By: Lynne Dzubow, Clinical Fellow
The Emmett Environmental Law & Policy Clinic (EL&PC) submitted two sets of comments in August 2018 challenging the Environmental Protection Agency’s (EPA) proposed rule on scientific “transparency” in its decision-making. While transparency is a laudable goal, EPA’s rule would wrongly limit—not clarify or expand—the pool of scientific and medical knowledge available to the agency when issuing regulations to protect human health and the environment.
The Trump Administration has a troubling, topsy turvy relationship with the concept of transparency. On the one hand, it uses “transparency” as a pretext for preventing federal agencies from using the best available science to inform policy decisions. On the other hand, it tries to restrict access to government records, for example, through recently proposed Freedom of Information Act (FOIA) regulations.
Indicative of this trend, EPA issued a proposed rule entitled “Strengthening Transparency in Regulatory Science” in April 2018. The proposal requires that certain data and models be made “publicly available in a manner sufficient for independent validation,” and indicates that information will only satisfy this standard when “it includes the information necessary for the public to understand, assess, and replicate findings.”
By conflating public disclosure with the peer review process available and necessary to validate research, this requirement would deprive EPA of the data necessary to inform environmental health standards. Indeed, the proposal could have severe deregulatory effects by preventing EPA from using studies which rely on confidential medical data, older information that is not readily available, or evidence that was obtained from one-time events that cannot be replicated for moral or ethical reasons. Using the false crisis of “secret science” as a red herring, this proposed rule would not only threaten EPA’s mantle as one of the world’s leading environmental and human health research organizations, but would also place the agency in untenable legal jeopardy for most future regulatory actions.
Confidentiality of Private Health Information
As written, the proposal requires that the raw data establishing the scientific foundation for EPA’s regulations be made publicly available. However, as the Clinic’s comment letter representing the medical and research community points out, studies conducted on human research subjects are generally held to strict confidentiality standards. Under federal laws such as the Health Insurance Portability and Accountability Act (HIPAA) health care providers and associated research components are required to protect research subjects’ private health information. The Federal Policy for the Protection of Human Subjects, also known as the Common Rule, further requires federally-funded researchers to obtain Institutional Review Board (IRB) approval and informed consent of research subjects, during which process the researcher will typically need to make promises regarding confidentiality. Many academic institutions adopt the Common Rule as best practice for their research, even when it is not federally-funded.
These laws, along with customary research contracts and the Hippocratic Oath, form the basis of trust between a physician/researcher and her patient/subject. Requiring health study data to be made publicly available would have a chilling effect on the types of research necessary to inform standards on multiple environmental issues, from particulate matter in air to lead in drinking water.
For example, EPA’s 1997, 2006, and 2012 National Ambient Air Quality Standards (NAAQS) for fine particulate matter all relied on studies using confidential data, such as the 1993 Harvard Six Cities Study. Under the proposed “transparency” rule, such studies (and dozens of others) would be excluded from EPA’s regulatory process, likely skewing cost-benefit analyses and scientific conclusions to favor dangerously lax standards.
Best Available Science
The proposal not only conflicts with privacy laws, but also undermines the mandate Congress has imposed on EPA to use the “best available science” in developing regulations and standards. As an illustration, the Safe Drinking Water Act requires that EPA use “[t]he best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices,” and the Toxic Substances Control Act states that EPA “shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science.” While the precise terminology varies across statutes, a common theme of these requirements is that EPA use scientific information that is considered “best,” regardless of whether the underlying raw data is publicly “available.”
By preventing EPA from considering peer-reviewed studies whose underlying data is not publicly available, the proposal unlawfully restricts and undermines EPA’s regulatory process.
Preparing for Litigation
The Clinic’s comment letters representing both the scientific and legal communities demonstrate the multi-disciplinary outreach of the EL&PC and the important connection between science, law, and the environment.
EL&PC’s letter on behalf of the scientific and medical community was signed by nearly 100 people, including Harvard President Larry Bacow, the deans of Harvard Medical School (HMS) and the Harvard T.H. Chan School of Public Health, and the presidents of Massachusetts General Hospital (MGH), Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, and Massachusetts Eye and Ear.
The Clinic’s letter on behalf of itself and other environmental law clinics had 12 signatories, representing clinics from the Columbia University School of Law, University of Chicago Law School, and University of Colorado Law School, among others.
EPA has delayed the finalization of the “transparency” rule until 2020. The significant backlash against the proposal by public health, medical, academic, and scientific groups has seemingly given EPA pause. Should EPA, however, move forward with the rule, these comment letters will become an important part of the administrative record. By reaching out and forming a coalition between the medical and legal communities, EL&PC created a strong basis for challenging EPA’s justification for implementing the “transparency” rule in court.