expert panel's peer-review comments, and the documents have been posted on the NTP website. Keywords cancer; hazard identification; congressional mandate; National Toxicology Program; Department of Health and Human Services; exposure; regulations; human cancer studies; animal cancer studies; genotoxicity; biological mechanisms