Document wabG7bxbqv08vD2oyBVvjmgD

uf The Society of The fltasflcs Industry, Inc. October 16, 1967 Mr. Art Gellner CertalnTeed Corporation Lake Charles Polymer Plant #283 P.O. Box 253 Pete Manona load Sulphur, Louisiana 70664 Ret SARA 110 Toxicological Profiles Dear Art* As a follow-up to ay conversation with your secretary this morning, is the October 15th Federal Register notice ./announcing, the schedule the availability of the first 25 profiles. As noted, the draft profile for vinyl chloride is targeted for Hovembcr 30thh with a 90-dav coament period. Also enclosed is a letter I have written to the deelgnated contact at the Agency for Toxic Substances and Disease Registry requesting the vinyl chlor ide profile. Let me know if there is anything alee I can do to assist your efforts on this issue. Sincerely yours. jAjLLLCUJJc.----------- Meredith II. Scheck Assistant Director cct VI Health, Safety & Environment Comittee gEV-239348 Waytm Interchange Plaza II 155 Route 46 Wtoat Vteyn* i U0T4m * (20 0904299 IB. 07 0^:44 pm * * I INC s* o s 98340 DEPARTMENT OPMALTH AND HUMAN BCflVICSB Apeney For T0M0 ImWihmi ond Pm--i ftegtelry ENVIRONMENTAL PROTECTION AGENCY tATtOmt; mUSMO-7) AvafleMtty of Toxfoofegtatf Profited Dspartmsnt of Health and Human Bervteea (DHHS)t Agency for Toxic Substance* and DIimh Registry (ATSDR)! and Environmental Protwtlon Agency (SPA). Acnom Notice. MMMWVi The Superfund Amendments and Rseuthorixetion Act (SARA) (Pub. L 90-499) amanda tha Comprehensive Environmental Response, Compensation, and Liability Act (CSRCLA or Suparfund) (43 U.S.C- 9901 / *#9.) by aatabllahlng certain requirement* for tha Agency for Toxic Subatanoaa and Disease Raglftnr (ATSDR) of DHHS and ffA with regard to haaardoua aubatanoaa which era moat commonly found at facUlttaa on the CSRCLA National Frtorttloe Ult (NFL). Among these statutory requirements is a mandate for the Administrator of ATSDR to proper* toxicological profile* for each substance previously inefodad on tha tint priority list of 100 chemicals. Tha Uet identified tha first 100 chemicals which both Agencies determined posed tha most significant potential threat to human health. This Uat was published In tha Federal Jteglstar on April 17th, 1997 (92 PR 12000) as required by SARA section 110. This nottca aiwtouyt-- the expected availability dataajjjh* drat 28 draft toxicological liiuMpil laiilsii and comment ** Availability %HK' Tha following draft tcxioologloal profiles are axpeeted to be publicly available by the dais indicated; OASMitar OHW TT, TW7 M-flM e*naM*mnM-------------- MUM eyeun.~---........................,, CKomteni SV4S-S CNemWS.-.- 744*474 Owyww ___ I1M14 oo*anKUi)irM<u~-.-.m~. ss-re-e TS-444/t0SM74 NWw<_.... .... ............. --____ >4404*4 *404 oroear as. 1S*T AUMVSMWn. - SeS40-|/SO-t7-1 A full 90-day public comment period will be provided for *oh profile. . starting from the actual release date. The dose of tha comment period for each draft profile will be indicated on the front ot each profile. Requests for draft toxioologtaal profiles should be sent tot Me. Oeorgl jonss. Director, Office of External Affair*. Agency for Tcnde Qpbstmnoee and Disease Regtetiy, Ghamble* 29 South. 1900 Clifton Rd, AtUnU, GA 30323. 8paUV the profiles you wish to review. One oopy of eaoh profile requested will be forwarded* free of charge, as they become available. In the case of undue delays, requestor* will be notified. Five copies of all ceamente should be sent to Ms. Jones at tbs above address by die end of die comment period All written comments and the draft profile* will be available for public Inspection at the Agency for Toxic Substances and Disease Registry (ATSDR), Building 28 South. Room 1109.4770 Buford Highway. NB., Chamhlea. GA, from 9 am to 430 pm. Monday through Friday, except legal holiday*. Written comments and other data submitted in response to this notice and the draft toxicological profiles should bear die docket control number AT8DR-2. --LiMUTAnv iweonmTto: 2. Background On October 17,1986. the President signed tha Superfund Amendments and Resuthoriaatton Act of 1986 (Pub. L 89499). which extends and emends the Comprehensive Environmental Response. Compensation, and Liability Act of i960 (CBRCLA or Superfund 42 U.S.C. 9801 t*MU Section 110 of SARA amends section loa(i) of CERCLA by establishing requirements for the preparation oft (1) Lists of bacardous substance* in order of priority. (2) toxicological profiles of thoss substances, and (3] a reseeroh program to HU data gaps associated with the substances. In compliance with section 10HUOKA) of CSRCLA Atm and EPA published on April 17,1997 (82 FR 12908) the first priority list of 100 haserdous substance*. This priority Ust of 100 was further broken down into fear groups of29 chemicals. The first group of 25 was to be the subject of the second phase of the requirements. La., the development of the first eat of toxicological profile*. 8ectioo 104(11(3) of CERCLA spells out the content of these profiles and the timetable by which they must be developed Profiles on at laeet substances on the first priority list were to be completed withiaona year of the enactment of SARA (by October 17, 1997). The remaining seventy-five are to be oompleted at a rate ofat least twenty-five per year with tha'total 100 oompleted within four years after the enactment of the SARA amendments. Revision end republicstion is mandated es necessary but no less oftetnhen once every throe years. | Each profile is required to lwuda an examination, summary and interpretation of available toxicological Information and epidemiologic evaluations. This information and data are to be used to ascertain the levels of significant human expoeura tor tha substance end the associated health affect*. The profile* must also include a determination ofwhether adequate information on the health effects of each substance is available or In the process of development The Agencies' intention ie that this information ot used to identify the key toxicological tasting needs that when filled will improve our ability to define significant human exposure levels. The toxicological profiles are to be provided to the States and mads available to the public. The profiles are to be prepared in accordance with the guideline* developed by ATSDR aftd EPA These guidelines were published long with the priority list of 100 In the April 17,1997 Federal Register Notlot (92 FR 12970). This current notice announces tha protected availability dates of the first 28 draft toxicological profiles. The document* have undergone extensive internal review end have been subject to scientific and technical peer review by outside experts. We are now announcing their availability and encouraging public participation and comment on tha further development of these profiles. Although the profiles will not be completed by the October 17. 2997 deadline, we believe that the extra time given to pew review end public ^EV-239349 lO. 16.07 O 4 * A, INC PO3 ami review and comment U important to foe development of quality profiles of dentine merit Although wo era raeeonably confident that the key etudlee for eech of the 20 *ubetenets were considered daring foe profile development process. foie federal Regtoter notice solicits eny significant etudlee. Including unpublished dele, which mey eid hi the revision of those draft profiles- 1L Levels of Wgriftrrat Homea Iqwwe The setting of specific levels of slgnifioent humen exposure has presented unique eet of problems. The significance of e specific level of a haserdous substance depends on the context in whloh thet level to evaluated. For example, e low level thet mey be Insignificant with respect to cat acute, immediately debilitating symptoms mey be highly elralnaent with respect to causing gradual. chronic Sects over e longer term. Since these profiles era intended for use by e diverts group of people who have different sanations in whloh to interpret the efenlfteanee of specific levels, it wee considered appropriate at this time to describe the range of exposures over which effects nay oocor (where data are available), and to allow foe user to make determinations as to which type of effect is significant in any particular instance. A format for graphically displaying the levels ofsignificant human exposure has been developed and to used in foe profile* to present foe ranges over which effects may be observed. We encourage publlb comment and recommendations on this specific issue. HI Solicitation of Fuhfce Comment We an solid loommsnton all pha_s_e_s_o__f _fo_e___________ ^ of the toxioological peu^KA previous Federal RegtotoeMBhpublished on April 17. igSF inWtmm aofidtod comment on the first priority list of haiardoue substance. We era currently reviewing those comments end an evaluating foe impact that those comments may have on the priority list end the methods used in Its development. As the first as toxicological profiles become available In draft form, we an eager to provide them to the States Industry, public health professionals, dentists end the general public. Wa welcome comment end feedback on the content of the profile*! the format end scope of the documents; the process used in the development of foe levels of significant human exposure and foe overall process used la foe development of the profiles. These are specific items that wa would like to drew to foe attention of the reader end would strongly encourage as candidates for does attention during foe comment period. A. Public Health Statement The draft profiles include a public health statement which to intended to concern. The summary a* originally planned should be tote to stand alone. If removed from the rest of the document. It should still be capable ofoooveylng to the public the substantive health concerns associated with the eubetaaee. We art also considering tin development of more abbreviated version* of the public health statements and an evaluating a number of different formate. This notice specifically invitee comments on foe existing public health effects statements in the draft profiles end solicits recommendations for elteraetlve approaches. B. Data/StudJee CJeed in foe Development of the Profilee In general, and for each chemical- specific profile, have the appropriate studies bean used in the development of these documents? Our concern nan to that wa capture the critical, or "key", studies but not miss other data that may ba important in the valid evaluation of the toxicological profile chemicals. C Format and Content ofthe Profilee The draft profiles represent our best effort to proviIddeefo*i'informutton required by seoti,oo 'glofCERCLA the various Identified users of foe profiles, given the constraints olfoe tight timeframe. Every effort has been made to define sections cleeriy end to format foe documents br such a way that they can ba used ea resource documents by many different audiences. We specifically request comment on foe format and content of the initial set of profiles, including how the format might bo "***?* for subsequent sets of profiles. D. level* ofSignificant Human Exposure What to the most useful way of presenting this type of information? For this first generation of profiles wa have selected a graphic presentation that reflects a '*raage" of values that covers both upper ana tower bounds ofaffect levels, Is this men useful then a single number? An there other ways of presenting this type of information that would be more useful to the eventual user? E Identification ofSignificant 0ato 1 Cape I The process used to devtloprao draft profiles has resulted In foe ideupfleation of the foil range ofhealth effects data gape associated with etch ohemicaL However, depending on individual dreumstseoes soma subset of the Identified data gape may be essentia! In determining levels of significant txpoaura. while other date gaps may be lew immediate. ATSDR. BPA. and foe National Toxicology Program (NTP1 have been exploring ways to Identify the critical data slsmsots that are needed to establish slgnlfieast human exposure levels. This notice specifically requests comment end suggestions for approaching thto phase of the toxtootogies! profile process. For The Agency For Toxto Substances sad DtMsss Registry. Dated: September so, tsar. |saes O. Masse. Administrator. Agencyfar ToxicSubstances andDisease Registry. For The Environments! Protection Agency. Detsd: October 7.1907. lee M. Thomas, Administrator* EnvironmentalProtection Agency. (PR Doo. S7-ae Piled UM4-S7; M3 *m] enim coos 4tes*rau *t % *3>3S0