IMPLEMENTATION OF THE OEL HIERARCHY APPROACH: THE MULTI-NATIONAL EXPERIENCE SUSAN D. RIPPLE, MS, CIH, FAIHA May 22, AIHce 2013 Roundtable 231

Multi-National Chemical Company  Supplies a broad range of products and services to customers in approximately 160 countries  More than 5,000 products manufactured at 188 sites in 35 countries  Use or isolate ~70,000 chemicals to make the 5,000 products  Employs 50,000 employees & >50,000 contractors worldwide

Multi-National Use of the “Hierarchy of OELs”  Only about 1,000 viable OELs exist – Dow developed ~1,000 IHGs – BUT there are >70,000 chemicals in our facilities!  Exposure Risk Assessment and Management is done for all 70,000 hazards using....  the Hierarchy of OELs, and  the process operating parameters to develop a protocol for exposure assessment and management.

 Dow’s process:  Hazard Identification – List of hazards on Hazard Communication List –  Assess the Hazards - Use Authoritative OEL (Regulation, TLV®, WEEL®, etc.) Use or set an internal Dow Industrial Hygiene Guideline Categorize into Health Effect Ratings (aka: Hazard Bands) when a viable OEL does not exist  Risk Assessment – Qualitatively assess exposures and Prioritize Degree of Exposure, Duration, Frequency of Exposure  Risk Management Strategies – Work to document the operating parameters such as physical state, temperatures, pressures, spraying, etc. to heighten the Priority for assessment  Verification that Control Strategies - Perform exposure monitoring where a validated method exists, or verify with a reasonable surrogate if possible Every Substance is Qualitatively Assessed

As more toxicological and epidemiological data becomes available, we move up the hierarchy of OELs. Hierarchy of OELs Hazard Banding + Exposure Banding  Control Banding Health Based OELs Regulatory, Authoritative Traditional (TLVs, MAKs, WEELs, PELs, MACs, RELs) Working Provisional OELs (internal company, trade association, vendor limits) Hazard Banding Strategies Pharmaceutical banding Occupational exposure bands Prescriptive Process Based OELs (REACH DNELs/DMELs & EPA’s PMN NCELs)

But we are a Large Company with Resources  How would this work in small and medium size customers’ facilities?

Would it be impossible to proceed with exposure risk assessment and management?

What Tools Do We Need?  Our risk assessment tools provide a suite of resources  E XPOSURE ESTIMATION - MODELING - SAMPLING  OCCUPATIONAL EXPOSURE BANDS  OCCUPATIONAL EXPOSURE LIMITS  We pick the right tool for the job based on systematic and documented applications of:  P ROBLEM F ORMULATION  T IERED R ISK A SSESSMENT M ETHODS

If We Never Develop Another PEL, REL, TLV, WEEL ---  We do exposure assessments all the time without exposure limits!  Qualitative Exposure Assessment based on Professional Judgment  Biohazard Levels  Ergonomics  Thermal Stressors

As more toxicological and epidemiological data becomes available, we move up the hierarchy of OELs. Most Extensive Data Requirements ( human epidemiology studies) > quality, > certainty Hierarchy of OELs Hazard Banding + Exposure Banding  Control Banding Health Based OELs Regulatory, Authoritative Traditional (TLVs, MAKs, WEELs, PELs, MACs, RELs) Working Provisional OELs (internal company, trade association, vendor limits) Hazard Banding Strategies Pharmaceutical banding Occupational exposure bands Prescriptive Process Based OELs (REACH DNELs/DMELs & EPA’s PMN NCELs) Moderate Data Requirements (in vitro and animal studies and anecdotal reports of human health effects) > quality, > certainty Least Data Requirements (in vitro and animal studies)

Effective and Efficient Exposure Risk Assessment and Management Hierarchy of OELs / Banding Strategies Hierarchy of Exposure Controls Hierarchy of Exposure Assessment Traditional OEL Elimination of HazardsValidated Monitoring Working/ Provisional OEL Engineering ControlsMonitoring DNEL / DMEL (Prescriptive) Administrative ControlsModeling Hazard Banding - OEBs PPEQualitative Most Effective Least Effective SUSTAINABILITY of CONTROL AVAILABILITY of TOXICOLOGICAL DATA CERTAINTY of EXPOSURE JUDGMENT

The Future for Various OEL-Types and Other Data Sources

Today’s Discussion on OELs …..  You’ve heard from my colleagues that set various types of OELs and the promise and challenges for each organization.  There is another OEL-setting group that you may be familiar with formerly housed under the AIHA  AIHA transferred the Workplace Environmental Exposure Levels Committee (WEEL Committee) to the TERA group (Toxicology Excellence for Risk Assessment) under the Occupational Alliance for Risk Science (OARS)

Risk Information Exchange (RiskIE) WEELs Full WEELs External WEEL Peer Review TERA and NLM Web Posting Training Boot Camp Webinar Series Mentoring Program WEEL Committee Alliance Advisory Board TERA WEEL Exec Affiliates & Sponsors Occupational Alliance for Risk Science

What else is there? Alternatives to Health-Based OELs

Example: COSSH Essentials

WEEL Banding Matrix – DCA Example

Hazard Banding  NIOSH OEB Matrix  With GHS advancing to the USA, the traditional Hazard Banding Matrix just got somewhat easier

NIOSH Project Plan 1. Establish minimum viable dataset, including data quality requirements 2. Establish process and decision logic 3. Validate data endpoints and band cut points, process, and decision logic 4. Identify data sources 5. Develop NIOSH guidance 6. Educate stakeholders

Hazard Banding (OEB) Criteria  Criteria include qualitative, semi-quantitative, and quantitative data for each toxicological endpoint  Acute toxicity  Skin corrosion/irritation  Serious eye damage/eye irritation  Respiratory and skin sensitization  Germ cell mutagenicity  Carcinogenicity  Specific target organ toxicity, both single and repeated exposure  Reproductive toxicity

OSHA-GHS Link  OEB toxicological endpoints are aligned with GHS classification and labeling system*  Important goal is to relate potency of each toxicological hazard-banding endpoint to GHS hazard statements and categories, when possible *CLP

Qualitative Criteria and GHS Information BandABC (default)DE GHS Signal Word Warning Danger OEL (Control) Ranges > 1,000 µg/m 3 > 100 and < 1,000 µg/m 3 > 10 and < 100 µg/m 3 > 1 and < 10 µg/m 3 < 1 µg/m 3 > 1000 ppm> < 1000 ppm> 10 - < 100 ppm> 1 - < 10 ppm< 1 ppm Examples of Health Outcomes and Potency Considerations Minor, reversible health effects occurring at high doses. Skin and eye irritation. Reversible organ toxicity, skin and eye corrosion (reversible), possible dermal sensitizer at high doses. Irreversible organ toxicity at high doses, irreversible skin and eye corrosion, dermal sensitizer at moderate doses. Irreversible organ toxicity at low doses, in vivo genotoxicity, dermal sensitizer at low doses, evidence of mutagenicity, potential developmental and reproductive toxicants. Human carcinogens at low doses, respiratory sensitization Examples of GHS Hazard Statements and Hazard Categories May cause drowsiness or dizziness Harmful if inhaled (4). Harmful in contact with skin (4). Toxic if inhaled (3). Toxic in contact with skin (3). Suspected of causing cancer (2). May cause damage to organs (2) Fatal if inhaled (2). Fatal in contact with skin (1). Causes damage to organs (1). May cause cancer (by route of exposure)— 1A or B. Presumed or known human reproductive toxicant (1A or 1B). Causes damage to organs through prolonged or repeated exposure (1) Fatal if inhaled (1). Fatal in contact with skin (1). May cause cancer (by route of exposure)—1A. May cause allergy or asthma symptoms or breathing difficulties if inhaled (1A resp.). Known human repro toxicant (1A). Causes damage to organs through prolonged or repeated exposure (1)

BandABCDE GHS Signal Word PrecautionaryWarningDanger GHS Hazard Category GHS Hazard Statements Harmful if swallowed. Harmful if inhaled. Harmful in contact with skin Toxic if swallowed. Toxic if inhaled. Toxic in contact with skin. Fatal if swallowed. Fatal if inhaled. Fatal in contact with skin. “H” Codes H302, H332, H312H301, H331, H311H300, H330, H310 Acute Toxicity Oral Toxicity LD 50 Technical Criteria (mg/kg bodyweight) >2000>300 and ≤ 2000>50 and ≤ 300>5 and ≤ 50≤ 5 Example: Acetylene tetrabromide Inhalation Vapors (mg/l) LC 50 Technical Criteria (mg/kg bodyweight) >10.0 and ≤ 20.0>2.0 and ≤ 10.0>0.5 and ≤ 2.0≤ 0.5 Band D (OSHA PEL: 1 ppm) H330 (fatal if inhaled) category 2 (LC50 inhalation rat: mg/l/4 h) H319 (causes serious eye irritation) category 2

Band ABCD E Consider “Ceiling” for respiratory sensitizers GHS Signal Word Warning Danger GHS Hazard Category 1B (skin)1A (skin)1B (resp.)1A (resp.) GHS Respiratory and Skin Sensitization Hazard Statements May cause an allergic skin reaction May cause allergy or asthma symptoms or breathing difficulties if inhaled Respiratory and Skin Sensitization “H” Codes H317 H334 Sensitization Respiratory and Skin Example: Isopropyl Glycidyl Ether Band D or E (NIOSH REL: 50 ppm C; IDLH 400 ppm) H332 (harmful if inhaled) category 4 H341 (suspected of causing genetic defects) category 2 H317 (may cause allergic skin reaction) category 1 H334 (may cause allergy or asthma symptoms…) category 1

Carcinogenicity BandABCDE GHS Signal Word Warning Danger GHS Hazard Category 221B1A GHS Carcinogenicity Hazard statement Suspected of causing cancer May cause cancer Carcinogenicity “H” Codes H351 H350 Example: 4-Aminobiphenyl Band E (French OEL: ppm or 7 µg/m3) H350 (may cause cancer) category 1A H302 (harmful if swallowed) category 4 (oral)

In Conclusion  Hygienists prefer OELs – Health-based OELs  Hygienists perform exposure risk assessments with professional judgment all the time without OELs  Some OELs are stronger than others but none are a line of “absolute safe exposure”  Remember the tools you have to assess exposure:

As more toxicological and epidemiological data becomes available, we move up the hierarchy of OELs. Most Extensive Data Requirements ( human epidemiology studies) > quality, > certainty Moderate Data Requirements (in vitro and animal studies and anecdotal reports of human health effects) > quality, > certainty Least Data Requirements (in vitro and animal studies) Hierarchy of OELs Hazard Banding + Exposure Banding  Control Banding Health Based OELs Regulatory, Authoritative Traditional (TLVs, MAKs, WEELs, PELs, MACs, RELs) Working Provisional OELs (internal company, trade association, vendor limits) Hazard Banding Strategies Pharmaceutical banding Occupational exposure bands Prescriptive Process Based OELs (REACH DNELs/DMELs) PMN – Significant New Use Registration (NCELs – New Chemical Exposure Limits)

OELs: The Future Supply for Risk Assessment

Risk Assessment is Alive and Well  Tools for Risk Assessment continue to be available and to improve  Various types of OELs are being developed with current science and data ..... and will be available on the internet in “one place” – many for free!  OEL-setting and outcomes are being harmonized  NIOSH OEB process will be available as a new competency for those interested in a Tiered Level approach to facilitate our Risk Assessments!

Just expand your toolbox !!! Susan Ripple The Dow Chemical Company (989)