NIOSH Occupational Exposure Banding Decision Logic

NIOSH Occupational Exposure Banding Decision Logic
Lauralynn Taylor McKernan, Sc.D., CIH National Institute for Occupational Safety and Health Centers for Disease Control and Prevention

NIOSH Occupational Exposure Banding Team
Charles Barton, Ph.D., DABT Steve Gilbert, M.S. George Holdsworth, Ph.D. T.J. Lentz, Ph.D. Eileen Kuempel, Ph.D. Andy Maier, Ph.D., CIH, DABT Lauralynn Taylor McKernan, Sc.D, CIH Melissa Seaton, M.S. Christine Whittaker, Ph.D. Christine Uebel, B.S. Donna Heidel, M.S., CIH (formerly NIOSH)

The findings and conclusions in this presentation have not been formally disseminated by the National Institute for Occupational Safety and Health and should not be construed to represent any agency determination or policy .

Overview Background Value of Occupational Exposure Bands (OEB)
NIOSH framework and decision logic OEB Tier 1 process OEB Tier 1 Validation process Case studies OEB Tier 2 process Tier 2 Examples Next Steps

What are some challenges of our profession?
Question: What are some challenges of our profession? Do we always have the OELs we need?

Occupational Exposure Limits
Chemicals in Commerce New Occupational Exposure Limits Approximately 1,000 chemicals with authoritative OELs NIOSH RELs OSHA PELs California PELs TLVs WEELs MAKs Push enter 1 Approximately 1000 chemicals with authoritative OELs (RELs, PELs, CalPELs, TLVs, WEELs, and MAKs). The EPA reports that the Toxic Substances Control Act (TSCA) Chemical Substance Inventory contains over 84,000 chemicals According to the Society of Chemical Manufacturers and Affiliates (SoCMA), there is no process for EPA to remove chemicals from the list if they are no longer being produced. SoCMA estimates that over half of the chemicals on the list are no longer in production, so 84,000 may be a significant overestimate of what is actually in commerce in the US. Push enter again

How do we handle all the new chemicals?
Mechanism to quickly and accurately assign chemicals into “categories” or “bands” based on their health outcomes and potency considerations, is needed Occupational Exposure Bands (OEBs)

Hierarchy of OELs Hazard Banding Strategies
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OEB value Stakeholders NIOSH
Provides guidance for materials without OELs Identifies hazards to be evaluated for elimination or substitution Aligned with GHS for hazard communication Facilitates the application of Prevention through Design principles NIOSH Facilitates more rapid evaluation of health risk Used with minimal data Highlights areas where data are missing Supports the definition of OEL- ranges for families of materials Provides a screening tool for the development of RELs

Tier 2 Tier 3 Tier 1 Ease of use, accessibility, speed of evaluation
Begin here. Rapid evaluation with least data requirements Tier 2 Determine if sufficient data is available. Assign bands with more confidence. Tier 3 Use expert judgment and all available data to perform an assessment of health risk Use GHS H-codes to identify bad actors (C, D and E) Start at Tier 1. Move on to Tier 2 and Tier 3 as resources become available. Use point of departure information to band in A, B, C, D or E. Ease of use, accessibility, speed of evaluation Use all available information Data Requirements, OEB confidence, required user expertise

Tier 3—Weight of Evidence
Tier 1 —Qualitative User: Health and safety generalist A Tier 1 evaluation utilizes GHS Hazard Statements and Categories to identify chemicals that have the potential to cause irreversible health effects Tier 2—Quantitative User: Skilled occupational hygienist A Tier 2 evaluation produces a more refined OEB, based on point of departure data from reliable sources. Data availability and quality are considered. Tier 3—Weight of Evidence User: Toxicologist or experienced occupational hygienist Tier 3 involves the integration of all available data and determining the degree of conviction of the outcome.

A B D C E Overview of tier approach to OEBs
Less Hazardous More Hazardous Tier 1 —Qualitative Use GHS Hazard Statements to identify chemicals with potential for irreversible health effects at relatively low doses (Bands D or E) or reversible health effects (Band C). Use GHS Hazard Categories to assign chemicals into Bands C, D or E. Tier 2—Quantitative Determine point of departure, factoring data availability, hierarchy, and quality to support assigning chemicals into alternate bands. Tier 3—Weight of Evidence Involves integration of all available data and determining the degree of conviction of the outcome.

Health Hazards/ Endpoints
Hazard Class Hazard Category Acute Toxicity 1 2 3 4 Skin Corrosion/Irritation 1A 1B 1C Serious Eye Damage/ Eye Irritation 2A 2B Respiratory or Skin Sensitization Germ Cell Mutagenicity Carcinogenicity Reproductive Toxicity Lactation Specific Target Organ Toxicity (STOT) – Repeated Exposure STOT: Specific Target Organ Toxicity (STOT) category distinguishes between single and repeated exposure for Target Organ Effects * Slide courtesy of OSHA 13

DRAFT Endpoint Band C D E OEL Ranges Particles
OEL Ranges Particles > 0.1 and < 1 mg/m3 > < 0.1 mg/m3 < 0.01 mg/m3 Vapors > 1 < 10 ppm > 0.1 < 1 ppm < 0.1 ppm Acute Toxicity GHS Hazard Category 3, 4 2 1 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 H301, H302, H331, H332, H311, H312 H300, H330, H310 Skin Corrosion/Irritation 1A, 1B, 1C Skin corrosion / irritation GHS Hazard statement Causes skin irritation. Causes severe skin burns and eye damage. Skin corrosion / irritation “H” Code H315 H314 Serious Eye Damage/ Eye Irritation 2A, 2B GHS Serious Eye Damage/Eye Irritation Hazard statement Causes eye irritation Causes serious eye irritation Causes serious eye damage Serious Eye Damage/Eye Irritation “H” Codes H319 H318 DRAFT So, I’ve described why were think hazard banding is important, now its time to show you what are criteria overview might look like… Our This is a draft snapshot of one of our methodologies. This is not set in stone yet. Even as I speak right now, there is a meeting downstairs with 5 toxicologists discussing some issues on our methodology.

OEL Ranges Particles > 0.1 and < 1 mg/m3 > < 0.1 mg/m3 < 0.01 mg/m3 Vapors > 1 < 10 ppm > 0.1 < 1 ppm < 0.1 ppm Respiratory and Skin Sensitization GHS Hazard Category 1B (skin) 1B (resp.) 1A (skin) 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 Germ Cell Mutagenicity 2 1B 1A GHS Germ Cell Mutagenicity Hazard Statement Suspected of causing genetic defects May cause genetic defects GHS Germ Cell Mutagenicity “H” Codes H341 H340 Carcinogenicity GHS Carcinogenicity Hazard statement Suspected of causing cancer May cause cancer Carcinogenicity “H” Codes H351, H350 DRAFT

OEL Ranges Particles > 0.1 and < 1 mg/m3 > < 0.1 mg/m3 < 0.01 mg/m3 Vapors > 1 < 10 ppm > 0.1 < 1 ppm < 0.1 ppm Toxic to Reproduction GHS Hazard Category 2 1B 1A GHS Reproduction Hazard Statement Suspected human reproductive toxicant Known human reproductive toxicant Presumed human. reproductive toxicant Known human reproductive toxicant. Reproduction “H” Codes* “Suspected of damaging fertility or the unborn child”—H361f, H361d, or H361fd “May damage fertility or the unborn child”—H360f, H360d, or H360fd Specific Target Organ Toxicity (Single Exposure) 2 (H371) 3 (H335 and H336) 1 GHS Hazard Statement May cause damage to organs May cause respiratory irritation; or May cause drowsiness or dizziness Causes damage to organs “H” Codes H371, H335, H336 H370 Specific Target Organ Toxicity (Repeated Exposure) May cause damage to organs <...> through prolonged or repeated exposure <<...>> Causes damage to organs <...> through prolonged or repeated exposure <<...> H373 H372 DRAFT

Example #1 Folpet White crystal, powder, or granule
Used as a fungicide for deciduous fruit, vegetables, and ornamental plants No OEL exists, but serious potential health effects To demonstrate the Occupational Exposure Banding process, let’s walk through an example chemical. Folpet is a white crystal, powder or granule. It is a leaf protecting fungicide and is often used on fruits, vegetables, flowers, and other plants. Exposure to folpet has the potential to lead to serious health effects, but there is currently no OEL.

Tier 1 Example: Folpet Workers involved in mixing, loading and applying folpet may be occupationally exposed Some qualitative and quantitative data exist, but… No OEL exists Can be formulated into liquid, wettable powder, and solid forms Applied by dipping, soaking, or spraying Also used as a paint additive, wood surface treatment, and high volume spray Has been known to cause irritation to eyes, skin, respiratory tract Again, folpet is a powder but it can be formulated into a liquid and is applied to plants and other surfaces by dipping, soaking and spraying. Folpet is also used as a paint additive, in plastics, and on structural surfaces to prevent the growth of mildew. This application is sometimes done as a high volume spray, which leads to a huge potential for occupational exposure for workers who mix, load or apply folpet. The chemical is known to cause irritation to the skin, eyes, and respiratory tract. Like many other chemicals, Folpet has no OEL. The key here is that there is SOME qualitative and quantitative data that exists, which makes it a candidate for Occupational Exposure Banding.

Examples of Data SDS

Examples of Data National Library of Medicine

Reliable sources for Tier 1
GESTIS ECHA Annex VI to CLP

Does Tier 1 process solve everything?
No. But it does provide a quick and easy look at the chemical using a few information sources

Tier 1 Example: Folpet Step 1: Locate GHS H-codes and categories from recommended databases Search by name or CASN To begin our Tier 1 evaluation of folpet, the first step is to locate GHS hazard codes and classification.

Tier 1 Example: Folpet Step 1: Locate GHS H-codes and categories from recommended databases

Tier 1 Example: Folpet Folpet CAS: 133-07-3 H332 4 H319 2 H317 1 H351
Step 1 : Locate GHS H-codes and categories from recommended databases Folpet CAS: Health Endpoint Hazard Code Hazard Category H-code source Endpoint Band Acute Toxicity H332 4 GESTIS Skin Corrosion/Irritation Serious Eye Damage/ Eye Irritation H319 2 GESTIS Respiratory and Skin Sensitization H317 1 Germ Cell Mutagenicity Carcinogenicity H351 2 GESTIS Toxic to Reproduction Specific Target Organ Toxicity M

Tier 1 Example: Folpet Step 2: Determine corresponding band with NIOSH Tier 1 OEB Criteria Chart Endpoint Band C D E OEL Ranges Particles > 0.1 and < 1 mg/m3 > < 0.1 mg/m3 < 0.01 mg/m3 Vapors > 1 < 10 ppm > 0.1 < 1 ppm < 0.1 ppm Acute Toxicity GHS Hazard Category 3, 4 2 1 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 H301, H302, H331, H332, H311, H312 H300, H330, H310 Skin Corrosion/Irritation 1A, 1B, 1C Skin corrosion / irritation GHS Hazard statement Causes skin irritation. Causes severe skin burns and eye damage. Skin corrosion / irritation “H” Code H315 H314

Tier 1 Example: Folpet Folpet CAS: 133-07-3 C H332 4 H319 2 H317 1
Step 2: Determine corresponding band with NIOSH Tier 1 OEB Criteria Chart Folpet CAS: Health Endpoint Hazard Code Hazard Category H-code source Endpoint Band Acute Toxicity H332 4 GESTIS C Skin Corrosion/Irritation Serious Eye Damage/ Eye Irritation H319 2 GESTIS Respiratory and Skin Sensitization H317 1 Germ Cell Mutagenicity Carcinogenicity H351 2 GESTIS Toxic to Reproduction Specific Target Organ Toxicity

Tier 1 Example: Folpet Folpet CAS: 133-07-3 H332 4 C H319 2 H317 1 D
Step 2: Determine corresponding band with NIOSH Tier 1 OEB Criteria Chart Folpet CAS: Health Endpoint Hazard Code Hazard Category H-code source Endpoint Band Acute Toxicity H332 4 GESTIS C Skin Corrosion/Irritation Serious Eye Damage/ Eye Irritation H319 2 GESTIS Respiratory and Skin Sensitization H317 1 D Germ Cell Mutagenicity Carcinogenicity H351 2 GESTIS E Toxic to Reproduction Specific Target Organ Toxicity

Most conservative band:
Tier 1 Example: Folpet Step 3: Select the most conservative band as the Tier 1 OEB Folpet CAS: Health Endpoint Hazard Code Hazard Category H-code source Endpoint Band Acute Toxicity H332 4 GESTIS C Skin Corrosion/Irritation Serious Eye Damage/ Eye Irritation H319 2 GESTIS Respiratory and Skin Sensitization H317 1 D Germ Cell Mutagenicity Carcinogenicity H351 2 GESTIS E Toxic to Reproduction Specific Target Organ Toxicity Most conservative band: Band E Melissa- I assume that there wasn’t any infor for the other endpoints? If yes, please fill that in, maybe shading it grey? No, there was no information on those endpoints. I shaded it grey.—mgs

Based upon the Tier 1 banding process,
the chemical should be in Band E Tier 2 could be completed.

Banding Chemicals in Tier 2

Tier 2 Tier 2 - Semi-Quantitative Skilled industrial hygienist
Based on readily available secondary data from authoritative sources (government, professional health agencies, authoritative toxicological benchmarks) Needs sufficient data to generate reliable OEB Prescriptive analytical strategy to ensure consistency Potential for chemicals to moved from the Tier 1 OEB to a more or less protective OEB Tier 2 is a semi-quantitative approach that requires that the user do a thorough search of several publically accessible databases in order to retrieve hazard information. Tier 2 is performed by a skilled IH or toxicologist, and relies heavily on information gathered from secondary data sources. Examples of these sources are from the government (like CDC and EPA), and professional health agencies. Tier 2 also has a threshold for data sufficiency, meaning that if there isn’t enough information available, a Tier 2 evaluation cannot be performed. The strategy for performing Tier 2 is prescriptive and outlined in detail in our document to ensure that the results of the process are consistent among users. After a Tier 2 evaluation, there is potential for a chemical to be moved into a more or less protective band from the Tier 1 OEB. As previously mentioned, the Tier 2 band is more reliable than a Tier 1 band.

What is Tier 2? Tier 2 is an additional level of analysis used when:
there are no GHS H codes the outcome of the Tier 1 analysis is incomplete, or an insufficient reflection of the health potency of the chemical

What is Tier 2? Tier 2 is based on the findings for eight standard toxicological endpoints and/or health outcomes: acute toxicity skin corrosion and irritation serious eye damage and irritation respiratory and skin sensitization germ cell mutagenicity carcinogenicity reproductive/developmental toxicity target organ toxicity resulting from repeated exposure

DRAFT Acute Toxicity Technical Criteria Band A B C D E
Oral Toxicity LD50 (mg/kg bodyweight) >2000 >300 and ≤ 2000 >50 and ≤ 300 >5 and ≤ 50 ≤ 5 Dermal Toxicity LD50 (mg/kg bodyweight) > 2000 >1000 and ≤ 2000 >200 and ≤ 1000 >50 and ≤ 200 Inhalation Gases (ppmV/4h) LC50 > 20000 >2500 and ≤ 20000 >500 and ≤ 2500 >100 and ≤ 500 ≤ 100 Inhalation Vapors (mg/liter/4h) LC50 > 20.0 >10.0 and ≤ 20.0 >2.0 and ≤ 10.0 >0.5 and ≤ 2.0 ≤ 0.5 Inhalation Dusts and Mists (mg/liter/4h) LC50 > 5.0 >1.0 and ≤ 5.0 >0.5 and ≤ 1.0 >0.05 and ≤ 0.5 ≤ 0.05 DRAFT Here is a example of our tier 2 criteria for Acute toxicity. Remember that there are 8 total health endpoints, so this is just the criteria for one of those eight. For acute toxicity, the endpoint specific band is based on LD50 values retrieved from secondary data sources. Those values are compared to this criteria, and an endpoint specific band is assigned.

What is Tier 2? Some of the endpoints draw on categorical health outcomes (mild, moderate, severe) Others are based on quantitative toxicity information and/or potency data (LD50s, LC50s, NOAELs)

Tier 2 Banding Principles
7/8/2014 Tier 2 Banding Principles For 8 specified health endpoints, search authoritative databases for summary toxicity information Collate results for each endpoint Find a Total Determinant Score and/or Occupational Exposure Band (this is done automatically in the electronic spreadsheet) There are a number of important principle for Tier 2. For each of the 8 endpoints, a search of the authoritative databases must be completed in order to gather summary toxicity information. Once information on each endpoint is gathered, a TDS and an OEB is assigned. 10/20/2014

Total Determinant Score
Total determinant score (TDS) = weighted average indicating the presence/absence of data for a specific health endpoint. Example: a cancer inhalation unit risk value tells us a lot about the hazardous nature of a chemical, so the presence of that information corresponds to a TDS of 30. However, an LD50 value is only weighted as a TDS of 5. The sum of all health endpoint TDSs must be at least 30 for a chemical to be banded in Tier 2. The TDS is an indication of the presence or absence of data. It essentially tells the user whether or not there is enough data to make a decision about the potency of the chemical in question. Different types of data contribute to the TDS differently. For example, an cancer IUR (which is a quantitative potency measure of cancer risk) describes a lot about hazardous nature of a chemical, so the presence of this information contributes 30 points to the TDS. An LD50 value only contributes 5 points. 10/20/2014

Tier 2: Step 1: Folpet Examples Check Key Sources for Data Availability
Rank Source Y/N Strategy 1. Sources of toxicity benchmarks for banding according to systemic toxicity (RE) (layer 1) EPA/IRIS If Y: Document the animal-specific NOAELs for each toxicity benchmark (layer 1). Precludes searching for other resources in Rank 2 sources. If N: Search for other toxicity benchmarks in Rank 2 sources (layer 2). ATSDR Health Canada CalEPA 2. Potential sources of acute toxicity, incidence information, and benchmarks for systemic toxicity (layer 2) HSDB List all available findings in the worksheet according to the rules for each endpoint. IPCS IUCLID REACH 3. Sources for median lethal doses/concentrations (only) ChemID List all available values in the worksheet according to the rules Lewis So let’s do an example of Tier 2… The first step is to check your key sources to see if there is data available for the chemical.

Step 2: Collect data (source by source) EPA IRIS Search for Folpet, Carcinogenicity Data
The second step is to collect the critical information from each of the sources. Here we have pictured a screenshot of the EPA IRIS database. Here we search alphabetically and select the IRIS summary for folpet.

Banding According to Carcinogenicity

Slope Factors (mg/kg-day)−1 Assigned Band ≥ 10 E <10 but ≥ 0.01 D < 0.01 C From the IRIS summary, you can easily pull up relevant cancer data for folpet. From this screenshot, you can see that the oral slope factor for Folpet in mg/kg/day. The user enters this information into the worksheet, and that slope factor is compared to the NIOSH criteria (click) shown here. Our process determines the appropriate band based on where the oral slope factor falls within our criteria. For this example, the endpoint specific band for cancer is C.

Putting it all together
7/8/2014 Putting it all together Each endpoint subscore is summed to find the Total Determinant Score (TDS). Banding is only valid if there is a TDS of 30 or greater. UNLESS, if any individual valid endpoint band corresponds to band E, the overall band is determined to be band E, regardless of the TDS. This can only be modified by a Tier 3 assessment. The Tier 2 worksheet will calculate This same process is repeated for all 8 endpoints. An endpoint specific band is assigned based in on the toxicity data that is input into the spreadsheet and a predetermined value for TDS is assigned for each endpoint if there is data for that endpoint available. Each endpoint subscore is summed to find the TDS. The TDS must be 30 or greater to assign a band, unless any one individual valid health endpoints corresponds to band E. In that case, the information is considered sufficient to band the chemical into E, which is the most protective band. This sounds very complicated, but the Tier 2 worksheet will calculate all of this for you. I’ll give you a sneak peek into how the spreadsheet works. 10/20/2014

(30 points possible) Band A Band B Band C Band D Band E EPA IRIS Weight Of Evidence EPA IRIS Slope Factor X EPA IRIS Inhalation Unit Risk Health Canada TD05 Health Canada TC05 California Slope Factor California Inhalation Unit Risk Other cancer (Layer 2) Information manually entered into worksheet is electronically matched to NIOSH technical criteria and populated into final worksheet Going back to our example, we learned that the Slope Factor according to EPA IRIS corresponds to Band C in the NIOSH criteria. (click) That information manually entered into the worksheet is electronically matched to our criteria and populated into a separate worksheet.

As additional data for other endpoints is entered, the Tier 2 band selection adjusts based on the most conservative band. In this summary worksheet, you can see that the information from the user input is used to determine an endpoint specific band and total determinant score. In this example, the cancer data is seen here (click). Based on the slope factor that the user entered, the endpoint specific band for cancer is C and the Tier 2 band for the chemical is C.

Final Tier 2 Band: Band D Final Band Selection Chemical: Folpet
CAS Number: Endpoint/Toxicity parameter Most conservative band represented by the data Determinant Score Endpoint-specific band selection (Score for the presence of data) A B C D E Cancer potential WOE (U.S. EPA) (20 for qualitative info, 30 for quantitative) SF (U.S. EPA) 30 IUR (U.S. EPA) TD05 (Health Canada) TC05 (Health Canada) California Slope Factor California Inhalation Unit Risk Determinant sub-score (cancer) Reproductive (30) Target organ toxicity (repeat exposure) RfD (U.S. EPA) D (Layer 1)a RfC (U.S. EPA) (30) MRL (ATSDR) TDI (Health Canada) TC (Health Canada) Data on reproductive and developmental toxicity (Layer 2)b Other DNELs (oral) Other DNELs (inhale) Determinant sub-score (systemic toxicity) Genotoxicity (5) 5 Respiratory sensitization (10) Skin sensitization (5) Acute Toxicity (5) LD50 (oral) LD50 (dermal) LC50 (gases) LC50 (vapors) LC50 (dusts/mists) Determinant sub-score (acute toxicity) Skin irritation/corrosion (5) Eye irritation/corrosion (5) TDS (Threshold for sufficient data = 30) 125 Yes, assign Tier 2 band Tier 2 Band selection Final Tier 2 Band: Band D When all of the information is entered, and endpoint specific band is assigned for each health endpoint that is relevant to the chemical, and the presence of each data point contributes to the TDS. (click) The final band is D and the TDS is 125.

Tier 2 Band After a Tier 2 evaluation, the chemical is assigned Band D. Tier 1 uses a very conservative approach, due to fewer data requirements. By performing a Tier 2 evaluation, the user can incorporate quantitative data and refine the band assignment. Following Tier 2, an additional level of evaluation can be performed if the necessary data and user expertise are available.

Tier 3 Tier 3 - Toxicologist or experienced industrial hygienist
Determine the critical study from which a scientifically sound point of departure (POD) can be determined Quantitative risk assessment to determine OEB/OEL

Tier 2 User Check Approximately 115 chemicals were selected:
EPA IRIS database The TLV “Under Study” List MAK list of “Substances for which no MAK value can be established at present” Health Canada Validation Exercise: Divided into 2 groups (New Users and Experts) Completed significant training in Tier 2 OEB process Assigned chemicals randomly Provided draft guidance document, paper submittal sheets and Electronic Tool Compared the banding results from multiple users for seven health endpoints

Issues identified in Tier 2 Evaluations
Inappropriate conversion of units Confusion of respiratory irritation with respiratory sensitization Trawling for information in sources other than those specified in the methodology Need for Toxicology Primer

Next Steps Evaluate how validation staff conducted reviews and identify where confusion occurred in the details Improve criteria and guidance document Peer review and Public Comment Computer tools

Expected project outputs
NIOSH guidance Overall process, including the decision logic Tools to facilitate finding and evaluating hazard data and assign chemicals to hazard bands Electronic tools to help users create OEB online Education materials for H&S professionals, managers, emergency responders and workers

Acknowledgements CDC OPHPR Funding Bernard Gadagbui, Ph.D., DABT
Chuck Geraci, Ph.D. Steve Gilbert, M.S. Donna Heidel, M.S., CIH (formerly NIOSH) George Holdsworth, Ph.D. Thomas Lentz, Ph.D. Eileen Kuempel, Ph.D. Michael A. Maier, Ph.D., CIH, DABT Melissa Seaton, M.S. Christine Sofge, Ph.D. Christine Uebel, A.S. Lutz Weber, Ph.D., DABT CDC OPHPR Funding

Provide a business card or email LMcKernan@cdc.gov
Looking for Bandits Volunteer to help verify the NIOSH OEB decision logic Provide a business card or

Tier 1 Validation Compared bands obtained from Tier 1 process for 744 chemicals with full shift OELs from the following authoritative bodies: National Institute for Occupational Safety and Health (NIOSH) – Recommended Exposure Limits (RELs) Occupational Safety and Health (OSHA) – Permissible Exposure Limits (PELs) American Conference of Governmental Industrial Hygienists (ACGIH) – Threshold Limit Values (TLVs) American Industrial Hygiene Association (AIHA) – Workplace Environmental Exposure Levels (WEELs) California OSHA Program (Cal/OSHA) – PELs German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area – Maximale Arbeitsplatz-Konzentration (MAK, translated as Maximum Workplace Concentration)

Tier 1 Validation - criteria
Greater than 80% of Tier 1 bands at least as protective as the OEL The cut points for the Tier 1 vapor banding : Band A: > 100 ppm Band B: > 10 ppm and ≤ 100 ppm Band C: > 1 ppm and ≤ 10 ppm Band D: > 0.1 ppm and ≤ 1 ppm Band E: ≤ 0.1 ppm For example, if the OEL for a vapor is 5 ppm, then we want the Tier 1 band to be C (> 1 ppm and ≤ 10 ppm), D (> 0.1 ppm and ≤ 1 ppm), or E (≤ 0.1 ppm) so that there is a value in each of the Tier 1 bands at least as small as the OEL (1 ppm < 5 ppm, 0.1 ppm < 5 ppm, and 0.01 ppm < 5 ppm) Tier 1 bands, if assigned, can only be C, D, or E so they will always be at least as protective for chemicals with OELs that would fall into bands A, B, or C

76.7% of chemicals had Tier 1 Bands equally or more protective than corresponding OEL-based bands
23.3% of chemicals had Tier 1 Bands less protective than the corresponding OEL-based bands

Tier 1 Validation - Vapors
76.7% of chemicals had Tier 1 Bands equally or more protective than corresponding OEL-based bands 23.3% of chemicals had Tier 1 Bands less protective than the corresponding OEL-based bands

Greater than 80% of Tier 1 bands at least as protective as the OEL

Tier 1 Validation – Particulates
Greater than 80% of Tier 1 bands at least as protective as the OEL The cut points for particles: Band A: > 10 mg/m3 Band B: > 1 mg/m3 and ≤ 10 mg/m3 Band C: > 0.1 mg/m3 and ≤ 1 mg/m3 Band D: > 0.01 mg/m3 and ≤ 0.1 mg/m3 Band E: ≤ 0.01 mg/m3

Tier 1 Validation Results
84.7 % of chemicals had Tier 1 bands equally or more protective than the corresponding OEL-based bands 15.3% of chemicals had Tier 1 bands less protective than the corresponding OEL-based bands

Tier 1 Validation –Thoughts
The overall rate of Tier 1 bands being at least as protective as the OEL was 79.4% ( combined vapor and particulate) Recommend always doing a Tier 2 assessment since about 20% of the time the Tier 1 band is not as protective as the OEL Possible to skip the Tier 2 process if you get band E in Tier 1 Particles + vapors = 79.4

NIOSH Occupational Exposure Banding Decision Logic

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NIOSH Occupational Exposure Banding Decision Logic

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