Secret Science

Mask the participants, not the study.

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The US Environmental Protection Agency (EPA) is responsible for identifying air, soil and water pollutants which can be harmful to human health and safety, determining the exposure levels at which those pollutants become harmful to human health and establishing and administering regulations which limit the emissions of those pollutants to maintain safe exposure levels.

The control levels for each pollutant are established in many cases by analyzing studies of populations which have been exposed to the pollutant and have manifested adverse health effects. These studies are a sensitive issue because they involve the collection of data on individuals including family history, personal health history, personal habits, exposure frequency and duration, specific adverse impacts and their severity. This information is required to be secured by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to prevent uncontrolled and unnecessary access to protected health information.

These studies are frequently referred to as “secret science” because EPA has been unwilling to share access to more than the reported results of the studies. During the first Trump Administration, EPA issued the “secret science rule” which required scientists to disclose their raw data and confidential medical records for their results to be used in developing agency regulations. This rule was later vacated by a federal court.

This should not have been an issue since coding the medical records to protect the names of the study subjects would avoid the release of protected personal data while allowing access to the detailed information about the subject relative to the study objectives. Analysts assessing the validity of the study have no need for nor interest in the names of the study subjects. Alternatively, the analysts could be subjected to the same Non-Disclosure Agreements (NDAs) as the scientists who conducted the study and analyzed its results.

The primary concerns regarding secret science are the statistical validity of the studies’ conclusions and of the emissions limits established by EPA based on those conclusions. This is a particular concern because EPA tends to attempt to apply the concept of the Linear No Threshold hypothesis, which holds that any exposure greater than zero increases the risk of adverse effects, even in the case of low dose and limited exposure. This approach to regulation leads to very restrictive emissions limits which can result in very high compliance costs or the inability to comply.

This issue is of specific concern regarding climate science because the conclusions of numerous climate studies and numerous climate related health studies have been determined to be invalid or the reported adverse effects statistically insignificant because of improper study structure or scope and inaccurate or improper statistical analysis of the results. These issues have led to the issuance of overly restrictive regulations which have imposed unnecessary and excessive costs on affected industries.

This issue is of special concern regarding climate because the resulting regulations are based not on measured, statistically valid studies of actual effects, but rather on projections of potential future adverse effects based on the outputs of unverified and unvalidated climate models.

Originally published here.