Document 5LONBEEkvz9ZmdYZDLjqGEXMe

m !f - Chemical' Manufacturers Association October 18,1996 /' OCT?/ L .. - Dear Vinyl Chloride Health Committee Members: Enclosed you will find additional information from Caffey Norman on CalEPA's Proposition 65 activities that are relevant to vinyl chloride. These materials describe a public workshop scheduled for November 15,1996 to receive comments on the procedures for prioritizing candidate chemicals for consideration under Proposition 65. The two committees of CalEPA's Science Advisory Board known as the Carcinogen Identification Committee and the Developmental and Reproductive Toxicant (DART) Identification Committee serve as the State's qualified experts for rendering an opinion as to whether a chemical is known to the State to cause cancer or developmental and reproductive toxic effects. The materials previously describe a meeting of the DART Identification Committee scheduled for December 4,1996 to determine whether the data summary for vinyl chloride clearly demonstrates tlrat vinyl chloride is a developmental/reproductive toxicant; written comments are due no later than November 20,1996. If you have any questions on these activities, please call me at 703/741-5639. Sincerely, Enclosures Robert A. Venezia, Dr. P.H. Manager Vinyl Chloride Health Committee w Responsible Care' 1300 Wilson Boulevard, Arlington, VA 22209 Telephone 703-741-5000 Fax 703-741-6000 A PublicCommitment SL 110064 OCT 11 '96 08:17AM DOW CHEM & METALS 51? 636 S699 OCT-06-1996 1?*B CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT SAFE DRINKING WATER AND TOXIC ENFORCEMENTACT OF 1986 (PROPOSITION 65) NOTICE TO INTERESTED PARTIES October 4i 1996_ Availability ofRevised Drift Procedure for Prioritatag Candidate Ow Consideration Under Proportion 65 by tbc "State's Quafi&ad Expert 60-day Pabfie Comment Period ou the Draft FriarttfeatiOB Fraecdi (fenater 1*. MM, MB.Wtrintep Refinement oftha Prioritisation Procedure November 15,1996, Public Forum to Reochre Comments ofl the Draft Prioritized Cn<IB>i dwjali Under CWbUbKIw for Caniaogwiirfty 8wtmto'>id Reproductive Toxidty Evaluation tad Draft Date Summaries, and 60-day Public Conusant Period oa Draft Prioritized Cbamfcuh mad Drift Data Summaries The California, Environmental Protection Agency'* Office ofEnvironmental Health Hazard Aisaurwrat (OEHHA). as lead agencyfir the Implementation ofthe Safe Drinking Water and Toxic Enfbreemcnt Act of 1916 (Proposition 65). baa developed a procedure fer prioritizing Candida** chenticali far coxmdemion tauter Preposition 65 by the "State's qualified experts''. Two committee* ofthe Science Advisory Board (SAB), known aa the Csccinogea Identification Comu&oec, aad (be Devalepmantal and Reproductive Toxicant (DARI) Identification Comatose, serve as tile State's qualified ftn-Twirfrinfl n npirrinw mhetWm. ehewiiea] i known to Aa State m catiae cancer or developmental and nquoduetive toxic efiaet*. As put of (he dcvalQpx&eoc ofdie prioritization process, comment has been aolicitad from tiic public aad (be two SaB commiffwa, during a workshop (December 1994), public cosuuest periods (Fall 1994, Winter 1994, Spring 1995. Summer 1996), and SAB committee meetings (March 1994; May 1995. Ally 1996). The October 1996 daft of OEHHA's prioritisation proposal, entitled Procedurefor Prioritising Candidas* Chemicalsfar Consideration Under Proposition 65 by the "State's QualifiedExperts ", reflects comments received thus far aad identifies options for fiufba rdbwxwm ofthe procedure. A workshop to present this draft procedure and provide fiathar opportunity . for public comment is scheduled to be held on Friday, November IS, 1996 at 400 P Street, Rooms 1160 and 1170. Sacramento, Cetooia^inm 10:0014&. Until all business bas been conducted or until 5:00 pnu The members oftbs Carcinogen Identification Committee aad the Developmental aad Reproductive Toxicant (DART) Identification Committee will be invited to attend. PoeMt" brand fax tranamittal memo 7671 C1P3 c^oo-pftft-XOgixad OCT 11 '96 08:17AM DOW CHEM & METALS 517 636 9899 OCT-ee-1996 i?*18 p.aSP-^.2r/4 < Thir wcrishop will also saroe u public farm to receive comments on Hie May 1996 prioritized r.hemicaia tor camnoggairity eoasidgatinn. and on. Specific chanicals prlAritizadoatbeb*sctfz^raduedvtexieityGOBieaoL Veriwl and written canaaaju the prcvimia pufalie eenment pwtfld fer chamlceh priaritid m tb* basisofcataiiQfamcitfcgaoemwiflbacoMidawdandBeediiotbeitaubniued. Three chemicals from tha Mty 1996 group [S-chlnto-ariAe-tnluidine and its hydrochloride (CASKN: 95-79-4), quinoline (CASRN: 91-22-5), and2,4.S-trin>itylanilinc and its hydrochloride (CASRN: 137-17-7)] are the sstgcct of asepinie request for iofocmsuon. published elsewhere in today's register. Them cbesdcab therofore an not oo the agenda for poblic comment at the November 15.1996 public forum. .* Choxucals ptiorioxed on the basis ofearcuiogaucityco&oen art: - CHEMICAL AMttoinopfam (pneetamol) Acetoximc Aerolem Batumi acetate Butyl benzyl pbthalaw Carberyl Chlammbea Chloroacetaldefcydc Chlomfluoromctbane (fluorocarbon 31) CXDupose Yellow 3 Qomipbcoe and hs salts Coumaria Deeabruznohipbeiiyl ooddc 2>-Dtchlon>-p-phcaylcawdiaininc Ethyl pinziuoQ Eugcaol Hydralazine cod its hydrochloride Hydraqumone Isophoroae Mercuric chloride Naphthalene Nttroftnatohi S-Nitro-orfho-tohridine 2-Niuv-p-pbcoylcncdienrinc Ozone Pauachloioaaieole CpemachloromclfaoaybeivrHw) Propyl gallate Semicarbezide hydrochlorida Trtfturalin Vinyl acetate CASRN 103-90*21 127-06-0 107-02-8 140-1104 85-68-7 045-2 133-90-4 107-204) 593-704 283X40-8 911-45-5 91-64-5 1163-19-5 609-20-1 56-38-2 97-53-0 86-54-4 and 20420-1 123-31-9 78-59-1 7487-94-7 91-20-3 67-209 99-55-8 5307-14-2 10028-15-6 IS2S4Z1-4 121-79-9 563-41-7 15824)9-8 1084)5-4 39tid 239-868-103: XW 31A1I1SNI TANIA: QI SL 110066 TQ:frT 96, 60^01 OCT 11 'So ee:ia=IM DOW CHEM & METALS 517 636 9899 OCT-ee-1996 1?:19 p 3/ P.04/05 prioritiaed on th/; basis ofreproductive toxicity concern lie: CHEMICAL Acrylamide Aldrin 1,3-buxsdieae Cerbaaazcpine --=- Carbon tetrachloride DDT Ethylene dibxomide Formaldehyde HcptacUor --Methylene chloride Progesterone 2,4,5-T butyl ester ^--Trichloroethylene ---Vinyl chloride CASKN 7946-1 309-00-2 106-99-0 298-46-4 56*23-5 57-74-9 50-29-3 106-93-4 50-00-0 76-44-S 75-093 57-83-0 93-79-8 7941-6 75-01-4 r CASKN - Chemical Abstracts Service Resiitradcm Number In the interest of assuring that tine is provided for (be dncoMton ofboth ratgetts (the prioritization procedure end the prioritised chemicals) tbc Novqnbcr IS, 1996 easaian will be divided into two segments. During the ftor part ofthe aasidon. a fariafsummary ofthe October 1996 draft procadurewiU be presaged, followed bythe Opportunity for comments, questions. and dialogue among tbc participants. During the second part oftht session,whichQEHHAantiripeteawillbeginatlUftpm nhrirTAsTTpiriwiiTiiinnmi the prioritized chemicals for carcinogenicity and reproductive toxicity caniiderettan will be presented, followed by the opportunity for gflnwnents, questions, end dialogue among the participants. Dependent upon the participants'imaest. after the public ducuHtanoa the prioritized chemicals, additional time win be provided b father discus refinement or the prioritization procedure, u needed. QEHHA is committed to poblie participation end external sekatifle peer review in its implementation, ofProposition 65, and welcomes public injxtt oa the prioritizsrion procedure. The publication ofthis aotiea maria the ion ofa 60-day public period on the October 1996 draft priodtiation procedure. Ibis procedure, as well as lists ofprioritized chemicals and draft data summaries ere eveilsble from QfcBHA'TPioposItioa 65 Implementation Office aithe addreaaand telgphottc'BiBilbcr miibcamd bttow, or aom thslreeinat ei tbc foUowiat address: http://www.caiepa.caiiwnct.fov/odiha/. Other materials available from the Proposition 65 Implementation Office include mmmegn received on bese chemicals during an earlier public comment period which dosed on July 15,1996. 39bd 99-868-105:Xbd aimusNi -wNm:ai SL 110067 T0:n 96, SCKOI OCT 11 '96 38= ISflfI DQU CHET1 & METALS 51? 636 9899 OCT-0B-1W6 1? 19 P.0Sj-4/4 Written connncns* mey be icnt by mail or fix to: CyntbiiOshia Office ofEovnomdeoai Heelth Hiznd Aiseumco: PXX Box 9*2732 e. i iitaum CA 94234-7320 FAX (916) 327-1097 Wnoec msy be delivoed in person or by courier m: CynAUOahitt OQjienrruiirniiiriniiBlTTnlthH----- 601 North Serath Street SeetaoKSto, CeUftRiia In order to be coialdRed, eommeai* mat be poatnaritKl (Ifseat by mifl) weaved i QEHHA (ifdelivered iapgsau orient by fix) by 3 pJB.W>daoarteytTTru'mI.jr 4,1996. S 39ttd 99-868-102:Xdd HiAlIiSNI TANIA:QI TOTAL P.05 SL 110068 so:n 96. avoi DRAFT: 10/4/96 DRAFT PRIORITIZED CANDIDATE CHEMICALS UNDER CONSIDERATION FOR DEVELOPMENTAL/REPRODUCTTVE TOXICITY EVALUATION Office of Environmental Health Hazard Assessment California Environmental Protection Agency October 4,1996 Chemicals ate prioritized for consideration by the Developmental and Reproductive Toxicant (DART) Identification Committee ofOEHHA's Science Advisory Board by the process described in the draft document entitled "Procedure for Prioritizing Candidate Chemicals for Consideration Under Proposition 65 by the State's Qualified Experts". The process involves selecting frorr agents proposed for evaluation by the DART Identification Committee and evaluating the potential levels of developmental/reproductive toxicity concent through review ofinformation available from secondary sources. Secondary sources consulted include: databases such as ReprotoxTM, Reprotext, Shepard's Catalog ofTeratogenic Agents and RTECS; publications by bodies such as USEPA. ATSDR, IPCS; and standard texts such as Reproductive Hazards OfIndustrial Chemicals, and Chemically Induced Birth Defects. Data summaries, which provide an overview ofthe available data identified, were prepared for each ofthese chemicals, and each chemical was given a draft level of devdoptnental/reproductive toxicological concern as a result ofthis initiai evaluation. The particular set ofagents evaluated below were previously identified as high priority for evaluation through a earlier prioritization process, and so have been used as the Initial candidates for evaluation under the present process. It should be noted that (I) this prioritization process reflects a preliminary, rather than an in-depth review of developmental/reproductive toxicity and exposure data and (2) the process is continuous; e.g., candidate agents continue to be identified, and review of available information appropriate to each step in the process is ongoing for chemicals in the prioritization tracking data base. This process will result in the further prioritization of agents, including production of data summaries on additional chemicals and periodic updates ofpriorities. Further consideration oftwo chemicals, caxbamazepine and progesterone, has been postponed pending further investigation oftheir potential status with regard to listing through an administrative mechanism. Ifit is determined that these agents are not appropriate candidates for such action, they will resume their status as candidates for consideration by the DART Identification Committee. -1SL 110069 DRAFT: 10/4/96 Name of Chemical and Level of Deveiopmentai/Reproductive Toxicity Concern Level of Exposure Concern HIGH Deveiopmentai/Reproductive Toxicity Concern acrylamide DDT (1.1.1-trichloro-2^-b(D-cftloroohenyOethane) medium medium MEDIUM-HIGH Deveiopmentai/Reproductive Toxicity Concern formaldehyde trichloroethylene chtordane ethylene dibramtde heotachlor high Wah law law law MEDIUM Deveiopmentai/Reproductive Toxidty Concern butadiene, 1.3- cartoon tetrachloride vinyl chloride aldrin medium medium medium law LOW Deveiopmentai/Reproductive ToxidtV Concern 2.4.5-t butyl ester law methylene chloride hiqh Postponed cartoamazepine*1* Clarification of labeling requirement and possible determination of developmental/reproductive toxicity requested from US FDA on 10/4/96 progesterone *u Clarification of labeling requirement and possible determination of developmental/reproductive toxicity reauested from US FDA on 10/4/96 Pag 3 9- 20 20 30 38 42 46 46 56 60 66 68 7t 79 i by the US Food tad Dray Admmoxnaoa. OdwtfaagsbdafeqMt,thm tea public i t already tabpet to ttnngmt contreb 4 Pntaitiil li*im Ytewthoritahw bodtei paxtmm (22 CCR i 12306) b Potmnml liMt na fonnally required to b labeled or idanofied prevraon (22 CCR | 12902) -2SL 110070 draft PROCEDURE FOR PRIORITIZING CANDIDATE CHEMICALS FOR CONSIDERATION UNDER PROPOSITION 65 BY THE "STATE'S QUALIFIED EXPERTS" Introduction Reproductive and Cancer Hazard Assessment Section Office of Environmental Health Hazard Assessment California Environmental Protection Agency October 1996 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 chemicals known to cause cancer and reproductive toxicity. One of the mechanisms by which a chemical is placed on this list is a finding by the "state's qualified experts" that a chemical 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 of Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA) has formed two committees within its Science Advisory Board (SAB) to serve as the state's qualified experts. These committees, which are independent panels of scientists and health professionals, are the Developmental and Reproductive Toxicant (DART) Identification Committee and the Carcinogen Identification Committee (CIC). The purpose of this document is to describe the procedure used by OEHHA to identify, prioritize, and select candidate chemicals for consideration by the SAB Identification Committees, and to lay out potential process refinements. OEHHA welcomes public participation and public input, and is seeking comment on these issues. In particular, OEHHA asks those submitting comment to include their views on the potential process refinements noted below. The prioritization procedure is designed to ensure that the efforts of the SAB are focused on chemicals of concern to the state of California, and that these chemicals are selected in an open, objective and predictable manner. Prioritization also ensures that chemicals posing the highest level of carcinogenic, reproductive or developmental hazard concern are addressed first. Key elements of the process include: (1) a database to track chemicals suggested for consideration, (2) development of draft data summaries which contain information on potential human exposure, and assignment by OEHHA of draft priorities based on a preliminary evaluation of the developmental/reproductive or carcinogenic level of concern (high, medium high, medium, or low), (3) public review of draft priorities and data summaries, (4) review of comments received and assignment of final priorities, and (5) selection of high priority chemicals for preparation of comprehensive hazard identification documents, to be used by the Committee in its subsequent deliberations. Opportunity is provided for input and review by state agencies SL 110071 DRAFT OEHHA Prioritization Procedure October 1996 and departments, individual SAB Identification Committee members, the Committees as a whole if they so choose, the scientific community, and other interested parties. Evolution of the Prioritization Process Prioritization was discussed by the DART Identification Committee at its October 25, 1993 meeting and by the CIC at its March 1,1994 moeting. A draft version of this document was discussed at a public workshop held on December 14,1994. Based upon comments received, the prioritization document was revised and presented on May 11, 1995 at the CIC meeting, and on May 12, 1995 at the DART Identification Committee meeting. Comments from the public and the members of the CIC and the DART Identification Committee were considered in.the preparation of a revised draft, dated May, 1996. That draft was presented on July 22, 1996 at the CIC meeting. Comments received at that meeting were considered in the preparation of this prioritization process document. This document describes the process, potential refinements to the process, and how the process would work if those refinements were to be incorporated. Starting Point--The Process as Described in the May 1996 Draft In the May 1996 draft, the tracking database was organized into tiers. Tier I included all chemicals nominated or otherwise identified. Tier II was to contain all chemicals which appeared to have data sufficient to begin prioritization based on the initial screening. The procedure for selecting chemicals for hazard identification by the appropriate SAB Identification Committee included the following steps: Progression of Tier II chemicals to the draft priority list, following the completion of a draft data summary and assignment of a draft priority . Public comment on the draft data summaries and the draft priority list solicited during a 60day comment period Assignment of final priorities by the Committee at a public meeting, in concurrence with the Director of OEHHA At the same public meeting, Committee selection of chemicals from the final priority list for preparation of synopses Public comment on synopses solicited during a 60-day comment period Committee review of synopses and selection of chemicals for hazard identification at a public Committee meeting Potential Refinements Based on Comments from the Carcinogen Identification Committee and the Public A variety of comments were provided by the Carcinogen Identification Committee and the public at the Committee's July 22,1996 meeting. In brief, the Committee suggested that its role in general be limited to the final determination as to whether a chemical has been clearly shown to cause cancer. Earlier screening steps, although recognized as necessary, were 2 SL 110072 DRAFT OEHHA Prioritization Procedure October 1996 considered by the Committee to be within OEHHA's purview. The Committee also suggested that the process as a whole be expedited, while retaining adequate opportunity for public comment. The Committee expressed interest in developing terminology that would avoid giving unwarranted negative connotations to chemicals found to be of lesser concern. Finally, the Committee indicated that it would benefit from having the public comments on the hazard identification document available for review prior to its consideration of a chemical. Based on these and other comments received, OEHHA has identified several potential refinements to the process: OEHHA Selects Candidate Chemicals Members of the CIC indicated that OEHHA, rather than the Committee, should be responsible for prioritizing candidates for consideration under Proposition 65. In particular, the members of the CIC asked that OEHHA assign final priorities and select chemicals for hazard identification. In response to this comment the process could be refined such that OEHHA will perform all prioritization steps up to and including the selection of chemicals for preparation of hazard identification documents. OEHHA would assign draft priorities, then, following public comment and a public workshop, assign final priorities. SAB members would be free to provide comment as.individuals or as a Committee if they so choose. As described more completely below, chemicals selected for preparation of hazard identification documents would be those with a high level of carcinogenic, reproductive, or developmental hazard concern. Use `Tiered" Evaluation Process The Committee also expressed interest in expediting the overall process. In response to this comment, OEHHA could refine the process by tailoring the level of analysis employed during the course of assigning final priorities. Under this approach, a "synopsis" step would not be required for every chemical. Instead, when warranted an issue-specific supplemental analysis would be performed as part of the assignment of draft priorities. Preparation of a data summary may provide sufficient information for many chemicals, while for others, additional analysis supplemental to the'data summary may be necessary to resolve particular scientific issues prior to the assignment of a final priority. For example, a supplemental analysis may be beneficial by providing a focused evaluation of a key toxicological issue germane to a specific chemical, such as.the design of a critical study, apparent inconsistency in results in a given species, or by providing additional chemical-specific information regarding mode of action, or apparent route or species specific toxicity, or with respect to the relationship, if any, of developmental toxicity and maternal toxicity. Public comment is invited as to the criteria for undertaking a supplemental analysis. Organization of the Database The tracking database identifies the status of chemicals in the prioritization process. In the May 1996 draft, the tracking database was described as a series of tiers. Tier I included all 3 SL 110073 DRAFT OEHHA Prioritization Procedure October 1996 chemicals nominated or otherwise identified. Tier II contained all chemicals which appeared to have data sufficient to begin prioritization based on the initial screening. Chemicals then were selected from Tier II for the preparation of data summaries and the assignment of draft priorities, and prioritized chemicals were placed on a Priority List. As OEHHA has gained experience in implementing the process, it has learned that from a work flow standpoint the determination of whether adequate data exists (needed to move from Tier I to Tier II) is closely linked to the development of a draft data summary (needed for prioritization). It thus is more efficient to perform both steps at once. In response, OEHHA is considering changes to the terminology and organization of the tracking database. Under the proposed refinement, the database is organized into three mutually exclusive groups. Category I includes all chemicals nominated or otherwise identified for entry into the tracking database, which have not been assigned a final priority status. Category II includes those chemicals in the tracking database which have been assigned a final priority status other than high. The Candidate List would be composed of chemicals with a final priority status of high level of carcinogenic, reproductive or developmental hazard concern. If data are inadequate, the priority status for the chemical is "inadequate data". Recognizing the ongoing nature of the prioritization process, assigned priorities may change as new scientifically valid toxicological information showing cancer, reproductive or developmental effects becomes available. In such circumstances, notice would be provided regarding a proposal to revise the prioritization, and opportunity would be provided for public input. Focus Initial Work on Chemicals with "High" Hazard Level of Concern As noted above, in the May 1996 process, all prioritized chemicals were placed on a "priority list", from which chemicals were to be selected for further consideration. Public comment was received noting that referring to a chemical as "priority", even if found to have a low level of hazard concern, gave rise to unwarranted negative connotations. The CIC then expressed interest in'developing alternative terminology. In response, OEHHA is considering eliminating the term "priority list". Instead, as noted above, prioritized chemicals with a final high level of carcinogenic, reproductive or developmental hazard concern would be assigned to a Candidate List, from which chemicals would be chosen for the preparation of a hazard identification document. All other final prioritized chemicals would be assigned to Category II. Chemicals with a high level of hazard concern would be brought before their respective Committee. Action would not be anticipated on Category II chemicals until the Candidate List consisting of high priority chemicals is exhausted. At that point, with Committee and public input, OEHHA would refine the existing process in order to determine which of the Category II prioritized chemicals should be brought forward for consideration by the CIC and the DART Identification Committee. 4 SL 110074 DRAFT OEHHA Prioritization Procedure October 1996 This approach would ensure that chemicals posing the highest level of hazard concern are addressed first. Taking into account the number of chemicals to be evaluated, OEHHA's goal is to complete the prioritization of roughly 520 candidates for carcinogen consideration and 280 DART candidates within three years. OEHHA Provide Committee with Public Comments on Hayard Identification Documents TT" _ Previously, hazard identification documents were reviewed and considered at public Committee meetings held at or shortly after the close of the 60-day public comment period for those documents. At the July 22 meeting, the C1C emphasized that its members need adequate time to review hazard identification documents and the public comments received on those documents. In response, OEHHA is considering having the 60-day public comment period on a hazard identification document close three to four weeks in advance of a Committee meeting. OEHHA then would organize and index the pubic comments received and provide the Committee with this information at least two weeks in advance of the meeting at which the candidate chemical is to be considered. Summary of Process, Incorporating Potential Refinements To assist in visualizing how the various potential refinements would work, the complete process, incorporating all of the potential refinements, is outlined briefly below and described in more detail in Appendix I. Figure 1 provides a flowchart of the process. [Note: If you downloaded this document from the OEHHA web site, due to formatting problems. Figure 1 is not available electronically. Please contact OEHHA at (916) 445-6900 to receive a hard copy,] If all of the potential refinements were adopted, the complete procedure for selecting chemicals for hazard identification would include the following sequential steps: Unbiased random selection of chemicals from Category I for preparation of the draft data summary Development of the draft data summary, followed by assignment of a draft priority Identification by OEHHA of any chemicals for which there is a key toxicological issue which requires a focused supplemental analysis, beyond a data summary. Solicitation of public comment on draft data summaries and draft priorities during a 60-day comment period, and solicitation of additional information on chemicals identified as requiring a focused supplemental analysis. Opportunity for verbal, as well as written comments will be provided by a public workshop held during the 60-day period. For those chemicals for which no focused supplemental analysis was found to be needed: Following review and consideration of public comments received, OEHHA will assign the final prioritized chemicals to Category II or the Candidate List. If public comment identifies a key toxicological issue, such that a supplemental analysis is necessary before a final priority can be assigned, OEHHA will identify the issue and solicit additional information as described in the previous step. For those chemicals for which a focused supplemental analysis was needed: 5 SL 110075 DRAFT OEHHA Prioritization Procedure October 1996 Solicitation of public comment on the supplemental analysis during a 60-day comment period. Opportunity for verbal as well as written comment will be provided by a public workshop held during the 60-day period. Following review and consideration of public comments received, OEHHA will assign the final prioritized chemicals to Category II or the Candidate List Selection by OEHHA of chemicals from the Candidate List for hazard identification. r- Under exceptional circumstances, the process described in this document may be abbreviated to allow OEHHA to respond to specific public health needs. Following consultation with the Committee Chair, the Director of OEHHA may request that a chemical be placed on the agenda of the next scheduled meeting. In all cases, the chemical would be noticed in the California Regulatory Notice Register and minimum notification periods would be followed. Implementation Considerations Startup and Transition The tracking database includes all nominated chemicals. These chemicals have been suggested by state agencies and other sources or obtained from literature searches. Over S20 potential candidate carcinogens have been entered into the tracking database and over 2S0 chemicals have been identified as potential candidate developmental or reproductive toxicants (DARTs). Originally, in implementing the prioritization procedure, for carcinogens OEHHA has first considered chemicals previously selected by the Carcinogen Identification Committee and other candidate chemicals with readily available toxicological data. For DARTs, OEHHA proposed to consider the previously identified candidate DARTs prior to considering new candidate DARTs in the following order: 1) all chemicals in the top five ranks of the Donald et al. list and all chemicals identified through the Delphi process; 2) chemicals in the remaining ranks of the Donald et al. list; 3) all chemicals published in the California Regulatory Notice Register as candidates, chemicals formally nominated by other state agencies, and chemicals identified by the SAP Reproductive Toxicity Subpanel (the predecessor to the current DART Identification Committee). Now, OEHHA is considering moving to the unbiased random selection process noted above. For DARTs, OEHHA would move to random selection following the completion of evaluation of two groups of chemicals identified by means of the Donald et al and the OEHHA Delphi processes. For carcinogens, OEHHA would move to random selection immediately. Availability of the Tracking Database The tracking database will be updated quarterly and will be available upon request for public review. 6 SL 110076 DRAFT OEHHA Prioritization Procedure October 1996 Current Status of the Prioritization and Selection of Carcinogens As noted above, at the July 22,1996 CIC meeting, the Committee suggested that its role in-general be limited to the final determination as to whether a chemical has been clearly shown to cause cancer. The Committee also suggested that the process as a whole be expedited, while retaining adequate opportunity for public comment, in response, as an interim measure OEHHA has implemented some of the refinements noted above for purposes of the prioritization of candidate carcinogens. Specifically, OEHHA has (1) called for data to assist in the preparation of hazard identification documents for three chemicals identified in the May 1996 draft data summaries prepared by OEHHA as posing a high level of carcinogenicity concern, and for which no public comments were provided, and (2) scheduled a public workshop for OEHHA to obtain comment on the remaining May 1996 draft data summaries and draft priorities. These actions are described in more detail in the October 4,1996 California Regulatory Notice Register, Concluding Remarks The purpose of this document is to describe and solicit public comment on various potential refinements to the prioritization process. The major elements of the procedure include use of a computer database to track chemicals, prioritization of chemicals based on scientifically valid toxicological data, scientific peer review, and input by interested parties. OEHHA's ongoing goal for prioritization is an approach that is consistent, predictable, open to public input at several important points throughout the process, and which focuses Committee resources on the issues that most merit their consideration. OEHHA seeks public comment on all aspects of this procedure, and in particular on the potential refinements noted above. Public comment may be submitted orally and/or in writing at a public workshop to be held November 15, 1996 at 400 P Street, Rooms 1160 and 1170, Sacramento, California, from 10:00 a.m. until all business has been conducted or until 5:00 p.m., or in writing only to Cynthia Oshita, Office of Environmental Health Hazard Assessment, P.O. Box 942732, Sacramento, California 94234-7320 [FAX (916) 327-1097] by December 4,1996. 7 SL 110077 DRAFT OEHHA Prioritization Procedure October 1996 APPENDIX I 1 THE PRIORITIZATION PROCESS, INCORPORATING POTENTIAL REFINEMENTS 1.1 Introduction To assist in visualizing how the various potential refinements would work, this Appendix describes the complete process, incorporating all of the potential refinements. Figure 1 presents a flaw chart of the prioritization and listing process, showing how a chemical is tracked, prioritized, may be placed on the Candidate List, and ultimately may reach the Committee for consideration. [Note: If you downloaded this document from the OEHHA web site, due to formatting problems. Figure 1 is not available electronically. Please contact OEHHA at (916) 445-6900 to receive a hard copy.) This flow chart incorporates processes previously described for hazard identification under Proposition 65 (OEHHA, 1993a) and some elements from previous proposals for compiling and prioritizing chemicals for Committee consideration (OEHHA, 1994; 1996). Procedures which have previously been applied for DARTs are described in reports by the California Department of Health Services (CDHS, 1991), OEHHA (1993b), and Donald et al. (1992). The steps of the prioritization process, with potential refinements indicated as appropriate, are described in the following sections. 1.2 Database of Suggested Chemicals for Consideration (Tracking Database) A chemical may enter the system by a number of mechanisms, including the following: (1) literature searches and reviews of databases by OEHHA, (2) suggestions by members of the SAB Identification Committees, (3) suggestions by other State agencies, (4) suggestions by the general public, and (5) suggestions by the scientific community. The basis for identifying a chemical as a candidate may be, for example, positive cancer or reproductive toxicity bioassays, or some evidence ofvery high production or use volume, particularly in California. The five primary sources of potential candidate chemicals are described below: 1. Literature searches and other sources. Sources of potential candidate chemicals include the following; Current scientific literature Chemical Carcinogenicity Research Information System (CCRIS) Database from Gold et al. (1984,1986,1987,1990) Survey of Compounds Which Have Been Tested for Carcinogenic Activity (National Cancer Institute) 8 SL 110078 DRAFT OEHHA Prioritization Procedure October 1996 Pesticide registrant data submitted to Cal/EPA Publications on DARTs (e.g., Schardein [1993]) Other databases OEHHA will conduct periodic reviews of the above sources. OEHHA and the Department of Pesticide Regulation will work together to identify potential candidate chemicals from pesticide registrant data. 2. Suggestions from the SAB Identification Committees. The Identification Committees, as the state's qualified experts, may bring candidates to the attention of OEHHA. 3. Suggestions from other State organizations. A process is being developed to establish an ongoing mechanism for soliciting candidate chemicals from other state organizations. The proposed elements of this process include: (1) a mechanism to regularly request suggestions of candidate chemicals from state organizations and committees and (2) forms requesting summary information on the chemicals . 4. Suggestions from the general public. Input from the public will be solicited through the California Regulatory Notice Register. Information supporting the suggestion of a chemical will also be requested, although such information is not specifically required for OEHHA to consider placement of a chemical on the tracking list. 5. Suggestions from the scientific community. Periodically, suggestions from the expert scientific community may be solicited or volunteered. Suggested chemicals are tracked using a computer database. In unusual cases, for example when a long list of chemicals without supporting data is received, OEHHA may screen the list to determine whether the chemicals should be entered into the database. The information categories for the tracking system will include the source of the suggestion (e.g., literature source, general public); the date the chemical is entered into the database, and other important dates such as assignment to Category II or the Candidate List (if applicable) and subsequent procedural steps; results of reviews by authoritative bodies; brief comments on available epidemiological studies, animal bioassays, and other studies relevant to an assessment of the carcinogenicity or developmental and reproductive toxicity; data on use, occurrence, and production, and other information relevant to an assessment of exposure; other pertinent comments; and key references. 1.2.a Category I Category I of the tracking database will include all chemicals nominated or otherwise identified, which have not yet been assigned a final priority status. OEHHA will search for information relevant to an assessment of developmental or reproductive toxicity, or 9 SL 110079 DRAFT OEHHA Prioritization Procedure October 1996 carcinogenicity for all chemicals in Category I. This information could be in the form of epidemiological studies, animal studies, or other relevant data indicating the potential developmental or reproductive toxicity or carcinogenicity of the chemical. OEHHA will also search for information on the occurrence, use, and level and extent of exposure for all chemicals in Category I. Refinements: in previous drafts the database wasmrganized into tiers; Tier I included all chemicals in the database. Here, the database is organized into three mutually exclusive categories. Category I includes only those chemicals which have not yet been assigned a final priority status. Chemicals will be randomly selected from Category I in batches of ten for evaluation of the available toxicological and exposure data, development of a draft data summary, assignment of a draft priority status, and progression into Category II or the Candidate List. An unbiased random method for selecting chemicals for further evaluation is proposed as a means to proceed efficiently through prioritization and avoid any suggestion of bias on the part of OEHHA. Comment is invited regarding how best to accomplish a random selection. OEHHA will publish in the California Regulatory Notice Register on a quarterly basis notice of those chemicals selected from Category I, indicating which appear to have data sufficient to begin prioritization based on the initial screening and which appear to have inadequate data. The draft priority status will be based on a review and evaluation, in most instances of the secondary literature, resulting in an assignment of a level of developmental or reproductive toxicity or carcinogenicity concern of "high", "medium high", "medium", "low", "no identified concern", or "inadequate data". Chemicals will also be assigned a level of exposure concern of "high", "medium", "low", "no identified concern", or "inadequate data", but this information will not be used in the assignment of priorities. Refinements: (1) Here, the process whereby a chemical is selected from Category I for initiation of prioritization is specified in greater detail. (2) In previous drafts, chemicals which appeared to have data sufficient to begin prioritization based on an initial screening were placed in Tier II; a listing of all Tier II chemicals was available for release to the public prior to each SAB Identification Committee meeting. Here, OEHHA will publish in the California Regulatory Notice Register on a quarterly basis notice of those chemicals selected from Category I, indicating which appear to have data sufficient to begin prioritization based on the initial screening and which appear to have inadequate data. 1.2.b Category II A chemical progresses from Category I to Category II or the Candidate List following preparation of a draft data summary, assignment of a draft priority, public review and comment. 10 SL 110080 DRAFT OEHHA Prioritization Procedure October 1996 review by OEHHA of comments, and assignment of a final priority. Category II includes those chemicals which have been assigned a final priority other than high level of carcinogenic, reproductive or developmental hazard concern. Action would not be anticipated on Category II chemicals untiLthe Candidate List consisting of high priority chemicals is exhausted. Refinements: In previous drafts the database was organized into tiers; Tier II was defined as the subset of all Tier I chemicals which appearedto have data sufficient to begin, prioritization. Here, the database is organized into three mutually exclusive categories; chemicals progress into Category II or the Candidate List once a final priority status has been assigned. The assignment of a priority to a chemical is based on the level of developmental/reproductive toxicity or carcinogenicity concern. Evidence for prioritization would come from epidemiological or animal toxicity studies or other relevant data indicating the potential carcinogenicity or developmental/reproductive toxicity of the chemical. Epidemiological studies: The evidence considered will include the study population, exposure situation, tumor type or developmental/reproductive toxicity endpoint, nature of the dose-response curve, possible roles of bias and confounding, and quality of studies. In judging the epidemiological evidence, greater weight will be given to analytical epidemiological studies and lower weight to descriptive studies and case reports. Both positive and negative studies will be considered in assessing the overall level of hazard concern. Animal studies: The evidence considered will include the number of experiments and species tested, route of administration, frequency and duration of exposure, numbers of test animals, and consideration of dose-response. Both positive and negative studies will be considered in assessing the overall level of hazard concern. Other relevant data: Evaluation of other relevant data for use in prioritizing candidates will also be made. Such data include information on mechanism of action, chemical structure, metabolism, and genotoxic activity. A qualitative appraisal ofthe potential for a chemical to cause cancer or developmental/reproductive toxicity will be made on the basis of a scientific evaluation of the available information. Chemicals will then be assigned a level of concern of "high", "medium high", "medium", "low", "no identified concern", or "inadequate data". This process is not a final hazard evaluation, but rather a preliminary appraisal for the purpose of prioritizing chemicals. Chemicals will be assigned a high level of hazard concern ifthis preliminary evaluation indicates the existence of evidence that is likely to demonstrate a strong potential to cause cancer or developmental/reproductive toxicity. Chemicals which appear to have less evidence will be 11 SL 110081 DRAFT OEHHA Prioritization Procedure October 1996 assigned lower levels of hazard concern, which reflect OEHHA's preliminary evaluation of the weight of the available information. For developmental toxicants, chemicals are likely to be assigned a high level of hazard concern if they appear, in animal or human studies, to cause developmental toxicity which is not secondary to concurrent maternal toxicity. In general, the nature and severity of both the developmental effects and any reported maternal toxicity will be taken into account in assigning levels of hazard concern. Chemicals which appear to have less evidence will in general be assigned lower levels of hazard concern, which reflect OEHHA*s preliminary evaluation of the weight of the available information. For male and female reproductive toxicants, chemicals are likely to be assigned a high level of hazard concern if they appear, in animal or human studies, to cause reproductive toxicity which is not secondary to concurrent systemic toxicity. In general, the nature and severity of both the reproductive effects and any reported systemic toxicity will be taken into account in assigning levels of concern. Chemicals which appear to have less evidence will in general be assigned lower levels of hazard concern, which reflect OEHHA*s preliminary evaluation of the weight of the available information. At times, for particularly difficult scientific issues, the OEHHA Director or designee may request assistance from outside experts in assessing the level of carcinogenic or developmental/reproductive toxicity concern. Although not used in the assignment of priorities, direct or indirect evidence of exposure in California, including information on level and extent of exposure, will be noted and included in the data summary. In general, direct exposure data from monitoring are not likely to be available, as most monitoring programs target only those chemicals that are known hazards. Indirect information may be more widely available. Quantitative information such as amounts produced or used in California will be collected when possible. The tracking system will record use and occurrence information such as whether the chemical is used in California industries, is a byproduct of industries operating in California, is a pesticide used on food crops grown or imported into California, or is a component of consumer products or drugs sold in California. Information on current restrictions on exposure to the chemical will also be noted when readily available. In the absence of information specific to California, evidence of exposure in the U.S. will be assumed to reflect the experience in California. A qualitative evaluation of the level of concern in terms of exposure will be expressed as "high", "medium", "low", "no identified concern", or "inadequate data" The reporting of priority status will also address evaluations conducted by authoritative bodies. (If an authoritative body formally identifies a chemical as a carcinogen or DART, and the nature of the authoritative body action and the evidence for carcinogenicity or reproductive toxicity meet the criteria outlined in Title 22 Section 12306, of the California Code of Regulations, then the chemical is administratively added to the Proposition 65 list The United States Environmental Protection Agency, the International Agency for Research on Cancer, the 12 SL 110082 DRAFT OEHHA Prioritization Procedure October 1996 National Toxicology Program, the National Institute for Occupational Safety and Health, and the United States Food and Drug Administration have been designated by the state's qualified experts as authoritative bodies under Proposition 65.) Chemicals for which it is anticipated that evaluations will be released within a reasonable time frame (e.g., one to three years) may be assigned a priority but would generally be postponed from further consideration until completion of the review by the authoritative body. Postponement will be noted in the tracking database, and actions by the authoritative body tracked. In addition, chemicals that have been-recently reviewed by an authoritative body and found to have minimal or no evidence of carcinogenicity or developmental/reproductive toxicity would likely be categorized as "low" or "no identified concern". Exceptions to these generalizations may occur. For example, if an authoritative body has evaluated a chemical but failed to review all relevant data, or compelling new data have become available since the evaluation, the chemical may be categorized at a higher level of concern. In the process of reviewing the available data on chemicals in the tracking database, data gaps will likely be identified. To the extent possible, OEHHA will inform other appropriate agencies of this information. For example, if a high exposure chemical is found to be inadequately tested for carcinogenicity, but there is some scientific evidence to suggest carcinogenic potential, OEHHA may recommend this chemical to the NTP for toxicological testing. Refinements: In previous drafts OEHHA would act to inform other agencies of identified data gaps under the direction of the SAB Identification Committees. Here, OEHHA may initiate action on its own. Once draft priorities have been assigned, OEHHA will publish a notice in the California Regulatory Notice Register, announcing the release of draft priorities and data summaries on these chemicals, the start of a 60-day public comment period, and the date, time and place when a public workshop will be held to provide opportunity for oral as well as written comments. Occasionally, in the course of assigning draft priorities, OEHHA may identify scientific issues germane to prioritization which could not be adequately addressed in the data summary. In such instances, OEHHA will notice the intent to address specific scientific issues related to individual chemicals at the public workshop. For example, a supplemental analysis may be beneficial by providing a focused evaluation of a key toxicological issue germane to a specific chemical, such as the design of a critical study, apparent inconsistency in results in a given species, or by providing additional chemical-specific information regarding mode of action, or apparent route or species specific toxicity, or with respect to the relationship, if any, of developmental toxicity and maternal toxicity. Public comment is invited as to the criteria for undertaking a supplemental analysis. Following review and consideration of the comments received, OEHHA will assign final priorities to chemicals and update Category II and the Candidate List. OEHHA will publish 13 SL 110083 DRAFT OEHHA Prioritization Procedure October 1996 notice of this action. In some cases, OEHHA may determine that additional analysis and public comment are needed in order to address scientific issues not adequately addressed in the data summary. Once OEHHA has completed the necessary supplemental analysis, this information will be released for public comment and undergo the same comment and review process (i.e., public workshop, 60-day comment period) as that employed for the original data summary. Refinements: (1) In previous drafts, the SAB Identification Committee in concurrence with the Director of OEHHA assigned final priorities and finalized the priority list at a public meeting, after review and consideration of the comments received. Here, OEHHA holds a public workshop during the course of a 60-day public comment period to solicit comments on the draft data summaries and draft priorities. Following review of public comments, OEHHA would assign the final priorities. (2) In previous drafts, after finalizing the priority list, the Committee selected chemicals from this list for synopsis preparation. Here, OEHHA may determine, following public consideration and comment, that a data summary has provided sufficient information in order to assign a final priority to some chemicals, while for others, additional analysis supplemental to the draft data summary may be necessary to resolve particular scientific issues prior to the assignment of a final priority. U Candidate List The Candidate List will consist of those chemicals found by OEHHA to have a final priority of high carcinogenic, developmental or reproductive hazard concern. All other final prioritized chemicals would be assigned to Category Q. Chemicals with a high level of hazard concern would be brought before their respective Committee. Action would not be anticipated on Category II chemicals until the Candidate List consisting of high priority chemicals is exhausted. At that point, with Committee and public input, OEHHA would refine the existing process in order to determine which of the Category II prioritized chemicals should be brought forward for consideration by the CIC and the DART Identification Committee. Refinements: In previous drafts, the SAB Identification Committee selected chemicals for which hazard identification documents were to be prepared from a priority list, which included all prioritized chemicals in the tracking database. Here, in response to Committee comments, OEHHA, rather than the Committee, selects chemicals for which hazard identification documents are to be prepared. In addition, in order to focus Committee resources on issues that most merit their consideration, here the Candidate List will consist only of those chemicals assigned a final priority ofhigh carcinogenic, developmental or reproductive concern, rather than all prioritized chemicals. 1.4 Chemicals Under Consideration for Listing OEHHA will select chemicals from the Candidate List, and begin the preparation of hazard identification documents for those chemicals. The chemicals selected by OEHHA for the preparation of hazard identification documents and Committee consideration will be published in 14 SL 110084 DRAFT OEHHA Prioritization Procedure October 1996 the California Regulatory Notice Register, and data concerning carcinogenicity or developmental/reproductive toxicity will be requested. During a public meeting the SAB Identification Committee may suggest, as a goal, the number of chemicals to be considered at their next meeting. Refinements: The May 1996 draft called for the SAB Identification Committee to review synopses and other documentation on a group ofiChemicals previously identified from the priority list and, at a public meeting, select chemicals for the preparation of hazard identification documents and consideration at subsequent Committee meetings. Here the selection of chemicals for the preparation of hazard identification documents is performed by OEHHA, rather than the SAB Identification Committee, and the chemicals are chosen from a Candidate List. In addition, here the Committee may suggest, as a goal, the number of chemicals to be considered at their next meeting. Under exceptional circumstances, the process described in this document may be abbreviated to allow OEHHA to respond to specific public health needs. Following consultation with the Committee Chair, the Director of OEHHA may request that a chemical be placed on the agenda of the next scheduled meeting. In all cases, the chemical would be noticed in the California Regulatory Notice Register and minimum notification periods would be followed. 2 FINAL STEPS IN THE CONSIDERATION OF CHEMICALS BY THE STATE'S QUALIFIED EXPERTS The final two steps of the process under which chemicals are considered by the state's qualified experts, while not part of the prioritization procedure, are described below. As a result of comments received at the July 22,1996 CIC meeting, OEHHA is considering modifications to the process for the review and response to public comments received on hazard identification documents. This modified process would have as its goal improvement of the Committee's ability to fully consider public comments in its deliberations. 2.1 Development and Publication of a Hazard Identification Document OEHHA will gather and analyze the available data on the candidate chemicals for consideration by the Committees. Comment from and participation by scientists with the relevant expertise from other state agencies and departments will be solicited. Public input and comment will be solicited by issuing a notice in the California Regulatory Notice Register requesting that relevant data on the candidate chemical be submitted to OEHHA within 60 days. The Director of OEHHA may hold a public workshop to provide for exchange of information on a candidate chemical and dialogue with the community. OEHHA and, if appropriate, scientists having relevant expertise from other state agencies and departments, will develop a hazard identification document utilizing information in the 15 SL 110085 DRAFT OEHHA Prioritization Procedure October 1996 published scientific literature, and that received from the public and other sources. Internal review of the predecisional draft document in progress may be conducted by Cal/EPA and other state agencies and departments, as appropriate. When the draft is complete, a notice announcing the public availability of the hazard identification document and commencement of a 60-day public comment period will be placed in the California Regulatory Notice Register, and the draft document will be submitted to the members of the relevant SAB Identification Committee. At the close of the 60-day public comment period, OEHHA will organize and index the^comments received and provide this information to the Committee at least two weeks prior to the meeting at which the candidate chemical will be considered. Refinements: In previous drafts, hazard identification documents were reviewed and considered at public Committee meetings held at or near the close of the 60-day public comment period for those documents. Here, in order to provide greater opportunity for the Committee to consider public comments prior to deliberation, the 60-day comment period associated with a hazard identification document will close three to four weeks prior to the Committee meeting at which the candidate chemical is to be considered. In addition, OEHHA will organize and index the public comments received and provide the Committee with this information at least two weeks in advance of the meeting at which the candidate chemical is to be considered. 2J SAB Committee Meeting and Decision The hazard identification document and the public comments received during the 60-day comment period will be considered by the appropriate SAB Committee at a public meeting. The Committee chairperson will facilitate the meeting, during which the public will have further opportunity to comment At the conclusion of the deliberations, the Committee, as the state's qualified experts, may render an opinion as to the developmental or reproductive toxicity or carcinogenicity of a chemical, as appropriate. The Committee may render an opinion that the chemical has been clearly shown to cause cancer or reproductive toxicity, may fail to reach such a conclusion, or may defer the decision to a later meeting. In those cases where the decision is to defer, the Committee will prescribe an action plan that will discuss further steps to be taken and indicate the timeline for reconsideration of the chemical. For example, the action plan could require reanalysis of data and revision of the hazard identification document, with reconsideration of the chemical at a subsequent meeting. The dates of Committee deliberations on specific chemicals will be recorded in the tracking database. Following Committee deliberation, the draft hazard identification document will be finalized by OEHHA. 23 The Proposition 65 List Chemicals that the SAB Identification Committees find to have been clearly shown, through scientifically valid testing according to generally accepted principals, to cause cancer or reproductive toxicity will be proposed for inclusion on the Proposition 65 list in accordance with 16 SL 110086 DRAFT OEHHA Prioritization Procedure October 1996 procedures specified in statute (California Health and Safety Code 25249.5 et seq.). The Proposition 65 list is updated at least annually. 17 SL 110087 DRAFT OEHHA Prioritization Procedure October 1996 3 REFERENCES California Department of Health Services (CDHS, 1991). Prioritization ofCandidate Reproductive/Developmental Toxicantsfor Consideration by the Proposition 65 Scientific Advisory Panel. Reproductive and Cancer Hazard Assessment Section, CDHS, California Health and Welfare Agency, Sacramento, CA. Donald JM, Monserrat LE, Hooper K, Book SA, Chemoff GF (1992) Reproductive Toxicology 6:99-108. Gold L, Sawyer C, Magaw R, Backman G, de Veciana M, Levinson R, Hooper N, Havender W, Bernstein L, Peto R, Pike M, Ames B (1984). A carcinogenic potency database of the standardized results of animal bioassays. Environmental Health Perspectives 58:9-319. Gold L, de Veciana M, Backman G, Magaw R, Lopipero P, Smith M, Blumenthal M, Levinson R, Bernstein L, Ames B (1986). Chronological supplement to the carcinogenic potency database: Standardized results of animal bioassays published through December 1982. Environmental Health Perspectives 67:161-200. Gold L, Slone T, Backman G, Magaw R, Da Costa M, Ames B (1987). Second chronological supplement to the carcinogenic potency database: Standardized results of animal bioassays published through December 1984 and by the National Toxicology Program through May 1986. Environmental Health Perspectives 74:237-329. Gold L, Slone T, Backman G, Eisenberg S, Da Costa M, Wong M, Manley N, Rohrbach L, Ames B (1990). Third chronological supplement to the carcinogenic potency database: Standardized results of animal bioassays published through December 1986 and by the National Toxicology Program through June 1987. Environmental Health Perspectives 84:215-285. National Cancer Institute (NCI). Survey ofCompounds Which Have Been Testedfor Carcinogenic Activity. Prepared by Technical Resources, Inc., Rockville MD. NIH Publication No. 91-3243 (formerly Public Health Service Publication No. 149). NCI, US Department of Health and Human Services, National Institutes of Health, NCI, Bethesda, MD. Office of Environmental Health Hazard Assessment (OEHHA, 1993a). Establishment ofthe OEHHA Science Advisory Board with Committeesfor the Listing ofChemicals Under Proposition 65. OEHHA, California Environmental Protection Agency, Sacramento, CA. Office of Environmental Health Hazard Assessment (OEHHA, 1993b). Status Report on the Priority Lists ofCandidate Agents. OEHHA, California Environmental Protection Agency, Sacramento, CA. Office of Environmental Health Hazard Assessment (OEHHA, 1994). Proposalfor Compiling and Prioritizing Candidate Agentsfor Consideration by the Carcinogen Identification 18 SL 110088 DRAFT OEHHA Prioriti2ation Procedure October 1996 Committee. OEHHA, California Environmental Protection Agency, Sacramento, CA (January 28). Office of Environmental Health Hazard Assessment (OEHHA, 1996). Procedurefor Prioritizing Candidate Chemicalsfor Consideration Under Proposition 65 by the "State's Qualified Experts". OEHHA, California Environmental Protection Agency, Sacramento, CA (May 17). Schardein JL (1993). Chemically Induced Birth Defects, 2nd ed., Marcel Dekker, Inc., New York. 19 SL 110089 DRAFT revised October 15, 1996 Figure 1 Flowchart for Consideration of Chemicals Under Prop 65 Category I CRandom Selection^ dlPcriodic (quarterly) notice of status Draft Data Summaries Draft Priorities ^Supplemental Analysis Neede3m> CSpecify Issues to be Evaluate^ CFotice, Public Comment. WorksSSj^ (^Supplemental Analysis Nee3e3?^ Supplemental Analysis| C^Sotice. Public Comment WorksEop^> Final Category Q No Action Planned At this Time Final Candidate List High Level of Hazard concern Caprice, Data Call in. Workshop Draft HID Notice, Public Comment Draft HID and Comments SAB MEETING i) SL 110090