EPA Releases Draft Updates to Its Scientific Integrity Policy for Public Comment

On January 24, 2024, the U.S. Environmental Protection Agency (EPA) began a 30-day public comment period on the draft updates to its Scientific Integrity Policy (Policy). 89 Fed. Reg. 4606. EPA states that in accordance with the requirements of the 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-based Policymaking, it is revising its Policy. The updated Policy will adopt a new federal definition of scientific integrity and “meaningfully strengthen several policy elements that will help ensure a culture of scientific integrity at the Agency.” EPA notes that it will incorporate the model scientific integrity policy from the National Science and Technology Council’s A Framework for Federal Scientific Integrity Policy and Practice (2023), lessons learned over the years, and the results of previous surveys of EPA staff on scientific integrity. Comments are due February 23, 2024.

The draft Policy defines scientific integrity as “the adherence to professional practices, ethical behavior, and the principles of honesty and objectivity when conducting, managing, using the results of, and communicating about science and scientific activities. Inclusivity, transparency, and protection from inappropriate influence are hallmarks of scientific integrity.” The draft Policy states that while the responsibility for upholding scientific integrity lies with all of EPA and other covered entities, EPA has designated a senior career employee as its Scientific Integrity Official (SIO) “to champion and promote scientific integrity throughout the Agency, and to oversee implementation and iterative improvement of scientific integrity policies and processes.” The SIO:

• Chairs a standing committee of Deputy SIOs (DSIO) representing each EPA office and region;

• Is empowered with the independence necessary to further a culture of scientific integrity;

• Gathers and protects information to support the review and evaluation of scientific integrity concerns;

• Supports the Scientific Integrity Committee, ensuring implementation of corrective actions to restore or strengthen scientific integrity and coordinating with appropriate Agency authorities to enforce corrective and administrative actions, including those that may prevent scientific integrity concerns; and

• In conjunction with the Chief Scientist, “the most senior career scientist in the Agency,” advocates for appropriate engagement of career scientists with relevant decision-making expertise.

The draft Policy introduces and clarifies roles and responsibilities, such as the new role of the EPA Chief Scientist, who:

• Is the Principal Deputy Assistant Administrator for the Office of Research and Development;

• In cooperation with the SIO and Scientific Integrity Committee, oversees the implementation and iterative improvement of policies and processes affecting the integrity of science funded, conducted, communicated, managed, or used by the Agency, as well as policies affecting federal and non-federal scientists who support the scientific activities of the Agency, including policies related to scientific integrity;

• Ensures Agency compliance with corrective scientific actions when violations of this policy are substantiated, and along with administrative actions for substantiated violations of scientific integrity policies, designates responsibility for each aspect of accountability. May seek assistance from the National Science and Technology Council Subcommittee on Scientific Integrity in cases of disagreement; and

• Provides science oversight and management of the Science and Technology Policy Council (STPC), including ensuring the consistency of its actions with the Policy.

According to EPA, the draft Policy updates will significantly strengthen several Policy elements (e.g., protecting scientific processes, reviewing science, ensuring the free flow of scientific information, supporting decision-making processes, and ensuring accountability) “that will help ensure a culture of scientific integrity at the Agency.” EPA will review and consider incorporating comments into or modifying the text of the final revised Policy. The final revised Policy will undergo internal EPA review and revision and be posted on EPA’s website.

Commentary

Bergeson & Campbell, P.C. (B&C^®) applauds EPA for updating its Scientific Integrity Policy. It is vital for EPA’s decisions to be based on the best available science and the weight of scientific evidence. Reaching that standard requires that EPA rely on quality science and collaborative disagreements. We note that many of the provisions in the draft Policy appear to have relevance with EPA’s decision-making under the Toxic Substances Control Act (TSCA). Below, we provide several representative examples of the interplay between the draft Policy and EPA’s activities under TSCA Section 6.

Under Section 1 “Protecting Scientific Processes,” the draft Policy states that “To protect the integrity of scientific processes, it is the policy of EPA to:”

Ensure the independent validation of scientific and laboratory methods and models and that all novel methods or models are appropriately peer reviewed prior to use. Appropriate instruction on the application of the methods or models and the peer review of these instructions should be developed and finalized before the method or model is used in Agency scientific products or decision making.

It is important that EPA not use past delays to telescope instances in which EPA is asking an advisory panel to review both the quality of a model and the application of that (unreviewed) model in a risk assessment. That conflicts with the mandate to “[e]nsure the independent validation of scientific and laboratory methods and models and that all novel methods or models are appropriately peer reviewed prior to use.”

Under Section 2 “Reviewing Science, Including the Use of Federal Advisory Committees,” the draft Policy states that “It is the policy of EPA to: Ensure EPA decisions are based on or informed by science that has completed independent peer review and has been finalized.” EPA has yet to publish in final a systematic review protocol, meaning that EPA is relying on its flawed 2018 systematic review policy (which the U.S. National Academies of Sciences, Engineering, and Medicine (NASEM) criticized as inadequate) or its draft protocol from 2021 that is not yet final. Either way, EPA has yet to complete its policy for evaluating what data are available and if those data are of sufficient quality to be used. Under these circumstances, EPA is in a difficult position of having to complete TSCA Section 6 reviews while it develops the very policies and procedures to which it must adhere to satisfy its legal obligations under TSCA. The simultaneity of these actions is troubling.

Also under Section 2, the draft Policy states that “It is the policy of EPA to: Ensure FAC [federal advisory committee] charge questions address all relevant scientific questions, including those raised in DSOs [differing scientific opinions], and are free from any interference, especially interference that may inappropriately limit the scope of the review.” By narrowing the scope of its charge questions, EPA can effectively avoid peer review of some aspects of its risk evaluation while simultaneously claiming that the product was peer reviewed. EPA must ensure that a FAC is properly charged to consider all outstanding questions. As an example, EPA published its final risk evaluation for 1,4-dioxane (1,4-DX) in 2020 concluding that 1,4-DX is a non-threshold carcinogen (is carcinogenic at any dose). Conversely, Health Canada (2021) and the European Chemicals Agency (2022) concluded that 1,4-DX is a threshold carcinogen (is only carcinogenic above a certain threshold dose and is non-carcinogenic below that dose). Despite the newer science and conclusions by related regulatory bodies, EPA did not charge the Science Advisory Committee on Chemicals (SACC) to review EPA’s classification of 1,4-DX as a non-threshold carcinogen. This strikes us as a key question for the SACC that reflects a difference in scientific opinion that went unexamined. It may be that EPA is correct and Canadian and European competent authorities are wrong, but by not asking the SACC to review EPA’s current view, EPA undermines the scientific integrity of its assessment.

Under Section 4 “Supporting Decision Making Processes,” the draft Policy states that “It is the policy of EPA to: [Ensure] that science-based decisions are informed by the best available science.” A representative example on this point is EPA’s activities on trichloroethylene (TCE) under TSCA Section 6. We mention TCE because EPA, under the Trump-Pence Administration, stated in the 2020 Risk Evaluation for Trichloroethylene (the 2020 TCE RE) that “[A]cute immunosuppression and chronic autoimmunity were the best overall non-cancer endpoints for use in Risk Evaluation under TSCA, based on the best available science and weight of the scientific evidence…[emphasis added].” On January 9, 2023, EPA released a final revision to the risk determination for the 2020 TCE RE. In that announcement, EPA, under the Biden-Harris Administration, stated it “views the peer reviewed hazard and exposure assessments and associated risk characterization [in the 2020 TCE RE] as robust and upholding the standards of best available science and weight of the scientific evidence per TSCA sections 26(h) and (i) [emphasis added].” Yet, EPA issued a statement on January 9, 2023, that it will develop “existing chemical exposure limits (ECEL) [for TCE] based on both the immune endpoint [i.e., the best available science] and the CHD endpoint [i.e., fetal cardiac defects; not the best available science] in support of risk management.” EPA elevating the CHD endpoint in its risk management rule despite EPA rating it as not the best available science gives the appearance that EPA is intending on using the weaker scientific study to justify its sweeping ban on TCE in conflict with the draft Policy’s provisions on implementing “scientific products and activities independent of any pre-determined desired outcome.”

Section 4 of the draft Policy also states that “It is the policy of EPA to: Use transparent criteria in instances where a statute gives the Agency discretion in weighing scientific information in its actions and make the criteria publicly available.” We note that TSCA Section 26 requires the Agency to use the best available science and weight of scientific evidence in its decision-making. The statutory language does not define these terms, which gives the Agency discretion to interpret them as EPA did when it codified definitions for these terms under 40 C.F.R. Section 702.33. EPA has, however, proposed to eliminate these definitions, as part of its proposed amendments to the “Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA).” This proposal seems to conflict with the draft Scientific Integrity Policy.

Under Section 6 “Protections for Employees,” the draft Policy states that “Not all differing scientific opinions [DSOs] or reports of allegations are covered disclosures [under the Whistleblower Protection Act of 1989 and the Whistleblower Protection Enhancement Act of 2012].” EPA’s draft Policy goes on to state that “It is the policy of EPA to: Protect individuals who in good faith report allegations…[emphasis added]” and “Prohibit the inclusion of good faith employee expression of DSOs as negative behavior in performance appraisals [emphasis added].” This is a critical emphasis because allegations of scientific integrity violations that are not made in good faith can be weaponized and used to bully or retaliate against subordinates, fellow employees, supervisors, or managers. Scientists must be free to disagree. Good faith DSOs should be resolved not by disciplinary action or grievances but by scientific rigor.

We encourage readers to review EPA’s draft Policy and associated support documents, such as EPA’s “Approaches for Expressing and Resolving Differing Scientific Opinions.” The draft Policy states that “Scientific integrity is the responsibility of the entire EPA workforce.” We note, however, that members of the public also have a role to play with ensuring scientific integrity. For example, EPA’s process for “Reporting an Allegation of a Loss of Scientific Integrity” is available to individuals (entities) that are internal or external to the Agency. As discussed herein, the draft Policy when issued in final will apply to EPA’s decisions under TSCA and the other statutes that EPA administers. Given the central importance of scientific integrity in all that EPA does, we encourage interested parties to provide comments on EPA’s draft Policy.