On behalf of the Society for the Study of Evolution, the American Society of Naturalists, and the Society of Systematic Biologists (over 4600 members in total), we are writing to express significant concerns regarding the proposed EPA rule[1] [2] announced on April 24, 2018.

The proposed rule would mandate that research conducted by the EPA must be based on data that are publicly available. The rationale for the proposed revision is that it is 'intended to strengthen the transparency of EPA regulatory science' through ensuring 'that the data underlying those are publicly available in a manner sufficient for independent validation.' In effect, the proposed rule would severely limit the type of data able to be used by EPA scientists:  it would restrict them to use only data made publicly available by parties that may be affected about the outcome of EPA research, and it would restrict EPA scientists from using data that has proprietary information, patient confidentiality issues, or other ethical restrictions to the dissemination of confidential information.  In short, it could bias the data used by EPA scientists, preventing objective analysis and resulting policy recommendations.

We agree that data transparency strengthens the rigor of published scientific work. However, there are certain cases in which data cannot be made public, for example when they contain personal identifiers. In such cases, the proposed rule could unduly remove the use of otherwise appropriate data from scientific studies, significantly limiting the types of data used to inform decisions on public and environmental health.

The scientific community has a high standard of scientific rigor and has already instituted mechanisms to deal with cases in which not all data can be made public. Prior to publication, peer reviewers can sometimes have access to confidential information. Both before and after publication, work is evaluated by scientific peers on the appropriateness and clarity of the methods that were used, the analysis that was performed, and the logical interpretation of the results. Lastly, data are shared with specific researchers who seek to replicate or build upon the published work.

Decisions are best made when all evidence is considered. Peer reviewed evidence has passed a high level of rigor. Excluding studies because their associated data contain specific confidential details will make it more difficult for the EPA to act in the best interest of the public and the environment. We are deeply concerned that this rule will significantly bias the information that is used, resulting in poor policy decisions.

Sincerely,

Dr. Hopi Hoekstra; President, Society for the Study of Evolution
Dr. Sharon Strauss; President, American Society of Naturalists
Dr. Susana Magallón; President, Society of Systematic Biologists

[1] [3] U.S. Environmental Protection Agency, News Release (2018), “EPA Administrator Pruitt proposes rule to strengthen science used In EPA regulations”; www.epa.gov/newsreleases/epa-administrator-pruitt-proposes-rule-strengthen-science-used-epa-regulations [4].