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Global Chemical Policy Drivers—Impact on the Way We Do Business Susan D. Ripple, MS, CIH Sr. Industrial Hygiene Manager The Dow Chemical Company Midland,

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Presentation on theme: "Global Chemical Policy Drivers—Impact on the Way We Do Business Susan D. Ripple, MS, CIH Sr. Industrial Hygiene Manager The Dow Chemical Company Midland,"— Presentation transcript:

1 Global Chemical Policy Drivers—Impact on the Way We Do Business Susan D. Ripple, MS, CIH Sr. Industrial Hygiene Manager The Dow Chemical Company Midland, MI

2 CIHC December 2010 Topics  Broader Global Chemical Regulation Drivers  Evolution of OELs  Current status of Chemical Policies  Challenges today

3 CIHC December 2010 Global Chemical Regulations/Policies  REACh 1 – Can’t sell if not registered – puts risk assessment squarely on manufacturer’s shoulders  Green Chemistry – Sustainability - Registrations – following the REACh pathway  EPA – TSCA reform; NCELs 2 for the workplace  California – Biomonitoring and PELs  Global Harmonized System (GHS) – Reclassify all chemicals globally (soon to be USA) on MSDSs 1 – NCEL: New Chemical Exposure Limits (NCELs) determined by EPA during the Significant New Use Rules under TSCA 5e consent orders. 2 - REACh: EU Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals

4 CIHC December 2010  eCOSHH – Risk-phrases retiring  use GHS phrases which don’t correlate in the Control Banding Tool  OSHA – redirecting funds from Alliances and Voluntary Protection Program to Enforcement  Corporate Citizenship and Responsibility (BP incident) heightened  NIOSH – NORA initiative and Prevention Through Design Global Chemical Regulations/Policies 1 1 eCOSHH: UK Health and Safety Executive electronic tool for Control Banding under the Control of Substances Hazardous to Health (COSHH) 2 NORA: CDC/NIOSH - National Occupational Research Agenda (NORA)

5 CIHC December 2010 Help on the Horizon:  Nanomaterials – Control Bands & Measurement Techniques  Globally Harmonized System for MSDSs  “Prevention Through Design”  Injury Illness Prevention Programs (I2P2)  Increased OSHA Enforcement and Increased Fines  REACh Derived No Effect Levels (DNELs) as de facto OELs  Hazard Bands and Control Bands

6 CIHC December 2010 The Conundrum  Exposure Assessment & Control is the Occupational Hygienist’s core competency  Without ‘safe limits’ such as OELs, the Hygienist has no ‘arsenal’ for discussion  Without regulatory OELs, few employers will do the needed risk assessments or implement controls

7 CIHC December 2010 Recognition of the Need for OELs  Chronology shows many major occupational chemical exposure problems known for almost 2,000 years  Only the last years have seen that these hazards are no longer acceptable  Change in culture started in Europe in late 1880s  50 years later before this cultural change took hold in the USA

8 CIHC December 2010 Evolution of EH&S vs Development of OELs  Prior to the development of OELs, insights into industrial hygiene (occupational hygiene) and chemical exposure were developed ca, BC: Roman architect/engineer Marcus Vitruvius Pollio noted lead workers had pale gray complexions ca, AD: Roman Pliny the Elder described workers’ use of sheep bladders as masks to protect from mercury dust and vapors ca, 1556: Agricola warned of “black lung” in miners (Italian) ca, 1700: Ramazzini, “father” of occupational medicine recommended hygiene, posture, ventilation and protective clothing for workers (Modena, Italy) ca, 1736: state of Massachusetts in USA prohibited use of lead in whiskey stills after fatalities of drinking alcohol from the stills. ca 1840: France issued a policy discouraging the use of lead as a pigment in paint ca 1912: Kobert of Germany published a list of acute exposure limits for 20 substances

9 CIHC December  U.S. Bureau of Mines published Quartz OEL 10 mppcf  In the late 1920’s a company in West Virginia ignored the 1917 OEL and allowed 2,000 miners to be grossly over exposed to over 98% pure silica quartz dust as they tunneled through a mountain. >400 workers died within 2 years Almost all remaining workers eventually died of silicosis

10 CIHC December 2010 In Fact….  1918 Worker’s Compensation denied an 18-year old painter’s compensation for exposure to deadly paint fumes and gases 2 days after warming the paint so it would brush onto the building walls Since lead poisoning was considered usual and customary incident to painters, compensation was denied  Today, lead poisoning would be covered under worker’s compensation in most countries with occupational safety and health legislation.

11 CIHC December ’s  U.S. Bureau of Mines published 33 OELs  International Critical Tables published 27 OELs

12 CIHC December ’s  American National Standards Institute (ANSI) Z-37 published U.S. exposure “standard” for Carbon Monoxide ppm  Thresholds Committee of ACGIH published first table of 63 ‘Maximum Allowable Concentration” (MACs) – later to be known as “Threshold Limit Values”  Germany outlawed use of asbestos for insulation in ships  India passed the Factories Act with a table of exposure limits Note that this was 58 years after Germany published the original OEL list in 1912!

13 CIHC December ’s  People’s Republic of China published their first list of exposure standards

14 CIHC December ’s  Many countries adopt the latest version of the ACGIH TLVs® as the basis for their exposure standards and health laws  U.S. Consumer Product Safety Commission outlawed lead in commercial paint Note that this was 138 years after France outlawed lead in paint in 1840!

15 CIHC December ’s  “Control Banding” concept is first proposed  U.S. updated OSHA Permissible Exposure Limits in Table Z-1 (1989)

16 CIHC December  Global Harmonized System (GHS) for chemical labeling introduced by the European Union to further chemical safety

17 CIHC December 2010 Trivia – But are the Hazards really different?  Most countries have OELs that date from 2003 or more recently Except India and USA  G8 countries have active committees to study, develop and update federally-enforceable OELs USA does not  Germany has most advanced system for developing OELs and store all occupational hygiene data in a database. Exposure data used with national health care data system to look for health effects of chemicals in workers

18 CIHC December 2010 Is there any wonder we have different OEL values?  Some EU countries list an OEL of “0” for certain chemicals – these are banned chemicals in those countries  Hungary has the most comprehensive OELs for carcinogens and mutagens  Japan differentiates inhalation sensitizers and skin sensitizers  New Zealand adjusts the OELs for respiration rate of the worker  Some countries adjust OELs for altitude, standard temperature and pressure or for a 48-hour work week

19 CIHC December 2010 Re-Examining the Value of OELs  60 years of developing OELs  Changes during those 60 years include: Regulatory changes Litigation in some countries Shifting centers of manufacturing growth More global view on issues Better science and testing Better communication of hazards globally Differences in risk tolerance and access to relevant data results in many OEL values around the world

20 CIHC December 2010 Where We Go From Here  For a global economy to work, the workforce must be valued and not squandered All OEL-setting bodies should harmonize worker protection using the same standard of care  The accumulated research globally on OELs is huge Why are the OELs different in many countries? How do we make available the ‘hazard data’ on materials so that control strategies and risk management can be prepared?  As shown in this brief overview of the history, the hazards have been known for many chemicals for thousands of years.

21 CIHC December 2010 ~1,500 OELs in North America  Only a modest number of OELs available compared to total list of chemicals More than 80,000 products in North American commerce

22 CIHC December 2010 United States  OEL-Setting falls within six frameworks: Occupational Safety & Health Administration (OSHA) National Institutes of Safety and Health (NIOSH) American Conference of Governmental Hygienists (ACGIH) American Industrial Hygiene Association (AIHA) State OSHA PELs Environmental Protection Agency (EPA) Some manufacturers and employers set limits in the absence of regulations

23 CIHC December 2010 Setting OELs: Many Challenges  Prioritization of substances needing OELs  Diversity of committee membership  Expertise & Experience required  Availability of data  Perception of committee setting OELs  Resources time, data, and finance  “Harmonization” of OELs

24 CIHC December 2010 OEL-Challenges in United States  Regulatory OELs (with socio-political influence by regulation) is a level of “acceptable risk” and not true “threshold of toxic risk”  Litigation in USA precludes development of additional PELs and TLVs and has slowed the AIHA Workplace Environmental Exposure Levels (WEELs)  Lack of Political Support Various political administrations do not support adding government regulations such as PELs USA budget to NIOSH has slowed the NIOSH REL development  REACh – new default OELs in North America? It will definitely force sharing of data globally

25 CIHC December 2010 Mission Impossible: Developing more OELs ? or just Mission Difficult?

26 CIHC December 2010 A Reminder About OELs  Variety of OEL sources  Very few OELs relative to number of chemicals  OELs are based on toxicology and human data and require robust analysis by experts  OELs are built on: Uncertainty or Safety Factors Margins of Safety Margins of Exposure

27 CIHC December 2010 In Fact:

28 CIHC December 2010 TLVs WEELs BOEL MAK PELs Vendor OELs NCEL Hazard Bands GHS MAC IOEL REL DNEL

29 CIHC December 2010 Why Worry About DNELs?  Over 150,000 substances exist in commerce Only about 1,500 substances have OELs anywhere around the world  Every substance in commerce in the EU (thus the Rest of World) will have a DNEL The concern is that risk assessments require some level of ‘safe’ for risk management! DNEL

30 CIHC December 2010 Simple Comparison  DNELs are: Threshold-based non-cancer endpoints considered to be “No Effect Levels” for humans based on NOELs and AFs  Worker DNELs are: Calculated from Population DNELs Prescriptive & Conservative – not based on judgment  OELs are: Levels of acceptable risk for workers based on NOAELs and LOAELs with SF (AF) **We target 10 – 50% of the OEL for compliance  OELs Utilize Professional judgment and ‘weight of evidence’ with peer review by experts who draw comparative analogy between animal and human toxicology parameters

31 CIHC December 2010 DNEL Refresher  Manufacturers’ burden to prove use of their substances is not harmful to human health After gathering toxicology data and derivation of the DNEL or DMEL, the next step is to assess the risk of use.  Exposure Scenarios determine the risk of use to human health compared to the DNEL.

32 CIHC December 2010 Hypothesis: In the Occupational Setting, the DNEL could be construed to be a de facto OEL.

33 CIHC December 2010 Concerns & Issues for DNELs vs. OELs  Most chemicals do not have PELs, TLVs, or a unified, codified exposure limit  Can regulators use DNELs to demonstrate non-compliance?  Will EU member-states abandon their current OEL processes and default to the DNELs? Will the EU grab hold of the DNELs and turn them into regulatory OELs?  Will manufacturers derive overly conservative DNELs to shield themselves from liability?  Will manufacturers “adjust” their DNELs to achieve a favorable chemical risk assessment outcome?  Will we see multiple DNELs for the same substance when manufacturers can’t agree?

34 CIHC December 2010 DNELs vs. OELs  Risk Management Measures (RMMs)* a. Limit Concentration b. Ventilation c. PPE (Specific) d. Training e. Limit Duration of Exposure  SDS Section 8 a. OELs listed b. Ventilation c. PPE considerations d. Hazard Awareness e. Time-specific values TWA, STEL, Ceiling DNELs will be presented along with OELs in Section 8 !

35 CIHC December 2010 Perhaps We Adjust the DNELs for use as OELs  That risk typically not quantified, led to conservatism in IH practice.  Along with statistical conservatism if exposures > 50% OEL.  Also embodied in the < 1/2 to 1/10 OEL concept to prove compliance.

36 CIHC December 2010 Oh, By the Way  DNELs also provide data for: Standardized hazard assessment for use by IH’s in Risk Management (previously not available for most substances) Data available to do “Hazard Banding” OEL development (vs. worker DNELs) Air sampling methods (or development) Standardized respirator, body cover and glove material selection

37 CIHC December 2010 Navigation through Solutions  Global Issues  USA Issues  State Issues  Partnerships – Agencies, Manufacturers, Workers / Employers, Countries  Volunteer to be involved at any level that interests you!

38 Don’t rely on everyone else or the government to solve the problem… Be a part of the solution ….

39 CIHC December 2010 Contact: Susan Ripple, MS, CIH Manager Industrial Hygiene Expertise Center The Dow Chemical Co. Midland, MI


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