Document 4y950J7k6n41Bp3ODOp8ZzDj

T FOR CCMOTTEE USB ONLY ' AMERICAN PETROLEUM INSTITUTE MEDICAL AIVISORY COKrTTEE- 2dTfl MEETING 9:00 A. M. Honda/, Noveaiber 9, 1959 Conrad Sllton Hotel Chicago, Illinois NOT FOR PUBLICATION MEMBERS PRESENT: V. C. Baird, M. D., Chairman J. V. Osborn, M. D., Vice Chairman c. R. Miller, M. D., Secretary V. 0. Armstrong, M. D. C. H. Baylor, M. D. R. G. Blrrell, M. D. F. F. Bo/s, M. D. L. E Curtisf Ms Da Kieffer Davis, M. D. R. E. Eckardt, M. D. T. M. Frank, M. D. J. E. Hege, M. D. R. Ehmet Kelly, M. D. T. J. Kelly, M. D. B. S. Miller, M. D. - B. B. Reeve, M. D. J. C. Ruddock, M. D. George M. Saunders, M. D. Ralph Schneider, M. D. - (Rep. by N. J. Roberts, M. D.) W. V. Stewart, M. D. Leo J. Hade, M. D. TECHNICAL ADVISORS PRESENT: E. W. Adams V. H. Barcus B. E. Bennlson, M. D. C. T. Brown G. H. Colllngs, Jr., M; D. E. K. Daniels A. E. Dooley Geo. Bitwistls P. D. Halley J. W. Eaaaond . K. V. Hendricks J. H. Johnston P. K. Kuhne . C. A. Nellson A. C. Pabst T. B. Rendel L. E. Renes F. J. Sanders (Rep. by V. B. Scorill) J. A. Spence 0. M. Vilkeulng MEMBERS ABSENT: R. M. Adams, M. D. Richard Call, M. D. J. V. Crookshaak, M. D. K. R. Fourcher, M. D. F. D. Gassavay, M. D. OTHERS PRESENT: ' Se Ke ZaiOd/Srp Me De B. P. Luongo, M. D. T. H. Mitchell, M. D. Re Ce | Me De Re Je PottSj Me De EB 006891 L. E. Carvue . J. C. Colandra Philip Drinker W. W, Hitchcock Barry Levin D. T. Staples - Carter 011 Company - BloTest Labs - Harvard University (Consultant) - Sinclair Refining Company - Texaco Incorporated Tidewater Oil Company (Chairman, Medical and Health Coomittee) API 07533 SC-API-3155 -2 - I. INTRODUCTION CF NEW MEMBERS ASP GUESTS Dr. V. C. Baird introduced new member* and guest*. II. APPROVAL OP MmfTE8 The chairman asked IT there were any correction* or addition* to the minutes of the 27th meeting of the Medical Advisory Camnittee, held April 27, 1959, in Chicago. ACTION; It ve* regularly moved, seconded, and unanimously . passed that the minutes be approved as distributed. III. CERTIFICATE OP APPRECIATION Mr. D. T. Staples, chairman of tbs Medical and Health Coemlttee of the Board of Directors, presented a Certificate of Appreciation to B. B. Reeve, M. D. of the Standard Oil Company (Indiana). Dr. Reeve responded with a brief history of the origin and early activities of the Medical Advisory Committee. . IV. SUBCOMMITTEE REPORTS A. Operating Subcommittee Dr. Clark Miller presented the report of the Operating Subcommittee, re viewing the various recomnended actions, This report Is attached as Appendix A. ACTION: It was regularly moved, seconded, and unanimously passed that the actions of the Operating Subcanalttee be approved and their report be accepted. B. Program In the absence of B. K. Linder, M. D., chairman of the Program Sub committee, Leo J. Made, M. D. presented the report for this group. Next year the Industrial Hygienists have been asked to prepare the program for the round table discussion. ACTION: It was regularly moved, seconded, end unanimously passed that the report of the Program Subcommittee be aooepted. C. Atmospheric Pollutant* Chairman J. C. Ruddock, M. D. reported on the activities of his eubcamittee. The minutes of his subcommittee are attached as Appendix B. ACTION: It was regularly moved, seconded, and unanimously passed that the report be accepted. D. Cq - Cig Aromatics EB 006892 Kleffer Davis, M. D., chairman, reported on the activities of this group. A copy of the report Is attached as Appendix C. ACTION: It was regularly moved, seconded, and unanimously passed that the report be accepted. API 07534 -3- S., Carcinogenicity R. S. Bckardt, M. D., chairman, reported oa this committee's activities. Hi a report is attached as Appendix D. ACTION: It was regularly moved,- seconded, and unanimously passed that the report he accepted. F. Dermatology Leo J. Wade, M. D., chairman, reported on this group's activities. His report is attached as Appendix S. ACTIOS: It vas regularly moved, seconded, and unanimously passed that the report be accepted. 0, Epidemiology George M. Saunders, M. 0., chairman, reported on this aevly formed sub* committee. His report is attached as Appendix F. ACTION: It vas regularly moved, seconded, and unanimously passed that this report be accepted. H. Inhalation of Oil Mist - B. S. Bennlaoh, M. 0., chairman, reported on this nevly formed group. His report is attached as Appendix G. . ACTION: It vas regularly moved, seconded, and unanimously passed that this report be accepted. I. Medical Policies and Administrative Practices In the absence of Ralph Schneider, M. 0., chairman of the subcommittee, George M. Saunders, M. D. reported for the activities of this group. Dr. Saunders' report is attached as Appendix H. ACTION: It vas regularly moved, seconded, and unanimously passed that this report be accepted. J. Physical Agents . J. H. Hege, M. D., who vas appointed chairman of this group to replace C. H. Hlne, N. D. vho resigned, reported on the activities of this subccsnlttee. His report is attached as Appendix I. ACTION: It vas regularly moved, seconded, and unanimously passed that this report be accepted. K. Specialty Petrolevaa Products EB 006893 J. W. Osborn, M. D., chairman, reported on the activities of this group. His report is attached as Appendix J. ACTION: It vas regularly moved, seconded, and unanimously passed that this report be accepted. API 07535 T L. Toxicological Review* - If - / B. E. Benniaon, M. 0. reported for E. W. Gerards, M. D., ebtinu of thia gubeoamlttee. The report of thia subcommittee la attached u Appendix K. ACTION; It wee regularly moved, seconded, and unanimously passed that this report be accepted. M. Industrial Hygiene J. A. Spence, chairman of the Subcommittee on Industrial Hygiene, re ported on the activity of this group. The report Includes the activities of the ASA representatives on Sectional Committees Z-4, Z-37, and -62. The report of this subcommittee is attached as Appendix L. ACTION: It was regularly moved, seconded, and unanimously passed that the report be accepted. V. REPORT OP LIAISOS MEMBERS A. Dermatology Studies Leo J. Wade, M. D. stated that there was no activity to report. B. Staoke and Fumes J. C. Ruddock, M. D. reported on the activities of the Division of Refining'8 Smoke and Fumes Committee. Els report is attached as Appendix M. C. American Medical Association J. V. Osborn, M. D. reported on the activity of the AHA Committee on Toxicology and the Interdlvlsional Comlttee on Labeling In the development of pro posed legislation on hazardous substances labeling. His report is attached as Appendix N. D. Interdlvlsional Cowittee on labeling C. H. Baylor, M. D. reported for C. H. Hlne, M. D. who has resigned. His report is attached as Appendix 0. B, First Aid Training T. H. Frank, M. D. reported on the activity of the Subcommittee on First Aid of the Central Coadttee on Accident Prevention. F. Wax Committee R. E. Eckardt, N, D. reported on the activity of the Advisory Coeaittee to the Wax Research Project. His report la attached as Appendix P. G. Quarantine Service George M. Saunders, M. D. reported on this activity. His report Is attached as Appendix Q. EB 006894 API 07536 - 5B. Petroleum Food Additives L. B. Curtis, M. D. reported on the activities of thle group. Dr. Curtis distributed an Industrial Hygiene Bulletin, prepared hy his company, a copy of vhlch is attached as Appendix R. VI. BUDGET FOR 1960-61 " C9 - C]_2 Aromatics Keroslne Poisoning Toxicological Revievs Noise Consultant Administrative ficpensea Total $10,000 12,500 5/000 2,500 3/000 1,000 $34,000 ACTION: It vas regularly moved, seconded, and unanimously passed that the proposed budget be presented to the Medical and Health Coemlttee VII. NEW BUSINESS A. Reception for B. B. Reeve. M. D. Dr. Baird called on Paul Halley vho Invited all members of the Medical Advisory Committee, subcommittee members, technical advisors, end guests to a reception given In the honor of B. B. Reeve, vho vill be retired early next year. B. World Congress Leo J. Wade, M. D. spoke on the need of supporting the World Congress on Occupational Medicine, vhlch vill be held in Rev Toxic in July i960. C. Air Pollution Prof. Philip Drinker indicated that any information he obtains on air pollution vill be sent to the API staff in Nev fork for distribution to the Medical Advisory Committee and Its technical advisors. VIII. NEXT MEETING The desirability of having the next meeting of the Medical Advisory Committee and Its subcommittees In conjunction vltb the Industrial Medical Association Conference, In Rocteater, Nev York, vas discussed. ACTION; It vas regularly moved, seconded, and unanimously passed that tbs next meeting of the Medical Advisory Comlttee and its subcommittees be April 22nd through 25th, i960 In Rochester, Nev York IX. CONCLUDING REMARKS BY CHAIRMAN ~ EB 006895 Dr. Baird adjourned the meeting, stating his appreciation of the great v*lue of Mr. E. 0. Mattocks to the Medical Advisory Coamlttee and Its activities. Approved: V. C. Baird, M. D., Chairman W28/59 J. W. Hammond, Recorder API 07537 ____ APPETODC A-l MINUTES GF MEETING OPERATING STCCWCnlffTTSRCAL ADVISORY CCM4ITTB8 --------------------------------- hi to F.TT-------------------------------- Sunday, Novesbar 8, 1959 Coorad Hilton Hotel Chicago, Illinola THOSE PRESENT: V. C. Baird, M. D., Chairman J. V. Oeborn, H. D., Vice Chairman C. R. Miller, M. D., Secretary L. B. Curtla, M. D., Paet Chairman B. E. Bennlaon, M. D. Kieffer Darla, M. D. R. B. Eckardt, M. D. E. V. Gerarde, M. D. (Rep, by B. E. Bennlaon, M. D.) J. E. Hega, M. D. E. K. Linder, M. D. (Rep. by L. J. Wade, M. D.) J. C. Ruddock, M. D. Ralph Schneider, M. D. (Rep. by N. J. Roberta, M. D.) 0. M. Saundera, M. D. Jade Spence Leo J. Wade, M. D. VISITORS: j, Vi. Hammond E. 0. Mattocke I. INTRODUCTORY RWARK3 V, C. Baird, M. D., Chairman of the Medical Adrlaory Committee and the Operating Subcommittee, announced that Ralph Schneider, M. D. had requested N. J. Roberta, M. D. be hie alternate. II. APPROVAL CT MCTOTB8 ACTION: The mlnutee of the April 25, 1959 meeting of the Operating Subcommittee vere approved a* dletrlbuted. III. REPORT OP SUBOQMUTKBB 8 006896 A. Program Lao J. Made, K. D. reported, in the abeence of B. K. Linder, M. D., Chair* man. He indicated that the Induetrial Rygienlata hare been invited to conduct the round table ecealon at the next meeting. B. Atmospheric Pollutant# J. C. Ruddock, M. D., Chairman, dlacuaeed poeBible financial arrangements to continue the work being done by Dr. Goldblatt in ftigland. There atlU remain# $6,155*85 from the original $20,000 raised by the Division of Refining to support the work 00 the study of the medical aspects of air pollution. Dr. Ruddock explained that Dr. Goldblatt would be willing to continue his study for another year if provision could be made to pay his expenses for travel, possibly to the Uhlted States and to other places, and other Incidental expenses. The ccsmlttes was of the opinion that if $5,000 were made available to Dr. Goldblatt for travel expenses, this arrangement would be satisfactory. It was further agreed that no time limit ihould be placed on tba expenditure of $5,000. API 07538 -2- A-2 Or. Ruddock discusMd tbs policy of distributing Information to the judical Advisory Committee members sad technical advisors. Bs questioned whether msaber of tbs Medical Advisory Cosndttee should be permitted to subait to the ffl staff material for distribution to the Medical Advisory Ooao&ttee aeabers ^thout having the material first renewed by tbs chairman of tbs appropriate #ubcommittee. There was violent objection to this procedure. It was pointed out that if a subcommittee chairman seriously objected to any distributed material, he could write a letter to the aeabers indicating his objection. It was agreed generally that It wae the reepooelbllity of each amber of the Medical Advleory Ccamittee to bring to the attention of the other aeabers any data or articles In vhich be thought the aeabers would have an interest. - C. C9 ~ Cj2 Aroaatlca Kleffer Dsns, M. D. reported that his subcomlttee had hoped that this project would be completed by July 1, i960. However, the work on monkeys will require an extension of time. They recoenendad that tbs budget provide $10,000 for the continuation of the work to Daceaber 31, 19&>. . Dr. Dans requested that. If possible, more aeabers be assigned to this subcomttee. p. Carcinogenicity . R. S. Bekardt, M. D. reported that their ii>committee had no budget request. The final report from Kettering Laboratory on their work had Just been received by the subcceadttee aembere. Dr. Bekardt requested that the report be distributed to the Medical Adnaory Committee aeabers and technical advisors and they be requested to submit any comments they bare to Dr. Bekardt prior to the fubeanlttee meeting with Kettering. The ocassents should be submitted prior to January 1, i960. Dr. Bekardt questioned whether the scope of the flutirc--slttee on Carcinogenicity should be broadened to take into consideration carcinogenicity of other petroleum products, the inhalation of mists, and a review of literature on. this subject for possible Inclusion In n new scope. Dr. Bekardt asked to be re lieved as chairman of this eubeoomlttee. It was agreed that at the mast sub committee meeting they would consider the fallowing: an enlarged scope, possible need to change the name of the subcommittee, end a suggested reconstituted subcommittee. B. Dermatology . Leo J. Made, M. D., chairman of this subcommittee, reported on the lurvey he had conducted on "creeping eruption" In the Louisiana area. Bis group bad concluded there is no major problem. They need more Information before *oy reccsmmndatlon could be made. EB 006897 API 07539 -3- t A-3 No comment n. Inhalation of Oil Mitt No pressing question on policy. g. Medical Policies and Administrative Practices G. M. Saunders, M. fi. reported for Ralph Schneider, M. 0. This sub* cooftittee is planning a study of back injuries. I. Physical Agents J. B. Begs, K. 0., Chairman, indicated that his subcaanlttee thought that the API should continue its contribution to fir. Qlorig for the study of noise. His group recommended that if any money could be made available that the API contri bution should be continued. . Dr. Begs reported that Title 20 of the Atomic Energy Carnal8aion Regula tions vas to be discussed at a public hearing. His group recooaended that the API develop a statement, if at all possible, to be read at the hearing. It vas generally agreed that the Medical Advisory Coonlttee members should be notified of sny such hearing in order that their companies could be present and submit a statement, if the company thinks it is desirable. J. Specialty Petroleum Products J. V. Osborn, M. D., Chairman, reported on the activities of their three grant-in-aid projects studying the method of treating kerosine poisoning. Or. . Osborn indicated the need to Increase their suggested budget from their previous recosnendation of $7,500 to $10,000. This vas necessary since the blood analysis previously being run by Horace Gerards, M. D., Esso Research k Engineering Co., nov vi11 have to be run by the universities. . The desirability of discontinuing the work being done by Sr. Bau, Ifaiveraity of Texas, vas revleved carefully. . K. Toxicological Reviews - B. E. Beanlson, M. D. reported for B. V. Gerards, M. D. and indicated that they had no problems. 1. Industrial Hygiene Jack Spence stated that the liaison members to the ASA Sectional Cooalttees would nov make their report directly to the Industrial Hygiene Subcanittee. W. 1960-61 BUDGET The following was suggested for the nev budget: 006898 API 07540 C9 - C12 Aromatics Keroslne Poisoning Toxicological Reviews Noise Consultant Administrative QcpOnses Total $10,000 12,500 5,000 2,500 3,000 1.000 $3^000 ACTION: It was regularly moved, seconded, and unanimously passed that the above distribution for Medical Advisory Committee budget I of $3*1,000 be recomanded to the Medical Advisory Committee for transmittal to the Medical and Health Committee. V. CERTIFICATE OP APPRECIATION V. C. Baird pointed out the dealrOblllty of establishing a permanent Certificate of Appreciation Subcommittee who would have the responsibility of Automatically recommending nominees to receive Certificates of Appreciation. ACTION: It was regularly moved, seconded, and unanimously passed that a permanent Certificate of Appreciation Subcommittee be appointed, composed of the current chairman, vice chairman, secretary of the Medical Advisory Committee, plus any active past recipients of Certificates of Appreciation until such time as there are at least three active past recipients who will then become the permanent subcommittee. 71. PUBLICITY The desirability of securing greater publicity of the activities of the Medical Advisory Committee was reviewed. The last issue of the Department of Technical Services Newsletter contained several items on the activities of the Medical Advisory Ccnnittee. The group, in general, thought this was very good. They did not believe, however, that the activities of this group should be publi cised too extensively. The desirability of transmitting to the Medical Advisory Coonlttee and technical advisors the official transcript of the Joint meeting which the Sub committee on Atmospheric Pollutants bad with the Public Health Service in Cincinnati, was dlaeuasad. ACTION: It was regularly moved, seconded, and unanimously passed that the transcript of the Joint meeting of the Subcommittee on Atmospheric Pollutants with the Public Health Service should be transmitted to the Medical Advisory Committee and its technical advisors and the Smoke and Fuses Cosnlttee. EB 006899 VII. SUBCOMMITTEE CHAIRMEN It was generally agreed that the technical advisors as wen as members of the Medical Advisory Committee may become chairmen of subcommittees. ACTION: It was regularly moved, seconded, and unanimously passed that technical advisors to tbe Medical Advisory Comlttee can pro perly become chairman of a subcosnittee of the Medical Advisory Committee. API 07541 With the recent consolidation of subsidiaries into a parent company, the Ration of the definition of a member on the Medical Advisory Committee vaa dis cussed. The API Board of Directors, at their April 21, 195^ meeting, defined seobera of the Medical Advisory Committee aa follow: "Physicians noalnated by petroleum companies, aad appointed annually by the Chairman of the Medical and Health Coonlttee. Tbeae phyaldana nay be employed by petroleum coapaniea either full-tine, part-time, or aa conaultanta." After reviewing thia definition, it we the opinion of the Operating Sub committee that the definition vaa adequate aa it vaa written by the Board of Directors and did not confine membership from one company to a tingle physician. ACTION: It vaa regularly moved, aeconded, and unanimously passed that the Operating Subcommittee's interpretation of the Board of Directors' definition of Members to the Medleal Advisory Caoaittee provided for any number of physicians from a single company. U. M8W Bcsmgss A. Air Pollution Committee A letter received from Richard A. Prindle, M. D., Chief of the Air Pollution Medical Program, Division of 8pedal Health 8ervlcc of the Department of Health, Education, and Welvnre, dated October 28, 1959, to B. 0. Mattocks, indicated that they bad formed an Air Pollution Committee which la a technical task group on suto exhaust atudlea. This eoamlttee was formed by the Public Health Service for the purpose of assisting in tba coordination of research activities in furthering cooperation between Interested groups involved in the studies of automobile exhaust sir pollution. Mr. William Clausen represents the API on this committee, bevlng beta appointed by Dr. Jerry McAfee, Chairman of the Smoke and fusee Oawlttee of the Division of Refining. ACTION: It was regularly moved, seconded, and unanimously passed that the Medical Advisory Committee should Inform Mr. William Clausen that this group stands reedy to offer to him may service possible in the performance of his duty as a member of the Air . Pollution Committee. B. Visitors EB 006900 Dr. Baird indicated that he had asked Dr. franklin Youder aad Dr. B. Dixon Holland of the Amarlcnn Medical Association to attend the Medical Adviaory Committee meeting. Also, Dr. Oolaadra, who did consulting service for Sinclair, bad been invited to attend the MAC meeting. ACTION: It was regularly moved, seconded, aad unanimously passed that the action of the chairman la inviting the three doctors- to attend the MAC meeting be approved. C. Division of Refining's Smoke and Fumes Committee API 07542 Dr. Ruddock stated that be Lad been invited to appear before the division of Refining's Smoke and fuses Committee and. give a report of bis Subttwmlttee's activities. Dr. Ruddock asked if there were any objections to his appearing before this committee. -6- A-6 ACTION-. It was regularly moved, seconded, and unanimously passed that Dr. Ruddock should accept the invitation to appear before the Division of Refining's Smoke and Pumes Committee. Dr. Malcolm Hargraves Possible vays of presenting information on the petroleum Industry to . pr. Malcolm Hargraves, of the Mayo Clinic, were reviewed. It was Indicated that Dr. Roberts was a former member of the Mayo Clinic and could possibly help. The staff was directed to collect all of the material relating to Dr. Hargraves' I published statements on the petroleum industry and transmit them to Dr. Roberts for j^ls review. It was Indicated further that Dr. Carl Nau of the University of Texas would be very helpful in presenting facts to Dr. Hargraves. X. NSW MAC OFFICERS It was generally agreed that J. W. Osborn, M. D. should be recoanended for appointment to the chairmanship of the Medical Advisory Committee. It was further agreed that the new chairman, together with the staff and what other assistance he may chose, should recommend to the chairman of the Medical and Health Committee the nev slate of officers. The possibility of two vice chairmen was briefly discussed. E. 0. Mattocks, Recorder Approved: V. C. Baird, M. D., Chairman .12/28/59 I I ! ( EB 006901 API 07543 I ArPSSDIX 3-1 REPORT OF SUBCOMMITTEE OH A3MQSPHERIC POLLUTAJfTS John C. Ruddock, M. D., Chairman MINUTES SUBCCWITTEB OH jCggSWiyiC POI-LUTASTS 9:00 A. M. Friday, November 6, 1959 Conrad Hiltoo-Hotel Chicago, Illinois The meeting vas called to order by the chairman at 9:00 A. K. There vere six members of the subcommittee present and 15 visitors. Minutes of the last meeting, held on September 22, 1959, at the SheratonGibson Hotel In Cincinnati, Ohio, vere approved as presented. msPosmoH of goldblatt report A discussion, which considered publishing the report In book form for general distribution,vas carried on by the subcommittee, as veil as the possibility of publishing this report by USPHS; finally It vas unanimously approved that the matter be tabled until after the entire report bad been received and reviewed by the subcommittee. Publication should not be done in Its present form but be edited by the author prior to publication. Continuation of. Project MD-h by Dr. Goldblatt vas passed by this sub committee on two previous occasions. Since the meeting of September 22, 1959, Sr. Goldblatt has been offered $5,000 which he refused as a fee, but accepted If this amount vas offered for an expense account. It vas suggested by Hr. Mattocks that the unused portion ($6,100) of the original grant be used to continue the study. This vas moved, seconded, and approved. The chairman also read a letter from Dr. Prindie, of the USPHS, In which Dr. FrIndie Indicated that the USPHS would accept an application for a grant to Dr. Goldblatt to continue his work as already started by the API, as . a critical clinical survey of the world's medical literature on air pollution. The subcommittee felt that this is a matter between the USPHS and Dr. Goldblatt. It vas felt that application forms should be forwarded to Dr. Goldblatt for submittal and that his vork be continued as presently stated. There are three sore portions of this report yet to be received. The matter of'distribution of reprints-and public articles'through the various committees vas discussed and referred to the Operating Subcommittee. DISCUS3IQH OF CdtlHnCATIPBS VICTIM IHDU3TBT. COMPANIES, AHD INDIVIDUALS Mr. Mattocks explained that before a statement Is released by the API that it must have the O.K. from the Medical and Health Committee of the Board of Directors and a substantial unanimity on the matter fTom Its main members by letter ballot. When such Is not Obtained, then a public release is not made. . CALIFORNIA AIR QUALITY AHD AUTO EXHAUST BCES3I0H STAHDABD6 Tentative standards, which will be adopted into lav in February 19&0 in California, on air quality vere presented and have been circulated to all members of the MAC. Tentative auto exhaust standards vere presented as follows: EB 006902 Hydrocarbon reduction from 1600 ppm to 275 ppm Carbon monoxide reduction from 3*8 vt. to 1.5 vt API 07544 -2Trtiirr MEETDC WITH TEE USFES (BCOTH MEDICAL AHD TBCHHICCAAL). AA1UTCHCBUS MANUFACTURERS rSS'fictA.TloM IWOTTiWfiEmTIVES yfeOM OH1EHAL MOTORS rrife: Aiffi dBMIgrHKir fg.h a*s-fs<ovc'VIAartfiTiqnhs , mUBeL^fAMfeose acbf>rsourrBarCT OiflMkE. ahA uiHEha It was the general opinion of those persons attending this meeting that it was interesting and worthwhile ^especially because it gave all interested parties in Air Pollution Abatement a chance to be heard and exchange ideas and vork together toward a common goal. Such a meeting, the first of its kind, should pa held every two years. A certified report of the meeting will be circulated to members. Please read it as it is a documented report of statements by AHA, public Health, Railroad Association, and others. Meeting adjourned at 11:15 A. M. John C. Ruddock, M. D. Chairman Subcommittee on Atmospheric Pollutants EB 006903 API 07545 # AFpareix c-i REPORT OF SUBCOMMITTEE <* Cg - C12 AROMATICS . Kieffer fiavls, M. D., Chairman The Subconnittee on Cg - C12 Arcmatlea met at 2:00 P. M. November 6, 1959 5t the Conrad Hilton Hotel. ^sabers present - Dr. Frank Mr. Spence Mr. Hammond Dr. Davis .Members absent - Dr. Crookshank . Dr. Potts Mr. Bent Some twenty guests were present. . ' Dr. Nau, the chief investigator, reviewed a previously submitted progress report to the subcommittee. The major features of this report were: X. Work completed: (1) Rat Inhalation studies at 3*2 mg/llter for the four chemicals, N-Decane, Cg - C10 aromatics, C]j_ - C]p aromatics, and benzene. (2) Rat inhalation studies at 200 ppm for the three chemicals, Cg - c10> C10 - Cn, and benzene. (3; Rat inhalation studies at 50 ppm for the two chemicals, Cg - C^q and benzene. (4) Determination of LC50 values on rats for the three chemicals, Cg - C]_q, On - C]_2, and benzene for one 7 hour exposure. (5) Cellular study of the bone marrow of rats exposed by inhalation to N-Decane, Cg - Cj_q, C]j - Cx2, and benzene. II. Significant Findings Not Previously Reported Are: . (l) There are significant hematological findings in rats exposed 16 hours a day to the inhalation of 3*2 mg per liter of Cg - C101 Cjj, - Cj^, and benzene, but not in rats exposed for the same period of time and concentra tions of N-Decane vapors. (2;) LCcq for rats shows the increasing order of toxicity as follows: (1; benzene, (2) Cg - Cio> nd (3) Cjj, - Cj (3) A large number of rats develop cataracts after being exposed to high con centrations of Cg - C10 vapors, and a lesser concentration of benzene. (4) Preliminary work bn monkeys Indicates exposure to 200 ppm of Cg - C^q vapors causes significant effects. III. Recommendations For Continuation Of Work: EB 006904 (1) Expose monkeys to test materials at 50 ppm and 200 ppm for an adequate length of time. (2) Determine the threshold of odor and tolerance for humans to the test materials. (3) Complete all test studies now in progress and prepare a final report. . API 07546 -2- . C-2 It la anticipated by the subcommittee that this experimental project will ^ ended on or about the first of the year 19&.. Accordingly, It Is recommended that additional funds in the amount of |10,000 be appropriated for the continuance of the program to Its completion. Kleffer Davis, M. D., Chairman Subcommittee on Cj - Cjj) Aromatics EB 006905 API 07547 f Apparoix p-i REPfRT OF SUBCOWQTIEE OS CARCI50GIBICITY R. E. Eckardt, M. D., Chairman The final report of the Kettering Laboratory vas not received in sufficient tlae by the subcommittee to be revleved prior to its sieeting on November 7, 1959* It is the plan of the subcommittee, therefore, to reviev this report vlth the Kettering Laboratory and submit it, or a finalized version, to the Medical Advisory Committee at its April, i960 meeting. In the meantime, the subcommittee will circulate the report as received from the Kettering Laboratory to the members and technical advisors of the Medical Advisory Committee, in order to receive their comments, before holding a final discussion vlth the . Kettering Laboratory, probably sometime in late January or early February. R. E. Eckardt, M. D., Chairman Subcomnlttee on Carcinogenicity EB 006906 i AFEEHDDC E-l REPORT OF SUBCOMCTTEB ON DERMATOLOGY . Leo J. Wade, M. D., Chairman MEMBERS PRESHTT: Leo J. Wade, M. D., Chairman Curtis Baylor, M. 0. Allan Dooley^ Jaaea Osborn, M. D. GUEST: L. X.. Qurtis, M. D. ,. . " On Tmht&ry'tMs^imftbamigttee to Investigate report submittedby kin unidentified Louisiana physician' that "creeping eruption" la an increasingly important occttpatlooal'haalth haaard for petroleum production vorkera along the Oulf Coast. The letter implied the need for financial aid to investigate the alleged problem. The Dermatology Subcomlttee circularised the members of the Medical Advisory Committee seeking Information re the magnitude of the skin complaint among petroleum workers. The results were as follows: 10 - Ho producing operations In area 14 - Producing operations In area 11 - Ho knowledge of any cases 3 - Aware of few cases (Cities Service, Standard Oil (Ohio), Humble } Dr. Crookshank of Cities Service indicated some limited experience with the problem but Indicated that he had "a great deal of Information" re the situation. Ho replies have been received to two subsequent letters to Dr. Crookshank. Dr. Osborn of Standard Oil (Ohio) had two possible cases reported to him by local physicians. Follow-up letters to these physicians for additional infor mation have not been answered. Dr. Wise of Enable reported two cases but none within the past year. These were seen by Dr. Rodney Jung, Associate Professor of Topical Medicine, Tulane University. Els associate. Dr. James Burks, Is preparing a manuscript for pre sentation at the next Southern Medical Association meeting. Be has premised to send a copy of the manuscript as coon as It is completed. Your subcoamittee reports, therefore, that Its investigation Is incomplete but will continue. Findings to date suggest a relatively minor problem affecting only a few member* at the API. We have no Immediate recommendations. The subcommittee stands ready to accept other assignments as desirable. . " Leo J. Made, M. D., Chairman Subcommittee on Dermatology EB 006907 API 07549 * Appen lx ?-i REPORT OF SUBCOMMITTEE ON EPIDEMIOLOOY 6eo, m. Saunders, M. Ii., Chairman INTRODUCTION An ad hoc Subcommittee on Epidemiology In a report to the MAC on 10 November 1958 defined epidemiology as a method of study and recom mended again that a standing Subcommittee on Epidemiology be appointed. At A:meeting on. 27 April 4959, the MAP,authorized the ereatlon of u ~. the MAC to the presehv^ai^'r:6fr.:l^:r.5ua^|iimittee->m^^ requested that he propose names for mesfeirship on t&e -Subcommittee This was done ar.d a Subcommittee of four members. Including the Chairman, was formed. The members have been In frequent communlcatlon and a meeting to draft recommendations for future studies was held on 11 August 1959. As a background. It Is pertinent to quote from the report of the former ad hoc Subcommittee which stated: "Epidemiology is the study of the occurrence of qualities, con ditions, diseases and deaths as mass phenomena among groups of people." It was emphasized that for any studies to have statistical validity, the events or conditions being observed and recorded be susceptible of clear definition and be related to a population group whose other characteristics are known. In other words, if the number of events tabulated is the numerator of a fraction, then the denominator must also be known in order to be meaningful. To carry this one step further, the element of time must be introduced If rates of occur rence of events are to be calculated. It Is recognized that there may be certain health problems which are more or less limited and unique to the petroleum industry but it is felt that epidemiologic studies should not be limited to these unique problems. Health records on employee groups, particularly in many units of the petroleum Industry, constitute an Important source of valuable information upon the health level of the "normal" and "well" population. It is felt that where practical such information should be brought to light and critically examined. This present report will present general principles of methods of operation needed to collect valid data, will list areas for possible future study which may be productive and will recommend certain specific conditions or areas for present pilot studies. METHOD OP OPERATION EB 006908 It has already been suggested that it Is necessary to have an accurate reporting of events or characteristics or qualities or conditions occurring in any given unit of time In a limited group of employees. To accomplish this will require not only the cooperation but also the active participation of medical department personnel in units of many oil companies where the medical observations and records are suitable API 07550 -2 * to the purpose and where the population at risk is known. Reporting to the Subcommittee must be In a uniform, standard way. As an example, let us consider that it is recommended by the MAC that a study be made of the frequency of myocardial infarction among refinery maintenance and operating personnel (blue collar workers) to compare with the frequency of this condition among refinery office workers such as engineers and laboratory Workers (white collar workers). - . .. . .. &t'V- _ '.matflcacjr volunteering tQ'for diagnosis must be standihdized antf'the~ poptdatlbn at risfc'must alsobe defined as to Job category, age, length of service, and. In other ways to be determined. Reports would be requested periodically on the number of cases occurring in each participating group over a period of time to be determined by the study group In order that the frequency of occur rence of the condition could be stated in terras of person-years of of risk by age and Job. Data from reporting on a predetermined standard form would be coded for transfer to punch cards for analysis and tabulating. . Ill SUGGESTED AREAS POR FUTURE STUDY Among the many conditions which were considered as possibly provid ing valuable Information, the following may be listed: A. Mortality Rates Age specific rates by cause. Age specific crude mortality rates. 8. Health Status of Truck Drivers Sampling survey to include a record of age, length of service, present physical status and disqualifying conditions, if any. C. Study of Blood Pressure Levels By age, height, weight, job category and length of service. D. Chest X-Ray Pindings in Refinery Maintenance Workers By age, length of servloe, etc., to compare with group of office workers. There has been some suggestion that there is an Increased risk of pneumooonlosls among refinery maintenance workers. E. Hematological Studies on Refinery Workers Exposed to Aromatics with Studies on a Control Group F. me Incidence of Lung Cancer Among Selected Groups G. Results of Proctoscopic Examinations H. Absenteeism EB 006909 I. Radiation Exposure Related to Evidence of Physiologic Effects API 07551 -3- 7 3 These and many others might be listed as potentially valuable sub jects for investigation. However, the various areas to be explored should be recommended and authorized by the MAC as a whole with the voluntary and active collaboration of suitable units within the numerous companies. At present It is believed that no request for an operating budget is In order. However, If pilot studies to be proposed prove valuable and productive, then funds may be required In the future. A. The Frequency of Myocardial Infarction B. The Health Status of Truck Drivers The methods and procedures will be defined In a protocol If collators tlon of suitable medical units is assured. The first study will require a reporting of all cases of myocardial Infarction among known population units over a given period of time. The second will require the reporting on a standard form to be devised results of the most recent examinations of truck drivers. Subcommittee on Epidemiology George M. Saunders, M.D., Cnairman C. H. Baylor, M.D. B. E. Bennlson, M.D. N. V. Hendricks EB 006910 API 07552 7 Appendix j-i REPORT OP SUBCOMMITTEE ON INHALATION OP OIL MISTS 6. E. Bennison, M. D., Chairman 1. Following the authorization of this Subcommittee at the Spring MAC Meeting, replies were invited from members or technical advisors who had an interest in serving on this Sufeomwnlttsjt.. ' -. . .. . berwelwme " yjt.- r-X-- 2. The published 1 iterirttbrif' arid:'e&'&tS'ddbtnsented cbmpany experiences have been assembled for critical review. It is apparent that there are a number of important areas that merit the attention of this-Subcommittee. Two examples may be mentioned: a. The oil mist levels that occur around certain large-scale machine shop operations. b. The increasing agricultural use of oil sprays. ' 3. It is anticipated that a more detailed progress report of this newest Subcommittee will be available for the next meeting of the Medical Advisory Committee. It is recoramended that this repoi*t be accepted as a preliminary report. Respectfully submitted, /s/ B. E. BENNISON /s/ B. E. BENNISON, M. D., Chairman EB 006911 API 07553 TI APFDH3IX H-l I REPORT CP SUBCCMMITTEE CN MEDICAL POLICIES AMD AOUKISTHAnVE PRACTICES r " Ralph Schneider, M. D., Chairman 1. After further discussion and deliberation at a meeting of the subcoonittee on November 7# 1959* It vas decided that the "Guiding Principles" is not yet ready for submission to the Medical Advisory Committee. 2. It is recomnended to the Medical Advisory Cosmittee that if further Investigation on the value of lov back X-rays is desired, that the project be referred to the Subcommittee on Epidemiology. It is moved that this report be accepted. G. M. Saunders, M. D. Acting Chairman Subcommittee on Medical Policies and Administrative Practices ' . > > Appendix 1-1 REPORT OP SUBCOMMITTEE ON PHYSICAL AGENTS J. H. Hege, to. >., Interim Chairman The subcommittee convened on one occasion since the 195^ November meeting, the majority of Its business being carried on by correspondence. The subcommittee has continued, during the past year, to abstract the literature and develop bibliographies on Important develop ments for the various categories of physical agents. These have been circulated to members of the MAC as appropriate. A progress report has been received from Dr. Qlorig in which he described his research activities to Include; 1. Effects of lntermittant noise exposure on temporary threshold shift. 2. Effects of Impulse noise on temporary threshold shift. 3. Study of over 100,000 records to determine the extent of hearing loss in the general population as compared to an industrial population. . 4. Preparation of International Standards for specific noises. Dr. Qlorig has requested continued financial support in his research work. The API has, in the past on recommendation of the MAC, granted a total of $12,500 for this purpose. We have been advised that by reason of budgetary considerations, the API Board of Directors has deleted all appropriation for continuation of this project from the 1960-61 MAC budget. By reason of the circumstances necessitating the directive of the Board of Directors, the subcommittee accedes to their action and recommends to the MAC that a budgetary allowance not be requested for Dr. Qlorig's research projects for the year 1960-617 This, however, is not to be construed to indicate a loss of Interest in Dr. Qlorig's work. The subcommittee Is of the opinion that Dr. Qlorig's work is both of great importance and unique. Eliminating human considerations, work on noise is of serious Import solely on the basis of financial loss to Industry. Dr. Qlorigs work is unique in that little or none of the work his group Is doing has been or Is being done by other research groups. The subcommittee recommends that, if any money budgeted for other MAC activities might be considered to serve a more useful pur pose as support for Dr. Qlorig'a work, permission be secured to transfer an appropriate sum to be awarded as a grant to Dr. Qlorig. If this recommendation is not feasible, it is the consesus of the subcommittee that a request for reinstatement of this grant be made by the MAC at the earliest appropriate time. . The subcommittee recommends that the MAC as individuals con tinue to support ir. Qlorig by providing him with material from plant noise surveys, hearing conservation programs, etc. EB 006913 API 07555 On 27 September 1959 AEC Regulations Title 20 promulgating regulatory changes governing the use of radioisotopes was published, gecause many objections were made, implementation of Title 20 was delayed pending public hearings. A summary of the objections Indicate Chat Industry would have a difficult if not impossible task living under the proposed changes. The subcommittee, upon notice, will promulgate the date of the public hearings so that those who wish can voice their opinions either as individuals or representatives of their company. The subcommittee recommends that the MAC call this matter to the attention of the API in event the API wishes to have a representatlve appear at these hearings in its behalf. J. H. Hege, M. D., Interim Chairman Subcommittee on Physical Agents Addendum: The Operating Subcommittee at its meeting of 8 November 1959 advised that $2,500 of funds appropriated for the 1960-61 budget is available for use as a grant to Dr. Olorlg. The Subcommittee voted to grant this $2,500 to Dr. Olorlg for continuation of his research on noise. /s/ J. H. Hege, M. D. EB 006914 API 07556 APPENDIX J-l RZPCRT CF SUBCOMMITTEE OR SPECIALTY PEEROLEW PRODUCTS ~ J. V. Osborn, M. 0., Chairman lfp/qgpg PBgSEWT; J. W. Osborn, H. D., Chairman C. H. Baylor, M. 0. J. W. Hasnond N. J. Roberts, M. D., representing R. F. Schneider, M. D. CUESTS: E. W. Adams R. G. Blrrell, M. D. " G. H. Collings, M. D. A. E. Dooley Geo. Entvlstle N. V. Hendricks C. A. Hau, M. D. - Leo Wade, M. D. Minutes of the special meeting, held October 2, 1959* at linden and Rev Brunswick, 5. J., were thoroughly reviewed resulting in the following consents and fecoonendations. . 1. CLERICAL RESEARCH AMD BLOOD HYDROCARBON ANALYSES 1, Dr. Gerarde has developed a new method for determining the aromatic fraction of hydrocarbons in blood, entitled "A Photoelectric Colorimetric Method for the Deter-' aination of Keroslne In Blood." This method Is to replace, at once, the original Ultra-Violet Spectrophotometrie Analysis Method. 2. Esso Research Center can no longer perform these analyses for either our research program or the Cooperative Clinical Project under Dr. Edward Press. Drs. Caeschner and McKay will probably prefer to do these analyses In their own labora tories but this will require special training of at least one pereon In each laboratory. It is possible that a method may be worked out whereby these, analyses can be done la some other central laboratory thus reducing costs. Dr. Carl Hau has offered his laboratory as a possible place. The mechanism of this will be worked out in the near future, however, additional funds will he necessary from API ources to pay for these analyses. - 3. The subcoesdttee, therefore, asks the MAC to approve $10,000 for our overall keroslne research program, for the fiscal year 1960-61. This is a $5,000 increase - to cover this additional expense as needed and possibly to support other observations felt needed in laboratory research if experience In the next six months with the costs of the new test method reveal there will he any balance available within this $10,000. This money le requested as a graat-ln-ald. (The . Operating Subcommittee on U/8/59 approved an additional $2,500 to support Dr. Hau's industry research proposal, the work to he done In the sinner of i960./ 1- SUMMARY OF LITBUTURE OH KEROSENE P0I30HINQ EB 006915 Br. Daeschner's summary and annotated bibliography of the available literature on Petroleum distillate poisonings is about 90-9551 complete, with sumsarles on 35 nicies. Some 8 or 10 other articles, including Dr. Gerards's "V. Keroslne," Just published in September 1959, will he reviewed in the near future. Dr. Carl Hau, vtose library is larger, will assist Dr. Daeschner in obtaining the other 6 or 10 API 07557 -2 - J-2 able before next spring's meeting, at vhlch time ve expect to sake specific re commendations on hov it should he distributed. r. LABORATORY RESEARCH OR KEROSINE Dr. Nau discussed vlth the subcommittee a report of the work which be and his staff performed this summer, financed in part by our API grant-in-aid to him of $2,500, entitled "A Study of the Ingestion of Karoslne." Be also discussed with us a pro posal for further continuation of his experimental work for next sunnier. His re port and proposal will be attached as part of these minutes. It was the consensus of the subcaamittee that due to the financial situation of tbs API budget, that ve should not specifically recommend to the MAC, at this time, positive support for Dr. Bau's proposal. It was fslt that If the $10,000 asked for, to make sure that the clinical program did not hog down, tuned out to be sufficient to leave a balance for the next fiscal year, that we may wish to use this balance for further support of Dr. Nau'a work. During the next six months, sufficient experience should develop regarding the costs of the new method for blood hydro carbon analysis so that by next spring's meeting the subcommittee should know whether or not there will be any funds available within the $10,000 for the fiscal year 196o-6l. (The Operating Subcommittee on 11/8/59 approved an additional ' $2,500 to support Dr. Bau's industry research proposal, the work to be done in the summer of I960.) D. AMERICAS ASSOCIAJIOH CP POISCH COMBQL CEBTBRS At the personal request of the subcommittee chairmen. Dr. B. B. Reeve attended the second annual meeting of this association, at the Palmar House in Chicago on October 6, 1959* A copy of his report, dated October 20th, Is attached. Based on Dr. Reeve's report and our discussion, tha subcommittee voted to recommend that the Medical Advisory Committee should become a member of this association. Annual dues for a person are only $5.00. The details of this membership can be worked out vlth the chairman of the MAC, if approved. 8. COOPERATIVE CUBICAL PROJECT WISH E7AUXATIQH OP KBR06IHS AflP RELATED PETBOLEW distillate hkbskioi " She subcommittee chairman replied on August lfeth to Dr. Btwmrd Press, at the American Public Health Association, regarding our decision of lest spring not to seek further informal liaison with this project. Our contacts with Dr. Daeschner and Dr. McKay, who are also members of this project, are considered adequate. The subcoiailttee chairman will keep In touch with Dr. Press regarding further developments In this project vhlch Is certainly not yet ready for publication. Subcommittee Members Approving Disapproving C. H. Baylor J. W. Haunond * J. Roberta for R. P. Schneider J. V. Osborn, M. D., Chairmen subcommittee on Specialty Petroleum Products EB 006916 API 07558 3333 J-3 THE UNIVERSITY OF TEXAS--MEDICAL BRANCH School of Medicine School of Nursing 'Technical Curricula Post-Graduate Program Galveston The John Seely Hospital The Children's Hospital The Psychopathic Hospital The Rosa and Henry Ziegler Hospital October 6, 1959 James V. Osborn, M.D. Standard Oil Company Midland Building Cleveland, Ohio Dear Jim: In accordance with our conversation, I vlsh herein to make a proposal for further continuation of our experimental work here at the Medical School, said work involving the possible Ingestion of kerosene. It is proposed that: 1. Quantitative studies of the amount of kerosene occurring In the various organs under varying conditions and amounts of kerosens administered be dona and that efforts be made to correlate such data vitfa gross and microscopic pathological findings. This suggestion Is based upon our findings that there la conclusive evidence that damage occurs In the lung, liver, kidney and the heart if and when karosene is detected In the blood. 2. We vlll do further studies on radiography In relation to the amount of kerosene that vlll be administered into the stomach. 3. Further work In autoradiography is contemplated. This vould Include liquid scintillation counts on the plasma and extraction and deposit on chromatographic paper of the kerosene vlth sub sequent analyses of tbs nount extracted from the various organa and tlasmee. 4. Efforts will be ends to eliminate rapid transfer of karosene from the gaetro-lntestlnal tract to the blood through various means. For this proposal. It Is Intended to uee medical students vho have both ability and Interest. This would not only accomplish something worthwhile vlth reference to our study of kerosene but would also be EB 006917 API 07559 COPY J-4 James W. Osborn, M.D. October fl, 1959 Page 2 of some value in recruitment of future industrial physicians. For this proposal, it would be suggested that funds equal to those which were allocated to us last year be provided on the basis identical to that for last year. I would be happy to supply any other information that you may wish. 1 find that the radiographic vfork that was done in this laboratory is new, extremely Informative and worthwhile. I was pleased to have the opportunity of attending our recent meeting at the Esso Laboratories and I am herein sending you my expense account to cover this trip. Kindest regards. Sincerely yours, CARL A NAU, M.D. CAN/bb EB 006918 API 07560 THE L^TVFJLSm <)c I EX AS - MEDICAL DRANCH uALVaSTON J-5 .g^OOtr.f IWOI 'MOW rrjtmcju ci mjclu* T4AUHT1 tttmLtM September 14, 1959 C*rlA. Neu, Sr.. 14. D. yairsrsity o< Texas Medical Bruch Texas tM lOM**. J*AI r HOim u TOl rMMiilN f NOVfTAL ' TMh W HOf ATKJC HQtftrAi m >ou ^ hint nut tmmu . p|r Dr. Ku: puriag tha t year, Mr. J. DeLeon ud Joacqulm Marrow have made nunuroui ,0lc res actions of organa from rata given 0. 3 cc. of keroalne labelled with 10 me. ^ radioactive hydrogen (HJ). Aatoradlogrepha have demooatrated kerosine in the following organa and/or spaces: U gtomach l) Plasma 3) 4) Liver 5) Kidney . 6) Bladder 7) Heart muacle (Only kidney, plaama, . and atomarh really convincing.) [va now, many anticipated dliflcultlea have not been aurmauated, Theae Include: 1) Mlcroeectlon preparation, including cutting, mounting, and staining. 1) Exposure and development of apodal film and emuialon. HECOMMENDATIONS. I) That qualitative autoradiography be continued, sharply limiting the number of actions and tha methods of processing. 1) That quantitative organ aanlyeie be instituted. Liquid scintillation counting could be employed on plasma; however, color Interference would probably introduce too much variability for organ analysis. Extraction and :lep>sit or. chromato graph paper would permit analysis on the equipment in the F-adiology Isotope Laboratory. This will require consider able precision and knowledge of radiatlon physics, especially with low energy levels. CHA-chs tc D*-. R. N. Cooley D . L.. B. Beeotjes Department ni Radio.ugy_ EB 006919 API 07561 A 3TU!JY OF THE INGESTION OF KEROSENE Jam dsLson Joequia Mirron Carl A. Nau, M D. Depart meat of Pfnrmll Medicine and Public Health Umvernty of Taxes Medical Branch Galveston. Texas For a long period of time there haa been a controversy as to whether the pneumonitis associated with or arising out of the ingestion of kerosene is due to the aspiration of the kerosene or whether it is due to the hematogenous transmission of the ingested kerosene to tne lungs (and to other organa and tissues). The answer to this question will help deteimine whether a parson who has swallowed kerosene should be iayaged. The Academy of Pediatrics, the American Public Health Association and the American Medical Association presently are conducting a clinical study in an effort to answer the question of how to treat a patient who haa Ingested kerosene. It la our purpose, by using rabbits, mice and rats, to determine If keroeene la absorbed from the gastro-lntestlnal tract and if kerosene can be detected in the blood and various organ# - such aa lung, Uvar and kidney - after ingestion. It is also our purpose to determine if changes from the normal occur in these organs and tissues whers kerosene may be detected. EB 006920 API 07562 I J-7 2 iUUriMi *x4 Matkada Far var 1M7 * ***4 kiruiM fvralik^ kf tea Hxmkla 0(1 u( Cmilif u4 karlag Ik* fallaxlaf ayaciAcatisxa: ISli Crtiit7, *AF1 ru*k Fatal. ?, Mia. Jaykalt C*Ur. Mia. Carraataa. J If*, at 122* F. Max. aa AJTM ccala Dacter T**t Buraiag Taat, kaaa, Mia. PtatWatlaa. F. BP, Mia. . lit lUcmrai 95te Baaavarad, la. Bai. Fatal. Mas. Nlkf, vt. I, Mas. Hlt* 41-44 120 IS 1 Jvaat 24 )N 349-425 449 139 I.IS T**t M<kd AJTM 0 297 AJTM D 54 AJTM D 154 AJTM O 139 FtM 5203 AJTM D 197 AJTM X>94 Bakkite. rata aa4 adca vara aaa4 a* teat aalaaals. Earaaama vaa. jim ta rabklte latrartaMilr aa4 ky atamack taka la 4o*aga ay ta 39c c par Eg. 1 ta rate ky atesaaak taka la Jaaagaa varyiag tram 5 to 29 cc par Eg.; aa4 ta mica is 4a*agaa at 9. S cc cask via if rk taka. Tka klaad vaa 4rava after S mlaatea (ar laagar) aa4 aa laag aa 24 kaara after tka aJaalaiatratlaa af tka karaaaaa. Vkaa tea aatmala vara ucrUcat ar axa4 4aa4. a asapUte yatkalagical aralaatlaa (graaa aa4 aateraacapU) vaa auta. . EB 006921 Siaca karaaaaa la aaiaclkla la laa-aateaa. tela material (ayactra- grad# aa faraiak*4 ky tka IkilUpa Patrolearn Camp*ay) vaa a*4 aa tka axtractlag kid*. It rasurraa karaaaaa from klao4 aftactiraly. API 07563 1I A cMcnlntlM etrT* *i nui far katk ml tka karaaaaa puki a lac a It u faaarf Uut krsiu nlu4 wife ii*Ktu pro4wcaa a thary jm*1e at van laaftk 121 aallliaaicraa, aaA a aligkt paak at war* laaftk 273 millLaicrow wkaa raa4 am a Barkwiaa Maial OU l^actraplataaiataf. Tka astracU4 aampla was rial (ram van laaftk 2if aiUlimlcroa feraagk vara laaftk 401 naiUimlcraa nia| tka altravtalat li^t. Balk poaitivw aa wall aa aagatlva "coatral kloada" wara raai. (Saa flgara kalow). Aa afaal valaaaa ml blood mod iaa-actaaa wara a a#4 far 4 mlaviaa ml astractiaa. API 07564 J-9 4 U*rf dosages of kerosene -warm employed la rabbits aad rats; comparable doss# la man would bars bssa beyond wbal oas might si* pset s person to consume. Thsrsfors, It was decided to bars kerosene labelled with radio-active tritium by the New Caglaad Nuclear Corpora tion sad to use autoradiography to demonstrate gastrointestinal ab sorption and cellular deposition of this radi one tire material given in minute doses to mice. Autoradiographic permeable base stripping film (emulsion No. JI-1906) and permeable base emulsion (NTB^) were furnished by the Kastman Kodak Company for our uae. Thirty mica, starrad for 12 hours, were eneathetised using sodium amytal tntraperitoneally- An incision was made below the left costal arch from the xiphoid process to tbs posterior axillary fold. The exposed muscle wae cut carefully with sharp ecisaora and the stomach and lower end of the oesophagus were exposed. A ligature was passed under the oesophagus and tied carefully thus insuring that no radioactive keroaena could be regurgitated end aspirated into the lunge. Using a fine hypodermic needle, tl (eleven) millicure of radioactive kerosene (0. ) cc kerosene) was injected into the etomach. Following this ingestion the etomach wee placed bacx into normal position and the muscle and skin were sutured. Six hours later the m:ce were anesthetized, killed and the anterior part c( (be thoracic well wae removed end each mouse was immersed in isopentane cooled down to 160 F ov ri<*ar.s oi liquid nitrogen. Pressing wae instantaneous <."-10 5 Tka bUci v*r riamd (iaa tka leopeatiae a4 placed la dry lea. UUr tka doaired argaaa vara ckipped oat aitk a pick aad bammor and tored at I* C. aatll needed. Latar. aader vary loa temperatara, 4 micro* aactlaaa vara cat eelag a alldiag microtome. Tkaaa aectioae vara lifted vitk a cam*la kalr break lata a beaker filled vitk cold metkyl alcakol aad atored at 0* C. for oao day. Tbe follovieg day tka matkyl alcakol aaapaadad aactioaa vara tlleved to atoad la tko matkyl alcakol at room tempo ratera (or oee*bai( a '` * boar aad tkea (looted eeto egg albamla - glycerol ameared alidaa. allowed to dry to a 37* C. ova* overaight. Blood aouara vara treated la a ijailer nuaaor. Tka elide* voro tkea dipped la 1% celloidia eolation la 100% etkyl alcakol to eliminate artifact# aad tkea lato aakblog Held (3% eolatioa of gelatia aad 0. 03% ebromo alum) to affect good emelsioa biadiog. Tka olid** voro tka* covered vitk tka omaleioa from tka atrippiag aad atarod la U#tt proof bakelite boaoa for eafflcieat laagtk of time to expeae A* film adequately to aay radioactire eaaterial. Folloviag aacb expoaar# tko elide* vere developed aad eaamiaad. ******* eb 00692^ Tko mister* ofberoeeae aad lee-octaaa `'peaked" at vave laagtk 221 milltmlcrm vitk a ellgkt peak at 273 mlllimic ron wbaa eramlaad vitk tka Bacbmoa DU Spectrophotometer. Tka curve obtaiaad from API 07566 ) J-U t> mull | rat Qiuou w'.4h iso-octane 'peaked'1 *t *ivt length 209 milll- .nicron and steadily billnd to wnt length 400 millimicron. Hie curve after 1 tc o( k*roieD t< given IS rata ria itomirk fibs, the ra;a killed and blood Or awn from the la/ertor vena cava, the blood extracted with io-octane and thia examined wUh the DU Spectro- pbotometer - peaked ' at 221 aod 273 millimicrons. The greatest amount of kerosene found in the blood after 1 cc wae given via etomacb was detected 2 to 4 hours after the administration of the kerosene. Calculation was made using the formula of H. W. Gerarde. ' VPkl m itrnii.i/ m m pr aromatic material iwl X mliinn of atnpla X lfl6 Sample weight (dp g. of blood X volume) Thr largest anounl of kerosene detected in the blood of our rate four hours after plat ing the Kerosene into the stomach was 142 ppm. Twenty-four hours later, no kerosene wae detected in the rata' hiood. . When rahbita were used, kerosene wee detected in the urine 2d hours after administration of the keroseae via stumach tube. X-raye of (ha cheat of rahbita given kerosene revealed increased densities In those animale tit which kerosene wae detected in the blood. Grose and microscopic examination of the tissues revealed areas of . onsolidetlon in the lung, degenerative changes in the liver, tubular cells of the kidney and heart T'.rse .nangee we.-e always found when kerosene was detected in the blood and vsi not (t served in our control animal#. EB 006925 API 07567 Gxuniuc.on of the radio-autographic elides reveals tha presence of tha "ta gf4" ha ro aaoa In tha following organa and tiaauaa: 1. Stomach z. Plasma 3. Luage 4. Llvar 5. Kidney h. Urinary bladder 7. Heart muscle Tha apnctrophotomatrtc evaluation of tha karoaana In tha blood of a rat gtran k. roaaaa via atomach ta harato attachad. See page 3. Coaglualona - 1. Karoaana can bo dlaeemlnated rapidly by hematogenous route a . from tha atocaach to many organa and tiaauaa and can be detected in tha blood by apectrophotometrlc methoda. Poaitlva cheat x-ray finding! are found in thoaa rabblta in which karoaane ia found tn tha blood. i Significant pathological chan go a are obaerved in tha lunge, liver, kidney and heart of animala in which karoaane ia placed into the atomach and loft there. 3. Radioactivity in karoaana adminiaterad to m-cr via atomach tuba in minute doeagee can subsequently be detected in the blood and varioue organa by autoradiography. EB 006926 J-13 This study ti financed ia part by the American Petroleum Institutes Uadical Advisory Cocnralttaa through Us sob-committee oo SpocJalty Petroleum Products, J. W. Osborn, U. D. , Chairman. Ths assistance and advice o/ Colvin H. Agnew, M. D. and L. B. Beentjes. Ph. D.. of ths Department oi Radiology is acknowledged with gratitude. 1 I \ EB 006927 API 07569 r i STANDARD OIL COMPANY (INDIANA) 910 South Michigan Avenue Chicago Qo, 1111nois October 20, 1959 J-14 J# W. OSBORN, M.D. Standard Oil Company (Ohio) K^iland Building Cleveland 15, Ohio per 0r> Oebom: At your request, I attended the Second Annual meeting of the American Association of Poison Control Centers at the Falser Bouse in Chicago, on October 6, 1959. following is a brief ausaary of vhat took place. I as also enclosing material tbet was distributed. - Dm nesting vas fairly well attended and it was reported that there were 121 partic ipating members in the organisation at this time. Due to their previous by-laws, 1 quorum was not present until late in the meeting. By-law changes have taken care of this matter. The dues have been $2.00 per member but due to a change in the ty-laws, voted at this meeting, the dues will be $5*00. Many of the members present vert pediatricians and pharmacologists. By-law changes were mads with which they expect to broaden their membership to other organisations. In tbs committee reports, there was a request for educational material for dis tribution--pamphlets, etc. on poisonous drugs--which could be handled through Health Department contacts. It was recommended that an Bducatloo Coamittee he formed ud funds solicited to carry on their activities. To date, there are 302 poison control centers and it is the desire of the organisa tion to have control centers every 50 adits. Soma canters are for information only, vhile others are for both information and treatment. It was emphasised that adequate training should be given to persona giving out information and recognise the advlstbllity of getting legal advice on matters that may aria# as the result of giving out information. The Research Ommdttee has no funds to date. A film lending library and a national clearing house for poison control centers is dar the Bureau of State Services, Public Health Service, Department of Public fcalth, Education sod Welfare, Washington 25, D.C. They ere now getting information Iren the control centers. Sixty centers report every case treated. At the present Alas, they have 15,000 poison eases reported on the epidemiological survey and of tfalr 15,000 cases, there are 631 eases of kerosene poisoning. A control of alterBiting lavage and not-lavags treatment vas-made on 192 cases. It was reported that *5$ of those receiving lavage had cooglications and 6jft of those not lsvaged bad *plications. It wee the concensus of opinion at this masting that lavage was Seated. Dr. R. K. Richards of Northwestern reewntended lavage. EB 006928 API 07570 J-15 -2Leslie Corsa at*tad that it wa* doubtful that center* were saving nany live* ^ they were permitting an excellent epldeaiologleal survey of poison* and It vu educating both the public and the doctors la regard to poison control. .feel that It night be worthwhile for the A.P.I. to become a neater of this organi sation in ortor that they nay be In touch with what Is taking place and they should ble to add something, pertaining to petroleum products, to the control center. Yours trutly, /*/ B.B. Deere, M.D. ' Medical Director ;0: rl pel. EB 006929 API 07571 APPEHTIX K-l REPORT OF SUBCCMGTTEE OH TCOtlCOLOOICAl REVIEWS H. W. Gerards, M. b., Chairman 1. The second editions of the Toxicological Reviev* on Butadiene, Naphthenic Adds, Copper Naphthenate, and Naphthalene have been published. 2. Final drafta have been prepared on Benzene, Toluene, and Xylene. Publication is expected in early i960. 3. A large number of first drafta of Toxicological Revievs have been received from Dr. Phillip Drinker. 4. It is anticipated that $$,000 will be needed for re vision of the Toxicological Revievs during the cooing year. 5. The first drafts of the Toxicological Revievs vtll be circulated In groups of four to the aenbers of the Medical Advisory Coonltta* for consents and suggestions. Respectfully submitted, B. W. Gerarde, M. D., Chairman Subcasolttee on Toxicological Revievs EB 006930 API 07572 If APPENDIX L-i . REPORT OF SUBCOMMITTEE OH INDUSTRIAL HTGIENE ' J. A. Spence, Chairmen This subcommittee net on November 7, 1959 with 10 members and 15 guests present. Mr. E. P. Wheeler was absent. Liaison members reported on the activities of the American Standards Committee Z-37 Toxic Duata and Gases, Z-4 Industrial Sanitation, and Z-62 Industrial Hygiene Standards. Mr. Dooley reported work is in progress revising certain standards. Mr. Hendricks reported the first draft of Guide To Good Industrial Hygiene Practices vill be presented at the April i960 meeting of the 2-62 Committee. Work on the petroleum catalyst project has been completed. The sub committee submits to the Medical Advisory Cooslttee the report "Some Catalysts Used in Petroleum Refining" with the recoanendation it be used for distribution within API only. . The subcosnlttee has begun the preparation of Industrial hygiene infor* nation on various petroleum refining proceasee. Initial attention vill be given to the following processes: 1) reforming, 2) cracking, 3) alkylation, and U) isomerization. Members have accepted the follovlng assignments. - Alkylation - Mr. Spence Cracking - Messrs. Daniels, Pabst, and Wilkenlng Isomerization - Messrs. Dooley and Raines Reforming - Messrs. Halley and Hendricks . Mr. Wilkenlng will be project leader. Deadline for completion of the first draft Is March 1, i960. Follovlng completion of this first phase, attention will be given to l) polymerization, 2) solvent refining, 3) treating, and k) selected refining processes. Present work by the C9 - Cjjj subcommittee indicates these aromatics may be more toxic than previously considered. There Is therefore a need to evaluate the Industrial hygiene aspects associated with these aromatics. Since there Is an apparent lack of information, the subcommittee members have agreed to gather data on their uses and related environmental health conditions. It is anticipated that by the November i960 meeting additional information on the industrial byglene problems vill be available to supplement the final findings of the C9 - C12 subcosnlttee. J. A. Spence, Chairman Subcommittee on Industrial Hygiene EB 006931 API 07573 ti SUBCCMCTtTEE CH ATMOSPHERIC P0LU7EANTS LiAisctf RgKiMTd SMokS ATO'Ttftttg ftmMgg APFHTOIX M-l Tbs Subcosmlttee of tbs Medical Advisory Committee of API which concerns Itself with atmospheric pollutants brings greeting to you gentlemen bare through me u Its liaison. You gentlemen ara wall avare that the Petroleum Industry has been accused of being responsible for certain pollutants found In the air and that these pcllu. .. teats have been alleged to arise fromthe manufacture, refining, production, storage, transportation, sale and use of petroleum and petroleum products. When you have dis cussed and analyzed these air pollutants, you find they make a considerable list vhich includes - SOg and its variants, Oj, 00 and oxidants such as hydrocarbons, KO2 vlth its olefins, etc. Because the public, or people, hare at times complained of eye irritation, decreased visibility, coughing, etc., all of the pollutants I have mentioned have teen accused of injuring our health. Zt vas presumed and supposed that air pollu- tlon vas a menace to public health and that anyone coming in contact with polluted air, as ve have it in our urban areas, vould became a cancer victim, might die of tuberculosis, vould acquire a continuous bronchitis, vould lose their eyesight or finally might suffocate to death. . Our aevspaper and feature writers and the people themselves blasted our industry for causing this terrific nuisance, this nuisance that might kill, this nuisance that has been caused by a large, proeperous industry, worldwide in its operations, and which is accepted in the Uvea of each one of us for our comfort and existence. We, as people, are very anxious to abate air pollution and parti cularly if ve find ve are responsible for it. As ve learn the answers ve have attempted to meet the problems. If there are still problems, ve may still find answers as ve are still working at it. In the past years, the petroleum industry baa spent many millions of dollars and, to quota Mr. McAfee, during years 1956, 1957 end 1956 approximately 66 million dollars was spent to abate this nuisance. These abatement efforts have been good because there has been a control on our stack effluents, there have been changes in our refinery methods, there baa bean a redesigning of storage tanka and tank trucks and terminal distribution stations and many other worthwhile changes. In addition, huge sums of money have become available for our use in technical re searches which ve hope will solve, eventually, the problem of air pollution. Much of this technical money la available on the assumption that air pollution is a menace to the health of mankind. Those in favor of this assumption always argue that the Sonora, Meuse Valley and London incidents are examples of medical hazards. . Communication baa been bad, especially through newspapers and other articles published by individuals In scientific magazines. These articles conceraing "smog" often stress unproved facta and many of them are deleterious to the Petroleum Industry-. Politicians have become vary vocal, especially when running for office in localities where air pollutants are more obnoxious than in other parts of the country. It is now rapidly becoming evident that the weather, the population density, geographical locations, seasonal changes, industry and the number and type of automobiles on the highways are certainly not subject to lavs or county ordi nances . The opinion of people and particularly the fringe of armchair scientists who are always vocal, will be a deciding factor in the elimination or abatement of air pollution because in their demands they will push researchers and others to extreme activity in eliminating this nuisance. In spite of the claim that air pollution, or "smog", affect* the health of EB 006932 API 07574 M (/ -2- M-2 the Individual, both physically and mentally, ve have found no case, nor have ve found any pathological effects, attributable to atmospheric pollutants. There are many poisonous and noxious fumes which only become noxious when they exceed a certain density and are either respired or Ingested - not once but continuously over a period of time. The human being may withstand the effects of a relatively large dose of a substance for a short time without any harmful effect but cannot with stand the same substance in smaller doses for a long period of time. It therefore seems necessary that certain standards be developed that are scientific and not based on assumption or fear concerning concentrations of pollutants which.the. human _ being may /contact, without harmful effects ... This ie coepljested by ega. health of the individual and indirectly by hia actirity or IhactlTlty. -7. ; establishing standards we aunt establish standards at an extremely low level so . that the pcllut*nts will not harm the most susceptible Individual} whether it be one with an allergy or one who has a disease such as bronchitis, tuberculosis, heart disease, etc. We must establish these standards not because we think it will harm the human being, but because we think it "ip^t bans him. ; To date In our urban ccemunltles, the U. S. Public Health Service has been unable to prove aggravation of such diseases as asthma, tuberculosis, bronchitis, etc., due to air pollution, nor does air pollution particularly affect the aged or the very young. Four precepts are necessary to establish any casual relationship between air pollutants and health - namely: . .1. A toxic effect has occurred. . 2 A pollutant capable of causing this effect Is (or has been) present. . 3. There is (or has been) an excessive exposure to the pollutant. 4. Other causes of the toxic effect do not exist. By toxic effect is meant real injuries that are self-evident or readily demonstrable by appropriate medical examination. Your attention is called to the difference between a nuisance and a hazard. When does an annoyance or a nuisance become a medical hazard? If a thing Interferes with the comfort or the enjoyment of a man's property, or it renders life uncom fortable, it should be considered a nuisance. It may be a nuisance in one place but not in another. If a nuabex of people are affected it ie a public nuisance, other- vise with one person it becomes a private nuisance. When ve have an obnoxious odor it is an aesthetic nuisance and may cause by reducing the price of reed . estate, but it certainly la not a medical hazard because it has not mads anyone sick. It could be a medical nuisance because it makes you sneeze or it might annoy you because your eyee smart, but it does not hurt them. There has been no case of any permanent damage to anybody's eyesight because of air pollutants. . It is sincerely hoped that this Coaaittee will differentiate, in its research and in its reporting and evaluation of constituents of air pollution, . between medical hazard and nuisance and not prestos that all are medical hatarda. As true Americana we do not like to have our rights infringed upon, whether it is the inability to see as far as ve desire or whether it is the dis comfort and eye smarting that occurs at*times with air pollution. We Just don't like it and we in the Petroleum Industry, who are people, will do everything in our Power to assist in the abatement of air pollution. Gentlemen, this talk I have Just given to you Is a condensed version of a balk I recently gave to a combined tvo-day meeting of my Subconmittee and members of the Automobile Manufacturers Association, the American Association of Railroads API 07575 EB 006933 sa / -3- M-3 jcd technical and medical representatives of the U. S. Public Health Service at tbe Robert A. Taft Sanitary Engineering Center In Cincinnati. The API, through its SubccBBittee on Atmospheric Pollutants, hosted this meeting which was the first of Its kind to be held. Representatives of your Cosnittee who were present and who participated in the program were Hr. W. T. Gunn and Mr. Jerry McAfee. In addition to this, the Medical Advisory Ccesslttee has received to date two parts of Dr. M. W. Goldblatt's final report. His contract with the API con cerning Project MC-U terminated on..July 1,1959 and he informs ue we can expect. - three aare .jogtlep^e^.^jji>i|r|iiftItfiQiPfi sifTiitinbul ' TheJiedical Advisory .. Oomsittsie is requesting or reprodaeed In ' book fora for distribution W the various oil companies within the Institute and others Interested Id* tide research. This report is one of the best works ever to be done concerning a critical, clinical analysis and review of the world's literature todate, especially that literature which concerns air pollutants which might be caused by the manufacture, refining, production, storage, transportation, sale and use of petroleum and petroleua products. Respectfully submitted. John C. Ruddock, M. D., Chairman Subconalttee on Atmospheric Pollutants, Medical Advisory Committee, Anarioea Petroleum Institute EB 006934 API 07576 / Apporoix s-i REPORT OF LIAISON MBCBffi TO THE A.M.A. CCM4ITTES 08 TOXICOLOGY ' AND THE IMTiER-j!lJUSTHY CM LAB 1, status of Hazardous Substances Labeling Legislation - A. Federal Level - The first session of the 66th Congress adjourned in September without taking any action on 3.1283 and H.R.926O (identical bills jpcnsoredL by the Inter-Industry Group "to regulate the Interstate distribution and Ifia of packages of hazardous substances Intended or suitable for household use"), -fhi.fleaata Qq--ittee pa Interstate and Foreign Connsrce held one hewing August 13 the'Att uaairepstaacntod 'D. 'dlrte:~eaSf;''JF^;Vrr; Oatkiru, It. D*-1:^ Osborn read, a prepared' statement on behalf of the APIsupportlng tbe positioo o? tbs Ihter-Industry Group. So hearings were held on E.R.4260. Likewise, no hearings Mre held on H.R.7352, a bill sponsored by the Aaerlcan Medical Association "to regulate the labeling of hazardous substances for non-manufacturing purposes." Or. Osborn is in touch with Mr. GJerde, Chairman of the API Interdivlslonal Coanlttee on Labeling, and with Mr. Ackerly, counsel for the C.S.M.A. Labeling Cosnlttee, on current developments. It is expected that further^action will occur soon after Congress convenes its second session in January, i960! B. State Level - 1. Ohio -- Amended Substitute Senate Bill (To. 440 was enacted by the Ohio General Assembly to become effective November 4, 1959- As of October 20, the Ohio Department of Health had not promulgated any regulations for the admlnlsteraticn of the labeling lav. Also, department officials indicated that the General Assembly did not appropriate any money for hiring of additional personnel necessary to pro perly enforce the lav. These officials said that because of the lack of an appro priation, they would move rather slovly in promulgating regulations and adopting enforcement procedures but emphasized that they would expect the lav to be complied with. The above information is tha gist of that supplied by Mr. Addison E. Devey, Director of the Ohio Petroleum Council in Columbus in his information bulletin dated October 20, 1959- A printed copy of the Ohio lav was sent to Mr. B. 0. Mattocks on October 22 for duplication and distribution to interested API members. 2. Illinois Senate Bill No. 911 -- As of June 11, 1999 this bill covering household products and almost identical to the model lav which the API Labeling Committee helped to develop had Just been adopted. This Act is supposed to take effect January 1, i960 but no further information has been received regarding Issuance of rules and regulations by the Director of Health. 3. Indiana -- Amended Senate Bill No. 103 was pasted March 1999 is expected to taka effect January 1, i960. Likewise, no rules or regulations for its enforcement have been made available to this member to date. 4. City of New York -- Revision of the Sanitary Code, Title IV; Environmental Sanitation, Article 211: Hazardous Substances. Presumably, this new lav announced last February as being passed vent into effect in New York City on or about October 1, 1999* No further information on any rules or regulations or en forcement procedures has been received by this member to date. 5* Vermont H. 283 -- This bill introduced March 13, 1999 was essentially the same as the Inter-Industry Group draft of January 5, 1999* Subsequently, on April 1, 1999 Vermont H.B.460 vas introduced. This bill did empower the Department of Health to regulate the labeling of food, drugs, cosmetics, and all hazardous substances. The legal section of the Consittee on Public Affairs of the API indi cated that the sections of this bill dealing with hazardous substances followed closely the model bill sponsored by the Inter-Industry Group. No word has been EB 006935 API 07577 I 2 - N-2 r#ceive<l on the subsequent fate of either of these bills. 6. Washington - H.B. No. 437 passed the House vith minor amendments but vs* killed by a Senate Committee on March 5 The State Legislature adjourned on ,v|arch 12 with no opportunity to revise the bill at that session. There may be bills before other State assemblies during 1959 but this has no information on other than the above. - ... . . .... J. W. Osborn, M. D. Vice Chairman, Medical Advisory Committee eB006936 API 07578 %4 IMRTE&PfOflRVTIbON^^AXCTT5IVII?T^IEHSgO'~F 0TyH~E nA^PLI IN0 APPENDIX 0-1 During the past year the API Xaterdlvisioaal Comalttee on Labeling has continued its work to determine requirements for precautionary labeling of petroleum products. In accordance with the policy established by API, we hove also followed the general situation with respect to pending or anticipated legislation which may be of concern in this connection. At their meeting yesterday, the committee approved label wording for Ethylene Qlycol Anti-Freeze, Methanol Anti Freeze, Aromatic Petroleum Oils (with fraction boiling over 700?)', Cut-Back Petroleum Asphalts (flash 20F. - 80F.), and Cut-Back Petroleum Asphalts (flash 80OF. - 1207.). The above will be Included la a new issue of. API Bulletin (2511) on Precautionary Labels, bringing the total to 21 product labels. Liaison has been maintained with trade organizations having interest similar to ours with respect to. labeling legis lation. It is the committee's intention to continue this effort to encourage proper labeling requirements pmaulgated at both State and Federal levels. Mr. GJerde will communicate with the MAC on request of the committee for early revision of toxicological reviews on kerosine, aromatic naphtha, methyl aloobol, and others, if needed. . Prepared by M. D. GJerde and Dr. C. H. Bine. EB 006937 API 07579 / Apparcix p-i WAX RESEARCH ADVISORY CCMQTISB The vx research project, under the direction of Dr. P. Shubik of the Chicago Medical School, la proceeding noit satisfactorily. To date, no known carcinogen bad been found la any of the waxes examined. The limit of sensitivity of the teat Is 0.01 p.p.m. Of the five waxes subjected to extensive biological testing (souse skin painting, rabbit skin painting, injection into sd.ce, and feeding at a 10f level in the diet of rats), none have shown any significant biological results. Some of these tests have now been in progress over 65 weeks. In the spring of 95'J, unfavorable publicity, attributed to a Rational Cancer Institute specialist, appeared in a great number of newspapers throughout the United States. Through the efforts of Dr. Shublk sad many of the members of the Wax Research Advisory Committee, tbs imnedlate crisis was met. Ultimately, on June 29, 1999, representatives of the Committee and Dr. Shubik met with Secretary Fleming of the Department of Health, Education, and Welfare, 8urgeon General Burney of the U. S. Public Health Service, Commissioner Larrlck of the Food and Drug Administration, and Dr. Major, Associate Director of the Rational Cancer Institute. The results of this meeting was the attached statement by Secretary PIearning at his news conference on June 30, 1959. As s result of tbs work sponsored by the Wax Research Advisory Committee, . Mr. Frank Porter has written to Secretary Flemming requesting on extension of time for wax for one year beyond March 6, i960, the date on which, under Public Lav 65-929, s decision on the suitability of wax as food container coating would otherwise have bad to be rendered. Mr. Porter has received the attached reply from Mr. Larrlck, Commissioner of the Food sad Drug Administration. Tbs Wax Research Advisory Committee believes it essential that the work at Chicago Medical School be continued for another year, at a budgetary level of *150,000. ' There is urgent need to acquaint the public with the advantages of petroleum wax for use in food packages. This is especially needed st this time with petroleum wax competitors undermining tbs public confidence in petroleum wax. The Wax Research Advisory Committee plane to request the Medical and Health Const ttee to recommend to the API Board of Directors that they Instruct their Committee on Public Affaire to undertake this task ianedistely and to form a Wax Advisory Committee to assist them la their program. The Committee would like to commend Mr. E. 0. Mattocks for bis invaluable guidance and assistance throughout the year. Respectfully submitted in behalf of the Wax Research Advisory Committee R. E. ECXARDT, M. J., Chairman RES: Mew Attach.: Statement by Secretary Flemming, June 30, 1959. EB 006938 API 07580 THRELEASE AT C0NCLU3ION STREWS CONFERENCE ' / Statement* by Arthur 3. Flemming Secretary of Health, Education, and Welfare I am informed that both the Food and Drug Administration and the Public gealtb Service are receiving many inquiries about possible cancer producing agents 10 wax used for milk cartons and other food containers. ' I think ve should try to clarify the situation with respect to these waxes. I During the latter part of 1956, Dr. W. C. Hueper, of the Public Health Service, arranged with the Milk Industry Foundation to collect waxes used by dairies for the impregnation of milk containers. Several months later the Foundation asgeabled about 40 waxes for further chemical and biological analysis and sent them to tbs National Cancer Institute. In June 1957, 24 of these waxes were sent for study i to Dr. Philippe Shubik, Division of Chemistry, Chicago Medical School. Dr. Hueper , provided Dr. Shubik with suggestions for the work and data on the economic, chemical, I . tsi biological aspects of dairy waxes. A representative sample of each of these ! waxes was retained by the National Cancer Institute's Environmental Cancer Section of which Dr. Hueper is chief. In the fall of 1957, Dr. Hueper received a report from Dr. Shubik on results of preliminary teats of the 24 vaxes. The studies were performed by Dr. William Lljlnsky, an associate of Dr. Shubik*s. It was demonstrated in these jtudies that one of the vaxes contained a known carcinogen (cancer producing agent), 1,2,5,6,-dlbenzanthracene. Three additional vaxes were suspected but no carcinogen could be Identified. It should be noted that while this compound has produced cancer In laboratory animals, 1,2,5,6, -dibenzanthracene has hot been shown to pro* luce cancer in man. A report of the results of this Investigation was ccsmunlcated to Hr. Ernest Kellogg, Secretary of the Milk Industry Foundation. As a result, Mr. Kellogg asked the American Petroleum Institute for assistance in Investigating the problem. Dairy Industry representatives also met with Public Health Service milk and food personnel to map out a program to assure that the vaxes used were free frcm I impurities. In November, 1957, the American Fetrolew Institute made available | $100,000 a year far five years to support additional studies by Dr. Shubik (Dr. Shubik I has indicated that the reeulta will be published as the studies are. completed.) Accordingly, Dr. Shubik was supplied an additional sample of 26 represent ative vaxes by the petroleum Industry. By the time these new samples were received, Dr. Shubik had improved his analytical techniques to the point where be could Identify as little as one part of 1,2,5,6,-dlbenzanthracene in one-half billion parts of wax. In the earlier experiments, sensitivity was one part of 1,2,5,6, -dibenzanthracene in one million parts of wax. With the high sensitivity of the new techniques, no di benzanthracene has been found in any of the 26 samples. . 1 : -j .i1i l li 'Released at Neva Conference, Washington, D. C.; June 30, 1959* ~ 006939 API 07581 -2 - / ?-3 Meanwhile, In 1958* samples of the 34 waxes sent to Or. Shubik by Or. Hueper in 1957 also were sent to Dr. Paul Kotin, Associate Professor of Pathology at the University of Southern California. The major results of this study, made by Falk, Kotin and Miller, were published in the April 25, 1959, issue of a British scientific journal, Nature (pp. 1184-85). The Kotin investigations confirmed the Shublk findings that one wax con tained between 0.5 and 1.0 micrograms per gram of 1,3,5,6, -dibenzanthracene. The Kotin investigations demonstrated, in addition, that 1,3,5,6,-dibenzanthracene added to dairy waxes for experimental purposes was extracted from thin layers of wax by milk. The results of these studies have been reviewed by scientists of both the public Health Service and the Food and Drug Administration. I am advised that the findings are not final but no indications of a health hazard have been found. The Food and Drug Administration advises there is at present no basis for action con cerning these waxes under the Food, Drug, and Cosmetic Act. The scientists are also agreed that more information is needed. The Food sod Drug Administration plans a study of these waxes in its own laboratories if its appropriation for I960 as now approved by both House and Senate is finally enacted. The Public Health Service also plans to support further studies and to provide technical assistance to the industry in its control program. It should be pointed out that the new food additives amendment to the Federal Food, Drug, and Cosmetic Act covers the safety of food container materials which Incidentally contaminate food. Just as it covers additives for direct addition to food. EB 006940 API 07582 1f rftANfC American Petroleum Institute so west join stmcct new York 20. N. Y. **C(OC*T 15, I55f for tr. Mar . I1m1% Nnter mirWTl af lMlk litlM, a* Uftn 1, use m. a.1 Wjr tm, la 1 at. Utf, itflm of w I.L a. a. OjfL^aNiutf i ^***WOGRSS AUjUI 'v'/l "/3- Cop/ Froa K. 0. Mattooks For Information Of N#n Of: Adrlaorr CcaaitWo to ttao Wax Raaaureh Projaet ui Obaarraro; Intardirlaiconl Co--ltt-- on patrolv Food Additivaa 10/15/59 EB 006941 API 07583 'r department or HEALTH, education, and welfare POOO AND ORUG ADMINISTRATION WASHtNOTon . o c October 27, 1959 Mr. Frank M. I'orter American Petroleum institute 50 West 50ch Street .'lev York 20, New York Dear Mr. Forcer: Secretary cleaning has asked char, we reply Co your letter of Occober 15, .1959, in which you requested an exteusion of time under the food Additives Amendment, permitting che continued use of pecroleum waxes pending completion of che current research'program. The food and Drug Administration haa not, as yet, granted ex tensions as authorized by che Food Additives Amendment. Wo have adopted the policy that such extensions will be granted where there is a shoving that che.material to be covered by an exemption haa been used without apparent injury to consumers and data Is avail able demonstrating that concinued use would be without hazard co che public health and chat the extensions are.necessary. Wc recog nize chat the studies on petroleum waxes are in progress, were started seasonably, and further, that they cannot be completed prior Co March 5, 1960. Thus, wc stay ba in a position to grant an extension in this instance of up to one year, which, incidentally, is the maximum period of time which we can grant under che exist ing lav. We have no statutory cuchorlzacion for granting exten sions beyond Karch 5, 1961. . Before we can take final action in this matter, we will need more precise information as to the identity of the petroleum waxes you would propose be covered by such extension and che food usea to which they will be put. We would also need for the record a summary of ehe work completed indicating that the waxes to be covered by che excensioa ny be safe and a status report on che investigations still in progress, it may be that it would be advisable first to havt these scientific matters discussed at & conference between che sclentlate of the Food and Drug Administration and Chose engaged in the study. Wc would suggest chat this be arranged for early Janu ary, which will permit an additional two month's experience with the studies currently in progress. EB 006942 API 07584 Mr. Frank M. Porter - OcCobr 27, 1959 A* indicated Above, If Che date which you furnish us in Janu ary indicates that continued use of the pecroleua waxes does not present a hazard to che public health, ve will be agreeable Co au extension for whatever additional time is necessary, up Co March 5, 1961. Sincerely yours Ceorge P. Larrick Cooaissloner of Food and Drugs EB 006943 API 07585 )) API MAC QUARANTINE SERVICE APPENDIX M Miss Regina Burns informed us by telephone today that their branch of the Public Health Service is being re* organized as of the first of the year. Dr. Ralph W. McComas will be Chief of the Epidemiology and Domestic Operations Branch. In the meantime, Miss Burns vlU continue to act as liaison with us in the field of quarantine. 0. M. Saunders, M. D. EB 006944 API 07586 appendix R-i INDUSTRIAL HYGIENE BUL LETIN ^ r1 M. I I rn a I * 1958 POOD ADDITIVE AICNDMENF Typical Information Which Kay be Needed for Petitioning PDA Tbe most 1gal flcent feature of the 1956 Pood Additive Amentent to tbe federal Pbod, Drue end Cosmetic Act it that It places tbe responsibility on tbe user sod manufacturer to show affirmatively that tbe product to be used is safe and presents no hazard to its consvmer. Tbe lew requires that tbe user now file a petition for use- of bis food additive under conditions of Intended use. If be can prove it Is safe, tbe PDA will approve Its intended use. "Tbe term 'Pood Additive* means any substance tbe In tended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting this characteristic of any food including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or bolding food." ' To assist those who wish to seek clearance of Company products under tbe Food Additive amendment, tbe following inforaatlon should be included in tbe petition: A. Pood additive identification sad composition B. Pood additive use C. fbysleal end technical effects establishing tbe food additive as affecting tbs food D* Methodology B. 8afety of the food additive EB 006945 ) ' ) R-2 1. mmWATTOIf HBQUIRB) FCB PBTmCWIIIO FDA food ADprnn rparrmcATioii 1. Itaae of Product ) cornea nftSM b) other nsmet, incluAiog trade name c) chealoal name following the nomenclature accepted by Chemical Abstracts 2. Formula ) Bipirlcal formula b). Structural formula . c) Molecular weight 3. Deflnltloa of food additive A. Components f tft. Brief description of manufacturing process . Include equations for chemical reactions Involved EB 006946 API 07588 )) 2. U. Description of product: liquid, solid, crystalline, soorphous, color, odor, taste, stability 5. physical, chealcal and/or biological properties Solubility Cold vater Hot vater Alcohol k acids, etc. Melting point Bolling point Specific gravity Refractive index ' Viscosity Optical rotation Ph Ash HgO content Iodine nuaber .' Saponification matter ' Alkoxyl content ' Volatile natter .Water*Insoluble natter . Other extractablea " . ' - , . .. - " EB 006947 . j j j 1 ; API 07589 ) Biological activity Absorption spectra in ultraviolet and Infrared Fluorescence spectra Readily carbooizable substs. Readily oxidisable eubete. Stability, etc. R-U 3- 6. Purity. Specification prescribing the nlntnua content of desired cooponenta. 7. Inpurities. Specifications Uniting arsenic and lead and also other known undesirable reaction byproducts or Inpurltlea. Details of suitable tests for checking tbe^specifications. (Where such lnforoatlon is not available, a statement aa to why it is not should be submitted) EB 006948 API 07590 8. Identification teat* a-5 u. i, roc AJDirm us* 1. The asouat of the food additive proposed for uee 2. Purpose for vhich it ia proposed R-6 5. a* Directlone, recooueudatloas and suggestions regarding the proposed uee b. Include sanple of propoaed label for tbe food additive 3-. "If the additive results or aay aspect to result from the use of packaging aaterial, the petitioner shall shoe hov this nap occur and vhat residuals aay reasonably be anticipated." a. Determine quantity of each residue on various foods and identify residue. B 006950 API 07592 > s-7 6. (1) Calculated maxima contaminations, include sample calculations (2) 8olvent extraction using 5 solvents at 135F for one week (water, 200 sucrose, 10 citric acid, 30 acetic acid, 30 aodl\a chloride, edible oil or lard) - with solubility curvet If indicated. (3) Quantity and transfer data and description of method used. 4. Suggested tolerance limitation on food C. PHYSICAL AID TBCHglCAL gmCTB E3TABUSH3TIO THE FOOD AEOmVB A3 AFFBCTHIQ THK'TCog ~ 1. la the additive stable or unstable 2. Will it be expected to become a component. If yea, bow sucht What products are fonasdt 3. Will it affect the characteristics of tbs food directly or indirectly! If yea, howl Hots: These data should Include information in sufficient detail to permit evaluation with control data. EB 006951 API 07593 a-5 7. 4. What is the smallest quantity of the additive necessary to produce effect expected! Data from carefully cootrolled experiments shoving the degree of effect accomplished by the additive at several different levels of concentration in food Boat be obtained. The number of levels of concentration will depend upon a nvaber of factors such as the toxi city of the additive, the particular foods involved, the proposed usage level and the Increment of the additive required to induce any notice able change in the food. D. HETBOOOLOQX 1. "A description of practical analytical nathods to determine the amount of food additive in rev, processed and/or finished food or any substance formed in or on such ^ood because"of its use.11 "In order to demonstrate that the analytical method is sufficiently re liable and specific, validation data should be submitted. These data will consist of food 'blanks' (values obtained by the method on food containing no additive and expressed as 'apparent* additive) and recov eries of the additives added to such food at approximately the tolerance level, both In the presence and in the absence of other chemicals ex pected to be in the food, further, the validation data must demonstrate that the method Is applicable to each food in which the additive is to be used. The method should generally be accurate to within at leaat 10f at the tolerance level and be sensitive to about 10 of the tolerance level. The blank on a food containing no additive should be reasonably reproducible and should not emceed 10 of the tolerance." "The teat proposed shall be one that can be used for food-control pur poses end that can be applied with consistent results by any properly quipped end trained laboratory persc.-nsl." EB 006952 API 07594 I 1  a-9 8, iavssnoAnow hade ow tbs safety ow the food APomvEa 1. Recults of tolad tolerances (detailed results sod description of aethods) a) Acute oral LDjq Rats b) Acute darnel Rabbits c) JO or 90 Day Subacute Feeding Rats d) 2-year Feeding Rats e) 2-Year Feeding Dogs 2. Reports of Investigation that would bias a "safe" evaluation of tbs food additive. 3. Check for presence of known carcinogens. If expected. EB 006953 API 07595 f, PRQP06g> TOtaUJICEa KB TP FOOD AEDITIVZPCB 3FBCIFIC USB (A petltlooT --y Include propq--d regulation) r-:o 9.