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OCCUPATIONAL EXPOSURE BANDING
Donna S. Heidel, CIH, FAIHATechnical Director – Industrial Hygiene
NIOSH PROCESS
Adopted from NIOSH Occupational Exposure Banding Process
Guidance for the Evaluation of Chemical Hazards, external review
draft (March 8, 2017)
2
TODAY’S PRESENTATION MATERIALS
ORGANIZATION OF DOCUMENT
Executive Summary
Chapter 1: Introduction
Chapter 2: Tier 1 Banding Process
Chapter 3: Tier 2 Banding Process
Chapter 4: Tier 3 Procedures
Chapter 5: Special Issues in Occupational Exposure Banding
Chapter 6: Preliminary Evaluations of Tier 1 and Tier 2 Protocol
References
Appendix A: Helpful Information for Tier 1
Appendix B: Helpful Information for Tier 2
Appendix C: Examples
23
PROPOSED NIOSH OCCUPATIONAL EXPOSURE BANDS
Occupational
Exposure Band
Airborne Target Range for
Particulate Concentration
(mg/m3)
Airborne Target Range for Gas
or Vapor Concentration (ppm)
A >10mg/m3 >100 ppm
B >1 to 10 mg/m3 >10 to 100 ppm
C >0.1 to 1 mg/m3 >1 to10 ppm
D >0.01 to 0.1 mg/m3 >0.1 to 1 ppm
E ≤0.01 mg/m3 ≤0.1 ppm
31
HOW IS THE PROCESS ORGANIZED?
Bands are assigned based on the findings for nine standard toxicological endpoints:
acute toxicity
skin corrosion and irritation
serious eye damage and irritation
respiratory sensitization
skin sensitization
genotoxicity
carcinogenicity
reproductive/developmental toxicity
specific target organ toxicity resulting from repeated exposure
38
Tier 1 —GHS Hazard Codes
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— Secondary Data Sources
User: Properly trained 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—Expert Judgement
User: Toxicologist or experienced occupational hygienist
Tier 3 involves the integration of all available data and determining the degree of conviction of the outcome.
39
HOW TO COMPLETE THE OEB PROCESS
46
Pencil and PaperOnline using
draft NIOSH OEB e-tool
TIER 1
GHS hazard codes and categories provide the basis for Tier 1 criteria
Relatively low data requirements
Chemicals can be banded in bands C, D, and E
Chemicals are assigned Tier 1 OEBs based on severity and reversibility of effects
Tier 1 is useful as a screening tool, but Tier 2 is recommended if data and expertise are available
56
Chemical of interest has no OEL
Locate GHS hazard codes and categories in recommended databases
Compare hazard codes and categories with NIOSH criteria for each health endpoint
Assign band for each relevant health endpoint based on criteria
Assign a Tier 1 OEB for the chemical based on most protective endpoint band (C, D, or E)
TIE
R 1
OV
ERV
IEW
58
TIER 1 Criteria C D E
OEL RangesParticle > 0.1 to < 1 milligrams per cubic
meter of air (mg/m3)> 0.01 to < 0.1 mg/m3 < 0.01 mg/m3
Vapor > 1 to < 10 parts per million (ppm) > 0.1 to < 1 ppm < 0.1 ppm
Acute Toxicity
H301
Category 3 H300
Category 2
H300
Category 1H302
Category 4
H331
Category 3 H330
Category 2
H330
Category 1H332
Category 4
H311
Category 3 H310
Category 2
H310
Category 1H312
Category 4
Skin Corrosion/ IrritationH315
Category 2
H314
Category 1, 1A, 1B, or 1C
Serious Eye Damage/ Eye
irritation
H319
Category 2, 2A or 2B
H318
Category 1
Respiratory and Skin
Sensitization
H317
Category 1B
H317
Category 1 or 1A
H334
Category 1B
H334
Category 1 or 1A
GenotoxicityH341
Category 2
H340
Category 1, 1A or 1B
Carcinogenicity
H350
Category 1, 1A, or 1B
H351
Category 2
Toxic to ReproductionH361 (including H361f, H361d, and
H361fd)
Category 2
H360 (including H360f, H360d,
and H360fd)
Category 1B
H360 (including H360f, H360d,
and H360fd)
Category 1 or 1A
Specific Target Organ Toxicity
H371
Category 2
H370
Category 1
H373
Category 2
H372
Category 159
GHS CODES NOT USED IN BANDING
H200 codes (physical hazards)
H400 codes (ecological hazards)
H303, H304, H305, H313, H316, H320, H333, H335, H336, H362
Not occupationally relevant, OR
Not sufficient to affect the result of Tier 1 banding
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TIER 1 EXAMPLE: ABIETIC ACID
CAS# 514-10-3
Organic compound that occurs naturally in trees
Extracted from tree rosin, used for
Caulking ships
Treating bows on musical instruments
Depackaging integrated circuits from epoxy coatings
Known to be an allergen
Some qualitative and quantitative data exist, but…
No OEL exists
64
Chemical of interest has no OEL
Locate GHS hazard codes and categories in recommended databases
Compare hazard codes and categories with NIOSH criteria for each health endpoint
Assign band for each relevant health endpoint based on criteria
Assign a Tier 1 OEB for the chemical based on most protective endpoint band (C, D, or E)
TIE
R 1
OV
ERV
IEW
65
RELIABLE SOURCES FOR TIER 1
GESTIS SubstanceDatabase
www.dguv.de/ifa/gestis-database
ECHA Annex VI to CLP
66
Abietic acid CAS: 514-10-3
Health Endpoint Hazard Code Hazard Category H-code sourceEndpoint
Band
Acute Toxicity
Skin Corrosion/Irritation H315 2 GESTIS
Serious Eye Damage/ Eye Irritation H319 2 GESTIS
Respiratory and Skin Sensitization
Germ Cell Mutagenicity
Carcinogenicity
Toxic to Reproduction
Specific Target Organ Toxicity H335 3 GESTIS
TIER 1 EXAMPLE: ABIETIC ACIDLocate GHS H-codes and categories from recommended databases
70
Chemical of interest has no OEL
Locate GHS hazard codes and categories in recommended databases
Compare hazard codes and categories with NIOSH criteria for each health endpoint
Assign band for each relevant health endpoint based on criteria
Assign a Tier 1 OEB for the chemical based on most protective endpoint band (C, D, or E)
TIE
R 1
OV
ERV
IEW
71
TIER 1 Criteria C D E
OEL RangesParticle > 0.1 to < 1 milligrams per cubic meter of
air (mg/m3)> 0.01 to < 0.1 mg/m3 < 0.01 mg/m3
Vapor > 1 to < 10 parts per million (ppm) > 0.1 to < 1 ppm < 0.1 ppm
Acute Toxicity
H301
Category 3 H300
Category 2
H300
Category 1H302
Category 4
H331
Category 3 H330
Category 2
H330
Category 1H332
Category 4
H311
Category 3 H310
Category 2
H310
Category 1H312
Category 4
Skin Corrosion/ IrritationH315
Category 2
H314
Category 1, 1A, 1B, or 1C
Serious Eye Damage/ Eye irritationH319
Category 2, 2A or 2B
H318
Category 1
Respiratory and Skin Sensitization
H317
Category 1B
H317
Category 1 or 1A
H334
Category 1B
H334
Category 1 or 1A
TIER 1 EXAMPLE: ABIETIC ACIDCompare codes and categories with NIOSH Tier 1 OEB Criteria Chart
72
Abietic acid CAS: 514-10-3
Health Endpoint Hazard Code Hazard Category H-code sourceEndpoint
Band
Acute Toxicity
Skin Corrosion/Irritation H315 2 GESTIS CSerious Eye Damage/ Eye Irritation H319 2 GESTIS
Respiratory and Skin Sensitization
Germ Cell Mutagenicity
Carcinogenicity
Toxic to Reproduction
Specific Target Organ Toxicity H335 3 GESTIS
TIER 1 EXAMPLE: ABIETIC ACIDLocate GHS H-codes and categories from recommended databases
73
Abietic acid CAS: 514-10-3
Health Endpoint Hazard Code Hazard Category H-code sourceEndpoint
Band
Acute Toxicity
Skin Corrosion/Irritation H315 2 GESTIS CSerious Eye Damage/ Eye Irritation H319 2 GESTIS CRespiratory and Skin Sensitization
Germ Cell Mutagenicity
Carcinogenicity
Toxic to Reproduction
Specific Target Organ Toxicity H335 3 GESTIS no band
TIER 1 EXAMPLE: ABIETIC ACIDLocate GHS H-codes and categories from recommended databases
76
Chemical of interest has no OEL
Locate GHS hazard codes and categories in recommended databases
Compare hazard codes and categories with NIOSH criteria for each health endpoint
Assign band for each relevant health endpoint based on criteria
Assign a Tier 1 OEB for the chemical based on most protective endpoint band (C, D, or E)
TIE
R 1
OV
ERV
IEW
77
Abietic acid CAS: 514-10-3
Health Endpoint Hazard Code Hazard Category H-code sourceEndpoint
Band
Acute Toxicity
Skin Corrosion/Irritation H315 2 GESTIS CSerious Eye Damage/ Eye Irritation H319 2 GESTIS CRespiratory and Skin Sensitization
Germ Cell Mutagenicity
Carcinogenicity
Toxic to Reproduction
Specific Target Organ Toxicity H335 3 GESTIS no band
TIER 1 EXAMPLE: ABIETIC ACIDLocate GHS H-codes and categories from recommended databases
Most protective band:
Band C
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Based upon the Tier 1 banding process,
the chemical should be in Band C.
Tier 2 is recommended.
79
TIER 1 EVALUATION
Compared bands obtained from Tier 1 process for 744 chemicals with full shift OELs from
the following authoritative bodies:
NIOSH Recommended Exposure Limits (RELs)
OSHA – Permissible Exposure Limits (PELs)
ACGIH– Threshold Limit Values (TLVs)
AIHA – Workplace Environmental Exposure Levels (WEELs)
California OSHA Program (Cal/OSHA) – PELs
German Maximale Arbeitsplatz-Konzentration (MAK)
** Greater than 80% of Tier 1 bands at least as protective as the OEL
80
TIER 1 EVALUATION
The overall rate of Tier 1 bands being at least as protective as the OEL was
91.5% (combined vapor and particulate).
This exceeds our original goal of 80%.
It is recommended to proceed to Tier 2
GHS hazard codes may not be as up-to-date as the literature.
Some H-codes (e.g. Cancer codes) automatically lead to band E
83
TIER 2
Tier 2 – Both Qualitative and Quantitative
Some training in toxicology
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 be moved from the Tier 1 OEB to a more or less
protective OEB
86
Begin Tier 2 process
Search recommended databases for toxicity information
Compare data to NIOSH criteria for each health endpoint and assign endpoint band
Ensure that total determinant score is sufficient for banding
Assign a Tier 2 OEB for the chemical based on most protective endpoint band
TIE
R 2
OV
ERV
IEW
87
TOTAL DETERMINANT SCORE
Endpoint determinant score (EDS) = weighted score indicating the
presence/absence of data for a specific health endpoint.
Total determinant score (TDS) = sum of weighted scores for each health
endpoint. Overall score gives an indication of sufficiency of data for banding.
TDS ≥ 30: sufficient data for banding in Tier 2
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 for the acute toxicity endpoint is only weighted as a TDS of 5.
89
TOTAL DETERMINANT SCORE
Health EndpointEndpoint Determinant Score
(EDS)
Skin Irritation/Corrosion 5
Eye Irritation/Corrosion 5
Skin Sensitization 5
Acute Toxicity/Lethality (LD50 or LC50) 5
Genotoxicity 5
Respiratory Sensitization 10
Systemic Target Organ Toxicity (STOT-RE) 30
Reproductive and Developmental Toxicity 30
Cancer Weight of Evidence Descriptor 20 or 30
Cancer Quantitative Measures 30
Data Sufficiency/Total Determinant Score (TDS) 30/125
90
TIER 2 EXAMPLE:
BANDING CANCER ENDPOINT
Main sources of information relevant to Cancer
93
For Cancer, both Qualitative and Quantitative Data are used
Qualitative data:
Looking for Carcinogen Classifications – also known as “Weight of Evidence” descriptors
Endpoint (Carcinogenicity) Band based on Carcinogen Classification
TIER 2 EXAMPLE:
BANDING CANCER ENDPOINT
95
QUALITATIVE (WOE) CANCER BANDING CRITERIA
TIER 2 EXAMPLE: BANDING CANCER ENDPOINT
96
EXAMPLE: BANDING CANCER ENDPOINT
Quantitative data:
Quantitative measures of potency
Slope factors, inhalation unit risks or tumorigenic concentrations
When we have both, quantitative data supersedes qualitative data
98
QUANTITATIVE CANCER BANDING CRITERIA
TIER 2 EXAMPLE: BANDING CANCER ENDPOINT
99
EXAMPLE: TIER 2
Chemical name: Benzo(k)fluoranthene
CAS #: 207-08-9
Found in fossil fuels
Occurs ubiquitously in products of incomplete combustion.
Detected in:
cigarette smoke
gasoline engine exhaust
emissions from burning coal and from oil-fired heating
Lubricating/motor/crude oils
Found in soil, surface waters, and groundwater at hazardous waste sites.
No OELSource: Department of Energy, Risk Assessment Information System
114
TIER 2 SOURCES OF DATA
Rank 1
Rank 2
116
121
TIER 2 WORKSHEETNTP Reasonably
anticipated to be
human carcinogen
124
NIOSH QUANTITATIVE CANCER CRITERIA
(oral)
SF: 1.2 (mg/kg day)-1
IUR: 1.1x10-4 (ug/m3)-1
126
TIER 2 WORKSHEET
NTP, EPA IRIS, IARC
Qualitative
data
1.2 (mg/kg day)-1
1.1x10-4 (ug/m3)-1
127
SUMMARY OF BENZO(K)FLUORANTHENE CARCINOGENICITY
Qualitative (WOE): band E
Quantitative (IUR): band D
Quantitative data takes precedence over qualitative, so
Tier 2 Carcinogenicity = band D
EDS = 30128
Chemical Name: Benzo (k) fluoranthene
CAS: 207-08-9
Endpoint Data EDS Endpoint Band
Acute ToxicitySource:
Skin Corrosion/IrritationSource:
Serious Eye Damage/ Eye IrritationSource:
Respiratory SensitizationSource:
Skin SensitizationSource:
GenotoxicitySource:
CarcinogenicitySource: California Slope Factor
30 D
Reproductive ToxicitySource:
Specific Target Organ ToxicitySource:
OVERALL Tier 2 BAND TDS =
1.2 (mg/kg day)-1
129
Continue process with remaining endpoints
Chemical Name: Benzo (k) fluoranthene
CAS: 207-08-9
Endpoint Data EDS Endpoint Band
Acute ToxicitySource:
Skin Corrosion/IrritationSource:
5 C
Serious Eye Damage/ Eye IrritationSource:
5 C
Respiratory SensitizationSource:
Skin SensitizationSource:
GenotoxicitySource: NTP
5 E
CarcinogenicitySource: California Slope Factor
30 D
Reproductive ToxicitySource:
Specific Target Organ ToxicitySource:
OVERALL Tier 2 BAND TDS =
1.2 (mg/kg day)-1
1 positive result
Irritation, severity unspecified
REACH
Irr., photosensitivity severity unspecified
HSDB
130
Chemical Name: Benzo (k) fluoranthene
CAS: 207-08-9
Endpoint Data EDS Endpoint Band
Acute ToxicitySource:
Skin Corrosion/IrritationSource:
5 C
Serious Eye Damage/ Eye IrritationSource:
5 C
Respiratory SensitizationSource:
Skin SensitizationSource:
GenotoxicitySource: NTP
5 E
CarcinogenicitySource: California Slope Factor
30 D
Reproductive ToxicitySource:
Specific Target Organ ToxicitySource:
OVERALL Tier 2 BAND TDS = 45
1.2 (mg/kg day)-1
1 positive result
Irritation, severity unspecified
REACH
Irr., photosensitivity severity unspecified
HSDB
132
TDS=45
TDS>30
Data sufficiency reached
Chemical Name: Benzo (k) fluoranthene
CAS: 207-08-9
Endpoint Data EDS Endpoint Band
Acute ToxicitySource:
Skin Corrosion/IrritationSource:
5 C
Serious Eye Damage/ Eye IrritationSource:
5 C
Respiratory SensitizationSource:
Skin SensitizationSource:
GenotoxicitySource: NTP
5 E
CarcinogenicitySource: California Slope Factor
30 D
Reproductive ToxicitySource:
Specific Target Organ ToxicitySource:
OVERALL Tier 2 BAND TDS = 45 E
1.2 (mg/kg day)-1
1 positive result
Irritation, severity unspecified
REACH
Irr., photosensitivity severity unspecified
HSDB
134
Final Tier 2 band for benzo (k) fluoranthene is Band E, on the
basis of genotoxicity
4
3