M. Andrew Maier, Ph.D., CIH, DABT, Fellow AIHA

Principal, Toxicology, Health, and Ecological Sciences

M. Andrew Maier, Ph.D., CIH, DABT, Fellow AIHA Principal, Toxicology, Health, and Ecological Sciences

Dr. Andrew Maier has more than 30 years of professional work experience in the areas of environmental health, occupational hygiene, and toxicology. He has provided oversight for diverse risk and safety assessment projects and spearheaded new initiatives. In his capacity as an industrial hygienist, toxicologist, and risk assessor, he has led numerous projects and has coauthored toxicological reviews, technical reports, and human health risk assessment documents for several hundred individual substances. These assessments include critical examination of epidemiology and toxicology data for deriving cancer and noncancer risk values. He also completed numerous cancer risk assessments, includi...

Dr. Maier has an established history in occupational toxicology and industrial hygiene and has managed industrial hygiene programs for a diverse array of facilities while serving as an industrial hygienist in the petrochemical industry. He has also directed academic and continuing education courses on evaluating workplace exposures. Based on this experience, he is well versed in the areas of occupational, consumer, and environmental exposure assessment, development and implementation of control strategies, hazard communication and training, and health and safety management systems. He has recently served in facilitating multistakeholder dialogs among federal agency (EPA, OSHA, National Institute for Occupational Safety and Health [NIOSH]) and professional society practitioners (AIHA) in methods for the conduct of occupational risk assessments.

Dr. Maier continues to be actively engaged in developing research to improve risk assessment approaches through the integration of basic biology and risk assessment science. Recently his research efforts have focused on methods and approaches for using biological exposure and effect markers to reduce uncertainties in risk assessment and methodologies for deriving occupational exposure limits. He has served for multiple reappointments as a Toxicology Fellow at NIOSH in support of exposure limit methods development, and currently holds such a position with a focus on expanding the coverage of occupational exposure limits (OELs) for worker health protection using new approach methodologies.

Dr. Maier remains active in communicating his findings to the broader scientific community through active participation and leadership in professional societies, routine publication of his work, development and conduct of training courses, and presentation of invited lecturers. Current efforts include developing and improving the use of collaborative approaches to resolving chemical exposure and risk issues.

M. Andrew Maier, Ph.D., CIH, DABT, Fellow AIHA

Principal, Toxicology, Health, and Ecological Sciences

Industrial Hygiene and Occupational Toxicology

TSCA Risk Evaluations Developed comments and recommendations regarding EPA risk evaluations for dichloromethane (i.e., methylene chloride), carbon tetrachloride, trichloroethylene (TCE), and perchloroethylene on behalf of a consortium. Supported development of industrial hygiene sampling test plans for inhalation and dermal exposures for 1,2-dichloroethylene. Also supported development of hazard assessments and occupational exposure sampling for other consortia including those representing certain flame-retardant chemistries, formaldehyde, and propylene dichloride. Developed manuscripts on occupational risk methods and best practices for use in educational outreach.

Task-Based Screening Exposure and Hazard Assessment For private sponsors in the food and beverage sector and manufacturing sector, developed screening tools for assessing occupational exposure and risk for selected tasks in product manufacturing.

Cobalt Occupational Limits, Europe Conducted a critical review of the European Committee for Risk Assessment proposed OEL for inorganic cobalt and assessed possible sampling methods.

Nitric Acid Occupational Limits Developed a critical review of current and proposed OELs, including an American Conference of Governmental Industrial Hygienists (ACGIH) proposed threshold limit value for nitric acid. Submitted comments to ACGIH for consideration of their derived value.

Assessment of Silica Exposure in Bulk Product Handling Designed a simulation and exposure characterization study for crystalline silica from use of bulk products in powder product formulation. Supported evaluation of hazard communication and product labeling requirements.

Enzyme OELs For a major pharmaceutical manufacturer, conducted a benchmarking effort and developed a framework for setting exposure banding requirements for biocatalytic enzymes. A similar assessment was developed for setting worker exposure control targets for medicinal enzymes.

Occupational Silica Risk Assessment As part of a technical consulting project for a private sponsor, evaluated the basis for silica occupational toxicology, reliability of OELs, and impacts of protective equipment on exposure and risk in mining environments.

Indoor Air Quality Assessment, California As part of a project for a large federal facility in California, developed and implemented a strategy for evaluating indoor air quality concerns. Project included strategy for worker engagement.

Assessment of Models of Occupational Exposure Estimation On behalf of an industry organization, led an effort to assess alternative models for estimating worker exposure for TSCA risk evaluations. Analyses have led to recommended approaches for dermal exposure assessment, use of nearfield exposure models, and analyses of data for identifying representative exposure groups.

Diketone Substitutes Risk Assessment For a food manufacturing company, reviewed literature and bases for OELs for diacetyl and related compounds. In addition, coauthored an updated book chapter on diacetyl toxicology.

Phthalic Anhydride Occupational Risk Developed a critical review of exposure limits for phthalic anhydride and evaluated risk management and exposure scenarios for a chemical manufacturing site. The project also included evaluation of current state of clinical diagnostic approaches.

Product Ingredient Health Benchmarks For a private sponsor in the automotive technology sector, developed and implemented an assessment approach for worker OELs and handling guidance. Ongoing support includes analysis of OELs for new technologies.

OEL and Impurity Assessments for the Pharmaceutical Industry Evaluated nonclinical toxicology, epidemiology, and clinical data to develop OELs and allowable daily exposures (ADEs) for active pharmaceutical ingredients, impurities, and industrial chemicals. Coauthored more than 150 OEL or ADE documents for numerous companies including molecule innovators and contract manufacturing organizations.

OEL Development for Chemical Company Sponsors Evaluated toxicology and epidemiology data to develop OELs for industrial chemicals and product ingredients. Coauthored more than 10 OEL documents including one for carbon disulfide.

Laboratory Animal Chemical Safety, Cincinnati, Ohio For the University of Cincinnati, developed a toxicology and exposure evaluation tool for ensuring safety in handling laboratory animals for pharmaceutical and chemical research.

Home Health Care Worker Risks, Cincinnati, Ohio In research supported by a NIOSH-funded center at the University of Cincinnati, developing risk assessments for potential exposure to cleaning product ingredients and pharmaceuticals.

Exposure Estimation for Petrochemical Tasks, Cincinnati, Ohio In research supported by a NIOSH-funded center at the University of Cincinnati, developing an analysis of the effects of local factors (such as worker position and wind direction and speed) on task-based exposures.

Guidance for TCE Inhalation Limits for Commercial Workplaces Assessed the basis for applying health-based inhalation risk assessment values for nonindustrial workplaces.

Assessment of Variability in Exposure Limits for Diacetyl Assessed the basis for variability in the current guidance on diacetyl for workplace exposure scenarios.

Assessment of Occupational Risks of Coal Transport Evaluated potential aerosol exposures associated with options for transporting coal and coke via railcars.

Benzene Exposure during Automotive Cleaner Application Developed an exposure assessment for mechanics using automotive cleaning tasks.

NIOSH Cumulative Risk Assessment For a project involving NIOSH-developed methods and guidance on tools, assessed the impacts of multiple stressors on worker health.

Occupational Exposure Assessment for Enzymes Developed strategies to assess exposures to enzymes in product manufacturing.

Hanford Tank Farm Industrial Hygiene Programs, Washington Served as vice-chair of an expert team to conduct a review of the industrial hygiene programs for the management of the nuclear waste storage facility at Hanford, Washington, and served on second panel to assist in implementation.

Developmental Risk for Health Care Workers Evaluated potential development toxicity potential for occupational use of alcohol-based hand sanitizers among health care workers and safety assessment methods for consumer education.

NIOSH Occupational Exposure and Hazard Banding Developed an occupational exposure banding methodology. Responsible for concept development, adaptation of the methodology for emergency response scenarios, and integration of toxicity and physical hazards. Support includes developing and testing methodology and developing training and outreach on the approach.

Occupational Exposure Limits for Food Ingredients Developed methods for deriving and documenting OELs for food production operations.

NIOSH Dermal Risk Assessment For a project with NIOSH, developed an electronic library tool for identifying and prioritizing risk assessment resources for dermal exposures associated with emergency management and response.

OELs for High Priority Chemicals Provided critical analyses of existing OELs for high priority chemicals to support decisions regarding the adoption or modification of OELs for use in New Zealand.

Dose Response Support for Permissible Exposure Limits In collaboration with OSHA, provided critical review of dose-response information for high priority chemicals to support preliminary evaluation of data for derivation of permissible exposure limits (PELs). Developed summaries of key issues for data interpretation.

Chemical Hazards Emergency Medical Management (CHEMM) For a project with the National Library of Medicine, developed and reviewed content for a new on-line resource that provides information needed for chemical emergency response. Also developed outreach presentations.

OEL Development for Petroleum Hydrocarbon Mixtures Developed OEL documentation for petroleum hydrocarbon solvents applying the reciprocal calculation procedure.

Inorganic Borates Occupational Exposure Limit Conducted a critical evaluation of epidemiology and toxicology data and developed an updated concentration-response assessment based on human irritation studies.

Occupational Risk Assessment Issues for Diacetyl Provided in-depth analyses of human effects, exposure, and toxicology data for the butter-flavoring agent diacetyl in support of occupational risk assessment. Effort included developing a published manuscript with a recommended OEL and presenting findings to numerous stakeholder groups.

Immediately Dangerous to Life or Health Concentrations Provided support for NIOSH in developing methods for establishing immediately dangerous to life or health (IDLH) values and conducted data analysis and dossier development for more than 100 chemicals.

OEL Skin Notations For a project with NIOSH, developed and applied a NIOSH protocol for assigning dermal notations to chemicals of interest to occupational settings. Documented notations developed for 112 chemicals.

Biomarker Use for Occupational Risk Assessment For a project sponsored by NIOSH, developed an integrated decision support system to compile, format, and validate potential biomarkers for use in occupational risk assessment. Case studies using three different techniques were developed.

Control Banding Procedure for Biotechnology Company Developed a procedure for assigning control bands for laboratory chemicals and developed an OEL validation methodology for antineoplastic drugs.

Bromopropane OEL Conducted a critical evaluation of the scientific basis for several alternative occupational exposure limits that have been derived for 1‑bromopropane.

Risk Thresholds of Concern Collaborated with client scientists in developing an approach for setting risk assessment dose thresholds for occupational exposure and cleaning validation.

Comparative Health Hazard Ranking Surveyed available health hazard ranking tools and methods, and provided a comparative analysis of selected systems for hazard ranking and prioritization.

Onsite Program Management Managed all industrial hygiene programs at a 600‑employee, nine-process unit chemical manufacturing facility. Developed and conducted industrial hygiene training programs. Served as the industrial hygiene member on multidisciplinary teams assigned to evaluate overall risks for alternative process chemicals. Codeveloped a training course on human factors design that was adopted for companywide presentation to facility and corporate engineering groups. Developed and implemented facility procedures for asbestos and lead-based paint abatement and evaluated ventilation and noise control systems.

Comprehensive Industrial Hygiene Support and Services Provided support for 12 manufacturing plants, two research and development facilities, and 14 product distribution terminals. Provided technical support including onsite exposure assessments for multiple facilities, facility health and safety auditing, and training support. Served as an industrial hygiene reviewer on corporate environment, health, and safety audit teams.

Risk Assessment Documents, Toxicity Summaries, and Screening Assessments

Pharmaceutical Out-of-Specification Assessments Developed health risk assessments for product batches with various quality metrics outside of specifications, such as buffer components, pH variation, and presence of impurities including nitrosamines.

Alcohol-Based Hand Sanitizers and Developmental and Reproductive Toxicology Risk via Lactation Developed a hazard characterization and safety assessment for ethanol exposures during lactation as relevant to alcohol-based hand sanitizer use. The project includes analyses of developmental effects and internal doses assessed using an updated physiologically based pharmacokinetic (PBPK) model.

Cleaning Product Exposure and Safety Assessment for Surface Disinfectants Developed and implemented a research program related to student exposures to chemical ingredients in surface disinfectants used in educational institutions.

1,2-Dichloropropane Risk Assessment Developed a hazard characterization and dose-response for noncancer and cancer effects of 1,2-dichloropropane.

Ethylene Oxide Community Exposure Provided consulting and technical support for risk assessment and review for community cancer risks in areas adjacent to industrial and commercial facilities that handle ethylene oxide.

Application Support for Electronic Nicotine Delivery System Supported health guideline value selection, toxicological profile development, and risk assessment for premarket tobacco product applications submission requirements for a new electronic nicotine delivery system.

Ethylene Oxide Assessment Developed an evidence integration assessment for dose-response patterns for exposure to ethylene oxide. Assessment considered interspecies difference in key event data for cancer outcomes.

Arsenic Risk Assessment, Canada Coauthored a review of evidence for causality, mode of action, and dose-response implications for ingestion of inorganic arsenic compounds for cancer and noncancer endpoints.

New Molecule Hazard Assessment For a sponsor in the food and beverage sector, developed and implemented a protocol for developing hazard assessments for new molecules that do not have toxicology testing data. An in silico and read-across method was used.

Nitroparrafins Risk Assessment Developed tumor mode of action and cancer dose-response for estimation of a No Significant Risk Level determination for 2-nitropropane for consideration of California Proposition 65 assessment. For 1-nitroproprane, nitroethane, and nitromethane, developed a weight-of-evidence review for cancer, mutagenicity, and reproductive toxicity hazards. Applied read-across methodologies.

Alkanolamines Toxicology Review and Risk Characterization, Canada Served as senior quality assurance reviewer for the hazard and dose-response assessments for a screening risk assessment for alkanolamines.

Relationship between Cleaning Product Use and Asthma Conducted a series of projects on the relationship between cleaning products and asthma. Projects included a critical review of epidemiology studies with a method for reliability scoring; a novel weight of evidence approach for hazard characterization based on sensitization and irritation data; and a quantitative safety assessment method focusing on exposure and hazard for asthma. Tested the model on numerous chemicals including acetic acids, ammonia, and ethanol amines.

Hazard Data Compilation for Trace Organics in Biosolids Developed a data outreach and compilation approach to identify hazard endpoint data for 61 organic chemicals identified in biosolids. This project led to a request for a risk assessment approach for reuse of biosolids generated from a publicly owned treatment works.

Ingredient Review Process for GRAS Determination Evaluated food contact chemicals with regards to status as “Generally Recognized as Safe” (GRAS).

Acetone Toxicology Review and Risk Characterization, Canada Served as senior quality assurance reviewer for the hazard and dose-response assessments for a screening risk assessment for acetone.

Toxicokinetics Summaries for Health Effects Support Documents For EPA, Office of Water, served as coauthor or senior reviewer for toxicokinetics chapters of the Health Effects Support Document for alachlor, acetochlor, and metolachlor.

RfD Development for Alachlor and Acetochlor Degradates Reviewed and compiled key data in support of an expert panel consultation to derive oral reference doses (RfDs) for environmental degradation products for the two herbicides alachlor and acetochlor.

Hamilton County Annual Air Toxics Report, Ohio Developed a summary report for Hamilton County describing emissions, air monitoring data, odor complaints, and potential health risk.

EPA IRIS Toxicological Reviews Served as lead author, coauthor, or senior quality assurance reviewer for Integrated Risk Information System (IRIS) toxicological review documents for soluble nickel, decabromodiphenyl ether, tetrahydrofuran, and phenol.

Toxicology Support for EPA Office of Water 6-Year II Review Providing analysis and summaries of toxicity for 75 chemicals as part of the 6-year review cycle in support of the EPA’s drinking water regulations.

Pesticide Inert Ingredient Assessments Developed screening level exposure and health hazard assessments for additives to pesticide formulations using structural analog approaches.

Toxicology Review for Oxides of Nitrogen Under contract to EPA National Center of Environmental Assessment, developed an updated toxicology assessment for nitrogen dioxide, nitric oxide, nitric acid, and related chemicals in support of the update of the National Ambient Air Quality Standard.

EPA Sustainable Futures Under subcontract with EPA Office of Pollution Prevention and Toxics, provided screening level hazard assessments for noncancer toxicity for new chemicals under EPA’s pollution prevention initiatives.

Ammonium Perfluorooctanoate (C8) Screening Levels, West Virginia Conducted premeeting analysis and compilation of toxicological data and served on a team assembled to derive provisional risk values in a project sponsored by the State of West Virginia.

Risk Assessment Research and Methods Development

Role of Immunophenotyping in Risk Assessment Developed assessments of interpretation of white blood cell data for two compounds and developed an interpretation framework in collaboration with client on the use of immunophenotyping data for selection of adverse effect levels in conduct of risk assessments.

Comparative Risk for Disinfectant Products Developed a framework for integrating health risk considerations for chemical and biological agents. The risks are modified by product use compliance metrics.

Genotoxicity Framework for Food Relevant Chemicals Developed a risk assessment framework for chemicals in food for assessing genotoxicity. The tool will include a weight-of-evidence approach that incorporates mode of action and human exposure relevance of data streams.

Health-Based Exposure Limits for Endogenous Substances Working with a group of experts from numerous pharmaceutical companies developing a risk assessment pathway framework for setting health-based exposure limits for endogenous compounds, such as fatty acids, amino acids, and nucleic acids.

Risk Management Techniques for Noncancer Effects Developed methodology, outreach, and education support for addressing uncertainties and ranges in risk values for noncancer risk assessments. TCE and other solvents were used as examples.

Community Exposure Guidance for Intermittent Exposures, Canada Developed short dossiers applying a toxicity risk value for chemicals using a decision framework approach. Developed decision documents for nine chemicals.

Health Benchmarks for Alternative Temporal Patterns of Exposure Developed an issue paper and decision framework for evaluating whether acute or chronic health benchmarks are most appropriate for application to exposure scenarios having varying temporal patterns.

Hazard Screening Framework for Polymers, Canada Developed a novel framework to assess the hazard for polymers. The framework includes a series of hazard flags with a decision tree to identify hazard category.

Threshold for Toxicological Concern Approach for Reproductive and Developmental Toxicity Compiled and critically evaluated reproductive and developmental toxicity data for more than 300 chemicals to identify effect levels. The distribution of values was used to assess the degree to which the current threshold for toxicological concern approach accounts for these endpoints. Coauthored a manuscript describing the results.

Acrylamide Mode of Action Evaluated updated literature on the potential modes of action for tumorigenicity of acrylamide observed in animal bioassays. Served as lead author on evaluation of rodent mammary tumors. This effort supported responses to EPA and Proposition 65 assessments.

Water Safety Biosensors For the U.S. Army, developed an approach for identifying novel chemical biosensor technologies that may serve as part of a battery for monitoring safety of water supplies.

Metals Risk Assessment for EPA Provided support for developing a chapter on human health risk assessment practices and principles as they apply to the unique characteristics of metals. The chapter was part of an EPA document on metals risk assessment.

Canadian Domestics Substance List, Canada Completed several projects in support of hazard assessments for chemicals on the Canadian Domestic Substances list.

Nonlethal Weapons Risk Characterization In several separate projects sponsored by the U.S. Department of Defense, developed a general framework for risk characterization of nonlethal weapons, and conducted separate risk characterization reports for several nonlethal weapon technologies.

Litigation Support

Occupational Risk Assessment Retained as occupational risk assessment expert in matter involving exposure to various vapors from chemicals stored in basement of building. Deposition pending.

Personal Protective Equipment Retained as expert regarding OSHA violation for personal protective equipment. Deposition pending.

Metal Plating Retained as an occupational hygiene expert in a matter involving exposure to various vapors during metal plating process in manufacturing facility. Deposition pending.

Rail Transportation Retained as an occupational risk assessment expert in matters related to claims of adverse health effects among workers in the rail transportation industry.

Dry Cleaning and Parts Washing Retained as an occupational hygiene expert in a matter involving exposure during handling of used solvents in dry cleaning and parts washing operations.

Silicosis Retained as an occupational hygiene expert in a matter involving claim of silicosis arising from use of electrical saws in construction trades.

Pool Disinfectant Chemicals Provided consulting expertise in a matter involving potential acute exposure to pool disinfectant chemicals.

Solvents Used in Manufacturing Retained as an occupational toxicology expert in a matter involving exposure to various solvents including styrene in manufacturing.

Exposure to Fuels Petitioner Steven Frohling v. Respondent Conserv FS. Re: Application for Adjustment with the Illinois Workers’ Compensation Commission alleging injury to his lungs due to work exposure to fuels. Served as exposure and risk expert.

Sarcoidosis Served as toxicology expert in matter involving claims of lung injury and sarcoidosis in resident of a home following installation of a stone countertop.

Ethylene Oxide Handling Provided expert consulting support on workplace handling practices regarding ethylene oxide.

Acrylamide Carcinogenicity in Food Related Intake Scenarios California Chamber of Commerce v. Attorney General of The State of California. The United States District Court Eastern District of California. Provided expert opinion regarding acrylamide carcinogenicity in food related intake scenarios.

Butter Flavors Provided expert consulting support on litigation matters related to butter flavors including diacetyl and 2,3-pentanedione.

Bulk Coal Handling Oakland Bulk & Oversized Terminal, LLC v. City of Oakland, Case No. 3:16-cv-07014-VC, United States District Court, Northern District of California. Provided expert opinion regarding degree of potential inhalation risk for bulk coal handling.

CATT Proceedings Moody v. E. I. du Pont de Nemours & Co., 2:15-cv-803. The United States District Court Southern District of Ohio Eastern Division. Case No. 2:13-MD-2433. Provided expert opinion on CATT proceedings.

Community Exposures from Solvent Treatment Facility James Nickels et al. v. Valicor Environmental Services, LLC. Court of Common Pleas Hamilton County, Ohio. Case Number A1401156. Provide expert opinion in a case involving community exposures arising from a solvent treatment facility in Sharonville, Ohio.

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