N. Davis Esq., T.G. Mitchell TGM/BTM 1 May 1991 Product Contamination As requested I have drafted a short guidance note on the above topic and have formulated a list of questions for consideration in Production Reviews. Both are attached. T.G. Mitchell Aft. cc: D.J. Stimson Esq., 9b -tz~- C) (z) (-n -14 L4 co BATCo document for Legal Services : Health Canada 20 October 1999 PRODUCT CONTAMINATION Contaminants can occur in tobacco products from a diversity of sources including the tobacco itself, the other components as well as from attrition of equipment or accident during processing. It is also a possibility that it can arise from deliberate intent. Major incidents of contamination are usually obvious and will cause automatic reaction and assessment. Such occasions may arise from equipment failure (e.g. large pieces of belting becoming integrated With the product flow, or valve failure leading to gross oil spillage). 1101 Small incidents, either in occurrence or due to very small amounts of contaminant being present, will be unlikely to cause immediate disruption of production and may then pass unnoticed until the product is consumed. Despite their relative size, these effects can be potentially very damaging in causing off-taste or other physical sensations on smoking, whilst even the visual impact of grease spots or inclusions in cigarettes can weaken confidence. It is essential that contamination of our products is minimised at all times. To achieve this requires the constant cooperation and vigilance of all involved in production operations. This includes all stages from leaf and material purchase to processing, packing and distribution. Attention is drawn to the following as potential sources of product contamination: a) Off-type tobacco - mouldy or discoloured tobacco occurring on the outer faces of cases or hogsheads of leaf, cut tobacco or reconstituted tobacco. b) Foreign matter in tobacco: metals, plastic or other items in tobacco from auction floors or in GILT processing. c) Contamination occurring in primary or secondary processing from machinery wear - metallic fragments, plastic orfabrics from guards, skips, belting, selvedges, flaps. d) Minor components in casings, flavours, wrapping materials etc., or contamination occurring in stores. (-n BATCo document for Legal Services: Health Canada 20 October 1999 e) Inclusion of non-tobacco wastes in materials being recycled. f) Foreign matter from its presence in the production area, such as food, drink, confectionery or wrappings from them. Production controls should ensure that all the above areas, and others as they are identified, are monitored on a regular basis and changes made as necessary to minimise their occurrence. is BATCo document for Legal Services : Health Canada 20 October 1999 PRODUCTION REVIEWS Issue: Product Contamination 1. Leaf - GLT Is leaf inspected for evidence of mould or discolouration? Are there rules abouts its removal or use? If removed is it destroyed or discarded? Is GLT waste sent for reconstitution? If so, is it screened for waste or standards applied for foreign matter content? Is total volume of foreign matter removed recorded and monitored? If so, what action is taken when this changes? 2. GLT - Machinery Is physical state monitored, particularly fabrics and beltings, against possibility of particles contaminating product stream? How frequent is this inspection? Are replacement parts (particularly flaps and similar items) specified in accordance with company recommendations? (Technical Services). 3. PMD Is leaf (strips, stem, recon, expanded) inspected for foreign matter (mould, discoloured material, rubber, plastic etc.) on receipt? What sorting ortrapping systems are in place to preventforeign matterentering product stream? (separators, magnets). Is factory equipment inspected regularly for wear and tear to ensure early action on preventing foreign matter addition? -:tl. C) CD Un "Ni Xh. BATCo document for Legal Services : Health Canada 20 October 1999 AreaU replacement items specified as "tobacco compatible"for their particular application? (flaps etc., paints, metal finishes, oils and greases)? (recornmendations of Technical Services). 4. Purchasing Are all casing ingredients of specified grade (i.e. food quality)? Have all casing and flavour ingredients received AMGP approval? Are wrapping materials AMGP approved and of defined quality (e.g. food contact minimum)? S. Cigarette manufacture, recovery Is foreign matter occurrence monitored in any way? What action is taken should it be recorded? (Splicing tapes). 6. Cigarette recovery Is "foreign matter" in recovered tobacco monitored (paper, filter material including carbon etc.) and controlled? 7. Distribution, consumption Are complaints monitored to determine possible incidents of contamination? How are they followed up? 4::~b C) 4t:b r-Q BATCo document for Legal Services : Health Canada 20 October 1999 400574143 CD CD CD CD m 0 0 CD CP C4 1 -~=4 cc -J E 0 m 0 RZSTRICTED PRODUCTIOW REVIEW CpxpxXT F Ac TOR Y D A T E PRODUCTION PLANNING AND DZVZLOPMZNT XILLBARK D J 8 -t~b C) 4ZD Qn 11-JF -t~, BATCo document for Legal Services : Health Canada 20 October 1999 I MARKETING 1. 1 Volumes -3 years present 1 year 3 years Cigarettes RXG Pipe Tobacco 1.2 No. of brands and market shares of major Name share Share share (Additionally, give details of 4 n brands 2 3 4 BRIUM Rams PT or Plain Tar levels mg/cig Blended or F/c Vg Pack Style (EL,SC,s/S) Pack Sizes %of manufact=e 1-3 Market Share- -3 -2 -1 Present year same own Share CoqqM'tItor1 Conpetit=2 Market Volu~ 1.4 market Pressures: (e.g. price sensitive, trading down, change between "Virginia, and 'Blended, sectors, qnslity isimen) I C) U1 RATCo document for Legal Services : Health Canada 20 October 1999 i 2 LE" 2.1 Green IAmf %?Lreshinc.- Amount of leaf processed par season: This year - 1990 3 years ti - 1989 1988 1987 Proportion of cmr own use/export: How is leaf receLved? (i.e. prized bales, farmers bal , shouts) Bow in 'en preowted? (i.e. bundles, tangled, loose straight laid) Is leaf re-graded on entry? (i.f so, bow?) Green leaf storage? (i.e. post pallets, racking system, loose Stack) It.nal 4 green leaf from entry to storage to threshing line? (i.e. tow tractor, trailers, fork tz ck, sack truck) Maximum and -4-1- moisture of incoming leaf Lenqth of threshing season; monthly intake percetntages. 0 Maximum storage time of green after receipt Plard- capacity on threshing gr Description of plant. (Prov1de on a separate sheet a flow chart indicating size and type of equipment) 01-- BATCo document for Legal Services : Health Canada 20 October 1999 pr-ovids following data (on separate ahsfft) for each leaf threshing grade: Strips hold on l-, 112", 1/4'. 1/81, tray OR Through 1/4- CompaxL- with target f- year (K.B. QR tests should be done on a Cardwell test shaker fitted with standard 'clear swab' screens. If not available, state type of test sieve and used-) parcecutage stAM in 1AmjnA. Percentage lamf~ an xachi or harld tested? A through 1/4" -11 strips 0 packed separately? pravi t : data for the following: Stem length at pack Ist. thresher load &9/cm) for the va.rLous threshing grades lot thrasher efficiency (how obtained.7) Stage separation efficiencijes In-bale pack off temperature Pack-off moisture targets fcw, lan- atom Type of packing equipment for, 2-4- sten size, weight, and packagings for, lamina atom List labcmr (permanent staff and casual) for whole plant permanent Casual Productivity (Xg/mn.br) 2-2 Leaf Warebonnincr: Location Duration held on site Storage/stacking method Anti-in station programs _9~b CD ui ,*-j BATCo document for Legal Services : Health Canada 20 October 1999 3 PRODUCrIOK 3.1 Volume of 1Pactory: Capa ity of Iractory IMND: SUD: 1 Morkinq houre and ahif-tn-. Overtime (when worked, and average) Arknnal Cloeur& 3.2 Production Department Mannina T'st what in included lftmber P9MD - DIXUCt P3W - Indirect SMD - Direct SUD - Indirect P20 - QC SMDW other QC Engineering Filter -ki Administration Kanagement Xaterial Warehousing/ Purchasing Others (epecify) -- Are all these included in cpah? (If not, why?) 7 C> (XI 1-4 Co BATCo document for Legal Services : Health Canada 20 October 1999 3.3 ProductionPerformance (Tarmets -. overall Cigarette Tobacco Waste.- - Bow calculated - Levels achieved - Kai n causes wrapping waste.-- - Method of calculation - Actual Vests levels - Mal- causes Machinery Efficiencies Bov calculated TA nt iklicuances - Levels achiew (I month) Maker Packer Linked rilter Rod - Limitations to impmvement 0 Machinery Utilisation.-- - Bov calculated - Levels achieved - Explanatory notes 0 Cigarettes per man-hour - Now calculated - Levels achieved Productivity other Products: ->b CD Ln ®-4 J>b .C:b %JD BATCo document for Legal Services : Health Canada 20 October 1999 4 PRODUCTION - PKD 4.1 PMD Gerieral: supervision cleant routines/persomml In station ocatrol 4.2 BLe-ndu no. of blonds Difference between th- 0 Sizes of operations 150. of grades smallest compnent size 4.3 Type of I on handled at entry to P2W I Lea received in what forn? Type and weight and size of leaf packs 4.4 Lamina Rated capacity actual throughput Reasons for difference Utilisation Process sequence: - .1~:b CD (D - il - (.n C) BATCo document for Legal Services: Health Canada 20 October 1999 Bale opening and conditioning Pre-cowwlitionLng equLpment (if in use) cycle tl~ T-sperature Zffectiveness - DCC t7 of cylinder temperature moisbxre content consistency (pads?) - bow is moisture checked? - Caning and steaming - type of casings r. % addition - flow control - evenness of applicatIon - qm&LLty of absorption - Cased leaf dryer - throughput - type - flow control - consistency - Blendf - effectiveness of blending - evenness of fill - Small strips - bypassed round conditioning or caming cylinders? round cutters? - if so, type of sieve - size of me-shes - consistency of GiArving? - added from CLT? - addback points and method -C:…b CD CD BATCo document for Legal Services : Health Canada 20 October 1999 I - cutting &Y and no. of cutters Type of food sy - for food possible? - Type of cut-bar protectlon devices (bow chocked) - Zffectiveness - CPL - opportunity for -4 ction? - level of pullouts - frequency of cutter breakdowns - Drying - type of dryer - bow, operated - teniperaturs dwell time - co=col system - flow control - conaLmrtency/accuracy of moLst=e at exit (over 1 day) I ow - Mixing stems addback - method of proportioning - shorts a small strip adkIback - level a method of proportioning - cooling and mLxinq - final product bins? - if not, is there space for them7 - transfer to cut tobacco store - Cut Tobacco Store - type/diwatIon of storage - humidity - Consistency Of humidity - feed to make a (consistency?) 0 BATCo document for Legal Services : Health Canada 20 October 1999 4-S PXD - stmo Rated capacity Actua.1 throughput (Reasons for Difference) No. of blends used Process sequence QuaxLty of 4"Oenj stv~= ftPMV& CleAnj tacil Conditioning - equipment - moisture consifirtency - effectLvemes. of conditioning is casing applied? (type? quantity?) Bul Id - /blending - time - consistency of fill Rolling (:Lf still in use) tests on non rolling roll gap - condition of roll& moisture AAd;+*icU at roller cutting - type and number of cutters - feed system - CPL. - effect of changing cpi.? - ISVel Of pullouts - frequency of cutter breakdowns C) 17 (D Ln Un kA BATCo document for Legal Services: Health Canada 20 October 1999 WTS Process - nceinal process us" - bow monitored and checked - actual process: measured t ax steaming Unit flow control moisture at entry to dryer appearance of m&terial before drying Stems Drying - type of dryer and bow operated - moisture at exit - metbod of control - consistency of moisture (ower I day) - filling power (Borgwaldt) of -it material - moisture displayed? - appearance of material 4.6 PMD Other Casing Kitchen' - no. of casings - Jim prepared - Ekm delivered to calling CTIS zzpanded Tobacco., - Type used - Bow stored - Addback equipment - Lmmis of addition other Products: - pipe Give detailS of Process on 8ep=at8 sheets- - RTO Sequence and 7lows - Cut Tobacco for Xxport 0 - 19 - CD (il 1-4 (-n -ib. BATCo document for Legal Services: Health Canada 20 October 1999 54 PRODucrzcw - WM 5.1 SMD GeneXal clan"i 5.2 machime/Pro-duct Svw. Maker 7T& Ciq®utte specification la. Spend Util Type Type Lsngth riitur circ. M/cIs Pac3mr Wrap Box or cig cign/ Pack Cign/ Bundle 30. Speed Util. TYPe Type over Length Pack Type Bundle Ty a/c's wrap -01 MI -9~b CD CD - 21 Un BATCo document for Legal Services : Health Canada 20 October 1999 S.3 Machine IMMIJOST: IGLker crwing Packer craving Supervision JUMCLIUAriets Cr .1. pin" figure 0 5.4 TraininUt Timis and items covered for; - operators - Technicians others - Facilities used _::~b C) C) U-1 23 - Ln C7% BATCo document for Legal Services : Health Canada 20 October 1999 6 PRODUM101F - CENEM 6.1 rilterProduction: vaste levalB XA~M crewing MAn1hilrien/Product Spec.: xjk&h4 rilter Rod Spec- 30. Speed Util. Lenqtl% Circ. PD aic'a 0 6.2 Wrarvino Xaterials store: Average stock level (weeks) (potential for reduction) Quality of storage 6.3 Centralised Dust Collection: Location Dust handling arrangesnents Kanning 6.4 Cigarette Ripping: Type of equipment 'field (% dustlsmalls) (s tobacco in paper) Smalls quality Kanning - 25 - Ln VI -~4 BATCo document for Legal Services : Health Canada 20 October 1999