Richard C. Pleus, Ph.D., M.S.
Founder, CEO, Chief Toxicologist
RICHARD C. PLEUS, Ph.D., heads Intertox Inc., the scientific research and consulting company he founded in 1995. Within Intertox, he brings deep knowledge of toxicology to assist in protecting public health. To date, he has performed more than 600 toxicological assessments and has analyzed the impact of hundreds of chemicals on human health for aviation and space travel, medicine, medical products, consumer products, air, soil, water, food and waste.
Dr. Pleus has particular experience and expertise in:
- Aerospace, reproductive and endocrinological toxicology and neuro- and neurodevelopmental toxicology.
- Determining effects of chemicals on the human body, including chemical warfare agents, metals, nanomaterials, pharmaceuticals, chlorinated hydrocarbons, pesticides, volatile and non-volatile organic compounds and mycotoxins.
- He is known for his ability to synthesize complex scientific information and to present accessibly for diverse audiences.
- Developing Environmental Health and Safety compliance processes for workplaces and industries.
- Developing and implementing experimental study designs for product-based health research.
- Conducting toxicological assessments for residents residing near industrial facilities.
- Conducting toxicological product and workplace safety assessments.
- Discussing science and presenting to state, federal and foreign governmental agencies.
- Communicating toxicological risks.
- Serving as expert witness for attorneys representing both plaintiff and defense cases or as a consulting expert on toxicology and pharmacology in litigation.
Expertise
Dr. Pleus has conducted extensive scientific research at Intertox as an individual and with his global network of colleagues. He has won 6 grants for research in the last 10 years, published numerous peer-reviewed articles and written and edited books and chapters on diverse subjects in toxicology and nanotechnology. He has served as a U.S. delegate for national and international scientific conferences, including the U.S.-Russia Bilateral Presidential Commission on Science and Technology. His consistent presentation of scientific information in clear, layman’s terms, has made him a sought-after expert and presenter for businesses, trade organizations, and universities across North America, Europe, Asia, Africa, South America, and the Middle East.
Education
Dr. Pleus earned a Ph.D. in environmental toxicology from the University of Minnesota, where he had earlier completed his Masters of Science in environmental public health. Dr. Pleus’ undergraduate work was at Michigan State University, where he graduated with honors in physiology. He conducted his post-doctoral training in neuropharmacology at the University of Nebraska Medical Center.
Pro Bono Work
Dr. Pleus currently leads the U.S. delegation for Environmental Health and Safety (Working Group 3) to the International Organization for Standardization (ICO) Technical Committee (TC) 229’s.
Dr. Pleus provides scientific expertise on a matter for the Innocence Project Northwest; University of Washington School of Law.
Gretchen M. Bruce, DABT
Director of Toxicology
GRETCHEN M. BRUCE, DABT, is Director of Toxicology at Intertox, where she began in 1999. She has over 32 years of experience in conducting toxicological risk assessments in a variety of settings. These include human health impact analyses, regulatory compliance assessments, and workplace exposure hazard assessments. Her expertise in data analysis and modeling allows her to conduct these assessments with unique skill.
Ms. Bruce has particular experience in:
- Developing risk assessment models and data analyses for a broad range of human health risks in industrial facilities and workplace environments;
- Conducting toxicological evaluations to support extractable/leachable chemicals (E&T) assessment, including developing analytical evaluation thresholds (AETs);
- Conducting risk assessments to consumers of allegedly biologically and chemically contaminated air, water, food, and soil;
- Evaluating human health impacts from chemicals in pharmaceutical medical devices, consumer products, water, and the environment;
- Developing acceptable dose levels and human health impacts for pharmaceuticals, personal care products, and endocrine disrupters in water;
- Providing scientific litigation support;
- Assessing compliance with toxicity standards in accordance with federal CERCLA, RCRA, TSCA, state (e.g. Prop. 65), and local regulations.
Expertise
Ms. Bruce has particular expertise in developing and implementing data analysis methods and risk assessments. She is well-versed in the process of litigation, and provides expert toxicological analyses to support legal cases. Ms. Bruce’s expertise allows her to assist clients in maintaining compliance with local, state, and federal toxicological regulations.
Education
Ms. Bruce earned her Bachelor of Science in Environmental Toxicology from the University of California at Davis and is a certified Diplomate of the American Board of Toxicology (DABT).
mmccabe@intertox.com
+1 610 255 2171
Michael McCabe, Jr., PhD
Principal Scientist
Dr. McCabe is an internationally trained and nationally recognized scientist with a proven track record of accomplishment in toxicology and related disciplines. He has broad-based knowledge and possesses a depth of understanding and experience necessary to analyze exposures to a wide variety of chemicals and drugs and to assess the relevance of such exposures to human health and diseases as well as human performance.
Dr. McCabe applies his extensive scientific research and teaching experience to litigation matters involving, but not limited to, toxic torts, workers compensation claims, product liability, medical malpractice and personal injury cases. His participation on numerous government scientific review panels contributes to his ability to understand both sides of an issue, while his background as a medical and graduate school lecturer allows him to explain complex concepts in an easily understood way.
Dr. McCabe provides medico-legal support to both plaintiff and defense counsel and has testified in civil and criminal litigation in numerous state and federal courts.
Lisa M. Corey, PhD, DABT
Senior Toxicologist
LISA M. COREY, PhD, DABT, joined Intertox in 2004, and currently works as a senior toxicologist. She has studied the effects of chemicals that may pose a threat to human health for more than 18 years. Her knowledge of human health risks in air, water, and the workplace enables her to have a significant impact in all areas of environmental health and human toxicology.
Dr. Corey has particular experience in:
- Evaluating the health risks of metals, halogenated compounds, organophosphates, pesticides, solvents, and nanomaterials;
- Evaluating risk with special consideration towards sensitive populations;
- Conducting product assessments for chemical compounds;
- Preparing labels and Safety Data Sheets (SDS) for industrial chemicals in accordance with OSHA guidelines;
- Ensuring compliance with governmental toxicity regulations including REACH, EPA Maximum Contaminant Levels (MCL), and State of California standards;
- Developing company-wide hazard/safety plans to manage human health risks to a broad range of chemicals;
- Providing litigation support and expert testimony for cases involving human health risk and exposures to hazardous chemicals.
Expertise
Dr. Corey is adept at evaluating human health risks from exposure to chemical and biological agents in air, water, soil, and food. She has provided scientific comments and Maximum Contaminant Level (MCL) of perchlorates in water in accordance with California Public Health Goal (PHG) criteria. She has also conducted assessments of jet engine oil and hydraulic fluid in aircraft cabin air. Dr. Corey’s extensive knowledge of human health risks from chemicals allows her to promote her clients’ compliance with local, state, federal, and international Environmental Health and Safety (EHS) regulations, provide litigation support as either a consultant or an expert witness, and develop new toxicological assessments for measuring chemical impacts on human health.
Education
Dr. Corey earned her PhD in Environmental Toxicology from the University of Washington, where she also earned her Master of Science in Environmental Toxicology. She conducted her undergraduate studies in biology at the University of Washington. Dr. Corey is also certified as a Diplomate of the American Board of Toxicology (DABT).
Heidi C. O’Neill, PhD, DABT
Senior Toxicologist
Heidi O’Neill, PhD, DABT, joined Intertox in 2024 and currently works as a senior toxicologist. She has studied the effects of various chemicals as both pharmacological therapeutics that may benefit and as toxicants that may pose a threat to human health for more than 20 years.
Dr. O’Neill has particular experience in:
- Evaluating the health risks of flavoring compounds in oral/food products and inhalation devices;
- Evaluating the health risks of solvents, organophosphates, and pesticides;
- Preparation of FDA submissions for consumer products (inhaled and oral nicotine products);
- Providing scientific litigation support;
- Conducting product stewardship assessments for chemical compounds;
- Conducting toxicological evaluations to support extractable/leachable chemicals (E&T) assessment;
Expertise
Over the last 4 ½ years, Dr. O’Neill has focused on human health risk assessment for consumer products (tobacco products, cannabis vape products, food, and personal care products) as well as in an industrial setting for pharmaceutical products. She also has extensive experience assisting companies with FDA regulatory submissions for tobacco product, both oral and inhaled. She also has experience providing expert toxicological analyses to support legal cases. Dr. O’Neill has also assisted with developing the basis of an SDS screening system to build a database for go/ no go decisions for worker safety at a large food company.
Education
Dr. O’Neill earned her PhD in Toxicology from the University of Colorado, where she developed a model for evaluating upper respiratory effects of sulfur mustard gas inhalation, later using this model to screen various therapeutic compounds for prophylactic treatment intended for first responders. Following her graduate studies, she studied the genetics of nicotine addiction, nicotine pharmacology and the multigenerational effects of developmental nicotine exposure. Dr. O’Neill is also certified as a Diplomate of the American Board of Toxicology (DABT).
Gavin Bell
Staff Scientist
GAVIN BELL began his work at Intertox, Inc. in 2011. With a background in mathematics, his work at Intertox spans areas from litigation support to product safety.
Mr. Bell has particular proficiency in:
- Evaluating workers’ compensation claims;
- Assessing textiles for potential human health risk;
- Evaluating human health impacts from exposure to chemicals in water, products and the environment;
- Development, conduct, and analysis of complex air sampling and analysis for product safety.
Expertise
Mr. Bell has significant experience in litigation support of workers’ compensation claims, litigation support related to cabin air safety, development of sampling and analysis plans, sampling and analysis of fabrics used in clothing, product stewardship, and regulatory publishing.
Education
Mr. Bell earned his Bachelors degree from Reed College in Portland, Oregon.
Kelli R. Hackney
Staff Scientist
Kelli R. Hackney joined Intertox in January 2022 as a staff scientist. Her work primarily focuses on providing industry and litigation support related to exposures to odors and chemicals in the air. Ms. Hackney’s expertise includes:
- Conducting odor impact assessments for exposures to source emissions of odorous chemicals.
- Developing and executing on-site and off-site air quality and odor sampling plans.
- Analyzing, modeling, and presenting data through easy-to-understand visualizations.
- Communicating complex scientific concepts effectively to convey risks to diverse audiences.
Ms. Hackney’s interest in assessing odor impacts, combined with her skills in data analysis and risk communication, has benefited industries such as waste disposal, cannabis, and aviation. She aims to expand the application of odor impact assessments into new industries to safeguard individuals, communities, and businesses from the health impacts of odors.
In addition to her work on odor assessments, Ms. Hackney has experience conducting human and ecological risk assessments across various exposure pathways, including air, water, food, and soil. She has contributed to projects such as researching the ecological effects of DDT and its breakdown products in the Southern California Bight and has authored technical documents for agencies including the Oregon Department of Environmental Quality, Oregon Department of Fish and Wildlife, and Willamette River Keepers.
Outside of her professional role, Ms. Hackney actively engages in community service as a volunteer scientist. She participates in activities such as urban amphibian surveying, invasive plant removal, and community outreach to promote native plant restoration.
Education
Ms. Hackney earned her B.S. in Environmental Science, graduating summa cum laude from Portland State University in 2021.
Contact
Madison Arnold, MS
Scientist
MADISON A. ARNOLD joined Intertox in January 2023 as a scientist. Prior to joining Intertox, Ms. Arnold had worked as a graduate student researcher at Oregon State University.
Expertise
Ms. Arnold has particular proficiency in:
- Evaluating ecological and human health impacts from chemicals in various media;
- Performing toxicological literature searches and reviews;
- Comprising toxicological databases;
- Interpreting and explaining toxicological data;
- Presenting toxicological data.
Ms. Arnold has significant knowledge in chemical behavior, environmental fate and transport, public health toxicology, and human health and ecological risk assessment.
Education
Ms. Arnold earned her M.S. in Toxicology from Oregon State University, graduating Magna cum laude in 2022. She conducted her undergraduate research on microplastics at Oregon State University awarding her a B.S. in Bioresource Research.
Michael C. Maloney, RAC
Senior Advisor, Regulatory Affairs
MICHAEL C. MALONEY, RAC, works with Intertox clients who need to gain Food and Drug Administration (FDA) approval for drugs and medical devices. Mr. Maloney has helped medical device and drug companies bring products to market for more than 30 years. He has regularly provided hands-on management of companies in these fields. Both as a consultant and as an employee, he has led new product development step-by-step from approval process to launch.
Mr. Maloney has particular experience in:
- Developing consultancy programs for medical device companies seeking to establish regulatory compliance;
- Crafting and overseeing national and international product regulatory dossiers;
- Submitting dossiers in compliance with electronic Common Technical Document (eCTD) specifications;
- Directing successful negotiations with FDA (CDRH, CDER, CBER);
- Managing nonclinical safety and biological activity programs;
- Overseeing clinical investigations to establish safety, proof-of-concept, and efficacy;
- Negotiating with regulators over product classification, labeling, advertising, and promotional materials;
- Managing prior approval supplements for CMC;
- Acting as regulatory liaison in cases involving 510(k), PMA, NDA and BLA approvals.
Expertise
Mr. Maloney has an extensive experience as a regulatory affairs subject matter expert. He co-founded the Novent Group in 1991, providing regulatory consultation for a broad range of medical products leading to numerous marketing authorization successes. He has also provided regulatory consultation as the president of LaHaye Laboratories (1996-2001) and the Head of Regulatory Affairs at ZymoGenetics (2005-2009), he shepherded numerous products to FDA approval, including the clotting solution Recothrom. As an expert in regulatory affairs, Mr. Maloney serves as a liaison on major cases, working with clients to create strategies to win regulatory approval, craft the appropriate dossiers for submittal to regulators, negotiate with regulators, and maintain post-approval commitments to ensure continued regulatory compliance.
Education
Mr. Maloney earned a degree in Biological Sciences from San Jose State University. He holds Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professionals Society, which is the only certification in this field recognized worldwide.