Occupational Legislation Overview - Rest of the World

1. Occupational Legislation Overview- Rest of the World Steve Binks ILA Regulatory Affairs Director

2. Introduction • Long been recognised that occupational exposure to lead can cause adverse health effects • Not only are particulates (dust & fume) important routes of exposure, must also consider eating (and smoking) with contaminated hands due to poor hygiene • Biological monitoring and health surveillance is superior to measuring workplace airborne lead • There are difficulties in attempting to correlate blood lead with airborne lead levels From Kentner et al., 1994 Source: UNEP

3. Are Global Lead OEL’s and Biological Limit Values Harmonised? NO

4. Case Study- Europe • In Europe Directive 98/24/EC establishes a Binding Occupational Exposure Limit and associated Biological Limit Value • Also requires that medical surveillance is carried out if: • Lead in air >0.075mg/m3, or • Blood lead >40µg/100ml • Member States make their own arrangements that result in • Different OELs and BLVs • OELs range from 0.05-0.15mg/m3, BLVs range from 20-70µg/100ml • Different criteria for when to initiate medical surveillance, frequency of monitoring blood lead and suspension from work • Suspension limits range from 10-70µg/100ml • Different approaches to protecting women and the unborn child • Lower BLV for ALL ♀ in Fr & Es, those <45 in De, Hu, Po; those of childbearing age/capacity in UK, It; removal of pregnant and lactating ♀ in Swe, Fin • Different approaches to protecting young workers • Working with lead not permitted for <18years in De, Fr; lower BLV’s for <18years in UK

5. What are the Reasons for Differences? • Existing OELs and BLVs have been set over an extended time period • EU BOELV 1998, UK 2002, Denmark 2002, Germany 2005, Sweden 2005, China 2007, Australia 2009…….. • Science on health effects constantly evolving • 2006 - IARC considers inorganic • lead compounds as • “probable human carcinogens” • (Group 2A) and metallic lead • as a “possible human • carcinogen” (Group 2B) • 2010 - EFSA calculate BMDL for • Developmental neurotox: 1.2µg/dL • Effects on blood pressure: 3.6µg/dL • Chronic kidney disease: 1.5µg/dL • 2012 - US NTP publish report on health • Effects of low level Pb exposure

6. What are the Reasons for Differences? • Levels considered “Industry good practice” reducing over time • Public policy changing as to what represents an adverse effect and whether acceptance of workplace risks should be different to that for general public

7. Recent Developments • In 2012, based upon the 2006 IARC conclusion on the carcinogenicity of inorganic lead compounds, the German Committee on Hazardous Substances (Ausschuss für Gefahrstoffe – AGS) initiated a review of the German OEL and BLV using a relatively new concept for assessing the risks associated with exposure to carcinogenic substances (“traffic-light” system”) • Discussions still on-going but important development is that in evaluating the point of departure for kidney toxicity the author is debating whether to use the BMDL10 of 1.5µg/dl derived for the general population by the EFSA in 2010 or workplace data that would allow derivation of an biological limit value of ~ 25µg/dl • These considerations will also be addressed by SCOEL who have been instructed to initiate a review of their 2003 recommendation in preparation for a much needed update of the EU Binding Limit Values

8. Conclusion • There is still a good deal of disparity in National OELs, BLVs and procedures adopted to protect the health & safety of lead workers • Science and public policy continues to evolve that is driving the adoption of higher regulatory demands in the form of lower blood lead limits and workplace air standards • Against this background of inconsistency Companies are encouraged not to adopt strategies for worker protection that are fixed and compliance based • Continuous improvement targets to minimise worker exposures to lead makes sense for employees AND for the long term sustainability of the Industry