occupational exposure banding and exposure risk management

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Susan Ripple, MS, CIH, Fellow Global Manager Industrial Hygiene The Dow Chemical Company Midland, MI. Occupational Exposure Banding and Exposure Risk Management. Topics for Discussion. Value of Occupational Exposure Bands (OEB) to supplement other authoritative OELs - PowerPoint PPT Presentation

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Occupational Exposure Banding and Exposure Risk Management

Occupational Exposure Banding and Exposure Risk ManagementSusan Ripple, MS, CIH, FellowGlobal Manager Industrial HygieneThe Dow Chemical CompanyMidland, MIValue of Occupational Exposure Bands (OEB) to supplement other authoritative OELs

Value of OEBs to the industrial hygiene process (ERAM)

OEB Framework

Exposure Risk Assessment & Management (ERAM)

Topics for Discussion2Question!How many of you are familiar with the AIHA Exposure Assessment Strategies for performing qualitative exposure assessment?

Bread and Butter of Industrial HygieneTraditional IH Definition:AnticipateRecognizeEvaluate

ControlHazard AssessmentRisk Assessment (Qualitative or Quantitative)Risk Management4

What is it?ERAM General Definition of Exposure Risk Assessment and Management (ERAM)ERAM is a concise framework to help illustrate the core skills of the industrial hygiene profession. Taken at a high level, ERAM is the anticipation, recognition, evaluation and control of chemical, physical and biological hazards to prevent illness and injury in workers, customers and communities.

It is the science of understanding and managing human exposure risks.Strengthen our CORE, Expand our ImpactERAM is the core competency of IH. Owning the science of ERAM both strengthens our CORE and expands our market opportunities.ERAM is an important skill set needed for parts ofSustainabilityProduct StewardshipEHS Management

When we are viewed as being ERAM experts, these Allied Professions will put a higher value on our services. This creates greater need for internal and external IH ConsultantsIH ExpertIH GeneralistAffiliated ProfessionalsEHS GeneralistLevel of ERAMExpertiseERAM Discipline Under the Umbrella of Public HealthIH ExpertIH GeneralistAffiliated ProfessionalsEHS GeneralistHypothetical Amount of ERAM Expertise for each job type. (illustration only)Percent of ERAM needed in job100%50-100%5-50%1-15% 1000 tons production volume or those of high concern Butonly ~ 500 PELs, ~ 650 RELs, ~ 125 WEELs, ~ 650 TLVs

*REACH Registration, Evaluation, Authorization, and Restriction of Chemicals11Scope of challenge to design-out chemical hazards~21,000,000 commercially available chemicals107,067 REACH* registrations (1-3-11) for >1000 tons production volume or those of high concern Butonly ~ 500 PELs, ~ 650 RELs, ~ 125 WEELs, ~ 650 TLVs

*REACH Registration, Evaluation, Authorization, and Restriction of ChemicalsMissed Opportunity for ERAM12The Gap . . . . . . . . . .Hygienists prefer the more official peer-reviewed Traditional OELs,

But . . . . . . . .1314

You cant always get what you want, but if you try some times you might find, youll get what you need Mick Jaeger. . . . . . . . . . .Occupational Exposure Banding provides a mechanism for the evaluation of hazard and risk to offset the misconceptions by employers and workers that a substance must be non-toxic if there is not an OEL!

MIHSOccupational Exposure vs. Control BandingHazard banding is simply the first step in the control banding process

Susan D. Ripple. The Synergist: October 2009

Occupational Exposure Bands are a more appropriate description of Hazard Grouping or Hazard Banding

Donna Heidel and Susan Ripple. The Synergist: April 2012

BOHS OEL-Setting Plenary

Hazard Bands = Occupational Exposure Bands (OEBs)OEBs for a chemical provide a range of acceptable exposure levels based on expert evaluation of the dose-response relationships provided through animal testing. 17

OEBs simply highlight the concept of this modelObjective of OEBs

Develop the framework to systematically evaluate occupational hazards of chemicals without authoritative OELs (PELs, RELs, TLVs, etc.) and communicate the hazards in terms of occupational exposure bands (OEBs).

Value of Occupational Exposure BandingFacilitates more rapid evaluation of health risk & provides guidance for many materials without OELsHighlights areas where data are missing (highlights uncertainties)Identifies hazards to be evaluated for elimination or substitutionAligned with GHS for hazard communicationSupports the definition of OEL-ranges for families of materials

By analogy (structure activity relationships and functionality)

22Project planEstablish minimum viable dataset, including data quality requirements Establish process and decision logicValidate data endpoints and band cut points, process, and decision logicIdentify data sourcesDevelop NIOSH guidanceEducate stakeholders23CriteriaCriteria include qualitative, semi-quantitative, and quantitative data for each toxicological endpoint

Acute toxicitySkin corrosion/irritationSerious eye damage/eye irritationRespiratory and skin sensitizationGerm cell mutagenicityCarcinogenicitySpecific target organ toxicity, both single and repeated exposureReproductive toxicity

Toxicological criteria for the banding is the same as the criteria used for the GHS system. Our goal for hazard banding is to begin with qualitative data to identify the highly hazardous materials and use quantitative methods when establishing OEBs for compounds that are less hazardous. This will support rapid identification of the chemical hazards that should be considered for elimination or substitution. For those chemical agents that cannot be eliminated or substituted, it will prompt the inclusion of appropriate risk-based controls in the design.

24OSHA GHS LinkOEB 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

Data quality is also consideredSimilar processes have been developed by major pharmaceutical and chemical companies to safely discover, develop, and synthesize new chemical entities. These processes are often called control banding since they result in the development of risk-based control approaches. NIOSH is currently investigating the first step in this process, a step we call hazard banding. The outcome of the Hazard Banding process is an occupational exposure band. The OEB concept groups together chemicals without authoritative OELs, based on toxicology and potency. Each band is linked to an order of magnitude range of OELs, based on benchmark chemicals.Our goal for this first step is to develop occupational exposure bands using information that is now required under the revisions to the OSHA hazard communication standard that align the US occupational chemical labeling and classification with the Globally Harmonized System, or GHS. This will assure that data quality is considered and the information is readily available on a compliant SDS or associated databases.

25DRAFT Examples of Qualitative Criteria and GHS PhrasesBandABC (default)DESignal WordWarningWarningDangerDangerDangerOEL Ranges> 1,000 g/m3> 100 and < 1,000 g/m3> 10 and < 100 g/m3> 1 and < 10 g/m3< 1 g/m3> 1000 ppm> 100 - < 1000 ppm> 10 - < 100 ppm> 1 - < 10 ppm< 1 ppmExamples of Health Outcomes and Potency ConsiderationsMinor, 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 CategoriesMay cause drowsiness or dizzinessHarmful 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)This slide depicts a very high level DRAFT summary of the five OEBs under consideration, the GHS signal words that are associated with each band, and anticipated OEL ranges for each band. In the row marked Examples of health outcomes and potency considerations you can see how the health outcomes range from minor, reversible health effects at relatively high doses to irreversible effects at moderate doses, to irreversible effects, including death, at low doses. In the row marked examples of GHS hazard statements and hazard categories, you can see the language that will be included in SDS and the associated hazard categories. We are now in the process of determining how close our OEBs come to NIOSH RELs.

26Now A Little Detail to Give You Confidence in the OEB Process!MIHS

Tier 1aQualitativeUse GHS Hazard Phrases to identify chemicals with potential for irreversible health effects at relatively low doses (Band D-E) or remain at default Band CTier 1bSemi-quantitativeUse GHS Hazard Categories to assign chemicals into Bands D or E or remain at default Band CTier 2QuantitativeDetermine point of departure, factoring data availability, hierarchy, and quality to support assigning chemicals into Bands A, B, or CABCDETier 3Weight of Evidence