- The supplemental notice expands what was already a sweeping proposed rule. The new provisions clarify that the rule now applies to all “influential science” at the agency (not just science used in regulatory efforts) and that it applies to all data and models (not just dose-response models).Many of the original concerns that we had still stand, including the disclosure of sensitive data, effect of restricting science, and how it gives the EPA administrator broad authority to permit or exclude the use of studies on a case-by-case basis.
- The rule expanded a provision that would give consideration to concentration-response models, applying not only to dose-response but all agency models. This expansion increases the proportion of EPA work where this rule would disrupt current processes to develop and implement models on environmental threats. Inclusion of such models beyond what is already in established epidemiologic and toxicologic literature and left to the scientific judgment of experts in and outside of the agency is not scientifically justified. The proposed rule exploits scientific uncertainties in ways that tend toward less protective standards.
- As an alternative to excluding all science based on data availability, the supplemental notice offers other options that are still flawed. Tiered access would be a huge time and resource burden on EPA and on scientists outside of the agency, which would mean less capacity for serving the public. Weighting options would unfairly downgrade legitimate science. Neither option will address the primary concern: This rule will restrict the science the agency can use because many important studies for EPA decisions rely on data that cannot legally or ethically be made public.
- Its focus on reanalysis opens up opportunities for industry stakeholders to recalculate data. The reason for making the data underlying influential scientific information and pivotal regulatory science available, according to the supplemental notice, is so that EPA can reanalyze studies using the original data to confirm the findings and show that they are “capable of being substantially reproduced.” By shifting the focus to reanalysis, the agency clarified that the underlying data must be made available so that interested stakeholders (i.e., regulated industry) may take the original data and modeling methods to confirm reproducibility and “assess potential analytical errors and variability in the underlying assumptions of the original analysis.” The goal of the rule is clearly not to increase transparency, but to introduce a new avenue for stakeholders with enough time and resources to recalculate study data to better meet desired outcomes.
- Changes to study evaluation will exclude key scientific studies for non-scientific reasons, which threatens important internal research and science-based regulations. EPA research on pressing issues could be affected, including:
- COVID-19 wastewater: EPA is currently working with CDC, FDA, and other agencies to help mitigate the threat posed by the COVID-19 pandemic. One area of promising research from more than a dozen research groups worldwide falls under EPA’s purview: how the testing of wastewater for the novel coronavirus can act as an evidence-based way to determine the total number of infections in a community. Researchers believe that this methodology could serve as a non-invasive, early-warning tool to alert communities to new COVID-19 infections and offer a community-level picture of how the disease has spread. However, an interagency public health measure based on this methodology will need to reference certain clinical studies to answer key questions, like how long people excrete the novel coronavirus and how much virus is being excreted at different stages of the disease. Because these clinical studies often contain confidential medical information, the publishing of these data, even in an anonymized form, risks re-identification of patients and exposing their confidential medical information.
- Wildfire research: A significant number of the studies that the California Air Resources Board supports are epidemiological/cohort studies that are likely to be precluded from U.S. EPA consideration as a result of this rule. Studies currently in progress are examining the impacts of wildfire smoke on lost work days and on respiratory symptoms. These studies would be critical to review as EPA attempts to understand the potential health impacts due to cumulative exposures from repeated, multi-day wildfire smoke exposures or multiple, consecutive fire seasons.
More than 8,200 wildfires have burned "well over" 4 million acres in California this year, killing 31 people and destroying 8,450-plus structures, Cal Fire confirmed todayhttps://t.co/FUzZT5cNo4
— Axios (@axios) October 4, 2020
- EPA’s own science will exclude the best evidence. We witnessed this happen in EPA’s chlorpyrifos revised human health risk assessment released last week, in which EPA’s concludes, “Despite several years of study, the science addressing neurodevelopmental effects remains unresolved.” This is a significant departure from its 2016 human health assessment which used neurodevelopmental effects as the critical effect and raised health alarms. The 2020 assessment chose not to use those studies because, “although EPA does not have a specific reason to believe that CCCEH have inappropriately handled the data or statistical analysis, it remains unable to verify the reported findings of the CCCEH papers. Moreover, EPA and interested stakeholders are unable to conduct alternative statistical analyses to evaluate the robustness and appropriateness of the approaches used by the investigators.” This is despite Columbia’s offer to share its data with EPA at a secure location. By not making that effort to review the data, it showed that the agency isn’t interested in reviewing the science—it is just searching for reasons to exclude it.
- While this rule has transparency in its name, it would not help EPA achieve its purported goal of openness of data or of the policy process. To the contrary, the proposal politicizes the process of relying on the best available science by using a non-scientific criterion — public availability of unanalyzed data — to determine the importance of scientific evidence.
- There is still no clarity on how the rule would be implemented and who would take on the time and resource-intensive burden that it would require. Placing the burden of making underlying data available in a tiered-access system would be an excessive amount of work unachievable for many, and this may make researchers wary of participating in policy-relevant research. This potential effect is antithetical to the stated goals of the proposed rule.
- EPA has failed to provide an analysis of economic impact of the rule, yet is considering it not to be economically significant despite its potential to touch all of its scientific and regulatory work. The administrative record for this rulemaking fails to address the types and number of studies that would be affected, the costs that the proposed rule would impose on the agency and individual researchers, and how the rule would impact the agency’s mission to protect public health and safety.
After 20 minutes, we were asked one question by an OMB representative: since the rule would apply to industry studies as well as other research, wouldn’t it be useful for the scientific community to have access to industry data?
Our response was that we are in favor of transparency applying to academia and industry, but not if the requirements limit EPA’s use of studies for which that level of transparency is not possible. Further, it is not clear that the rule as written in the supplement and original draft rule would even apply to industry in the same way as academic researchers, given broad administrator authority to decide when the rule applies, the original carve out for data that is commercially relevant, and the potential for industry to claim data as confidential business information at their discretion. In theory, industry data made public could be useful for research endeavors, but in this context where it is tied to rulemaking, it is neither useful nor feasible to release all underlying data from studies used in EPA decision-making. And given that companies decide what data and studies to make public and share, and may withhold data at their discretion, the utility of industry data in an independent research context is very limited.
The OMB should halt the advancement of this rule, which in no way, shape, or form promotes transparency at EPA and threatens EPA’s mission-critical work to protect our health and safety. There is still time to meet with OMB, as we did, and share your concerns. You can do so by going to this online scheduling form, entering the RIN for EPA’s rule which is 2080-AA14, providing your contact information, and finding a time that works for a thirty minute conference call.