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NIOSH-Qualitative Banding
NIOSH-Qualitative Banding
NIOSH-Qualitative Banding
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DHHS (NIOSH) Publication No. 2009–152
August 2009
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.
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:
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
1
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.
1
2
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)
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 strat-
egy 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 catego-
rization 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 man-
agement and CB* concepts and their references in the literature
Element(s) References
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
7
Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)
8
Chapter 3 | The Origins of Control Banding for Chemical Agents
9
Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)
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).
11
Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)
→
Control Approach
Type of approach needed to
achieve adequate control
→
Generic Risk Assessment
Combination of health haz-
ard and exposure potential
factors determined desired
level of control
12
Chapter 3 | The Origins of Control Banding for Chemical Agents
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 avail-
able 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 se-
ries of articles [Russell et al. 1998; Brooke
3.3.2 France (Risk Potential
1998; Maidment 1998] explaining the ba-
sic concepts of COSHH Essentials, toxi- Hierarchy)
cologic 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)
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 con-
trol strategies to minimize exposure via The expansion of EMKG 2.0 to substances
inhalation or skin contact. with OELs makes it adaptable for addi-
tional 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].
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; how-
ever, the Regetox strategy requires train-
ing of prevention advisors and planning
3.3.6 Belgium (Regetox and 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,
high-risk processes have been selected
3.3.8 Korea (KCT) 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.
19
4
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 categoriza-
tion guidelines [CIA 1997] for their mem-
4.1 Occupational Exposure ber organizations.
Bands and Occupational Built on the 1993 CIA guidance and the
work of Gardner and Oldershaw [1991],
Exposure Limits
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 3. OEB* and corresponding concentrations for gases and vapors (ppm)
and dust (mg/m3)
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)
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 main-
tained “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)
Target airborne
Hazard band concentration range (Note 1) Risk phrases
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 haz-
ard 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
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 prop-
erties of a substance are not expressed.
Brooke describes an important point re-
garding the proper use of the COSHH Es- Equally important and essential to the
sentials strategy: successful implementation of CB strate-
gies 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-
pliers. It is the R-phrases applied to a
Considerations
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)
EPS Description
28
Chapter 4 | The Architecture on Which Control Banding is Based
EPL Description
29
Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)
30
Chapter 4 | The Architecture on Which Control Banding is Based
Table 11. Prediction of CS* from hazard band and exposure potential (solids)
Table 12. Prediction of CS* from hazard band and exposure potential
band for liquids
31
5
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’ expo-
sures 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)
34
Chapter 5 | Validation and Verification of Control Banding Strategies
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 millili-
ter or ton ranges.) Based on data available
5.2.3 German Bundesanstalt (i.e., 958 data points—732 for liquids and
226 for solids), the researchers limited their
für Arbeitsschutz und
analyses to scenarios in which the CS could
Arbeitsmedizin Study 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)
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 pro- cess 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 poten-
tially 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)
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
3 – Highest skin All R-phrases in hazard Any amount of par- Seek specialist advice.
hazard group group E, plus R43 ticulate or liquid
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 aware-
ness, 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)
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 applica-
tion. 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 serv- ing 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 imple-
mentation 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 w w w.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-
fectiveness of Control Banding was held
Control Banding
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 pre-
vention 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
47
8
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.
Much of the literature on these characteris-
Weaknesses and
tics 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=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
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 de-
velopment 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 scientifical-
ly 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
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 com-
panies 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 ac- tion of CB, particularly in small businesses.
cording to the hazard criteria in the stan-
dard 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 rec-
ognize 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
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
56
Chapter 8 | Critical Analysis of Control Banding 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
research that focuses on prospective and
8.3.3 Expanding to an ORM
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 expo-
sures relating to construction work. Con-
8.3.2 Implementation in Small struction work is an important example
for showing how an application moving
Businesses
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
58
Chapter 8 | Critical Analysis of Control Banding Strategies
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
Expansion of the ORM Toolbox could also
Existing National Models
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
creation of simplified training programs. 8.3.7 Implementing a National
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’ compen-
sation 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.
60
Chapter 8 | Critical Analysis of Control Banding Strategies
8.4 How Can International of efforts and instead will build capacity
by combining resources. It can also serve
Cooperation Assist in 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
hazard guidance sheets (such as Silica Es- into Occupational Safety
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
be to include safety and health. The Oc-
8.4.3 Expanding to an ORM 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
62
Chapter 8 | Critical Analysis of Control Banding Strategies
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
2002, the maintenance, updating, and im-
Globally Harmonized plementation 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)
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 poten-
tial 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
educating trainers and developing train-
Noise, and Traumatic ing 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-
dustrialization taking root in developing
Ergonomics
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
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 solu-
tions 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
was determined to require an upgrade in
Nanotechnology
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
69
9
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 man-
agement 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)
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 mea-
sures that are more protective.
10.1 Recommendations for Perhaps the CGSs could include
Improving Awareness a link to professional associations
(e.g., AIHA, ACGIH), accredited
and Standardization of 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)
74
Chapter 10 | Recommendations to Facilitate the Implementation of CB Strategies in the United States
75
Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB)
76
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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 expo-
sures Tischer M [2001a]. What does low expo-
sure 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
87
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
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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 informa-
tion. 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
Stakeholders include implementers (in-
Partners cluding 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)
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, test-
ing, 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
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
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.
96