Document kDN8G9vxV89360r0X6ZDv7BjB

Lead Industries Association, Inc. 295 Madison*Avenue New York. N.Y. 10017 Tel. (212) 578-4750 Fax (212) 684-7714 NQXE^EBQMC^jTRAL CONFERENCE CALL Smelter Blood Lead Survey Program January 29,1992 PAEXKhRAmLa Paul Deveau Karen Hogan Jeff Miller Patrick Phillips Bob Putnam Don Robbins Gene Shippen Jerry Smith Dan Vomberg Noranda EPA LIA MO Dept, of Health PES/CITE ASARCO Consultant for Exide LIA ' Doe Run . program.descriphok The committee reviewed the program description and made several modifications as indicated in the latest draft. The program is being distributed to the Central Committee members for final review and approval. The consensus of the committee was that the central laboratory should have the capability to detect blood lead levels as low as 1.0 |ig/dl. Gene Shippen offered to contact two additional laboratories for proposals -- Smith Kline and American Medical -- in addition to ESA and Metpath. It was stressed that selection of laboratory must be completed promptly so that an anlytical protocol can be written, reviewed and approved. CDMEAIg-RESRfMS EG GRAM It was agreed that some smelters would need encouragement and further counselling in order to persuade them to participate in the program. Dan OR67000SS Vomberg will be discussing the program at a meeting of the Association of Battery Recyclers 15^ early February and Karen Hogan offered to draft a letter of encouragement. QommLlimm Pat Phillips is researching the identification of control cities as part of the program. The committee offered to assist Pat through the one-day hiring of a clerical assistant for research gathering. Pat will distribute a proposal by March 2, 1992 to the Epidemiological Subcommittee (Phillips, Hogan, Putnam, Shippen) for review. The subcommittee will then make recommendations to the full committee. * . SUEKEY .FORMS ' The committee agreed that the sample forms for parental consent and background questionnaire were either too brief or too detailed. Miller will prepare two new draft forms for review by the committee. (2/6/92) CONFIDENTIAL RS700086 DMEI mELTERBMKmr^mSnMEI^BDmMd, A. G^^ID_PIIKQ^^^XIEY^ 1. Survey Objectives . The objective of this survey is to establish an up-to-date cross sectional survey of blood lead levels of young children, pregnant mothers (as a surrogate for unborn children), women planning to become pregnant, and nursing mothers, living in communities around operating Primary and Secondary Lead Smelters within the United States. This outline will be used to provide a uniform method of surveying the blood lead level of the target population. The results will be used by individual smelters and Communities to assess the lead status of the at-risk population and by the industry as a whole to provide a comprehensive picture of the actual impact of the smelting industry today. It is expected that the actual sampling will occur in calendar year 1992. Smelters will not be asked to repeat surveys in communities if similar surveys have been conducted within the last two years (1990 or 1991). However, the results from these previous surveys will be included in the final report in order to present a comprehensive picture. Participation is premised on the voluntary cooperation of the individual smelters and the communities in which they operate. B. COOfiDIHAIIOH/MANAGEMENT..OF THE STUDY CONFIDENTIAL 1. Central Committee Central Committee will oversee the development of the program, its administration, the hiring of the laboratories, the preparation of the reports, selection of the Control R6700037 Communities and guidance to the local committees with regard-to public relations and other matters. Members of the central committee: Gerry Dumas RSR Corporation Jeff MiHer LIA Patrick Phillips Epidemiologist - MO Dept, of Health Bob Putnam Public Health Consultant ' Don Robbins ASARCO, Inc. Gene Shippen Physician Dan Vomberg The Doe Run Company Karen Hogan EPA John Baranski Exide Corporation 2. Local Committee ' Each participating smelter will appoint a company representative to be a survey project manager and will organize a Local Committee that will implement the survey within that community. The Local Committee might include local and/or state health officials, regional EPA representatives, smelter representatives, local political leaders, as well as community representatives if appropriate. This committee would be responsible for coordination of the sampling, informing and obtaining permission where appropriate of local officials and the public, individual and local release of the survey results, and coordination with the Central Committee. c. QQUMmmjmBmELES, CONFIDENTIAL 1. Population Surveyed The survey would target four categories: 100% of the 6 - 72 month old children, expectant or nursing mothers, ^or women planning to become pregnant that live m the target W1 area. In practice something less than 100% will be sampled although it has been shown that participation above'90% is a `-A- ".A: possible. r A.-'. A AA' ''''a/A;, firainiH RS700088  The study area for all smelters will be a radius of 1 - 1.5 mile around- the main stack as determined by the Local Committee. These distances are suggested because they are zones of anticipated impact based on ambient air modeling. These may be varied somewhat for specific geographic reasons, or if a study has already been completed in the area. - The study area should not be expanded simply to include a larger population, as this will skew the results. Smelters without any population within the specified radius will simply be reported as such. . 2. Control Populations Control communities will be utilized to represent urban and rural controls in order to validate methods on non-impacted areas and to provide a frame of reference for current background blood lead levels. Such Control Communities will be selected by the Epidemiological Subcommittee of the Central Committee (Phillips, Hogan, Shippen and Putnam). 3. Approach to Sampling Sampling may be conducted in one of two ways; either door to door sampling or by visits to a clinic within the sample area. Sampling should be done by a team selected by the Local Committee which could include a public health representative, a smelter representative, and a qualified phlebotomist. The months, days, times of sampling will be determined by the Local Committee. The procedures for the sampling will be developed by the Local Committee. Samples will be by venipuncture. A questionnaire will be administered at the time of the sampling (see sample Attachment I). 1. Selection of Laboratory A single laboratory with CDC accreditation will be selected by the Central Committee with a second laboratory utilized to run quality control on the first (10% of the total number of samples will be sent to the second lab.) The selected laboratories will demonstrate a lowest limit of detection for blood leads at 1 pg/dl. 2. Quality Assurance Quality control will be part of the analytical protocol., The laboratory will provide sampling vessels, mailing systems and instructions to the participants in the program to insure uniformity and assure quality. RESULTS 1. Presentation of Nationwide Results Local Committee will provide results to the Central Committee for preparation and release of a Composite Nationwide Report. 2. Use and Release of Local Results Local release of sampling results will be coordinated by the Local Committee. Individual results will be released to the individual, not to the general public. Individual privacy shall be protected by a confidentiality agreement. (See sample Attachment II.) 3. Follow-up When appropriate, blood lead results will be referred for follow-up to the local health department on the basis of CDC guidelines. COSTS COHEIDEKTIAL 1. Health Department " ' "i ~ `&1- Health Departments would pay for their own representatives on the Local Committees.'1' Otter clerical help, office space, furniture, or eqtnpmenti'will be resolved by the Local Committee. - V ;. Iff.1; -r ' ; OR6700090 2. Smelter SmeltSrs should expect to pay all other costs, including sampling, lab work, labor, rents, and public notices. 3. Central Committee . Costs of the members will be borne by their respective organizations. 7 Costs for sampling the Control Communities will be home by the LIA Product Stewardship Program. 1. Smelter Activities Identify a Survey Project Manager and additional smelter staff as needed. Solicit the cooperation and assistance of the local, county and/or state health departments, community leaders, political, and school officials, etc. Help establish a Local Committee of company, medical, health and other community elements. 2. Local Committee Activities Define the study area. li^. Uj f Select either the door to door sampling protocol or the clinic visit protocol. Design the sampling campaign. Plan for the dissemination of the results. Proceed with the survey. Disseminate the results of the study. Follow-up as appropriate. (2/6/92) -4 -iv- ^.............. :s I DR6700091 Lead Industries Association, Inc. 295 Madison Avenue New York. N.Y. 10017 * Tel. (212) 578-4750 Fax (212) 684-7714 RETURN FAX TO JEFF MILLER, LIA - (212) 684-7714 BY FEBRUARY 17, 1992 Below is my approval (non-approval) of the draft Smelter Blood Lead Survey Program dated February 6, 1992. Approved as written. Approved with the following minor changes. Rejected for the following reasons. NAME Date - ~.'*t ... ` > 4>v,,r ' -' 'itVy -:^--':(2/6/92) --"o` 111... ORS700092 HEAELSAMELE-H1SM (COUNTY DEPARTMENT OF HEALTH LETTERHEAD) -^Participant Consent for Blood, Lead Testing Outline: The (County) Department of Health, in cooperation with the (Company Name), is conducting a survey of possible exposure to lead among selected residents of (County). My participation (or my child's) will help de termine if there is exposure to high lead levels. This test is for . () Myself () My child/ward A blood sample of approximately 7 milliliters (ml) [3 ml for children less than 6 years old] will be taken with a needle from a vein in the arm by a licensed medical professional. There is little risk associated with this procedure. Temporary discomfort and a small bruise may occur at the site where the needle enters the skin. Participation: I understand that my participation will take no more than thirty minutes. There will be no physical examination. There will be no provision for injury compensation or medical treatment as a result of my (or my child's) participation, and I hereby release the (County ) Department of Health from any obli gation in that regard. I understand that I can stop our participation at any time. If I choose not to partici pate or to stop, there will be no penalty. Results: As a result of my (my child's) participation in this survey I (my child) will receive a blood test for lead. No other laboratory tests will be run. There will be no charge to me for any of these tests. The (County) Department of Health will send me a letter with the test results and will refer us for medical eval uation, and possible additional testing, if indicated by our results. Confidentiality: I understand that the (County) Department of Health will take every reasonable precau tion to keep our records confidential.. Any reports of this survey will not identify specific individuals by name, address, etc., and will only give group information. ' Participant consent: I have read the description of this survey. All of my questions have been satisfactorily answered. I (my child) _________________ . voluntarily agree(s) to participate. Printed Name Participant/guardian name (print) ________ Signature Date_____________ _____ Witness Participant ID No._____________________ (Name), (County) Health Department, Phone: (Name), (Company Name), Phone: CONFIDENTIAL M.:'. `.rite:- SiJf.`A*. - ' A.;'.' .. A \ tDISCLAIMER: This is a proposed draft consent form. The final form of any consent is the sole responsibilir-\j ty of the County Department of Health and its Legal Department administering the survey. The Lead In-* [dustries Assodation ainjwceptjio resjjonsibility for useofall ormy portion of the form. " ;; J DR6700093 DMT (COUNTY) HEALTH DEPARTMENT BLOOD LEAD SURVEY QUESTIONNAIRE A. name of Participant; Address: Phone #: CATEGORY: 6 - 72 month child G Nursing mother Pregnant woman Woman planning to be pregnant Date of Birth: ___________________ If child: Name of Parent/Guardian: Address (if different): Phone: B. HOUSING. 1. Do you Ohrwn G rent? 2. Approximate aere of house 3. Type of exterior Brick Paint Q Block Siding Q Other G Don't know 4. Source of water: City Bottled Well G Other G Don't know 5. Type of Water Piping: Of Copper Plastic Lead G Iron/Steel Q Other G Don't know 6. Is the. exterior paint peeling? Yes G No 7. Is the interior paint peeling? Yes No 8. Have you done any recent paint stripping, scraping, sanding? Yes No 9. Type of heating fuel. Gas Oil Q Electricity Coal Wood Q Other Don't know CONFIDENTIAL RS700095 c. o 1. Does anyone4n your household work in the following occupations? Smelting Q Battery making G Mining Automotive repair Plumbing G Electronic manufacturing G Paint removal G Highway striping G Ceramics Q Ammunition G Firing ranges G Stained glass G Crystalware - Q Scrap metal recovery G Bridge painting 2. Is anyone in your household involved in the following hobbies? G Artist painting G Stained glass G Electronic soldering G Pottery G Ceramics G Self casting of bullets/fishing weights/figurines G Gun clubs G Home gardening 3. Have you recently purchased any new ceramicware? Yes Q No D. PERSONAL HYGIENE 1. Does your child chew on fingernails? Yes No 2. Does your child suck his/her thumb? Yes No 3. Does your child wash his/her hands before meals? G Yes G No 4. Does your child put foreign objects in his/her mouth? Yes No 5. Does your child teethe on furniture, window sills, or other painted objects? .. -V' . Yes No . :''*%' (2/6/92) //< 7 2. )'' / ' / / / -' ?/ 5*7* - 7/21/ Af / Y C / -t ' / V > >3^t. *^ 7*^/ JLf-t*/ C o -f />.' -/ ,, . .'/T' s ~^y ^ ^ cr `j ^ ^r/^t^ 5- ^ /y^~-._ ^ /S~ - Z.& V/ '; *<-/> //' . - *a Aw -*^\ <,4L -- ,' S~^-f -' - d-A/i. . /4 5) ) J? /* 7) i) c ~Y- T~<2-5' a- <-C s- Y-? ^.,c_ /' *- ' - #-: CL.-J&K <= A/s> *7 ^s. /A /$ ^*w>f ^$.1A? / / p <_*/ /" -. *,, - C.iQ/ ~JjL^yy ^ "$u * <T; 7? Ci &71Cl 4X. <*> -A A/ />** , T dU^c.r sSZ-f.'c.*" /; i,"**., Ujy j) 7^e'"/j"^H' / 7^3 ^ : - j <r/ ^`s ; c o <?io>/4. '' flmUH R6700097 Lead Industries Association, Inc. 295 Madison Avenue New York, N.Y. 10017 * Tel. (212) 578-4750 Fax (212) 684-7714 January 17, 1992 TO: Central Committee Smelter Blood Lead Survey Program I am scheduling a conference call for Wednesday, January 29 at 10:30a.m. EST (Eastern Standard Time) to discuss a number of issues regarding the smelter blood lead survey program. The agenda for the conference call is as follows: Approval of the Program Description (attached) Review and Selection of Analytical Laboratory (see attached table) Discussion on Company Responses to Program (see attached table) Update on Control Cities (Pat Phillips) Discussion and Approval of Survey Forms (see my memo of December 3,1991) Other items Please call Karen if you are unable to participate in the conference call. I have also invited several smelter representatives to join us on the conference call, as shown by the carbon copies/distribution below. JTM/kfb cc: J.J.L. Davies J.A. De Paul B. Freudiger R.J. Muth E. Puckett J.F. Smith M. Sousa J. Tapper T. Wilson J.L. Zelms CiMMITXERJsiEMMJ^ John Baranski Gerry Dumas Karen Hogan Patrick Phillips Bob Putnam Don Robbins Gene^Shippen Pn Vomberg DR 2100794 DRAFT SMELTER BLOOD LEAD SURVEYPROGRAM A. OPAL AND purpose of survey 1. Surrey Objectives The objective of this survey is to establish an up-to-date cross sectional snapshot of blood lead levels of young children, pregnant mothers (as a surrogate for unborn children), women planning to become pregnant, and nursing mothers, living in communities around operating Primary and Secondary Lead Smelters within the United States. This outline will be used to provide a uniform method of surveying the blood lead level of the target population. The- results will be used by individual smelters and Communities to assess the lead status of the at-risk population and by the industry as a whole to provide a comprehensive picture of the actual impact of the smelting industry today. It is expected that the actual sampling will occur in calendar year 1992. Smelters will not be asked to repeat surveys in communities if similar surveys have been conducted within the last two years (1990 or 1991). However, the results from these previous surveys will be included in the final report in order to present a comprehensive picture. CDC has indicated that it is supportive of such screening surveys being conducted and it will review and comment on the protocol, but will not participate in all aspects of the study. EPA has expressed interest in participating in some aspects of the Program. Participation is premised on the voluntary cooperation of the individual smelters and the communities in which they operate. DB 2100795 1. Central Committee Central Committee will oversee the development of the program, its administration, the hiring of the laboratories, the preparation of the reports, selection of the Control Communities and guidance to the local committees with regard to public relations and other matters. Members of the central committee: Gerry Dumas RSR Corporation Jeff Miller LIA Patrick Phillips Epidemiologist - MO Dept, of Health Bob Putnam Public Health Consultant Don Robbins ASARCO, Inc. Gene Shippen Physician Dan Vomberg The Doe Run Company Karen Hogan EPA John Baranski Exide Corporation 2. Local Committee Each participating smelter will appoint a company representative to be a survey project manager and will organize a Local Committee that will implement the survey within that community. The Local Committee might include local and/or state health officials, smelter representatives, local political leaders, as well as community representatives if appropriate. This committee would be responsible for coordination of the sampling, informing and obtaining permission where appropriate of local officials and the public, individual and local release of the survey results, and coordination with the Central Committee. 1. Population Surveyed The survey would target four categories: 100% of the 6 - 72 month old children, expectant or nursing mothers, or women planning to become pregnant that live in the target CONFIDENTIAL DR 2100796 women planning to become pregnant that live in the target areal In practice something less than 100% will be sampled although it has been shown that participation above 90% is possible. The study area for all smelters will be a radius of 1 - 1.5 mile around the main stack as determined by the Local Committee. These distances are suggested because they are zones of anticipated impact based on ambient air modeling. These may be varied somewhat for specific geographic reasons, or if a study has already been completed in the area. The study area should not be expanded simply to include a larger population, as this will skew the results. Smelters without any population within the specified radius will simply be reported as such. Control Populations Control communities should be utilized to represent urban and rural controls in order to validate methods on nonimpacted areas and to provide a frame of reference for current background blood lead levels. Such Control Communities will be selected by the Epidemiological Subcommittee of the Central Committee (Phillips & Putnam). Approach to Sampling Sampling may be conducted in one of two ways; either door to door sampling or by visits to a dime within the sample area. Sampling should be done by a team, induding a public health representative, a smelter representative, and a qualified phlebotomist. The months, days, times of sampling will be determined by the Local Committee. The procedures for the sampling will be developed by the Local Committee. Samples should be by venous puncture. A questionnaire should be administered at the time of the sampling (see sample Attachment I). 3 DR 2100797 F. Costs ' 1. Health Department Health Departments would pay for their own representatives on the Local Committees. Other costs, e.g. phlebotomists, clerical help, office space, furniture, or equipment, will be resolved by the Local Committee. 2. Smelter Smelters should expect to pay all other costs, including sampling, lab work, labor, rents, and public notices. 3. Central Committee Costs of the members will be borne by their respective organizations. Costs for sampling the Control Communities will be borne by the LIA Product Stewardship Program. G. mgAhOXIThl^^ 1. Smelter Activities Identify a Survey Project Manager and additional smelter staff as needed. Solicit the cooperation and assistance of the local, county and/or state health departments, community leaders, political, and school officials, etc. Help 'establish a Local Committee of company, medical, health and other community elements. 2. Local Committee Activities Define the study area. Select either the door to door sampling protocol or the clinic visit protocol. Design the sampling campaign. Plan for the dissemination of the results. Proceed with the survey. Disseminate the results of the study. Follow-up as appropriate. (12/19/91) 5 G0HF10EHT1AI qR 2100799 JAN 31 '92 16:13 LEAD INDUSTRIES & SILVER TRUST P.1/13 TO: Central Commmittee Smelter Blood Lead Survey Program FROM: Jeff Miller RjELlJEROGM^ In follow-up to our conference call on January 29, I am enclosing a copy of my notes. Also attached is a revised draft of the Smelter Blood Lead Survey Program as amended according to the conference call. Kindly review it and return fax to ms by February 17, 1992 the accompanying approval form. Also attached is a draft consent form and draft questionnaire to accompany the program and to be used by local committees. I would appreciate your comments on these two items by March 2nd, 1992. Thanks again for your assistance. JTM/kfb Attachment -- cc: J.J.L. Davies P.J. Deveau R.J. Muth E.A. Romagnoli E.H. Seeger J.F. Smith J.L. Zelms Port-11TM brand fax transmittal rnarno 7871 fofpcgtt e* Vc& guD om- ** L/ft Tenons i ' CONFIDENTIAL DR 2100800 JAN 31 '92 16*13 LEAD INDUSTRIES & SILVER TRUST P.2/13 mmi Return fax to Jeff Miller, LIA - (212) 684-7714 by February 17,1992 Below ia my approval (non-approval) of the draft Smelter Blood Lead Survey Program dated February 3,1992, Approved as written. Q Approved with the following minor changes. r--i LJ Rejected for the following reasons. NAME DATE CflHflStSTlAL (2/3/92) DR 2100801 JAN 31 '92 16*. 14 LEAD INDUSTRIES & SILVER TRUST P.3/13 :Smelteb Blood Isad Survey Program January 29,1992 EajaiiciEMia Paul Deveau Karen Hogan Jeff Miller Patrick Phillips Bob Putnam Don Bobbins Gene Shippen Jerry Smith Dan Vomberg Noranda EPA LIA MO Dept, of Health pes/cite ASARCO Consultant for Exide LIA Doe Bun The committee reviewed the program description and made several modifications as indicated in the latest draft. The program is being distributed to the Central Committee members for final review and approval. The consensus of the committee was that the central laboratory should have the capability to detect blood lead levels as low as 1.0 jug/dl. Gene Shippen offered to contact two additional laboratories for proposals - Smith Kline and American Medical - in addition to ESA and Metpath. It was stressed that selection of laboratory must be completed promptly so that an anlytical protocol can be written, reviewed and approved. It was agreed that some smelters would need encouragement and further counselling in order to persuade them to participate in the program. Dan Vomberg will be discussing the program at a meeting of the Association of DR 2100802 JAN 31 '92 16:15 LEAD INDUSTRIES & SILVER TRUST P.4/13 Battery Becyclers in early February and Karen Hogan offered to prepare a letter of encouragement to be sent to each individual smelter company. Fat FhilHpa is researching the identification of control cities as part of the program. The committee offered to assist Pat through the ohe-day hiring of a clerical assistant for research gathering. Pat will distribute a proposal by March 2, 1992 to the Epidemiological Subcommittee (Phillips, Hogan, Putnam, Shippen) for review. The subcommittee will then make recommendations to the full committee. The committee agreed that the sample forms for parental consent and background questionnaire were either too brief or too detailed. Miller will prepare two new draff forms for review by the committee. (2/3/92) DR 2100803