Enhanced Scientific Leadership and Capacity in the US Environmental Protection Agency - Science For Environmental Protection: The Road Ahead - page 167

advisory committees, established under the Federal Advisory Committee Act,
provide scientific advice on such issues as environmental justice and children's
environmental health. A 2009 review of EPA's Office of Cooperative Environ-
mental Management found that although committees like NACEPT were useful
tools for the agency, there was a lack of coordination between other committees
and agency advisory boards, such as SAB and BOSC (EPA 2009c). External
advisory groups—including SAB, BOSC, and NACEPT—play an important
role in helping EPA to ensure the credibility and quality of its scientific studies
and science-based decisions. They will remain a valuable resource for the
agency assuming the members of these bodies continue to be chosen based on
the virtue of their expertise and experience and are appropriately tasked with
providing advice that falls within the purview of scientific experts.
Even when the underlying science meets the highest standards of quality
and integrity, judgment is used to select and weigh studies that will be used for
decision-making. EPA has developed various guidelines to weigh studies and
evaluate science, such as guidelines developed in response to sections 108 and
109 of the Clean Air Act. However, EPA has sometimes been criticized for its
failure to describe clearly its criteria and methods to identify, evaluate, and
weigh scientific studies. For example, National Research Council (NRC) reports
over the last decade have evaluated health assessments developed for EPA's
Integrated Risk Information System (IRIS) and indicated a need to improve
formal, evidence-based approaches to increase transparency and clarity for se-
lecting datasets for analysis, and to focus more on uncertainty and variability
(NRC 2005, 2006, 2010b).
Many of the above observations were reflected in the Review of the Envi-
ronmental Protection Agency's Draft IRIS Assessment of Formaldehyde (NRC
2011) . In its review, the authoring committee of that report noted a lack of clar-
ity and transparency in the methods used to assess the health effects of formal-
dehyde. Specifically, that committee found the assessment did not contain “suf-
ficient documentation on methods and criteria for identifying evidence from
epidemiologic and experimental studies, for critically evaluating individual stud-
ies, for assessing the weight of evidence, and for selecting studies for derivation
of the [reference concentrations] and unit risk estimates” (NRC 2011). The re-
port made several recommendations that were specific to improving the formal-
dehyde IRIS assessment, but also provided some suggestions for improving the
IRIS process.
Deficiencies in EPA's IRIS assessments have resulted in some critics cast-
ing doubt on the science used to support agency decisions. EPA is aware of
those stakeholder criticisms and of the problems identified by the NRC (2005,
2006, 2010b, 2011), and it has announced improvements in the IRIS assess-
ments that will be reviewed by the recently assembled NRC Committee to Re-
view the IRIS Process. This example illustrates the need for formal evidence-
based approaches that are clearly documented and well-reviewed; they can be
protective of EPA's science-informed policies.