Document M4Nm7NEe2GRR4rZmpg7z2bb87

alifornia Environmental Protection Agency FFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT January 27,1995 State of California Pete Wilson. Governor Has Shah, Ph.D. Chemical Manufacturers Association 2501 M Street NW Washington D.C., 20037 Dear Dr. Shah: Thank you for your phone call yesterday, following-up on a copy of a letter from this Office dated September 19,1994 to Francoise Drion, M.D., Association of Plastics Manufacturers in Europe, regarding the worldwide registry of cases of liver angiosarcoma from occupational exposure to vinyl chloride. As explained in the letter, the Office of Environmental Health Hazard Association (OEHHA) is completing a health risk assessment of exposure to vinyl chloride in a residentialoommunity immediately adjacent to a closed hazardous waste landfill. Enclosed, as you requested, is a copy of the November 1990 interim health risk assessment of the landfill, and the October 1990 proposed identification of vinylchloride as a Toxic Air Contaminant in California. In Decem*iar1890, Hie Air Resources Board adcjted the unit risk value for vinyl chloride recommended in the October report (20 x 10" [ppbf1). In July 1991, Governor Wilson created the California Environmental Protection Agency (Cal/EPA). The Hazardous Waste Toxicology Section, which prepared the interim health risk assessment and the Air Toxicology and Epidemiology Section, which prepared the Toxic Air Contaminant report, were transferred from the Department of Health Services to OEHHA in Cal/EPA You mentioned the Chemical Manufacturers Association nine-member panel of manufacturers of vinyl chloride in the United States. I would like to take this opportunity to ask if any of the manufacturers could provide clarification regarding the New York resident diagnosed with liver angiosarcoma reported by Brady etaL, in "Angiosarcoma of the Liven An Epidemiologic Survey", Journal of the National Cancer Institute, 1977, 59(5): 1383-11385. The authors state "Of possible importance is the fact that the ambient emissions of VC monomer for the factory located approximately 1,700 feet from the residence of patient #10 were as high as 92,800 parts per million in 1975."' I am looking forward to receiving the articles and information you are sending, and to further discussions with you. Sincerely, Enclosure Lillian J. Kelly, M.P.H. Associate Hazardous Materials Specialist Hazardous Waste Toxicology Section 601 North 7ih Street P O. Box 942732 Sacramento, CA 94234-7320 (916)324-7572 R&S145738 PROPOSAL FOR PRIORITIZING CANDIDATE AGENTS FOR CONSIDERATION UNDER PROPOSITION 65 BY THE OEHHA SCIENCE ADVISORY BOARD Reproductive and Cancer Hazard Assessment Section Office ofEnvironmental Health Hazard Assessment California Environmental Protection Agency April 7,1995 1 BACKGROUND The Safe Drinking Water and Toxic Enforcement Act (Proposition 65, California Health and Safety Code 25249.5 et seq.) requires the Governor to publish lists of agents known to cause cancer and reproductive toxicity. One of the mechanisms by which an agent is placed on this list is a finding by the "state's qualified experts'* that an agent has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity. As lead agency for the implementation ofProposition 65, the Office of Environmental Health Hazard Assessment (OEHHA) has formed two committees of the Science Advisory Board (SAB) to serve as the state's qualified experts. These committees are the Developmental and Reproductive Toxicant (DART) Identification Committee and the Carcinogen identification Committee. The purpose of this draft document is to propose a mechanism for compiling and prioritizing candidate agents for consideration by the SAB Identification Committees. The proposed mechanism provides a systematic process for compiling and tracking possible candidate agents and for prioritizing these agents for consideration by the Identification Committees. Key elements include (1) a database to track agents suggested for consideration, (2) development by OEHHA of a priority list of agents, grouped into high, medium, or low priority on the basis of their potential for human exposure and developmental/reproductive or carcinogenic hazard, and (3) expert review in the final prioritization of agents. Opportunity is provided for input and review by state agencies and departments, the scientific community, and other interested parties both in the suggestion of candidate agents and the development of the priority lists. As emphasized by California's Court of Appeal (1989), Proposition 65 directs the state "to engage in a diligent, thorough, and continuing search for additional chemicals which evolving scientific knowledge demonstrates are subject to the Act." Accordingly, the meeting agendas of the Identification Committees will largely be taken up by consideration of potential candidates for listing generated by this process. Other items that may compete for space on the agendas include, for example, proposed delistings of particular agents or general scientific issues to be considered in listing. 1 R&S145739 FIGURE 1: FLOWCHART FOR CONSIDERATION OF AGENTS UNDER PROPOSITION 65 4/7/q*; OEHHA REVIEWS DATA AND CONDUCTS PRIORITIZATION: OEHHA PREPARES SUPPORTING D'(bCUMENTATION ON ALL AGENTS AND SYNOPSES ON HIC H PRIORITY AGENTS C PRIORITY LIST 3 PUBLIC MEETING: COMMITTEE REVIE WS AND DISCUSSES PRIORITY LIST. AND SELECTS AGENTS FROM HIGH PRIC RITY CATEGORY FOR CONSIDERATION c AGENTS UNDER COMMITTEE CONSIDERATION FOR LISTING 3 45-DAY PUBLIC NOTICE ISSUED; DATA < OLLECTED AND ANALYZED BY OEHHA c I' _L. HAZARD IDENTIFICATION DOCUMENT 3 DOCUMENT RELEASED 60 DAYS PRIOR TO PUBLIC MEETING; DELIBERATION OF AGENTS PUBLIC COMMITTEE MEETING [ c AGENTS LISTED C AGENTS NOT LISTED i ( AGENTS *\ I DEFERRED \ \ DEVELOPMENT OF ACTION PIAN R&S145740 TRACKING DATABASE TIER I SCREENING BY OEHH/k FOR AVAILABILITY OF DATA XD BEGIN PRIORITIZATION T TIER II OEHHA REVIEWS DATA AND CONDUCTS PRIORITIZATION; OEHHA PREPARES SUPPORTING D (JJCUMENTATION ON ALL AGENTS AND SYNOPSES ON Hl<3H PRIORITY AGENTS i C )PRIORITY LIST D500* C-sJjl  w-** Name f Agent acetazolamide acrylamide acrylonitrile aldrin aminoacetonitrile aminonicotinamide, 6* aminopropionrtrile, Bammonium perfluorooctanoate aniline apholate arsenic (inorganic) arsenous oxide asparaginase, L AY-9944 azacytidine, 5azauridine balagnn benzene benzo(a]pyrene beryllium betamethasone boric acid boron bromo-^-deoxyuridine. 5bromodichloromethane butadiene, 1,3butyl ester, 2,4,5-T butyl ester, 2,4-0 cadmium cadmium sulfate caffeine cannabis captan carbamazepine carbon dioxide carbon tetrachloride carbutamide chloramphenicol chlordane chlorfenvinfos chloroform chlorohydrin chloroprene chromium trioxide chromium VI copper sulfate corticosterone cyclizine [DDE GAS# 59665 79061 107131 309002 540614 329895 151188 3825261 62533 52460 7440382 1327533 9015683 366938 320672 54251 71330433 71432 50328 7440417 378449 10043353 7440428 59143 75274 106990 93798 94804 7440439 10124364 58082 8063147 133062 36507309 124389 56235 339435 56757 i 57749 470906 ! 67663 ; 96242 126998 1 1333820 I 18540299 7758987 50226 i 82928 1 72559 R&S 145742 PROPOSITION 65 PRIORITY LIST - CANDjjttTE AGENTS UNDER CONSIDERATION hOK DEVELOPMENTAL AND REPROBTCTIVE TOXICITY EVALUTATION*1* Nam of Agent Acrylamide Aldrin 1,3-Butadiene Carbamazepine Carbon tetrachloride Chlordane ddt(3> Ethylene dibromide Formaldehyde Heptachlor Methylene chloride Progesterone 2,4,5-T, butyl ester Trichloroethylene Vinyl chloride CAS ft Level of Toxicological Concern^2*3 4 79061 309002 106990 36507309 56235 57749 50293 106934 50000 76448 75092 57830 High High Medium High Medium High High High Low High Low High 93796 79016 75014 Low Medium Medium Level of Exposure Concern Medium Low Medium Low Medium Low Medium Low High Low High Low Low .High Medium Priority Status - DART High Medium Medium Medium Medium Medium High Medium Medium Medium Medium Medium^ Low High Medium (1) Priority chemicals from Donald, JM, Monserrat, LG, Hooper, K, Book, SA and Chemdff, GF (1992). Prioritizing candidate reproductive/developmental toxicants for evaluation. Reprod Toxicol 6:99*108. (2) The evaluation of the level of toxicological concern is based on secondary sources (databases and reviews). It is fikely that data exist which have been considered in the evaluation. In a more detailed review, additional data may be found that wifi after the assigned "level of toxicologic concert Consequently, a "low" or "medium" level of toxicologic concern should not be interpreted to mean that the chemical has littfe or no potential to cau reproductive or developmental effects. (3) Would also include consideration of major metabolites and breakdown products such as DDE (CAS # 72559) and DDD (CAS # 72546). (4) Progesterone is intentionally used as a contraceptive. Unintentional exposures are believed to be low. 4/7/95 ewsnsvu Page 1 of 1 DRAFT LO exposure concern; HI/MED toxicity concern aldrin chlordane ethylene dibromide heptachlor 2,4,5-butyl ester progesterone carbamazepine HI exposure concern; LO toxicity concern formaldehyde methylene chloride MED exposure concern; MED toxicity concern 1,3-butadiene carbon tetrachloride vinyl chloride HI PRIORITY AGENTS acrylamide DDT trichloroethylene DRAFT P65 DART TRACKING DATABASE - TIER I AGENTS Name of Agent acetazoiamide acrylamide acrylonitrile aldrin aminoacetonitrile aminonicotinamide, 6aminoproptonitriie, B- ammonium perfluorooctanoate aniline apholate arsenic (inorganic) arsenous oxide asparaginase, L AY-9944 azacytidine, 5azaundine balagrin benzene benzofalpyrene beryllium betamethasone boric acid boron bromo-Z-deoxyuridine, 5bromodichloromethane butadiene, 1,3butyl ester, 2.4.5-T butyl ester, 2.4-D cadmium cadmium sulfate caffeine cannabis captan carbamazepine carbon dioxide carbon tetrachloride carbutamide chloramphenicol chlordane chlorfenvinfos chloroform chlorohydrin chloroprene chromium trioxide chromium VI copper sulfate corticosterone cyclizine DDE 4/7/95 I CAS# 59665 79061 107131 309002 540614 329895 151188 3825261 62533 52460 7440382 1327533 9015683 366938 320672 54251 71330433 71432 50328 7440417 378449 10043353 7440428 59143 75274 106990 93798 94804 7440439 10124364 58082 8063147 133062 36507309 124389 56235 339435 56757 57749 470906 67663 96242 126998 1333820 18540299 7758987 50226 82928 1 72559 R&S145745 Page 1 of 4 DRAFT P65 DART TRACKING DATABASE - TIER I AGENTS DDT diaminostilbene dichloroethylene. 1,1dichloropropane, 1.2diekJrin diethylene glycol diethyl ether diethylene glycol dimethyl ether diethylene glycol methyl ether diethyihexy! phthalate diltiazem dimethyl acetamide dimethyM ,2-benz(a)anthracene. 7,12dimpylate dinitrotoluene, 2.6dromostanolone propionate EM 12 endrin enflurane environmental tobacco smoke epichlorohydrin estradiol. 17-beta ethisterone ethosuximide ethoxyethyt acetate. 2ethylene dibromide ethylene glycol diethyl ether ethylene glycol dimethyl ether ethytnitrosourea ethylnytestradiol etizoiam fluoroacetate folpet formaldehyde formamide furylfuramide gnseofulvin hadacidin halothane heptachlor heroin hexamethylene diisocyanate hexane. N- hydroxy-oxo-L-norvaline hydroxyprogesterone hydroxytryptophan. 5hyroxyurea idoxundine indomethacin insulin (natural) karathane * 4/7/95 1 50293 1 621965 ! 75354 I 78875 1 60571 1 112367 1 111966 1 111773 1 117817 142399417 1 127195 1 57976 1 333415 125321146 1 521120 126581817 i 72208 13838169 i 106898 1 50282 1 434037 1 77678 1 111159 1 106934 1 629141 1 110714 1 759739 1 57636 i40054691 1 144490 133073 50000 75127 1 3688537 | 126078 1 689134 1 151677 I 76448 1 561273 I 822060 i 110543 1 4439843 1 68962 1 56699 1 127071 1 54422 1 53861 I 9004108 139300453 R&S145746 Page 2 of 4 DRAFT P65 DART TRACKING DATABASE - TIER I AGENTS 4/7/95 manganese 7439965 mestranoi 72333 methadone 76993 methandrostenolone 72639 methoxyethyi acetate. 2- 110496 methoxyflurane 76380 methyl 2(p*allophanoylbenzyi)hydrazine. 1- 60344 methyl butyl Ketone 591786 methyl chloride 74873 methyl PGA, X- methyl salicylate 119368 methylacetamide, N- 79163 methylazoxymethanol 590965 methylene bis(4-cyclohexyiisocyanate) 5124301 methylene chloride 75092 methylformamide 123397 methylpyrrotidone. N- 872504 monocrotophos 6923224 monosodium glutamate 142472 myclobutniil 88671890 N-methylnitrosourea (n-nitroso-n-methylurea) 684935 n-nitroso bis(2-oxopropyl)amine 60599384 nickel carbonyl 13463393 nitrochlorebenzene. p- 100005 nitrofen 1836755 nitroquinolone-1 -oxide, 4- 56575 nitrous oxide 10024972 ochratoxin A 303479 oxydemeton-methyl oxytocin phencyclidine (PCP) 301122 50566 77101 phenol 108952 phenoxybenzamine 59961 phenylalanine (DL) 3617445 prednisolone 50248 primidone 125337 progesterone 57830 propargite 2312358 propylene glycol methyl ether, beta-isomer (PGME-beta. 2-methoxy-1 -propanol) 1589497 pyrimethamine 58140 razoxane red palm oil Ro 10-9359 24584096 8002753 54350480 strontium (unspecified salt) styrene 543942 100425 tetrachloroacetone 31422614 tetrahydrocannabinol (THC) 1972083 thiouracil 141902 thiram 137268 thyroxine 51489 R&S 145747 Page 3 of 4 DRAFT P65 DART TRACKING DATABASE - TIER I AGENTS tolbutamide toluene 2.4-diisocyanate toxapnene triamcinolone trichloroethylene trichlorofon tricyanoaminopropene triethylene glycol dimethyl ether trypan blue vinyl chloride vitamin D xylene 4/7/95 64777 n 584849 \~5001352 124947 79016 52686 112492 72571 75014 1 1406162 1330207 R&S 145748 Page 4 of 4 PROPOSITION 65 PRIORITY LIST - CANDIDATE AGENTS UNDER CONSIDERATION FOR DEVELOPMENTAL AND REPRODUCTIVE TOXICITY EVALUTATION*1* Name of Agent Acrylamide Afdrin 1,3-Butadiene Carbamazepine Carbon tetrachloride Chlordan dot*3* Ethylene dibromide Formaldehyde Heptachlor Methylene chloride Progesterone 2,4,5-T, butyl ester Trichloroethylene Vinyl chloride CAS# Level of Toxicological Concern*2* 79061 309002 106990 36507309 56235 57749 50293 High High Medium High Medium High High 106934 50000 76448 75092 57630 High Low High Low High 93798 79016 75014 Low Medium Medium Level of Exposure Concern Medium Low Medium Low Medium Low Medium Low High Low High Low Low High Medium Priority Status - DART High Medium Medium Medium Medium Medium High Medium Medium Medium Medium Medium*4* Low High Medium (1) Priority chemicals from Donald, JM, Monserrat, LG, Hooper, K, Book, SA and Chemoff, OF (1992). Prioritizing candidate reproductive/developmental toxicants for evaluation. Reprod Toxicol 6:99*108. (2) The evaluation of Ihe level of toxicological concern is based on secondary sources (databases and reviews). It Is likely that data exist which have not been considered in the evaluation. In a more detailed review, additional data may be found that wilt alter the assigned level of toxicologic concern". Consequently, a "low" or "medium" level of toxicologic concern should not be interpreted to mean that the chemical has little or no potential to cause reproductive or developmental effects. (3) Would also include consideration of major metabolites and breakdown products such as DDE (CAS # 72559) and DDD (CAS # 72548). (4) Progesterone Is intentionally used as a contraceptive. Unintentional exposures are believed to be low. 4/7/95 et'ZGns'su Page 1 of 1 DRAFT