Document zdyopJg11zYJd9LM1xw2Ybkmz

To MEMORANDUM 1989 January 31 RE: California Proposition 65 - Update FDA Preemption The Whitehouse (Domestic Policy Council) gave the go ahead for the FDA to issue a preemption Regulation. The scope of such a regulation is not known but proposals could be published in the Fed. Reg. as early as March. Reportedly the FDA's proposal was sent to OMB last week for their review. Updated California List For your information an updated California list is attached which includes all chemicals recommended for listing Dec. 16 by the SAP (Science Advisory Panel). This new list includes: 238 carcinogens 39 reproductive toxicants 277 total chemicals Reproductive Toxicant Safety Factor SAP says the current 1000 fold safety factor for reproductive toxins is inappropriate and has no scientific basis. A bill has been introduced in California to replace the lOOOx safety factor with a sliding scale based on the quality of toxicology data. Passage of this bill would permit California's HWA to adopt less stringent safety factors for chemicals if there is good quality, human data. Despite the reasonableness of this proposal, this bill is not expected to pass in its present form. L. L. RIPPEY Prop65L.FDA LLR:mz r a ALCOA 511961 0002 STATE OF CALIFORNIA HEALTH AND WELFARE AGENCY SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT OF 1986 CHEMICALS KNOWN TO THE STATE TO CAUSE CANCER OR REPRODUCTIVE TOXICITY ( The Safe Drinking Waeer and Toxic Enforcement Act of 1986 requires that the Governor revise and republish at least once per year the list of chemicals known to the State to cause cancer or reproductive toxicity. The identification number indicated in the following list is the Chemical Abstracts Service (CAS) Registry Number. No CAS number is given when several substances are presented as a single listing. The date refers to the initial appearance of the chemical on the list. CHEMICALS KNOWN TO THE STATE TO CAUSE CANCER Chemical CAS Number Date Acetaldehyde 75070 Acetochlor 34256821 2-Ac e ty1aminofluorene 53963 Acrylonitrile 107131 Adriamycin 23214928 AF-2;[2-(2*furyl)-3-(5-nitro-2-furyl))acrylamide 3688537 Aflatoxins -- Alachlor 15972608 Alcoholic beverages, when associated with alcohol abuse -- Aldrin 309002 ortho-Aminoazotoluene 97563 4-Aminobiphenyl (4-aminodiphenyl) 92671 2 Amino-5-(5-nitro-2-furyl)-1,3,4-thiadiazole 712685 Amitrole 61825 ortho-Anisidine and ortho-Anisidine hydrochloride 90040 Analgesic mixtures containing phenacetin -- Aramite 140578 Arsenic (inorganic arsenic compounds) -- Asbestos 1332214 Auramine 492808 Azaserine 115026 Azathioprine 446866 April 1, 1988 / January 1, 1989 * July 1. 1987 July 1. 1987 July 1, 1987 July 1, 1987 January 1, 1988 y January 1, 1989S July 1, 1988 July 1, 1988 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 Benz[a]anthracene Benzene Benzidine [and its salts] Benzo[b]fluoranthene Beq*o[j]fluoranthene Betizo[k] fluoranthene Benzo[a]pyrene Benzotrichloride Benzyl violet 4B Beryllium and beryllium compounds Bis(2-chloroethyl)ether N,N-Bis(2-chloroethyl)-2-naphthylamine (Chlornapazine) Bischloroethyl nitrosourea (BCNU) Bis(chloromethyl)ether 1,3-Butadiene 1,4 -Butanediol dimethanesufonate (Mvleran) 56553 71432 92875 205992 205823 207089 50328 98077 1694093 -- 111444 494031 154938 542881 106990 55981 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 October 1, 1987 April 1, 1988 February 27, 1987 July 1, 1987 February 27, 1987 April 1. 1988 February 27, 1987 511961 0004 beta -Butyrolactone Cadmium and cadmium compounds Captafol Carbon tetrachloride Certain combined chemotherapy for lymphomas Chlorambucil Chlordane Chlordecone (Kepone) Chlordimeform 1- (2-Chloroethyl)*3-cyclohexyl-1-nitrosourea (CCNU) 1- (2-Chloroethyl)-3-(4-methylcyclohexyl)-1- nitrosourea (Methyl-CCNU) Chloroform Chloromethyl methyl ether (technical grade) 4 - Chloro-ortho -phenylehediamine Chlorothalonil Chromium (hexavalent compounds) Cisplatin Coke oven emissions Conjugated estrogens Creosotes para-Cresidine Cupferron Cycasin Cyclophosphamide Dacarbazine Daunomycin DDD (Dichlorodiphenyldichloroethane) DDE (Dichlorodiphenyldichloroethylene) DDT (Dichlorodiphenyltrichloroethane) DDVP (Dichlorvos) 2,4-Diaminoanisole sulfate 4,4'-Diaminodiphenyl ether 2,4'Diaminotoluene Dibenz[a,h]acridine Dibenzfa,j]acridine Dibenz[a,h]anthracene 7H-Dibenzo[c,g]carbazole Dibenzo[a,e]pyrene Dibenzo[a,h]pyrene Dibenzo[a,i]pyrene Dibenzo[a,1]pyrene .1,2-Dibromo-3-chloropropane (DBCP) p^Cichlorobenzene 3-3'-Dichlorobenzidine 3.3' -Dichloro-4,4'-diaminodiphenyl ether Dichloromethane (Methylene chloride) Dieldrin Diepoxybutane Di(2-ethylhexyl)phthalate 1,2-Diethylhydrazine Diethyl sulfate Diethylstilbestrol Dihydrosafrole 3068880 ___ 2425061 56235 ... 305033 57749 143500 6164983 13010474 13909096 67663 107302 95830 1897456 -- 15663871 -- -- -- 120718 135206 14901087 50180 4342034 20830813 72548 72559 50293 62737 39156417 101804 95807 226368 224420 53703 194592 192654 189640 189559 191300 96128 106467 91941 28434868 75092 60571 1464535 117817 1615801 64675 56531 94586 July 1. 1987 October 1, 1987 October 1, 1988 October 1, 1987 February 27, 1987 February 27, 1987 July 1. 1988 January 1, 1988 January 1, 1989 January 1, 1988 October 1, 1988 October 1, 1987 February 27, 1987 January 1, 1988 January 1, 1989 is February 27, 1987 October 1, 1988 February 27, 1987 February 27, 1987 October 1, 1988 January 1, 1988 January 1, 1988. January 1, 1988 February 27, 1987 - January 1, 1988 January 1, 1988 / January 1, 1989. January 1, 1989 / October 1, 1987 January 1, 1989 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 July 1, 1987 January 1, 1989i/ October 1, 1987 January 1, 1988 April 1, 1988 July 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 February 27, 1987 January 1, 1988 511961 0005 3-3'-Dimethoxybenzidine (ortho-Dianiasidine) 4-Dimethylaminoazobenzene trans-2-[(Dimethylamino)methylimino]-5-[2-5-nitro-2- furyl)vinyl]-1,3,4-oxadiazole 3,3'Dimethylbenzidine (ortho-Tolidine) Dimethylcarbamoyl chloride 1,2 Dimethylhydrazine Dimethyl sulfate 2,4-Dinitrotoluene 1,4-Dioxane Diphenylhydrazine Direct Black 38 (technical grade) Direct Blue 6 (technical grade) Direct Brown 95 (technical grade) Epichlorohydrin Erionite Estradiol 17 B Estrone Ethinylestradiol Ethylene dibromide Ethylene dichloride (1,2-Dichloroethane) Ethyleneimine Ethylene oxide Ethylene thiourea Ethyl methanesulfonate Folpet Formaldehyde (gas) 2-(2-Formylhydrazino)-4-(5-nitro-2-furyl)thiazole Glycialdehyde Gyromitrin (acetaldehyde methylformylhydrazone) Heptachlor Heptachlor epoxide Hexachlorobenzene Hexachlorocyclohexane (technical gtade) Hexachlorodibenzodioxin Hexamethylphosphoramide Hydrazine and hydrazine sulfate Hydrazobenzene Indeno [1,2,3-cdjpyrene Iron'^dextran complex Lactof^n Lasiocarpine Lead acetate Lead phosphate Melphalan Merphalan Hestranol 8-Methoxypsoralen with ultraviolet A therapy 5-Methoxypsoralen with ultraviolet A therapy 119904 60117 55738540 119937 79447 540738 77781 121142 123911 122667 1937377 2602462 16071866 106898 12510428 50282 53167 57636 106934 107062 151564 75218 96457 62500 133073 50000 3570750 765344 16568028 76448 1024573 118741 -- 34465468 680319 302012 530507 193395 9004664 77501634 303344 301042 7446277 148823 531760 72333 298817 484208 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 July 1. 1988 January 1, 1988 April 1, 1988 January 1, 1988 January 1, 1988 October 1, 1988 October 1. 1987 October 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 July 1. 1987 October 1, 1987 January 1, 1988 July 1, 1987 January 1, 1988 January 1, 1988 January 1, 1989 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 July 1, 1988 July 1, 1988 October 1. 1987 October 1, 1987 April 1. 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1989 April 1, 1988 January 1, 1988 April 1, 1988 February 27, 191 April 1, 1988 April 1, 1988 February 27, 191 October 1, 1988 V f3 511961 0006 5 .ethyIchryscne ' Methylaziridine (propyleneiroine) e thy1azoxyme thanol Metnylazoxymethanol acecace 4,4' -Methylene bis(2-methylaniline) 4 ,4'Methylene bis(2-chloroaniline) 4,4'Methylenedianiline and its dihydrochloride Methyl iodide Methyl methanesulfonate 2-Methyl-l-nitroanthraquinone (of uncertain purity) N-Me thyl-N'-Nitro-N-nitrosoguanidine Metronidazole Michler's ketone Mirex Mitomycin C Monocrotaline 5- (Morpholinomethyl)-3-((5-nitro-furfurylidene)- amino]-2-oxalolidinone Mustard Gas 3697243 75558 14901087 592621 838880 101144 101779 74884 66273 129157 70257 443481 90948 2385855 50077 315220 139913 505602 Nafenopin 3771195 2-Naphthylamine 91598 Nickel refinery dust from the pyrometallurgical process Nickel carbonyl 13463393 Nickel subsulfide 12035722 Niridazole 61574 Nitrilotriacetic acid 139139 4-Nitrobiphenyl 92933 5-Nitroacenaphthene 602879 Nitrofen (technical grade) 1836755 1 - [ (5-Nitrofurfurylidene)-amino]-2-imidazolidinone 555840 N-(4-(5-Nitro-2-furyl)-2-thiazolyljacetamide 531828 Nitrogen mustard 51752 Nitrogen mustard hydrochloride 55867 Nitrogen mustard N-oxide and its hydrochloride 302705 2-Nitropropane 79469 N-Nitrosodi-n-butylamine 924163 N-Nitrosodiethanolamine 1116547 N-Nitrosodiethylamine 55185 N-Nitrosodimethylamine 62759 p-Nitrosodiphenylamine N-Nitrosodi-n-propylamine 156105 621647 N-Nitroso-diphenylamine 86306 N-Nitroso-N-ethylurea 759739 N-Nitroso-N-me thylurea 684935 N-Nitroso-N-methylurethane N-fJitrosomethylvinylamine 615532 4549400 N-Nitrosomorpholine 59892 N-Nitrosonornicotine 16543558 N-Nitrosopiperidine 100754 N-Nitrosopyrrolidine 930552 N-Nitrososarcosine 13256229 Oil Orange SS c Oxymetholone 2646175 434071 April 1, 1988 January 1, 1988 April 1. 1988 April 1. 1988 April 1. 1988 July 1, 1987 January 1, 1988 April 1, 1988 April 1. 1988 April 1, 1988 April 1. 1988 January 1, 1968 January 1, 1968 January 1, 1988 April 1, 1988 April 1. 1988 April 1. 1988 February 27, 1987 April 1, 1988 February 27, 1987 October 1, 1987 October 1, 1987 October 1, 1987 April 1. 1988 January 1, 1988 April 1, 1988 April 1, 1988 January 1, 1988 April 1. 1988 April 1. 1988 January 1, 1988 April 1, 1988 April 1. 1988 January 1, 1988 October 1, 1987 January 1, 1988 October 1, 1987 October 1, 1987 January 1, 1988 January 1, 1988 April 1, 1988 October 1, 1987 October 1, 1987 April 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 October 1, 1987 January 1, 1988 April 1. 1988 January 1, 1988 511961 0007 P .ifuran S ' lenazopyridine and its hydrochloride henoxybenzamine and its hydrochloride Phenytoin and sodium salt of phenytoin Polybrominated biphenyls Polychlorinated biphenyls (containing 60 or more percent chlorine by molecular weight) Polygeenan Ponceau MX Ponceau 3R Procarbazine and its hydrochloride Progesterone 1,3-Propane sultone beta-Propiolactone Propylene oxide Propylthiouracil -- 136403 59861 57410 ... ... 53973981 3761533 3564098 366701 57830 1120714 57578 75569 51525 Sodium saccharin 128449 Safrole 94597 Silica, crystalline (airborne particles of -- respirable size) Soots, tars, and lubricant base oils and derived -- products, specifically vacuum distillates, acid treated oils, aromatic oils, mildly solvent-refined oils, mildly hydrotreated oils, and used engine oils; and mineral oils, when used in occupations such as mulespinning, metal machining, and jute processing. Sterigmatocystin 10048132 Streptozotocin 18883664 Styrene oxide 96093 Sulfallate 95067 Telone II (1,3-Dichloropropene) Testosterone and its esters 2,3,7,8-Tetrachlorodibenzo-para-dioxin (TCDD) Tetrachloroethylene (Perchloroethylene) Thioacetamide 4,4'-Thiodianiline Thiourea Thorium dioxide Tobacco, oral use of smokeless products Tobacco smoke ortho-Toluidine and its hydrochloride Toxaphene (polychorinated camphenes) Treosulfan 2, dy6-Trichlorophenol Trichloroethylene Tris(l-aziridinyl)phosphine sulfide (thiotepa) Tris(2.3-dibromopropyl)phosphate Trp-P-1 (Tryptophan-P-1) Trp-P-2 (Tryptophan-P-2) , 542756 58220 1746016 127184 62555 139651 62566 1314201 -- -- 95534 8001352 299752 88062 79016 52244 126727 62450060 62450071 Unleaded gasoline (wholly vaporized) Uracil mustard Urethane (Ethyl carbamate) -- 66751 51796 January 1, 1988 January 1, 1988 April 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 April 1, 1988 April 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 January 1, 1988 October 1, 1988 January 1, 1988 ' January 1, 1988 January 1, 1988 October 1, 1988 February 27, 1987 April 1, 1988 January 1, 1988 October 1, 1988 January 1, 1988 S' V / January 1, 198Sr April 1, 1988 January 1, 1988 April 1, 1988 January 1, 1988 April 1, 1988 January 1, 1988 February 27, 1987 April 1, 1988 April 1, 1988 January 1, 1988 January 1, 1988 February 27, 1987 January 1, 1988 April 1, 1988 January 1, 1988 January 1, 1988 April 1, 1988 April 1, 1988 April 1, 1988 April 1, 1988 January 1, 1988 511961 0008 Vinyl bromide Vinyl chloride Developmental toxicity All-trans retinoic acid Aminopterin Busulfan Chlorcyclizine hydrochloride Chlorambucil Chlordecone (Kepone) Cycloheximide Cyclophosphamide Cyhexatin Cytarabine Diethylstilbestrol (DES) Dinoseb Diphenylhydantoin Ethyl alcohol in alcoholic beverages . fl Ethylene glycol monoethyl ether ,i Ethylene glycol monomethyl ether tyJijfcdL Etretinate ^ Flugraur^cil Hexachlorobenzene Iodine-131 Isotretinoin Lead Mechlorethamine Methotrexate Methyl mercury Thalidomide Tojhacco smoke (not environmental * tobacco smoke) Valproate Warfarin Female reproductive toxicity Aminopterin Ethylene ox'rfo (j 593602 75014 October 1, 1988 February 27, 1987 SE REPRODUCTIVE TOXICITY 302794 54626 55981 82939 305033 143500 66819 6055192 13121705 147944 56531 88857 57410 64175 110805 109864 54350480 51218 118741 24267569 4759482 ... 51752 59052 -- 50351 -- 99661 81812 January 1, 1989 ^ July 1, 1987 / January 1, 1989 / July 1, 1987 . January 1, 1989 // January 1, 1989 // January 1, 1989*^ January 1, 1989 * January 1, 1989 v/ January 1, 1989 July 1, 1987 January 1, 1989 July 1. 1987 / October 1, 1987 . January 1, 1989 / January 1, 1989 ,y July 1, 1987 January 1, 1989 January 1, 1989 January 1, 1989 July 1, 1987 February 27, 1987 ^ January 1, 1989 January 1, 1989 July 1, 1987 July 1, 1987 April 1. 1988 July 1, 1987 July 1. 1987 54626 75218 July 1, 1987 February 27, 1987 511961 0009 Lead Tobacco smoke (not environmental tobacco smoke) Male reproductive toxicity 1,2-Dibromo-3-chloropropane (DBCP) Dinoseb Ethylene glycol monoethyl ether Ethylene glycol monomethyl ether Lead Tobacco smoke (not environmental tobacco smoke) Date: January 1, 1989 February 27, 1987 ----- April 1, 1988 96128 888S7 110805 109864 -- February 27, 1987 January 1, 1989^ January 1, 1989 January 1, 1989 February 27, 1987 April 1, 1988 S71967 0010