Document wq231Bx3m5ZRGnMdM9mRQrjVo

From L.L. RIPPEY PITTSBURGH OFFICE RE: PROPOSITION 65 UPDATE -fc-L To SEE DISTRIBUTION 1987-12-31 Prop 65 Warnings Products containing chemicals which were listed February 27, 1987 by California have warning requirements which are effective February 28, 1988. These warning requirements include any that may be necessary for consumer exposures, industrial exposures as well as environmental exposures. Recent Developments FDA Commissioner Frank Young testified at the December 11 meeting of the Science Advisory Panel on the "substantial equivalency" of the FDA style risk assessment to that proposed by California in draft compliance guidelines. This, in combination with the diligent work of manufacturing trade associations, seems to have swayed the administration into a more reasonable position. This is expected to be reflected in emergency regulations to be enacted in January or early February at the latest. These regulations are expected to acknowledge if only temporarily, that compliance with FDA regulations indicates that products do not pose a significant risk in terms of carcinogenesis. Such a regulation would exempt FDA-regulated products from warning requirements for carcinogens listed by California. This exemption has not been extended to apply to reproductive toxins. The state also intends to develop a 50-chemical priority list for the purpose of conducting individual chemical risk assessments. Ultimately, they would like to develop their own "no significant risk" levels to supplant any exemption for FDA-regulated products from the requirements for carcinogens under Proposition 65. Many comments concerning the nature of "clear and reasonable warnings" were heard at the December meeting. Manufacturers associations are asking that, in addition to direct product labeling, other forms of warnings also be accepted such as newspaper ads, in-store compendia, or even toll-free information lines. This issue also may be addressed in the anticipated regulations. ALCOA Prop 65 Update Page Two 87/12/31 California's environmental activists are expected to challenge these regulations, so any relief it offers may be short-lived. While exclusion of products complying with FDA from Prop 65 via rulemaking would be a very positive move, it still wouldn't protect manufacturers from "bounty hunter" suits. Such an exclusion would however aid in building a defense to win any citizens suit over a product complying with FDA regulations. Alcoa's Response Alcoa's response to Proposition 65, insofar as it covers our products, has not changed. We are endeavoring to determine the "no significant risk" dose for listed chemicals known to be in Alcoa products, then we are conducting a risk assessments to determine if various products will present "no significant risk" or if warnings should be supplied. New chemicals for list Dr. Bruce Ames' caveat was added to each of the 55 new chemicals proposed by the Science Advisory Panel for listing at their October 30 meeting. This caveat espouses the panel's opinion that low dose exposures to many of these chemicals pose very little, if any, risk to humans. These October 30 recommendations are expected to be officially listed by January 1, 1988. The Science Advisory Panel (SAP) at its December 11 meeting, reviewed 46 more chemicals, 39 of which were recommended to the governor for listing. The proposed agenda for the SAP's January 29 meeting has been published with a list of 51 candidate chemicals for their review. All three of these new lists in addition to the current list are attached. Future Action Manufacturers associations from the FDA-regulated community are still preparing lawsuits to challenge Prop 65 on constitutional grounds, but the timetable has been moved back until after California issues its emergency regulations. 1" LAURA L. RIPPEY Attachments prop65d.FDA 511961 0026 Prop 65 Update Page Three 87/12/21 MEMORANDUM DISTRIBUTION: C.E. Luke - Richmond - CSI W.L. Denhart - Richmond - CSI Lee Albrecht - Advanced Closure Systems J. Pierce - H. C. Industries Chuck Schiele - H. C. Industries Sheldon Wilde - H. C. Industries G.M. Nall - Davenport T.S. Brown - Lebanon R.L. Moore/M.J. Jackson - Davenport A.M Dennis - ATC -A J.R. Greenwald - ATC - A J.E. Stillwagon - ATC - A D.A. Smith - ATC - A E.M. Jasinski - ATC - A R.E. Atkinson - ATC - C J.T. Laemmle - ATC - C H.G. Reavis - Warrick F.P. Swigon - Lebanon T.S. Ebright - Lebanon C.F. DiMascio - Pittsburgh 6 H.D. Belk - Pittsburgh 6 R.W. Sauer - Pittsburgh 6 L.F. Schneider - Pittsburgh - 13 P.R. Atkins - Pittsburgh - 7 J.W. Brust - Pittsburgh - 16 J.F. Riley, Pittsburgh - 16 T.L. Levendusky - ATC - A J.M. Meister - Richmond - CSI J.S. Boyt - Pittsburgh - 7 C.w. Green - Genesis A. Silverman - Genesis J.W. Davie - Genesis J.M. Conner - Genesis J.C. Dorris - Genesis K.D. Brenner - Davenport T.P. Scanga - ATC - A D.E. Festa - ATA - A R.L. Holz -'Pittsburgh - 14 E.B. Perry - Pittsburgh - 28 ^D.D. Roeber/B. Steverson - Pittsburgh - 28 * Terry Dillman - Illinois Water Treatment Terry Bean - Arkansas B.C. Young - Arkansas J.L. Hudson - Arkansas J.E. McConnell - Pt. Comfort R.C. Flournoy - Pt. Comfort A.B. Piecka - Vernon Works Z. Washington - Corona Operations J. Carter, TRE Corp., Weslock Div., 13344 So. Main St., Los Angeles, CA 90061 R. Kresky, Alcoa Defense Systems, 16761 Via Del Campo Court, San Diego, CA 92127 P. Pruitt, TRE Corp., (Astech Div.), 3030 South Red Hill Av., Santa Ana, CA 92711 511961 0027 SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT OF 1986 (PROPOSITION 65) CHEMICALS KNOWN TO CAUSE CANCER OR REPRODUCTIVE TOXICITY October 1, 1987 The Safe Drinking Water end Toxic Enforceaant Act of 1986 requires that the Governor revise end republish at least once per year the list of cheaicals known to the State to cause cancer or reproductive toxicity. Consents should be directed to the Seats's lead agency for iaplsaantation of the Safe Drinking Water and Toxic Enforceaant Act: State of California Health and Welfare Agency 1600 Ninth Street, Rooa 450 Sacraaento, CA 95814 Note: (1) The identification nuaber is the Cheaieal Abstracts Service (CAS) Registry Nuaber. No CAS nuaber is given when several substances are presented as a single listing. (2) The date refers to the initial appearance of the cheaieal on the list. CARCINOGENS Chemical CAS Nuaber Date 2-Acetylaainofluorene Acrylonitrile Adriaaycin AF-2:[2-(2-furyl)-3-(5-nitro-2-furyl))acrylamide ortho*Aainoazotoluene 4-Aainobiphenyl (4-Aminodiphenyl) 2 Aaino-5-(5-nitro-2-furyl)-l,3,4-thiadiazole Anitrole ortho-Anisidine and ortho-Anisidine hydrochloride Analgesic mixtures containing phenacetin Aramite Arsenic .(inorganic arsenic coapounds) Asbestos Aurarain* Azaserine Azathioprine Benz[a J anthracene Bcnxene Benzidine [and its salts) 3enzo[b]fluoranthene Ber.zo {j ] fluoranthene 3enzo[ 1: ] fluoranthene 5enzo[a]pyrene Benzotrichloride St-nzyl violet 4B 53965 107131 23214928 3686537 97563 92671 712685 61825 90040 -- 140578 -- 1332214 492808 115026 446866 56553 71432 92875 205992 205823 207089 50328 98077 1694093 July 1. 1987 July 1, 1987 July 1, 1987 July 1. 1987 July 1. 1987 February 27, 1987 July 1. 1987 July 1. 1987 July 1, 1987 February 27. 1987 July 1, 1987 February 27. 1987 February 27. 1987 July 1. 1987 July 1, 1987 February 27, 1987 July 1. 1987 February 27, 1987 February 27. 1987 July 1. 1987 July 1, 1987 July 1, 1987 July 1, 1987 July 1. 1987 July 1. 1987 . . 511961 0028 b Chemicals Known Co Cause Cancer or Reproductive Toxicity Page 2 Chemical Beryllium and berylllua compound* N,N-Bis(2-chloroethyl)-2-naphthyla*ine (Chlornapaxine) Bischloroechyl nitroeourea (BCMU) Bis(chloromechyl)*th*r 1,4-Butanediol dinethaneaufonate (Myleran) be ca-Butyrolactone 494031 154938 542881 55981 3088880 Cadmium and cadmium compound* Carbon tetrachloride Certain combined chemotherapy for lymphoma* Chlorambucil Chloroform Chloromethyl.methyl ether (technical grade) Chromium (hexavalent compound*) Coke oven emission* Conjugated estrogens Cyclophosphamid* ... 56235 ... 305033 67663 107302 ... ... -- 50180 DDT (1,1,l-Trlchloro-2,2-bia(p-chlorophenyl)eth*ne) l,2-Dibroao-3-chloropropane (DSC?) 3 - 3'-Dichlorobenzidine Diethylstilbestrol 50293 96128 91941 56531 Epichlorohydrin Ethylene dlbromid* 1,2-Dichloroethane (Ethylene diehloride) Ethylene oxide Hexachlorobenzene Hexachlorocyclohexane (technical grade) 106898 106934 107062 75218 118741 -- Helphalan Hethoxsalen with ultraviolet A therapy (PUVA) 4,4'Methylene bls(2-chloroaniline) Hustard Gas 148823 298817 101144 505602 2-Haphthylamine 91598 Nickel refinery dust from the pyrometallurgical process| - - - Nickel carbonyl 13463393 Nickel subsulfide 12035722 N-nltro*odi>n>butylaaine 924163 N-nlcrosodiethylamlne 55185 N-nitrosodimethylamine 62759 N-nitroso-N-ethylurea 759739 N-nitroso-N-methylurea 684935 N-nitrosopyrrolidine 930552 Date October 1, 1987 February 27, 1987 July 1, 1987 February 27, 1987 February 27, 1987 July 1, 1987 October 1. 1987 October 1, 1987 February 27, 1987 February 27, 1987 October 1. 1987 February 27, 1987 February 27, 1987 February 27, 1987 February 27, 1987 February 27, 1987 October 1. 1987 July 1. 1987 October 1, 1987 February 27. 1987 October 1, 1987 July 1, 1987 October 1, 1987 July 1, 1987 October 1, 1987 October 1, 1987 February 27, 1987 February 27, 1987 July 1, 1987 February 27, 1987 February 27, 1987 October 1, 1987 October 1, 1987 October 1, 1987 October 1, 1987 October 1, 1987 October 1, 1987 October 1, 1987 October 1, 1987 October 1. 1987 511961 0029 chemicals Known to Cause Cancar or Reproductive Toxicicy Page 3 7 MgglCll CAS Number Soots, cart and lubricant base oila and darlvad -- produces, specifically vacuus distillates, acid treated oils, aromatic oils, mildly solventrefined oils, mildly hydrotreated oils, used engine oila, and mineral oils, whan used in occupations such as aulespinning, etal machining, and jute processing. Thorium dioxide Treosulfan 1314201 299752 Vinyl chloride 75014 REPRODUCTIVE TOXICANTS Aainopterin Chloreycllzlne hydrochloride l,2*Dibromo-3*chloropropane (DBCP) Diethylstilbestrol (DES) Diphenylhydantoin Ethyl alcohol in alcoholic beverages Ethylene oxide Etretinate Isotretinoin Load Methyl mercury Thaiidomide Valproate Warfarin 54626 82939 96128 56531 630933 64175 75218 54350480 4759482 7439921 -- 50351 99661 81812 ----------Mi February 27, 1987 February 27. 1987 February 27. 1987 February 27. 1987 July 1, 1987 July 1, 1987 February 27, 1987 July 1, 1987 July 1, 1987 October 1, 1987 February 27, 1987 July 1, 1987 July 1, 1987 February 27. 1987 July 1, 1987 July 1, 1987 July 1, 1987 July 1, 1987 T- 511961 0030 RECOMMENDATIONS OF THE SCIENTIFIC ADVISORY PANEL AT ITS MEETINC OF OCTOBER 30, 1987, FOR LISTING AS CHEMICALS KNOWN TO THE STATE TO CAUSE CANCER Carcinogens 1. Aflatoxins 2. Carrageenan (degraded) (not food grade carrageenan) 3. Chlordecone (Kepone) 4. l-(2-Chloroethyl)-3-cyclohexyl-l-nltrosourea (CCNU) 5. 4-Chloro-ortho-phenylenediamine 6. para*Cresldlne 7. Cupferron 8. Cycasln 9. Dacarbazine 10. Daunomycin 11. 2,4-Dlaainoanisole sulfate 12. 4,4'-Diaminodiphenyl ether 13. 2,4'Dlanlnotoluene 14. Dlbenz{a,h]acridine 15. Dibenz[a,J]acridine 16. Dibenz[a,h]anthracene 17. 7H*Dlbenzo(c,g]carbazole 18. Dlbenzo(a,e]pyrene 19. Dibenzofa,h]pyrene 20. Dlbenzo[a,1]pyrene 21. Dlbenzo[a,l]pyrene 22. 3,3*-Dichloro-4,4'-diaalnodiphenyl ether 23. Dlepoxybutane 24. Dl(2-ethylhexyl)phthalate 25. 1,2-Dlethylhydrazine 26. Diethyl sulfate 27. Dihydrosafrole 28. 3-3'-Dimethoxybenzldlne (ortho-Dianlasidine) 2- - 29. 4>Dinethylanlnoazobenzene 30. trans-2-((Dlmethylamino)methylinlno] -5- [2-5-nltro-2-furyl) vinyl]-1,3,4-oxadlazole 31. 3,3'Dlnethylbenzldlne (ortho-Tolldlne) 32. Dimethylcarbanoyi chloride 33. 1,2 Dimethylhydrazlne 34. Dinethy1 sulfate 35. l,4*Dloxane 36. Direct Black 38 (technical grade) 37. Direct Blue 6 (technical grade) 38. Estradiol 17B .39. Estrone 40. Ethlnylestradlol 41. Ethyleneimlne 42. Ethylene thiourea 43. Ethyl nethanesulfonate 44. Formaldehyde (gas) 45. Formylhydrazlno)-4-(5-nltro-2*furyl)thiazole 46. Glyclaldehyde 47. Gyronltrin (acetaldehyde nethylforaylhydrazone) 48. Hexanethylphosphoramlde 49. Hydrazine and hydrazine sulfate 50. HydraZobenzene ^ 51. Panfuran S 52. Polychlorinated biphenyls (containing 60 or more percent chlorine) 53. 2,3,7,8-Tetrachlorodlbenzo-para-dloxln (TCDD) 54. Toxaphene (polychorinated camphenes) 55. 2,4,6-Trlchlorophenol 511961 0032 CAVEAT We are asked to identify chemicals Toiuwn" to cause cancer or reproductive toxicity. The identification of chemicals that are potential human carcinogens or teratogens relics largely upon results of rodent bioassays. About 1/2 af all chemicals examined for carcinogenicity, whether natural or man-made, induce tumors in rodents, and over 1/3 of all chemicals tested for teratogenicity Induce birth defects. The tests are conducted at the maximum tolerated (toxic) dose, and few of these chemicals have been tested below 10% of the toxic dose and scarcely any below 1% of the toxic dose. Thus, a chemical may not be said to be "known" to cause cancer except at doses dose to the toxie dose, yet pollution levels are rarely above 0.001% of the toxie dose. Neither sdentiiic theory nor technique is capable at present of resolving the question of whether hazards exist for human exposure to chemicals at levels far below the toxic dose: expert opinion of the risk ranges from small (proportional to exposure dose) to zero. A high percentage of the neutral chemicals ingested by humans arc likely to be rodent carcinogens or teratogens at near-toxic doses. For example, natural carcinogens are present in mushrooms, celery, parsley, basil, mustard, peanut boner, fruit juices, coffee, tea. cooked food, bread, cola drinks, and alcoholic beverages. The vast bulk (at least 99.9%) of the chemicals wc am exposed to in our food and drink are natural substances, and only a tiny proportion have been examined for carcinogenicity or teratogenidty. However. Proposition 65 does not specify what level of carcinogen, other than the detectable level, poses a significant risk. This is especially important as scientists are now capable of detecting chemicals at a level of one putt per billion (one person in all of Ouna) or one pan per trillion (1/16 of an inch of the distance from here to the moon). For the pand to list chrmicah without setting a tie minimis levd to the listing creates a substantial likelihood that the listing will have important legal and practical consequences, and may suggest sdenafic conditions, that are totally unwarranted by the scientific data underlying the listing. Thus, we believe that it is essential to set a tie minimis level for all of the chemicals. Since scientists do not know enough to calculate risk for humans for low exposures to chemicals and in view of the above points, the panel believes a relative rale is the best tie minimis guide to follow. The panel believes an appropriate tie minimis level for the daily intake into humans for the carcinogens) under discussion is the level giving a possible hazard equivalent to that EPA now cans:den acceptable as a result of chlorination of drinking water. EPA allows 100 ppb of chloroform due to chlorination and assumes 2 liters daily consumption: the avenge U-S. tap water hai been estimated at about 83 ppb. In proposing this standard wc stress that wc do not imply that exposure to levels above the tie minimis lcvd pose a significant risk. The natural carcinogens in our daily food and drink rank enormously higher as possible hazards than tap water, yet it is not at all dear that even these represent significant risks, as normally the levels are sufficiently bdow me toxic lcvd. We are merely saying that a listed chemical should be ign6red in terms of public health concern where the chemical is present bdow the tie nunimis level because that level of risk should be regarded as irrelevant. r Addendum We recognize that this is a complex subject requiring consideration of a number of interrelated issues, including how and where possible hazard is measured, what length of exposure is assumed, and bow de minimis is defined for both carcinogens and teratogens. We believe, therefore, that this issue should be the subject of a separate hearing by this pand or by the Health and Wdfare Agency with our panicipauon. In the interim, however, the pand is prepared to adopt the above provisional standard. 511961 0033 CWaorucoi3 reoieujGci b<-j Ca.lforma SftP o3 DfiCJ5.mtxir U j putii'nfl SAP made no decision on chemicaxs marked with check. CHEHICAL Indeno[1,2,3-cd]pyrene Iron dexcren conplex Lead aceCaCe ^ Lead phosphate 2 He thy1 az 1 r Idlne (propylene inine) 4 ,4' -Methyl*nedianiline and Its dlhydrochlorlde \SMethyl lodite Metronidazole Hlchler's ketone Klrex Nltrllotrlacetlc acid V" 5-Nitro-o*anisidlne Nitrofen (technical grade) Nitrogen austard 2-Nltropropane N-Nitrosodiethanolaalne p-Nitrosodiphenylaaine N-Nitrosodi-n-propylaislne N-Nltrosoaethylvinylamlne N-Nitrosoaorpholine N-Nitrosonornicotine N-NltrosoplperIdlne N-Nltrososarcosine Oxynetholone N/^Phenacetln Phcnazopyrldlne and its hydrochloride Phenytoln and sodlua salt of phenytoin Polybroalnated biphenyls Procarbazine and its hydrochloride Progesterone 1,3-Propane sultona bete-Proplolectone Propy1thlourec11 'S'Keserplne Saccharin Safrole V^Sclentua sulfide Streptozotocln Sulfallate Thioacetaalde Thiourea V^toluene diisocyanate' ortho-Toluldlne and Its hydrochloride Trls(l-azlrldlnyl)phosphlne sulfide (thiotepa) Trls(2,3-dlbroaopropyl)phosphate Urethane 511961 0034 CAS Nv^ex 193395 9004664 301042 7446277 75558 101779 74884 443481 90948 2385855 139139 99592 1836755 302705 108032 1116547 156105 621647 4549400 59892 16543558 100754 13256229 434071 62442 136403 57410 366701 57830 1120714 57578 51525 50555 128449 94597 7488564 18883664 95067 62555 ; 62555 -584849 95534 52244 126727 51796 PROPOSED ACENDA Safe Drinking Water and Toxic Enforcement Act of 1986 Scientific Advisory Panel January 29, 198J 9:00 a.a. Wyatt Pavilion University of California, Davis I. Staff Reports II. Consideration of (1) tobacco smoke and (2) tobacco, oral use of snokeless products, which have been Identified by the International Agency for Research on Cancer (IARC) as having sufficient evidence of carcinogenicity in hunans, as chemicals known to the State to cause cancer. III. Consideration of tobacco smoke as known to the State to cause reproductive toxicity. IV. Consideration of candidate chemicals identified as probable carcinogens by IARC as known to the State to cause cancer. Chemical CAS Number Lasiocarpine 303344 Herphalan Mestranol 5-Methyl chrysene Methylazoxymethanol; methylozaoxymethyl acetate 4,4'-Methylene bis(2-methylaniline) Methyl methanesulfonate 2-Methyl-l-nitroanthraquinone (of uncertain purity) N-Hethyl-N'-Nitro-N-nitrosoguanidlne Mitomycin C Monocrotaline 5- (Morpholinomethyl)-3-[(5-nitro-furfurylldene)- amino]2-oxalolidlnone 531760 72333 3697243 592621 838880 66273 129157 70257 50077 315220 139913 Nafenopin Nirldazole 4- Nitrobiphenyl 5- Nitroacenaphthene 1-[(5-Nitrofurfurylidene)-amino]-2-lmidazolidinone N-(4-(5-Nitro*2-furyl)-2-thiazolyl]acetaraide Nitrogen mustard and its hydrochloride Nitrogen mustard N-oxide and its hydrochloride N-Nitroso-N-methylurethane 3771195 61574 92933 602879 555840 531828 51752 302705 615532 Orange Oil SS 2646175 Phenoxybenzamlne and its hydrochloride Ponceau MX Ponceau 3R 598&1 3761533 3564098 Sterlgmatocystin 10048132 511961 0035 -2- Testosterone and it* esters 4,4' -Thiodianiline * ortho-Toluidine and its hydrochloride Trp-P*l (Tryptophan-P-1) Trp-P-2 (Tryptophan*P-2) Trypan Blue (commercial grade) Uracil Bustard 58220 139651 636215 62450060 62450071 72S71 66751 V. Consideration of the following chemicals identified as probable carcinogens by the Environmental Protection Agency's Carcinogen Assessment Croup, as known to Che State to cause cancer. Chemical CAS Number Acetaldehyde Aldrin Allyl chloride 1,3-Butadiene Chlordane Dichloromethane (Methylene chloride) Dicldrin 2,4-Dinitrocoluene Diphenylhydrazine Bis(2-chloroethyl)ether Heptaehlor Heptachlor epoxide Hexachlorodibenzodioxln N-nitroso-diphenylamine Tetrachloroethylene (Perchloroethylene) Trichloroethylene Unleaded gasoline vapor 75070 309002 107051 106990 57749 75092 60S71 121142 122667 111444 76448 1024573 34465468 86306 1071 79016 --- VI. DISCUSSION ITEM. At the next meeting, consideration of ethyl alcohol and/or alcoholic beverages as substances known to the State Co cause cancer. ^ VII. Public Comments NOTE: Anyone interested in submitting comments to the Panel on any agenda item should sent those comments to: State of California, Health and Welfare Agency, 1600 Ninth Street, Room 450, Sacramenco, California 95814. NEXT MEETINC: April, 1988 (tentative). Agenda: (a) ethyl alcohol/alcoholic beverages as carcinogens (b) reproductive toxins. 511961 0036