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
Source: UNEP
From Kentner et al., 1994

3. 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

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 mg/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
IARC considers inorganic
lead compounds as
“probable human carcinogens”
(Group 2A) and metallic lead
as a “possible human
carcinogen” (Group 2B)
EFSA calculate BMDL for
Developmental neurotox: 1.2µg/dL
Effects on blood pressure: 3.6µg/dL
Chronic kidney disease: 1.5µg/dL
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