Ernest Fung, Ph.D., DABT, ERT

Determination of Health-Based Exposure Limits, United States — Determined health-based exposure limits including occupational exposure limits, permissible daily exposure limits, acceptable daily intake values, and occupational exposure bands for active pharmaceutical ingredients, raw materials, inactive ingredients, and impurities in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance and industry best practices.

Review of Health-Based Exposure Limits, United States — Reviewed health-based exposure limit documents to determine whether limit is determined according to appropriate guidance and is sufficiently protective of human health.

SDS Document Preparation, Worldwide — Prepared safety data sheet (SDS) documents for individual compounds and mixtures for various jurisdictions worldwide.

Health Hazard Evaluation for Out of Specification Events, United States — Prepared health hazard evaluation for out of specification events in pharmaceutical settings. Specifically, determined the amount of impurity, degradation product, or unintended active pharmaceutical ingredient present in a therapeutic, estimated patient exposure to the unintended compound, and conducted human health risk assessment to determine potential impact on patient health.

Microbial Contamination Hazard Identification and Risk Assessments, United States — Conducted hazard identification assessments and microbial risk assessments related to microbial contamination identified in pharmaceutical settings.

Occupational Toxicology SOP Development, United States — Developed occupational toxicology standard operating procedures (SOPs) related to derivation of health-based exposure limits, assignment of occupational exposure bands, handling practices for active pharmaceutical ingredients, and others.

Impurity Genotoxic Assessments, United States — Determined genotoxic classification of pharmaceutical impurities. Specifically, evaluated available impurity empirical data and available read across information, and conducted quantitative structure-activity relationship (QSAR) evaluations where necessary to determine genotoxic classification in accordance with ICH M7 (“Assessment and Control of DNA Reactive [Mutagenic] Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk”) guidance.

Active Pharmaceutical Ingredient Contamination of Dietary Supplement, United States — Determined active pharmaceutical ingredient contamination levels in various dietary supplements. Estimated human exposure to active pharmaceutical ingredient resulting from consumption of contaminated dietary supplements. Evaluated risk of potential health effects resulting from consumption of contaminated dietary supplements.

Biocatalytic Enzyme Handling Framework, United States — Developed framework for handling biocatalytic enzymes in occupational settings. Specifically, reviewed available literature on handling practices and health-based exposure limits of various biocatalytic enzymes and developed a framework to determine the appropriate exposure limits for different classes of biocatalytic enzymes.

Framework for Evaluating Active Pharmaceutical Ingredient Degradation under Space Flight Conditions, United States — Developed framework for evaluating active pharmaceutical ingredient degradation under space flight conditions. Specifically, reviewed and summarized literature.

Bovine Feed Additive Toxicity Characterization, United States — Directed toxicity testing for bovine feed additive. Specifically, conducted genotoxicity testing and oral toxicity testing on bovine feed additive to determine potential impact to human health through consumption of milk from cows that consumed bovine feed additive.

Natural Cosmetic and Personal Care Product Ingredient Safety Evaluation, United States — Evaluated natural cosmetic and personal care product ingredients to determine potential hazards and determined appropriateness for use in cosmetic and personal care products.

Surfactant Safety Evaluation, United States — Evaluated various surfactants for different product applications. Specifically, prepared toxicity profile for various surfactants, estimated surfactant exposure to humans based on product application, and conducted human health risk assessment by benchmarking with applicable health guidance values.

Nucleic Acid Dye Toxicity Evaluation, United States — Evaluated nucleic acid dye for potential hazards through QSAR evaluation and applicable read across information. Estimated occupational and non-occupational exposures and conducted human health risk assessment by benchmarking with applicable thresholds of toxicological concern.

Extractables and Leachables Safety Evaluation — Directed extractables and leachables testing for various medical and nonmedical devices. Specifically, conducted extractables, simulated extraction, and leachables testing for various devices; analyzed extractables and leachables testing data; estimated exposure to extractables and leachables; and conducted human health risk assessment by benchmarking to appropriate health guidance values.

Disperse Dye Toxicity Assessment, Europe — Determined toxicity profile of various disperse dyes used in the clothing industry through available empirical data and applicable read across information.

Cosmetic and Personal Care Product Ingredient Safety Evaluation, United States — Evaluated ingredients of cosmetic and personal care products to determine potential hazards and determined ingredient safe levels for different product types.

Electronic Cigarette PMTA Submissions, United States — Characterized e-cigarette device and prepared Premarket Tobacco Product Application (PMTA) submissions to FDA for various clients. Specifically, characterized aerosol emissions from e-cigarette device, prepared toxicological profiles for relevant hazardous or potentially hazardous compounds, conducted extractable and leachable testing, conducted toxicological testing, and performed human health risk assessment to determine whether e-cigarette device is appropriate for the protection of public health.

Metal-on-Metal Hip Implant State-of-the-Art Review, United States — Conducted a state-of-the-art review of metal-on-metal hip implant literature. Presented the history and evolution of metal-on-metal hip implants, summarized the clinical performance, and evaluated the adverse health effects in metal-on-metal hip implant patients.

Metal-on-Metal Hip Implant Wear Debris Characterization, United States — Directed laboratory to produce metal-on-metal hip implant wear under normal and abnormal wear conditions. Characterized the amount, size, morphology, agglomeration, and chemical composition of wear particles.

Cardiomyopathy Risk from Metal-on-Metal Hip Implant, United States — Reviewed and summarized available literature and case reports related to cardiomyopathy in metal-on-metal hip implant patients. Conducted analysis to determine cobalt levels in hip implant cardiomyopathy patients. Determined whether cobalt exposure resulting from normal hip implant wear is expected to cause cardiomyopathy.

Wearable Adhesive Safety Evaluation, United States — Reviewed wearable adhesive curing procedure. Determined potential chemicals present resulting from incomplete curing and evaluated potential hazards of these chemicals.

Evaluate the Safety of Sunscreen Active Ingredients, United States — Reviewed and summarized available toxicological clinical and nonclinical studies for various sunscreen active ingredients. Assigned reliability tier for reviewed studies. Prepared weight of the evidence conclusions for various toxicological endpoints.

PCB Contamination of Dietary Supplements, United States — Determined PCB contamination levels in various dietary supplements. Estimated human exposure to PCBs resulting from consumption of contaminated dietary supplements. Evaluated potential health effects resulting from consumption of contaminated dietary supplements.

Active Pharmaceutical Ingredient Contamination of Pet Food, United States — Estimated pet exposure to an active pharmaceutical ingredient through pet food consumption. Evaluated potential health effects resulting from consumption of contaminated pet food.

BPA in Plastic Container, Human Health Risk Assessment, United States — Directed testing laboratory to determine bisphenol A (BPA) content wiped from a plastic container. Conducted human health risk assessment by benchmarking potential dermal exposure to safe harbor level (Proposition 65).

Preservative Safety Evaluations, United States — Determined toxicity profile for preservatives. Determined consumer exposure based on specific use scenarios. Conducted human health risk assessment by benchmarking consumer exposure to appropriate health-based guidance values.

Cosmetic and Personal Care Product Safety Evaluation, United States — Evaluated ingredients for potential hazards. Determined consumer exposure based on specific use scenarios. Conducted human health risk assessment by benchmarking consumer exposure to appropriate health-based guidance values.

Multisurface Cleaner Safety Evaluation, United States — Evaluated ingredients for potential hazards. Determined consumer exposure based on specific use scenarios. Conducted human health risk assessment by benchmarking consumer exposure to appropriate health-based guidance values.

Hand Soap Safety Evaluation, United States — Evaluated ingredients for potential hazards. Determined consumer exposure based on specific use scenarios. Conducted human health risk assessment by benchmarking consumer exposure to appropriate health-based guidance values.

Bovine Feed Additive Human Health Risk Assessment, United States — Determined human exposure to bromoform, iodine, and bromide from consumption of milk from cows fed a bovine feed additive. Conducted human health risk assessment by benchmarking human exposure to appropriate health-based guidance values.

Chromium in Leather Products Human Health Risk Assessment, United States — Directed testing laboratory to determine chromium content from various leather products. Conducted human health risk assessment by benchmarking dermal exposures to safe harbor levels (Proposition 65).

1,4-Dioxane Safety Evaluation, United States — Determined occupational and non-occupational exposures to 1,4-dioxane in a plaster product and conducted human health risk assessment by benchmarking occupational and non-occupational exposures to safe harbor levels (Proposition 65).

BPA in Sunglasses Human Health Risk Assessment, United States — Directed testing laboratory to determine absolute and leached BPA content from various sunglasses. Conducted human health risk assessment by benchmarking dermal and hand-to-mouth exposures to safe harbor levels (Proposition 65).

BPA in Clothing Human Health Risk Assessments, United States — Directed testing laboratory to determine absolute and leached BPA content from various items of clothing. Conducted human health risk assessment by benchmarking dermal and hand-to-mouth exposures to safe harbor levels (Proposition 65).

Hair Dye Ingredients Human Health Risk Assessment, United States — Determined exposure to carcinogenic ingredients in hair dye and evaluated whether an increased risk of cancer results from consumer exposure.

Risk Assessment on Chlorinated Substances Exposure, United States — Estimated exposure and evaluated human health risk from exposure to chlorinated substances in mobile homes following groundwater vapor intrusion.

Expert Witness for Plastic Container BPA Case, United States — Retained by client in litigation matter related to plastic container product. Prepared expert report.

Expert Witness for Shampoo Preservative Cases, United States — Retained by client in litigation matters related to shampoo product. Prepared expert report and testified in deposition.

Expert Witness for Shampoo Preservative Cases, Canada — Retained by client in litigation matters related to shampoo product. Prepared expert report.

Technical Support for Asbestos and Talc Litigation, United States — Provided technical support to various expert witnesses in various asbestos and talc litigation cases.

Technical Support for Alcohol-Related Litigation, United States — Provided technical support to expert witnesses in alcohol litigation cases.

Pharmaceutical Risk Assessment Training, United States — Conducted various pharmaceutical risk assessment trainings for different clients with focus on occupational toxicology and health-based exposure limit determination.

Medical Devices Risk Assessment Training, United States — Conducted risk assessment training for medical device client with focus on requirements from ISO-10993 guidance.