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

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. Also supported development of hazard assessments and occupational exposure sampling for other consortia, including those representing certain flame-retardant chemistries; formaldehyde; propylene dichloride; 1,2-dichloroethylene; 1,1-dichloroethylene; 1,1,2-trichloroethylene; and 1,4-dioxane. 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.

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.

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.