Document LKbDy4DYGB6DErndJbB4LJ51z

A I#W Vinyl W m Institute A Division of The Society of The Plastics Industry, Inc. October 16, 1987 Mr. Art Gellner CertainTeed Corporation Lake Charles Polymer Plant #283 P.O. Box 253 Pete Manona Road Sulphur, Louisiana 70664 Dear Art: Re: SARA 110 Toxicological Profiles As a follow-up to my conversation with your secretary this morning, enclosed is the October 15th Federal Register notice announcing the schedule for the availability of the first 25 profiles. As noted, the draft profile for vinyl chloride is targeted for November 30th, with a 90-day comment period. Also enclosed is a letter I have written to the designated contact at the Agency for Toxic Substances and Disease Registry requesting the vinyl chlor ide profile. Let me know if there is anything else I can do to assist your efforts on this issue. Sincerely yours, MNS/pmb enclosure Meredith N. Scheck Assistant Director cc: VI Health, Safety & Environment Committee cTL017820 Wayne Interchange Plaza II 155 Route 46 West Wayne, NJ07470 (201) 890-9299 lo. 15. S'? O 4 : 4 4 PM * * f* I INC PO2 38340____________ Federal Reglatet / Vol 62. No. 199 / Thuroday, October 15, 1887 / Notices DEPARTMENT OP HEALTH AND HUMAN SERVICES Agency For Toxic Subetaneee end Disease Registry ENVIRONMENTAL PROTECTION AOENCY [ATSDR-2; PRL-32M-71 Avsilatoillty of Toxicological Profiles AOXNCISS: Department of Health and Human Sarvices (DHHS): Agency for Toxic Subitancai and Disease Registry (ATSDR): and Environmental Protection Agency (EPA). ACTIONS Notice. SUMMARY! The Superfund Amendment! and Raauthorizatton Act (SARA) (Pub. L 99-499) amends the Comprehensive Environmental Response, Compensation, and Liability Act [CERCLA or Superfund) (42 U.S.C. 9601 el itq.) by establishing certain requirements for the Agency for Toxic Substances and Disease Registry (ATSDR) of DHHS and EPA with regard to hazardous substances which are most commonly found at facilities on the CERCLA National Prioritise List (NPl). Among these statutory requirements is a mandate for the Administrator of AT9DR to prepare toxicological profiles for each substance previously included on the first priority list of 100 chemicals. The list identified the first 100 chemicals which both Agencies determined posed the most significant potential threat to human health. This list was published in the Federal Register on April 17th, 1967 (52 FR 12686) as required by SARA section 110. This notice announces the expected availability dates of the first 2S draft toxicological profiles for review sod comment. Availability The following draft toxicological profiles are expected to be publicly available by the date indicated: 0tm/PmHt CASdumtar OcMmt 17,1N7 fawuxntnripr---.-........... IMM *ntMi)pyTM ,,............. .... ....... so-u-e Boylhini............. ..................... 744041-7 Cwomtem....................... .......... VAM Ovvnuffl>.ii...................... ....... 744047-1 CHfy*w..................... ......... J1*4I4 nwmpw.hmruhraefw .............. M-70-J HMenlorfH(0tMhlor noMi. 70444/10*447-3 Niek*i.............................. ........... 74404*4 M-004 OrteMr It, 1MT AWnw/{Ni>l.....----- --------------- 9Cft-00-J'IO~97-1 744$OI-a eraglbMiugrwWw* --------------- MAM CWWWnW CAimlW SCU-AracMr IteO. 17M. iSAt. im*. im t*ti. id#. Mil 1100S41-M10SMS-1. ir*4*-a urn*114. 11141-1*4. 111044*4.1*174- 11-* 174(414 WnMMrl. 1M7 71-43-t aaa-MiyihwqiOpMuUM--------- 11741-7 7440-434 1 LflkMftttMaM_________ 100-44.7 MWiyWM OMond#____ -- 7*404 NoWOMrM 1N7 CyMW-.-.-- *7-114 k*M--------- ------------------...-- 74W4S-1 117.1*4 7*414 Vn)N DVOIW min--.4im> A full 90-day public comment period will be provided for each profile, starting from the actual release date. The close of the comment period for each draft profile will be Indicated on the front of each profile. Requests for draft toxicological profiles should bs sent to: Ms. Ceorgi Jones, Director, Office of External Affairs, Agency for Toxic Substances and Disease Registiy. Chamblee 28 South. 1600 Clifton Rd.. Atlanta, GA 30333. Specify the profits* you wish to review. One copy of each profile requested will be forwarded, free of charge, a* they become available. In the case of undua delays, requestors will be notified. Five copies of all comments should b sent to Ms. Jones at the above addrest by the end of the comment period. All written comments and the draft profilts will be available for public inspection at the Agency for Toxic Substances and Disease Registry (ATSDR), Building 28 South. Room 1103,4770 Buford Highway, NE,, Chamblee, GA, from 6 am to 4:30 Jim. Monday through Friday, excapt egal holidays. Writtsn comments and other data submitted in response to this notice and the draft toxicological profiles should bear the docket control number AT8DR-2. UmSMINTARV INFORMATION: L Background On October 17,1988, the President signed the Superfund Amendments and Rssuthorization Act of 1988 (Pub. L. 99499). which extend* and amends the Comprehensive Environmental Reiponse. Compensation, and Liability Act of 1980 (CERCLA or Superfund. 42 U.S.C. 9601 el teq.). Section 110 of SARA amsnds faction 104(i) of CERCLA by establishing requirements for the preparation of: (1) Lists of hazardous substance* in order of priority. (2) toxicological profiles of those substances, and (3) a rasetrch program to fill data gaps associated with tba substanesa. In compliance with section 104(t)(2](A) of CERCLA. ATSDR and EPA published on April 17,1987 (82 PR 12866) the first priority list of 100 hazardous substances. This priority list of 100 was further broken down into four groups of 23 chemicals. The first group of 28 was to be the subject of the second phase of the requirements. i.e., the development of the first stt of toxicological profiles. Section 104(l)(3] of CERCLA spells out the content of these profiles and the timetable by which they must bs developed. Profiles on at least substance* on the first priority list were to be completed within one year of the enactment of SARA (by October 17, 1967). The remaining seventy-five are to be completed at a rata of at least twenty-five per year with the total 100 completed within four yesr* after the enactment of the SARA amendment*. Revision and republication is mandated e necessary but no less often than once every three year*. Each profile is required to include an examination, summary and interpretation of available toxicological Information and epidemiologic evaluations. This information and data re to be used to ascertain the levels of significant human exposure for the substance and the associated health effects. The profiles must also Include a determination of whethar adequate information on the health effects of each substance is available or in the process of development The Agencies' intention is that this information b* used to identify the key toxicological teiting needs that when filled will improve our ability to define significant human axposure levels. The toxicological profiles are to be provided to the Statse and made available to the public. The profiles are to be prepared In accordance with the guideline* developed by ATSDR and EPA. Thee* guidelines were published along with the priority list of 100 in the April 17,1987 Federal Register Notice (82 FR 12870). This current notice announces the projected availability dates of the first 28 draft toxicological profiles. The documents have undergone extensive internal review and have been subject to scientific and technical peer review by outside experts. VVs are now announcing their availability and encouraging public participation and comment on the further development of these profiles. Although ths profiles will not be completed by the October 17. 1987 deadline, we believe that tha extra time given to pear review and public CTL017821 to. is. e i 04 : 4 4 P M x< S p. j INC F O 3 Federal Register / Vol. 52, No. 139 / Thursday, October / Notices_______ 38341 review and comment l* important to the development of quality profiles of scientific merit. Although w are reasonably confident that the key studies for each of the 29 substances were considered during the profile development process, this Federal Register notice solicits any significant studies, including unpublished data, which may aid in the revision of these draft profiles. If. Levels of Significant Human Exposure The setting of specific levels of significant human sxposura has presented a unique set of problems. The significance of a specific level of a hasardous substance depends on the context In which that level is evaluated For example, a low level that may be insignificant with respect to causing acute, immediately debilitating symptoms may be highly significant with respect to causing gradual, chronic offsets over a longer term. Since these profiles are intended for use by a diverse group of people who have different sutiadons in which to Interpret the tignificance of specific levels, it was considered appropriate at this time to describe the range of exposures over which effects may occur (where date are available), and to allow the user to make determinations as to which type of effect is significant in any particular instance. A format for graphically displaying the levels of significant human exposure has been developed and Is used in the profiles to present the ranges over which effects may be observed We encourage publib comment and recommendations on this specific issue. Ill Solicitation of Public Comment We are soliciting public comment on ell phases of the development of the toxicological profiles. A previous Federal Register notice, published on April 17,1887 (92 FR12886) solicited comment on tbs first priority list of hasardous substance. We are currently reviewing those comments and are evaluating the impact that those comments may have on the priority list end the methods used in its development. As the first 29 toxicological profiles become available in draft form, we are soger to provide them to the States,. Industry, public health professionals, scisntists and the general public. We welcome comment and feedback on the content of the profiles; the format and scops of ths documents; the process used in the development of the levels of significant human exposure and the overall process used in ths development of the profiles. Thssa era specific itsms that we would Uke to draw to the attention of the reader and would strongly encourage as eandldatas for close attention during the comment period. A. Public Health Statement The draft profiles Include a public health statement which is intended to provide the lay public with a concise statement of the general health Hike associated with the ehtmicel of concern, lie summary as originally planned should be able to stand alone. If removed from the rest of the document it should still be capeble of conveying to the public the substantive health concerns associated with the substance. We are also considering the development of more abbreviated versions of ths public health statements and are evaluating a number of different formats. This nodes specifically Invites comments on the existing public health effects statements in the draft profiles and solicits recommendations for alternative approaches. B. Oata/Studiee Used in the Development of the Profiles In general, end for each chemlcalspeoine profile, have the appropriate studies been used In the development of these documents? Our concern here is that we capture the critical or "key", studies but not miss other data that may be Important in the valid evaluation of the toxicological profile chemicals. C Format and Content of the Profiles The draft profiles represent our beet effort to provide the information required by section 104(f)(3) of CERCLA In the most useful format for the vtrtoue identified user* of the profiles, given the constraints of-the tight timeframe. Every effort has been made to define teettons clearly and to format the documents in such a way that they can ba used as resource documents by many dlffsrsnt audiences. Ws specifically request comment on the format and content of the Initial set of profiles. Including how the format might be modified for subsequent sets of profiles. D. Levels ofSignificant Human Exposure Whet is ths most ussful way of presenting this type of information? For this first generation of profiles we have selected a graphic presentation that reflects a "range" of values that covers both upper and lower bounds of effect levels. Is this mors ussful than a single number? Are then other ways of presenting this type of Information that would be more useful to the eventual user? Identification ofSignificant Data Gape The process used to develop the draft profiles has resulted in the identification of ths full range of health effects date gaps associated with each chemical However, depending on individual circumstances some subset of the Identified date gaps may be essential in determining levels of significant exposure, while other data gaps may be less Immediate. ATSDR. EPA. and the National Toxicology Program (NTP) have been exploring ways to identify the critical data elements that are needed to establish significant human exposure levels. This notice specifically requests comment and suggestion! for approaching this phase of the toxicological profile procees. For The Agency For Toxic 8ubtanoe and Disease Registry. Dated: September 90,1987. [ernes O. Mams, Administratori Agencyfor Toxic Substances andDisease Registry. For Tha Envtronmantal Protaction Agency. Dated; October 7.1917. lee M. Thomas. Administrator. Environmental Protection Agency. (FR Doa 87-23920 FUed 10-14-87; *43 t] eiume com 4ia*.r*M CTL017822 A Division of The Society of The Plastics Industry, Inc. October 16, 1987 Ms. Georgi Jones, Director Office of External Affairs Agency for Toxic Substances & Disease Registry Chamblee 28 South 1600 Clifton Road Atlanta, Georgia 30333 Res Availability of Toxicological Profiles (52FR38340-41 - October 15, 1987) Dear Ms. Jones: Please forward to me at the address indicated below, the toxicological profile for VINYL CHLORIDE. As the Vinyl Institute intends to review and comment on the draft, I would appreciate receiving the material as soon as it is available for distribution. Thank you for your attention to this matter. Sincerely yours, MNS/pmb Meredith N. Scheck Assistant Director CTL017823 Wayne interchange Plaza II J55 Route 46 West Wayne, NJ 07470 (201) 890-9299 A Division of The Society of The Plastics Industry, Inc. October 15, 1987 TOs The VI Health, Safety and Environment Committee RE: Enclosed Material - September 30, 1987 Meeting The following items are enclosed as follow-up to the September 30th meeting of the Health, Safety and Environment Committee: 1. The minutes of the meeting. 2. A set of charts on labeling practices as reviewed and revised at the meeting. 3. A September 17, 1987 news clipping from the POST/SOUTH entitlted "Georgia Gulf Neighbors File $19 Million in Suits". 4. Material provided by Herm Waltemate regarding OSHA citations. Update: SPI v. EPA Peter de la Cruz advised me on October 14th, that REDACTED MNS/pmb enclosures Meredith N. Scheck Assistant Director CTL017824 Wayne Interchange Plaza II 155 Route 46 West Wayne, NJ 07470 (201) 890-9299