Standard (WES) and Biological Exposure Index (BEI) Review

Transcription

1 Exposure Standard (WES) and Biological Exposure Index (BEI) Review H E A LT H & S A F E T Y AT WO R K HSWA AC T Workplace LEAD AND INORGANIC COMPOUNDS AS LEAD (CAS NUMBER ) April 2017

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3 TABLE OF CONTENTS 01 INTRODUCTION 2 02 PHYSICAL AND CHEMICAL PROPERTIES 5 03 USES AND EXPOSURE IN NEW ZEALAND 7 04 LEAD IN THE BODY AND HEALTH 9 05 EXPOSURE STANDARDS AND GUIDANCE VALUES IN USE AROUND THE WORLD New Zealand ACGIH Australian review SCOEL SAMPLING AND ANALYTICAL METHOD FOR THE ASSESSMENT OF AIRBORNE LEAD DISCUSSION AND RECOMMENDATION 17 APPENDICES 20 Appendix 1: Glossary 21 Appendix 2: Methods for setting OELs 22 Appendix 3: References 25 TABLES 1 Chemical and physical properties of lead 6 2 Exposure standards for lead from around the world 12

4 01/ INTRODUCTION 2

5 SECTION 1.0 // INTRODUCTION This WorkSafe New Zealand (WorkSafe) review considers the need to change the Workplace Exposure Standard (WES) and Biological Exposure Index (BEI) for lead and its inorganic compounds. The review includes a recommendation to change the current WorkSafe values published in the Special Guide Workplace Exposure Standards and Biological Exposure Indices, 8th Edition (WorkSafe New Zealand, ). These are: > > a WES-TWA of 0.1 mg/m 3 > > a BEI of 1.5 mol/l whole blood (=31 g/dl) > > a suspension (removal) level of 2.4 mol/l whole blood (=50 g/dl) > > a return to work level of 1.93 mol/l whole blood or below (= 40 g/dl). This WorkSafe review is based largely on the recent Safe Work Australia review of their lead WES and BEI. In 2009, Safe Work Australia (SWA) established a tripartite Lead Working Group in response to evidence published by the National Health and Medical Research Centre (NHMRC) and the Australian Institute of Occupational Hygienists (AIOH) on the health effects of lead exposure and associated blood lead levels. In consultation with the tripartite group, Safe Work Australia commenced a program of work to review both the lead WES and BEI. In 2014 SWA commissioned an independent, evidence-based report on the health effects of exposure to lead and to advise on appropriate blood lead removal levels and a WES for lead (SWA, ). The report included an extensive literature review and referenced over 350 individual reports and documents to support its findings. The report was peer reviewed by the United States National Institute for Occupational Safety and Health (NIOSH) and public consultation was carried out. The report recommended SWA reduce both the blood lead removal level and the WES to protect workers from the adverse effects of lead exposure. Currently the WES-TWA in Australia is set at 0.15 mg/m 3 and in states that apply the Model Work Health and Safety Regulations (2011), a person conducting a business or undertaking is to ensure that no person is exposed to an airborne concentration of lead that exceeds that WES. This WES value applies to inorganic lead dust and fume. In states that apply the Model Work Health and Safety Regulations (2011), workers must be immediately removed from carrying out lead-risk work if their blood lead levels are at or greater than: 1) 50 g/dl for females not of reproductive capacity and males, and 2) 20 g/dl for females of reproductive capacity, and 3) 15 g/dl for females who are pregnant or breastfeeding. In December 2015, SWA published a Consultation Regulation Impact Statement (Consultation RIS) which proposed several options for the WES for lead (SWA, ). The options included: 1. no change to the current SWA WES of setting a new WES of 0.05 mg/m 3 3. setting a new WES to protect the most vulnerable people of 0.01 mg/m 3 4. a non-regulatory approach (non-mandatory) workplace airborne level of 0.15 mg/m 3, 0.05 mg/m 3 or 0.01 mg/m 3 dependant on the adopted blood lead level option. 3

6 WORKPLACE EXPOSURE STANDARD (WES) AND BIOLOGICAL EXPOSURE INDEX (BEI) REVIEW: LEAD AND INORGANIC COMPOUNDS AS LEAD The document also proposed several options for the BEI. The options included: 1. status quo (no changes to mandated blood lead removal levels) 2. amending mandated blood lead levels to (1) a 20 g/dl target level (BEI) and 30 g/dl removal level for females of non-reproductive capacity and males, and (2) a 10 g/dl removal level for females of reproductive capacity and those pregnant and/or breastfeeding. SWA received 30 responses to the Consultation RIS from industry and interest groups across a wide range of lead process workplaces. Targeted follow-up consultations were also conducted to clarify responses and to fill any information gaps. In August 2016 SWA produced a Decision Regulation Impact Statement (Decision RIS) aimed at assisting government Ministers responsible for work health and safety in deciding the best way to reduce the potential for adverse health outcomes caused by exposure to lead in the workplace (SWA, ). It provided the various options for WES and BEI, and recommended that the WES be reduced to 0.05 mg/m 3. It also recommended the BEI be set at 20 g/dl with a 30 g/dl (removal level) for females of non-reproductive capacity and males. For females of reproductive capacity and those pregnant and/or breastfeeding a 10 g/dl removal level. The document became publicly available in January SWA state on their website that A majority of state, territory and Commonwealth Ministers responsible for work health and safety support implementation of the preferred options in the Decision RIS through model work health and safety legislation. The Decision RIS analysed the options proposed in the Consultation RIS based on both quantitative cost benefit analysis and qualitative analysis of information provided during the consultation process. In accordance with the Council of Australian Governments Best Practice Guidelines, the Decision RIS recommended the options which provide the greatest net benefit to business and the community. If the Australian work health and safety Ministers agree to the preferred options in this Decision RIS, the model WHS Regulations will be amended to reflect the preferred options and the WES would change. The document recommends that from the time the regulations are changed there should be a two year transition period for compliance with the new regulatory requirements. Terms that are bold (first occurrence only) are further defined in the Glossary. 4

7 02/ PHYSICAL AND CHEMICAL PROPERTIES 5

8 WORKPLACE EXPOSURE STANDARD (WES) AND BIOLOGICAL EXPOSURE INDEX (BEI) REVIEW: LEAD AND INORGANIC COMPOUNDS AS LEAD Lead is found in a wide variety of workplaces and can be a component in metal alloys, older paints, lead-acid batteries, glass, plastics and ceramics. Workplaces where lead exposure can occur include smelting and refining scrap metal, radiator repair, construction and demolition, lead paint removal and firing ranges. Chemical and physical properties of lead include: Molecular weight Specific gravity Melting point C HSNO classifications 6.1C (All routes), 6.1C (Oral route), 6.6B, 6.7B, 6.8A, 6.8C, 6.9A (All), 6.9A (Dermal route), 6.9A (Inhalation route), 6.9B (Oral route), 9.1A (All), 9.1A (Crustacean), 9.1B (Algae), 9.1B (Fish), 9.3B Table 1: Chemical and physical properties of lead 6

9 03/ USES AND EXPOSURE IN NEW ZEALAND 7

10 WORKPLACE EXPOSURE STANDARD (WES) AND BIOLOGICAL EXPOSURE INDEX (BEI) REVIEW: LEAD AND INORGANIC COMPOUNDS AS LEAD Notification of blood lead levels equal to or exceeding 0.48 mol/litre are required to be notified under the Health Act (1956). Reports on the number of cases notified per year across New Zealand indicate that in 2015, 37 cases were notified where occupation was recorded as the source of exposure. In 2014 and 2013 respectively 56 and 81 cases were notified where occupation was recorded as the source of exposure (Centre for Public Health Research, ; Centre for Public Health Research, ; Centre for Public Health Research, ). 227 blood lead tests from occupationally exposed workers in the Auckland region indicates that lead exposure is occurring in the following industries: battery supply and maintenance, boat manufacture, construction/demolition; crematoria; equipment manufacture; foundries; heavy engineering; heavy machinery maintenance; house building/painting; lead light glass manufacture; radiator repair; roofing manufacture; scrap metal recycling; and tile manufacture (Source: WorkSafe notification data from 2008 to 2016). Defining the number of people potentially exposed in New Zealand is difficult as not all people working in the above industries will be exposed to lead at work. SWA in 2016 estimated the number of lead exposed workers across Australia at 9,893 workers (SWA, ). They estimated there are around 582 businesses carrying out lead-risk work in Australia. Of these businesses, there are approximately five with more than 500 workers (mines and smelters), around 100 medium to large businesses (including manufacturers, recyclers) and probably around 500 small businesses (including radiator repairers, lead lighters, painters and other trades persons) whose workers are regularly exposed to lead. It is reasonable to assume that the number of lead exposed workers in New Zealand is significantly less, after correction for population, especially considering the lower number of mine workers exposed to lead. 8

11 04/ LEAD IN THE BODY AND HEALTH EFFECTS 9

12 WORKPLACE EXPOSURE STANDARD (WES) AND BIOLOGICAL EXPOSURE INDEX (BEI) REVIEW: LEAD AND INORGANIC COMPOUNDS AS LEAD Exposure to lead in the workplace occurs via ingestion and inhalation of fume and particulate. Absorption of lead through the skin is negligible. Once inhaled, lead fume and some particulates can pass readily through the lung alveolar wall and directly into the blood stream and once in the body lead binds to red blood cells and circulates in the blood (SWA, ). While most lead is excreted via urine, faeces, sweat, breast milk, nails and hair, and generally within 30 days, some can remain in human tissues and organs (SWA, ). Lead can remain in bones for decades and can represent up to 95% of the body burden (SWA, ). SWA s 2014 report Review of hazards and health effects of inorganic lead implications for WHS regulatory policy lists the adverse effects of most concern as: > > carcinogenicity: lead compounds have been classified by the International Agency for Research on Cancer as probable human carcinogens and numerous studies have found links with exposure to lead and cancers including lung, stomach, kidney, brain and oesophageal cancers > > nervous system effects: difficulty concentrating, anger, anxiety, depression, hearing loss, panic, balance dysfunction and tremors > > changed risks for cardiovascular disease resulting from small lead- associated increases in blood pressure > > changes in sperm quality that may be important for men with a natural tendency towards having low sperm count > > increased risk of detrimental intellectual development in unborn children, and > > increased risk of spontaneous abortion (SWA, ). 10

13 05/ EXPOSURE STANDARDS AND GUIDANCE VALUES IN USE AROUND THE WORLD IN THIS SECTION: 5.1 New Zealand 5.2 ACGIH 5.3 Australian review 5.4 SCOEL 11

14 WORKPLACE EXPOSURE STANDARD (WES) AND BIOLOGICAL EXPOSURE INDEX (BEI) REVIEW: LEAD AND INORGANIC COMPOUNDS AS LEAD Table 2 below shows the lead exposure standards from around the world, as published by the Institute for Occupational Safety and Health of the German Social Accident Insurance (Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung) and available at JURISDICTION OR ADVISORY BODY 8-HOUR LIMIT VALUE SHORT-TERM LIMIT VALUE Inhalable lead mg/m 3 Inhalable lead mg/m 3 Australia 0.15 (current) 0.05 (proposed) Belgium 0.15 Germany (AGS) 0.15 Hungary Ireland 0.15 Italy 0.15 Singapore 0.15 Spain 0.15 United Kingdom 0.15 Austria Finland 0.1 France 0.1 Japan 0.1 New Zealand 0.1 Sweden 0.1 Switzerland 0.1 Canada Ontario 0.05 Canada Quebec 0.05 China 0.05 Denmark Poland 0.05 South Korea 0.05 ACGIH 0.05 NIOSH 0.05 OSHA 0.05 Table 2: Exposure standards for lead from around the world 12

15 SECTION 5.0 // EXPOSURE STANDARDS AND GUIDANCE VALUES IN USE AROUND THE WORLD 5.1 NEW ZEALAND WorkSafe s WES-TWA for inorganic dust and fumes of lead is currently set at 0.1 mg/m 3. This has remained unchanged since it was set in In 2010, WorkSafe s predecessor (the Department of Labour) reduced the lead suspension level (level at which a worker may be suspended from lead work) from 66 g/dl (3.2 mol/l) whole blood to 50 g/dl (2.4 mol/l). 5.2 ACGIH In 2001 the American Conference of Governmental Industrial Hygienists (ACGIH ) set an 8 hour WES (TLV-TWA) of 0.05 mg/m 3. This value is based on maintaining blood lead levels below their recommended BEI of 30 g/dl. Their TLV is intended to minimise the potential for: blood dyscrasias (abnormalities in the blood cells), adverse peripheral nervous system effects such as reduced nerve conduction velocity and peripheral neuropathies (disease and damage of the peripheral nerves), possible kidney dysfunction, adverse effects on sperm production, impaired intellectual development in children exposed to lead during gestation, and carcinogenicity (as reported from animal studies) (ACGIH, ). 5.3 AUSTRALIAN REVIEW SWA s 2014 report Review of hazards and health effects of inorganic lead implications for WHS regulatory policy concluded that most adverse health endpoints are associated with average blood lead levels of > 20 g/dl. The associations become more evident at mean blood lead levels > 30 g/dl 2. As such they consider the NOAEL to be 20 g/dl for females not of reproductive capacity and for males. They say that as this was a pragmatic NOAEL this level should act as a rational precautionary limit for the protection of nearly all workers (excluding females of reproductive capacity and those who are pregnant or breastfeeding, due to the effects on the developing foetus and children) (SWA, ). To establish a relationship between blood lead levels in exposed workers and airborne lead levels, the report drew on a range of studies to develop an air slope factor. The report notes that the air slope factor: > > reflects the incremental increase in blood lead level for each unit increase in lead air concentration and has the units ( g/dl)( g/m 3 ) -1 > > is not linear; the relative contribution of lead in air to blood lead is greater at low air concentrations compared to high concentrations, and as such a single factor to describe the relationship would be misleading > > takes into account only exposure via inhalation, not ingestion as it is difficult to estimate the contribution from ingestion > > contains uncertainties such as the physiological differences between people resulting in differences in their blood lead level from any given airborne exposure. Due to these uncertainties the air slope factors may overestimate the relationship between airborne lead and blood lead. 13

16 WORKPLACE EXPOSURE STANDARD (WES) AND BIOLOGICAL EXPOSURE INDEX (BEI) REVIEW: LEAD AND INORGANIC COMPOUNDS AS LEAD Using the air slope values the report concluded that at the current mandated workplace exposure standard of 0.15 g/m 3 * it was estimated the average blood lead level a worker population would experience is likely to be 30 g/dl, with an upper limit of ~ 60 g/dl. The report further concluded that Based on the air slope factor modelling a level of 0.05 mg/m 3 would correlate to a blood lead level of less than 30 g/dl in most cases. Based on the results of these calculations the report recommended a revised WES for dusts and fumes of inorganic lead of 0.05 mg/m SCOEL In 2002, the European Scientific Committee on Exposure Limits (SCOEL) recommended an occupational exposure limit (equivalent to an 8 hour WES) of 0.1 mg/m 3. This value was based on the LOAEL that was considered by SCOEL at the time to be 40 g/dl blood lead (SCOEL, ). They reported that some studies indicated effects at lower concentrations. SCOEL s recommended WES is based on field studies on lead battery workers and using the SCOEL preferred values approach. This approach is that as a general rule, SCOEL recommendations for 8-hour WES will use, as preferred values, decimals of the integers 1, 2 or 5 ppm or mg/m 3, if scientific reasons do not suggest a more specific value. However, it is the opinion of SCOEL that further discrimination, resulting in proposals falling in between any two of these integers, suggests a precision that, in reality, is unjustifiable, given the limitations of the databases for the vast majority of the substances considered and the uncertainties involved in toxicological extrapolations (SCOEL, ). * This appears to be a typographical error as the current Australian WES is 0.15 mg/m 3. 14

17 06/ SAMPLING AND ANALYTICAL METHOD FOR THE ASSESSMENT OF AIRBORNE LEAD 15

18 WORKPLACE EXPOSURE STANDARD (WES) AND BIOLOGICAL EXPOSURE INDEX (BEI) REVIEW: LEAD AND INORGANIC COMPOUNDS AS LEAD A common practice in New Zealand is to measure airborne lead using a filter in an inhalable sampling head. In terms of analysis the standard method is to analyse elements by ICP-AES (Inductively coupled plasma atomic emission spectroscopy). NIOSH have published methods including 7302 and 7304 for sampling and analysis of elements including lead (NIOSH, ). The limit of quantification (3.3 x limit of detection) of NIOSH 7302 is 2.5 g of lead per sample. An 8-hour sample taken at 2 L per minute and resulting in a mass of lead at the limit of quantification (2.5 g) would give an airborne concentration of around mg/m 3. An 12 hour sample taken at 2 L per minute and resulting in a mass of lead at the limit of quantification (2.5 g) would give an airborne concentration of around mg/m 3. The limit of quantification indicates that concentrations down to 1/10th of the ACGIH TLV and the proposed SWA WES of 0.05mg/m 3 are feasible. 16

19 07/ DISCUSSION AND RECOMMENDATION 17

20 WORKPLACE EXPOSURE STANDARD (WES) AND BIOLOGICAL EXPOSURE INDEX (BEI) REVIEW: LEAD AND INORGANIC COMPOUNDS AS LEAD Based on the recent Australian review, WorkSafe does not consider its current WES-TWA, BEI or suspension levels are acceptable. Worksafe considers that the SWA review is the most comprehensive and recent review of health risks and the air slope factor. As such it is proposed that WorkSafe New Zealand: 1. lower the WES-TWA for inorganic lead dust and fume to 0.05 mg/m 3 2. lower the BEI to 20 g/dl (0.97 mol/l) and the suspension (removal) level to 30 g/dl (1.45 mol/l) for females of non-reproductive capacity and males 3. set the suspension (removal) level for females of reproductive capacity and those pregnant and/or breastfeeding to 10 g/dl (0.48 mol/l), and 4. remove the current return to work level. SWA carried out full public consultation on their report Review of hazards and health effects of inorganic lead implications for WHS regulatory policy (SWA, ). The process sought detailed feedback from stakeholders and businesses to address the lack of available information on the magnitude of lead exposure in workplaces, and the likely impact of the proposed options on Australian industry. SWA received 30 submissions from the following industries: mining, foundries, ammunition manufacturers and handlers, occupational hygienists, regulators, lead battery manufacturers, recyclers and distributers, painting and associated trades, unions, industry groups, and other lead-risk workplaces. SWA produced a cost benefit analysis of the various WES and BEI options provided in the health effects report, the purpose being to measure the economic and social impact of government action and measure the net social benefits that action might produce. To develop the cost benefit analysis SWA used data from the public submissions, targeted consultation, worker s compensation data, blood testing data provided by jurisdictions, and data from health agencies. Cost considerations included: testing the blood-lead levels of lead-process workers, the frequency that these tests are undertaken, costs associated with removing workers from leadrisk work when they have exceeded the relevant threshold, and the cost of control measures. The benefit considerations included: economic benefits that would follow from a reduction in the incidence of lead-related diseases and illnesses. This includes reductions in financial costs such as health system expenditure, increased productivity, transfer costs and non-financial costs (eg burden of disease ). SWA also carried out public consultation on their cost benefit analysis. 3 SWA report in their Decision RIS document (SWA, ) that: 1. The cost benefit analysis of reducing the WES to 0.05 mg/m 3 showed a quantifiable benefit over 10 years with a benefit to cost ratio of 1.4 to one. 2. A majority of submitters who indicated a preference supported reducing the WES for lead to 0.05 mg/m 3, regardless of the cost involved with upgrading control measures or changing the frequency of air sampling procedures. 18

21 SECTION 7.0 // DISCUSSION AND RECOMMENDATION 3. The values proposed as the new WorkSafe BEI and suspension levels were supported by a majority of submitters who indicated a preference. SWA report that Of the public submissions one did not support this option due to severe financial impacts and one did not believe the option was protective enough. The key concerns around the proposed levels were: the process of changing internal target blood lead values, and the time needed for workers once suspended, to reach blood lead levels below the BEI. 4. No submitters indicated a lack of support for a WES of 0.05 mg/m Although the costs for air monitoring were difficult to quantify, submissions indicated that air monitoring is most often used as part of a control strategy for workplace lead and therefore many of the costs for compliance with the WES were considered to be included in controlling blood lead levels. 6. The cost benefit analysis indicated that even if additional air monitoring is required to comply with a reduction in the WES to 0.05 mg/m 3 (ie an increase in frequency of monitoring), the benefits still outweigh the costs at a ratio of 1.46 to one. 7. Some lead businesses indicated they already meet a WES of 0.05 mg/m 3 and therefore there would be no change in ongoing expenditure if this option was implemented. However, others indicated they would need to increase their ongoing expenditure or make capital investments to improve lead processes to comply. In direct consultations, some businesses indicated that if 0.05 mg/m 3 were implemented, they would make changes to their operations and ensure resultant workers blood lead levels were well below the new BEI s. 8. In regards to the cost benefit analysis of reducing the blood lead standards (BEI) to new proposed levels, submissions from regulators and targeted interviews indicated that approximately 70 per cent of businesses are already meeting the proposed new levels and the reduction would: show a quantifiable benefit over 10 years by a ratio of 1.57 to one, and show quantifiable health benefits of $5 million per annum which can be reached within three years of implementation. 19

22 APPENDICES IN THIS SECTION: Appendix 1: Glossary Appendix 2: Methods for setting WES Appendix 3: References 20

23 APPENDICES APPENDIX 1: GLOSSARY TERM ACGIH BEI ICP-AES LOAEL mg mg/kg mg/m 3 ml NIOSH NOAEL OEL SCOEL TLV-TWA g g/dl mod/l WES WES-TWA MEANING The American Conference of Governmental Industrial Hygienists (ACGIH ) is a 501(c)(3) charitable scientific organization, established in 1938, that advances occupational and environmental health. Examples of this include their annual edition of the TLVs and BEIs book and Guide to Occupational Exposure Values. Biological Exposure Index (BEI) is a guidance value for assessing biological monitoring results. A BEI indicates a concentration below which nearly all workers should not experience adverse health effects from exposure to a particular substance. Inductively coupled plasma atomic emission spectroscopy. A method of analysing samples for elements. Lowest observable adverse effects level. Milligram or one thousandth of a gram. Milligrams of substance per kilogram of body weight. Milligrams of substance per cubic metre of air. Millilitre, or thousandth of a litre. The National Institute for Occupational Safety and Health. The United States federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness. NIOSH is part of the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services. No observable adverse effects level. Occupational Exposure Limit. The Scientific Committee on Occupational Exposure Limits is a committee of the European Commission, established in 1995 to advise on occupational health limits for chemicals in the workplace within the framework of Directive 98/24/EC, the chemical agent s directive, and Directive 90/394/EEC, the carcinogens at work directive. Threshold Limit Value Time-Weighted Average; the TWA concentration for a conventional 8-hour workday and a 40-hour workweek, to which it is believed that nearly all workers may be repeatedly exposed to, day after day, for a working lifetime without adverse effect. An ACGIH term. Micrograms (of lead). Micrograms of lead per decilitre of blood. Micro-mols of lead per litre of blood. Workplace Exposure Standard WESs are values that refer to the airborne concentration of substances, at which it is believed that nearly all workers can be repeatedly exposed to, day after day, without coming to harm. The values are normally calculated on work schedules of five shifts of eight hours duration over a 40 hour week. A New Zealand term. The average airborne concentration of a substance calculated over an eight-hour working day. A New Zealand term. 21

24 WORKPLACE EXPOSURE STANDARD (WES) AND BIOLOGICAL EXPOSURE INDEX (BEI) REVIEW: LEAD AND INORGANIC COMPOUNDS AS LEAD APPENDIX 2: METHODS FOR SETTING OELs ACGIH STATEMENT OF POSITION REGARDING THE TLVS AND BEIS The American Conference of Governmental Industrial Hygienists (ACGIH ) is a private notfor-profit, nongovernmental corporation whose members are industrial hygienists or other occupational health and safety professionals dedicated to promoting health and safety within the workplace. ACGIH is a scientific association. ACGIH is not a standards setting body. As a scientific organization, it has established committees that review the existing published, peer-reviewed scientific literature. ACGIH publishes guidelines known as Threshold Limit Values (TLVs ) and Biological Exposure Indices (BEIs ) for use by industrial hygienists in making decisions regarding safe levels of exposure to various chemical and physical agents found in the workplace. In using these guidelines, industrial hygienists are cautioned that the TLVs and BEIs are only one of multiple factors to be considered in evaluating specific workplace situations and conditions. Each year ACGIH publishes its TLVs and BEIs in a book. In the introduction to the book, ACGIH states that the TLVs and BEIs are guidelines to be used by professionals trained in the practice of industrial hygiene. The TLVs and BEIs are not designed to be used as standards. Nevertheless, ACGIH is aware that in certain instances the TLVs and the BEIs are used as standards by national, state, or local governments. Governmental bodies establish public health standards based on statutory and legal frameworks that include definitions and criteria concerning the approach to be used in assessing and managing risk. In most instances, governmental bodies that set workplace health and safety standards are required to evaluate health effects, economic and technical feasibility, and the availability of acceptable methods to determine compliance. ACGIH TLVs and BEIs are not consensus standards. Voluntary consensus standards are developed or adopted by voluntary consensus standards bodies. The consensus standards process involves canvassing the opinions, views and positions of all interested parties and then developing a consensus position that is acceptable to these parties. While the process used to develop a TLV or BEI includes public notice and requests for all available and relevant scientific data, the TLV or BEI does not represent a consensus position that addresses all issues raised by all interested parties (e.g., issues of technical or economic feasibility). The TLVs and BEIs represent a scientific opinion based on a review of existing peer-reviewed scientific literature by committees of experts in public health and related sciences. ACGIH TLVs and BEIs are health-based values. ACGIH TLVs and BEIs are established by committees that review existing published and peer-reviewed literature in various scientific disciplines (e.g., industrial hygiene, toxicology, occupational medicine, and epidemiology). Based on the available information, ACGIH formulates a conclusion on the level of exposure that the typical worker can experience without adverse health effects. The TLVs and BEIs represent conditions under which ACGIH believes that nearly all workers may be repeatedly exposed without adverse health effects. They are not fine lines between safe and dangerous exposures, nor are they a relative index of toxicology. The TLVs and BEIs are not quantitative estimates of risk at different exposure levels or by different routes of exposure. 22

25 APPENDICES Since ACGIH TLVs and BEIs are based solely on health factors, there is no consideration given to economic or technical feasibility. Regulatory agencies should not assume that it is economically or technically feasible for an industry or employer to meet TLVs or BEIs. Similarly, although there are usually valid methods to measure workplace exposures at TLVs and BEIs, there can be instances where such reliable test methods have not yet been validated. Obviously, such a situation can create major enforcement difficulties if a TLV or BEI was adopted as a standard. ACGIH does not believe that TLVs and BEIs should be adopted as standards without full compliance with applicable regulatory procedures including an analysis of other factors necessary to make appropriate risk management decisions. However, ACGIH does believe that regulatory bodies should consider TLVs or BEIs as valuable input into the risk characterization process (hazard identification, dose-response relationships, and exposure assessment). Regulatory bodies should view TLVs and BEIs as an expression of scientific opinion. ACGIH is proud of the scientists and the many members who volunteer their time to work on the TLV and BEI Committees. These experts develop written Documentation that include an expression of scientific opinion and a description of the basis, rationale, and limitations of the conclusions reached by ACGIH. The Documentation provides a comprehensive list and analysis of all the major published peer reviewed studies that ACGIH relied upon in formulating its scientific opinion. Regulatory agencies dealing with hazards addressed by a TLV or BEI should obtain a copy of the full written Documentation for the TLV or BEI. Any use of a TLV or BEI in a regulatory context should include a careful evaluation of the information in the written Documentation and consideration of all other factors as required by the statutes which govern the regulatory process of the governmental body involved. POLICY STATEMENT ON THE USES OF TLVS AND BEIS The Threshold Limit Values (TLVs ) and Biological Exposure Indices (BEIs ) are developed as guidelines to assist in the control of health hazards. These recommendations or guidelines are intended for use in the practice of industrial hygiene, to be interpreted and applied only by a person trained in this discipline. They are not developed for use as legal standards and ACGIH does not advocate their use as such. However, it is recognized that in certain circumstances individuals or organizations may wish to make use of these recommendations or guidelines as a supplement to their occupational safety and health program. ACGIH will not oppose their use in this manner, if the use of TLVs and BEIs in these instances will contribute to the overall improvement in worker protection. However, the user must recognize the constraints and limitations subject to their proper use and bear the responsibility for such use. The Introductions to the TLV /BEI Book and the TLV /BEI Documentation provide the philosophical and practical bases for the uses and limitations of the TLVs and BEIs. To extend those uses of the TLVs and BEIs to include other applications, such as use without the judgment of an industrial hygienist, application to a different population, development of new exposure/ recovery time models, or new effect endpoints, stretches the reliability and even viability of the database for the TLV or BEI as evidenced by the individual Documentation. It is not appropriate for individuals or organizations to impose on the TLVs or the BEIs their concepts of what the TLVs or BEIs should be or how they should be applied or to transfer regulatory standards requirements to the TLVs or BEIs. (Approved by the ACGIH Board of Directors on March 1, 1988.) 23

26 WORKPLACE EXPOSURE STANDARD (WES) AND BIOLOGICAL EXPOSURE INDEX (BEI) REVIEW: LEAD AND INORGANIC COMPOUNDS AS LEAD Special Note to User: The values listed in the book are intended for use in the practice of industrial hygiene as guidelines or recommendations to assist in the control of potential workplace health hazards and for no other use. These values are not fine lines between safe and dangerous concentrations and should not be used by anyone untrained in the discipline of industrial hygiene. It is imperative that the user of this book read the Introduction to each section and be familiar with the Documentation of the TLVs and BEIs before applying the recommendations contained herein. ACGIH disclaims liability with respect to the use of the TLVs and BEIs. EUROPEAN SCIENTIFIC COMMITTEE ON OCCUPATIONAL EXPOSURE LIMITS (SCOEL) SCOEL adopts a case-by-case approach to setting OELs. Wherever possible SCOEL will attempt to establish a health-based OEL, using the following general procedure: > > assemble all relevant data on the hazards (experimental information, data on physical properties etc) > > determine whether the database is adequate for the setting of an OEL > > identify adverse effects that may arise from exposure, and establish those that are crucial in deriving an OEL > > identify, and review relevant human and animal studies > > establish whether the substance acts via a non-threshold mechanism or whether a conventional (threshold) toxicological model can be used. Where non-threshold mechanisms are involved, SCOEL considers that health-based OELs cannot be established and different considerations apply (such as applying a numerical risk assessment process) > > assess dose/response data for each key effect, establish no observed adverse effect levels (NOAELs) where possible, or lowest observed adverse effect levels (LOAELs), or benchmark doses > > decide whether a STEL is required in addition to an 8-hour TWA limit > > decide whether a biological limit value (BLV) might be established, and what it will be > > establish a numerical value for an 8-hour TWA OEL at or below the NOAEL (or LOAEL as the case may be), incorporating an appropriate uncertainty factor > > establish a numerical value for a STEL and for a BLV, if required > > document the process so the rationale for the OEL is clear > > assess the technical measurement feasibility of the air and biological values. 24

27 APPENDICES REFERENCES 1 WorkSafe New Zealand (2016). Workplace Exposure Standards and Biological Exposure Indices, 8th Ed. govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposureindices 2 Safe Work Australia (2014). Review of Hazards and Health Effects of Inorganic Lead Implications for WHS Regulatory Policy. 3 Safe Work Australia (2015). Consultation Regulation Impact Statement Managing risks associated with lead in the workplace: blood lead levels and exposure standards. 4 Safe Work Australia (2016). Decision Regulation Impact Statement Managing Risks Associated with Lead in the Workplace: Blood Lead Removal Levels and Workplace Exposure Standard SWA decision. sites/swa/about/publications/pages/decision-regulation-impact-statement-for-managing-lead-risk 5 Centre for Public Health Research, Massey University (2016). National Hazardous Substances and Lead Notifications January December Centre for Public Health Research, Massey University (2015). National Hazardous Substances and Lead Notifications January December Centre for Public Health Research, Massey University (2014). National Hazardous Substances and Lead Notifications January December American Conference of Governmental Industrial Hygienists (ACGIH ) (2001). Lead and inorganic compounds: Documentation of the Threshold Limit Values for Chemical Substances and Physical Agents & Biological Exposure Indices, 7th Edition, ACGIH, Cincinnati, Ohio. Copyright Reprinted with permission. 9 SCOEL (2001). Recommendation from the Scientific Committee on Occupational Exposure Limits for Lead and its inorganic compounds SCOEL/SUM/ SCOEL (2013). Methodology for the Derivation of Occupational Exposure Limits. Key Documentation version NIOSH (1994). Manual of Analytical Methods (NMAM), 4th Ed. 12 American Conference of Governmental Industrial Hygienists (ACGIH ), (2016) TLVs and BEIs book. ACGIH, Cincinnati, Ohio. Copyright Reprinted with permission. 25

28 Notes

29 DISCLAIMER WorkSafe New Zealand has made every effort to ensure the information contained in this publication is reliable, but makes no guarantee of its completeness. WorkSafe may change the contents of this guide at any time without notice. This document is a guideline only. It should not be used as a substitute for legislation or legal advice. WorkSafe is not responsible for the results of any action taken on the basis of information in this document, or for any errors or omissions. Published: April 2017 Current until: 2019 PO Box 165, Wellington 6140, New Zealand Except for the logos of WorkSafe, this copyright work is licensed under a Creative Commons Attribution-Non-commercial 3.0 NZ licence. To view a copy of this licence, visit In essence, you are free to copy, communicate and adapt the work for non-commercial purposes, as long as you attribute the work to WorkSafe and abide by the other licence terms. WSNZ_2598_April 2017

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