Document bdmDnx5XKa0p4NVEbM8dLypy

fX'C-ft- !' <1 AL AVrW* I " ftu(A (jj TAt, b*A~*^*--t - t3w') k> *M: '{ *i ^ btW<l t u* -if*-- CHEMICAL MANUFACTURERS association r..C-lVEO :,n,, 19 198?- li! ic. eI fsi.RS D^r'i November 10, 1986 c/'K TO: FROM: HEALTH AND SAFETY CONTACTS OF CMA MEMBER COMPANIES O. Nancy G. Doerrer Manager, Health, Safety-^And Chemical Regulations SUBJECT: lARC's Classification of Potential Chemical Carcinogens: March 1987 Monograph Meetings As part of a chemical industry initiative to promote the development and application of sound scientific principles, CMA requests your continued participation in the 1986-1987 IARC Monograph program. BACKGROUND The Chemical Manufacturers Association has been invited to nominate an observer to participate in tvo upcoming meetings of the International Agency for Research on Cancer (IARC). Since July 1986, many of you have assisted CMA in evaluating key indus trial chemicals in preparation for IARC Monograph meetings to be held 2-9 December 1986 in Lyon, France. At that time a working group of experts chosen by IARC will assess the activity of approximately 200 chemicals/ exposures in short-term tests. Dale W. Matheson, Ph.D., of Stauffer Chemical Company will attend the December meeting as the official CMA Observer. Richard H. McKee, Ph.D., of Exxon Biomedical Sciences, Inc., will serve as the Alternate. Final preparations for the December meeting are well under way. At a second meeting, to be held 10-17 March 1986 in Lyon, the degrees of evidence for carcinogenicity in humans and experimental animals will be assessed for the 200 chemicals/exposures. An overall evaluation of carcino genic risk to humans wild. then be made based on experimental and epidemio logical data. The list of chemicals/exposures is attached for your review (Attachment 1). These substances have previously been evaluated by IARC in Volumes 1-41 of the Monographs,.but are now,.un<iergoing a second review. OLI 4296 Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872. 2501 M Street. NW Washington, DC 20037 Telephone 202/887-1100 Telex 89617 (CMA WSM) CMA Health and Safety Contacts November 10, 1986 Page 2 INDUSTRY PARTICIPATION The CMA Health and Safety Committee's IARC Work Group is organizing industry participation in the March 1987 meeting. The number of chemicals and short time period for assessment of this list has dictated a method of action that requires full CMA member company participation. The following schedule has been constructed to prepare for effective scientific input at this important meeting: DEADLINE: DECEMBER 1, 1986 o Identify chemicals/exposures on the list (Attachment 1) that are of specific concern to your company. o Identify company expert(s) to assess the health effects literature and evaluate the carcinogenic data on chemicals of concern to your company. Return the attached form (Attachment 2) to CMA by December 1, 1986. o Nominate the CMA Observer to attend the March 1987 IARC Monograph meetings. The CMA Observer will not have a vote at the upcoming Monograph meetings, but will have the opportunity to contribute to discussions concerning the scientific evidence for classifying chemicals as carcinogens. The nomination of this observer will consist of careful selection from a list of names generated by representatives of CMA member companies. The CMA IARC Work Group encourages you to suggest potential nominees. H. Vainlo, M.D., Chief of IARC's Unit of Carcinogen Evaluation and Identification, has requested that CMA submit the name of the Industry observer to IARC by 31 December 1986. DEADLINE: DECEMBER 15, 1986 o Submit to CMA a bibliography of recently published animal and epidemiological information relevant to the carcinogenic assessment of chemicals of concern to your company. (Dr. Vainlo recently made this specific request in a letter to CMA of 29 October 1986. By "recently published," we interpret Dr. Vainio's request to mean relevant articles published since the IARC Monograph in question was Issued.) DEADLINE: JANUARY 14, 1987 o Submit to CMA an executive summary (using the format outlined in Attachment 3) describing IARC's assessment of the chemical/exposure in question, your assessment, and a full bibliography, including unpublished studies. A logical method for arriving at the conclusions in your executive summary is as follows: ,, OLI 4297 CMA Health and Safety Contacts November 10, 1986 Page 3 Begin your review by locating the appropriate 1ARC Monograph(s) in which the original IARC carcinogenicity evaluation was described. By refer ring to the cumulative index at the back of the latest volume of the IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans, you will easily access the appropriate Monograph(s). Next, identify IARC's conclusions on a given chemical's carcinogenic potential. These conclusions will be expressed as "degrees of evidence" for carcinogenicity from studies in humans, in experimental animals, and from short-term tests. An overall evaluation of carcinogenic risk to humans may have been made for chemicals assessed in Volumes 1-29. These evaluations appear in Supplement 4 of the IARC Monographs (October 1982) as classifications into Groups 1, 2a, 2b or 3. (Refer to the "Preamble" to each Monograph for an explanation of the "degrees of evidence" and the groupings.) CMA suggests that you review the appropriate IARC Monograph for accurate interpretation and inclusion of relevant information. Identify in stances where you believe IARC may have misinterpreted the evidence. Secondly, identify key information not considered by IARC, i.e. data that was overlooked at the time of consideration by the IARC Committee and/or new information that has been developed since the Monograph was published. CMA contends that published and unpublished data should be reviewed in IARC evaluations. IARC's policy is to consider only published informa tion; nevertheless, this policy does not preclude the chemical industry from including valid, high quality industrial test data in our written submission of chemical reviews to IARC. In the event that you find key information that is new to the IARC carcinogen evaluation, consider submitting the data for publication to a peer-reviewed journal or some other written public forum. Taking this step assures that the data will be officially considered by the IARC Committee. Although it may be unrealistic to expect reclassifications for chemicals in Group 1, it is nevertheless important to review any new or un published information previously unavailable to the IARC Working Groups. At the March 1987 meetings, IARC will make "... evaluations of the degrees of evidence for carcinogenicity in humans and experimental animals ... for these chemicals and exposures and an overall evaluation of carcinogenic risk to humans will be made based on experimental and epidemiological data." To assist you in making your own evaluation, CMA suggests that you review two papers: a) Review and Recommendations for the Revision of the Preamble and Criteria of the IARC Monographs, CMA/AIHC/APX/NACA/FMA, lfui~y,~T986 (recently sent to you under separate cover). b) Criteria for Identifying and Classifying Carcinogens, Mutagens and Teratogens, CMA/SOCMA/CEFIC/CCFA. In press, Reg. Toxicol. Pharmacol., December 1986, OLI 4298 CMA Health and Safety Contacts November 10, 1986 Page A .Please contact me If you need copies of either of these documents. Finally, write an executive summary on your findings, and include a full bibliography. Retain your file of collected articles, manu scripts or other forms of information at your office for future reference by the CMA 1ARC Work Group and the CMA Observer. CMA anticipates that in your executive summaries you will divulge no confidential Information. If such information is included, please designate it with a CBI notation. ******** CMA recognizes that there may be significant overlap in company inter ests in a given chemical. When we receive your list of chemicals and names of company experts, we will put you in touch with other member companies who have expressed the same interest so that you may equitably distribute the task of literature searching and carcinogen evaluation. If you are interested in having your company's chemicals represented at the March 1987 IARC Monograph meetings, please make every effort to meet the deadlines cited in this memo, I can be reached at 202/887-1282 with your questions or comments. I look forward to hearing from you. Attachments cc: IARC PROJECT PARTICIPANTS: December 1986 IARC Monograph Meetings CMA Health and Safety Committee OLI 4299 ATTACHMENT 1 IARC MONOGRAPHS ON THE EVALUATION OF THE CARCINOGENIC RISK OF CHEMICALS TO HUMANS: CHEMICALS AND INDUSTRIAL PROCESSES ASSOCIATED WITH CANCER IN HUMANS: UPDATING OF SUPPLEMENT 4 (FART I A PART II) Exposure TENTATIVE LIST OF SUBSTANCES AND EXPOSURES TO BE CONSIDERED (At IARC Monograph Meetings December 2-9, 1986, and March 10-17, 1987) Exposure Acetaldehyde Acrolein Acrylonitrile Actincoycin D ASriamycin Aflatoxins Aldrin Aluminium production ^^-Aoi nobiphenyl Ami trole Anaesthetics, volatile Analgesic mixtures containing phenacetin Phenacetin Aniline {and its hydrochloride) Arsenic and arsenic craipounds Asbestos Attapulgite Auramine, manufacture of Auramine Azathicprine Benzene Benzidine Benzidine-based dyes: Direct Blade 38 Direct Blue 6 Direct Brown 95 Berylliun and beryllium compounds Betel quid with and without tobacco (chewing) Betel leaf Areca rut N,N`-Bis(2-chloroethyl J-2-naphthyl*" amine (Chlomaphazine) Bisdiloroethyl nitrosourea (BOJU) Bis(chlorocethyl)ether and technicalgrade chloramethyl methyl ether Bitunens Bleomycins Boot and shoe manufacture and repair Bracken fern 1.3- Butadiene 1.4- Butanediol dimethanesulphanate (Myleran) Cadmium and cadmium compounds Carbon blades Carbon tetrachloride Carpentry and Joinery Oianotherapy for lyrphocas: MDPP, etc. Chlorambucil OLI 4300 Chloramphenicol Chlorrtn^ Afcfcmfa/'+O nrr Exposure - 2- Chlorinated toluenes* production of: Benzal daloride Benzotrichloride Benzoyl chloride Benzyl chloride l-(2-Chloroethyl)-3-cyclchexyl-lnitxosourea (CQJU) Chloroform Qilarcphenols 2,4-Dichlorophenol Pentachlorqphenol 2.3.4.6-Tetrachlorophenol 2*4,5-TricWorcphenol 2.4.6-Trichlorcphenol Oil roprene Cholesterol QircBuun and chromium compounds ortho-Chrysoidine Cisplatin Clofibrate Coal gasification Coal-tar pitches Cbal-tars Coke production Creosotes . Cyclaoates Cyclophosphamide Efecarbazine Etepsane DDT azeivun 12-Dibrcmo-3-chloroprcpane Exposure ATTACHMENT 1 ortho-Pidilorobenzene and para-Oichlorobenzene 33 '-Pichlarobenridine Di chi orase thane 1.3-0i chlarcprcpene Dieldrin Diethyl sulphate 3,3'-Oiaethoxybenxidine (orthoDianisidine) Dimethylearbamoyl chloride Dimethyl sulphate 1.4-Dioxane EpidUorohydrin Erionite Ethylene difc* amide Ethyleae oxide Ethylene thiourea Fluorides (inorganic, in drinkingwater) 5-Fluorcuracil Fbrmldehyde Furniture and cabinet making Haematite mining, underground (with exposures to radon) Hsenatite (iron oxide) Hexa chlorobenzene Hexa chlorocyclohexane Hydralazine Hydrazine oli 4301 Iron and steel founding Exposare -J- Iron dertran eocplex Iscnicotinic acid hydrazide I*cprcpyl alochol mnufacture (strong-acid process) Isopropyl alcohol Isopropyl oils Lead and lead ccopounds Leather dusts leather goods mnufacture Leather tanning and processing Iintoer and sawmill industry Magenta, nanufaeture of Magenta Melphalan 6-Mer captopjr ine Methotrexate 5-Methoxypsoralen (+ UVR) 6-Methoxypsoralen (+ UVR) Methyl bromide 4,4'^fethylene bis(2-chloroaniline) 4,4*Methylene bis(2-methylaniline) N-Methyl-N'-nitro-N-nitrosoguanidine Metronidazole Mineral oils Mustard gas 1-Naphthylamine 2-Naphthylamine 1-Naphthylthiourea Exposure AlXALHMi-Kl I Nickel refining Nickel and nickel cccpounds Nitrogen mxstard Ochratoxin A Oxyvetholone Rienazopyridine (and its hydrochloride) Rtenelxine Phenobarbital Rienoxyacid herbicides 2,4-0 and esters 2,4-DP MCPA MCPP Silvex * 2,4,5-T and esters Phenylbutazone N-Rieny1-2-naphthyl amine Fhenytoin Polybromirated biphenyls Polychlorinated biphenyls Prednisone Procarbazine hydrochloride Propylene oxide Propylthiouracil Pulp and paper mnufacture Reserpine Rubber industry Sacdv^in Sepiolite OLI 4302 . -Eijosur 4 Sex hormones: Cbefcined oral contraceptives Sequential oral contraceptives Other oestrogen-progestin combinations Androgens: Testosterone Oestrogens: Chlorotrianisene Conjugated oestrogens Dienoestrol Di ethy1st i lboestrol Diethylstilboestrol diprcpionate Ethinyloestradiol Hexoestrol Mestranol Oestradiol-178 and esters Oestriol Oestrone and oestrone benzoate Progestins: Chloraadinone acetate Dimethisterone Ethynodiol diacetate 17o-Hydroxyprogestercne eaproate Lynoes trend Medroxyprogesterone acetate Megestrol acetate Norethisterone Norethisterone acetate Norethyrodrel Norg strel Prog sterone Other: deed phene Clomiphene citrate ShaleKJils Silica Snokel ss tobacco products Soots (and soot extracts) Spironolactone Styrene Sulfafurazole famethoxazol* Talc* Exposure ATTACHMENT 1 Tetracilorodibenzo-para-dioxin (Tax)) % 1*1,2,2^Tetradiloroethane Tetrachlaroethylene Tbbacao smoke 2,4- end 2,6-Tbluene diisocyanates ortho-Toluidine Treosulphan Trichloroethylene 4,5,,BJTriaethylpsoralen (+ UVR) Tris(aziridinyl)-para-benzcquincne (Triaziquone) Tris(l-aziridinyl) phosphine sulphide (Thiotepa) Uracil sustard Vinblastine sulphate Vincristine sulphate Vinyl chloride Vinylidene chloride Wbllastcnite Wood dusts OLI 4303