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

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 Source: UNEP From Kentner et al., 1994

Are Global Lead OEL’s and Biological Limit Values Harmonised? Country OEL-Air (inhalable) Biological Limit (Blood)   mg/m³ µg/dl (male) µg/dl (female) EU 0.15 70 Germany 0.1 40 (suspended) 10 (suspended) Finland 50 Denmark 0.05 20 Sweden 30 Italy 60 40 France Belgium Spain Portugal Netherlands UK Ireland Switzerland Hungary Slovenia Poland Australia (AIOH) 10 Canada (Ontario) Japan China 0.03 (fume) 0.05 (dust) India South Africa REACH DNEL N/D EU SCOEL (2003) NO

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

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

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

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

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