Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB) a Literature Review and Critical Analysis

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Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB) A Literature Review and Critical Analysis

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health Disclaimer

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SAFER • HEALTHIER • PEOPLE™

ii FOREWORD

When the U.S. Congress passed the Occupational Safety and Health Act of 1970 (Public Law 91–596), it established the National Institute for Occupational Safety and Health (NIOSH). Through the Act, Congress charged NIOSH with recommending occupational safety and health standards and describing exposure levels that are safe for various periods of employment, including but not limited to the exposures at which no worker will suffer diminished health, functional capacity, or life expectancy as a result of his or her work experience. NIOSH communicates recommended standards to regulatory agencies (including the Occupational Safety and Health Administration [OSHA]), health professionals in academic institutions, industry, organized labor, public interest groups, and others in the occupational safety and health community through criteria documents. Yet limited resources, incomplete data, and the ever-expanding inventory of chemical hazards in the workplace and global commerce make it infeasible to develop standards for all possible hazards. Consequently, NIOSH has also been tasked with assessing and providing technical solutions and promising intervention strategies to protect the safety and health of workers. One such emerging strategy has gained increasing attention among safety and health practitioners: a qualitative risk characterization and management strategy, also referred to as control banding (CB). This strategy groups workplace risks into control bands based on evaluations of hazard and exposure information. The utility of CB is recognized by a number of international organizations, and widening interest can be gauged by the growing literature describing qualitative risk assessment and management strategies. Despite limitations, in the absence of recommended standards, CB may be a useful strategy for assessing and controlling occupational hazards as part of a comprehensive safety and health program. This document is generated from literature reviews of recent developments describing such exposure-characterization and risk-management strategies in occupational settings. In particular, this document summarizes the literature describing qualitative risk assessment and strategies of risk management. The intent of this review is to provide a broad description of qualitative strategies to reduce risk of exposure to occupational hazards, recognizing that a deliberate and extensive review of the literature on this topic will help guide decisions for where CB applications may be most effective. Also important is finding where limitations in our understanding may require additional research or modification or may preclude the use of CB strategies altogether. In meeting these objectives, this document intends to inform its audience—mostly occupational safety and health practitioners, researchers, policy and decision makers, employers, and

iii workers in potentially hazardous work places—of the concepts of CB and the promise it holds as a tool for use within a broader comprehensive occupational safety and health program.

Christine M. Branche, Ph.D. Acting Director, National Institute for Occupational Safety and Health Centers for Disease Control and Prevention

iv EXECUTIVE SUMMARY

The majority of chemical substances in commerce have no established occupational exposure limits (OELs). In the absence of established OELs, employers and workers often lack the necessary guidance on the extent to which occupational exposures should be controlled. A strategy to control occupational exposures that may have value when there are no relevant OELs is known as control banding (CB). CB is a qualitative strategy for assessing and managing hazards associated with chemical exposures in the workplace. The question about the utility of the CB strategy for workplaces in the United States has been raised, warranting a critical review of its concepts and applications. This report is the result of a review of the published literature and related proceedings on CB. The conceptual basis for CB is the grouping of chemical exposures according to similar physical and chemical characteristics, intended processes/handling, and anticipated exposure scenarios (amount of chemical used and how workers would be exposed). Based on these factors, appropriate control strategies (that is, risk management options) are determined for each of these groupings. In one of the least complex forms, a four-level hierarchy of risk management options for controlling exposures to chemicals includes— 1. good occupational hygiene practices, which may be supplemented by use of appropriate personal protective equipment (PPE) 2. engineering controls, including local exhaust ventilation (LEV) 3. containment 4. seeking specialist advice To determine the appropriate control strategy, one must consider the characteristics of a particular chemical substance and the potential for exposure (based on quantity in use, volatility [for liquids], or dustiness [for solids], and the relative hazard as described in what is known as a risk phrase, or R-phrase). Determining potential exposures for airborne particulates or vapors involves characterizing the process or activity in which the chemical substance is used. Work processes help in assigning the chemical substance to a CB. These CBs provide guidance for various control options and recommendations for PPE based on a qualitative assessment of the chemical exposure. The published literature on CB revealed different models, each with varying levels of complexity and applicability. The utility of qualitative risk management strategies such as CB has been recognized by a number of international organizations. Widening interest in this strategy can be gauged by the growing literature describing elements of qualitative risk assessment and management strategies and in some cases, very well- developed models of practice. This report attempts to capture the state-of-the-science of CB as reflected in research and practice. From the published literature and information gleaned from proceedings of recent international workshops, symposia, and conferences on this subject, the following major themes related to CB have emerged:

v • Factors influencing the evolution of qualitative risk characterization and management of occupational hazards • Strategies of practice • Applicability and limitations of practice • Needs for future research, evaluation, and validation These themes are based on interpretations of current studies and an understanding of the topic. By providing the appropriate background information and resources, this literature review can serve as a means to educate employers, workers, safety and health practitioners, and other audiences about the concepts of CB and to stimulate further dialogue about its potential usefulness in the United States. The scope of this document includes CB strategies, presented within the context of qualitative occupational risk management concepts. The risk management strategy associated with CB is characterized by selection and implementation of appropriate control solutions, often in the absence of OELs, to reduce work-related exposures that may lead to occupational disease, illness, and injury. The use of R-phrases or their equivalents in the Globally Harmonized System (GHS) for Classification and Labeling of chemicals in CB is a useful practice, but it is not intended to replace OELs, exposure assessment, or classic Industrial Hygiene protocol (i.e., hierarchy of controls) on which CB is based. This review indicates that CB is a potentially valuable tool for risk management of some chemical agents and other occupational hazards; however, continued research and validation efforts are needed. Investigation and application of CB principles to other hazardous agents also appear warranted. If CB is to be useful in the United States, it is recommended that the following actions occur: 1. Increase awareness and standardization of concepts associated with CB. 2. Ensure validation of qualitative risk assessment and management strategies, tools, and control-focused solutions. 3. Coordinate efforts for developing, implementing, evaluating, and disseminating qualitative risk assessment and risk management strategies to improve awareness and utility of task-specific, hazard-control guidance. 4. Foster national and international coordination on applications for control- focused solutions for high-risk tasks, industries, and small businesses. 5. Consider CB models for broader application to address additional workplace hazards (e.g., more complex chemical exposures, dermal exposure hazards, ergonomic hazards, other physical hazards). The CB process should be expanded to include occupational safety components to address injury and illness prevention. 6. Incorporate economic analyses into the process of selecting exposure control methods, with the goal of developing a more complete understanding of the relationship between the hierarchy of controls and their cost effectiveness.

vi In summary, this review and analysis have led to recognition of the following key messages: • Control banding is a potentially valuable tool for risk management of source chemical agents and other occupational hazards. • Despite limitations, in the absence of OELs, CB may be a useful strategy for assessing and controling occupational hazards as part of a comprehensive safety and health program. • CB is not meant to be a substitute for OELs. • The use of CB does not alleviate the need for environmental monitoring and industrial hygiene expertise. • CB strategies may be useful for providing hazard control guidance to small and medium size enterprises (SMEs); larger businesses may find CB strategies of greatest utility for prioritizing hazards and for hazard communication. Additional development, evaluation, and discussion are required before widespread implementation of CB in the United States can be recommended. This document is intended to set the stage for that discussion. At this time, the existing toolkits for CB may not be appropriate for the United States and will need modification before being applied. Critical is the need for a dynamic system that incorporates changing factors over time for both control implementation and managerial oversight. It is recommended that a taskforce of safety and health professionals, labor and management, and government representatives be established to advance the research and development needs for CB in the United States.

vii

CONTENTS

Foreword ...... iii Executive Summary ...... v Abbreviations ...... xiii Glossary ...... xv Acknowledgments ...... xvi 1 | Challenges of Traditional Risk Management Using Occupational Exposure Limits ...... 1 2 | Problems Implementing Measures to Limit Workplace Exposures . . . . . 3 3 | The Origins of Control Banding for Chemical Agents ...... 5 3.1 Core Principles of Control Banding ...... 8 3.2 Possible Components of Control Banding ...... 8 3.2.1 Hazard Category ...... 9 3.2.2 Hazard Classification ...... 9 3.2.3 R-Phrases ...... 9 3.3 Early Models of Control Banding ...... 9 3.3.1 COSHH Essentials ...... 11 3.3.2 France (Risk Potential Hierarchy) ...... 13 3.3.3 Germany (Chemical Management Guide) ...... 14 3.3.4 The Netherlands (Stoffenmanager) ...... 16 3.3.5 Norway (KjemiRisk) ...... 16 3.3.6 Belgium (Regetox and SOBANE) ...... 17 3.3.7 Singapore (SQRA) ...... 18 3.3.8 Korea (KCT) ...... 19 4 | The Architecture on Which Control Banding is Based ...... 21 4.1 Occupational Exposure Bands and Occupational Exposure Limits . . . . 21 4.2 Levels of Facility Design and Construction Based on Carcinogenicity of Chemicals to Be Used ...... 23 4.3 Exposure Assessment ...... 24 4.4 Toxicologic Considerations (Brooke 1998) ...... 24 4.5 Occupational Control Considerations (Maidment 1998) ...... 27 4.6 Providing Control Guidance to Users ...... 30 5 | Validation and Verification of Control Banding Strategies ...... 33 5.1 Variables for Validation ...... 33

ix 5.1.1 Exposure Prediction ...... 33 5.1.2 Hazard Prediction ...... 33 5.1.3 Control Recommendations ...... 33 5.1.4 Training ...... 34 5.1.5 Control Implementation ...... 34 5.2 Studies Performed for Validation of Control Banding ...... 34 5.2.1 Tischer et al. 2003; Brooke 1998; Kromhout 2002a,b; Topping 2002a ...... 34 5.2.2 U.K. Health and Safety Executive Studies (Maidment 1998) . . . 35 5.2.3 German Bundestalt für Arbeitsschutz und Arbeitsmedizin Study ...... 36 5.2.4 University of California–Berkeley Study (Jones and Nicas 2004, 2006a,b) ...... 36 5.3 Expert Opinions on Control Banding ...... 38 6 | Specific Issues in Control Banding ...... 41 6.1 Dermal Absorption ...... 41 6.2 Silica (HSE) ...... 43 6.3 Asthmagens (HSE, NIOSH, OSHA) ...... 44 6.4 Asbestos Essentials (HSE) ...... 44 7 | Special Events Surrounding Control Banding ...... 45 7.1 First International Control Banding Workshop (ICBW1) ...... 45 7.2 Second International Control Banding Workshop (ICBW2) . . . . . 46 7.3 Third International Control Banding Workshop (ICBW3) ...... 46 7.4 Fourth International Control Banding Workshop (ICBW4) . . . . . 47 7.5 International Agreements ...... 47 8 | Critical Analysis of Control Banding Strategies ...... 49 8.1 A Discussion of Weaknesses and Strengths of CB Efforts ...... 49 8.1.1 General Control Banding v. COSHH Essentials ...... 49 8.1.2 Estimated Controls v. Specific Science ...... 51 8.1.3 Control Banding Strategies v. Full-time Industrial Hygiene Professionals ...... 51 8.1.4 Control Banding v. Reliance on OELs ...... 51 8.1.5 Not Monitoring v. Monitoring ...... 52 8.1.6 Qualitative Output v. Quantitative Input ...... 52 8.1.7 Static Control v. Dynamic ...... 53

x 8.2 Determine the Barriers to, and Considerations for, Implementing Control Banding to Address Safety and Health Hazards in U.S. Workplaces . . 53 8.2.1 Use of Standardized Hazard Statements in Control Banding . 54 8.2.2 Considerations for Implementing control Banding ...... 55 8.2.3 OSHA and Its Voluntary Consultative Services ...... 56 8.3 Implementation of a Risk Management System in the United States that Includes CB Strategies ...... 57 8.3.1 Can Toolkits and Toolboxes Reduce Occupational Exposures to Protect the Health of Workers on a National Basis? . . . . 57 8.3.2 Implementation in Small Businesses ...... 58 8.3.3 Expanding to an ORM for Chemical Control ...... 58 8.3.4 Develop Ergonomic Toolkits Based on Existing National Models ...... 59 8.3.5 Investigate Expansion to Safety and Environmental Parameters ...... 59 8.3.6 Investigate Expansion to Psychosocial Toolkits ...... 60 8.3.7 Implementing a National Control Banding Strategy ...... 60 8.4 How Can International Cooperation Assist in the Creation of Toolkits and ORM Toolboxes? ...... 61 8.4.1 Twinning Developed Countries with Developing Countries ...... 61 8.4.2 Americas Silica Control Banding Effort ...... 61 8.4.3 Expanding to an ORM Toolbox ...... 62 8.4.4 Fitting Control Banding into Occupational Safety and Health Management Systems ...... 62 8.4.5 Control Banding Compatibility with the Globally Harmonized System for Classification and Labeling of Chemicals ...... 63 8.5 Recognition of Specific Industries or Activities Where CB May Be Adopted ...... 65 8.6 Additional Applications of CB in Ergonomics, Noise, and Traumatic Injuries ...... 66 8.6.1 Control Banding for Ergonomics ...... 66 8.6.2 Control Banding for Noise ...... 67 8.6.3 Control Banding for Traumatic Injuries ...... 67 8.6.4 Control Banding for Nanotechnology ...... 68 8.7 Current Collaborations to Explore CB ...... 69 9 | Discussion and Conclusions ...... 71

xi 10 | Recomendations to Facilitate the Implementation of CB Strategies in the United States ...... 73 10.1 Recommendations for Improving Awareness and Standardization of Concepts ...... 73 10.2 Recommendations for Validation ...... 74 10.3 Recommendations for Expanding the Control Banding Model ...... 74 10.4 Recommendations for Disseminating Control Banding ...... 75 10.5 Recommendations for Coordination and Collaboration ...... 75 References ...... 77 Appendix A. Related Publications with Selected Annotations ...... 85 Appendix B. Allocation of Hazard Bands for Vapors ...... 89 Appendix C. International Agreements ...... 91

xii ABBREVIATIONS

ABPI Association of the British Pharmaceutical Industry ACGIH American Conference of Governmental Industrial Hygienists AIHA American Industrial Hygiene Association ANSI American National Standards Institute BAuA Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (German Federal Institute for Occupational Safety and Health) BOHS British Occupational Hygiene Society CB control banding CEFIC Conseil Européen de l’Industrie Chimique (European Chemical Industry Council) CGS control guidance sheet CHIP Chemical Hazard Information and Packaging CIA Chemical Industry Association COSHH Control of Substances Hazardous to Health CS control strategy dB decibels DREAM Dermal Exposure Assessment Method EASE Estimation and Assessment of Substances Exposure ECETOC European Centre for Ecotoxicology and Toxicology of Chemicals EMKG easy-to-use workplace control scheme for hazardous substances EPA U.S. Environmental Protection Agency EPL exposure predictor bands for liquids EPS exposure predictor bands for solids ES&H Environmental Safety and Health EU European Union GHS Globally Harmonized System for Classification and Labeling of chemicals GTZ Deutsche Gesellschaft für Technische Zusammenarbeit HCS Hazard Communication Standard HSE Health and Safety Executive (of the United Kingdom) ICBW International Control Banding Workshop ICCT International Chemical Control Toolkit IH industrial hygiene ILO International Labor Office INRS Institut National de Recherche et de Sécurité IOHA International Occupational Hygiene Association

xiii IPCS International Programme on Chemical Safety ISO International Organization for Standardization ITG International Technical Group KCT Korean Control Toolkit KOSHA Korean Occupational Safety and Health Agency LEV local exhaust ventilation LOAEL lowest observed adverse effect level MAK Maximale Arbeitsplatzkonzentration (maximum concentration of a substance in the ambient air in the workplace) MSDS Material Safety Data Sheet NIOSH National Institute for Occupational Safety and Health NOAEL no observed adverse effect level OEB occupational exposure band OEH Occupational and Environmental Health OEL occupational exposure limit OHSAS Occupational Health and Safety Assessment Series ORM Occupational Risk Management OSHA Occupational Safety and Health Administration PPE personal protective equipment ppm parts per million PRIMAT Psychosocial Risk Management toolkit R-phrases risk phrases REACH Registration, Evaluation, Authorisation and Restriction of Chemicals RSC Royal Society of Chemistry S-phrase safety phrase SME small and medium enterprise SOBANE Screening, Observation, Analysis, Expertise SQRA Singapore’s Semi-Quantitative Risk Assessment TLV Threshold Limit Value TWA time-weighted average U.K. United Kingdom WHO World Health Organization WHOCC WHO Collaborating Centers WIND Work Improvement in Neighborhood Development WISE Work Improvement in Small Enterprises

xiv GLOSSARY control banding (CB): A strategy that groups workplace risks into control categories or bands based on combinations of hazard and exposure information. The following four main CBs have been developed for exposure to chemicals by inhalation: Band 1: Use good industrial hygiene (IH) practice and general ventilation. Band 2: Use local exhaust ventilation. Band 3: Enclose the process. Band 4: Seek expert advice. This qualitative strategy to assess and manage risk focuses resources on exposure controls and describes how strictly a risk needs to be managed. COSHH Essentials: A CB strategy developed by the British Health and Safety Executive (HSE) to assist small- and medium-sized enterprises in complying with Control of Substances Hazardous to Health (COSHH) regulations. The COSHH Essentials guidance is available in both a published document and in a Web-based model known as eCOSHH Essentials [www.coshh-essentials.org.uk]. KjemiRisk: Assessment of chemical health risk based on experience and practice in the Norwegian oil industry. Occupational Risk Management (ORM): The process of using a combination of knowledge, training, and resources of IH practice to address hazards in the workplace. This process may encompass the use of a variety of toolbox strategies, which are defined below, (and within these, toolkits), including qualitative risk assessment and control- focused strategies to minimize hazardous exposures. Toolbox: A collection of strategies for the control of worker exposures and may be comprised of multiple toolkits. The toolbox concept is presented as a receptacle of various toolkits used to address various workplace hazards associated with specific industries and tasks. As such, the toolbox provides a mechanism for managing occupational risk and is currently referenced as an ORM or CB toolbox. Toolboxes with relevance for ORM in the United States include the broad (Environmental Safety and Health Toolbox), the industry-specific (Construction Toolbox), and the occupation- specific (Hair Dressers Toolbox). Toolkit: A narrowly defined, solutions-based strategy for the control of worker exposures that is focused to a discrete task or series of tasks.

xv ACKNOWLEDGMENTS

This document was developed by the Education and Information Division (EID), Paul Schulte, Ph.D., Director. Thomas Lentz, Ph.D., was the project officer for this document, assisted in great part by Richard Niemeier, Ph.D., and Charles Geraci, Ph.D. The basis for this document was a report contracted by NIOSH and prepared by Deborah Imel Nelson, Ph.D. (University of Colorado, Boulder) and David M. Zalk (Lawrence Livermore National Laboratory). The following persons and organizations were especially helpful in providing information for the initial report: Jennifer Silk (OSHA, retired), Andrew Garrod (HSE), Paul Evans (HSE), the National Control Banding Workshop Organizing Committee, and the Risk Assessment Committee of the American Industrial Hygiene Association. For review and contributions to the technical content of this document, the authors gratefully acknowledge the following NIOSH personnel:

Education and Information Division Division of Applied Research and Catherine Beaucham Technology Donna Heidel Duane R. Hammond Alan Weinrich Stephen D. Hudock, Ph.D. Ralph Zumwalde Andrew Maynard, Ph.D. Larry Reed John W. Sheehy Division of Respiratory Disease Studies Division of Safety Research Randy Boylstein Alfred A. Amendola, Ph.D. Mark Hoover, Ph.D. Greg J. Kullman Chris Piacitelli Division of Surveillance, Hazard Health Effects Laboratory Division Evaluations, and Field Studies Omur Cinar Elci, M.D. Chandran Achutan Martin Harper, Ph.D. Eric J. Esswein Aaron Sussell, Ph.D. National Personal Protective Office of the Director Technology Laboratory Marilyn Fingerhut, Ph.D. Heinz W. Ahlers, J.D. Matt Gillen Paul Middendorf, Ph.D. Spokane Research Laboratory Thomas M. Brady Pamela L. Drake

xvi The authors thank Jane Weber, Sue Afanuh, Anne Hamilton, Elizabeth Fryer, Vanessa Becks, Gino Fazio, and Jackie Rogers for their editorial support and contributions to the design and layout of this document. Clerical and information resources support in preparing this document was provided by Lucy Schoolfield, Norma Helton, Rosmarie Hagedorn, and Laurel Jones. Finally, special appreciation is expressed to the following individuals for serving as independent, external reviewers and providing comments that contributed to the development or improvement of this document: Anne Bracker, University of Connecticut Health Center, Farmington, Connecticut Patrick Breysse, Ph.D., School of Public Health, Johns Hopkins University, Baltimore, Maryland Warren Brown, American Society of Safety Engineers, Des Plaines, Illinois Alberto Camacho, Ph.D., Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ) GmbH, Germany Paul Evans, Health and Safety Executive, Bootle, United Kingdom Ho Sweet Far, Ph.D., Ministry of Manpower, Singapore Henri Heussen, Ph.D., Arbo Unie Expert Centre for Chemical Risk Management, the Netherlands Paul Hewett, Ph.D., EAS Solutions, Inc., Morgantown, West Virginia Walter Jones, Laborers’ Health and Safety Fund of North America, Washington, DC Byung Gyu Kim, Korea Occupational Safety and Health Agency, Republic of Korea Jacques Malchaire, Université catholique de Louvain, Belgium Rolf Packroff, Ph.D., Federal Institute for Occupational Safety and Health, Dortmund, Germany Carolyn Vickers, World Health Organization, Geneva, Switzerland Dee Woodhull, ORC Worldwide, Washington, DC

xvii

Challenges of Traditional Risk Management Using Occupational Exposure Limits

The traditional approach to protecting the proportion of injuries and illnesses re- worker health was pioneered in the late lated to chemical hazards is not known. 19th century when the first occupational Strict reliance upon sampling and analyz- exposure limits (OELs) were established ing airborne contaminants and compar- in Germany [Jayjock et al. 2000]. Sam- ing results with OELs has become increas- pling and analysis of airborne contami- ingly difficult in recent decades because of nants was performed, and results were the growing number of hazardous chemi- compared with OELs. In 1946 the Ameri- cals. The increasing number far outweighs can Conference of Governmental Indus- the ability and resources—of government trial Hygienists (ACGIH) published its and other agencies external to chemical first list of exposure limits for 148 chemi- manufacturers—to determine associated cals, then referred to as Maximum Al- OELs. To address this concern, the Euro- lowable Concentrations and renamed to pean Commission promulgated regula- Threshold Limit Values (TLVs) in 1956 tions known as the Registration, Evalu- [ACGIH 2007]. In the following decades, ation, Authorisation and Restriction of this sampling-and-analysis approach to Chemicals (REACH), which would shift risk management was adopted by many the burden of proof of chemical safety to of the industrialized nations and, as a re- manufacturers and would apply to most sult, contributed to the improvement of chemicals in commerce [EC 2001]. working conditions, increased span and quality of life for workers, and decreased Also contributing to the increasing difficulty compensation costs. As a case in point, for to protect worker health is the large variabil- the years 1972 and 2000, records from the ity in exposure measurements, both within U.S. Department of Labor, Bureau of La- and between workers. Because of these bor Statistics, indicate a reduction in oc- challenges, individual companies, trade as- cupational injuries and illnesses per 100 sociations, and government agencies have workers from 10.9 cases to 6.1 [Swuste and developed innovative strategies to protect Hale 1994; NIOSH 2002, 2004]. However, both worker health and the environment.

Problems Implementing Measures to Limit Workplace Exposures

To control workplace exposures to haz- interviews were conducted about chemi- ardous chemicals, in the late 1980s the cal use, sources of information, risk man- United Kingdom Health and Safety Exec- agement, and understanding of COSHH utive (HSE) developed a simplified strat- and OELs among 1,000 randomly selected egy to assess health risks in the workplace chemical users and 150 safety and health called Control of Substances Hazardous representatives of trade unions. The ma- to Health (COSHH). Despite much opti- jority (75%) of respondents worked at mism that these regulations would “bring facilities with fewer than 10 full-time greater emphasis on the assessment of workers, mirroring the makeup of British risks to health in industry” [Parker 1989], industry, although the majority of trade their effective implementation met many union representatives worked at compa- challenges [Winterbottom 1987]. An un- nies employing more than 100 workers. published survey of 2,000 companies, The findings follow: taken shortly after COSHH promulga- tion, showed “widespread ignorance of ■■ Decisions on control measures were the new regulations and their implications based largely on information from among smaller concerns…” [Seaton 1989]. suppliers and on personal experi- Through the 1990s, there were many re- ence. ports of deficiencies and needs of many ■■ Most respondents took measures workplaces in complying with COSHH to protect workers, primarily by regulations, particularly in healthcare set- making personal protective equip- tings [Hutt 1994; Menzies 1995; Fraise ment (PPE) available, followed by 1999; Barker and Abdelatti 1997; Cooke process controls. This finding in- et al. 1991; Harrison 1991; Waldron 1989; dicates that failure to comply re- Aw 1989]. sults more from lack of knowledge than from unwillingness to meet In an effort to understand better the prob- the requirements. lems with implementation of COSHH, HSE conducted market research to char- ■■ Only 35% of the respondents were acterize industry’s perception of OELs aware of COSHH; only 19% truly and the degree to which decisions on con- understood OELs. trol measures were affected by OELs [Top- ■■ Trade union representatives tend- ping et al. 1998; Tischer 2001b]. Telephone ed to have greater understanding

3 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

of COSHH and its requirements ■■ Measurement of workers’ exposure than the chemical users from small to chemicals is usually not possible firms. because of cost, lack of availability, ■■ Larger chemical companies and and difficulty in interpretation and occupational safety and health pro- application to microbusinesses. fessionals understand the COSHH These findings likely apply in the United requirements, yet “many small firms States because the employment composi- wanted to be told exactly what they tion of U.S. businesses is similar to that of need and do not need to do” [Top- the United Kingdom. ping 2001]. Topping et al. [1998] concluded that, giv- According to Oldershaw [2003], the prob- en the widespread lack of understanding lem of failing to understand and comply about OELs, generation of additional lists with COSHH regulations and OELs was of OELs would not be cost effective and greater for microenterprises (<5 workers). that OELs should be limited to widely used substances of concern. Consequently, rec- ■ ■ Microbusinesses are not just small- ognizing that OELs and other information er versions of larger businesses; un- about the chemical (e.g., physical proper- like big business, they cannot afford ties, use) could be used to recommend ap- occupational safety and health spe- propriate control measures, these authors cialists. suggested a reappraisal of the traditional ■■ OELs may be of no practical use to OEL system. Thus the birth of control microbusinesses. banding.

4 3

The Origins of Control Banding for Chemical Agents

In the late 1990s the advancements made areas, such as physical hazards, ergonom- since the 1970s in risk and control strate- ics, and psychosocial factors. gies were combined to result in a simple CB has grown from a number of qualita- but powerful concept: tive and semi-quantitative risk assessment Health Hazard + Exposure Potential → Generic strategies that began to appear in the 1970s Risk Assessment → Control Strategy [Money 2003; Lewis 1980; AIChE 1994; This equation indicates that information Nauman et al. 1996]. Examples of key el- about the health hazard and exposure as- ements in evolution of relevant strategies sociated with a chemical substance and its are presented in Table 1. Similarities are use can be used to perform a qualitative evident in these strategies because they risk assessment and determine the appro- borrowed elements from each other and built upon previous efforts [Money 2003] priate risk management or control strategy. and because ideas were exchanged among Control banding (CB) is a strategy for occupational health practitioners and sci- qualitative risk assessment and manage- entists in the pharmaceutical and chemi- ment of hazards in the workplace. The cal industries, governmental agencies, and strategy involves a process to group work- professional and trade associations. place risks into control bands based on The influence of the pioneering efforts of combinations of hazard and exposure in- the U.S. pharamaceutical industry in the formation. CB strategies are not intended 1980s and 1990s, including the origins of to be predictive exposure models. the concept of performance based exposure The earliest CB strategies evolved based control limits (PBECLs) [Naumann et al. on the premise that, although workers 1996], are undeniably tied to the evolution may be exposed to a number of chemi- of CB strategies. Because such concepts cals, only a few (generally four or five) were also quickly taking hold at the same categorical approaches exist to protect time elsewhere among groups like the Roy- them (e.g., occupational exposure limits al Society of Chemistry and the Chemical [OELs]). These strategies linked the haz- Industry Association, it is sometimes diffi- ard of a chemical substance, usually deter- cult to distinguish the sources of additional mined by a simple measure of toxicity, to advances. The professional interactions a suite of control measures. Though this were such that CB concepts were evolving literature review focuses on chemical risk, rapidly through technical exchanges of U.S. CB strategies are expanding into other and European groups.

5 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

Table 1. Key elements in the evolution of qualitative occupational risk management and CB* concepts and their references in the literature

Element(s) References

Safety risks from major facilities: risk matrices combining severity ICE 1985; AIChE 1992 and frequency of event Simplified strategy for workplace health risk assessment (COSHH†) HMSO 1988 Application of safety risk concepts to workplace health (in laborato- RSC 2003; Money 2003 ries): (1) categorization of hazard using R-phrases, (2) simple strategy to estimate exposure in laboratories or a workplace risk matrix using both to identify appropriate control solutions Health risk assessment for laboratories RSC 2003, 1996 Use of hazard ratings (e.g., for prioritizing IH‡ monitoring, installing Henry and Schaper 1990 engineering controls, selecting PPE§) Relationship between risk phrases (R-phrases) and OELs¶ Gardner and Oldershaw 1991 Use of carcinogenic ranking of aromatic amines and nitro com- Gardner and Oldershaw 1991; pounds to suggest practical workplace controls Crabtree et al. 1991; Money 1992a; CIA 1993 Application of the RSC strategy beyond laboratories (e.g., the phar- Naumann et al. 1996; Money maceutical industry); these strategies use R-phrases and simple algo- 1992a; CIA 1993 rithms to estimate exposures and combine both to suggest controls, representing the “first use of CB concepts for wider use in industry” [Money 2003]. These sector-specific strategies led to the idea that hazard classification could provide a basis for generic exposure control standards [Money 2003] and went beyond original categorization of carcinogens to include other toxic endpoints (e.g., CIA†† [1993]). (Note: Strategies used in the pharmaceutical industry now include lacrymators, highly toxic substances, reproductive hazards, irritants, sensitizers, and mutagens [Tait 2004].) Application for specific product classes and families, allowing more CIA 1992; Money 1992b detail in a more limited setting (ranking of carcinogens and linking with facility design and safe handling guidelines) Health risk assessment for product classes and families. The CIA Naumann et al. 1996; CIA 1993; [1993] includes a table for colorants that includes hazard category HSE 2001 (14), hazard classification (e.g., toxic, corrosive), associated R- phrase, guideline control level (8-hour TWA‡‡), and a separate set of recommendations for each hazard category. (Continued)

6 Chapter 3 | The Origins of Control Banding for Chemical Agents

Table 1 (Continued). Key elements in the evolution of qualitative occupational risk management and CB* concepts and their references in the literature

Element(s) References

Setting OELs and OEBs§§ for pharmaceutical agents ABPI 1995 Further development of RSC strategy RSC 2003 Additional proposals for generic OELs‡ or control strategies based ABPI 1995; CIA 1997; TRG 1996 on hazard categorization Marketed chemicals in general Russell et al. 1998; Brooke 1998; Maidment 1998; HSE 1999, 2000, 2001 Health risk assessment for industry HSE 1999; IOM 2005

Safety, health, and environmental risk assessment for users of chemi- UIC 1999 cals Strategies for the tiered and targeted risk assessment of chemicals ECETOC 2002 Work Improvement in Small Enterprises (WISE) ECETOC 2002 Work Improvement in Neighborhood Development (WIND) ECETOC 2002

Adapted from Money 2003. *CB=control banding †COSHH= Control of Substances Hazardous to Health ‡IH=industrial hygiene §PPE=personal protective equipment ¶OEL=occupational exposure limit **RSC= Royal Society of Chemistry ††CIA=Chemical Industry Association ‡‡TWA=time weighted average §§OEB=occupational exposure band

7 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

Development and implementation of a ■■ Install/operate controls to reduce CB strategy requires five actions: creation exposures. of the strategy, its application, the installation and operation/maintenance of con- Validation of a CB model will require that trols, postcontrol monitoring, and failure these activities be considered. analyses at each step of the CB process, as follows: 3.1 Core Principles of Suppliers Control Banding ■■ Assign risk phrase (R-phrase) (see According to Money [2003], one basic Section 3.2.3) or other toxicologic tenet for CB is the need for a method rating to a substance. that will return consistent, accurate results even when performed by nonexperts. ■■ Assign R-phrase to appropriate haz- Identifying key exposure determinants ard band (see Table 4). without relying on sophisticated sampling ■■ Report R-phrase on safety data sheets. methods is an important step towards sat- ■■ Consider hazard statements of the isfying this requirement. Other core CB Globally Harmonized System for principles follow: Classification and Labeling (GHS) ■■ The strategy must be understand- of chemicals. able by workers to facilitate risk ■■ Determine boiling point for liquid evaluation and communication. substances and preparations. ■■ The strategy must be user-friendly. ■■ Establish better terms to discrimi- ■■ Required information (e.g., mate- nate low, medium, and high po- rial safety data sheets [MSDSs]) tential exposures for airborne par- must be readily available to work- ticulates. ers, particularly at small and me- Users dium enterprises (SMEs). ■■ Acquire complete understanding ■■ Guidance on how to apply the strat- of the strategy, including R-phras- egy must be practical. es, quantity of substance in use, and ■■ Workers must have confidence in dustiness/volatility of substance. the strategy and the output advice ■■ Construct strategy to combine it provides. quantity in use, dustiness/volatility, ■■ Presentation of advice must be and other determinants, to predict transparent and consistent. exposure band. ■■ Use hazard information with task 3.2 Possible Components activities to determine the control guidance level. of Control Banding ■■ Select Control Guidance Sheet A key component of a CB strategy is the (CGS). ability to categorize easily the toxicity of

8 Chapter 3 | The Origins of Control Banding for Chemical Agents

substances using information that is The hazard posed by exposure to a chemi- readily available, linking hazard category cal via a given route was ranked according (1–4), hazard classification (e.g., toxic, to the chemical’s European Union (EU) corrosive), associated R-phrase, guideline risk phrases (R-phrases), and potential for control level (8-hour TWA), and recom- exposure was estimated by the quantity in mendations for each hazard category. use and the volatility of liquids or, for solids, potential for airborne particulates. 3.2.1 Hazard Category Gardner and Oldershaw [1991] present- Traditionally, the pharmaceutical industry ed a comparison of the American (AC- has established OELs for active ingredi- GIH TLVs) and German OELs to the ents using risk assessment methods. How- designated R-phrases for volatile organic ever, Naumann et al. [1996] investigated a substances [EEC 1987]. They found (1) new strategy because of (1) the increasing that the distributions of the OELs for potency of these chemicals, (2) difficulties substances consistent with grouping by in establishing no effect levels for certain R-phrase 23 (toxic by inhalation) and R- products, and (3) challenges in sampling phrase 26 (very toxic by inhalation) best and analyzing contaminants at very low fit a log-normal distribution and (2) that exposure levels. the means for both R-phrase groups were not significantly different. They concluded that the R-phrases, though not OELs, 3.2.2 Hazard Classification could be referenced as Pragmatic Expo- Based on biosafety-level concepts used sure-Control Concentrations and applied in laboratories and on toxicologic and as guides to control inhalation exposure pharmacologic properties of chemicals when other information was lacking. The used for various operations, Naumann authors suggested that such CB would be et al. [1996] distinguished five hazard useful in cases where toxicologic data on categories (performance-based exposure substances were incomplete or the ability control limits). Compounds were placed to understand such data was limited. into these categories based on the phar- Tischer [2001a] noted that the assignment maceutical active ingredients and on the of R-phrases to hazard bands, described engineering controls and administrative in Table 4, was still being debated in Ger- procedures known to be effective in con- many in 2001 and might well result in a trolling exposures to the necessary level. different model than the HSE characterization. 3.2.3 R-Phrases In 1998 the Annals of Occupational Hy- 3.3 Early Models of Control giene published a series of papers outlin- Banding ing a CB strategy in which the hazard categorization, or hazard band, was combined Interest in CB strategies on the part of the with the potential exposure to determine European occupational hygiene commu- a recommended level of control strategy. nity was spurred by the introduction of

9 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

the Chemical Agents Directive in 1998 exposure monitoring should be [Money 2003; EC 1998]. Several CB strat- conducted (see Figure 1). egies resulted [Money 2003], along with 3. European Centre for Ecotoxicol- other developments noted for their im- ogy and Toxicology of Chemicals pact on chemical risk management: (ECETOC) tiered and targeted risk assessment [ECETOC 2002] 1. REACH would shift the burden of could aid in the registration of a proof of chemical safety to indus- large number of chemicals un- try and would apply to most chem- der REACH (see Figure 2). Tier icals in commerce [EC 2001]. 0 screens out chemicals not pre- 2. The European Chemical Industry senting an immediate risk to hu- Council (CEFIC) exposure manage- mans or the environment. Tier 1 ment system [Money 2001] provides identifies uses of a chemical that a guidance tool for SMEs to collect may present further risks to be in- workplace exposure data that, when vestigated in greater depth in Tier coupled with hazard information, 2. In Tier 1, margins of exposure delivers advice on risks and risk man- are compared with generic OELs agement, recommending whether for the chemical’s hazard category.

Figure 1. The CEFIC exposure management system. Source: Money 2003 (with permission from Oxford University Press, British Occupational Hygiene Society, and the author).

10 Chapter 3 | The Origins of Control Banding for Chemical Agents

Figure 2. Key elements of the ECETOC strategy for the tiered and targeted risk assessment of chemicals. Source: Money 2003 (with permission from Oxford University Press, British Oc- cupational Hygiene Society, and the author).

Tier 2 assessments are conducted Commissions’ Advisory Committee on in accordance with EU risk assess- Toxic Substances—to develop a simple ment principles. system of generic risk assessment [Top- ping 2001]. This strategy, which leads to 3.3.1 COSHH Essentials selection of appropriate controls, was first published as COSHH Essentials: Easy Steps In the United Kingdom, the Health and To Control Chemicals [HSE 1999]. Safety Executive (HSE) was faced with the reality that OELs would never be de- HSE was faced with developing guidance veloped for a large number of chemical that was practical for SMEs, based on read- substances and that users at the major- ily available hazard information, and that ity of SMEs did not understand and did was easy to use and understand. Figure 3 not have the resources to meet COSHH illustrates the general pattern of processing requirements to conduct risk assess- hazard information to derive appropriate ments for chemicals used in the work- control approaches, a pattern associated place [Topping et al. 1998; Menzies 1995; with the HSE model [Russell et al. 1998]. Palmer and Freegard 1996]. In response, The model describes using R-phrases and HSE established a working group of key simple predictors of exposure to conduct stakeholders—the U.K. Health and Safety a generic risk assessment, which leads to

11 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

Health Hazard Exposure Potential Substances allocated to a Substances allocated to dust- hazard band using R-phrases + iness or volatility band and a band for the scale of use →

Control Approach Type of approach needed to achieve adequate control →

Generic Risk Assessment Combination of health hazard and exposure potential factors determined desired level of control

Figure 3. Factors used in HSE's core model [Russell et al. 1988].

straightforward recommendations on risk COSHH Essentials is the most fully de- management (i.e., control strategies). veloped CB strategy for chemical assessment, and guides users in selecting the Because COSHH Essentials is limited appropriate level of management based on to substances classified under Chemi- the following: cal Hazard Information and Packaging (CHIP) regulations, the model is not ap- ■■ The type of task being performed plicable to pesticides and pharmaceuticals (12 general levels) nor is it applicable to process-generated ■■ The assignment of the chemical hazards such as wood particulate and substance to Hazard Band A–E (see welding fumes. (Silica dust is also exclud- Section 4.4 and Table 4), based on ed, but has been addressed more recently its hazard with the HSE development of the silica ■■ The volatility (3 levels) or poten- hazard and task-specific guidance sheets.) tial for generation of airborne par- Hazard banding, exposure potential, and ticulate (3 levels) of the chemical control methods are the key components substance of the COSHH Essentials strategy (see ■■ The quantity of the chemical sub- Figure 4). stance used in the task (3 levels)

12 Chapter 3 | The Origins of Control Banding for Chemical Agents

Control Approach 1—General ventilation. Good standard of general ventilation and good working practices.

Control Approach 2—Engineering control. Ranging from local exhaust ventilation to ventilated partial enclosure.

Control Approach 3—Containment. Containment or enclosure, allowing for limited, small scale breaches of containments.

Control Approach 4—Special. Seek expert advice.

Figure 4. Control approaches used COSHH Essentials [Russell et al. 1988].

COSHH Essentials then provides specific COSHH Essentials is a valuable toolkit for guidance in the form of a CGS for specific protecting workers from airborne con- workplace procedures and the recom- taminants. In its original form it was lim- mended CB. Hudspith and Hay [1998] ited to the inhalation route of exposure agree with HSE to provide guidance in the and to certain chemicals used in manufac- form of CGSs, but they point out an addi- turing (others being regulated in specific tional obstacle to worker protection: com- statutes). Work is ongoing to expand ap- munication barriers within companies. plications to other topics, including der- They recommend that HSE continue to mal hazards, process-generated hazards such as airborne crystalline silica, and stress the value of workforce involvement asthmagens (see Section 6.0). in safety and health issues. CGSs are available in paper format or in electronic da- The COSHH Essentials builds on earlier tabase format on the Web at www.coshh- strategies (as described below) [Naumann essentials.org.uk. et al. 1996; CIA 1992, 1997; RSC 2003; Gardner and Oldershaw 1991; Money After an introductory passage titled “The 1992a,b] but adds two significant devel- sunset of exposure limits—and the dawn opments: it is specifically developed for of something better?” [Ogden 1998], the SMEs and it includes control advice. Annals of Occupational Hygiene ran a series of articles [Russell et al. 1998; Brooke 3.3.2 France (Risk Potential 1998; Maidment 1998] explaining the ba- Hierarchy) sic concepts of COSHH Essentials, toxicologic considerations, and occupational The Institut National de Recherche et de hygiene considerations. Sécurité (INRS) research center in France

13 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

reported on a system that uses simple and 3.3.3 Germany (Chemical available information to prioritize risk as- Management Guide) sessment of chemicals at the company level, taking into consideration hazard and Germany is the third largest chemical pro- exposure factors (translated from French): ducing nation in the world, and the largest chemical exporting nation [Adelmann This risk results from the conjunction 2001]. As such, it has taken measures to of a hazard and an exposure. In the assist developing countries in managing case of a chemical product, the risk chemicals by supporting implementation corresponds to the toxicological prop- of the Rotterdam (prior-informed-con- erties of the product; the exposure is sent) and Stockholm (Persistent Organic linked to a number of factors such Pollutants) Conventions by building ca- as the quantity used, the conditions pacity and by conducting demonstra- of use, the physical characteristics of tion projects [Tischer 2002; Tischer and the product, the means of prevention Scholaen 2003; Scholaen 2003]. Under its utilized, and the duration of exposure Convention Project on Chemical Safety, [Vincent and Bonthoux 2000]. the Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ) has developed a Based on information derived from MS- Chemical Management Guide as part of DSs and labels, chemicals are assigned to its Pilot Project on Chemical Safety. The categories based on (1) hazard classifica- Chemical Management Guide describes tion and labeling (I–V), (2) frequency of a method to demonstrate and document use (I–IV), and (3) quantity used (I–V). how chemical safety in developing coun- Quantity and frequency of use scores tries and SMEs can be improved and sus- are combined to create a classification tainability implemented in line with inter- by potential exposure (I–V, based on ex- national standards. The guiding principles pert opinion). The scores for hazard (D) of the Chemical Management Guide in- and potential exposure (E) are combined clude practicing sound management of based on the following equation: chemicals, reducing company production Product score = 10(D–1) × 3.16(E–1) costs, increasing product quality, protecting the environment, and ultimately re- The resulting scores have been ranked by ducing the risk to worker health. Its use experts into three priority classifications has been implemented at sites in Argen- (A=elevated, B=middle, and C=weak) tina, Indonesia, and EU countries. (The that can be used at the plant level to pri- guide is available via the Internet at www. oritize chemical substances for further gtz.de/en in English, French, and Span- risk assessment. Internal validation of the ish.) The GTZ Chemical Management model indicated overestimation in 19% Guide and training were also introduced of the cases and underestimation in only as a pilot project in the United States in 1%. The authors concluded that another 2006 through a collaborative effort be- method of evaluation of the real risks at tween the National Institute for Occupa- the workplace should be developed to tional Safety and Health (NIOSH), OSHA, complement this method. the Kentucky Safety and Health Network,

14 Chapter 3 | The Origins of Control Banding for Chemical Agents

Murray State and Eastern Kentucky Uni- a more detailed tool to assess dermal ex- versities, and local businesses in the Com- posure [German FMLS 2006]. CGSs for monwealth of Kentucky [AIHA 2007]. typical tasks give guidance on precise control measures within the control strat- Within the GTZ Chemical Management egy determined with the generic tool. In Guide, the first of three steps is to identify 2007 the generic control guidance sheets hot spots in a company’s manufacturing were supplemented with specific sheets processes (e.g., places where inefficient for activities with chemicals in the rubber storage, handling, use, and disposal can be industry. Currently 36 CGSs offered on observed). Preparing a detailed chemical BAuA´s Web page are consistent with the inventory is the second step. The last step analagous topics in COSHH Essentials. is use of one or more of the following re- The EMKG offers nonregulatory - guid sources: basic risk assessment, description ance, but, like COSHH Essentials, is well of control strategies, MSDSs, safety phras- supported by legal obligations and Codes es for hazardous substances, and symbols of Practice from the tripartite Hazard- for labeling hazardous substances. This ous Substances Committee in Germany. strategy has been ground-tested in Indo- In May 2008 an enhanced version of the nesia and proved successful. Although CB scheme (EMKG 2.0) was launched on the may be too sophisticated for many small BAuA Web site [Kahl et al. 2008]. EMKG enterprises, field observations suggest that 2.0 includes 300 additional substances since the medium and larger enterprises with legal OELs in Germany. Users of the have more MSDSs on site, they have a scheme begin the risk assessment with the greater potential for conducting risk as- OEL, which is aligned with a correspond- sessments using the International Labor ing hazard band. Two possible practical Office (ILO) Chemical Control Toolkit implementations of the scheme are (1) to (ICCT) [Tischer and Scholaen 2003]. use the hazard group that directly relates Since 2005, another effort in Germany to the target airborne concentration range led by the German Bundesanstalt für Ar- that covers the OEL or (2) to use the haz- beitsschutz und Arbeitsmedizin (BAuA) ard band below the OEL and the corre- has offered an easy-to-use workplace sponding control strategy. In the first case control scheme for hazardous substances the employer has to improve the obser- (EMKG) as practical guidance for work- vance of the OEL by applying workplace place risk assessment in SMEs [Packroff et measurements, and in the second case the al. 2006]. Applying information obtained employer can waive workplace measure- from MSDSs to basic workplace condi- ments. tions, the user of EMKG can derive control strategies to minimize exposure via The expansion of EMKG 2.0 to substances inhalation or skin contact. with OELs makes it adaptable for additional applications. EMKG can be used as EMKG is similar to COSHH Essentials. a simple tool to derive exposure scenarios The main differences between the two are for substances to be registrated under the some divergent allocations of R-phrases to REACH regulation by using the derived no hazard bands [German FMLS 2008] and effect level, which is the REACH surrogate

15 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

for an OEL. A more specific EMKG-based a risk inventory, obtaining a plan for con- online tool is under development at BAuA trol measures, making instruction sheets to help producers and importers of chem- for the workplace, and helping to store icals to fullfil the REACH requirement to chemicals according to guidelines. For derive control strategies (CSs) and to rec- the risk inventory, the employer uses R- ommend management measures (e.g., the phrases categorized according to COSHH corresponding CGSs). Essentials. Then the employer completes a qualitative exposure assessment by re- Additional work in Germany relates to sponding to questions to determine the the GHS. A guideline to assist implemen- chemical’s exposure class. The tool auto- tation of the chemical directive 98/24/EC matically calculates a risk score to com- [EC 1998] has been elaborated by a con- plete the initial assessment of the health tractor of the European Commission and risk. The employer reviews the selection has been reviewed by an ad hoc working of various control measures based on the group on chemicals of the tripartite advi- risk score, and chooses the most appropri- sory board to German employment. This ate and effective one accordingly [Tijssen guideline is a recommendation to mem- et al. 2004]. Stoffenmanager is currently ber states for implementation of 98/24/ generic, but the Dutch have plans to adapt EC and is not mandatory. As of publica- it to fit into various industry sectors at a tion date of this review, the guideline was later date. Industry sector-specific tools awaiting its final approval by the advisory would be very helpful and enhance its use body and then publication. [Tijssen et al. 2004].

3.3.4 The Netherlands 3.3.5 Norway (KjemiRisk) (Stoffenmanager) Developed through the cooperation of Stoffenmanager, a Web-based tool for corporations within the Norwegian oil SMEs for working safely with chemical industry, KjemiRisk, based on experience substances, factors exposure potential into and practice in this industry, is a strategy its strategy through the use of an interac- for the assessment of chemical health risk. tive chemical risk management method. The tool takes the following into account: It is available in English and Dutch at physical properties of the chemical; the www.stoffenmanager.nl. Stoffenmanager handling of the chemical; the appropriate- was developed by ArboUnie and TNO ness of the technical, organizational, and Chemistry, a Dutch contract research or- personal barriers established to control ganization. This tool was constructed by the chemical exposure; and the duration using “parts of methods from Germany, and frequency of the work task, using R- Austria, the United Kingdom, Sweden, and S-phrases (safety phrases) as its bases. and Finland” [Tijssen et al. 2004]. Stoffen- Chemicals are grouped into one of five manager supports the requirements for health hazard categories based on R- and maintaining inventory of hazardous sub- S-phrases. As part of the KjemiRisk appli- stances, assessing and controlling risks in cation, 15 common tasks are defined, and

16 Chapter 3 | The Origins of Control Banding for Chemical Agents

the handling of the chemical, its physical scribed in Section 3.3.2. Only products state, duration and frequency of use, po- receiving a rating of medium or high are tential for exposure, and the appropriate- carried forward to the second stage, which ness of controls in place are used in the uses COSHH Essentials. When mixtures conceptual strategy. The risk assessment are being used, the risks are evaluated for is divided into two phases: the potential each harmful component of the mixture risk and the final risk. These are adjusted by weight. For cases in which contami- based on the reliability and appropriate- nants are generated during the process ness of the established controls. The risk (e.g., aerosols generated during spray assessment provides an evaluation of task- painting), the EASE (Estimation and As- based work procedures that have the po- sessment of Substances Exposure) model tential to cause illness related to lungs, in- is used. Feasibility studies conducted at ternal organs, and skin [Smedbold 2004]. two facilities revealed lacking or inad- KjemiRisk is a rough risk assessment tool equate MSDSs. There was only one case in when used by line managers or safety and the two companies in which the strategy health generalists, and it is an expert tool failed to reveal need for improvement in when used by industrial hygienists. It the work situation. The authors felt that is currently available in Norwegian and simple examination of the work situation English as an individual or a network ap- would have indicated the need for semi- plication when integrated with an appro- quantitative risk assessment. Further- priate server. Expansion of Web applica- more, they concluded that for companies tions, increased reporting functionalities, not prepared to comply with the Europe- and substitution of capabilities are cur- an Chemical Agents Directive the use of rently being considered for improvement. the Regetox strategy can be helpful; however, the Regetox strategy requires train- 3.3.6 Belgium (Regetox and ing of prevention advisors and planning to involve employers, staff members, and SOBANE) workers to assist in collecting basic infor- A two-stage risk assessment strategy (Re- mation for the risk assessment. getox) was developed and tested in Bel- The Screening, Observation, Analysis, Ex- gium [Balsat et al. 2002a,b, 2003] in re- pertise (SOBANE) method is a four-level sponse to the European Chemical Agents risk prevention strategy developed around Directive 98/24/EC [EC 1998], which 2004 by Professor Jacques Malchaire at requires companies to assess and man- the Université catholique de Louvain, Oc- age chemical risks in the workplace. To cupational Hygiene and Work Physiology minimize the number of chemicals for Unit in Brussels, Belgium. which risk assessment must be conducted (and thus reduce costs), the first stage of The objective of the screening stage is to the strategy uses the French (INRS) rank- identify the main problems at the worksite ing of potential risk based on R-phrase, and solve the simple ones immediately. annual quantity in use, and frequency of During the observation stage, the more use [Vincent and Bonthoux 2000], as de- complex problems from the screening

17 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

stage are examined in more detail. Work- a need to implement and maintain con- ers and management are assisted through trols, review the assessment every 3 years, the observation process by a nine-page and determine if training and personal air guide. In analysis, if the problems remain monitoring are necessary. The third con- after the first two stages, an occupational trol strategy for the ICCT (containment) health practitioner carries out appropri- is comparable with the SQRA level 4 (high ate measurements to develop proper solu- risk), suggesting implementation of engi- tions. An expert is called in for the final neering controls, personal air monitor- stage to design a more sophisticated solu- ing and training, PPE requirements, and tion or improve an existing one. reassessment of risk after all controls are put into place. The ICCT fourth control strategy (special circumstances) aligns 3.3.7 Singapore (SQRA) with the SQRA level 5 (very high risk), The Semi-Quantitative Risk Assessment which directs users to consult specialists (SQRA) was developed in Singapore by for advice, to comply with requirements the Ministry of Manpower. The purpose for risk level 4, and reassess after controls of the SQRA is to help identify chemi- are implemented. cal hazards, evaluation exposure and its In the theoretical comparison of the CB potential, determine risk level, and pri- strategies, risk is calculated using variables oritize appropriate controls to address the of vapor pressure or particle size, ratio of identified risks. As the foundation for the the odor threshold to the applicable OEL, SQRA, three methods are recognized for amount of chemical used and duration exposure evaluation: monitoring personal of work per week, and control measures. exposure, selecting exposure factors and This result is then compared with the con- parameters, and applying empirical and trol strategy determined by the ICCT, giv- theoretical formulas to estimate exposures en a direct evaluation of the consistency at the plant- or process-design stage. The of the models because the ICCT does not ICCT, based on COSHH Essentials, was take into account existing hazard control tested in parallel with applications of the measures. To assess against the Toolkit’s SQRA to evaluate their utility and to per- control strategy, the empirical compari- form comparisons based on theoretical son of the models uses actual personal air and empirical aspects [Yap 2004]. Direct monitoring data that the SQRA method’s comparison of the two strategies can be risk level was based on. Selected processes stratified by their respective control strat- at 27 SMEs received this comparison. The egies based on risk levels. The first control processes included metal working, paint strategy of the ICCT (general ventilation) manufacturing, chemical processing, fits with SQRA risk level 1 (negligible risk) printing, dry cleaning, and electronics and level 2 (low risk), suggesting periodic industries. The results of the theoretical reassessment and personal air monitor- comparison indicate that the Toolkit and ing requirements. The ICCT second en- the SQRA method are somewhat consis- gineering control strategy aligns with the tent with a difference between the control SQRA level 3 (medium risk), indicating strategy and risk level being one to two

18 Chapter 3 | The Origins of Control Banding for Chemical Agents

bands. In the majority of cases using the and methylene diphenyl diisocyanate, and empirical comparison, it was determined crystalline silica. Another set of six chem- that the ICCT estimates a higher risk than icals and 513 companies were surveyed in the SQRA, thereby suggesting a higher 2007. The chemicals were toluene, styrene, level of control [Yap 2004]. formaldehyde, acrylamide, lead, and nick- el. Based on the results of these surveys, 3.3.8 Korea (KCT) high-risk processes have been selected and appropriate controls developed. The Korean Control Toolkit (KCT) for chemicals has been developed into a Web- The KCT was created by modifying the based tool for SMEs by the Korea Occu- COSHH Essentials and the ICCT. To use pational Safety and Health Agency (KO- the ICCT, the user may select 1 of the 12 SHA). It is currently available through the chemicals from a display menu. The user KOSHA Web site at www.kosha.net/index. will then enter the workplace conditions jsp; however, access is limited to members such as the R-phrase, quantity used, du- only. The KCT is a semi-quantitative as- ration and frequency of use, and physio- sessment strategy that provides advice on chemical properties. Based on the algo- controlling the hazards associated with rithm from the COSHH Essentials, the specific chemicals. Currently the KCT is results will be displayed as a grade of risk available for 12 chemicals, with plans to (A–E) and a band class (1–4). The user se- expand coverage to 30 chemicals that have lects the specific control tool, and the pro- frequently caused occupational diseases cess-specific control suggestions are then in Korea based on industrial disease sta- provided. KOSHA has discovered that tistics and epidemiologic investigations by the current MSDSs do not communicate KOSHA. The first survey effort on which well the hazard information to employees the KCT is based took place in 516 sys- because they are written in scientific and tematically selected companies in 2006 technical terminology rather than in sim- for n-hexane, trichloroethylene, methyl plified language. Therefore, the final -com bromide, dimethylformamide and n,n- ponent of the KCT project is to modify dimethylacetamide, toluene diisocyanate the MSDSs.

The Architecture on Which Control Banding is Based

The concept of CB grew out of the quali- in the European Inventory of Existing tative and semi-quantitative approaches Commercial chemical Substances [Guest that have been practiced as a complement 1998]. Because industry and government to the traditional model of air sampling could not follow the recommendations, and analysis. the CIA developed chemical categorization guidelines [CIA 1997] for their mem- 4.1 Occupational Exposure ber organizations. Bands and Occupational Built on the 1993 CIA guidance and the Exposure Limits work of Gardner and Oldershaw [1991], the new guidelines [CIA 1997] incorporate In their guidelines for safe handling of the CHIP R-phrases, guideline control lev- colorants (second version), the Chemi- els, and data on adverse effects in humans cal Industry Association (CIA) explored (see Table 2). The purpose of these guide- the five elements of CB: hazard category lines was to provide a simple, broad-based, (1–4), hazard classification (e.g., toxic, integrated strategy for use by CIA members corrosive), associated R-phrase, guideline in classifying hazards. The categories were control level (e.g., 8-hour TWA, OEL), to be called occupational exposure bands and recommendations for each hazard (OEBs) and would only be developed when category [CIA 1993] and took “the con- there were no other in-house, national, or cept forward to link hazard categorization international OELs. They would define the and exposure banding with structured upper limit of acceptable exposure. Because guidelines for control of occupational ex- the number of CSs is usually limited to per- posure” [Guest 1998]. haps three or four levels, this strategy was designed to cover six orders of magnitude For chemicals without official OELs, the plus a special category (shown in Table 3). COSHH Approved Code of Practice ad- The upper limits (OEB C for particulates, vises facilities to set self-imposed work- OEB D for gases/vapors) were designed to ing standards, but neither industry nor reflect good occupational hygiene practice government could follow the recommen- and a threshold of particulate concentra- dation. Three reasons for this inability in- tion: 10 mg/m3. If not classified elsewhere, clude (1) the technical complexity of es- a particulate concentration equal to or tablishing OELs, (2) the lack of adequate greater than 10 mg/m³ is defined as a sub- toxicologic databases and experts, and (3) stance hazardous to health, and COSHH the sheer volume of substances covered applies.

21 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

Table 2. Selected criteria for assignment of particulate to OEBs*

OEB Selected criteria for substances†

Category X Should be handled according to COSHH‡ carcinogens ACoP§ (R45, R46, R49) (Special considerations) Respiratory and skin sensitizers (R42, 43) Substances showing adverse effects in humans at low dose: <0.05 mg/m3 by inhalation or <0.01mg/ kg/day¶ OEB A Toxic to reproduction (R60, R61) Very toxic (R26, R27, R28) OEB B Toxic to reproduction (R62, R63) Toxic (R23, R24, R25, R48) Unknown toxicity not assigned to higher OEB OEB C Harmful (R20, R21, R22, R48) Dust not allocated to higher OEB

Source: Based on Guest 1998 * OEB=occupational exposure band. †This rating system is opposite that used in the COSHH Essentials rating. ‡COSHH=Control of Substances Hazardous to Health §Approved Code of Practice, current edition is from HSE 2002. ¶kg body weight

Table 3. OEB* and corresponding concentrations for gases and vapors (ppm) and dust (mg/m3)

Gases and vapors (ppm†) Dusts (mg/m3)

Category X Special considerations OEB A <0.5 <0.1 OEB B 0.5–5 0.1–1 OEB C 5–50 1–10 OEB D 50–500 Not applicable

Source: Derived from Guest 1998; CIA 1997 *OEB=occupational exposure bands †ppm=parts per million

22 Chapter 4 | The Architecture on Which Control Banding is Based

The main selection criteria for assignment 1995]. Thus the level of exposure recom- to the bands were information about ad- mended varies with the stage of product verse effects in humans and the CHIP R- development and toxicity testing. phrases, which were readily available in the United Kingdom. Classification was based on the most sensitive endpoint for 4.2 Levels of Facility Design which data are available. Table 3 summa- and Construction Based rizes the criteria. on Carcinogenicity of Table 3 is based on a more comprehensive Chemicals to Be Used table from Guest [1998], in which three considerations are stressed: (1) reclassi- In an early report linking toxicologic data fication of substances if/when more data to an appropriate level of control, Money become available, (2) other routes of ex- [1992b] presented a structured approach posure, and (3) requirements for health to design and operation of a chemical surveillance and occupational hygiene plant based on a carcinogenic ranking sys- measurements for substances with lim- tem for aromatic amines and nitro com- ited toxicologic data. Guest says testing pounds. This broad approach ensures that is necessary to “provide a high degree of appropriate measures are in place to con- confidence in the OEBs predicted.” The trol risks of exposure to these chemicals relationship between OEBs and OELs from both routine and abnormal opera- shows that “the majority of substances . tions; however, the report does not provide . . were correct to an order of magnitude specific solutions and controls. The author and that, for approximately five percent of suggests that the strategy, appropriate for the substances reviewed, the OEB was less both inhalation and skin contact, should stringent than the OEL.” Guest suggested be applicable to similar strategies ranking that the possibility of the latter observa- relative hazards of chemicals [Henry and tion was acceptable due to the margin of Schaper 1990; Gardner and Oldershaw safety built into most OELs and that the 1991; Woodward et al. 1991]. OEB guideline values were preferable to Money’s system described by four cat- inadequate standards of control. egories of carcinogenic potential is based COSHH regulations on inhaled substanc- on a system of six developed by Crabtree es that do not have Workplace Exposure et al. [1991] for which they considered Limits require employers in the United both carcinogenic potency and weight of Kingdom to control exposures to “a level evidence. (Money argued that although to which nearly all the population could distinguishing the potencies of different be exposed, day after day, without adverse substances is important, in reality such effects on health” [ABPI 1995;HSE 2002]. a separation is artificial and impracti- The pharmaceutical industry, especially cal.) For these four levels of carcinogenic during product development, typically en- potency, Money identified four levels of counters many substances for which data controls, with each level building on the to develop OELs are insufficient [ABPI previous in its complexity and stringency.

23 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

After he considered eliminating known methods for studying exposure determi- carcinogenic substances or substituting nants. Exposure determinants identified with safer alternatives, Money decided on in the studies included work tasks, equip- the following levels for design and con- ment used, environmental conditions, and struction of facilities based on consider- existing controls. Volume of product used ations of carcinogenicity. received little attention, and even less was ■■ Level 1 For all chemicals (regard- devoted to physical characteristics of chemi- less of carcinogenic potential), good cals in use. The exposure determinants were basic IH practice, with a plant built classified as factors that to sound industrial standards. 1. Directly increase exposure (e.g., pro- ■■ Level 2 For suspected animal car- cesses producing airborne contami- cinogens of low to moderate po- nants) tency, greater reliability and integ- 2. Directly decrease exposure (e.g., rity than Level 1, plus containment local exhaust) of the plant (or isolation of specific processes) by physical or proce- 3. Indirectly increase or decrease ex- dural measures, and possibly with posure (e.g., work location) health management systems. Another example of early consideration of ■■ Level 3 For moderate levels of sus- exposure determinants in a risk manage- pected human carcinogens with ment model is the Stoffenmanager (Sec- slight carcinogenicity to animals, tion 3.3.4), which approaches the use of or low doses of proven or suspect exposure assessment in a banding strat- animal carcinogens, a segregated egy [Tijssen et al. 2004]. Incorporating a plant with detoxification, high systematic consideration of descriptive reliability and containment, and workplace activities and environment, an regular technical audits. exposure model [Cherrie and Schneider ■■ Level 4 For low levels of proven 1999] is used to estimate exposure; the re- human carcinogens, suspect hu- sulting exposure estimate correlates with man/highly carcinogenic to ani- analytical exposure measurements across mals carcinogens, or very low lev- 63 jobs and different agents (asbestos, tol- els of proven or suspected animal uene, mixed particulate, and man-made carcinogens, an automated plant mineral fibers). with bulk or semi-bulk transfers, process control, and plant audits. 4.4 Toxicologic Consider- 4.3 Exposure Assessment ations [Brooke 1998] Among the considerable amount of re- Brooke outlined the following criteria for search involving exposure prediction which the toxicologic basis of the U.K. strategy: occurred throughout the 1990s, Burstyn 1. It had to be simple and transparent and Teschke [1999] reviewed 13 experimen- so that SMEs would be able to un- tal and 32 observational studies describing derstand and consistently use it.

24 Chapter 4 | The Architecture on Which Control Banding is Based

2. It had to make the best use of avail- Essentials and (2) it compared these as- able hazard information. signments with health-based OELs. Each 3. The control strategies it recom- hazard band, which is based on toxicolog- mended had to vary according to ic considerations, covers a log (10-fold) degree of health hazard of a sub- concentration range. Because the relation- stance. ship between the ppm (parts per million) concentration and the mg/m3 concentra- The R-phrases that are agreed upon through- tion of a vapor is a function of its molecu- out the European Union facilitated these cri- lar weight (and also temperature and pres- teria as they address all relevant toxicologic sure, though not discussed in this article), endpoints. Such an idea had been proposed the working group that oversaw develop- previously [Gardner and Oldershaw 1991] ment of this chemical classification de- and formed the basis of similar strategies cided to adopt a pragmatic strategy and to [ABPI 1995; CIA 1997; RSC 2003]. Brooke align the exposure bands as seen in Table noted three differences between the previ- 4. However, it must be noted that due to ous strategies (i.e., ABPI, CIA, and RSC) this alignment, in mg/m3 terms, the con- and that of HSE: centration range for substances in vapor 1. COSHH Essentials includes align- form is substantially higher than that for ment between particulate and va- the substance in particulate form, for the por target exposure ranges, and same toxicologic hazard band. the strategy taken to relate target In general, allocation of substances into exposure ranges to dose-level cut- hazard bands is influenced by presence of off values ensures adequate - mar an identifiable dose threshold, seriousness gins between exposure and health of the resultant health effect, and relative effect levels for particulates and exposure level at which toxic effects occur. vapors. If a substance has more than one R-phrase, 2. COSHH Essentials is based on the R-phrase leading to the highest level achievement of exposure lev- of control governs. See Appendix B for a els anywhere in the target range, more detailed explanation of allocation of whereas the CIA recommends vapors to hazard bands. that exposures should be maintained “as low as reasonably prac- To evaluate COSHH Essentials, the R- ticable” [ABPI 1995; Guest 1998; phrases and resulting target airborne con- CIA 1997]. centrations and the relevant health-based OELs were compared (U.K. and German 3. The COSHH Essentials strategy MAK [Maximale Arbeitsplatzkonzentra- was compared with health-based tion (maximum concentration of a sub- OELs (the CIA strategy was also evaluated per Guest [1998]). stance in the ambient air in the workplace)] values). This comparison was conducted Brooke’s article [1998] achieved two goals: (1) for 111 substances with recent, scientific- it explained the assignment of R-phrases to based OELs from the U.K. and MAK and the Hazard Bands A–E used in the COSHH with identifiable thresholds (thus excluding

25 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

Table 4. Allocation of Risk phrases to hazard bands

Target airborne Hazard band concentration range (Note 1) Risk phrases

A >1–10 mg/m3 particulate; R36, R38, all particulates and va- >50–500 ppm vapor pors not allocated to another band (Note 2) B >0.1–1 mg/m3 particulate; R20/21/22, R40/20/21/22 >5–50 ppm vapor C >0.01–0.1 mg/m3 particu- R48/20/21/22, R23/24/25, R34, late; >0.5–5 ppm vapor R35, R37, R39/23/24/25, R41, R43 D <0.01 mg/m3 particulate; R48/23/24/25, R26/27/28, <0.5 ppm vapor R39/26/27/28, R40 Carc. Cat. 3, R60, R61, R62, R63 E See specialist advice R40 Muta. Cat. 3, R42, R45, R46, R49 S: skin and eye Prevention or reduction of R34, R35, R36, R38, R41, R43, Sk contact skin and/or eye exposure (Note 3)

Note: COSHH (Control of Substances Hazardous to Health) Essentials is regularly reviewed to reflect any changes to risk phrases. Source: Brooke 1998

Hazard Band E, see Table 5.) Regarding [1998] stresses that the process is not in- particulates, for 33 substances (100%), the tended as a replacement for the health- OEL was within or higher than the target based OEL-setting process. airborne concentration range of the hazard band. For vapors, for 76 substances Concerns have been raised about the ac- (97%), the OEL was within or higher than curacy of the EU classification of chemical the target airborne concentration range. substances [Ruden and Hansson 2003]. Only two vapors had target ranges above In a comparison of EU classifications for the OEL. For one (dipropylene glycol acute oral toxicity for 992 substances with monomethyl ether), the OEL of 50 ppm those available in the Registry of Toxic Ef- was on the border between Hazard Bands fects of Chemical Substances, Ruden and A and B. The second (methyl ethyl ketone Hansson found that 15% were assigned peroxide) had a very small toxicologic da- too low a danger class and 8% too high. tabase, and the OEL was established based They were unable to determine the cause on analogy. Although concluding that the because of insufficient transparency of the R-phrases can be used effectively to allo- process. It should be noted that Registry cate substances to hazard bands, Brooke of Toxic Effects of Chemical Substances is

26 Chapter 4 | The Architecture on Which Control Banding is Based

Table 5. Overall results for comparison of COSHH* Essentials hazard bands with health-based OELs†, using all hazard bands

Dusts Vapors Total

Number of substances 33 78 111 Number for which OEL lies within target airborne 14 (42%) 44 (56%) 58 (52%) concentration range of hazard band Number for which OEL is higher than target air- 19 (58%) 32 (41%) 51 (46%) borne concentration range of hazard band Number for which OEL is lower than target air- 0 (0%) 2 (3%) 2 (2%) borne concentration range of hazard band Number for which scheme recommends control 33 (100%) 76 (97%) 109 (98%) equivalent to or better than that required by OEL

Source: Brooke 1998 *COSHH=Control of Substances Hazardous to Health †OEL=occupational exposure limit merely a registry and does not necessarily should, as far as possible, be appropri- provide an evaluation of chemical toxicity. ate to ensure that the hazardous properties of a substance are not expressed. Brooke describes an important point regarding the proper use of the COSHH Es- Equally important and essential to the sentials strategy: successful implementation of CB strategies is the effort to standardize the catego- Given that the toxicologic basis which rization of hazards, a primary objective of underpins the scheme relies on the use the global harmonization initiative dis- of R-phrases as the indicator of toxico- cussed in a later section. logic hazard, the success of the scheme is crucially dependent on the accurate 4.5 Occupational Control classification of substances by sup- Considerations pliers. It is the R-phrases applied to a substance or preparation which deter- [Maidment 1998] mine its allocation to a hazard band In writing about the development of the and thus the intended target airborne control predictive strategy, Maidment concentration range. Therefore, a - re stresses that, to control its complexity and sponsible strategy to classification for applicability, the number of factors con- all toxicologic endpoints is a key factor sidered should be limited. The steps thus for the scheme to be used successfully undertaken in developing the control pre- to recommend control strategies which dictive strategy are described below.

27 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

1. Characterize Control Strategies as the scale of the operation: small-, Control strategies can be collapsed medium-, and large-scale. into four main categories: general 3. Develop exposure predictive strat- ventilation, engineering controls, egy This strategy was developed by industrial closed systems, and spe- combining bands for operational cial controls. and physical exposure potential. 2. Characterize exposure potential They found that all combinations Characteristics of exposure poten- could be collapsed into four bands tial can be summarized as those each for solids and liquids, as de- related to physical properties and scribed in Tables 6 and 7. those related to substance handling. 4. Establish relationship between ex- With many parameters to consider, posure potential and hazard band Maidment [1998] focused on the The working group then integrat- dustiness of solids and the volatility ed the exposure predictor bands of liquids. The working group felt for solids (EPSs) and exposure that three dustiness bands would predictor bands for liquids (EPLs) adequately describe the proper- with the CSs 1–3, producing Ta- ties of particulates and maintain the simplicity of the strategy: low, bles 8 and 9. medium, and high. The volatility of Because the strategy does not sug- liquids also can be in three bands— gest the highest concentrations (i.e., low, medium, and high. Placement >10 mg/m3 for particulates, 500 into the appropriate band is ac- ppm for vapors, which is near the complished by consulting a graph highest HSE exposure limit of 1,000 of boiling point versus operating ppm), the remaining five bands can temperature. Operational factors, be aligned with the five toxicologic or quantities used, were captured hazard bands, as shown in Table 10.

Table 6. Definitions of EPS*

EPS Description

EPS1 Gram quantities of medium/low dusty material EPS2 Gram quantities of high dusty material; kilogram/ton quantities of low dusty material EPS3 Kilogram quantities of medium/high dusty materials EPS4 Ton quantities of medium/high dusty material

*EPS=exposure predictor bands for solids Source: Maidment 1998

28 Chapter 4 | The Architecture on Which Control Banding is Based

Table 7. Definitions of EPL*

EPL Description

EPL1 Millimeter quantities of low volatility material EPL2 Millimeter quantities of medium/high volatility material; m3/liter quantities of low volatility material EPL3 Cubic meter quantities of medium volatility material; liter quantities of medium/high volatility material EPL4 Cubic meter quantities of high volatility material

*EPL=exposure predictor bands for liquids Source: Maidment 1998

Table 8. Predicted airborne particulate exposure ranges (mg/m3)

Engineering CSs* EPS4† EPS3 EPS2 EPS1 CS1 >10 1–10 0.1–1 0.01–0.1 CS2 1–10 0.1–1 0.01–0.1 0.001–0.01 CS3 0.1–1 0.01–0.1 0.001–0.01 <0.001

Source: Maidment 1998 *CS=control strategy †EPS=exposure predictor band for solids

Table 9. Predicted vapor-in-air exposure ranges (ppm)

Engineering CSs* EPL4† EPL3 EPL2 EPL1

CS1 >500 50–500 5–50 <5 CS2 50–500 5–50 0.5–5 <0.5 CS3 5–50 0.5–5 0.05–0.5 <0.05

Source: Maidment 1998 *CS=control strategy †EPL=exposure predictor bands for liquids

29 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

Table 10. Relationship between exposure and hazard band

Exposure band—solid Exposure band—liquid (mg/m3) (ppm*) Hazard band >10 >500 Not recommended 1–10 50–500 A 0.1–1 5–50 B 0.01–0.1 0.5–5 C 0.001–0.01 0.05–0.5 D <0.001 <0.05 E Source: Maidment 1998 *ppm=parts per million

5. Substitute hazard band for expo- considered as a component supplemental sure potential and invert strat- to PPE, training, health surveillance, and egy to produce control predic- other elements of a comprehensive safety tive strategy. This produces an and health program. empirical model that can be used to predict the appropriate CS to achieve adequate control based on 4.6 Providing Control the hazard and the exposure bands Guidance to Users (Tables 11 and 12). CGSs form a key component of COSHH In applying this strategy for truly short ex- Essentials. The number of CGSs contin- posures (i.e., <30 minutes), the CS could be ues to grow to address the need for prac- dropped by one level (e.g., from CS2 to CS1). tical and effective guidance on control Even though this last strategy leans heavily for COSHH Essentials users, particularly on the work of previous models and strat- those in SMEs. Solbase, a databank of con- egies, it has a number of unique features, trol solutions for occupational hazards, including an electronic version accessible shows potential as a source from which via the Internet. In addition, it theoreti- CGSs could be developed. Using 535 new cally meets all six of Money’s [2003] core and existing solutions, Solbase has been principles: understandability, availability, tested throughout Europe, both for usabil- practicality, user-friendliness, confidence ity of the software and for suitability of the on the part of users, and transparent, con- recommendations yielded [Swuste et al. sistent output. Despite its attributes, vali- 2003; Swuste 2002]. Most solutions relate dation and verification remain important to manual or material handling, noise and requirements. Oldershaw [2003] has cau- vibration, machine guarding, and other tioned that the COSHH Essentials strategy safety issues, with few addressing air con- could not be adopted uncritically by other taminants. The databank can be queried countries; further, the strategy must be either by production process or by hazard.

30 Chapter 4 | The Architecture on Which Control Banding is Based

Table 11. Prediction of CS* from hazard band and exposure potential (solids)

Hazard band EPS4† EPS3 EPS2 EPS1

A CS2 CS1 CS1 CS1 B CS3 CS2 CS1 CS1 C Special CS3 CS2 CS1 D Special Special CS3 CS2 E Special Special Special Special

Source: Maidment 1998 *CS=control strategy †EPS=exposure predictor bands for solids

Table 12. Prediction of CS* from hazard band and exposure potential band for liquids

Hazard band EPL4† EPL3 EPL2 EPL1

A CS2 CS1 CS1 CS1 B CS2 CS2 CS1 CS1 C CS3 CS3 CS2 CS1 D Special Special CS3 CS2 E Special Special Special Special

Source: Maidment 1998 *CS=control strategy †EP=exposure predictor bands for liquids..

Validation and Verification of Control Banding Strategies

A significant issue for the implementation required, generally around 20 measure- of CB is the accuracy of the decision logic. ments on each of 10 workers when es- Underprescription of control could lead tablishing the average and range. If it is to serious illness, even death, and over- considered necessary to focus on the top prescription could lead to unnecessary ex- 5% or 10% of exposures, then larger num- pense. Future identification of either case bers may be required, or perhaps a model could lead to a loss of confidence in the can be introduced to evaluate the extreme system as a whole. Assurance can be pro- range of the potentially log-normal distri- vided by validation. Each step of the CB bution. strategy may be validated independently of the others. 5.1.2 Hazard Prediction Hazard is generally described in terms of 5.1 Variables for Validation the toxicologic endpoint of concern (e.g., 5.1.1 Exposure Prediction the description associated with specific R-phrases). Such phrases give the critical The data used to calibrate the exposure endpoints of disease but say little about prediction methodology probably came the relative severity of equivalent expo- from workplaces that had at least general sures to different chemicals with the same dilution ventilation. It is therefore reason- hazard identification. For example, acetic able to assume that exposures measured acid and trichloroacetic acid are both cor- where general dilution ventilation exists rosive, and classified R35 (causes severe can be used to test the system. In cases burns) by the European Union, but their where engineering controls are already ACGIH TLVs vary by an order of magni- in use, they could be discontinued for the tude. Where additional toxicologic data purpose of this test as long as workers are exist, they can be used for further assess- not put at risk. In order to characterize ment of the hazard ranking methodology. properly the entire range of workers’ exposures for the task or process under study, 5.1.3 Control Recommendations measurements must be taken to assess in- terworker, intraworker, and interworksite The accuracy of the outcome regarding variation. Repeated measurements involv- control determinations derives from rec- ing several randomly selected workers are ommendations of subject matter experts.

33 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

The CB control recommendations can be of California–Berkeley, and elsewhere have tested by matching them against expert been examining the worth of CB strategies. recommendations. This is best done using scenarios where the exposure predictions and hazard predictions have already been 5.2 Studies Performed for tested and found to be appropriate. Validation of Control Banding 5.1.4 Training 5.2.1 Tischer et al. 2003; Brooke A goal of CB is to provide a system that 1998; Kromhout 2002a,b; can be used by nonexperts in the field of IH practice, so training in the use of the Topping 2002a methodology is an essential part of many According to Tischer et al. [2003], three CB strategies. Training programs should aspects of evaluation can be applied to be evaluated with respect to the follow- COSHH Essentials: ing: target (e.g., was the training provided 1. Internal (conceptual) validation to those with authority to recommend or make changes?), reception (e.g., was ■■Are the underlying assump- the training offered sufficiently often, by tions plausible and consistent a source considered trustworthy, in an with established theories? environment conducive to processing?), ■■How uncertain are the strategy and outcome (e.g., was the training imple- assumptions? mented, and was the system used in the ■■Are all relevant parameters con- correct manner?). Evaluation of training sidered? effectiveness is an important step to pro- ■■Does the strategy correctly re- vide feedback addressing these and other flect the relationship between relevant questions. its parameters? ■■Does the conceptual structure 5.1.5 Control Implementation of the model reflect the structure of the real phenomenon? Once controls have been implemented, it is necessary to discover whether they 2. External (performance) validation were correctly implemented and whether ■■Do the strategy’s estimates cor- sufficient knowledge and expertise exist to respond to monitoring data or maintain them and to evaluate their effi- to the outcome of other strate- cacy when necessary (e.g., when processes gies? change). Routinely scheduled mainte- ■■What is the accuracy and pre- nance and evaluation can ensure this. cision of the predictions? Validation of all proposed CB strategies is 3. Operational analysis essential for determining credibility. Be- ■■How can it be ensured that the sides in-depth studies in the United King- target group uses the strategy dom, researchers in Germany, University correctly?

34 Chapter 5 | Validation and Verification of Control Banding Strategies

■■Is the strategy understandable Topping [2002a] responded that these ar- by, and of practicable value to, guments ignored the range of competen- the target group? cies in the workplace, and the number of ■■Does documentation of the re- firms handling chemicals. He stated that sulting recommendations meet COSHH Essentials is not intended to re- the needs of the target group place monitoring but rather to provide (language, skills, background needed help to SMEs, pointing out that knowledge)? the cost of conducting the extensive monitoring suggested by Kromhout would be Brooke’s work [1998] in comparing the R- “astronomical” and that the capacity to phrases and resulting target airborne con- do so does not exist. He allowed that the centrations with the relevant health-based COSHH Essentials were designed to “err OELs on national lists (U.K. and German on the side of caution,” that the strategy MAK) begins to address the first evalu- had been peer reviewed by the British ation category on internal validation. Occupational Hygiene Society (BOHS), The work of Tischer et al. [2003], Maid- and that there had been no complaints ment [1998], and Jones and Nicas [2004, about the recommended controls being 2006a,b], which is reported below, focuses too stringent. Kromhout [2002b] replied on the external validation category and that he and the editor of Annals of Occu- begins to answer some of the questions re- pational Hygiene questioned the role of garding external (operational) validation. tools like COSHH Essentials in contrib- However, many questions still need to be uting to a “collapse of full time training answered in all three categories. of occupational hygiene professionals in Kromhout [2002a] took strong exception Britain through lack of demand for ex- to the lack of exposure monitoring in “ge- pertise.” Kromhout’s strongest criticism neric risk assessment tools like COSHH was that COSHH Essentials and EASE Essentials and expert systems like the Es- had not been properly evaluated prior to timation and Assessment of Substances release and that BOHS review could not replace the rigorous evaluation of testing Exposure (EASE) . . . ” as these “. . . are for reproducibility and validity. He rec- known to be inaccurate and they do not ommended that COSHH and EASE be take into account the various components used in the initial screening process. of variability in exposure levels . . .” Krom- hout built a strong case, estimating the variability in 8-hour shifts to be between 5.2.2 U.K. Health and Safety 3,000- and 4,000-fold and identifying Executive Studies the sources of variability as spatial, both [Maidment 1998] among workers and among groups. He argued that although providing exposure The core model was validated by - com controls without having measured expo- parisons with exposure predictor bands sure concentrations would save money in for solids and for liquids (Tables 9 and the short term, in the long run it would be 10), comparisons with measured data, “penny wise but pound foolish.” and extensive peer review of the logic and

35 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

content. According to the author, finding was considered to be a problem that re- quality data for comparisons was extreme- quires additional attention. Scale of use was ly difficult, and, further, the information judged to be straightforward. (Most of the describing CSs often seemed to indicate available data corresponded to the medium that several were in use. scale of use, with very little in the milliliter or ton ranges.) Based on data available 5.2.3 German Bundesanstalt (i.e., 958 data points—732 for liquids and für Arbeitsschutz und 226 for solids), the researchers limited their Arbeitsmedizin Study analyses to scenarios in which the CS could be determined from the historical reports, Researchers at the BAuA examined the assigning one of the four CSs. external validity of COSHH Essentials Comparisons indicated that most of the and found that, in the majority of cases, compared with OELs, it provides equal or measured exposures fell within the pre- greater worker protection; however, the dicted ranges. The 95th percentile of data number of exposure scenarios compared from different operations fit within the was limited. Tischer et al. [2002, 2003] at ranges predicted by the COSHH Essen- the BAuA conducted the first complete tials model [Balsat et al. 2003; Tischer evaluation of the COSHH Essentials based 2001b]. Exceptions were noted where on independent measurement data. The some of the limited data points were primary empirical basis for their analysis above the predicted range: activities asso- was measurement data collected during ciated with carpentry workshops and ap- BAuA field studies within the preceding plication of adhesives, both of which rep- decade. The chemical industry provided resent small-scale, dispersive operations; additional data. Given that the data were and handling of powdery substances in not descriptive of all possible exposure kilogram quantities under local exhaust scenarios covered by COSHH Essentials, ventilation (LEV). the BAuA researchers were unable to eval- Tischer et al. [2003] note that limited data, uate the full range of the strategy. representing a limited number of pos- BAuA data were obtained from BAuA lab- sible combinations of Exposure Predictor oratories, and all workplace measurements Bands and CSs, were available for evalu- were conducted according to the German ation. In particular their data lacked de- Technical Rules. Sampling durations were scription of scenarios involving the han- usually 1–4 hours and were task-based dling of milliliter or ton quantities of low (i.e., corresponding to a specific scenario). or high volatility/dustiness substances. More than 95% were personal samples. Sources of uncertainty considered were 5.2.4 University of California— volatility/dustiness, scale of use, and CS. Berkeley Study [Jones and For example, the uncertainty associated Nicas 2004, 2006a,b] with volatility (of pure substances) was judged to be low, but quite complicated Also receiving attention is the ICCT, pro- when mixtures were considered. Dustiness duced as a result of collaboration among

36 Chapter 5 | Validation and Verification of Control Banding Strategies

HSE, International Occupational Hygiene OELs (see Brooke 1998) and also Association (IOHA), and ILO. ICCT is that it is not uncommon for ac- based on the HSE COSHH Essentials and ceptable risk levels of OELs to be is adapted for use worldwide [Jones and in the range of 10-4–10-3, in con- Nicas 2004, 2006a]. This version incorpo- trast to acceptable risk values in rates the GHS. environmental settings of 10-6–10-5 [Jayjock et al. 2000]. Researchers at the University of California– Berkeley [Jones and Nicas 2004, 2006a] 2. A comparison of the R-phrases evaluated the ICCT and have three major (taken from the HSE “Approved objections to it: Supply List” [National Chemical Emergency Centre at www.the- 1. Determined of safety margins ncec/cselite]) assigned to com- (No Observed Adverse Ef- monly used solvents indicated fect Level [NOAEL] or Lowest that the hazard group ratings Observed Adverse Effect Level assigned by the ICCT were lower (LOAEL), divided by the high air than in the COSHH Essentials concentration of the hazard band) for 12 of 16 solvents. In five cases, resulted in values less than 100 the ICCT included an S notation for Hazard Bands B and C, and (skin hazard) that was not on the less than 250 for Hazard Band D R-phrases. Jones and Nicas [2004, for vapors. They noted that these 2006a] suggested that the authors values should be in the range of of the ICCT should reconsider the 1,000–10,000 for R48/20 (Danger hazard classification plan as the of serious damage to health by variations among CB strategies prolonged (inhalation) exposure), reduce confidence in the toolkit depending on if either of the among its users. adverse effect levels (NOAEL or 3. Jones and Nicas determined the LOAEL) was used as the basis of appropriate control strategy and calculation. compared the actual measured These calculations are based on exposures with the maximum the generic COSHH criteria to value of the exposure band of the avoid any errors caused by incor- recommended exposure band. rect assignments of hazard bands. This comparison resulted in two Brooke [1998] reported that some types of control errors: situations categories of materials were arbi- in which insufficient exposure trarily assigned to a higher haz- control occurred in the presence ard category based on their toxic- of LEV (under-control errors) ity characteristics, and this would and situations in which sufficient provide an extra factor of 10. Also, exposure control occurred in the it must be pointed out that the absence of LEV (over-control er- hazard band values are generally rors). They found under-control in the same order of magnitude as errors in 96% of the 163 cases

37 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

where LEV was present in vapor No systematic assessment has been degreasing operations, and in 55% undertaken of the impact that control of the 49 cases where LEV was banding approaches have had on the present in bag filling operations. management of risk at the workplace or other levels. Thus, in terms of future Besides the three objections listed above, developments in the area, it would ap- Jones and Nicas formed multiple conclu- pear that before further refinements sions from their evaluation: are considered, there needs to be an 1. Recommended exposure bands extensive and systematic evaluation of do not provide consistent, or ad- the uptake and impact of a number of equate, margins of safety. the key approaches. 2. The high rate of under-control Swuste et al. [2003], referencing Krom- errors highlights the need to hout [2002b], state— evaluate the effectiveness of in- The COSHH Essentials has met some stalled LEV systems using capture criticism in the literature, focusing on efficiency and/or air monitoring the lack of a proper evaluation before techniques. its introduction into the occupational 3. The limited assignment of dusti- arena, as well as the generic nature of ness ratings to particulates com- the tool, which will lacks [sic] preci- plicates the process. sion and accuracy in situations where 4. Specific guidance must be pro- these are required.” vided in cases where there is in- Tischer et al. [2003] have said that in the sufficient or inappropriate hazard German occupational hygiene commu- information. nity— 5. The R-phrase procedures criteria (specifically the use of minimum …there was consensus that the scheme concentration values below which (COSHH Essentials) had great poten- classification using the R-phrase tial for further development. On the values would not be applicable) other hand, with respect to the ex- are not compatible with U.S. regu- posure predictive model it has been latory practice. argued that, due to its generic character, reliability and accuracy (safety) 6. Guidance about contacting pro- may have been sacrificed for the sake fessional assistance for engineer- of simplicity and transparency. How- ing controls should be included ever, this assumption is not based on on CGSs. real measurement but reflects the low degree of confidence generally associ- 5.3 Expert Opinions on ated with generic models. Control Banding Oldershaw [2003] has cautioned that the According to Money [2003]— COSHH Essentials strategy cannot be

38 Chapter 5 | Validation and Verification of Control Banding Strategies

adopted uncritically by other countries; ensure that controls are appropriate, effec- further, the strategy must be seen in the tive, and maintained. context of personal protection, training, and health surveillance as elements of a Like the AIHA, the ACGIH also com- comprehensive safety and health program. missioned an Exposure/Control Banding Task Force to assess and document the With regard to assessing the impressions CB topic for its membership. The result- about general usability of a CB model, ing document, titled Control Banding: Is- a telephone survey of 500 purchasers sues and Opportunities [ACGIH 2008], of the paper version of COSHH Essen- focuses primarily on the COSHH Essen- tials revealed that 80% of the purchas- tials and the ICCT and examines the four ers had used it, and only 5% had found it main components of CB: Hazard Group fairly difficult to use. Three-quarters had Prediction Model, Exposure Limit Predic- enough confidence in the model to take tion Model, Exposure Prediction Model, action based upon its guidance, and 94% and Predefined Control Strategies. The would recommend it to other businesses document illustrates how varying infor- [Topping 2002b]. mation on health hazards and exposure characterization affect identification of The American Industrial Hygiene As- CSs and their usefulness. The assessment sociation (AIHA) convened a Control of the Task Force is more critical of CB, Banding Working Group to research and cautioning that “users should not rely on document the evolution and potential Control Banding as it currently exists to contributions of CB within the practice identify the controls required to provide of IH. The resulting publication, titled adequate protection to workers.” The task Guidance for Conducting Control Banding force makes recommendations to address Analyses [AIHA 2007], describes the de- the shortcomings it identifies for each of velopment of methods based on control- the four main components of CB. Among focused strategies initially pioneered by these is the advice that users should rec- pharmaceutical and chemical industries. ognize the critical role that occupational This positive treatment of the topic de- health professionals must play in the risk scribes the “foundations and major ele- management process. This is a universal ments of Control Banding approaches in theme in critiques of CB strategies. Also, use today,” and provides case studies and as with the AIHA document, the ACGIH hazard-specific applications, as well as a recommends that CB represent an initial “glimpse of the future—a discussion of qualitative assessment as part of a more the challenges and opportunities present- formal exposure assessment and control ed by domestic and international devel- program. opments.” It emphasizes that CB focuses primarily on initial risk characterization. Zalk and Nelson [2008] published a more Consequently, the authors acknowledge recent review of the history and evolu- that CB outcomes (i.e., specific controls) tion of CB, citing and summarizing many should be reviewed by an industrial hy- of the resources recognized throughout gienist or other qualified professional to this NIOSH document. They recognize

39 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

that for CB strategies like COSHH Essen- comprehensive prospective research pro- tials, exposure bands do not always process will be important in understanding vide adequate margins of safety, there is implications of the model’s overall effec- a high rate of under-control errors, they tiveness. Consequently, they recommend work better with particulates than with further research to refine results and to vapors, an inherent inaccuracy in estimat- build users’ confidence in the utility of CB ing variability exists, and outcomes of this strategies. model, taken together, may lead to potentially inappropriate workplace confidence These studies and expert comments pre- in chemical exposure reduction. With the sented in this section emphasize the need accuracy of the toxicologic ratings and for collection of data under controlled hazard band classification currently in scenarios to validate the predictions of the question, the proper reevaluation of expo- model. This validation must be seen as a sure bands will be of great benefit to the separate activity from the verification of reliability of existing and future CB mod- proper installation and maintenance of els. The authors also suggest that a more controls prescribed by a CB strategy.

40 6

Specific Issues in Control Banding

Most CB strategies are limited to the in- posed alterations to the control strategies halation route of exposure and to certain (Bands 1–3). The current COSHH Essen- chemicals used in manufacturing (others tials strategy does not differentiate be- being regulated in specific statutes). Work tween substances that affect the skin (e.g., is ongoing to expand applications to other corrosives) and those that are absorbed topics, including dermal hazards, process- through the skin. This may be because the generated hazards such as airborne crys- EU system classified many chemicals be- talline silica, asthmagens, and asbestos. fore extensive data were available to rank the risk of skin uptake. Other complicat- ing factors include that some chemicals 6.1 Dermal Absorption can act as carriers for poorly penetrat- The challenge for application of CB for ing substances and that some R-phrases dermal hazards lies in the banding of der- do not have exposure route indicators mal exposures. Much research has been for systemic toxicity endpoints. Because devoted in recent years to developing of these limitations, Garrod and Rajan- methodologies for risk assessment of der- Sithamparanadarajah [2003] suggest that mal contact with chemicals, with the fo- most chemicals be considered as having cus on dermal exposure assessment. The the potential for skin uptake. In propos- Dermal Exposure Assessment Method ing three skin hazard bands (see Table 13), (DREAM—a method for semi-quantita- they considered the following questions: tive dermal exposure assessment) [Van- 1. Is there an identifiable dose thresh- Wendel-de-Joode et al. 2003] is a system- old for the toxicologic endpoint? atic and structured strategy for dermal 2. How serious is the health effect? exposure assessment; however, in its pres- 3. At what exposure levels do health ent form, it is highly complex. In DREAM, effects occur? the model’s 33 exposure determinants are mostly assigned by educated assump- Most of the chemicals in COSHH Essen- tions; it is time-consuming to conduct, tials Hazard Bands A, B, and C are con- and requires an occupational health pro- sidered in the lower skin hazard band. fessional to complete a questionnaire for Compared with the inhalation hazard model inputs. Garrod and Rajan-Sitham- rankings of chemicals, those that cause paranadarajah [2003] explored some of burns (R34), severe burns (R35), and skin the issues involved in developing a dermal sensitizers (R43) are moved to higher haz- module in COSHH Essentials and pro- ard bands.

41 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

Table 13. Skin hazard bands

Total daily skin Skin hazard bands Included risk phrases burden of concern Advice

1 – Lower skin All risk phrases in Dust: 500 mg Process: process modifica- hazard group COSHH* Essentials hazard Liquid: 10 mg tion, substitution of physi- groups A, B, and C except cal form R34 = causes burns Procedure: segregation, R35 = causes severe burns cleaning routines, training, hygiene procedures, laun- R37 = respiratory tract dry, skin care programs, irritation PPE† (disposable gloves), R43 = may cause sensitiza- skin condition reporting tion by skin contact

2 – Higher skin All R-phrases in hazard Dust: 50 mg Process: full containment hazard group group D, plus R34, R35 Liquid: 1 mg (except small amounts of certain substances) Procedure: as above, plus controls (e.g., biological monitoring, permits to breath containment) Advice: selecting gloves and other PPE, skin surveillance

3 – Highest skin All R-phrases in hazard Any amount of par- Seek specialist advice. hazard group group E, plus R43 ticulate or liquid

*COSHH=Control of Substances Hazardous to Health †PPE=personal protective equipment Adapted from Garrod et al. 2004

Regarding dermal exposure, Garrod et al. contaminants by gloves, contamination of [2004] present a strong case against con- the inside of gloves when contaminated sidering duration of exposure as a factor hands are put in them, and inevitable influencing uptake. Their argument is dermal contamination when working out- that skin can act as a reservoir, and thus side containment. They allowed for the contribute to uptake of contaminants possibility of two durations when consid- even after exposure has ceased. Addi- ering exposure banding: a single splash tional arguments for this position include that is immediately removed and all other documented penetration and retention of scenarios. These authors conclude that

42 Chapter 6 | Specific Issues in Control Banding

dermal exposure cannot currently be et al. 2003; Warren et al. 2003; Oppl et al. banded in the way that inhalation expo- 2003; Schuhmacher-Wolz et al. 2003]. In sures are banded and offer recommenda- March 2004, the RISKOFDERM Toolkit tions for altering COSHH Essentials to ac- became available on the Internet. RIS- count for dermal exposures: KOFDERM was intended to raise awareness, estimate exposures, identify control ■■ Providing guidance for actions to actions, recognize hazard potential, and take if containment is breached recommend control actions in hierarchi- ■■ Raising the control strategy in cer- cal order [van Hemmen et al. 2003]. The tain cases Toolkit was evaluated by a panel of inter- ■■ Disallowing any reductions in con- national industrial hygienists and revised trol strategy based on short-term according to findings of then ongoing usage RISKOFDERM research. Both paper and ■■ Using skin surveillance when skin electronic formats are available online, sensitizers are used more often which are now available for use by educat- than once per month ed nonexperts, who would ask fairly sim- ■■ Taking into consideration the con- ple questions and be guided to qualitative centration of liquid mixtures and scales for dermal exposure, resulting risk, the specific body area in contact and possible control measures. As this with chemicals. project includes several key persons from HSE, the outcome of RISKOFDERM may Protecting skin from exposure to occu- very well support a relatively simple der- pational hazards is a pervasive challenge mal exposure banding concept that could in many industries. Because the level of be incorporated into COSHH Essentials control cannot be quantified as increasing or other toolkits that are in the develop- levels of 10-fold protection (as can be done ment process. with inhalation exposure control), Gar- rod et al. [2004] recommend biological monitoring to assess adequacy of control. 6.2 Silica (HSE) They conclude that “. . . hazard banding HSE has developed CGSs for silica— is feasible, exposure banding is not, and Silica Essentials—which can be accessed control banding for skin cannot at present through the individual industry sectors at be done with any rigour [sic], but it is fea- www.hse.gov.uk/pubns/guidance. These sible to provide suitable control guidance sheets are part of a new phase of COSHH sheets for dermal exposure control.” Essentials where the guidance is task- RISKOFDERM is an EU-funded project specific and targeted to specific industry formed with the aim of providing a vali- sectors, such as foundries, construction, dated predictive model for occupational quarries, brick making, and ceramics. The dermal exposure assessment that could be Web page was launched in 2006 and pro- adapted into a practical dermal exposure vides practical standards that industry toolkit for SMEs [EC 2004; van Hemmen can apply to reduce exposure to silica. Sil- et al. 2003; Marquart et al. 2003; Goede ica Essentials is a good example of a CB

43 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

strategy where, based on good control- CB strategies. In 2003, HSE included in practice recommendations, users access their Strategic Outlook the intention to direct advice from industry experts. They build collaborations with international require no detailed data input from the technical and scientific organizations such user and do not rely on R-phrases. The ap- as NIOSH. This collaborative HSE and propriate CGS can be determined by iden- NIOSH work includes a focus on asthma- tifying the appropriate activity for which gens in relation to their inclusion within guidance is sought, such as rock drilling, CB strategies. Although no conclusive fettling castings, tile pressing, or abrasive blasting. The work to develop the CGSs is CGSs are currently available relating to complementary to other initiatives from this cooperative research, this strategy is HSE to raise awareness of industry haz- an example of international organizations’ ards and the importance of adequate con- belief that occupational exposures in the trol to reduce ill health. Such initiatives on workplace are worthy of consideration in silica include the silica information sheets a CB strategy. and a strategy to control exposure to silica dust in small potteries. 6.4 Asbestos Essentials (HSE) 6.3 Asthmagens (HSE, NIOSH, The guidance manual Asbestos Essentials: OSHA) Task guidance sheets for the building maintenance and allied trades [HSE 2001] includes In the United Kingdom, an estimated eight “Equipment and Method Guidance 1,500–3,000 new cases of occupational Sheets” on topics such as training, build- asthma occur each year. This increases to ing enclosures, use of a Type H vacuum 7,000 cases a year if asthma-made-worse- cleaner, and wet methods. R-phrases are by-work (work-related asthma) is includ- not included; rather, the guidance is pre- ed. In the United States, it is estimated that sented by task. The 25 Task Guidance occupational asthma incidences range Sheets cover tasks such as painting insu- from 6.3–44.1 per 100,000 [Henneberger et al. 1999], and task-related exposures lation boards and removing gaskets and associated with occupational asthma are floor tiles. Each Task Guidance Sheet is considered to be an appropriate focus for structured according to description of preventive strategies [Wagner and Weg- task, PPE, preparing the work area, repair, man 1998]. HSE and NIOSH are working cleaning, personal decontamination, and collaboratively to include asthmagens in clearance procedures.

44 7

Special Events Surrounding Control Banding

CB is currently the subject of much inter- to use and compatible with existing est, both nationally and internationally. work methods. International workshops have been held ■■ Adapted versions range from the in London (2002), Cincinnati (2004), sophisticated strategies pioneered concurrently in Pilanesburg, South Afri- by the pharmaceutical industry, to ca and Orlando (2005), and South Korea the holistic GTZ strategy (Chemi- (2008). International collaborative agree- cal Management Guide) [Adelmann ments have been forged to coordinate the 2001]. The GTZ strategy has been work of international agencies and their implemented by employers in Indo- partners, and a global implementation nesia, on the premise that the con- strategy has been developed. trol of chemicals reduces waste and loss in addition to protecting worker health and environmental quality. 7.1 First International ■■ Valuable in a large variety of work- Control Banding places, the wide range in versions of Workshop (ICBW1) CB is necessary for broad application. In particular SMEs in mostly The first International Control Banding developed countries and SMEs in Workshop (ICBW1) was held in London developing countries may require on November 4 and 5, 2002, with the separate strategies. sponsorship of BOHS, the British Institute ■■ The role of the International Pro- of Occupational Hygienists, HSE, IOHA, gramme on Chemical Safety (IPCS) the World Health Organization (WHO), International Chemical Safety Cards and the ILO. In addition to providing a in providing relevant information clear description of the CB process, signif- was acknowledged, with the possi- icant outcomes of the workshop include— bility of these cards being updated ■■ HSE, IOHA, and ILO collaborated to to include the necessary data (e.g., produce the ICCT, which was based GHS, to support CB being consid- on the HSE COSHH Essentials, ered) [Jackson 2002; Jackson and adapted for use internationally. This Vickers 2003]. version incorporates the GHS. During the workshop representatives of ■■ Participants agreed that any version national and international organizations of the CB strategy must be simple attended a strategic planning meeting.

45 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

It was agreed that a (now named) Inter- developed and developing countries and national Technical Group (ITG) on CB the creation of a National Control Band- would be organized, with the IPCS serving Workshop Organizing Committee. ing as secretariat. The major purposes of Also at ICBW2 was formed a consensus the ITG are to share the knowledge gained Global Implementation Strategy from the from trials and demonstration projects, ITG on CB. maintain the integrity of the ICCT, and ensure that the technical aspects of the The ITG on CB, led by WHO, IPCS, and system are maintained and updated (e.g., ILO, had the opportunity to meet before, to reflect changing national legislation during, and after ICBW2 to finalize the and implementation of the GHS). (See Global Implementation Strategy for re- Appendix C for the ITG’s Global Imple- lease after the event. The complete implementation Strategy. Also, see Zalk 2002b.) mentation plan is contained in Appendix C of this document. The National Control All the presentations from ICBW1 can Banding Workshop convened in March be viewed at www.bohs.org/mod. 2005 in Washington D.C. to review an php?mod=fileman&op=view_cat&id=14. early draft, which became the foundation of this document, and to discuss proposed U.S. strategies to employ CB concepts. 7.2 Second International CB Workshop (ICBW2) 7.3 Third International The ICBW2, subtitled Validation and Ef- Control Banding fectiveness of Control Banding was held March 1 and 2, 2004, in Cincinnati, OH. Workshop (ICBW3) Attendees from 13 countries shared their The Third International CB Workshop views regarding challenges currently fac- (ICBW3) was held in September 2005 at ing CB. Presenters from Europe, the Unit- the Pilanesberg National Park in South ed States, Asia, and South America spoke Africa in conjunction with the 6th Inter- of their specific research and experiences. national Scientific Conference of Occupa- During breakout sessions priority issues tional Hygiene. For the first time an ICBW emerged, including cost-effectiveness and convened outside the developed nations, efficiency to expand the reach of CB con- solidifying the inextricable involvement of cepts while minding the largely volunteer developing countries. The three focus top- effort bringing this forward. Presentations ics for ICBW3 included Global Trends in and discussions of CB topics covered the CB Collaborations, a Silica Workshop, and multiple tools and CB strategies for consid- CB’s Expansion of Range beyond chemi- eration. Most of the presentations from the cals. The last two highlighted the future ICBW2 can be viewed at www.acgih.org/ context of the ICBWs: to further develop events/course/controlbandwkshp.htm. specific professional areas of practical prevention needs. Areas considered for ex- Significant outcomes of ICBW2 were the panding CB applications included psycho- framework for a research agenda for social factors and safety management, and

46 Chapter 7 | Special Events Surrounding Control Banding

specifically, the possibility of creating an 7.5 International ergonomic toolkit, an effort initially pre- Agreements sented at ICBW2, which has increased to involve additional partners and activities ILO and WHO agreed to work together [Zalk 2003]. under the auspices of the IPCS on January 23, 2003. The roles of each organization 7.4 Fourth International were spelled out in the agreement [Vick- Control Banding ers and Fingerhut 2002]. Workshop (ICBW4) The Global Implementation Strategy for ICBW4 was held in Seoul, South Korea at the Occupational Risk Management Tool- the XVIII World Congress on Safety and box was outlined by the ITG at ICBW2 Health at Work in July 2008. At that ven- and approved on May 28, 2004. This ue, the CB discussions emphasized safety strategy, which discusses partners, stake- applications and exploration into the lat- holders, the ICCT, key elements, terms of est national programs (India, South Ko- reference, and the international research rea, and Japan). agenda, can be found in Appendix C.

Critical Analysis of Control Banding Strategies

The core of this review is a discussion of the 8.1 A Discussion of strengths and weaknesses of CB strategies. Weaknesses and Much of the literature on these characteristics describes concepts and misperceptions Strengths of CB Efforts about CB and its potential applications, In evaluating the weaknesses and strengths of similarities to other occupational safety the CB strategy, it is useful to refer to an out- and health interventions, potential conflict line of common issues, as shown in Table 14. with OEL development, and the need for environmental sampling and IH expertise. 8.1.1 General Control Banding This section also contains a critical analysis v. COSHH Essentials of the barriers and catalysts for implement- COSHH Essentials has met criticism in the ing CB in the United States. In addition, literature for its generic nature that does consideration is given to the areas where not adequately or accurately take into ac- expansion of CB concepts or development count the environment and parameters of new control-focused solutions and guid- within which the exposure occurs [Swuste ance might be explored. et al. 2003; Harrison and Sepai 2000]. And, because presenters of the CB concept have In the broadest scope, the CB strategies and highlighted COSHH Essentials, some mis- related guidance for addressing occupa- takenly believe that the two are the same. tional hazards are recognized for their po- Confusion stems from the misunderstand- tential to facilitate occupational safety and ing that the nature of COSHH Essentials health knowledge management. Knowl- is to use refined parameters to offer a best edge management is an emerging field fo- estimate of personal exposures; however, cusing on assessing the creation, transfer, predicting exposure is not the primary aim and use of knowledge to address specific of COSHH Essentials or CB. Rather, CB is challenges [Schulte et al. 2004]. Effective qualitative and is an overarching strategy knowledge management can be accom- for managing hazards in the workplace. A plished through the development of guid- benefit of the comparison is that critiques ance materials for hazard control and the of COSHH Essentials have led to improved application of CB strategies. revisions of the CB concept.

49 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

Table 14. Issues relating to the strengths and weaknesses of the CB* strategy

CB Strategy Issues Weakness summary Strength summary

General CB vs. Highlighting COSHH Essentials Current CB publications and events COSHH† Essentials within CB presentations led to mis- are clarifying that CB is an overarch- understanding that the two are the ing strategy and not a single toolkit. same. Research critical of COSHH COSHH Essentials critique led to im- is therefore critical of CB. proved revisions. Estimated controls vs. IH‡ practice in the United States is Traditional IH practice is expensive, specific science based on solid scientific protocols, and options are necessary so all U.S. so why replace them with potential- workers are protected. CB strategies ly underprotective CB outcomes? reduce costs and promote IH expertise as needed. CB strategies vs. full- Implementation of CB strategies CB strategy indicates thresholds that time IH professionals will reduce the need for IH consul- require IH expertise. With CB imple- tants and move profession toward mentation employers will be educated ES&H§ generalists. about IH concepts and practices. CB vs. reliance on Some professionals believe that CB strategies will not serve as a replace- OELs¶ moving CB forward in the absence ment for OELs in the United States. CB of OELs will strengthen the argu- validation protocol will include per- ment to eliminate them. sonal monitoring for OEL use. Not monitoring vs. mo- Traditional exposure assessment CB requires IH personal monitoring for nitoring relies heavily on personal IH moni- validation and maintenance. Task-based toring. Some perceive CB as elimi- control solutions are appropriate given nating this crucial step. sufficient historical data. Qualitative output vs. COSHH Essential’s interim step COSHH Essentials criticisms are as- quantitative input of predicting exposures is an area sisting in perfecting the strategy. Task- estimate, offering controls in the based point source models do not re- absence of workplace variations. quire exposure prediction. Static controls vs. dy- Current CB strategies implement CB validation protocol will include namic controls static controls. Validation needs to evaluating dynamic implementation include dynamic aspects of initial strategies. The database resulting from accuracy, process change, and con- this process will offer a useful task- trol degradation. based CB solutions database.

*CB=control banding †COSHH=Control of Substances Hazardous to Health ‡IH=industrial hygiene §ES&H=Environmental Safety and Health ¶OEL=occupational exposure limit.

50 Chapter 8 | Critical Analysis of Control Banding Strategies

8.1.2 Estimated Controls v. 8.1.3 Control Banding Strategies Specific Science v. Full-time Industrial Hygiene Professionals Because the known and scientifically founded parameters of a perfect system The above paragraph mentions that man- may not be economically viable or avail- agement may decide to eliminate the need able at small companies, managers offer for full-time IH staff in favor of qualitative CB as a means of achieving the best ex- strategies; however, the CB strategy indi- posure reduction process affordable. Re- cates thresholds that require IH expertise. search indicates that in some cases the With CB implementation, employers will guidance from CB models will likely ei- be educated about IH concepts and prac- ther underprotect the worker or prescribe tices. The CB strategy, should it reach a overprotective controls [Jones and Nicas point that it is viable for the nation’s in- 2004, 2006b]. Some believe these poten- dustries, may provide an opportunity to tially underprotective recommendations strengthen and promote the IH profes- will replace the solid scientific protocols sion. Specifically, IH professionals can use of IH practice, that is, the introduction of CB as a tool to improve hazard awareness and promote hazard communication and qualitative strategies could lead manage- control [Money 2003]. ment to consider replacing Environmen- tal Safety and Health (ES&H) staff with CB strategies and tools, justifying the lat- 8.1.4 Control Banding v. Reliance ter as being more economically efficient. on OELs The resulting control guidance obtained using the CB strategy could be less useful Some professionals believe that moving and protective than that recommended by CB forward in the absence of OELs will strengthen the argument to eliminate a professional. Most IH experts admit that them. To those with the scientific under- many workers are left unprotected, despite standing of the processes at work to derive available controls [Kalisz 2000]. Although appropriate exposure limits to protect the introducing a CB system might seem rela- health of the workforce, the possibility of tively easy in theory, ensuring controls eliminating the OELs is unconscionable. are properly implemented and evalu- However, in the United States, CB strat- ated for their effectiveness is a difficult egies will not serve as a replacement for and economically challenging endeavor. OELs. CB validation protocol will include Therefore, CB strategies benefit industry personal monitoring for OEL use. The val- because they reduce costs and promote ue of the CB strategy to the OEL-setting IH expertise as needed. In workplaces systems is two-tiered: (1) supplemental to where IH support may never extend, al- the concept of OELs, a successful CB strat- ternative strategies and mechanisms for egy will give a newly educated (by the IH providing control-focused guidance hold professional as described above), broad- great promise for reducing occupational spectrum audience a better understanding disease and illness. and respect for exposure prevention [Guest

51 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

1998; Russell et al. 1998] and (2) the CB 8.1.6 Qualitative Output v. strategy will assist users in managing the Quantitative Input increasing numbers of chemicals [Bal- sat et al. 2003; Swuste et al. 2003; Money The emphasis of the CB concept on sim- 2001; EC 2001; Vincent and Bonthoux plicity and transparency may result in reliability and accuracy being sacrificed. 2000; UIC 1999]. The majority of toolkits currently in development do not account for work-area 8.1.5 Not Monitoring v. exposure. Yet, a work-area exposure esti- Monitoring mate has been technically and scientifically proven to be a poor surrogate for an ac- Exposure assessment and risk assessment tual personal monitoring result obtained rely on personal exposure measurements as within a worker’s breathing zone [Kolanz a link to establish the probability of illness et al. 2001]. In addition, such estimates related to work or the environment. The may not account for the dimensions of CB strategy recommends a minimal level the work space; whether the chemical will of protection for the worker performing a be sprayed, rolled on, or poured in; how common task, but this may be at the risk much time is required for transfer; how of ignoring the variability between work- much is applied at each manufacturing ers. Monitoring results are essential for the step over time; and, whether there is an prioritization and organization of occupa- extraneous step such as welding or treat- tional and public health budgets and deriv- ing of the chemical after its application ing which strategies are most effective and [Tischer and Scholaen 2003]. economically viable [Kromhout 2002b]. For point source exposures, toolkits will Though CB does not require personal either use exposure prediction for the monitoring for implementation, valida- task-related controls they suggest or show that implemented controls are effective for tion and maintenance of the strategies reducing exposure regardless of predicted do. IH personal monitoring is a necessary exposure. The parameters of a particular part of the validation of toolkits to en- task performed by a single person are im- sure controls are appropriate [Tischer and portant, but more important is the reduc- Scholaen 2003; Money 2003; Swuste et al. tion of exposure even if the end result may 2003]. Developing a particular toolkit re- be above established OELs [Jones and quires established emissions assessments Nicas 2004, 2006a; Kromhout 2002b]. To for specific point sources. And, since fur- validate the CB, further exposure assess- ther exposure assessment will be required ment will be an essential confirmation and for CB validation, it can be argued that will also serve to improve the given tool- this process will contribute to the num- kit’s information basis to be applied in its ber of completed task-related exposure subsequent toolkit revisions [Oldershaw assessments available for reference [Jones 2003]. Exposure assessment would then and Nicas 2004, 2006a; Kromhout 2002a; not only benefit the individual worker but Maidment 1998]. would also provide scientific and technical

52 Chapter 8 | Critical Analysis of Control Banding Strategies

information to practicing IH professionals. concept relies on the goodwill of nontech- The lack of data for validation may cause nical overseers, who are likely to be under- problems with toolkits aimed at estimat- trained and ill-equipped with appropriate ing qualitative exposures for bulk chemical information to validate and maintain the processors [Money 2003]. The validation best controls [Tischer and Scholaen 2003; protocol within the CB strategy may then Maidment 1998]. provide more professional judgment for SMEs than already exists. A limitation of the current CB strategy is that it is static, whereas a system that is reviewed and updated periodically would 8.1.7 Static Controls v. Dynamic ensure that the controls implemented and the managerial oversight are maintained If businesses do not have full-time IH pro- over time. Consequently, part of valida- fessionals on staff, the recommended con- tion is comparison among the possible trols that result from CB strategies may not methods of implementing controls and be implemented for the long-term and the construct within which these methods may not be periodically assessed for effectiveness. The dynamic nature of industry are introduced—to employers and work- and manufacturing does not quite fit with ers. The validation effort supports devel- brief managerial consideration of safety and opment of task-specific guidance that in- health in the absence of onsite consultation. tegrally involves CB strategies in effective How is the IH profession to oversee that control solutions. PPE recommendations are implemented appropriately? If the wrong glove material 8.2 Determine the Barriers is recommended or an inappropriate respi- rator type is chosen, protection may be in- to, and Considerations for, sufficient, and the toolkit would not detect Implementing Control the error [Guest 1998]. The consequence Banding to Address of such scenarios is to render a false level of safety [Jones and Nicas 2004, 2006a]. In Safety and Health such a case, workers assume that they are Hazards in U.S. protected from hazardous exposures while Workplaces at work though current NIOSH research shows that is not the case for a portion of Among potential barriers to the implemen- them. To protect themselves, workers in tation of CB strategies in the United States are facilities managed with a strategy other legal implications, concerns about devalua- than CB, who are unsure of exposure lev- tion of worker protection, and application of els, must rely on their own knowledge and R-phrases. The creation of a dynamic pro- awareness of hazards to protect themselves. cess to ensure quality of implementation Relying on personal knowledge may seem over time and the use of CB strategies a better alternative than being incorrectly within U.S. regulatory and management informed that their workplace is safe based schemes could facilitate the implementa- on CB determinations. The overall CB tion of CB.

53 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

It is impossible to discuss any new sys- reflect the hazard of the chemical under tem that seeks to protect workers in the U.S. law. Therefore, one cannot simply use United States without addressing legal the R-phrases for a chemical to apply CB in considerations. One challenge relates to a U.S. workplace. implementing a generic CB system that may provide practical tools for managing In order for CB to work, the use of stan- and reducing hazardous exposures, yet dard hazard statements linked to specific may not be applicable or provide appro- criteria is necessary for consistency and priate protection in all cases [Jones and the determination of the proper level of Nicas 2004, 2006b; Money 2003; Krom- control. Many companies in the United hout 2002b]. It is essential to recognize States have developed their own databases these limitations and to address informa- of standard phrases that they use to con- tion gaps to ensure that use of CB strategies vey hazards for their products. Some com- achieve the appropriate levels of workplace panies in the United States have used the protection, rather than contribute to oc- hazard information on U.S. MSDSs and cupational illness and injury, as well as to applied their professional interpretation of employer liability. the data to link it to an EU R-phrase and then used the phrase to apply CB. Doing this successfully would require a level of 8.2.1 Use of Standardized professional expertise and judgment in Hazard Statements in toxicology and other disciplines that would Control Banding be limited to larger North American companies in most situations. The lack of this Under the CB strategy used in COSHH Es- piece of information—the standard hazard sentials, the hazard and degree of severity statement—for the CB equation is a signifi- of hazard are obtained from the R-phrases cant impediment to successful implemen- given on EU labels and MSDSs. The U.S. tation of CB in the United States. Ready classification and labeling system in the availability of standardized phrases linked workplace is the OSHA Hazard Com- to U.S. hazard criteria is necessary to en- munication Standard (HCS). The HCS sure the possibility of widespread applica- requires classification of chemicals action of CB, particularly in small businesses. cording to the hazard criteria in the standard and also requires the label preparer The GHS is intended to resolve some of to include appropriate “hazard warnings” the challenges associated with hazard clas- on the chemical label. It does not specify sification, labeling, and communication. the language to be used to convey the haz- The GHS is a common and coherent strat- ard information since it is a performance- egy to classifying the health, physical, and oriented standard. It also does not require environmental hazards of chemicals and that the label phrases appear on the MSDS to communicating the hazards through for the chemical. The U.S. definitions of labels and MSDSs. GHS includes a core hazard are similar to the EU’s but not iden- set of label elements and has harmonized tical. Thus the R-phrases assigned to par- hazard statements for each category and ticular chemicals may or may not accurately class of chemicals covered. It also has a

54 Chapter 8 | Critical Analysis of Control Banding Strategies

harmonized strategy for classifying mix- at this time because it is a static strategy tures of these chemicals. The United Na- without consideration for the multiple tions adopted the GHS strategy in 2003. factors that consistently affect change The United States, the European Union, in U.S. manufacturing and other indus- Canada, and many other countries are trial sectors. Therefore, a parallel effort is now considering its use. In the United necessary to create a dynamic system for States, four agencies have primary respon- the CB strategy that seeks to incorporate sibility for its implementation—Consum- changing factors over time for both the er Product Safety Commission (CPSC), controls implemented and the managerial Department of Transportation (DOT), oversight to ensure CB does not fall into Environmental Protection Agency (EPA), misuse, improper application, or lack of and Occupational Safety and Health Ad- implementation entirely. Essential to the ministration (OSHA). OSHA has pro- utility of a dynamic system is the protocol posed rulemaking activity (first published for validation to ensure that assessments as a draft in 2005, with an update expected and resulting control recommendations in 2009) for revising its hazard communi- are appropriate and effective and the abil- cation standard to incorporate the GHS ity to identify exceptions and areas requir- elements. The revised hazard communica- ing further evaluation and improvement tion standard will require use of standard [Guest 1998; Yap 2004; Tischer and Scho- hazard statements on U.S. labels as well as laen 2003; Jones and Nicas 2004, 2006a,b; on MSDSs. Brooke 1998; Loughney and Harrison 1998; Palmer and Freegard 1996]. Global implementation of the GHS would provide an international system upon Under the current static CB strategy, it is which to base CB. In recognition of this, anticipated that some employers will recognize the benefits of CB without being the ILO has included the GHS hazard cat- in a position to implement or enforce its egories in its ICCT. Action is also being use. An alternative dynamic CB strategy taken to modify the roughly 1,600 Inter- should incorporate management consid- national Chemical Safety Cards prepared erations that would facilitate putting the under the IPCS to follow the GHS crite- CB strategy into practice. This strategy ria for classification and the harmonized should be accompanied by a method of hazard statements for the most commonly measurement for the extent of institution- used chemicals. al implementation, for its ability to adapt to changes over time, and for determina- 8.2.2 Considerations for Imple- tion of the level of successes and reduc- menting Control Banding tion of exposure potentials. This dynamic strategy should be developed with a theo- Current efforts for creating a CB strategy retical strategy that involves consideration have focused almost entirely on evaluat- of costs and benefits. It should ensure that ing and perfecting existing toolkits. Yet, all tasks, chemicals, and exposures in- NIOSH research shows that this focus may volved are considered so the properties, be flawed for national implementation toxicity, application, and conditions during

55 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

Table 15. Current documented input to the ANSI* Z10 review committee for pertinent sections

■■ 3.2 Employee participation (Identify tasks, risks, and possible controls) ——no mention of evaluating exposures ■■ 5.4 Document and Record Control Process ——if CB† in an OHSAS,‡ it becomes part of the process ■■ 6.1 Monitoring and Measurement: F. “Other methods” ——does not rule out semi-quantitative/qualitative ■■ 6.3 “System” Audits: evaluating activities and corrective actions—recordable CB process fits audits ■■ 6.4 Track actions for effective implementation ——possible weak point with CB, needs strengthening

*ANSI=American National Standards Institute †CB=control banding ‡OHSAS= Occupational Health and Safety Assessment Series

applications are part of the decision ma- 8.2.3 OSHA and Its Voluntary trix. Creating this system with a task force Consultative Services of safety and health professionals working The U.S. OSHA Consultation Program in concert with managerial oversight and to Small Businesses was first promulgat- workplace employee representatives will ed more than 30 years ago and has since facilitate the best use of CB to maximize served as an effective mechanism for pro- its effectiveness, consistent application, moting safety and health guidance and and economic efficiency. An example of solutions for the small business audience a vehicle for this strategy is the American since. However, fear of government inter- National Standards Institute (ANSI) Z10 vention and penalties prevents many small committee (Table 15). A major premise businesses from using this service [Kalisz on which a dynamic strategy should rely 2000]. As a means to overcome this reluc- is the understanding that industry specif- tance among small businesses, introducing ic, worker-influenced solutions have the practical, qualitative risk assessment and management tools, such as a CB strategy, best possibility of being applied, achieving may provide opportunity for OSHA to success, remaining in place over time, and form strategic partnerships, possibly rec- having a mechanism for ensuring com- ognizing and rewarding successful control mensurate controls are in place regardless implementations in the process. Results of of changes in tasks, processes, products, effective partnerships might contribute to and the inevitable workplace rotation of a solutions database and provide effective affected worker populations. advertising of services focusing on worker

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safety and health education [Topping 8.3 Implementation of a 2001]. OSHA could assist in accomplish- Risk Management ing compliance by helping businesses develop guidelines. This could create a larger System in the United demand and respect for these consultative States that Includes services, emphasizing the assistance to CB Strategies businesses and working toward cooperative solutions [Money 2003]. In building The implementation of CB strategies in support for the partnerships and explora- the United States for qualitative risk assess- tion of CB applications, the involvement ment and management requires additional of organized labor representatives is para- research and development. Topic areas for further exploration include the provision mount. of national-level guidance and coordina- This envisioned CB strategy for implemen- tion, pilot projects at the state level, and tation synchronizes well with the existing expansion of the ORM (Occupational Risk OSHA Consultation Program offering free Management) Toolbox to include more consultation services.This program offers chemicals and ergonomic, safety, and en- employers the opportunity to find out about vironmental concerns. Cooperation with potential hazards at their worksites, im- international efforts to implement CB can strengthen efforts in the United States prove their occupational safety and health through bilateral sharing of research and management systems, and even qualify for experience. Linking CB strategies with Oc- a 1-year exemption from routine OSHA in- cupational Safety and Health Management spections. In the year 2000, 20 CFR* Part Systems and the GHS will add value. 1908 was amended to reflect many of the underlying tenets of the CB strategy: (1) provide for greater worker involvement 8.3.1 Can Toolkits and Toolboxes in site visits, (2) require that workers be Reduce Occupational informed of the results of these visits, (3) Exposures to Protect the provide for the confidential treatment of Health of Workers information concerning workplace consul- on a National Basis? tation visits, and (4) update the procedures for conducting consultation visits. Specific At present, data are not available to allow task-based hazard guidance concepts asso- appropriate validation of CB toolkit mod- ciated with CB might also have utility for els [Jones and Nicas 2004, 2006a,b; Money the OSHA Consultation Program for pro- 2003; Tischer et al. 2003; Kromhout 2002b; viding guidance to target smaller business- Maidment 1998]. Yet, such a task could be es. This can be accomplished while com- addressed through priorities established by the appropriate task force or working municating the distinction between OSHA group. Such a National Control Banding safety and health consultation services and Working Group would be charged with enforcement efforts. creating a validation process for evaluating *Code of Federal Regulations. See CFR in references. the existing toolkits, focusing on strategies

57 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

within selected industrial sectors and spe- both workers and employers in its de- cific trades. One objective of the valida- velopment [Money 2003]. This strategy tion process would be to emphasize field fits well with the intent of the OSHA Al- IH input for identifying needs for improv- liance Program created in 2002 to enable ing toolkits and determining the scope of organizations committed to safety and their implementation. This working group health to work cooperatively with OSHA will decide which measurable parameters to prevent illnesses, injuries, and fatalities for ranking hazards to consider in choos- in the workplace. Seeking and providing ing the appropriate CB, the prioritization end-user input as part of this focus on of controls, and the effectiveness of their the workforce will help improve the final application. Because personal sampling CB product and determine when its use requirements are essential to validation is most practical and how best to imple- of the CB strategy, the validation strategy ment it. should be developed using statistically supported bases and be coordinated with 8.3.3 Expanding to an ORM research that focuses on prospective and retrospective epidemiologic studies. Vali- Toolbox for Chemical dation efforts should simultaneously com- Control pare and contrast the success rates of dif- This effort should begin by including point ferent methods of implementing a given source emissions that do not involve the CB strategy. use of bulk chemicals, such as silica exposures relating to construction work. Con- 8.3.2 Implementation in Small struction work is an important example Businesses for showing how an application moving directly to exposure controls based on the During development of a validation pro- task performed is the best use of the CB cess, toolkits can still provide hazard strategy. Stoffenmanager (discussed earli- guidance in small business trades and er in Section 3.3.4) has evolved to include industrial sectors. A practical validation a Construction Stoffenmanager, developed effort could involve comparison of exist- by Arbouw, under commission from the ing toolkits and the type of system with- Dutch Association of Employers in the in which it is implemented [Oldershaw Finishing Sector of the Construction In- 2003]. The different state OSHA plan sys- dustry and the Association of Contractors tems may provide opportunities to apply of Tiling Work in the Netherlands. The a toolkit through demonstration or pilot demonstration modules for this instru- programs. If a state OSHA strategy can in- ment are intended to help employers of tegrate partnerships with trade organiza- plasterers and tilers to assess and control tions, organized labor groups, educational the risks of hazardous substances. Using institutions, and government agencies, then the construction industry as an important a pathway would exist to build this model emphasis area would allow expansion of with a participatory strategy by including IH aspects to include other chemical and

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physical exposures and perhaps to address could be developed, validated, and imple- biological exposures such as mold initially. mented prior to creation of a parallel chem- Validation of controls tied to specific con- ical-agents strategy. For applications in struction tasks that have an established this arena, the CB strategy could promote exposure assessment would be linked to the use of practical tools for assessing and achieving target reductions in exposure reducing risk based on recent advances on a task-by-task basis. The development in participatory ergonomics. Compiling of a complete ORM Toolbox will enable a repository of well-researched, validat- applications for addressing hazards that ed, existing work practices in the United cut across industry barriers. For example, States could lead to a solutions database silica dust exposures in construction have for musculoskeletal hazards and ergo- some similarity to conditions and activities nomic control options. Initial discussions in some mining processes. Experience of expanding CB strategies to include er- with exposure characteristics, processes, gonomics were first raised at the ICBW2, and controls in both industries may be and subsequently the International Ergo- transferable and could contribute to de- nomics Association has become involved velopment of a solutions database with through participation at both the ICBW3 established toolkit and toolbox controls and ICBW4. [Jones and Nicas 2004, 2006a,b; Guest 1998; Brooke 1998]. 8.3.5 Investigate Expansion to Safety and Environmental 8.3.4 Develop Ergonomics Parameters Toolkits Based on Existing National Models Expansion of the ORM Toolbox could also encompass the ES&H multidisciplinary One potential application of the CB strategy concepts that affect U.S. business establish- in the early stages of exploration is the re- ments. The example of creating a construc- duction of musculoskeletal disorders result- tion ORM Toolbox could serve as an ap- ing from ergonomic exposures. The more propriate initiation for a system that would traditional applications for chemical tool- incorporate occupational safety and health kits seek to address an extremely large and requirements at a given worksite and in- growing inventory of chemical substances. clude an additional focus on traumatic in- Chemical production involves the introduc- juries. In this system an appropriate context tion of new constituents that may never be for a safety-related toolkit would probably fully researched or adequately characterized emphasize integrated training that offers with regard to exposures, toxicity, and con- a simplified strategy to lessons learned by trol options. In contrast, ergonomics has a accumulated tasks within a given trade. As finite group of well-researched and defined an additional application, an environmen- risk factors and effective programs [Stewart tal toolkit could be developed to assist em- et al. 2005; Zalk 2003]. In theory, a compre- ployers and educate workers on the ben- hensive collection of ergonomics toolkits efits of waste management for improving

59 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

the air, soil, wastewater, and waste dispos- PRIMAT and associated products can be al streams. It is essential to involve stake- found at www.prima-ef.org. holders to define minimum performance standards, and to include this input in the 8.3.7 Implementing a National creation of simplified training programs. For implementation in the United States Control Banding Strategy and other countries, it would be progres- To coordinate multiple activities support- sive to incorporate pictorial training con- ing a control-focused risk management sistent with the GHS symbology to reduce initiative, each requiring field research, the need for multiple translations. A chal- validation, feedback, and improvement, lenge facing industrial hygienists in com- would require coordination to oversee the municating exposure reduction successes process and track progress. Participation is the dearth of appropriate yardsticks for in this effort by stakeholders, labor orga- measuring program benefits of a disease nizations, and the ES&H organizations prevented. Possible solutions to address this would be integral to its success. Part of challenge include better surveillance and this strategy would involve education for use of appropriate metrics to track the effec- national ES&H and labor organizations tiveness of hazard control interventions. to provide them with the foundation for a CB strategy and their role in its devel- 8.3.6 Investigate Expansion to opment, validation, and implementation. Psychosocial Toolkits Insurance companies, workers’ compensation agencies, and multinational com- The development of the Psychosocial Risk panies could also contribute by sharing Management toolkit (PRIMAT) started expertise, resources, and communication with the definition of key principles and a networks to prioritize efforts and promote framework of best practice for psychoso- the application of control-focused solu- cial risk management [Leka 2005]. Risk- tions to occupational hazards. reduction interventions and evaluation of those interventions will be developed for The scope of such a strategy requires link- organizations as part of the framework ing with other similar committees and CB guidelines on risk assessment. The frame- strategy entities internationally. A coor- work also considers key indicators and dinated, consistent effort could maximize aspects of corporate social responsibility, utility of limited resources and encourage identification of key stakeholders, cost ef- harmonization in an increasingly global fectiveness, and societal learning. It goes economy. As part of this strategy, explor- a step further to consider policy level and ing the twinning and regional partnering its link to practice, both at the enterprise of developed countries with developing level and the national context. The next countries for trial implementation, with steps of the project will include the devel- a focus on communicating and sharing of opment of toolkits for the enterprise and successes, may also assist in limiting the the national levels as well as training ma- need for translating programs that are de- terials. More information on the status of veloped in native languages.

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8.4 How Can International of efforts and instead will build capacity Cooperation Assist in by combining resources. It can also serve as the best method to test and improve the Creation of Toolkits existing toolkits, to identify the steps nec- and ORM Toolboxes? essary to successfully build new toolkits, and eventually to create the blueprint for 8.4.1 Twinning Developed developing complete ORM Toolboxes. Countries with Developing Countries 8.4.2 Americas Silica Control An effort to investigate twinning concepts Banding Effort was begun at the Control Banding Practi- Since 2005, NIOSH has been explor- cal Applications Workshop, held June 13– ing the utility of CB in its response to a 16, 2004, in Utrecht, The Netherlands. This request for assistance to address silica meeting was coordinated as part of the exposures in South American countries. WHO Collaborating Centers (WHOCC) Specifically, a multidisciplinary, interdi- Occupational Health Network 2001–2005 visional NIOSH team of researchers has Work Plan’s Task Force 10 on Preven- traveled to Santiago, Chile to provide tive Technologies. This event resulted in training and technical assistance to the planning to create and implement twin- Occupational Health Department, Insti- ning strategies for pilot projects with CB tuto de Salud Publica de Chile (Chile Pub- for South Africa, Benin, and India. De- lic Health Institute) and the Ministerio del veloping and overseeing these twinning Salud de Chile (Chile Ministry of Health) strategies and training protocols would as part of the Multinational Program for be coordinated with and economically Elimination of Silicosis in the Americas. assisted by more established programs These technical assistance visits to Chile in developed countries, such as those in have involved meetings with public health the United Kingdom, the United States, officials and training on occupational and The Netherlands. Attendees included safety and health issues, including several leadership and representatives from the intensive courses focusing on CB tools International Technical Group on CB and and applications. Courses have included attendees from The Netherlands, Switzer- live translation during classroom sessions land, India, Benin, South Africa, Brazil, and field visits to quartz quarries and rock Central America, Canada, Great Britain, crushing plants. Chilean participants re- and the United States. This cooperative ef- ceived training on strategies for assessing fort is a model for future cooperative work and controlling exposures to silica-con- between developed and for developing taining dust in mines and other high-risk countries. International collaboration can workplaces. In conjunction with the visits, appreciably strengthen national capabili- NIOSH researchers participated in joint ties for the protection of workers’ health field site visits to a large underground and the environment. Sharing knowledge and surface copper mine in the Andes and experiences will also limit duplication and a rock crushing small enterprise in

61 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

the Santiago region. The purpose of the Occupational Hygiene, which was held field visits was to observe work activities in September 2005, in South Africa. and tasks associated with potentially high exposures to crystalline silica dust and 8.4.4 Fitting Control Banding whether control-focused, task-specific into Occupational Safety hazard guidance sheets (such as Silica Es- sentials and NIOSH mining engineering and Health Management reports) might provide relevant informa- Systems tion to reduce hazards. This cooperative The International Organization for Stan- effort has been formalized through a letter dardization (ISO) is an existing network of agreement with NIOSH, the Chile Pub- of the national standards institutes in 147 lic Health Institute, the Chilean Ministry countries which could facilitate further of Health, and the Pan-American Health development of an appropriate CB strat- Organization (PAHO) in September 2006. egy with international relevance. With the Plans are also being made for continued success of ISO 9000 for working with qual- collaboration and expansion to include ity management and ISO 14000 for work- additional South American countries of ing with environmental management, a Brazil and Peru. natural extension of this concept would 8.4.3 Expanding to an ORM be to include safety and health. The Oc- cupational Health and Safety Assessment Toolbox Series (OHSAS), the OHSAS 18001–2, is For cooperative efforts internationally, a management system that seeks to help eventually a focus on large scale indus- organizations control occupational safety tries or sectors in developing countries and health risks. Similar to the objectives will be necessary to link ORM Toolbox of the CB strategy, OHSAS 18000 series is needs in developed countries. Selec- a method of assuring conformance with tion of appropriate industries will help an occupational safety and health policy. determine the effectiveness of exposure IOHA performed a critique of the OHSAS prediction related to some existing tool- 18001 for the ILO. (The resulting report kit applications. For practical purposes, can be accessed at the IOHA Online Li- activities and progress-implementing brary for WHO and ILO documents at elements of CB should consider the www.ioha.net.) Strengths identified within guidance presented in the International the critique include long-term employer Technical Group’s Implementation Plan savings by using risk assessments for cost (Appendix C). Such efforts would be con- avoidance, reducing workers compensa- sistent with the activities of the WHOCC tion and medical costs, focusing on proac- in their 2006–2010 Work Plan, which in- tive prevention to reduce safety and health cludes 25 risk management (CB) projects liabilities, and setting safety and health (www.who.int/occupational_health). dedication apart from other traditional The initial draft of the 2006–2010 Work areas of business and trade. Linking the Plan was drafted as part of the IOHA 6th CB strategy within an existing system like International Scientific Conference on OHSAS could provide a mechanism for

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toolkit and toolbox implementation to en- The GHS was developed as the result of sure it is maintained and improved within an international mandate adopted at the a management system that can be assessed United Nations Conference on Environ- at appropriate intervals. ment and Development in 1992. The goal was to have such a system developed by Part of integrating CB into a business mod- the year 2000, including criteria for the el is overcoming the difficulties safety and classification of hazards, labels, and MS- health professionals have in communicat- DSs. The work was to build on existing ing the value of their services. The collec- systems in the United States, Europe, tive professions of environmental and oc- Canada, and the United Nations trans- cupational safety and health generally have port systems. Classification and labeling limited understanding of the language of laws are based on countries recognizing businesses, which converts issues directly that the quantity of chemicals in com- into financial terms [Schulte et al. 2004]. merce is so extensive that no country can One possible exception is the pharmaceu- effectively regulate each one individually. tical industry, where this strategy has been Having laws that require information to successful and, consequently, could serve be transmitted to users regarding these as a model to be followed as a formal means chemicals is one way to ensure that steps of communication in other industrial sec- can be taken to provide protection from their hazards. Although similarities ex- tors. In addition, further benefit could be ist among international hazard classifica- derived if workers’ compensation and in- tion systems, the national, regional, and surance organizations could promote and international requirements are different lead the education efforts for learning how enough to require multiple classifications best to speak the language of business and multiple labels and MSDSs of a chem- [Schulte et al. 2004; Ennals 2002]. Self- ical to be shipped to different countries. insured multinational organizations have Therefore, the mandate from the United already learned the value of this process by Nations Conference on Environment and investing in research in improving return- Development was to encourage countries to-work rates [ILO 1998]. Therefore, har- to work together to eliminate these differ- monizing CB strategies with the develop- ences by harmonizing their requirements, ment of the American National Standards maintaining or enhancing protections in Institute (ANSI) Z10 version of OHSAS in the process, and eventually providing the the United States could potentially improve opportunity to eliminate technical barri- the effectiveness of both efforts. ers to trade in this area. Development of the GHS involved 10 8.4.5 Control Banding years of effort by multiple countries and Compatibility with the international organizations. Completed in Globally Harmonized 2002, the maintenance, updating, and implementation of the GHS are assigned to a System for Classification new United Nations Subcommittee of Ex- and Labeling of Chemicals perts on the GHS. The United States was

63 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

an active participant in the development to incorporate elements of the GHS into of the GHS, through contributions from the HCS. Both the OSHA analysis and ad- both the government and relevant stake- vanced notice are available on the OSHA holders, and is a member of the United Web site with links to the official text of Nations Subcommittee. An international the GHS as well. GHS implementation has goal to have as many countries as pos- also been a subject of discussion in OSHA sible implement the GHS by 2008 was es- meetings with its North American Free tablished by both the Intergovernmental Trade Agreement partners on handling of Forum of Chemical Safety and the World hazardous substances, and the three coun- Summit on Sustainable Development. tries (Canada, Mexico, United States) have Some countries have been successful in exchanged information about implemen- meeting this goal, while the United States tation activities on a regular basis. There and other countries are still involved in is also an existing U.S./EU pilot project to efforts (described below) to implement link the GHS with CB in order to imple- GHS requirements. ment the GHS seamlessly across the At- lantic, with CB as an integral part of this The United States lacks a system of stan- process that seeks to control exposures dardization, analogous to that used in the related to the international distribution of European Union, for hazard statements chemical inventory. Information relating on labels and MSDSs. As emphasized to this pilot project is at www.useuosh.org earlier, the United States cannot move with many useful discussions and subtop- forward with the GHS because of this ob- ics linked to the concepts presented. By stacle. Nevertheless, the availability of an 2006, the Asia-Pacific Economic Coop- internationally approved system to clas- eration established a goal of implementa- sify chemicals and prepare harmonized tion. The United States also participates in labels and MSDSs provides a strong im- this trade-related organization. petus for adoption. The additional impe- tus to adopt the GHS is provided by the The GHS is seen by international organi- potential widespread applications for CB zations as a significant tool to ensure the in the United States. sound management of chemicals worldwide. The GHS provides the information- Despite the barriers to adapting concepts al framework upon which comprehensive of the GHS in the United States, there is programs to address chemical safety and considerable interest in the system and health can be based in countries that do some activities related to its implementa- not have the infrastructure to create such tion. The four regulatory agencies poten- a system. The additional benefit of having tially affected by the GHS are all actively the system updated and maintained by an engaged in considering adoption (EPA, international body rather than by each in- DOT, OSHA, and CPSC). OSHA has pre- dividual country is significant in the con- pared an analysis comparing the GHS to text of global chemical safety and health. its HCS requirements, and in September Thus, WHO, ILO, IPCS, Organization of Eco- 2006 the Administration published an nomic Cooperation and Development, and advanced notice of proposed rulemaking other international organizations continue

64 Chapter 8 | Critical Analysis of Control Banding Strategies

to promote its adoption and implementation allow comparisons based on utility for worldwide. The United Nations Institute for medium and large chemical industries. Training and Research is also working with This effort has already begun with the ILO to promote implementation through testing of COSHH Essentials against ex- pilot projects in various countries as well as isting personal monitoring exposure as- other capacity-building activities. The United sessments in India. Beyond risk assess- States is a partner in this work, having pro- ments per COSHH Essentials and the vided some funding to the United Nations ICCT, work could begin by focusing on Institute for Training and Research to pro- point source emissions with known solu- mote implementation of the GHS. The ability tions databases such as the inclusion of at- to use CB in countries that have adopted the tributable portions of the Silica Essentials GHS has already been recognized as a poten- within a Construction Toolbox that seeks tially powerful tool to achieve chemical con- to incorporate silica dust, wood particu- trol in economies in transition. late, noise, safety, traumatic injuries, and other well-documented control solutions. On a grander scale, efforts to implement NIOSH has initiated projects that account the GHS also provide opportunities to work for a strategy of qualitative risk assess- with and cultivate multinational coopera- ment and management (CB) and the de- tion with private enterprises. Partnerships velopment of task-specific hazard control are established by investing time, experts, guidance. Because rates of illness and in- and financing for the necessary field imple- jury for specific industries are higher than mentation, validation, and development of for general industry, they are already be- long-term occupational safety and health ing targeted: pallet manufacturing; con- management systems essential for CB strat- crete products industries; roofing, siding, egies. It should be emphasized that the best and sheetmetal; plumbing, heating, and CB product, including toolkits and tool- air conditioning; auto and home supply boxes, will be one that is transcendent of stores; eating establishments; and medi- borders for implementation yet adaptable to cal offices and clinics. Additional systems the specific legal and sociocultural features are in place to evaluate CB use with glu- of the countries in which it will be applied. taraldehyde in healthcare facilities, metal working fluids, and silica exposure potential across all trades. 8.5 Recognition of Specific Multidisciplinary CB models for work- Industries or Activities related risk reduction in construction could Where CB May Be address the variety of hazards (chemical, Adopted ergonomic, safety, and environmental) in that industry. Thus, the incorporation of Small chemical manufacturing facili- individual toolkits into a Construction ties and trades that use chemicals within Toolbox is an appropriate next step. The their processes and procedures are the ICBWs have facilitated toolkit strategies for primary focus of existing toolkits. This ergonomics, silica, and safety in a manner focused effort should be structured to that includes the provision of national-level

65 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

guidance and coordination of pilot proj- health impacts, ergonomics has a finite ects at the state level. An ORM Toolbox group of well-researched and defined risk concept has become a byproduct of this factors and effective programs. For appli- coordination, which has broadened the cations in this arena the CB strategy could CB model to include a more comprehen- promote the use of practical tools for as- sive exposure control basis for universal sessing and reducing local risks, some industries such as construction and agri- of which have been derived from recent culture. Working to further develop this achievements in participatory ergonom- multidisciplinary effort is an internation- ics in developing countries. Participatory- al, informal working group that includes based programs in developing countries the United States, United Kingdom, and support low cost improvements in small the Netherlands that is seeking occupa- enterprises, such as Work Improvement tional health and safety professional input in Neighborhood Development, which toward the development of a task-specific focuses on agriculture, Work Improve- Construction Toolbox framework [Zalk ment in Small Enterprises [Muchiri 1995], 2008; van Thienen and Spee 2008]. and Participation-Oriented Safety Im- provement by Trade union Initiative. To tie these concepts together, an intercoun- 8.6 Additional Applications try network has been formed to exchange of CB in Ergonomics, positive experiences and collaborate in Noise, and Traumatic educating trainers and developing training tools, which, in Asia, are called Work Injuries Improvement Network. These can be ac- Ergonomics is a promising area for adap- cessed at www.win-asia.org. tation and adoption of CB strategies. Ad- A reduction in work-related musculoskele- ditional research and development is re- tal disorders is essential to the improvement quired before the utility of CB strategies in of occupational health in both industrial- noise, traumatic injuries, and nanotech- ized and developing countries. Currently nology can be evaluated. 40% of the world’s occupational and work- related health costs are attributed to mus- 8.6.1 Control Banding for culoskeletal diseases [ILO 1999]. With in- Ergonomics dustrialization taking root in developing countries, ergonomic interventions need to Ergonomics hazards are an area where a CB be adaptable in order to span several indus- strategy could provide practical solutions tries and work sectors. Ultimately, this will to physical agents that may cause musculo- require a programmatic process that is low skeletal disorders in the workplace. Where- cost, easy to understand, and sensitive and as chemical inventories and applications adaptable to the social, cultural, and politi- continue to expand, with many substanc- cal considerations of each targeted industry. es lacking data on toxicity, exposure One part of this process is putting in place characteristics, and potential adverse a permanent ergonomic infrastructure to

66 Chapter 8 | Critical Analysis of Control Banding Strategies

train and disseminate information to the ergonomics, an appropriate delineation internal groups and organizations in need. for control needs and effectiveness would Within the process of training, a combi- require precise exposure measuring nation of ergonomic hazard assessment equipment. There are too many factors, tools should be presented. These tools, or almost all specific to workplace and work- toolkits in development, could include a er, beyond the current concept for sim- brief manual that leads to checklists for ple toolkit-related strategies that render direct use by managers and workers of simplification impractical. The key field small enterprises in a manner that puts guideline that can be used is the distance into practice the ILO Ergonomic Check- required for understandable, normal con- points document published in 1996 and versation. This guideline, common in field currently being revised and updated. Ini- practice, is approximately 2–3 feet from tial toolkit versions could be implemented the speaker. If a person’s voice needs to be and assessed according to the usefulness raised for communication, then the noise of the strategies recommended. Examples exposure level is most likely at or above a of industry- and task-specific guidance key 85 dBA threshold. Above this thresh- that could be developed include an agri- old, the use of hearing protection for af- cultural ergonomics toolkit, a construc- fected workers is advised. Any further tion ergonomics toolkit, and a human/ recommendations above this level are di- computer interaction toolkit [Zalk 2003]. rectly tied to 3 dB (ACGIH TLV) or 5 dB Essential in this toolkit development (OSHA permissible exposure limit)limit) exex-- strategy will be a follow-up mechanism to change rates that halve the time of expo- ensure that the newly trained individuals sure with each elevation of exchange rate. (infrastructure) receive some expert guid- This precision would be difficult at best, ance when employing their new skills. Fi- and truly impractical in concept, to offer nally, an economic evaluation of expected appropriate worker exposure times. improvements should become an integral part of the process. This would help -fa 8.6.3 Control Banding for cilitate management’s acceptance of the proposed ergonomic interventions, pro- Traumatic Injuries viding justification for control develop- In the year 2005, the U.S. Bureau of La- ment to eliminate or mitigate the hazards bor Statistics reported almost 5,734 fatal with supporting business case models and occupational injuries (http://stats.bls.gov/ simple cost/benefit analyses [Zalk 2003; iifwc/cfoi/cfoi_revised05.htm). Within Stewart et al. 2005]. these injury statistics are specific industries and activities associated with higher 8.6.2 Control Banding for Noise rates of injuries (both fatal and nonfatal). An example of this is in the manufac- An example of the difficulties in apply- tured wood pallet industry, which has ing the CB strategy to physical agents is an overall increase of 245% in injury in controlling exposures to noise. Unlike rates compared with general industry, the above strategies for chemical risks and including more than a 1,300% increase

67 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

in amputations and more than an 800% worker exposures to constituents that are increase in cuts and punctures. Many found in the workplace in the absence of industrial sectors (e.g., agriculture, con- firm toxicologic and exposure data [Paik struction) with hazards (e.g., confined et al. 2008]. These strategies may be par- spaces, electrical hazards, fall hazards) ticularly useful in nanotechnology appli- that contribute to occupational injuries cations, considering— could benefit from control-focused solutions and guidance. Traumatic injuries ■■ The overwhelming level of uncer- can be addressed within a Construction tainty concerning which nano- Toolbox through task-specific hazard materials and nanotechnologies guidance provided in training and in- present as potential work-related cluded as control solutions. In addition, health risks control solutions and guidance devel- ■■ Characteristics of these materials oped for one industry sector (e.g., con- that might lead to adverse toxico- struction) often have relevance to other logic activity industries, such as agriculture and min- ■■ Possible strategies for assessing re- ing, and can be applied to address similar lated risk hazards. ■■ Management of these issues in the Similar to the banding of chemicals by tox- absence of this information icity, classifications already exist for differ- A pilot CB tool, or CB Nanotool, was de- ent variables of accident causation. Band- veloped specifically for characterizing the ing safety risks for selection of appropriate health aspects of working with engineered barriers for injury prevention is similar to nanoparticles and determining the level selecting appropriate engineering controls of risk and associated controls for five based on chemical hazard bands in CB. ongoing nanotechnology-related opera- Barriers to injury, including management tions being conducted at two Department factors, are strongly related to the qual- of Energy research laboratories. Four of ity of safety management systems and are the five operations evaluated in the study important parameters for risk prevention were found to have implemented controls [Swuste and Zalk (in press); Swuste 2007; consistent with what was recommended Zalk 2006]. by the CB Nanotool, with one operation even exceeding the required controls for 8.6.4 Control Banding for that activity. The one remaining operation Nanotechnology was determined to require an upgrade in controls. The authors conclude that appli- Also being considered is the potential for cation of CB appears to be a useful strat- applying CB strategies for the qualitative egy for assessing the risk of nanomaterial risk assessment and management of expo- operations, providing recommendations sures to nanomaterials. Researchers have for appropriate engineering controls, and explored the concepts of a “Nanotool” facilitating the allocation of resources to with simplified solutions for controlling the activities that most need them.

68 Chapter 8 | Critical Analysis of Control Banding Strategies

8.7 Current Collaborations ensure that national CB Work Plans are to Explore CB developed and implemented by relevant stakeholders. In addition to the multiple Collaboration with multiple stakehold- organizations discussed above, ITG is also ers, including national and international partnering with HSE, NIOSH, and the agencies, organized labor, trade groups, GTZ. academic institutions, and professional societies can build capacity and maximize Building upon international coordination resources, contributing to improved tool- efforts of the ITG and its Global Imple- kits to protect worker health globally. The mentation Plan, NIOSH and other orga- interest in CB strategies has grown and led nizations within the United States have to improvements based on partnerships to initiated activities to explore CB options, explore its utility for multiple applications research needs, and potential applications. and a variety of workplace settings. One The first effort to create greater awareness organization instrumental in bringing of this concept involved planning and co- forth the modern incarnation of CB is the ordinating the ICBW2. Although inter- IOHA, which is comprised of established national in concept, this workshop was IH organizations worldwide. The concept supported by an essential U.S. partnership is currently housed within the WHOCC matrix including ACGIH, AIHA, OSHA, Occupational Health Network Work Plan NIOSH, and the U.S. National Safety 2006–2010 (www.who.int/occupational_ Council, in addition to the above global health). The WHOCC is a collective effort organizations of ILO, IOHA, and WHO. that also maximizes partnerships with 65 In fact, the current ITG Global Imple- Collaborating Centres around the globe, mentation Plan was initially drafted at this working in concert with the ILO and the workshop. An outcome of this event was major occupational health Non-Govern- the need to consider U.S.-specific param- mental Organizations of IOHA, the In- eters for developing a national CB effort. ternational Commission on Occupational This led to the National Control Banding Health, and the International Ergonomics Working Group meeting in March 2005, Association. With the CB strategy having in Washington, D.C. For this event, the strong support within the development U.S. partnership matrix was expanded and dissemination protocol of the GHS to include representatives from the EPA, discussed in this document, it is also in- trade unions, corporations, and academia. tricately tied to the WHO/ILO IPCS of- These partnerships have allowed for con- fice. Under the auspices of the IPCS, an tinued discussion and consideration of ITG has been established to facilitate the CB strategies, in cooperative efforts to further development and implementation address research needs, barriers to imple- of the greater encompassing ORM Tool- mentation, validation concerns, and cre- box. ITG has developed a Global Imple- ation of awareness of control-focused so- mentation Strategy (see Appendix C) to lutions and guidance.

Discussion and Conclusions

CB strategies can be used effectively for The COSHH Essentials strategy from HSE performing workplace risk assessments was designed to help SMEs perform risk and implementing control solutions for assessments for all chemicals and mix- many, but not all, occupational hazards. tures of chemicals indicated under the COSHH Essentials is a popular toolkit COSHH regulations. The United States model that has been well researched—al- does not have any similar regulation that though further validation is important— requires risk assessments for all chemi- with narrowed applications in the larger cals in use. However, the basic premise scale of CB. CB strategies will not elimi- is of value to industries in the United nate the need for personal monitoring and States—thousands of chemicals are in use should lead to an increased appreciation and only a few levels of risk management for the role of the IH professional and use- (i.e., CB strategies) are available to control ful solutions-based databases. worker exposures to these chemicals. As an underlying principle, the COSHH Es- A review of the literature and the brief sentials toolkit is valuable for CB strate- history of CB evolution, applications, and gies because it meets all six of Money’s evaluation indicates that CB strategies [2003] core principles (understandability, cannot provide appropriate solutions for availability, practicality, user-friendliness, the assessment and management of all oc- confidence on the part of users, and trans- cupational hazards. There are situations parent, consistent output). The COSHH in which CB cannot provide the precision Essentials model must be viewed as a and accuracy necessary to protect worker supplemental tool in a comprehensive health; alternatively, there are undoubt- program that also accounts for personal edly situations in which CB will provide protection, training, health surveillance, a higher level of control than is necessary. hazard communication, and worker par- Despite these concerns, CB strategies have ticipation, and not as an unconditional re- the potential to be entry-level tools for oc- placement for a comprehensive risk management program [Oldershaw 2003]. cupational risk management. They can be an integral part of a tiered strategy for In addition, the process of applying R- risk assessment, in which simpler tools phrases to hazard bands is a useful prac- are used at a screening level, followed by a tice but is not intended to replace OELs more complex strategy as needed or as in- [Brooke 1998]. With regard to applica- dicated by the particular situation [Nelson tions of the CB strategy, Russell et al. et al. 2003; Mulhausen et al. 2004]. [1998] point out that when performing

71 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

risk assessments, employers should still on the inhalation route of exposure. consider other factors such as the need for Consideration of other potential routes health surveillance and the need to moni- of exposure and anticipated toxicologic tor exposure to ensure adequacy of con- endpoints could strengthen the utility of trol. Similarly, employers will want to con- CB strategies and broaden the scope for sider recommending controls appropriate recommending control options [Brooke for the processes within their particular 1998]. Further refinement of CB strate- workplace. CB strategies ideally have util- gies should include consideration of pro- ity in providing guidance for performing cedures for ensuring adequate margins of risk assessments and in selecting appro- safety and a schedule for frequent updates priate control measures; CB strategies are of information as it becomes available. not a replacement for traditional exposure monitoring and use of OELS. One potential benefit of CB implementation could be increased use of exposure- As described previously, the validity of assessment applications for field prac- the exposure assessment component is es- tice, providing additional information sential to the effectiveness of the CB strat- for surveillance of exposures and control egy. An additional critical component is the establishment of a uniform and stan- effectiveness. As a consequence, the CB dardized toxicologic characterization for strategy could also have the effect of rais- a chemical by the supplier, using either ing the profile of the industrial hygienist R-phrases or similarly recognized cat- while maximizing public health resources egorical designations. It is the R-phrases for the benefit of the profession and the that are applied to a substance or chemi- population at large. As part of the CB vali- cal mixture that determine its allocation dation plan, increased practice of expo- to a hazard band and thus the intended sure assessment will serve as the basis for target airborne concentration range. A evaluation of implemented controls and continuing concern with most CB strat- will provide the feedback to improve haz- egies, including COSHH Essentials, is ard control guidance for subsequent revi- the fact that they are primarily focused sions of the given toolkit.

72 10

Recommendations to Facilitate the Implementation of CB Strategies in the United States

Based on the potential utility of CB and the discussions, and application of con- fact that most chemical substances do not cepts. have established OELs, it seems appropri- 2. Following application of CB strate- ate to explore applications and implemen- gies, carefully consider the exposure tation of CB strategies in the United States. scenarios under which personal These recommendations are made under monitoring should be required, us- the categories of improving awareness of ing specific R-phrases or other ap- concepts, validation considerations, ex- propriate communication language. pansion of the CB model, dissemination, 3. Adopt the GHS to work toward en- coordination, and collaboration. From the suring standardized hazard state- review of the literature and of recent work- ments are available on U.S. chemical shops (including the U.S. National Control Banding Workshop in 2005), symposia, labels and MSDSs to promote wide- and conferences exploring the utility and spread CB applications. Include a potential applications of qualitative risk as- procedure for frequent updates of sessment and management (i.e., CB) strate- information. Educate the wider oc- gies, the following recommendations have cupational and ES&H community been identified with potential activities and on this change. programs to facilitate the implementation 4. Develop a resource so that SMEs of CB in the United States. can obtain additional assistance on implementing control measures that are more protective. 10.1 Recommendations for Perhaps the CGSs could include Improving Awareness a link to professional associations and Standardization of (e.g., AIHA, ACGIH), accredited labs and services, or provide a link Concepts to companies that provide techni- 1. Coordinate terminology to ensure cal services (e.g., accredited labs, a singular CB vocabulary is estab- consultants). lished, adopted, understood, and 5. Continue to develop and offer train- communicated for practical pur- ing for professionals and for SME poses such as training, professional operators on the implementation

73 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

of CB strategies and the toolbox 10.2 Recommendations for and toolkits available. Emphasize Validation the role of CB in the context of tiered risk assessment (i.e., selec- 1. Make sure that a validation proto- tion of the appropriate tool for a col accounts for the effectiveness specific risk scenario). of a given toolkit and its controls. 6. Develop an incentive system based 2. Use validation protocols to validate on input from broader groups of and compare various implementa- stakeholders, including insurance, tion methods and the construct in financial, trade, and legal interests. which they are introduced with 7. Incorporate economic analyses both employers and workers. into the process of selecting ex- 3. Validate each step of the CB strat- posure control methods, with the egy independently: exposure pre- goal of developing a more com- diction, hazard prediction, control plete understanding of the rela- recommendations, training, and tionship between the hierarchy of control implementation. controls and their cost effective- 4. Assess errors associated with CB ness. A key assumption underlying hazard classification, exposure as- CB appears to be that a higher de- sessment, and control recommen- gree of control (e.g., containment, dations to determine the accuracy followed by engineering control) of the model. is generally expensive and may be “overprotective” against exposure to substances in the lower risk cat- 10.3 Recommendations egories. This assumption has driv- for Expanding the en the idea that CBs should be rig- idly tied to specific risk levels. This Control Banding Model assumption may be inaccurate in 1. Develop a comprehensive, easy-to- many cases and may complicate use set of ergonomic hazard- and the CB strategy unnecessarily. In risk-assessment tools. These ergo- addition, for many substances nomics toolkits should begin with there is less than complete infor- a brief manual leading to check- mation concerning their long- lists for use by SME employers and term human health effects, mak- workers. ing R-phrases inadequate to fully describe the risk persons in the 2. Consider dermal absorption as a workplace face if they are exposed. factor that might make an impact In such situations, a higher level of on hazard classification, exposure control would be prudent rather assessment, and control solutions than overprotective. in a CB risk management model. 8. Conduct research on the utility of CB 3. Include guidance and control- to SMEs and the barriers to using it. focused solutions for additional

74 Chapter 10 | Recommendations to Facilitate the Implementation of CB Strategies in the United States

substances, specifically those 3. Identify strategies for promoting that were excluded by HSE be- the value and utility of CB using cause they were regulated un- business case models and exam- der other codes (e.g., pesticides, ples of broader workplace protec- lead, asbestos). tions despite limited resources. 4. Include processes that address combined chemicals use, mix- 10.5 Recommendations for tures, and compounds of vari- Coordination and able composition that can have additive or synergistic safety and Collaboration health consequences. National Coordination and 5. Convert existing guides and so- Collaboration lutions documents to toolkits by beginning the documents with 1. Encourage NIOSH and OSHA co- instructions on how to do a quali- operation in focusing on CB util- tative risk assessment of the work- ity for special emphasis areas, such place. as hazard communication and guidance for small businesses. The 6. Develop sector specific toolkits State OSHA plans, fitting within (e.g., construction, healthcare, and the OSHA Alliance, may provide manufacturing). mechanisms to implement CB strategies and demonstration proj- 10.4 Recommendations ects for control-focused solutions for Disseminating and guidance. Control Banding 2. Develop task-based CB toolkits that focus on point-source expo- 1. Develop public sector (govern- sures related to specific tasks and mental) and private sector (trade controls that have been validated. association, industry, organized Guidance can be developed and labor, academic consortia) strate- provided in a practical, applicable gies to coordinate efforts for -de format when historical data exist veloping, implementing, and eval- to characterize exposure for a par- uating qualitative risk assessment ticular task (e.g., silica in mining and risk management strategies or construction). and task-specific, hazard-control 3. Include worker involvement as guidance. part of a tripartite strategy within 2. Create awareness, implementa- a participatory process for any tion, and dissemination strategies implemented CB strategy. Provide among the regulatory, consulta- for assessment and feedback for tive, professional, and trade asso- this process using medical surveil- ciations consistent with research lance, with risk assessment based to practice concepts. on health measures.

75 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

4. Coordinate resources and curri- 2. Adopt the ITG implementation cula for training professionals and strategy to coordinate occupation- SME audiences on the implemen- al risk management concepts with tation of CB strategies and models international collaborative efforts, available. such as those within the WHOCC, in order to harmonize efforts and International Coordination and build capacity. Collaborations 3. Link the CB strategies to an exist- 1. Coordinate the development and ing system of Occupational Safety creation of an integrated system and Health Management Systems for both national and internation- for implementation. This will help al databases. This database system to ensure it is maintained and im- should also include a component proved within a management sys- that tracks voluntary submission tem that can be assessed at appro- of data for the validation of vari- priate intervals and modified as ous toolkits. necessary.

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84 Appendix A Related Publications with Selected Annotations

Falconer K [2002]. Pesticide environ- Money CD [2002]. European chemical mental indicators and environmental regulation and occupational hygiene. policy. J Environ Manage 65:285–300. Ann Occup Hyg 46:275–277. Falconer assesses the feasibility of devel- This source describes the drivers for risk oping environmental banding for more assessment of chemicals in the EU: effective pesticide policy, specifically, -de ■■ In 1998, the third largest manufac- veloping pesticide groupings. Groupings turing industry was chemical man- would be formed on the basis of broad ufacturing, employing 1.7 million similarities and differences rather than of people directly. precise individual ordering. However, be- ■■ Several leading multinationals and cause of the complexity of pesticides, their 36,000 SMEs were involved. usage, and impacts, no single ecotoxico- logical parameter can be used to define and ■■ Known adverse human health ef- quantify policy issues. Rather than using fects of many chemicals, and lack impact assessments, which must be con- of knowledge about the impacts of ducted for each site, to define the group- many chemicals. ing, Falconer suggests using hazard-based The number and volume of chemicals are indicators. Enhanced pesticide labeling also driving chemical risk assessment in could be useful in decision-making by us- the EU: ers. He concludes that pesticide groupings ■■ 400 million tons of chemicals pro- would be more feasible and useful than duced globally in 2001 ranking of individual products. ■■ 100,000 substances registered in Kirkwood P, Trenchard PJ, Uzel AR, the EU Colby PJ [1991]. SARAH (System for ■■ 10,000 chemicals marketed in vol- Advising on the Regulations for As- umes >10 tons and 20,000 market- sessing Hazards): an expert system for ed at 1–10 tons training non-hygienists in carrying out The article describes the REACH system, occupational hygiene assessments. Ann which is a regulatory system for chemical Occup Hyg 35:233–237. control. The REACH system uses a tiered Similar to COSHH Essentials, the SAR- approach to registration, triggered by pro- AH expert system can ease the workload duction volumes. The proposed system of occupational hygienists by providing would result in critical information about nonexperts with the tools to solve simpler most chemicals being registered in a cen- occupational safety and health problems. tral database. Higher anticipated risks It was designed for use by British Gas to would trigger higher levels of required in- assist in meeting COSHH requirements. formation.

85 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

Northage C, Marquart H [2001]. Oc- profiles are the shortage of data, conflict- cupational exposure information needs ing positions on data interpretation, poor for regulatory risk assessment of exist- transfer of toxicological information, inef- ing chemicals. Appl Occup Environ Hyg ficiencies in the use of available resourc- 16:315–318. es, and inadequate understanding of the science. Indications of progress include The authors describe the information re- increasing quantities of data (e.g., the quired to conduct a risk assessment per International Council of Chemical Asso- EU Regulation 1488/99, which requires ciations commitment to baseline data on risk assessments be conducted on existing the High Production Volume substances, priority chemicals. Assessments should harmonizing positions on data interpreta- include human health and environmental tion, better transfer of toxicological data concerns and are carried out at the na- to those exposed, more efficient use of tional level. Data requirements for expo- available resources, and improved under- sure assessment include the following: standing of the science). Oldershaw and ■■ Description of work activities Fairhurst called for several elements to ■■ Percentage of substance in product improve data quality: and amounts used ■■ More international collaboration ■■ Distinction between different ex- ■■ Assessment with an eye to interna- posure scenarios tional needs ■■ Measurement methods ■■ Better understanding on the part of ■■ Raw sampling data and statistical users descriptors ■■ Clear establishment of the state of ■■ Task information available knowledge ■■ Controls information ■■ A pragmatic approach ■■ Number of sites to which data apply ■■ Agreement/codification/expres- sion of scientific terminology ■■ Year ■■ Clear descriptions of extrapolation ■■ Explanation of outliers procedures ■■ Explanation of changes in exposures Tischer M [2001a]. What does low exposure mean? Exposure considerations in Oldershaw P, Fairhurst S [2001]. Sharing the testing of notified new substances. toxicological information on industrial Appl Occup Environ Hyg 16:228–232. chemicals. Ann Occup Hyg 45:291–294. Tischer suggests that, when notifying the Sound risk management relies on regu- EU of new substances, risk assessors use latory standards, and development of a R-phrases and the hazard banding model chemical’s standard requires its complete developed by the U.K. HSE to aid in de- toxicological profile. Some of the barriers cision-making on chemicals with no NO- to global access to robust toxicological AEL.

86 Appendix A | Related Publications with Selected Annotations

Zalk DM [2001]. Grassroots ergonom- Zalk emphasizes the important role of ics: initiating an ergonomics program worker participation in developing effec- utilizing participatory techniques. Ann tive ergonomics programs, in both indus- Occup Hyg 45:283–289. trialized and newly industrializing nations. Such an approach could be very valuable in worldwide application of CB techniques.

Appendix B Allocation of Hazard Bands for Vapors

A substance’s identifiable dose threshold day of exposure for 90 days, the substance influences its classification into Hazard is rated R48/20—Harmful. (0.025 mg/L Bands A–E, as used in the COSHH Essen- represents the lower cut-off value; severe tials. Classification also depends on rela- effects at a lower concentration would re- tive exposure level at which toxic effects sult in a rating of R23—Toxic.) Adjusting occur and on seriousness of the health to a time period of 8 hours (and convert- effect resulting from exposure. The gov- ing units) results in an equivalent 8-hour erning R-phrase, for substance with more TWA of 19–190 mg/m3. For three hypo- than one, is the R-phrase leading to the thetical vapors with molecular weights of highest level of control. Along with that 50, 100, and 150, the equivalent 8-hour explanation, the R-phrase assignments airborne concentrations are converted were compared to health-based OELs for from mg/m3 to ppm, for the lower (<19 a selection of chemical substances. Each mg/m3), mid (19–190 mg/m3), and up- hazard band, which is based on toxicolog- per (>190 mg/m3) concentrations from ical considerations, covers a log (10-fold) the R48 range, resulting in a range of con- concentration range[Brooke 1998]. centrations from 3–90 ppm. The resulting ppm concentrations are compared with Because the relationship between the ppm the concentrations that would be expe- concentration and the mg/m3 concentra- rienced in Hazard Band B (>5–50 ppm). tion of a vapor is a function of its molecu- These comparisons showed in safety mar- lar weight (and also temperature and pres- gins well below a value of 1.0 in the worst sure, though not discussed in this article), cases (generally involving high molecular the working group that oversaw develop- weight compounds). Best-case compari- ment of this chemical classification decid- sons, e.g., higher R48 cut-off values com- ed to align the exposure bands. However, pared with the lower airborne concentra- because of this alignment, if vapors and tions for Hazard Band B (associated with particulates are in the same hazard band, lower molecular weight compounds), re- the concentration range for vapors, in mg/ sulted in safety margins ranging up to 18. m3, is substantially higher than that for particulates. R48/20 was allocated to Hazard Band C because the results of this analysis indi- Because of concern about this alignment cated that allocating Hazard Band B for procedure, R-phrases for vapors are allo- vapors could result in significant concern cated based on additional considerations. for potential health effects under worst- For example, the classification of R48 in- case scenarios. dicates danger of serious damage to health by prolonged exposure. If severe effects A similar analysis for particulates indicat- occur in animal-inhalation toxicological ed higher margins of safety for them than studies at 0.025–0.25 mg/L for 6 hours/ for vapors. The analysis resulted in an

89 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

even greater safety factor for particulates with nongenotoxic mechanisms and iden- than for vapors. This logic was extended tifiable thresholds were allocated to Haz- to toxic substances based on repeated ex- ard Band D. Category 3 carcinogens with posures, assigning them to Hazard Band genotoxic mechanisms were assigned to D. Similar logic resulted in the assignment Hazard Band E, as were Category 1 or 2 of compounds to hazard bands based on carcinogens, based on the EU Carcinogens effects resulting from single exposures Directive. Substances with skin sensitiz- (Harmful to Hazard Band B, Toxic to C, ers and corrosive or severe irritant effects and Very Toxic to D). were assigned to Hazard Band C based on their identifiable threshold. Moderate eye For compounds with no identifiable dose and skin irritants were assigned to Hazard threshold and potentially serious health Band A. effects, e.g., R40 Muta. Category 3, R46 Muta. Category 1 or 2, and R42 (respira- Note: Only after a substance’s toxicologi- tory sensitization), the appropriate alloca- cal data are completely considered is it tion was Hazard Band E, which is always assigned to a hazard band. A substance referred to expert advice. R-phrases for should not be assigned to Hazard Band A reproductive toxicity and carcinogens simply because of lacking data.

90 Appendix C Global Implementation Strategy Occupational Risk Management Toolbox (Agreed by the IPCS International Technical Group on May 28, 2004)

This Global Implementation Strategy has been established to facilitate the fur- aims to build and implement an Oc- ther development and implementation cupational Risk Management Toolbox of the Toolbox. This Global Implemen- (Toolbox), containing toolkits to man- tation Strategy provides key high-level age different workplace hazards. The first approaches to achieve this aim. It is in- such toolkit, the International Chemical tended that work plans, focusing on par- Control Toolkit (Chemical Toolkit), is ticular applications, countries or regions, based on an approach to risk assessment would be developed and implemented by and management called control banding relevant stakeholders. A particular focus (CB). This approach groups workplace of this Strategy is implementation of the risks into control bands based on combi- Chemical Toolkit. nations of hazard and exposure information. It can also be applied to non-chem- Partners in this international effort in- ical workplace hazards. As this banding clude: IPCS (International Labour Orga- technique is semi-quantitative or quali- nization and World Health Organization); tative depending on the application, it is International Occupational Hygiene As- particularly relevant for use in small and sociation (IOHA); The Health and Safety medium-sized enterprises, developing na- Executive (HSE) in Great Britain; US Na- tions, and, in the case of chemicals, where tional Institute for Occupational Safety no occupational exposure standard has and Health (NIOSH); and the German been set. It may also be useful for environ- Gesellschaft für Technische Zusammen- mental risk assessment and management, arbeit (GTZ). As this Strategy is imple- as health and environment controls are mented, new partnerships will be encour- complementary, and often inseparable, at aged. The ITG Terms of Reference and the workplace level. Membership List are provided in Annex 1, which will be updated as needed. Aim of the Global Implementation Strategy Stakeholders and Implementation Partners Stakeholders include implementers (including employers), researchers and work- Under the auspices of the International ers/users of chemicals. Bodies that may Programme on Chemical Safety (IPCS), be involved in the implementation of this an International Technical Group (ITG) Strategy include: intergovernmental and

91 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

international non-governmental organiza- Key Elements of the tions (such as IOHA); government agen- Implementation Strategy cies; industry, including associations of chemical producers and suppliers; em- Key elements are listed below, with lead ployer and employee associations; indus- bodies in parenthesis where relevant. At trial hygienists; labour unions; labour the work plan level, detailed actions taken inspectors; researchers; and training pro- must take into account the different needs fessionals. of developing countries, economies in transition and developed countries. How- ever harmonized approaches should be The International Chemical used where possible to avoid unnecessary Control Toolkit duplication of effort. The Chemical Toolkit (adapted from the 1. Further develop the Chemical Tool- HSE’s COSHH Essentials) is available on kit, including the following: the internet through the ILO SafeWork ■■Development of new control Website. It is undergoing further devel- guidance sheets based on ex- opment, which will include technical im- perience, to meet the needs of provement and additions. This process developing countries in par- will also include translation and piloting ticular (ILO with the input of in selected countries. The hazard infor- others including GTZ; IOHA). mation employed by the Toolkit is either This includes piloting, testing, evaluating, and revising. the European Union (EU) label Risk (R) The need for country-specific phrases, or the hazard statements of the sheets will be explored. How- Globally Harmonized System for Classi- ever, unnecessary differences fication and Labeling (GHS). The target in the technical materials for global implementation of the GHS was should be avoided. Some guid- 2008, individual country implementation ance sheets should be trade dates could vary. Hence implementation and/or task specific. of the Chemical Toolkit will need to be ■■As guidance sheets begin to phased, initially focusing on building the be developed by implementers necessary skills, knowledge and mecha- (e.g. country-specific sheets), nisms for implementation, development a mechanism for peer review, and testing of guidance sheets, translation including peer review criteria. into other languages, and application of will be developed and the guid- more generic approaches, such as the GTZ ance sheets shared through an Chemical Management Guide (which international Clearing House is based on a simplified control banding (see key strategy ) (ILO, WHO). technique). Implementation of the full ■■ Development of sheets for work- Chemical Toolkit will be dependent on place processes that gener- that country’s use of EU risk phrases and/ ate chemical exposures (ILO, or GHS hazard statements. IOHA).

92 Appendix C | Global Implementation Strategy

■■Addition of the skin route of ■■The International Association exposure (the Chemical Tool- of Labour Inspectors (IALI) kit currently focuses on inha- (ILO to lead). lation exposure) (ILO with the ■■Identify potential donors and input of HSE). granting bodies. ■■Translation in local languag- ■■Use country to country part- es (WHOCC [Collaborating nerships (twinning), for exam- Centers], ILO, others). ple between a developed and 2. Enhance links between the GHS, developing country. the Chemical Toolkit and other 6. Foster the development of work workplace tools. plans in support of this Strat- 3. Include GHS phrases in the IPCS egy, focusing on specific applica- International Chemical Safety tions, industry/occupation situ- Cards (WHO-IPCS, ILO). ations, countries or regions and 4. Build and promote the Occupa- maintain links with national and tional Risk Management Toolbox, other working groups established through the following: to implement work plans. Work plans will aim to influence local ■■Development of toolkits for decision-makers and effect lo- workplace hazards other than cal implementation. Information chemicals (lead group ILO, about work plans will be included WHO, IOHA, NIOSH, linking to an expanded network in the Clearing House (see key be- of other international and na- low strategy). tional bodies). Identify ways to influence national ■■ Integration of other toolkits in decision-makers, including through: WHO CC Workplan (WHO CC ■■WHO CC network activities [Collaborating Centers] Task Force on Preventive Technology). ■■ILO-CIS Network ■■Adaptation of existing par- ■■ILO and WHO offices ticipatory processes that have ■■The EU effectively engaged local com- ■■Agenda of inter-governmental munities (e.g., WISE, WIND meetings, e.g. on EU-US Co- programme) (ILO). operation. 5. Explore new partnerships for im- ■■Promotion at international and plementation, including the fol- national Occupational Safety lowing: and Health/Industrial Hygiene ■■International bodies involved Conferences. in implementation of the GHS, ■■Holding annual or biannual for example to tap into GHS international CB workshops implementation and training (1st workshop held Novem- workshops (ILO). ber 2002; 2nd workshop held

93 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

March 2004). The 3rd work- ■■Augment the Web site with shop was held in September a Clearing House including 2005 at the IOHA 6th Inter- a web-based directory of re- national Scientific Conference search and validation studies (South Africa) and concur- (researchers list their ongo- rently the XVII World Con- ing studies and references for gress on Safety and Health completed work). (Orlando, FL). IOHA meeting ■■Include other activities in the was conducted back-to-back Clearing House, such as work with WHO CC meeting. plans developed by countries, ■■WHO CC Network meeting etc. (Milan, June 2006) back-to- ■■Include a repository of guid- back with ICOH meeting pro- ance sheets in the Clearing vides an option for CB plan- House. Centers could be iden- ning meeting and training. tified (regional, language- 7. Develop and publish a research based) to maintain these (e.g., agenda (lead: University of Okla- NIOSH), linked to the ILO homa, working with other leading Web site. agencies, for the ITG), including ■■Publish regular update/topi- sector-specific research (construc- cal articles in newsletters by tion, agriculture, mining). This email/net. Use existing ve- would include the areas listed be- hicles and meetings to distrib- low and would be updated regu- ute (IOHA, NIOSH, Global larly based on technical progress. Occupational Health Network A current research agenda will be Newsletter, etc). maintained on the Web site (refer 9. Develop and maintain a capacity below), and at Annex 2. Research building and training plan, focusing agenda will need to include ap- on developing countries (WHO- plication of the CB technique to OEH [Occupational and Environ- different hazards, e.g., chemical, mental Health]). This will be needed biological, physical, ergonomic for piloting work, then during the exposures, etc.; different industry full-scale implementation. It would situations, e.g., SMEs, large indus- include the following: tries, multi-nationals; developing ■■Explore use of the GTZ Chem- countries; developed countries. ical Management Guide to 8. Collect and communicate re- build capacities and prepare search and information, including countries for implementation the following: of the Chemical Toolkit. ■■Maintenance of the Web site, ■■Cultivate regional train-the- hosted by ILO, with links to trainer core groups. other relevant websites (lead: ■■Conduct train-the-trainer ILO). workshops in conjunction

94 Appendix C | Global Implementation Strategy

with other international/region- 2. The ITG makes its recommenda- al events. tions and decisions by consensus ■■Provide generic, translatable of those members present at a training materials. meeting. 10. Maintain an ITG to oversee the 3. The roles of Chair and Rapporteur Global Implementation Strategy alternate between the IPCS part- (quarterly telephone conferences, ners, i.e. ILO and WHO. with face-to-face meetings occur- 4. The ITG normally meets quarterly ring back-to-back with other events by teleconference. The ITG may where possible) (WHO-IPCS). agree to hold face-to-face meetings from time to time, and in International Technical these circumstances, participants make their own arrangements for Group (ITG) Terms of bearing the cost of attendance. Reference and Membership Membership Terms of Reference The members of the ITG are experts from 1. The functions of the ITG are: the following organizations: ■■To facilitate the further devel- American Industrial Hygiene Asso- opment and implementation ciation (AIHA) of an Occupational Risk Man- agement Toolbox, in particu- GTZ Convention Project on Chemical lar the International Chemical Safety, Germany Control Toolkit. International Labour Organization (ILO) ■■To maintain a Global Imple- International Occupational Hygiene mentation Strategy, including Association (IOHA) identifying lead bodies for key actions. Health and Safety Executive (HSE), Great Britain ■■To provide guidance to the relevant lead body/bodies con- National Institute for Occupational cerning the collection and dis- Safety and Health (NIOSH), United semination of information on States activities. World Health Organization ((OEH) ■■To coordinate other activities and( PCS)) undertaken in support of the Global Implementation Strat- International Research egy, in particular, those of its members. Agenda ■■To measure and communicate An international research agenda will be progress against the Strategy. developed and published (see key strategy

95 Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)

element 7). Proposals that have come for- ■■Further validation studies. ward to date are listed below. ■■ Validate controlling exposures 1. Chemical Toolkit Applications in in selected small business trades. Developing Countries ■■Field industrial hygiene input ■■Investigate applications within on expanding, ranking haz- large enterprises. ards, prioritizing controls. ■■Develop tools for SMEs. ■■Focus on small business trades ■■Effectiveness of predicting ex- and define success. posures. 4. Other Applications in Developed ■■Validation of controlling ex- Countries— posures. ■■Develop Ergonomics Tool- ■■Field test of current product. kit based on existing national ■■Translation of concepts and models. common phrases. ■■Expand industrial hygiene as- 2. Other Applications in Developing pects to include physical and Countries biological exposures. ■■Focus on large scale indus- ■■Investigate Occupational Risk tries, select appropriate indus- Management Toolbox concept tries and hazards. for SMEs. ■■ Develop other toolkits for the Occupational Risk Management 5. Research to Fill Gaps in the Chem- Toolbox. ical Toolkit— ■■ Adapt existing approaches (e.g., ■■Investigate applications to the WIND Program), build on suc- skin route of exposure. cesses. ■■Integration of skin and inhala- ■■Develop an ergonomics tool- tion routes of exposure. kit based on existing models. ■■Integration of useful elements 3. Chemical Control Toolkit Appli- from comparable tools, e.g. the cations in Developed Countries— German Column Model.