Improving EPA’s Integrated Risk Information System (IRIS) and how to better accommodate diverse types of evidence to evaluate associations and causation were the focus of discussions before standing-room-only crowds at the Society for Risk Analysis (SRA) annual meeting in Baltimore earlier this month.
But it’s important not to overlook two other sessions that took place on the fundamental topics of data availability and peer review. Attention to each of these outstanding issues may help speed real, tangible progress on improving the quality and credibility of federal chemical risk assessments.
Data availability and transparency
Access to the underlying data that drives risk assessments is important to inform a robust, transparent scientific evaluation and discussion, as ACC’s Ann Mason made clear in a session on modernizing the tools to improve data availability and transparency. Fortunately, the session made clear that the future is bright for increased data access and availability, and that we can all look forward to some impressive improvements in 2014 and beyond.
Pamela Marks of Beveridge & Diamond then laid out all the existing tools (yes, mostly legal) that are available to help outside stakeholders access this information.
Associate Director of the NIH National Library of Medicine, Mike Huerta, described one promising path forward: implementing the White House Office of Science and Technology Policy (OSTP) Memorandum entitled “Increasing Access to the Results of Federally Funded Scientific Research” (Feb. 22, 2013). That memo asked for plans to increase wide access to results of research supported with federal funding, and its timing coincided with the launch of the NIH under the Big Data to Knowledge (BD2K) initiative. A major thrust of BD2K is to facilitate the broad use of biomedical research data.
To increase data availability, BD2K recommends that that data management and sharing plans be submitted and peer reviewed for all NIH-supported research (regardless of the size of the project, the funding mechanism or whether it is generated intramurally or extramurally). BD2K will make biomedical research data discoverable, citable, and linked to other relevant data sets, software tools, and the scientific literature through a catalog or index of information about data sets generated with NIH support. These efforts would not only improve access to research data, but will also allow the NIH and others to evaluate how the data are being used and how they might be used in the future.
The session closed with a talk from Pertti (Bert) Hakkinen, also at the National Library of Medicine, who shared an update on how users are now able to access multiple free toxicological databases not only on our computers, but also on our smartphones.
In other words, in the near future, access to underlying data might be greatly improved.
Government peer review
Making EPA and decision-making bodies more accessible to stakeholders and expertise outside the agency is an essential step to improving the objectivity and quality of chemical risk assessments, start to finish.
In a session on government peer review, Jamie Conrad of Conrad Law & Policy Counsel laid out the basic legal framework governing agency peer review, noting that the biggest disconnect is the completely different legal frameworks governing peer reviews managed by agencies and those managed by government contractors. He also discussed what review panels should work to avoid, more than anything, is conflict of interest. One conflict can call the integrity of the entire peer review process into question.
EPA’s Tom Brennan then updated attendees on current practices of the EPA Science Advisory Board (SAB), and a new EPA memo detailing procedures for contractor peer reviews for “influential” and “highly influential” scientific information. It’s important to note that EPA is taking important steps to increase the robustness of these reviews.
Rick Reiss of Exponent then drew an in-depth comparison between a government-run peer review process and a journal peer review. The differences were interesting, although not too surprising, given the different goals of each peer review. There seemed to be a consensus that each program comes with its own set of virtues and vices, and that stakeholders should work together to eliminate any flaws or discrepancies in each peer review process.
TERA’s Jacqueline Patterson then closed out the session with a review of best practices for peer review and mention of one particularly hot topic in risk assessment – whether agencies should institute a practice of independent evaluation regarding how the peer review recommendations are addressed in finalized documents.
Safe to say, we will be hearing much more about peer review in the coming months (Congress has recently weighed in with the introduction of legislative reforms), and the SRA presentations provided an informative background to get us all up to speed.
Addressing the issues discussed in these panels, and other panels, will be vital to creating a federal chemical risk assessment program that will help people like Dr. Michael Honeycutt make more informed decisions when it comes to protecting public health.