Center for Tobacco Reference Products Update on 1R6F Production

and Proficiency Testing ProgramSeptember 20, 2015

Naples, FL

Funding for this presentation was made possible, in part, by the Food and Drug Administration through grant RFA-FD-14-001. The views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

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Center for Tobacco Reference Products Goals

• Develop and Provide Certified Tobacco Reference Products

• Establish Proficiency Testing Program• Enhance CTRP Tobacco Research Capability

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• 50 million cigarettes

• 8 production days (23 shifts)

• Contract analysis for HPHCs and physical parameters

• CTRP certificate of analysis• Without the certificate, the material

however costly its production, is valueless (ISO Guide 31)

Status of 1R6F Production/Certification

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University of Kentucky Center for Tobacco Reference Products

Certified Reference Material Certificate of Analysis

Certificate Number: 2015-001CTRP Certification Date: 10/__/2015

Description of CRM Blended Cigarette, unflavored, 84 mm length Lot/Batch Number 1R6F Major starting materials Flue-cured 34%, Burley, 24%, Oriental 12%, Reconstituted 20%, Expanded Flue-cured 7%, and Expanded

Burley 3%. Humectants added to total blend at 8-9% (Isosweet 6.3%, glycerin, 1.7%, propylene glycol 1%) Matrix Tobacco blend

Interpretation of Data

1. Certified values listed below reflect analysis results submitted by ISO 17025-accreditted laboratories using a combination of methods and instrumentation that emulate actual; methods and instrumentation techniques currently utilized in the analysis of given parameters in the analytical community

2. The “Uncertainty” is a combined uncertainty of the CRM as dictated by ISO Guide 35 (2006) using a coverage factor, k = 2.

1R6F Reference Cigarette Certified Values and Uncertainties

International System for Standardization (ISO) Smoking Regime Parameter Certified Value Uncertainty Unit Number of

accepted sets of results, p

Total Particulate Matter (TPM) Tar CO Nicotine Puff counts

1R6F Reference Cigarette Certified Values and Uncertainties

Health Canada Intense (HCI) Smoking Regime Parameter Certified Value Uncertainty Unit Number of

accepted sets of results, p

Total Particulate Matter (TPM) Tar CO Nicotine Puff counts

Draft

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Current Stocks Tobacco Reference Products

• 1R6F stocks ~50 million• 3R4F stocks ~16 million• 1A1, 1A2, 1A3, 1A4, 2R1, 2R1F, 2R4F, 1R1, 1R2, 1R3,

1R3F, 1R4F, 2A1, 4A1, 1R5F

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Additional tobacco reference products

• 1R6F and 1R5F ground filler• Ground burley, flue-cured, dark air-cured, dark

fire-cured and oriental tobacco• 2R5F ultra-low delivery

certified reference cigarette• Non-ventilated certified

reference cigarette

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• Must be registered user of CTRP website: https://ctrp.uky.edu

• Only authenticated users can order products

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Proficiency Test OrderingProtocol and Data Template is Downloaded from Website

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Report template

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Data Submission Step 1• Login to website and locate the proficiency test• Click “Submit Data”

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Data Submission Step 2• Upload Excel file with data• Review and Confirm data values

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Data Submission Step 3Any time after data submission, you can view the data that was submitted, but it cannot be changed.

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Planned Testing Parameters

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Planned Testing Rounds

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Proficiency Pilot Design

• 22 labs with linear machines• 13 labs with rotary machines• 6 Parameters: TPM, Carbon Monoxide, Nicotine,

Water, NFDPM (Tar), & Puff Count• Both ISO & Intense Measures• 5 replicates per measure per machine

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Next Proficiency Round

• New certified reference cigarette--1R6F • PT samples--subgroup 1R6F

(1,000,000 cigarettes)• The homogeneity testing of PT samples

will be done before shipping samples

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Topics for Discussion• Terms and Conditions; Data ownership

• The need for an interim report

• Protocol evaluation

• PT study cost

• 1R6F sub-batch for PT studies; homogeneity assessment

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CTRP Team

Statistics:Brent SheltonStacey SloneSocrates CaneteAndrew Shearer

Informatics:Eric DurbinIsaac HandsBront DavisJennifer Gregory

Operations:Orlando ChambersLing YuanAnne JackElizabeth ViceErin PyrekMatt CraftJames Hall

Advisory Committee:Ling YuanGeorge WagnerBrent SheltonLowell BushDavid OrrenDavid AtwoodMary HarbourRobert MillerEric Durbin

Analytics:Huihua JiSocrates CaneteLowell BushYing WuLaura FentonCassandra HaleNeil Fannin

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Contact Information:

Orlando Chambersochamb@uky.edu

Huihua Jihji4@uky.edu

Socrates CaneteSocrates.Canete@uky.edu

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