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Gradient Principal Dr. Steven R. Boomhower, Ph.D., ERT has been accepted as a Fellow of the Academy of Toxicological Sciences (ATS).

The Academy of Toxicological Sciences (ATS) is a nonprofit organization that exists to certify toxicologists who are recognized by their peers for their expertise and sound scientific judgment. The purpose of this recognition and certification is to ensure, through peer review of credentials, the competence and experience of professionals whose work affects public welfare. Candidates for certification must have demonstrated evidence of knowledge of toxicology and active involvement in toxicological activities. A Fellow of the Academy must have an exemplary record of professional accomplishment, as well as extensive evidence of recognition by peers of competency and sound scientific judgment in toxicology as reflected by appointment or election to councils, committees, etc.

The 23^rd International Congress of the European Society of Toxicology In Vitro (ESTIV 2026) will take place in Maastricht, Denmark, from June 29 to July 2, 2026. From the conference website, the theme for the event, “Ensuring Safety, Advancing Science: Bridging to the Future with NAMs,” aims to “explore the transformative impact of New Approach Methodologies (NAMs) in ensuring safety, promoting innovation, and shaping the future of toxicology.”

In this issue of Trends, we provide several articles on the topic of critical mineral mining.

Our first article gives an overview of the importance of critical minerals to the United States (US) mining industry and the current regulatory landscape. The second article discusses the limited information available about rare earth elements and their potential risks to human health. The third article examines the ecological challenges posed by critical mineral mining and ways to mitigate potential impacts. Our fourth article explores deep-sea mining of critical minerals as an alternative to land-based mining in the face of expanding global demand.

Gradient contributors to this Trends issue include Drs. Leonard Ancuta, Steven Boomhower, Tim Verslycke, and William Dowd; Meghna Swamy, M.S.; Jerry Hu, M.S.; David Dodge, M.S., DABT, CIH; and Sarah Zahn, M.S.

Gradient Principal Scientist Dr. Isaac Mohar will be presenting at the Respiratory Drug Delivery (RDD) 2026 conference, taking place May 10-14, 2026 in Phoenix, AZ.

The Lush Prize recently awarded Gradient scientist Lindsey Borton and Medtronic scientist Kelly Coleman the 2026 Lush Prize for Political Advocacy award for their work on alternatives to animal-based testing.

Gradient announces that Principal Toxicologist Lindsey Borton and Medtronic Sr. Distinguished Toxicologist Kelly Coleman have been awarded the 2026 Lush Prize for Political Advocacy for their work on alternatives to animal-based testing. Their award-winning research used a science-based approach to show shortcomings of an animal-based test used on medical devices and support of non-animal-based alternatives that do not compromise the safety of the device and human use. Borton and Coleman were selected from 60 nominations across all award categories, representing projects in 25 countries, with12 total prizes awarded. The award was announced at a live event ceremony in London, UK, and also on YouTube.

Lush Prize is a collaboration between the campaigning cosmetics company Lush and the campaigning research group Ethical Consumer. The £250,000 prize fund is the biggest prize in the non-animal testing sector, and is the only award to focus solely on the complete replacement of animal tests. It has been rewarding excellence in the field since 2012.

Borton and Coleman documented their work in an article that was published in the journal, Alternatives to Animal Experimentation (ALTEX).

Read the article in ALTEX: Borton, L; Coleman, K. 2025. “Material-mediated pyrogens in medical devices: Myth or reality?” ALTEX – Altern. Anim. Ex. doi: 10.14573/altex.2504231.

In this article, Borton and Coleman used an evidence-based toxicology approach to determine whether material-mediated pyrogens (MMPs) exist in a medical device context, and whether the rabbit pyrogen test (RPT) could detect the presence of MMPs in or on a medical device. The implications of their research have the potential to reduce animal-based testing requirements.

“The Lush prize is an honor and recognition of the impact of our research. The elimination of the rabbit pyrogen test in favor of more robust evaluation methods enhances the safety of medical devices,” said Lindsey Borton, of Gradient.

About Lindsey Borton: Lindsey Borton is a principal toxicologist and engineer with industry experience in medical device biological safety and risk assessment. At Gradient, she develops strategies for the biological safety assessment of medical devices in support of European, US Food and Drug Administration (US FDA), and other worldwide medical device regulations. Ms. Borton also performs toxicological risk assessments of extractable and leachable compounds for human health risk assessment.

About Gradient: Gradient is an environmental and risk sciences consulting firm renowned for scientific excellence. We provide cutting-edge risk sciences consulting services to design and strategize responsive and protective solutions to environmental and human health challenges.

About Lush: Lush is a campaigning manufacturer and retailer of fresh handmade cosmetics with shops in 52 countries. The Lush Prize is one element in a broader campaign called ‘Fighting Animal Testing’. www.fightinganimaltesting.com

About Ethical Consumer: Ethical Consumer Research Association is a not-for-profit research co-operative specialising in independent research into social, animal welfare and environmental issues. www.ethicalconsumer.org

US EPA’s proposed rule, issued April 13, 2026, would expand the use of site-specific, risk-based approaches for coal ash management and disposal and is open for comment through June 12, 2026.

The US Environmental Protection Agency (US EPA) has issued a proposed rule that would revise several provisions of the federal regulations governing the management and disposal of coal combustion residuals (CCR), including requirements applicable to legacy coal ash surface impoundments and CCR management units (CCRMUs). The proposal was published in the Federal Register on April 13, 2026, and is open for public comment through June 12, 2026.

The proposed rule includes several provisions that would allow for expanded use of site‑specific, risk‑based approaches. Notable elements of the proposal include:

Why This Proposed Rule Matters
If finalized, these revisions could significantly affect how regulated facilities evaluate closure, groundwater impacts, and corrective action obligations at coal ash sites. In particular, US EPA’s proposal signals an increased role for human health risk assessment and site‑specific technical analyses.

How Gradient Can Help
Gradient has been at the forefront of developing and advancing recommendations to US EPA for risk‑based strategies for coal ash regulation, including the appropriate use of human health and environmental risk assessment to inform decisions. In fact, Gradient’s analyses from November 2025, “Technical Evaluation of the Environmental Protection Agency’s 2024 Risk Assessment of CCR Management Units,” prepared for the Utility Solid Waste Activities Group and National Rural Electric Cooperative Association, are highlighted in the current proposed rule, including:

We would be happy to discuss how these proposed changes may affect your site and how Gradient can support compliance and strategic planning under the evolving coal ash regulatory framework.

A recent Executive Order directs federal agencies to expedite deep seabed mining. This, paired with a consolidated federal application process and the first US commercial mining application considered to be “in substantial compliance,” deep seabed mining has evolved from concept to reality.

The Deep Seabed Hard Mineral Resources Act (DSHMRA) of 1980 authorized the National Oceanic and Atmospheric Administration (NOAA) to issue exploration licenses and commercial recovery permits to US companies for hard mineral resources in waters beyond national jurisdiction. In April 2025, The White House issued Executive Order 14285, “Unleashing America’s Offshore Critical Minerals and Resources,” directing certain federal agencies, including NOAA, to expedite seabed mining to secure reliable supplies of critical minerals. The deep seabed contains valuable critical minerals, such as manganese, nickel, cobalt, and copper, which are used in everything from defense systems and batteries to smartphones and medical devices (NOAA, 2026).

Creation of a Consolidated Application Process
On January 21, 2026, NOAA issued a final rule (91 FR 2642) establishing a consolidated application process (15 CFR § 971.214) that allows for simultaneous application for both an exploration license and a commercial recovery permit.

First Application Under the New Process
On January 22, 2026, The Metals Company USA LLC (TMC) filed the first consolidated deep seabed mining application under NOAA’s new consolidated process, and, on March 9, 2026, NOAA determined the application to be in substantial compliance with DSHMRA requirements. The application covers approximately a 65,000 km² area in the Clarion-Clipperton Zone (CCZ) of the Pacific Ocean, targeting an estimated 619 million tonnes of polymetallic nodules containing nickel, cobalt, copper, and manganese. More recently, two other companies (American Metal Resources and SeaX, Inc.) have applied for exploration licenses (91 FR 13822).

Environmental Review Requirements
The new consolidated application process requires submittal of an exploration plan, a commercial recovery plan, and an environmental and use conflict analysis, among other things. Under the new process, NOAA has the option to prepare a single Environmental Impact Statement (EIS) to assess environmental impacts of both exploration and commercial recovery activities. The exploration and commercial recovery plans describe measures to protect the environment and to monitor the effectiveness of environmental safeguards, which may evolve related to the EIS findings (15 CFR § 971.6 Subpart F). The environmental and use conflict analysis describes physical, chemical, and biological information of the relevant area, as well as any potential use conflicts. In addition, the plans include environmental information critical to the EIS, such as environmental baseline studies (including presence of threatened and endangered species), assessment of sediment disturbances and potential mobilization of sediment-associated metals, and impacts to commercial fisheries or their prey. The data intensive nature of the application and review process was demonstrated by TMC’s recent submission, which included thousands of environmental samples, biological records, and geochemical data points.

How Gradient Can Help
Gradient has substantial expertise in several technical areas that are critical to evaluating the potential impacts of deep seabed mining projects, including:

Talk Overview: “To assess chemical risks, information on exposure and hazards (toxicity) is needed. Traditionally, hazard data has often come in part from animal testing. A new paradigm is to rely on New Approach Methods (also called New Approach Methodologies or NAMs) to try to minimize animal-based toxicity testing. NAMs can include read-across, computational methods, in vitro testing, and exposure-based refinements of the chemical risk assessment. Regulatory risk assessments for chemicals used in the semiconductor industry in the United States (US) may include new chemical assessments under the US Environmental Protection Agency’s (US EPA’s) Pre-Manufacture Notice (PMN) process and US EPA’s existing chemical risk evaluations under the Toxic Substances Control Act (TSCA). Regulators and scientists alike are advocating for a greater reliance on NAMs in these risk assessments to reduce the burden of animal testing. At the same time, there is a desire for confidence that NAMs can adequately address the “reasonable risk” standard under TSCA. This talk will review the available NAMs and frameworks for selecting appropriate NAMs. We will highlight how NAMs might be used to complement or replace more traditional toxicity testing with a case study from the Onium Photoacid Generator (PAG) Consortium.”

Dr. Jessie Kneeland is an environmental consultant with a diverse scientific background, including expertise in environmental chemistry, oceanography, and climate science. At Gradient, she interprets chemical signatures to discern different sources of chemicals in the environment. She also helps companies understand potential environmental impacts of new chemicals. Her scientific interests focus on using chemical signatures to trace biological, chemical, and physical processes in the environment.

Ms. Chase Butler is a chemist with experience in designing sampling plans and testing protocols, assessing data quality, and interpreting data to support the fulfillment of various regulatory obligations. At Gradient, she has provided technical support for chemical registration and compliance in multiple geographic regions and countries and advises on the use of appropriate chemicals for read-across of toxicological data. Prior to joining Gradient, Ms. Butler conducted research at Yale’s Center for Conservation and Preservation, studying the compounds generated during the oxidation of contemporary materials used in art and art conservation.