Tobacco Documents Online

ENVIRONMENTAL TOBACCO SMOKE AS A CANDIDATE AC'rIENT FOR CONSID'ERATION BY THE D'EVELOPIVIENTA::, AND REPRODUCTIV'E TOXICANT' (DART) IDENTIFICATION CONMTTEc Reproductive and Cancer Hazard' Assessment Section (RCHAS) Office of Environmental I-iealth Hazard Assessment (OEHHA)~ California Environmental Protection Agency April' 8„ 1994 introdiuctiion The purpose of this document is to provide informatidn on~ ETS' as a candidate for DART Identification Comrtuttee evaluation.. AIthou¢h ETS has not been formallv evaluated as, a DART. it has been discussed as a candidate on a number ot' occasions over the past five years. ETS was discussed as a candidate for consideration at the first meeting of the DART Iidentificationi Committee in October. 1993. `' ETS had already been given a high priority by a previous panel of "State's qwalifted experts , the Scientific Advisory Panel (SAP): In its February 198'9 meeting, the Reproductive Toxicity Subpanel of the SAP' praoritized 11 agents for future consideration and ETS was identified as the highest priority candidate.' ETS is also one of 12 agents selected as being of "high priority" by a committee of external scientific experts from a master list of 164 agents prepared by RCHAS.' The California DepartmenrofHealth Services (DHS) and OEHHA are developing a risk assessment document: addressing the reproductive: carcinogenic, cardiovascular andd respiratory effects of ETS, "Tobacco smoke (primary)" is already identified, under Proposition 65 as a developmental, male reproductive and female reproductive toxicant. Environmental Tobacco Smoke (F`TS)i is al high priority candidate: for consideration by the DART Identification Committee of the OEHRA Science Ad+visory Board (SAB). This is based on the following criteria developed for prioritizirtg agents for consideration: 1) concern about potential DART hazard exists: in the scientific community; 2)~there is significant potential for exposure. Additionally, there are sufficient data available to permit an evaluation of the reproductive and~ develbpmental toxicity of ETS to be made. ' Saience Advisory Board. Proposition 65 DART Identification Comrtnttee. Public Meeting, Monday Octotxr2'5, 1993. TranscriQt. p. 105. "'Chemncal' Listing Histor_v", memorandum to the Scientific Advisory Panel members from Stevem Book. November 25. 1992. ''"Stattts report on~the priority list of candidate agents7; prepared byOEHHiA. October. 1993„and presented at the October 25: 1993 meeting of'the DART Identification comm3ttee.

ETS Sl'INOPSIIS' Page 2' Potential DART Hazard Based on the ;.lection~ process for priority candidates', concern about potential'I DART hazard' inithe scientifiic communitv was evi'ent. Potential Exposure ]n 1991, the National Center for Health Statistics published a survey of 47,000 families regarding children's exposure to ETS before andafter birth: s The survey indicated that. 2'Z°i'oof children under 51 years, o~f age had mothers who were, exposed m ETS: during~theirpregnanciies. This number does not include children of mothers who were themselves smokers (2'9°'0). Exposures in California are similar to those that, occur nationally. Available Data There is ann extensive database available for evaluating the develbpmental. toxicitti of ETS_ The databases for evaluating the malle and female reproductive toxicitv of ETS' are less extensive. There are no existing regulatory documents or fwllliterature; revi ews on ithe ,dkvelop~mental and reproductive toxicity of ETS. Scientists in DHS and RCHAS have reviewed' the epidemii7logical and animal data publi5hedibetween 1966 and 1992. A number of studies are available on the developmental and reproductive toxicity of ETS. Type of Stud+v Endpoint, Human Animal Female fertility 6 2' Male fertilitv 0 2 Onset of menopause 1 0 Spontaneous abortion 4 0 Malforrrtation, 6 4 Pieninatal weight , 3 4 Birthweight 22' 1'2 Occurrence of SIDS 3 0 Postnatal cognition and behaviior 6 1 Postnatal growth 5 1 "'Pnontizrng;candidate reproducmveJdeveiopmental toxicants for evaluationi" J.M. Donald'et ad.. Reproductive Toxicology; 6. 99-1!08 , 1992. "'Children~s exposure to environmental tobacco smoke before and'after bittih." Advance Data fiom Viuall and Nlealth Statistics of the National Center for Health Statistics. No. 202. 1991.

ETS SYNOPSIS P,ase 3: The epidemiolo¢ical' database is characterized by many large studies of low birthweight fronn a number of countries; and by a s nall number of focused and well'=conducted studies of the incidence of ST1pS, Data are less extensive for the other endpoints, Animal studies are eonsidlered seeondarv bF:;ause of the availability of human data and the difficult2es in accuratelv, replicatrtng;condi"tions ofhuman~exposuretp ETS in animalmodels~. Adjunct information relevanr, to the evaluation of the ETS database is available frotn human studies on the effects of active smolting, and'fro~m,animal studiesonthe reproductive ~ and developmental toxicitvy of ETS componznts: Conclusion Environmental Tobacco Smoke meets the criteria for consideration, bv the DART Identif cat6on Committee as a hieh priority candidate. The nature and extent of the available data allowan evaluation of developmental and reproductive toxicity of ETS to be made for some endpoints. If the DART Committee decides to consider ETS at a fwture rneetang, OEHHA will provide materials for evaluation of the scientific evidence.