Development Of Occupational Exposure Limits Research Articles

Multi-instrument assessment of fine and ultrafine titanium dioxide aerosols

ABSTRACT The measurement of fine (diameter: 100 nanometers–2.5 micrometers) and ultrafine (UF: < 100 nanometers) titanium dioxide (TiO2) particles is instrument dependent. Differences in measurements exist between toxicological and field investigations for the same exposure metric such as mass, number, or surface area because of variations in instruments used, operating parameters, or particle-size measurement ranges. Without appropriate comparison, instrument measurements create a disconnect between toxicological and field investigations for a given exposure metric. Our objective was to compare a variety of instruments including multiple metrics including mass, number, and surface area (SA) concentrations for assessing different concentrations of separately aerosolized fine and UF TiO2 particles. The instruments studied were (1) DustTrak™ DRX, (2) personal DataRAMs™ (PDR), (3) GRIMMTM, and (4) diffusion charger (DC). Two devices of each field-study instrument (DRX, PDR, GRIMM, and DC) were used to measure various metrics while adjusting for gravimetric mass concentrations of fine and UF TiO2 particles in controlled chamber tests. An analysis of variance (ANOVA) was used to apportion the variance to inter-instrument (between different instrument-types), inter-device (within instrument), and intra-device components. Performance of each instrument-device was calculated using root mean squared error compared to reference methods: close-faced cassette and gravimetric analysis for mass and scanning mobility particle sizer (SMPS) real-time monitoring for number and SA concentrations. Generally, inter-instrument variability accounted for the greatest (62.6% or more) source of variance for mass, and SA-based concentrations of fine and UF TiO2 particles. However, higher intra-device variability (53.7%) was observed for number concentrations measurements with fine particles compared to inter-instrument variability (40.8%). Inter-device variance range(0.5–5.5%) was similar for all exposure metrics. DRX performed better in measuring mass closer to gravimetric than PDRs for fine and UF TiO2. Number concentrations measured by GRIMMs and SA measurements by DCs were considerably (40.8–86.9%) different from the reference (SMPS) method for comparable size ranges of fine and UF TiO2. This information may serve to aid in interpreting assessments in risk models, epidemiologic studies, and development of occupational exposure limits, relating to health effect endpoints identified in toxicological studies considering similar instruments evaluated in this study.

Modes of action considerations in threshold expectations for health effects of benzene

Understanding the Mode of Action (MOA) for a chemical can help guide decisions in development of Occupational Exposure Limits (OELs). Where sufficient information exists, it can provide the OEL developer the basis for selecting either a health-based or risk-based approach. To support the development of an OEL for benzene, scientific information relevant to MOA assessment for risk-based and health-based OEL approaches was reviewed. Direct-acting mutagenicity was considered as a basis for a risk-based OEL, versus MOAs consistent with a health-based approach: indirect mutagenicity via topoisomerase II inhibition, indirect mutagenicity via reactive oxygen species generation, or an immune-based bone marrow dysfunction. Based on the evidence against direct DNA reactivity, threshold expectations for remaining MOAs, and evidence for dose rate affecting acute myeloid leukemia and myelodysplastic syndrome risk, the weight of evidence favors a health-based OEL approach. In the case of benzene, development of an OEL based on observations of earlier key events (i.e., hematologic changes and genetic toxicity) is anticipated to provide protection from later adverse outcomes such as leukemia.

Exposure to metal oxide nanoparticles administered at occupationally relevant doses induces pulmonary effects in mice

In spite of the great promises that the development of nanotechnologies can offer, concerns regarding potential adverse health effects of occupational exposure to nanoparticle (NP) is raised. We recently identified metal oxide NP in lung tissue sections of welders, located inside macrophages infiltrated in fibrous regions. This suggests a role of these NP in the lung alterations observed in welders. We therefore designed a study aimed to investigate the pulmonary effects, in mice, of repeated exposure to NP administered at occupationally relevant doses. We therefore chose four metal oxide NPs representative of those found in the welder’s lungs: Fe2O3, Fe3O4, MnFe2O4 and CrOOH. These NPs were administered weekly for up to 3 months at two different doses: 5 μg, chosen as occupationally relevant to welding activity, and 50 μg, chosen as occupationally relevant to the context of an NP-manufacturing facility. Our results show that 3 month-repeated exposures to 5 μg NP induced limited pulmonary effects, characterized by the development of a mild peribronchiolar fibrosis observed for MnFe2O4 and CrOOH NP only. This fibrotic event was further extended in terms of intensity and localization after the repeated administration of 50 μg NP: all but Fe2O3 NP induced the development of peribronchiolar, perivascular and alveolar fibrosis, together with an interstitial inflammation. Our data demonstrate for the first time a potential risk for respiratory health posed by repeated exposure to NP at occupationally relevant doses. Given these results, the development of occupational exposure limits (OELs) specifically dedicated to NP exposure might therefore be an important issue to address.

Considerations for Using Genetic and Epigenetic Information in Occupational Health Risk Assessment and Standard Setting

Risk assessment forms the basis for both occupational health decision-making and the development of occupational exposure limits (OELs). Although genetic and epigenetic data have not been widely used in risk assessment and ultimately, standard setting, it is possible to envision such uses. A growing body of literature demonstrates that genetic and epigenetic factors condition biological responses to occupational and environmental hazards or serve as targets of them. This presentation addresses the considerations for using genetic and epigenetic information in risk assessments, provides guidance on using this information within the classic risk assessment paradigm, and describes a framework to organize thinking about such uses. The framework is a 4 × 4 matrix involving the risk assessment functions (hazard identification, dose-response modeling, exposure assessment, and risk characterization) on one axis and inherited and acquired genetic and epigenetic data on the other axis. The cells in the matrix identify how genetic and epigenetic data can be used for each risk assessment function. Generally, genetic and epigenetic data might be used as endpoints in hazard identification, as indicators of exposure, as effect modifiers in exposure assessment and dose-response modeling, as descriptors of mode of action, and to characterize toxicity pathways. Vast amounts of genetic and epigenetic data may be generated by high-throughput technologies. These data can be useful for assessing variability and reducing uncertainty in extrapolations, and they may serve as the foundation upon which identification of biological perturbations would lead to a new paradigm of toxicity pathway-based risk assessments.

The Past and Future of Occupational Exposure Limits

The Past and Future of Occupational Exposure Limits

Advances in Inhalation Dosimetry Models and Methods for Occupational Risk Assessment and Exposure Limit Derivation

The purpose of this article is to provide an overview and practical guide to occupational health professionals concerning the derivation and use of dose estimates in risk assessment for development of occupational exposure limits (OELs) for inhaled substances. Dosimetry is the study and practice of measuring or estimating the internal dose of a substance in individuals or a population. Dosimetry thus provides an essential link to understanding the relationship between an external exposure and a biological response. Use of dosimetry principles and tools can improve the accuracy of risk assessment, and reduce the uncertainty, by providing reliable estimates of the internal dose at the target tissue. This is accomplished through specific measurement data or predictive models, when available, or the use of basic dosimetry principles for broad classes of materials. Accurate dose estimation is essential not only for dose-response assessment, but also for interspecies extrapolation and for risk characterization at given exposures. Inhalation dosimetry is the focus of this paper since it is a major route of exposure in the workplace. Practical examples of dose estimation and OEL derivation are provided for inhaled gases and particulates.

Workshop report: Strategies for setting occupational exposure limits for engineered nanomaterials

Occupational exposure limits (OELs) are important tools for managing worker exposures to chemicals; however, hazard data for many engineered nanomaterials (ENMs) are insufficient for deriving OELs by traditional methods. Technical challenges and questions about how best to measure worker exposures to ENMs also pose barriers to implementing OELs. New varieties of ENMs are being developed and introduced into commerce at a rapid pace, further compounding the issue of OEL development for ENMs. A Workshop on Strategies for Setting Occupational Exposure Limits for Engineered Nanomaterials, held in September 2012, provided an opportunity for occupational health experts from various stakeholder groups to discuss possible alternative approaches for setting OELs for ENMs and issues related to their implementation. This report summarizes the workshop proceedings and findings, identifies areas for additional research, and suggests potential avenues for further progress on this important topic.

Occupational exposure limits in Europe and Asia – Continued divergence or global harmonization?

Occupational exposure limits (OELs) are used as a risk management tool aiming at protecting against negative health effects of occupational exposure to harmful substances. The systems of OEL development have not been standardized and divergent outcomes have been reported. However some harmonization processes have been initiated, primarily in Europe. This study investigates the state of harmonization in a global context. The OEL systems of eight Asian and seventeen European organizations are analyzed with respect to similarities and differences in: (1) the system for determining OELs, (2) the selection of substances, and (3) the levels of the OELs. The majority of the investigated organizations declare themselves to have been influenced by the American Conference of Governmental Industrial Hygienists (ACGIH), and in many cases this can be empirically confirmed. The EU harmonization process is reflected in trends towards convergence within the EU. However, comparisons of Asian and European organizations provide no obvious evidence that OELs are becoming globally harmonized.

Development of occupational exposure limits for the Hanford tank farms

Production of plutonium for the United States’ nuclear weapons program from the 1940s to the 1980s generated 53 million gallons of radioactive chemical waste, which is stored in 177 underground tanks at the Hanford site in southeastern Washington State. Recent attempts to begin the retrieval and treatment of these wastes require moving the waste to more modern tanks and result in potential exposure of the workers to unfamiliar odors emanating from headspace in the tanks. Given the unknown risks involved, workers were placed on supplied air respiratory protection. CH2MHILL, the managers of the Hanford site tank farms, asked an Independent Toxicology Panel (ITP) to assist them in issues relating to an industrial hygiene and risk assessment problem. The ITP was called upon to help determine the risk of exposure to vapors from the tanks, and in general develop a strategy for solution of the problem. This paper presents the methods used to determine the chemicals of potential concern (COPCs) and the resultant development of screening values and Acceptable Occupational Exposure Limits (AOELs) for these COPCs. A total of 1826 chemicals were inventoried and evaluated. Over 1500 chemicals were identified in the waste tanks headspaces and more than 600 of these were assigned screening values; 72 of these compounds were recommended for AOEL development. Included in this list of 72 were 57 COPCs identified by the ITP and of these 47 were subsequently assigned AOELs. An exhaustive exposure assessment strategy was developed by the CH2MHILL industrial hygiene department to evaluate these COPCs.

The development and regulation of occupational exposure limits in Taiwan

The occupational exposure limits (OELs) in Taiwan was promulgated in 1974 and has been revised five times since then. Many of the OELs were adopted from the most recent ACGIH TLVs and US OSHA PELs. A total of 483 chemicals were listed in the current Taiwan OELs Standard. The procedures of OELs development in Taiwan include the IOSH organized a recommended exposure limits (RELs) Committee to select the target chemicals and to recommend the RELs through literature review based on the health effects in the first stage, then, the CLA put policy needs, economical and technical feasibility into consideration and set up the final OELs at the second stage. A standard operation manual of RELs Committee has been developed. Based on our experience, several issues including the participation of representatives from a comprehensive spectrum, communication/education and training/enforcement, continuous collection of the local exposure data and health hazard information, use of health risk assessment, consideration of economic, and technical feasibility, as well as the globalization and information and experience sharing are critical in developing the appropriate OELs. Three examples including benzene, crystalline silica, and 2-methoxy ethanol are given to demonstrate the operation of system.

The development and regulation of occupational exposure limits in China

Of the 700 million workers in China, approximately 200 million workers are potentially exposed to industrial hazards. Although the promulgation and implementation of occupational exposure limits (OELs) in China began in the mid-1950, a systematic approach was not formalized until the formation of the Subcommittee of Occupational Health Standards Setting (SOHSS) in 1981. More recently, the 2002 Occupational Disease Prevention and Control Act of the People’s Republic of China crated the legislative framework for the development and enforcement of OELs. The SOHSS, whose members are primarily health professionals, is the organization responsible for the development of recommended standards, under the auspices of the Ministry of Health. The philosophy of OEL development of the SOHSS consists of a two-step approach: (1) an initial health-based recommended standard is established based on scientific data, and (2) a final law-based standard takes into consideration both socioeconomic and technological feasibility. Governmental agencies such as the Centers for Diseases Control and Prevention and the Institutes of Public Health Supervision at the state, provincial or municipal levels are charged with the responsibilities of the enforcement of OELs. The process and challenges in the enforcement of OELs are discussed. A comparison is made between selected Chinese OELs and those in other countries. The OELs for benzene and industrial dusts (including silica) are discussed in some detail.

Polyisocyanates in occupational environments: A critical review of exposure limits and metrics

Determination of polyisocyanates is important because they are a major contributor of exposure to the isocyanate functional group in many workplace environments and are capable of inducing sensitization and asthma. However, with multiple different measurement metrics in use, comparison of isocyanate exposure data between studies and development of occupational exposure limits (OELs) for polyisocyanates is difficult. An analysis of existing problems in the measurement and regulation of isocyanates is presented based on the published analytical, toxicological, and regulatory literature, and the authors' own analytical data and experience with isocyanates. This analysis supports a need for standardization of isocyanate measurement metrics and provides a framework for the development of an OEL for polyisocyanates. The total isocyanate group (microg NCO/m(3)) is recommended as the most feasible and practical metric (unit) by which to express polyisocyanate exposures for research, control, and regulatory purposes. The establishment of a comprehensive isocyanate OEL that simplifies the current agent-by-agent approach and expands coverage to polyisocyanates is also recommended.

New trends in the development of occupational exposure limits for airborne chemicals in China

Occupational exposure limits (OELs) are well established in many countries, which serve occupational professionals as benchmarks of industrial hygiene practice at workplaces worldwide. Starting in the mid-1950s, the central government of China began promulgating OELs for hazardous substances at workplaces. This paper discusses the historical basis, philosophical principles and schematic protocols of developing and setting OELs in China. The underlying principles include: (1) protection of human health being the first and the most important criterion; (2) the use of quantitative epidemiological studies in humans being given top priority; (3) integration and full use of all information sources, including animal experimental data for new chemicals or chemicals with new toxicity concerns; (4) considerations of socioeconomic and technological feasibilities in the country; and (5) amending existing standards based on new evidence. The strategy of the World Health Organization’s “Two-step Procedure” is applied to convert health-based recommendations to law-based operational OELs, with considerations for national technological and socioeconomic conditions and priorities. As a result of the recent passage of the new law Occupational Diseases Prevention and Control Act of the People’s Republic of China (ODPCAct), an official document Occupational Exposure Limits for Hazardous Agents in the Workplace containing a comprehensive list of new and amended OELs has been issued, which has now become one of the most essential regulations affiliated with the ODPCAct. This paper provides a brief summary of the salient features of the new law ODPCAct and the principles and processes of developing or amending OELs. This paper also discusses the challenges that lie ahead in enforcing the new regulations in China.

Scientific Criteria Used for the Development of Occupational Exposure Limits for Metals and Other Mining-Related Chemicals

The scientific approaches employed by selected internationally recognized organizations in developing occupational exposure limits (OELs) for metals and other mining-related chemicals were surveyed, and differences and commonalties were identified. The analysis identified an overriding need to increase transparency in current OEL documentation. OEL documentation should adhere to good risk characterization principles and should identify (1) the methodology used and scientific judgments made; (2) the data used as the basis for the OEL calculation; and (3) the uncertainties and overall confidence in the OEL derivation. At least within a single organization, a consistent approach should be used to derive OELs. Opportunities for harmonization of scientific criteria were noted, including (1) consideration of severity in identification of the point of departure; (2) definition of the minimum data set; (3) approaches for interspecies extrapolation; (4) identification of default uncertainty factors for developing OELs; and (5) approaches for consideration of speciation and essentiality of metals. Potential research approaches to provide the fundamental data needed to address each individual scientific criterion are described. Increased harmonization of scientific criteria will ultimately lead to OEL derivation approaches rooted in the best science and will facilitate greater pooling of resources among organizations that establish OELs and improved protection of worker health.

The Development of Occupational Exposure Limits for Chemical Substances in China

This paper presents a comprehensive review of the occupational exposure limits (OELs) of chemical substances in China. It provides historical background on the development of OELs in this country, with a complete list of traditionally adopted and newly developed OELs for chemicals in workplaces. The philosophical thoughts, the administrative system, the scientific protocols for setting and amending health standards, with emphasis on making health a basic criterion for setting health standards, strengthening epidemiological studies of the human population, integrating epidemiological and toxicological studies, considering technological and economical feasibilities, and making full use of literature information sources are discussed. Further perspectives with respect to practical issues of maximum allowable concentration and time-weighted average, selection of safety factors, and establishment of biological exposure limits are also considered, with the authors′ contributions to a discussion on these topics.

National and International Approaches to Occupational Standard Setting Within Europe

Occupational exposure limits (OELs) for chemicals in workroom air have been published in more than 70 countries. However, few countries generate or update their national lists of OELs independently. The acronym {open_quotes}OEL{close_quotes} is used here as a general term independent of what it is called in an individual country. OELs may be recommendations or they may have a legal status. They may be based on economic impact and technological feasibility. This makes a simple comparison of OELs from different countries partly misleading. OELs should not be compared without an opportunity to review the methods in each case. The development of OELs in Europe has been described previously. Briefly, the first recommendations for use of OELs were established in Germany as early as 1886. After the Second World War, the list of threshold limit values (TLVs) from the American Conference of Governmental Industrial Hygienists (ACGIH) was used in some European countries with a more or less mandatory function. In 1958, West Germany developed its own list and some countries (Austria, Switzerland) adopted the German list. In the 1970s, The Netherlands and Sweden introduced their own systems for establishing and validating OELs. Several other European countries followed later on. 15 refs., 1more » tab.« less

Scientific and practical considerations for the development of occupational exposure limits (OELs) for chemical substances

Occupational exposure limits (OELs) serve occupational health professionals as benchmarks for a healthy work environment. OELs are generally developed by manufacturers for substances which are not subject to governmental regulation or which have not been evaluated by consensus organizations such as the American Conference of Governmental Industrial Hygienists. This review is intended to serve as a practical guide to the standard-setting process. The discussion encompasses the evaluation of data, the different methods used for calculating limits, and the application of these limits to the workplace. The need for additional research to enhance the reliability of current methods is also discussed.

Optical radiation safety

Recent studies of light damage to the retina and studies of the hazards to the eye and skin from laser radiation have permitted the development of occupational exposure limits for optical radiation from lamps and lighting systems. Although concerns for potential hazards from the ultraviolet radiation emitted from some lamps have always existed, few have previously been concerned about potential harm to the eyes from visible radiation. Recent studies show that short wavelength light may in some instances be harmful to the retina. Furthermore, infrared radiation hazards to the eye are probably less than was once believed. Exposure limits for ultraviolet radiation and guidelines for visible and near-infrared radiation have been promulgated in the USA and some other countries. A proper understanding of the changing nature of environmental exposures to sunlight throughout the day permits the development of exposure limits for repeated, chronic exposure. The use of the present limits and guidelines for a given lamp or lighting system requires a careful study of exposure conditions if realistic control measures are to be devised. Misunderstanding of the limits or failure to consider realistic exposure conditions can lead to unwarranted concerns regarding lamp safety.