AQWCW1ICALS ON TM= I - PRESENT SITUATION 1 - Legislations : U.S.A., Germany and Italy U.S.A. - Establishes maximp Residues Limits (MM) for 16'pesticides (4 are considered tffrporary). -Does not establish MRL for pesticides approved to be used in the U.S.A. -Does not establish criteria for the iffportation of tobacco with pesticides residues giich are not registered in the U.S.A. and for which an ML has not been established. -The limits refer to tobacco leaf. G UAW - Establishes tK for 11 pesticides and recamvnds maxinn arcunts for 71, which are standards for the German tobacco industry. -Establishes the limit of less than 0,01 pprr for non-registered pest IC I C@es in Germany. -The limits refer to tobacco products. BATCo document for Province of British Columbia 16 April 1999 ITALY Establishes Maximum Residues Limits (MRL) for residues of 69 pesticides. Establishes the limit of less than 0,01 ppm for residues for non-registered pesticides in Italy. - Considers tobacco under the legislation for food-stuff of vegetal and animal or, - The limits refer to tobacco products. Jh- BATCo document for Province of British Columbia 16 April 1999 2 Tobacco-producing countries like Zimbabwe and Canada hay approved the use on tobacco of agrochemicals not registers in the U.S.A. in registering modern tobacco agroch err I Ca Is in th. 3 - Di U.S.A. and re-registration of products in use due to th, complicated toxicological studies and high costs involved. 4 - The nonexistence of an independent international forum foi discussion of matters with respect to the restriction in usin( tobacco agrochemicals. 5 Reduced number of standard analytical methods approved bj international regulatory entities for agrochemicals residues ot tobacco. Xh. BATCo document for Province of British Columbia 16 April 1999 11 - PREDICTED FUTURE SITUATION 1) An increase of restrictions in the use of agrocherr I Ca Is by the different countries and establishment of the EEC legislation. Use of political and non-technical criteria for the establishment of the MRL. "Clean tobacco' concept may be adopted. Improvement of the analytical methods may induce the MRL to an even lower level. 2) No economical feasibility of the re-registration of pesticides already being used and registration of new pesticides for tobacco. The consequence is the reduced number and a high incidence of old-fashioned pesticides for use on tobacco. The causes are: The tobacco crop has low economical significance for the pesticides manufacturers. High registration costs of new pesticides- in the U.K. and $40 rri I I ion approximately E30 rri in the U.S.A. More complicated toxicological tests for the tobacco are required. 'ble connection of pesticides residues with smoking and 3) Possi health issues. BATCO document for Province of British Columbia 16 April 1999 III - SOUZA CRUZ SUGGESTIONS A) B.A.T. IAternal Actions : 1) To centralize all pertinent information related with agrochemicals, such as registration, legislation, and other important matters, on the chairman of the Ingredient Review Panel (IRP) which would be in charge of evaluating and circulating them to all B.A.T. companies. 2) Regarding the use of agrochemicals, the IRP must have the following points among its purposes, as proposed during the first IRP meeting: a) Recommend appropriate criteria for assessing the suitability of agricultural chemicals for use on tobacco. A suggestion presented by Souza Cruz is being evaluated by IRP. representatives; b) Establish a list of agricultural chemicals which may be used on tobacco; c) Record any limits which should be advised or applied to the use of individual agricultural chemicals; d) Identify any agricultural chemicals which the Panel considers should not be used on tobacco on the grounds of potential adverse reaction; e) Exchange information on developments in legislation which could affect decisions on the usability of agricultural chemicals on tobacco; CD -Nj BATCo document for Province of British Columbia 16 April 1999 3) The IRP should coordinate the establishment of B.A.T. 's point of view to be taken to CORESTA on the following points: a) To identify CORESTA as an international forum to discuss the subject: Pesticides on Tobacco; b) To settle a new technical sub-group under the Phytopathology group at CORESTA with the objective described in Item B 2 - External Actions; O To propose new responsibilities for the sub-group on Pesticide Residues as described in Item B 3 - External Actions. 4) Souza Cruz R&D department has facilities for analyses of pesticides residues which could be used by B.A.T. group. companies. CD CD BATCo document for Province of British Columbia 16 April 1999 B) Exterpal Actions : 1) To identify CORESTA as an international forum to discuss the subject of pesticides on tobacco. 2) To settle a new technical sub-group at CORESTA, under the Phytopathology group, f o rmed by toxicologists and specialLiStS in pesticides, with the following objective: To propose criteria of toxicological evaluation for the registration and re-registration of pesticides for use on tobacco. To propose criteria for the determination of maximum limits of pesticide residues (MRL) on tobacco. To establish MRL for the main pesticides recommended for use on tobacco, which should be used as a standard for the tobacco industries in the world. 3) The present sub-group on pesticide residues should be responsible for: . To standardize and approve analytical methods. . To establish concepts of CORESTA official laboratories for pesticides residues determination. To establish a CORESTA bank for pesticides analytical standards. CD BATCo document for Province of British Columbia 16 April 1999 I ANALYTICAL METHODS.STANDARDIZED BY CORESTA/ISO a) Existing Maleic hydrazide (suckercide) Organochlorine (insecticide) Dithiocarbamate (fungicide) b) To be introduced Pendimenthalin (herbicide) Flumetralin (suckercide) n-Decanol (suckercide) Methoprene (insecticide) CD BATCo document for Province of British Columbia 16 April 1999 ANALYSES WHICH SOUZA CRUZ PESTICIDE RESIDUE ANALYSIS LABORATORY IS ABLE TO DO: a) Existing Organochlorine Dithiocarbawate Aldrin measured as Dieldrin CS2 total) Endrin . Heptachlor Maneb . Heptachlor epoxide Zineb Endosulfan I and II Mancozeb Endosulfan sulfate Propineb Chlordane (Alpha and gamma isomers) Oxichlordane Permethrin DDT.'s (o,p-' and p,p.' isomers) Cyperrrethrin DDD-'s (o.p.' and p,p.' isomers) Formothion DDE's (o,p.' and p,p..' isomers) 2,4 - D Toxaphene 2,4,5-T Methoxichlor Dicarpba HCB Carbaryl Lindane Acephate Mirex Metharridophos BHC.'s (Alpha,beta and delta isomers) Flumetralin Butralin Pendimenthalin Maleic hydrazide b) Being developed Methoprene Cyhalothrin Carbosulfan Carbofuran Sethoxydin Fluazifop-butyl cc BATCo document for Province of British Columbia 16 April 1999 0 0 M 0 REDUCTION OF "OTHER NOXAE" CD STRATEGIC OBJECTIVE T 0 To reduce minor constituents of mainstream smoke CD which are of current or potential interest to Regulatory 0 Authorities. Reductions must be relative to PMWNF or nicotine deliveries to give improvements over 0 0 current techniques such as filter ventilation. Cr The noxae should not be re-distributed to sidestream > smoke. 191160 [00 666@ Ili 9L eiqLunloo tISIIIJ9 JOGOUIAO-id jol juawn:)op oC).Lvs .-\j CD m I z 3 3 Z I H m M N 3 H 0 0 D H 0 (n 0 0 z 0 D D r 3 3 H M I m 0 z 0 1 m 0 H M 0 r I z 7 7 3 0 1 0 M H H T I x 3 1 D m I m z M H 3 0 3 H z 0 0 1 0 H 1 C4 I I m H I 0 n D H 0 z 0 z H U z w w z z z z H H H H C w (r w w w W 0 z 0 0 0 0 H X M @ x x x z I w J z > H Z w E w z > T 0 I z 11 H x CE H 0 z z z I 0 1 U z CD co Lill BATCo document for Province of British Columbia 16 April 1999 0 0 a 0 D 0 0 1 z 0 0 3 M 0 x H n D D CD 0 z D r M M 0 H 0 x 0 < H r H 0 h H H M 0 0 H z 0 z z 0 x G) (a r a) 0 3 z I 0 0 0 a 0 1c H M r r r c X Cr z z c c c c 0 w w w w M 0 D 0 r r r r r 0 > 0 M 0 M z M M M H r v M M 0 0 0 u r w 0 c c r + r o M 0 I z 6 0 0 0 CL 0 0 "GENERALLY RECOGNIZED AS SAFER (GRAS)PRODUCTS 3 STRATEGIES 1. GENERAL DELIVERY REDUCTION M TRADITIONAL LOW DELIVERY APPROACH 0 "GREENDOT" m REQUIRES SELECTIVE SENSORY "BUILD BACK" 0 0 2. IDENTIFY RISK ASSOCIATED SUBSTANCES E, 3 REMOVE SELECTIVELY cr OPPOSITE TO 1. ABOVE > "DAY" AND "OTHER NOXAErl 3. ASIMPLE CHEMICALLY DEFINED "SMOKE" to TOBACCO COMBUSTION NOT THE PRIMARY SMOKE SOURCE 11NOVAll . "PREMIER" 1A oo 0 0 CL 0 IDENTIFICATION OF RISK ASSOCIATED r+ SUBSTANCES PROBLEMS -ft 0 0 < 1. SMOKE CONTAINS THOUSANDS OF CHEMICALS - WEIGHTING CONTRIBUTIONS 0 2. NON ADDITIVE EFFECTS 0 0 3. NON CHEMICAL EFFECTS, eg., PHYSICAL IRRITATION BY SMOKE > 4. AT LEAST 3 DISEASE TYPES 7 5. PROOF THAT SELECTIVE REMOVAL OF SOME SUBSTANCES LESSENS RISK 9 9 I Z 6 0 1 0 V 6666@ I!jdV 9L L,,iqLunloo L4SII!Je 10 OOUIAOJd jol juawn3op oo.LVS 40 J911 87 0 0 CL 0 0 (D CONCLUSIONS 0 EVEN IF SELECTIVE REDUCTION OF A NUMBER OF TARGET NOXAE WERE ACHIEVED, THERE IS LESS CHANCE OF SUCH PRODUCTS BEING ACCEPTED AS "GRAS" COMPARED WITH GREENDOT AND NOVA PRODUCTS WHICH REDUCED ALL TOBACCO SMOKE =r DELIVERIES AND HENCE REDUCED UNKNOWN AS 0 0 WELL AS KNOWN NOXAE *HOWEVER SELECTIVE REDUCTION SHOULD HAVE > APPLICATION IF SPECIFIC SMOKE SUBSTANCES BECOME "LEAGUE TABLE" TARGETS 9 2 I6 0 i 0 V 0 0 CL 0 SUGGESTED "OTHER NOXAE" GOALS MAINTAIN A COMPANY KNOWLEDGE BASE, SUPPORTED BY OUR OWN RESEARCH, ON THE HEALTH CONTENTIOUS SUBSTANCES IN SMOKE AND THE FACTORS WHICH 0 INFLUENCE THEIR LEVELS. HENCE INTERACTION WITH ft REGULATORY AUTHORITIES ETC. 0 0 AS EXTENSION, PROVIDE BACKGROUND INFORMATION F s ON THE OPPORTUNITIES FOR, AND LIMITATIONS TO, THE cr SELECTIVE REMOVAL OF SPECIFIC NOXAE AS EXTENSION, DEVELOP PRODUCTS GIVING SELECTIVE REDUCTIONS IN SPECIFIC NOXAE, IF REQUIRED FOR "LEAGUE TABLES" ETC. 6 9 I z 6 o I o