By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On May 27, 2022, EPA announced that it is seeking nominations for technical experts to serve as Special Government Employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity. The deadline to submit nominations is June 30, 2022, and submissions should be made via the BOSC website. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in Bergeson & Campbell, P.C.’s (B&C®) March 14, 2022, memorandum.
By Lynn L. Bergeson
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 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.
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On January 6, 2021, EPA issued in final its rule titled “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” The rule establishes how EPA will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information. Under this rule, EPA will give greater consideration to studies where underlying dose-response data are available with sufficient independent validation. The rule also requires EPA to identify and make publicly available the science that serves as a basis for its regulatory decisions and actions at the draft stage to the extent practicable. Peer review required for pivotal science and criteria for the EPA Administrator to exempt certain studies from the rulemaking requirements are also part of the final rule. The rule became effective on January 6, 2021.
By Lynn L. Bergeson
DOE has announced that the Biological and Environmental Research Advisory Committee (BERAC) will host digital public meetings on October 22 and 23, 2020, from 12:30 to 4:30 p.m. (EDT). BERAC provides advice to DOE’s Director of the Office of Science on scientific and technical issues that arise in the development and implementation of the Biological and Environmental Research Program. Tentative agenda topics published in the Federal Register notice include:
- BERAC business and discussion;
- News from the Office of Biological and Environmental Research;
- News from the Biological Systems Science and Earth and Environmental Systems Science Divisions.
Oral comments will be permitted during the meetings, and written statements can be submitted prior to or after the meetings. Those interested in making oral statements regarding any agenda items must request so via e-mail at least five business days prior to the meeting.
By Lynn L. Bergeson
On March 3, 2020, 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.”
Bergeson & Campbell, P.C. (B&C®) is a proud sponsor of the Environmental Law Institute’s (ELI) GreenTech Conference, bringing together leaders from some of the world’s most innovative companies to engage with policymakers, lawmakers, technologists, and non-governmental organizations (NGO) to explore environmental protection in an era of transformative technological change. Dr. Andrey J. Zarur, CEO and President of GreenLight Biosciences, will discuss using targeted biocontrol of RNA interference to increase yields during the Food for the Future panel on October 2, 2019. Join B&C, ELI, Intel, Amazon, and Google, among others, in Seattle, Washington, from October 2-3, 2019, for this exciting conference.
On October 12, 2016, EPA convened a public advisory committee teleconference of the Biogenic Carbon Emissions Panel. This advisory meeting discussed comments from chartered Science Advisory Board (SAB) members from the draft report on EPA’s Framework for Assessing Biogenic CO2 Emissions from Stationary Sources. The SAB panel announced plans to overhaul the current draft report to provide emission examples at various time scales. This change, to include longer time spans, is supported by industry professionals who believe it better represents the full carbon sequestration benefits created through regrowth of biomass. Inside EPA (subscription required) quoted the Environmental Defense Fund’s Steven Hamburg, noting that the SAB should “make clear the implications of picking different time horizons, as opposed to a priori picking a time horizon.” There is not yet a schedule for when the next draft report will be released for review by the full SAB.
On June 15, 2016, the California Department of Toxic Substances Control (DTSC) announced three new members of the Green Ribbon Science Panel (GRSP). The new members are Jack Linard, Ph.D., Personal Care Regulatory Affairs Team for Unilever North America; Elaine Cohen Hubal, Ph.D., Deputy National Program Director for EPA's Chemical Safety for Sustainability (CSS) Research Program; and Mark Nicas, Ph.D., MPH, CIH, Associate Adjunct Professor Emeritus for the University of California, Berkeley. The new members will work with existing panel members to advise DTSC on Safer Consumer Products (SCP) regulations implementation. GRSP will also provide input and advice on other discussion topics, including the Department's Alternative Analysis Guide, and the implementation of the 2015-2017 Priority Products Work Plan.
As a follow-up to last week's item concerning Bergeson &
Campbell, P.C. (B&C®) and the Biobased and Renewable Products
Advocacy Group (BRAG®) sponsorship of the December 7, 2014, Women in
Industrial Biotechnology Networking Reception, we are pleased to share the video of Dr. Debbie Yaver's remarks
when she was awarded the Biotechnology Industry Organization (BIO) Rosalind
Franklin Award for Leadership in Industrial Biotechnology on December 9, 2014.
Congratulations to Dr. Yaver for this esteemed recognition.
Bergeson & Campbell, P.C. (B&C®) and the
Biobased and Renewable Products Advocacy Group (BRAG®) were honored
to sponsor the Women in Industrial Biotechnology Networking Reception, which
took place on December 7, 2014, at the 2014 BIO Pacific Rim Summit on
Industrial Biotechnology and Bioenergy in San Diego, California. The awardee
this year of the BIO Rosalind Franklin Award for Leadership in Industrial
Biotechnology was Dr. Debbie Yaver. During the reception, attendees dialogued
on the critical challenges and opportunities for today's women working within
the bioeconomy, as well as the need to ensure the best and brightest women
continue to pursue the biobased industry in the future.