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

62

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

78

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