Impact of Cigar Physical Variability on Cigar Exposure ... · Impact of Cigar Physical Variability...

Impact of Cigar Physical Variability on Cigar Exposure using Probabilistic Risk Assessment

ITG Brands Product Science

Greensboro, NC USA

F. Ayala-Fierro, K. Kosaraju, R. Stevens

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Cigars are unique tobacco products that come in wide variety of sizes:

length, diameter and weight. They can be separated into two categories,

Premium and Mass Market Cigars (MMCs)

• Natural variability in tobacco leaves and shapes

The variations in cigar size influence exposure by oral and inhalation

routes

MMC cigar smokers are typically dual users of cigars and conventional

cigarettes and practice partial smoking and re-lighting (CDC/CTP 2014)

• However, only 35.1% premium cigar smokers display dual use

Cigarillo consumption varies widely from as few as 1 per week to daily

consumption which determines total smoking time (days/year)

2017 CORESTA SSPT 8-12 October 2017

Cigar Variability

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Risk = Hazard x Exposure


Risk = Hazard x Exposure

Non-Carcinogenic = Analyte x Exposure

Carcinogenic

Inhalation Exposure (Lifetime Average Daily Intake):

LADI= (C x CpW x CW x ED x EF)/ (BW x DIR x AT x CF)

C: Constituent yield; CpW: cigars per week; CW: cigar weight; ED: exposure duration; EF: exposure

frequency; BW: body weight; DIR: daily inhalation rate; AT: averaging time

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PRA employs a probability based approach to address the contribution

of variability and uncertainty around assumptions used to estimate the

overall risk

Carcinogenic: Incremental Lifetime Cancer Risk, ILCR

Non-carcinogenic: Hazard Quotient, HQ

Probabilistic Risk Assessment (PRA)


QRA: Point estimates PRA: Probabilistic distribution

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Variable Likeliest Value Distribution (Min,Max) Reference

C Variable Mean ± S.D. CRM-64 HPHC yield (µg/g cigar)

CpW* 6 cigars/week BetaPERT (1-58) 6 units per week; internal survey data

CW* 9.85 g/cigar Lognormal (-18.56, 9.85,4.01) Public literature data

ED 32 years BetaPERT (7-70) Santamaria 2016

EF 52 weeks/year NA Default value

AT 11,680 days BetaPERT (2,555-25,550) 32 yrs x 365 days

DIR 193.99 L/kg-d Gamma (31.27, 2.46) CalEPA (2003)

CF 0.001 m3/L NA Conversion factor

BW 84.6 kg Lognormal (0, 4.44,0.23) NHANES 2013/2014

Exposure Variables for PRA


Variables are proposed for method validation purposes

*Variables are adjusted for each type and category of cigar

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Cigar Weight


Publically available data

Data points do not represent all type/category of cigars.

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Smoke Data for Selected Constituents


Smoke Constituent

[Yield]

Commercial Product 1

(2.39 ± 0.15 g)

Commercial Product 2

(2.28 ± 0.18 g)

µg/cigar µg/g tobacco µg/cigar µg/g tobacco

Acetaldehyde 2740 ± 203 1148 ± 84.9 2380 ± 359 1046 ± 157.6

Formaldehyde 17.1 ± 4.5 7.15 ± 1.9 18.9 ± 3.7 8.3 ± 1.6

NNN 0.469 ± 0.076 0.197 ± 0.032 0.571 ± 0.074 0.251 ± 0.032

Ammonia 44.5 ± 4.2 18.7 ± 1.7 57.9 ± 9.8 25.4 ± 4.32

Products are similar in manufacturing specs

CORESTA (CRM-64) - for method-validation purposes

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PRA Exposure Estimates


Smoke Constituent

[Yield]

Commercial Product 1 Commercial Product 2

Median 5th – Mean – 95th Median 5th – Mean – 95th

Acetaldehyde 723 99.6 – 1165 – 3720 646 87.8 – 1059 – 3357

Formaldehyde 4.34 0.56 – 7.24 – 23.3 5.09 0.69 – 8.41 – 27.3

NNN 0.12 0.02 – 0.2 – 0.64 0.16 0.02 – 0.25 – 0.82

Ammonia 11.8 1.62 – 18.9 – 60.7 15.8 2.17 – 25.7 – 83.3

LADI, Lifetime Average Daily Intake in µg/m3

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PRA Exposure Estimate - Acetaldehyde


Contribution to Variance (%): Acetaldehyde

Variable CP1 CP2

CW 50.3 49.8

CpW 17.7 17.4

ED 13.1 12.6

AT -12.3 -12.1

BW -3.9 -4.0

DIR - 2.0 -2.0

Other 0.6 0.9

1200

1000

800

600

200

400

CP1 CP2

Ac

eta

lde

hyd

e (

µg

/g)

1059 1164

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PRA Exposure Estimate - Formaldehyde


Contribution to Variance (%): Formaldehyde

Variable CP1 CP2

CW 47.3 48.9

CpW 16.7 17.1

ED 12.7 12.8

AT -11.5 -12.0

BW -3.7 -3.7

C (Formaldehyde) 5.9 3.4

Other 1.0 1.0

CP1 CP2

9

7

5

1

3

Fo

rma

lde

hyd

e (

µg

/g)

8.41 7.24

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PRA Exposure Estimate – NNN


Contribution to Variance (%): NNN

Variable CP1 CP2

CW 49.2 50.0

CpW 17.4 17.5

ED 12.8 13.0

AT -12.3 -12.4

BW -3.9 -3.8

C (NNN) 2.3 - -

DIR - - -1.9

Other 1.0 0.4

NN

N (

ng

/g)

250

200

150

50

100

CP1 CP2

0.25 0.2

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PRA Exposure Estimate – Ammonia


Contribution to Variance (%): Ammonia

Variable CP1 CP2

CW 50.1 49.2

CpW 17.7 17.2

ED 13.1 12.8

AT -12.3 -12.1

BW -3.9 -3.9

C (Ammonia) - - 2.6

DIR - 2.0 -0.1

Other 0.8 - -

25

20

15

5

10

CP1 CP2

Am

mo

nia

(µ

g/g

)

25.7 18.9

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Comparison of analyte point concentrations showed that two MMC cigar

products might be associated with different risk

However, a comparison of probability distributions of exposures showed no

significant differences for exposure estimates

Exposure estimates are mostly attributed to variability associated with the

parameters of exposure: cigar physical variability, CW; cigar consumption,

CpW; and exposure duration, ED

PRA is a good tool when comparing exposure of two products to better

understand the contribution of variability and uncertainty associated with

exposure/risk assessment

Conclusions


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Impact of Cigar Physical Variability on Cigar Exposure ... · Impact of Cigar Physical Variability...

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