CHRIS LASZCZ-DAVIS, MS, CIH - Exposure Limit Setting Processes: The Changing Landscape, The International Challenge
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Exposure Limit Setting Processes: The Changing Landscape, The International Challenge CHRIS LASZCZ-DAVIS, MS, CIH T H E E N V I R O N M E N TA L Q U A L I T Y O R G A N I Z AT I O N , L L C L A FAY E T T E , C A CIHC CONFERENCE SAN DIEGO, CA DECEMBER 3, 2012 CIHC 2012
Overview Historical Overview—Evolution, Processes and Tools Current Approaches in OEL Setting Global Challenges Changing Landscape Future Opportunities CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
Evolution of OEL Processes Worldwide OELs Europe United States China India Latin America Exposure Limit Setting Processes CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
European OEL Processes 1883 First attempts at OEL development in Germany on CO, NH3, HCl, etc. 1938 (Germany), list of OELs (MAK-Werte) proposed, not accepted. The MAK Kommission first list in 1956. 1930s Russia published first MAC list of 30 OELs. Later, several European countries created their own Committees to develop OELs—Sweden; Netherlands; UK; France. Often, ACGIH TLVs served as basis for their exposure standards and laws. CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
European OEL Processes 1980s Control Banding concept first proposed. 1988 Control of Substances Hazardous to Health Regulations (COSHH) 1991 First set of (27) Indicative Limit Values proposed. 1995 European SCOEL (Scientific Committee on Occupational Exposure Limits) established. 1998 Social Partner Advisory Committee for Safety, Hygiene and Health at Work (ACSHH) was formed. CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
European OEL Processes SCOEL recommendations reviewed with Social Partner Advisory Committee, made publicly available for comment and, once finalized, issued by the European Commission. 2000 Global Harmonized System (GHS) for chemical labeling introduced into EU. 2007 Regulation on Registration Evaluation & Control of Chemicals (REACh), with prescribed DNELs often Lower than traditional OELs and including full cycle EHS risks. CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
United States Environment OEL Setting Within 8 Frameworks 1927 Walsh Healey Act 1946 ACGIH 1971 OSHA 1971 NIOSH 1984 AIHA EPA New Chemical Exposure Limits (TSCA) State Level Efforts, More Restrictive Manufacturers CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
China’s OEL Development Great Wall CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
China’s OEL Process 1950s, Republic of China published first exposure standards. 1990s, Emphasis on Occupational Disease Prevention Today, 339 Conservative Compulsory OELs Today, Health is Primary Consideration Today, Strive for Economic & Technological Feasibility CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
Comparison: China’s OELs, TLVs and WELs Hazardous China’s OEL ACGIH TLV TWA UK OEL Agents PC-TWA (mg/m3) (mg/m3) TWA (mg/m3) Methanol 25 262 266 Lead 0.03 0.05 0.15 n-Hexane 100 176 72 Dimethylformamide 20 29.9 15 10%≤free 0.7 SiO2≤50% Crystalline Silica/ 50%<free 0.3 Quartz SiO2≤80% 0.025 0.1 (respirable) free SiO2>80% 0.2 Noise (8hr per day) 85dbA 85dbA 85dbA CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
Democratic Republic of India CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
India’s OEL Processes Safety Focus and Huge Unorganized Workforce Lack of Occupational Disease Data Meager Spending on Public Health No Coherent National Policy 1948 Factories Act, Permissible Limits of Exposure of Chemical and Toxic Substance CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
India’s Permissible Limits of Exposure Substance (mg/m3) ACGIH UK OEL INDIA Asbestos 0.1 f/cc 0.1 f/cc 2 f/cc Benzene 1.6 3.25 30 Beryllium 0.002 0.002 0.002 Carbon Monoxide 28 35 55 Hexavalent Cr (Sol) 0.05 0.05 0.50 Hexavalent Cr (Insol) 0.01 Manganese fume 0.2 0.5 1.0 Total Dust 10 10 10 Vinyl Chloride 2.5 7.8 10 CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
Latin America Overview CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
Latin America General Information Official Language: Spanish and Portuguese most spoken Number of Countries: 43 Social Inequality is a major roadblock. 25% of the population lives with less than $2 / day. Brazil leading country, followed by Mexico, Argentina and Colombia CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
Latin American Countries COUNTRY EXPOSURE LIMITS DATE BRAZIL ACGIH 1976 ARGENTINA ACGIH ACTUAL CHILE ACGIH ACTUAL COLOMBIA ACGIH ACTUAL MEXICO ACGIH ACTUAL VENEZUELA ACGIH 2001 (Under review) CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
Derivation of DNELs: 1,1,1 Trichloroethane Source: Alison Searl, PhD, Director of Analytical Services, IOM Consulting, Some Current Approaches to OEL Setting in the EU, BOHS, Occupational Hygiene Conference, Thistle Hotel, Bristol, 2008. CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
Summary--Global Challenges Number of Chemicals in Commerce OELs—Little Understanding Today’s Emphasis—Full Cycle EHS Risks Not all Value OELs Data—Shortage, Quality & Reliability Resources and Expertise REACh—New Rules and New Levels CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
Changing Landscape—What’s New? International Commerce Varying Global Risk Determination Processes and Limits Shortage of Scientific Data & Resources Electronics and Leveraging Banding--A Worthy Ally? CIHC 2012, C. Laszcz-Davis BOHS 2012 Cardiff, Wales
Quantitative Health Based Hierarchy of OELs OELs As more toxicological and Health Based OELs epidemiological data becomes Most Extensive Data Requirements • Regulatory, Authoritative available, we move up the (human epidemiology studies) •Traditional hierarchy of OELs. > quality, > certainty (TLVs, MAKs, WEELs, PELs, MACs, RELs) Working Provisional OELs (internal company, trade association, Moderate Data Requirements vendor limits) (in vitro and animal studies and anecdotal reports of human health effects) > quality, > certainty Prescriptive Process Based OELs (REACH DNELs/DMELs) Least Data Requirements (in vitro and animal studies) Hazard Banding Strategies • Pharmaceutical banding • Occupational exposure banding Control Banding = Hazard Bands + Exposure Risk Assessment + Exposure Measurement CIHC 2012, C. Laszcz-Davis Task force: M. Guillemin, D. Heidel, M. Jayjock, C. Laszcz- Davis, P. Logan, A. Maier, J. Mulhausen, K. Niven, D. O’Malley, J. Perkins, S. Ripple 11.08.12
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