By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 10, 2022, that registration is now open for the April 19-21, 2022, virtual meeting of the Science Advisory Committee on Chemicals (SACC). During the meeting, SACC will peer review the draft Toxic Substances Control Act (TSCA) Systematic Review Protocol. SACC’s virtual meeting is open to the public, and registration is required. EPA states that the draft Protocol, released in December 2021 for public comment, incorporates changes to address the recommendations from the National Academies of Sciences, Engineering, and Medicine (NASEM), as well as comments received from SACC and the public. According to EPA, the SACC review “will provide a transparent process to ensure that the protocol follows sound science and incorporates independent scientific advice and recommendations.” Stakeholders wishing to provide oral comments during the virtual meeting must register by 12:00 p.m. (EDT) on April 4, 2022. Stakeholders may register as listen-only attendees at any time until the end of the meeting on April 21, 2022. More information on the draft Protocol is available in our December 21, 2021, memorandum.

• Email This
• Print

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On January 11, 2022, the White House Office of Science and Technology Policy (OSTP) released the report of its Scientific Integrity Task Force on protecting the integrity of government science. According to OSTP, the scientific integrity principles and best practices identified in the report “aim to ensure that science is conducted, managed, communicated, and used in ways that preserve its accuracy and objectivity and protect it from suppression, manipulation, and inappropriate influence -- including political interference.” The report finds that:

• While violations of scientific integrity are small in number compared to the magnitude of the federal government’s scientific enterprise, they can significantly undermine federal decision-making and public trust in science;
• Existing federal scientific integrity policies are responsive to previous Executive actions but need to be strengthened to deter better inappropriate influence in the conduct, management, communication, and use of science; and
• Supporting scientific integrity requires attention to other policy areas, including greater transparency into research processes and outputs; clear guidelines for data and information that agencies release; and policies that promote safe, equitable workplaces free from harassment and discrimination.

OSTP notes that the Obama Administration identified six principles of scientific integrity in 2009. To not only restore, but to strengthen the integrity of federal science beyond the efforts of any previous Administration, the Task Force makes the following additional recommendations to guide policymaking and foster a culture of scientific integrity in federal agencies:

• All federal agencies -- not just those that fund and conduct scientific research -- should develop, implement, and periodically update scientific integrity policies. Protecting scientific integrity is essential for any federal agency or entity that communicates or makes use of scientific and technical information in decision-making;
• Scientific integrity policies should apply to all those in federal agencies who manage, communicate, or use science, not just to scientists and engineers who conduct research, and not just to career employees, but contractors and political appointees as well. All must be trained in scientific integrity and their roles in upholding it;
• Scientific integrity policies should be modernized to address important, emergent issues. They must advance diversity, equity, inclusion, and accessibility; address new concerns arising from the use of emerging technologies such as artificial intelligence and machine learning; and apply to emerging modes of science, such as citizen science and community-engaged research with federal involvement;
• There should be broader dissemination and adoption of good scientific integrity practices across the federal government, a task that could be facilitated by more formalized interagency collaboration; and
• There should be widespread training for agency scientists so they can communicate scientific findings effectively to nonscientists in their agencies and to lay audiences, with the idea of helping to ensure that policies and actions are based on an accurate understanding of the science.

OSTP states that in the coming months, it will draw upon the findings of the Task Force to develop a plan for the regular assessment and iterative improvement of scientific integrity policies and practices. In addition, agency leadership, working closely with OSTP, will deploy this framework to ensure that their scientific integrity policies are informed by the Task Force report and adhere to scientific integrity principles.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The White House Office of Science and Technology Policy (OSTP) announced on July 20, 2021, that it is organizing a series of three virtual listening sessions to hear about issues and concerns related to scientific integrity from members of the public who produce, communicate, and use scientific and technical information. 86 Fed. Reg. 38363. According to OSTP, it will use perspectives gathered during the virtual listening sessions to inform the assessment of federal agencies’ scientific-integrity policies and identification of best practices and lessons learned that the National Science and Technology Council’s Task Force on Scientific Integrity is preparing, pursuant to the January 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking.

Each of three listening sessions will be organized around a particular theme and audience:

• Session 1 (Wednesday, July 28, 2021, 2:00 p.m. to 4:00 p.m. (EDT)): Communications, including using effective policies and practices to improve the communication of scientific and technological information, including for engagement of federal scientists and contractors with news media and on social media. The target audience includes individuals from news media, science writers, and science communicators;
   
• Session 2 (Thursday, July 29, 2021, 11:00 a.m. to 1:00 p.m. (EDT)): Science and Education, including using effective policies and practices to support professional development of scientists and researchers of all genders, races, ethnicities, and backgrounds; to address scientific-integrity issues related to emerging technologies, such as artificial intelligence and machine learning, and evolving scientific practices, such as citizen science and community-engaged research; to improve training of scientific staff about scientific integrity; and to handle disagreements about scientific methods and conclusions. The target audience includes scientists, engineers, and educators from the federal and non-federal sectors; and
   
• Session 3 (Friday, July 30, 2021, 2:00 p.m. to 4:00 p.m. (EDT)): Use of Scientific and Technical Information, including using the effectiveness of federal scientific integrity policies to promote trust in federal science and address concerns about a lack of scientific integrity impeding the equitable delivery of the federal government’s programs. The target audience includes individuals who use federal scientific and technical information for decision-making or provision of services; individuals from disadvantaged communities; and other consumers of science.

Participants in all sessions may also comment on the predominant challenges they perceive to scientific integrity in federal agencies and effective practices for minimizing political or other inappropriate interference in the conduct, communication, or use of federal science. Speakers will have up to two minutes each to make a comment. As many speakers will be accommodated as the scheduled time allows. Individuals unable to attend the listening sessions or who would like to provide more detailed information may respond to the Request for Information (RFI) to Improve Federal Scientific Integrity Policies. Comments on the RFI are due July 28, 2021. The registration deadline for the virtual listening sessions is July 23, 2021, at 5:00 p.m. (EDT).

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On February 1, 2021, the U.S. District Court for the District of Montana granted the U.S. Environmental Protection Agency’s (EPA) January 31, 2021, unopposed motion to vacate and remand its January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” (86 Fed. Reg. 469).  EDF v. EPA, No. 4:21-cv-03-BMM.  On January 11, 2021, the Environmental Defense Fund (EDF), Montana Environmental Information Center (MEIC), and Citizens for Clean Energy (CCE) filed suit against EPA, claiming that the January 6, 2021, final rule was unlawful and that EPA’s decision to make the final rule effective on publication was unlawful.  On January 27, 2021, the court granted summary judgment to the plaintiffs, finding that EPA did not provide good cause to exempt the final rule from the Administrative Procedure Act’s (APA) 30-day notice requirement.  The court stated that “EPA’s decision to make the Final Rule immediately effective on publication was ‘arbitrary, capricious’ and ‘otherwise not in accordance with law.’”  In its January 31, 2021, motion, EPA states based on the court’s conclusion that the final rule constitutes a substantive rule and that EPA “lacked authorization to promulgate the rule pursuant to its housekeeping authority.”  According to EPA, where EPA lacked the authority to promulgate the final rule, “remand without vacatur would serve no useful purpose because EPA would not be able to cure that defect on remand.”  EPA notes that because the final rule was in effect for less than a month, and it had not applied the rule in any circumstance while the rule was in effect, “there would be no disruptive consequences in remanding and vacating the rule.”
 
Prior to EPA’s motion to vacate and remand the final rule, on January 20, 2021, President Joe Biden signed an Executive Order (EO) on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.  According to the EO, it is the policy of the Biden Administration “to listen to the science; to improve public health and protect our environment; to ensure access to clean air and water; to limit exposure to dangerous chemicals and pesticides; to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; to reduce greenhouse gas emissions; to bolster resilience to the impacts of climate change; to restore and expand our national treasures and monuments; and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals.”  The EO directs all executive departments and agencies to review immediately and, as appropriate and consistent with applicable law, take action to address the promulgation of federal regulations and other actions during the Trump Administration that conflict with the Biden Administration’s national objectives, and to commence work immediately to confront the climate crisis.  The EO calls for the heads of all agencies to review immediately “all existing regulations, orders, guidance documents, policies, and any other similar agency actions (agency actions) promulgated, issued, or adopted between January 20, 2017, and January 20, 2021, that are or may be inconsistent with, or present obstacles to,” the Biden Administration’s policy.  For any identified actions, the EO directs the heads of agencies to “consider suspending, revising, or rescinding the agency actions.”  In addition, for certain specified agency actions, the EO states that the head of the relevant agency “shall consider publishing for notice and comment a proposed rule suspending, revising, or rescinding the agency action within the time frame specified.”  The specified agency actions include EPA’s January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”
 
As reported in our January 11, 2021, memorandum, the origin of EPA’s January 6, 2021, final rule is rooted in legislative proposals more clearly intended to challenge important regulatory requirements, particularly related to EPA’s air program.  We predicted that the final rule would likely be among the first items subject to reversal or “clarifying” guidance making it consistent with previously established science policies (see Bergeson & Campbell, P.C.’s (B&C^®) Forecast 2021 memo).  With Democratic control of both houses of Congress, there might also be attempts to repeal the rule via action under the Congressional Review Act (CRA) of recently promulgated regulations.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On May 20, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled Further Efforts Needed to Uphold Scientific Integrity Policy at EPA.  OIG conducted an Agency-wide survey to determine whether EPA’s Scientific Integrity Policy is being implemented as intended to ensure scientific integrity throughout EPA.  OIG received 4,320 responses (a 23.5 percent response rate), showing that 3,987 respondents were aware of or had some familiarity with the Scientific Integrity Policy.  According to OIG, among those respondents with a basis to judge, the majority (56 percent; 1,025 of 1,842) were satisfied with the overall implementation of the Policy.  OIG states that the survey also revealed some concerns with specific aspects of scientific integrity at EPA, including dissatisfaction with EPA’s culture of scientific integrity (59 percent; 1,425 of 2,402) and the release of scientific information to the public (57 percent; 1,049 of 1,842).  OIG recommends that EPA’s deputy administrator lead an effort to examine the causes associated with the scientific integrity concerns identified in the survey and communicate the results to EPA employees, including planned actions to address the causes.  OIG also made 11 recommendations to the EPA science advisor, including developing procedures for addressing and resolving allegations of scientific integrity violations, communicating the outcomes of reports of scientific integrity violations, and improving the release of scientific information to the public.  OIG states that EPA agreed with its recommendations and provided acceptable corrective actions.  According to OIG, EPA has completed two recommendations, and the others are resolved with corrective actions pending.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On March 3, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule.  EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.”  The SNPRM:

• Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;
   
• Defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;
   
• Proposes a modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions, as well as an alternate approach; and
   
• Clarifies the ability of the Administrator to grant exemptions.

EPA published the SNPRM in the Federal Register on March 18, 2020.  85 Fed. Reg. 15396.  EPA states that it “is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.”  On April 2, 2020, EPA announced that it would extend the comment period to May 18, 2020.  EPA anticipates promulgating a final rule later in 2020.  More information is available in our March 9, 2020, memorandum, “EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science.”

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The House Science, Space, and Technology Subcommittee on Research and Technology will hold a hearing on “Benign by Design:  Innovations in Sustainable Chemistry” on July 25, 2019.  Witnesses will include:

• Dr. Tim Persons, Chief Scientist and Managing Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO);
   
• Dr. John Warner, President and Chief Technology Officer, Warner Babcock Institute for Green Chemistry;
   
• Dr. Julie Zimmerman, Professor and Senior Associate Dean, School of Forestry and Environmental Studiesa and Deputy Director, Center for Green Chemistry and Green Engineering, Yale University;
   
• Ms. Anne Kolton, Executive Vice President, Communications, Sustainability, and Market Outreach, American Chemistry Council; and
   
• Mr. Mitchell Toomey, Director of Sustainability, BASF in North America.

• Email This
• Print

By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

On May 25, 2018, the U.S. Environmental Protection Agency (EPA) extended until August 16, 2018, the comment period on its proposed rule titled “Strengthening Transparency in Regulatory Science.”  83 Fed. Reg. 24255.  EPA also announced that it will hold a public hearing on the controversial proposed rule on July 17, 2018.  The April 30, 2018, proposal (83 Fed. Reg. 18768) is intended to strengthen the transparency of EPA regulatory science.  The proposed regulation provides that for the science pivotal to EPA’s significant regulatory actions, EPA will ensure that the data and models underlying the science is publicly available in a manner sufficient for validation and analysis.  The rule has sparked controversy, as many stakeholders view it as an attempt by EPA to dilute science-based regulatory decisions.  Among other reasons for the extension is the request made of 20 Senators on May 15 seeking an extension of the comment period on the controversial proposal.  They joined various state Attorneys General, among others, in claiming the proposal had far-reaching implications and required far more than 30 days for comment.

More information about the proposed science rule is available in our memorandum EPA Releases Strengthening Transparency in Regulatory Science Proposed Rule.

• Email This
• Print

By Lynn L. Bergeson and Margaret R. Graham

On April 26, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt was grilled by Members of the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Environment at a hearing titled The Fiscal Year 2019 U.S. Environmental Protection Agency Budget.  The budget was plainly not the primary topic as the House Committee Members covered a lot of ground.  Pruitt fielded many questions and comments from House Democrats on his alleged ethical lapses regarding spending, security details, retaliation towards EPA employees who reportedly questioned his practices, and concerns about a hostile work environment.  Lawmakers from both sides of the aisle expressed concern over the installation of a secure phone booth in his office.  His opening statement addressed these criticisms only vaguely, stating that they are merely a distraction and an attempt to “attack and derail the President’s agenda and these administration’s priorities.”  There were also questions concerning the delay of the proposed rule banning the use of methylene chloride, and criticism regarding EPA’s recent proposed rule to strengthen transparency in regulatory science (the “secret” Science Rule). 

No attempt is made here to summarize the lengthy hearing.

Pruitt’s testimony statement is available here.  It does not contain information on the Science Rule, but it briefly references the implementation of the Toxic Substances Control Act (TSCA) in a section entitled “Ensuring the Safety of Chemicals in Commerce.”

More information on the many TSCA implementation initiatives is available on our TSCA Reform News & Information webpage, as well as the TSCAblog^TM.  A summary of Pruitt’s testimony before the Senate Committee on Environment and Public Works is available in our blog item “Pruitt Addresses Legacy Issues, TSCA Implementation in Oversight Hearing.” 

• Email This
• Print