In mid-November 2019 the NYTimes published an article based on a newly leaked proposed EPA policy that put forth three options of new rules on which EPA policies should be based – as well as greatly expanded the application of the proposed rule.

The EPA’s new proposed rule uses buzz words of transparency, replication, peer review process, and more to make it seems as if this policy is strengthening scientific inquiry. In reality, it would most likely result in the exclusion of relevant studies due to excessive data sharing requirements that would result in the violation of privacy and confidentiality in human subject studies. Rather than bettering science through increasing transparency, it would harm the scientific community by forcing scientists to either violate patients’ privacy or to not have their final studies usable by the EPA. This lack of scientific information also potentially harms the general public.

The leaked document greatly expands the applicability of the proposed rule to include all data and model underlying ‘pivotal regulatory science’ rather than just limiting to ‘dose-response data’ and ‘dose-response models’. As stated in the leaked policy, the EPA is proposing three data sharing models to support this regulation.

With three options for publicly available data/models, the first would exclude any studies without publicly available data/models. The first alternate option, the weighing option, would allow for the inclusion of studies that are unable to make their data/models publicly available as the basis of pivotal regulatory science, but the EPA could arbitrarily place less weight on said studies “to the point of entirely disregarding them.” This would greatly affect policymaking and result in the weakening or repealing of policies as this would apply to all studies regardless of when generated. As would the tiered access option, which would be a more reasonable option better balancing the issue of protecting privacy while also maintaining proper data sharing. See below  in the “changes in more recent, leaked document section” for details.

There are better methods, as set by Science and Nature, such that data sharing is enforced but for situations in which it is not fully possible, replication of studies is possible through confidential access for researchers.

Changes in more recent, leaked document

  • Apply to all data and models not just dose-response as originally stated
  • Use public availability of the data/models to determine if certain studies will be used
    • Whether computer code or data underlying a model is publicly available will be weighed with other factors to determine if the studies can be used as pivotal regulatory science
  • EPA shall clearly explain the scientific basis for each model assumption used and present analyses showing the sensitivity of the modeled results to alternative assumptions
  • Proposes a weighing option in which if underlying data/models are not publicly available EPA may consider a study as pivotal regulatory science if the other aspects of the data or model underlying the study were sufficiently robust but the EPA may assign a lower weight to the study’s evidence, findings, and conclusion
  • Tiered access option – Require tiered access to data & models with confidential business information (CBI), proprietary data, or Personally Identifiable Information that can’t be anonymized & require that all other data and models be made publicly available if to be used as pivotal regulatory science
    • For data/models not including CBI, proprietary info, or PII that can’t be anonymized, still require that all unrestricted data/models be publicly available.

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