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One way in which the National Institute of Environmental Health Sciences (NIEHS) National Toxicology Program (NTP) could demonstrate its commitment to transparency is by seeking public comment on its guidance documents prior to finalizing and implementing them. Not only would this help NTP to develop a robust approach, but it would also allow outside experts, all with diverse backgrounds and perspectives, to contribute what they have learned over the course of decades of experience.
When the National Research Council (NRC) conducted their review of the Integrated Risk Information System (IRIS) in 2014, they stressed the importance of ensuring broad and diverse stakeholder engagement in the IRIS process. There is no reason for the NTP program to be held to different standards, especially when developing new approaches that are relevant to multiple agencies and stakeholders.
With the publication earlier this summer of its new “Handbook for Preparing Report on Carcinogens Monographs,” NTP missed a valuable opportunity to increase confidence in the program’s accountability to the public and ensure its approaches and conclusions are based on the best available methodologies and information.
What the Handbook is and why it matters
The Handbook provides guidance and instructions for developing the Report on Carcinogens (RoC)—specifically, preparing monographs (focused evaluations) for substances the NTP considers for listing in the RoC. The monographs are the product of a literature-based review and evaluation. The Handbook is designed to provide a clear and formal process for NTP to follow in creating the RoC.
The Handbook is important because many stakeholders see the RoC as an authoritative body on the state of the science for a particular chemical or substance. RoC listings inform decisions by outside groups, including states and other federal agencies, to help manage the safety of certain chemicals and whether they should be present in products.
While NTP has always described its process for conducting literature reviews, the Handbook is essentially the first of its kind. It describes the actual approach for conducting a scientific evaluation for the RoC and includes sections on identifying and selecting studies, extracting data from studies, and evaluating the quality and utility of individual studies. It essentially spells out a process for NTP to follow that will determine the fate of a specific chemistry.
Although ACC views the current version of the Handbook as a needed addition to the NTP chemical review process, the guidance is not as strong as it should be—or as it could have been, if NIEHS had allowed other experts to offer their feedback first.
Below, there are three areas where NTP delivered improvements with its Handbook and seven significant and impactful areas where it could have delivered more improvements had it taken full advantage of the vast expertise outside of NTP.
What the Handbook delivers
What the Handbook missed
There is no doubt that NTP’s previous “black box” approach for developing the RoC needed to be changed, and the creation of its Handbook is a step in the right direction. However, it would be premature to view it as complete. It should be treated as a work in progress that could greatly benefit by incorporating review and comments from additional experts.
There is broad recognition in the NRC comments and elsewhere of the value of public input and dialogue, and so we strongly encourage NIEHS and other federal agencies that are developing and incorporating systematic review practices into their chemical specific evaluations to ensure that “handbooks,” “guidance documents,” and other important tools benefit from stakeholder input and dialogue.
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