Morgan Willming, Ph.D., DABT

Regulatory Toxicology Evaluations for PFAS, Worldwide — Critically examined the scientific basis of proposed PFAS rulemakings at the state, federal, and international levels, and assessed the extent to which they are founded on sound scientific principles. Prepared written technical comments evaluating the underlying toxicological assessments for proposed drinking water maximum contaminant levels, human health guidelines, aquatic life criteria, and hazardous substance designations for PFAS compounds.

PFAS Regulatory Tracking, United States — Maintains awareness of emerging regulations for PFAS in drinking water, groundwater, soils, and consumer products throughout the United States. Contributes updates to support Integral’s PFAS Regulatory Map.

Integral’s Monthly PFAS Alerts, United States — Participated in updating continuous literature reviews and summarizing scientific publications regarding PFAS occurrences, fate and transport, remediation and treatment, and toxicology, as well as environmental and human safety.

PFAS Stakeholder Coordination and Risk Communication, Idaho — Communicated PFAS toxicology and health risks to stakeholders via presentations and outreach materials for public drinking water system operators, state regulatory agencies, local public health officials, and the general public. Developed statewide PFAS risk communication plans and supported interagency PFAS response to address PFAS in drinking water.

Safety Data for Sunscreen Active Ingredients, United States — Supported the clinical and nonclinical safety assessment of seven sunscreen active ingredients for the sunscreen industry to meet FDA regulatory requirements for the safety of ultraviolet filters.  Provided toxicological support and study coordination for in vitro permeation testing, in vitro metabolism, and clinical trials to be conducted according to FDA guidance.  Conducted a written literature review integrating in silico predictions of ultraviolet filter metabolites expected in humans and rodents to identify and evaluate the toxicity of potential metabolites. Reviewed existing nonclinical safety data to identify data gaps under International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) and other regulatory assessment frameworks. Supported regulatory communications with FDA.

Safety Assessment of Personal Care Product Ingredients, United States — Provided critical evaluation of toxicity data and reports generated to support safety for more than 100 personal care product ingredients. Reviewed toxicity data for each ingredient compiled from publicly available databases, including the European Chemicals Agency, European Food Safety Administration, FDA, and Cosmetic Ingredient Review. Applied product-specific exposure assumptions according to industry standards to determine safety for each ingredient.

Improving the Sustainability Profile of a Portfolio of Consumer Product Ingredients, United States — Screened a library of ingredients based on chemical properties, biodegradability, and aquatic toxicity using publicly available chemical and toxicity databases to determine environmental risk profiles for each ingredient. Grouped ingredients according to chemical structure and determined surrogates appropriate for read-across.

Safety Assessment of Novel Oral Care Ingredients, United States and Europe — Evaluated toxicity data for two novel ingredients proposed for use in human and canine oral care products. Compiled data from publicly available databases, including the European Chemicals Agency, EPA, FDA, and Cosmetic Ingredient Review. Used read-across assessment to support ingredient safety. Derived product-specific exposure assumptions by age group and product type to determine the margins of safety for each ingredient and provided a comprehensive written safety assessment.

Derivation of Health-Based Exposure Limits for Pharmaceutical Industry, United States — Derived health-based exposure limits including occupational exposure limits, permissible daily exposure limits, and acceptable daily intake values for active pharmaceutical ingredients, raw materials, inactive ingredients, and impurities according to ICH guidance and industry best practices. Conducted quantitative structure-activity relationship (QSAR) modeling using the Organisation for Economic Co-operation and Development (OECD) QSAR Toolbox to address data-gaps.

Environmental Risk Assessment of Pharmaceuticals, United States — Evaluated the environmental risks of active pharmaceutical ingredients for FDA new drug applications and to meet requirements for a categorical exclusion. Identified relevant ecotoxicity data and derived predicted environmental concentrations according to FDA guidelines and using in silico modeling of down-the-drain concentrations.

Environmental Risk Assessment of a Novel Pharmaceutical, United States — Assessed the aquatic environmental risk of a pharmaceutical with a novel mode of action for its new drug application for the FDA.  Provided a weight-of-evidence assessment based on read-across compounds, mode of action analysis, adverse outcome pathways, and clinical and nonclinical safety data. Calculated expected environmental concentrations considering in silico phototransformation predictions, biodegradation, and effluent and stream modeling.

Environmental Fate and Ecotoxicity Assessment of a Novel Pharmaceutical, Europe — Provided study oversight and monitoring for environmental fate (e.g., biodegradation) and aquatic ecotoxicity testing of a pharmaceutical according to OECD guidelines and to support environmental safety for the European Medicines Agency.

Literature Search for Environmental Safety and Vulnerability Assessment of a Polymer, United States — Supporting the systematic review of environmental fate and safety literature to understand potential data gaps and business vulnerabilities for use of a polymer in environmental applications. Reviewing available fate, transport, biodegradation, and ecotoxicity literature for similar chemistries to evaluate environmental risks.

Environmental Risk Assessment of an Oral Care Active Ingredient, Switzerland — Evaluated the aquatic environmental risk of a new product indication for an oral care ingredient in support of a regulatory submission for Swissmedic. Derived predicted no effect levels and predicted environmental concentrations based on published literature and expected frequency of usage in Switzerland.

Toxicity and Regulatory Assessment of Hexavalent Chromium, United States — Provided a review of the carcinogenic mode of action for hexavalent chromium in humans and evaluated the implications for a trade association of proposed human health guidelines and regulatory levels in drinking water at the state and national level.

Petroleum Vapor Intrusion at a Child Care Facility, Southwest Idaho — Conducted a human health risk assessment for petroleum vapor chemicals from an underground storage tank release that was impacting a child care facility. Evaluated indoor air sampling data and assessed human health risks for children and facility workers. Provided a health risk assessment report and recommendations for preventing and reducing exposures.

Assessment of Metals in Fish and Derivation of Consumption Advisories, Coeur d’Alene, Idaho — Assessed health risks of metals in fish tissue (mercury, arsenic, cadmium, lead) associated with contamination from a mining Superfund site. Derived fish consumption advisory guidance for populations of concern and generated technical reports and stakeholder presentations.

Metals in Soils at a Former Mining Site, Idaho — Evaluated lead and other metals in soil and dust at a historical mining townsite to assess human health risks for recreational site users and residents. Determined human exposure pathways and assessed acute and chronic exposures. Evaluated lead exposures using the EPA Integrated Exposure Uptake Biokinetic and Adult Lead models.

Response to Residential Elemental Mercury Release, Boise, Idaho— — Evaluated mercury vapor clearance data after exposure of residents to acutely toxic levels of mercury vapors. Coordinated with EPA On-Scene Coordinators to ensure cleanup was conducted appropriately and evaluated indoor vapor clearance data to ensure no additional exposures. Generated a health consultation report and health-based recommendations for impacted site residents.

Ecotoxicity Prediction and Extrapolation Modeling, EPA, Office of Research and Development, United States — Expanded the development of acute toxicity extrapolation tools to improve cross-species toxicity prediction of aquatic threatened and endangered species. Developed tools to generate species sensitivity distributions for taxa with limited data to support environmental risk assessment. Analyzed and curated acute toxicity data sets derived from EPA’s ECOTOX database for use in developing models using R statistical software. Communicated results in peer-reviewed publications, conferences, and online tool platform.

Aquatic Ecotoxicity of Pesticides, Antimicrobial Compounds, and Temperature Regimes, Lubbock, Texas — Designed and performed acute and chronic toxicity tests using insecticides, fungicides, and antimicrobial compounds on aquatic invertebrates (daphnids, chironomids, amphipods), and larval amphibians in aqueous and sediment assays. Assessed toxicity of compounds under realistic daily temperature regimes. Completed statistical analyses and interpreted data to assess chemical mixture effects and generate dose–response relationships for ecotoxicological endpoints.

Exposure Assessment Regarding PCBs, United States — Assisted with data analysis regarding potential exposure to PCBs via inhalation of indoor air. Conducted literature reviews, evaluated health-based exposure guidelines, and compiled technical summaries of emerging literature on relevant chemical exposure pathways. Supported preparation of expert reports.

PFAS Toxicological and Regulatory Evaluation, United States — Reviewed human and animal toxicological evidence related to PFAS exposures and evaluated the toxicological basis of PFAS regulations. Supported preparation of expert reports.