Document 6B6v42ank3ZN4LG2NnExXY3j9

FILE NAME: Oil Industry and American Petroleum Institute (API) DATE: 1959 Nov 9 DOC#: API043 DOCUMENT DESCRIPTION: Minutes from API Medical Advisory Committee Meeting with Attachments FCR COMMITTEE USE ONLY NOT FOR PUBLICATION AMERICAN PETROLEUM INSTITUTE MEDICAL ADVISORY COMMITTEE 25TH MEETING 9:00 A. M. Monday, November 9 1959 Conrad Hilton Hotel Chicago, Illinois MEMBERS PRESENT: V. C. Baird, M. D., Chairman J. W. Osborn, M. D., Vice Chairman C. R. Miller, M. D., Secretary V. 0. Armstrong, M. D. C. H. Baylor, M. D. R. G. Birrell, M. D. F. F. Boys, M. D. L. E. Curtis, M. D. Kieffer Davis, M. D. R. E. Eckardt, M. D. T. M. Frank, M. D. J. Hs Me De R. Omet 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. Roberte, M. D.) W. W. Stewart, M. D* Lso J e VtadS, Me De TECHNICAL ADVISORS PRESEHT: E. W. Adams W. H. Barcus B. E. Bennison, M. D. C. T. Brown G* H* Collings, Jr*, M# D* E. K. Daniels A. E. Dooley Geo. Entvistle P. D. Halley J. W. Haianond N. V. Hendricks J. H. Johnston P. K. Kuhne C. A. Neilson A. C. Pabst T. B. Rendel L. E. Renes F. J. Sanders (Rep. by W, E. Scovill) J. A. Spence G. M. Wilkening MEMBERS ABSEST: Re Me Adam$ M D Richard Call, M. D. J. W. Crookshank, M. D. K. R. Fourcher, M. D. F. D. Gassavay, M. D. Se Ke Me De E. P. Luongo, M. D. T. H. Mitchell, M. D. R, C. Page, M. D. Re Je PottS) Me De OTHERS PRESENT: L. E. Carvue J. C. Colandra Philip Drinker W. W. Hitchcock Harry Levin D. T. Staples - Carter Oil Company - BioTest labs Harvard University (Consultant) - Sinclair Refining Company - Texaco Incorporated - Tidewater Oil Company (Chairman, Medical and Health Camittee) API 07533 2 I. INTRODUCTION CF NEW MEMBERS AND GUESTS Dr. V. C. Baird introduced new members and guests. II. APPROVAL OF MINUTES The chairman asked if there were any corrections or additions to the minutes of the 27th meeting of the Medical Advisory Committee, held April 27, 1959, in Chicago. ACTION: It was regularly moved, seconded, and unanimously . passed that the minutes be approved as distributed. III. CERTIFICATE OP APPRECIATION Mr. D. T, Staples, chairman of the Medical and Health Committee 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 sad early activities of the Medical Advisory Committee. IV. SUBCCMMITTEE^JR^PCNTS A. Operating Subcommittee Dr. Clark Miller presented the report of the Operating Subcommittee, re viewing the various recommended actions. This report is attached as Appendix A. ACTION: It was regularly moved, seconded, and unanimously passed that the actions of the Operating Subcommittee be approved and their report be accepted. B. Program In the absence of E. K. Linder, M. D., chairman of the Program Sub committee, Leo J. Wade, 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, and unanimously passed that the report of the Program Subcommittee be accepted. C. Atmospheric Pollutants Chairman J. C. Ruddock, M. D. reported on the activities of his sub committee. 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. Co - CI2 Aromatic8 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 - E. Carcinogenicity R. E. Eckardt, M. D., chairman, reported on this committee's activities His report is attached as Appendix D. ACTIOS: It vas regularly moved, seconded, and unanimously passed that the report be accepted. F. Dermatology Leo J. Wade, M. D., chairman, reported on this group's activities. His report is attached as Appendix E. ACTION: It vas regularly moved, seconded, and unanimously passed that the report be accepted. Q. Epidemiology George M. Saunders, M. D., chairman, reported on this nevly formed sub committee. His report is attached as Appendix F. ACTIOS: It vas regularly moved, seconded, and unanimously passed that this report be accepted. H. Inhalation of Oil Hist B. E. Bennison, M. D., 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. D., 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., vho vas appointed chairman of this group to replace C. H. Hine, N. D. vho resigned, reported on the activities of this subcommittee. His report is attached as Appendix I. ACTION: It vas regularly moved, seconded, and unanimously passed that this report be accepted. K. Specialty Petroleum Products 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 i . k - L. Toxicological Reviews S. E. Bennison, M. D. reported for H. W. Gerarde, M. D., chairman of this gubconsulttee. The report of this subconsulttee is attached as Appendix K. ACTION: It was 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-k, Z-37, and Z-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 CP LIAISON MEMBERS A. Dermatology Studies Leo J. Wade, M. D. stated that there was no activity to report. B. Smoke and ?umes J. C. Ruddock, M. D. reported on the activities of the Division of Refining's Smoke and Fumes Committee. His report is attached as Appendix M. C. American Medical Association J. W. Osborn, M. D. reported on the activity of the AMA Committee on Toxicology and the Interdivlslonal Committee on Labeling In the development of pro posed legislation on hazardous substances labeling. His report is attached as Appendix N. D. Interdivisional Committee on labeling C. H. Baylor, M. D. reported for C. H. Hine, M. D. who has resigned. His report Is attached as Appendix 0. B. First Aid Training T. M, Trank, M. D. reported on the activity of the Subcommittee on First Aid of the Central Coslttee on Accident Prevention. F, Wax Committee R. E. Eckardt, M. D. reported on the activity of the Advisory Coemittee to the Wax Research Project. His report is attached as Appendix P. 0. Quarantine Service George M. Saunders, M. D. reported on this activity. Sis report is attached as Appendix Q. API 07536 - 5 - H. Petroleum Food Additives L. E. Curtis, M. D. reported on the activities of this group. Dr. Curt distributed an Industrial Hygiene Bulletin, prepared by his company, a copy of which is attached as Appendix R. VI. BUDGET FOR 1960-61 C9 - C12 Aromatics Kerosine Poisoning Toxicological Reviews Noise Consultant Administrative Expenses 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 proposed budget be presented to the Medical and Health Committee VII. NEW BUSINESS A. Reception for B. B. Reeve. M. D. Dr. Baird called on Paul Halley who invited all members of the Medical Advisory Committee, subcommittee members, technical advisors, and guests to a reception given in the honor of B. B. Reeve, who will 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, which will be held in New York in July i960. C. Air Pollution Prof. Philip Drinker Indicated that any information he obtains on air pollution will be sent to the API staff in New York 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 with the Industrial Medical Association Conference, in Rochester, New York, was discussed. ACTION: It was regularly moved, seconded, and unanimously passed that the next meeting of the Medical Advisory Cosmittee and its subcommittees be April 22nd through 25th, i960 in Rochester, New York IX. CONCLUDING REMARKS BY CHAIRMAN Dr. Baird adjourned the meeting, stating his appreciation of the great value of Mr. E. 0. Mattocks to the Medical Advisory Cosmittee and its activities. Approved: V. C. Baird, M. D., Chairman 12/28/59 J. W. Baamond, Recorder API 07537 APPENDIX A-l MINUTES CF MEETING OPERATING SlfflCOmnfiiE'Qfr THE MEDICAL ADVISORY COMMITTEE 5Too P. W. Sunday, November 8, 1959 Conrad Hilton Hotel Chicago, Illinois THOSE PRESENT; V. C. Baird, M. D., Chairman J. W. Osborn, M. D., Vice Chairman C. R. Miller, M. D., Secretary L. E. Curtis, M. D., Past Chairman 3. E. Bennison, M. D. Kieffer Davis, M. D. R. E. Eckardt, M. D. H. W. Gerarde, M. D. (Rep. by B. E. Bennison, M. D.) J H Hege, M. D. E. K. Linder, M. D. (Rep. by L. J. Vade, M. D.) J. C. Ruddock, M. D. Ralph Schneider, M. D. (Rep. by N. J. Roberts, M. D.) G. M. Saunders, M. D. Jack Spence Leo J. Wade, M. D. VISITORS: j, w. Hammond E. 0. Mattocks I. INTRODUCTORY REMARKS V. C. Baird, M. D., Chairman of the Medical Advisory Committee and the Operating Subcommittee, announced that Ralph Schneider, M. D. bad requested N. J. Roberts, M. D. be his alternate. II. APPROVAL CF MINUTES ACTION: The minutes of the April 25, 1959 meeting of the Operating Subcommittee were approved as distributed. III. REPORT OP SUBCO#gTTEE3 A. Program Leo J. Wada, M. D. reported, in the absence of E. 1C. Linder, M. D., Chair man. He indicated that the Industrial Hygienists have been Invited to conduct the round table session at the next meeting. B. Atmospheric Pollutants J. C. Ruddock, M. D., Chairman, discussed possible financial arrangements to continue the work being done by Dr. Goldblatt in England. There still remains $6,155.85 from the original $20,000 raised by the Division of Refining to support the work on 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 United States and to other places, and other incidental expenses. The coonlttee was of the opinion that if $5,000 vere made available to Dr. Goldblatt for travel expenses, this arrangement would be satisfactory. It was further agreed that no time limit should be placed on the expenditure of $5,000. API 07538 ; A-2 2 - Dr. Ruddock discussed the policy of distributing information to the Medical Advisory Comit tee members and technical advisors. Be questioned whether aDy member of the Medical Advisory Committee should be permitted to submit to the PI staff material for distribution to the Medical Advisory Committee members without having the material first reviewed by the chairman of the appropriate 8Ubcommittee. There was violent objection to this procedure. It was pointed out that if a subcommittee chairman seriously objected to any distributed material, he could write a letter to the members indicating his objection. It was agreed i generally that it was the responsibility of each member of the Medical Advisory Coamittee to bring to the attention of the other members any data or articles in which he thought the members would have an Interest. C, C$ - C1 2 Aromatics Kieffer Davis, M. D. reported that hie subcoomlttee had hoped that this project would be completed by July 1, i960. However, the work on monkeys will require an extension of time. They recoemended that the budget provide $10,000 for the continuation of the work to December 31, i960. Dr. Davis requested that, if possible, more members be assigned to this subcommittee. D. Carcinogenicity R. B. Sckardt, M. D. reported that their aviicommittee bad no budget request. The final report from Kettering Laboratory on their work had Just been received by the subcamittee members. Dr. Sckardt requested that tbs report be distributed to the Medical Advisory Committee members and technical advisors and they he requested to submit any comments they have to Dr. Sckardt prior to the subcommittee meeting with Kettering. The cosnente should be submitted prior to January 1, i960. Dr. Sckardt questioned whether the scope of the Subcosmdttee 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 a new scope. Dr. Sckardt asked to be re lieved as chairman of this subcommittee. It was agreed that at the next sub committee meeting they would consider the following: an enlarged scope, possible need to change the name of the subcommittee, and a suggested reconstituted subcommittee. g. Dermatology Leo J. Wade, M. D., chairman of this aubcoamlttaa, reported on the survey be had conducted on "creeping eruption" in the Louisiana area. Bis group had concluded there is no major problem. lhey need more information before soy reconmendation could be made. API 07539 g. Epidemiology -3 i A-3 No comment a . Inhalation of Oil Mlet No pressing question on policy, g. Medical Policies and Administrative Practices G. M. Saunders, M. D. reported for Ralph Schneider, M. D. This sub committee is planning a study of back injuries. I. Physical Agents J. H. Bege, M. D., Chairman, indicated that his subcoomittee thought that the API should continue its contribution to Dr. Glorlg 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. Bege reported that Title 20 of the Atomic Energy Commission Regula tions was to be discussed at a public hearing. His group recomaended that the API develop a statement, if at all possible, to be read at the hearing. It vas generally agreed that the Medical Advisory Comnittee members should be notified of any 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. W. Osborn, M. D., Chairman, reported on the activities of their three grant-in-aid projects studying the method of treating keros1ne poisoning. Dr. Osborn Indicated the need to Increase their suggested budget from their previous recommendation of $7,500 to $10,000. This vas necessary since the blood analysis previously being run by Horace Gerarde, M. D., Esso Research A Engineering Co., nov will have to be run by the universities. The desirability of discontinuing the work being done by Dr. Hau, University of Texas, vas reviewed carefully. K. Toxicological Reviews B. E. Bennlson, M. D. reported for H. W. Gerarde, M. D. and indicated that they had no problem. L. Industrial Hygiene Jade Spence stated that the liaison members to the ASA Sectional Committees would nov make their report directly to the Industrial Hygiene Sub committee. IV. 196o -61 BUDGET The following was suggested for the new budget: API 07 5-,0 - k - c9 " c12 Aromatics Kerosine Poisoning Toxicological Reviews Noise Consultant Administrative Expenses 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 of $3*1,000 be recommended to the Medical Advisory Committee for transmittal to the Medical and Health Comalttee. V. CERTIFICATE OF APPRECIATION V. C. Baird pointed out the desirability 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 Subcoranlttee 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. VI. 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 Committee. The group, in general, thought this was very good. They did not believe, however, that the activities of this group should be publi cized too extensively. The desirability of transmitting to the Medical Advisory Ccsnlttee and technical advlBors the official transcript of the joint meeting which the Sub committee on Atmospheric Pollutants had with the Public Health Service in Cincinnati, was discussed. 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 treaamitted to the Medical Advisory Committee and its technical advisors and the Smoke and Fumes Coamlttee. VII. SUBCOMMITTEE CHAIRMEN It was generally agreed that the technical advisors as well as members of the Medical Advisory Committee may become chairman of subcommittees. ACTION: It was regularly moved, seconded, and unanimously passed that technical advisors to the Medical Advisory Coamlttee can pro perly become chairman of a subcoamlttee of the Medical Advisory Committee. API 07541 - 5 - A-5 tfTlI. MAC MEMBERSHIP With the recent consolidation of subsidiaries into a parent company, the question of the definition of a member on the Medical Advisory Conmittee was dis cussed. The API Board of Directors, at their April 21, 195k meeting, defined ^embers of the Medical Advisory Committee as follows: "Physicians nominated by petroleum companies, aad appointed annually by the Chairman of the Medical and Health Committee. These physicians may be employed by petroleum companies either full-time, part-time, or as consultants." After reviewing this definition, it was the opinion of the Operating Subcosmittee that the definition was adequate as it was written by the Board of Director* and did not confine membership from one company to a single physician. ACTICW; It was regularly moved, seconded, and unanimously passed that the Operating Subcommittee's interpretation of the Board of Directors' definition of Members to the Medical Advisory Committee provided for any number of physicians from a single company. a. new b u s c b s s A. Air Pollution Committee A letter received from Richard A. Prlndle, M. D., Chief of the Air Pollution Medical Program, Division of Special Health Service of the Department of Health, Education, and Welvare, dated October 28, 1959, to B. 0. Mattocks, indicated that they had formed an Air Pollution Conmittee which is a technical task group on auto exhaust studies. This coonittee was formed by the Public Health Service for the purpose of assisting in tbs coordination of research activities in furthering cooperation between Interested groups involved in the studies of automobile exhaust air pollution. Mr. William Clausen represents the API on this conmittee, having been appointed by Dr. Jerry McAfee, Ghalnaan of the Smoke and Fumes Committee of the Division of Refining. ACTICW: It was regularly moved, seconded, end unanimously passed that the Medical Advisory Committee should inform Mr. William Clausen that this group stands ready to offer to him any service possible in the performance of his duty as a member of the Air Pollution CoHdttee. B. Visitors Dr. Baird indicated that ha had asked Dr. Franklin louder and Ifr. B. Dixon Holland of the American Medical Association to attend the Medical Advisory Conmittee meeting. Also, Dr. Colandra, who did consulting service for Sinclair, hid been invited to attend the MAC meeting. ACTICW: It was regularly moved, seconded, end unanimously passed that the action of the chairman in inviting the three doctors to attend the MAC meeting be approved. c. Division of Refining's Smoke and Fanes Ccemittee API 07542 Dr. Ruddock stated that he had been invited to appear before the Division of Refining's Smoke and Fumes Coonittee and give a report of hie Sub committee's activities. Dr. Ruddock asked if there were any objections to hie Appearing before this committee. -6 - A-o 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 Fumes Committee. D, Dr. Malcolm Hargraves Possible ways of presenting information on the petroleum industry to Dr. 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' published statements on the petroleum industry and transmit them to Dr. Roberts for bis 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. NEW MAC OFFICERS It was generally agreed that J. W. Osborn, M. D. should be recommended 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 new 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 API 07543 AFFiSDIX 3-1 I RSPCRT OF SUBCOMMITTEE CN ATMOSPHERIC POLLUTANTS John C. Ruddock, M. D., Chairman MINUTES SUBCOMMITTEE ON ATMOSPHERIC POLLUTANTS 9:00 A. M. Friday, November 6, 1959 Conrad Hilton Hotel Chicago, Illinois The meeting was called to order by the chairman at 9*`0O A. M. There were 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, were approved as presented. DISPOSITION OF OOLTBIATT REPORT A discussion, which considered publishing the report in book form for general distribution,was carried on by the subcommittee, as well as the possibility of publishing this report by USPHS; finally it was unanimously approved that the matter be tabled until after the entire report had 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 MC-4 by Dr. Goldblatt was passed by this sub committee on two previous occasions. Since the meeting of September 22, 1959; Dr. Goldblatt has been offered $5,000 which he refused as a fee, but accepted if this amount was offered for an expense account. It was suggested by Mr. Mattocks that the unused portion ($6,100) of the original grant be used to continue the study. This was moved, seconded, and approved. The chairman also read a letter from Dr. Prindie, of the USPHS, in which Dr. PrIndie 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 was felt that application forms should be forwarded to Dr. Goldblatt for submittal and that his work be continued as presently stated. There are three more portions of this report yet to be received. The matter of'distribution of reprints and public articles through the various committees was discussed and referred to the Operating Subcommittee. DISCUSSION OF C C m i C A T I O n S WITHIN INDUSTRY. COMPANIES. AND 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 from its main members by letter ballot. When such is not obtained, then a public release is not made. * CALIFORNIA AIR QUALITY AND AUTO EXHAUST B4ISSI0H STANDARDS Tentative standards, which will be adopted into law in February i960 in California, on air quality were presented and have been circulated to all members of the MAC. Tentative auto exhaust standards were presented as follows: Hydrocarbon reduction from 1600 ppm to 275 Pin Carbon monoxide reduction from 3*8 wt. to 1.5 wt. API 07544 I tnCTT MEETJUS WITH THE USPHS (BOTH MEDICAL AND TECHNICAL), AUTOMOBILE MANUFACTURERS rgflOCimOH (with RmBahHTATltVES FROM GENTOAL MOTORS, FORD. AMD CHRYSLER^, RAIL- fnSD AS5CCIATIOH. MEMBERS OF SUBCOMMITTEE. AM) OTHERS ~ 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 work together toward a common goal. Such a meeting, the first of its hind, should pe 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 AMA, Public Health, Railroad Association, and others. {Meeting adjourned at 11:15 A. M. John C. Ruddock, M. D. Chairman Subcommittee on Atmospheric Pollutants API 07545 0 APPENDIX C-l REPORT OF SUBCOMMITTEE ON C9 - C12 AROMATICS Kieffer Davis, M. D., Chairman " The Subcommittee on Cg - Cip Aromatics met at 2:00 P. M. November 6, 1959 3t the Conrad Hilton Hotel. Members 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: I. Work completed: (1) Rat inhalation studies at 3*2 mg/liter for the four chemicals, N-Decane, Cg - C10 aromatics, C]j_ - C]_2 aromatics, and benzene. (2) Rat inhalation studies at 200 ppm for the three chemicals, C9 - C^q , C10 - C]j_j and benzene. (3; Rat inhalation studies at 50 ppm for the two chemicals, Cg - C^q and benzene. (10 Determination of LC50 values on rats for the three chemicals, Cg - C^q , CU " c12> od benzene for one 7 hour exposure. (5) Cellular study of the bone marrow of rats exposed by inhalation to N-Decane, Cg - C^q , C u - C]_2, and benzene. II. Significant Findings Not Previously Reported Are: (l) There sure significant hematological findings in rats exposed 18 hours a day to the inhalation of 3*2 mg per liter of Cg - Cio> C11 " Cl2> 404 benzene, but not in rats exposed for the same period of time and concentra tions of N-Decane vapors. (2.) LC50 for rats show the increasing order of toxicity as follows: (1) benzene, (2) Cg - C^o, and (3) C u - C^. (3) A large number of rats develop cataracts after being exposed to high con centrations of C9 - C10 vapors, and a lesser concentration of benzene. (!<) Preliminary work on monkeys indicates exposure to 200 ppm of Cg - C^q vapors causes significant effects. III. Recommendations For Continuation Of Work: (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 is anticipated by the subcommittee that this experimental project will be ended on or about the first of the year 1961. Accordingly, it is recommended that additional funds in the amount of $10,000 be appropriated for the continuance of the program to its completion. Kieffer Davis, M. D., Chairman Subcommittee on C9 - C]_2 Aromatics API 07547 5 REPSRT OF SUBCOMMITTEE ON CARCINOGENICITY R. E. Eckardt, M. D., Chairman APPENTIX D-l 1 . The final report of the Kettering Laboratory was not received in sufficient time by the subcommittee to be reviewed prior to its meeting on November 7, 1959* It is the plan of the subcommittee, therefore, to review this report with the Kettering Laboratory and submit it, or a finalized version, to the Medical Advisory Committee at its April, i960 meeting. 2. 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 with the Kettering Laboratory, probably sometime in late January or early February. R. E. Eckardt, M. D., Chairman Subconsnittee on Carcinogenicity i APEENDIX E-l REPORT OF SUBCOMMITTEE ON DERMATOLOGY Leo J. Wade, M. D., Chairman MEMBERS PRESENT: Leo J. Wade, M. D., Chairman Curtie Baylor, M. D. Allan Dooley James Osborn, M. D. GUEST: L. E. Curtis, M. D. On February 9th, Chairman Baird requested this subcommittee to investigate a report submitted by an unidentified Louisiana physician that "creeping eruption" is an increasingly important occupational health hazard for petroleum production workers along the Gulf Coast. The letter implied the need for financial aid to investigate the alleged problem. The Dermatology Subcommittee circularized 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 - No producing operations in area 1^ - Producing operations in area 11 - No 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. No replies have been received to two subsequent letters to Dr. Crookshank. Dr. Osborn of Standard Oil ((Mo) 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 Humble reported two cases but none within the past year. These were seen by Dr. Rodney Jung, Associate Professor of Tropical Medicine, Tulane University. His associate, Dr. James Burts, is preparing a manuscript for pre sentation at the next Southern Medical Association meeting. He has promised to send a copy of the manuscript as soon as it is completed. Your subcommittee reports, therefore, that its investigation is incomplete but will continue. Findings to date suggest a relatively minor problem affecting only a few memberr of the API. We have no immediate recommendations. The subconed.ttee Btands ready to accept other assignments as desirable. Leo J. Wade, M. D., Chairman Subcommittee on Dermatology API 07549 * $ Appendix ?-i REPORT OF SUBCOMMITTEE ON EPIDEMIOLOGY oeo. M. Saunders, M. >., Chairman I 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 1959, the MAC authorized the creation of such a Subcommittee and by letter of 15 June 1959, the Chairman of the MAC to the present Chairman of the Subcommittee on Epidemiology requested that he propose names for membership on the Subcommittee. This was done and a Subcommittee of four members, including the Chairman, was formed. The members have been in frequent communica tion 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. II METHOD OP OPERATION 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 0 F-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). In order to collect meaningful data, it would be necessary to have a standard system of reporting from a number of refinery medical units volunteering to participate in the study. The criteria for diagnosis must be standardized and the population at risk must also be 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 terms 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. HI SUGGESTED AREAS FOR FUTURE STUDY Among the many conditions which were considered as possibly provid ing valuable information, the following may be listedi A. Mortality Rates Age specific rates by cause. Age specific crude mortality rates. B. 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 Findings in Refinery Maintenance Workers By age, length of service, etc., to compare with group of office workers. There has been some suggestion that there is an Increased risk of pneumoconiosis among refinery maintenance workers. E. Hematologioal Studies on Refinery Workers Exposed to Aromatics with Studies on a Control Group F. The Incidence of Lung Cancer Among Selected Groups G. Results of Proctoscopic Examinations H. Absenteeism I. Radiation Exposure Related to Evidence of Physiologic Effects API 07551 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. V PROPOSAL FOR SPECIFIC STUDIES As preliminary pilot studies to explore the practicality of conduct ing meaningful epidemiological investigations through the MAC, two studies are proposed: A. The Frequency of Myocardial Infarction B. The Health Status of Truck Drivers The methods and procedures will be defined in a protocol if collabora tion 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. Bennison, M.D. N. V. Hendricks API 07552 Appendix G-l REPORT OF SUBCOMMITTEE ON INHALATION OF OIL MISTS B. E. Bennlson, 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 . Subcommittee. Additional suggestions for membership will be welcome. 2. The published literature and certain documented company 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 recom mended that this report be accepted as a preliminary report. Respectfully submitted# /s/ B. E. BENNISON /s/ B. E. BENNISON, M. D., Chairman API 07553 % APPENDIX H-l report cf subcommittee cn medical policies and administrative practices Ralph Schneider, M. D., Chairman 1 . After further discussion and deliberation at a meeting of the subcommittee on November 7, 1959, it was decided that the "Guiding Principles" is not yet ready for submission to the Medical Advisory Committee. 2. It is recommended to the Medical Advisory Committee that if further investigation on the value of low 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 API 07554 Appendix!-1 REPORT OF SUBCOMMITTEE ON PHYSICAL AGENTS J. H. Hege, M. D., Interim Chairman The subcommittee convened on one occasion since the 1956 fjovember 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. Olorig in which be described his research activities to include: 1. Effects of intermittent 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. Olorig 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. Olorig's research projects for the year 1960-517 This, however, is not to be construed to indicate a loss of interest in Dr. Olorig's work. The subcommittee is of the opinion that Dr. Olorig'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. Olorig's 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. Olorig's work, permission be secured to transfer an appropriate sum to be awarded as a grant to Dr. Olorig. 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. Olorig by providing him with material from plant noise surveys, hearing conservation programs, etc. API 07555 - 2- 1-2 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 representa tive 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. Olorig. The Subcommittee voted to grant this $2,500 to Dr. Glorig for continuation of his research on noise. /s/ J. H. Hege, M. D. API 07556 > APPENDIX J-l REPORT OF SUBCOMMITTEE ON SPECIALTY PETROLEUM PRODUCTS J. W. Osborn, M. D., Chairman ^nafRERE PRESENT: J. W, Osborn, M. D., Chairman C. H. Baylor, M. D. J. W. Hammond N. J. Roberts, M. D., representing R. F. Schneider, M. D. GUESTS: E. W. Adams R. G. Birrell, M. D. G. Hi Collings, M. D. A. E. Dooley Geo. Entwistle N. V. Hendricks C. A. Nau, M. D. Leo Wade, M. D. Minutes of the special meeting, held October 2, 1959 at Linden and New Brunswick, H. J., were thoroughly reviewed resulting in the following comments and recommendations. . A. CLINICAL RESEARCH AND BLOOD HYDROCARBON ANALYSES I , Dr. Gerarde has developed a new method for determining the aromatic fraction of hydrocarbons in blood, entitled "A Photoelectric Colorimetric Method for the Deter mination of Keroslne in Blood." This method is to replace, at once, the original Ultra-Violet Spectrophotometric Analysis Method. 2. Esso Research Center can no longer pefform these analyses for either our research program or the Cooperative Clinical Project under Dr. Edward Press. Drs. Eaeschner and McKay will probably prefer to do these analyses in their own labora tories but this will require special training of at least one person in each laboratory. It is possible that a method may be worked out whereby these analyses can be done in some other central laboratory thus reducing costs. Dr. Carl Nau has offered his laboratory as a possible place. The mechanism of this will be worked out in the near future, however, additional funds will be necessary from API sources to pay for these analyses. - 3. The subcommittee, therefore, asks the MAC to approve $10,000 for our overall keroslne research program for the fiscal year 1960-0I. 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 be any balance available within this $10,000. This money is requested as a grant-in-aid. (The Operating Subcommittee on 11/8/59 approved an additional $2,500 to support Dr. Nau's Industry research proposal, the work to be done in the summer of i960.) h SUMMARY OF LITERATURE ON KEROSINB POISONING Dr. Daeschner's summary and annotated bibliography of the available literature on Petroleum distillate poisonings is about 90-95$ conqplete, with summaries on 35 articles. Some 8 or 10 other articles, including Dr. Gerarde's "V. Keroslne," Just published in September 1959 will be reviewed in the near future. Dr. Carl Nau, vtase library is larger, will assist Dr. Daeschner in obtaining the other 8 or 10 API 07557 % *> -2 - J-2 articles. The subcommittee expects that this annotated bibliography will be avail- ' able before next spring's meeting, at which time we expect to make specific re- | commendations on how it should be distributed. C. LABORATORY RESEARCH ON KEROSINE Dr. Nau discussed with the subcommittee a report of the work which he and bis 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 Kerosine." He also discussed with us a pro posal for further continuation of his experimental work for next summer. His re port and proposal will be attached as part of these minutes. It was the consensus of the subcommittee that due to the financial situation of the API budget, that we should not specifically reeonmend to the MAC, at this time, positive support for Dr. Nau's proposal. It was felt that If the $10,000 asked for, to make sure that the clinical program did not bog down, tuned out to be sufficient to leave a balance for the next fiscal year, that ve may wish to use this balance for further support of Dr. Nau's 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 subcosnittee should know whether or not there will be any funds available within the $10,000 for the fiscal year 1960-61. (The Operating Subcosnittee on 11/8/59 approved an additional $2,500 to support Dr. Nau's industry research proposal, the work to be done in the simmer of i960.) p, AMERICAS ASSOCIATION OF POISCK CONTROL CEHTBR3 At the personal request of the subcommittee chairman, Dr. B. B. Reeve attended the second annual meeting of this association, at the Palmer 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, the subcosnittee 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 with the chairman of the MAC, If approved. B. COOPERATIVE CLINICAL PROJECT WITH EVALUATION OP KBB06IHB AHD RELATED PETROLEUM DISTILLATE IMOBSTICH The subcosnittee chairman implied on August ikth to Dr. Edward Press, at the American Public Health Association, regarding our decision of last spring not to seek further informal liaison with this project. Our contacts with Dr. Daeschner and Dr. McKay, id are also members of this project, are considered adequate. The subcommittee chairman will keep in touch with Dr. Press regarding further developments in this project which is certainly not yet ready for publication. Subcosnittee Members -- ------ --------- Approving Disapproving C. H. Baylor J. W. Hanmond J. Roberts for R. F. Schneider J. W. Osborn, M. D., Chairman Subcoomittee on Specialty Petroleum Products-.... API 07558 J-3 THE UNIVERSITY OF TEXAS-MEDICAL BRANCH School of Medlcine je School of Nursing Technical Curricula ff Po6t-Graduate Program Galveston The John Sealy Hospital The Children's Hospital The Psychopathie Hspital The Rosa and Henry Ziegler Hospital October 6, 1959 James W. 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 experimented 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 kerosene administered be done and that efforts be made to correlate such data with gross and microscopic pathological findings. This suggestion is based upon our findings that there is conclusive evidence that damage occurs in the lung, liver, kidney and the heart if and when kerosene is detected in the blood. 2. We will do further studies on radiography in relation to the amount of kerosene that will be administered into the stomach. 3. Further work in autoradiography is contemplated. This would include liquid scintillation counts on the plasma and extraction and deposit on chromatographic paper of the kerosene with sub sequent analyses of the amount extracted from the various organs and tissues. it. Efforts will be made to eliminate rapid transfer of kerosene from the gastro-intestinal tract to the blood through various means. For this proposal, it is intended to use medical students who have both ability and interest. This would not only accomplish something worthwhile with reference to our study of kerosene but would also be API 07559 COPY J-4 James W. Osborn, M.D. October 8, 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. I find that the radiographic work 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 API 07560 J-5 THE UNIVERSITY Of 'IEXAS -- MEDICAL BRANCH oALVESTON |gc^OOir.f MBUOM ,*** * K-.ViUW THi jo h s iiA i r H Q irn it THI rH Jii-l-IN I HO0TTAL CIUJCLU now September 14, 1959 rmra/ >gum rw> rr> hihi hotsthk momital \m v mowttax cU*nrilvAer-sity of TSra.u, tMM. eDd.ical Branch . 0*lvatof T au t jjitr Dr* Hia: ^duicrrinagaotkctaiopnaastofyaoarrg,aaMa rf.roJm, DraatLaaogniveannd0.Jo5accqca. i.oruf kMeraorarioawa hlaabveallmadadweitnhum10amroei.u ofoflrloawdiinogacotrivgeanhaydarnodg/eonr (gHpja)c.es:Autoradiograph have demonstrated keroaina in tha 21)) gptloamsmacab 4))) LLuivnegre i) Kidney ^ 6) 7) HBleaadrdt emr u a c l a (Only kldnay, plasma, and stomach really convincing.) [yea now, many anticipated difficulties have not baan surmounted. These include: l) Mlcroaaction preparation, including cutting, mounting, and staining. I) Exposure and development of special film and emulsion. RECOMMENDATIONS: 1) Thsaetctqiounaslitaantidvethaeumtoertahdoiodgsroafphpyrobceescsoinntgin. ued, sharply limiting the number of 2) Thbast eqmuapnlotyiteadtivoen oprlgaasnmaa;aahloywsieevebre, incostliotrutiendt.erfLeriqeunicdeswcionutlidllaptrioobnabcolyunintitnrgodcuocueld tgoroapmhupcahpverarwiaobuillditypefromr iotragnanalyasniaslyoanieth. s Eeqxutripacmtieonnt ainndthdeepRoasdiitoolor.gy-.IhsrootmopaetotLioanboprhaytosricys., eTshpiescwiaillllyrewqituhirleowcoenneeirdgeyralbelveeplsr.ecieion and knowledge of radia CHA'cks tc D<". R. N. Cooley 0 . L . . B . Beeatjes Departm ent at RadtOiogy API 07561 J-6 A STUUY OF THE INGESTION OF KEROSENE Joe da Laon Joaquin Marron Carl A. Nau, M D. Department of Preventive Medirina and Public Health Umveraity of Texaa Medical Branch Gal ve aton, Texaa For a long period of tim e there hae been a controveray aa to whether the pneumonitia aaaocleted with or anaing out of the ingeation of keroaene ia due to the aepiration of the keroeene or whether it ia due to the hematogenoua tranamlaalon of the ingeated keroaene to tne lunga (and to other organa and tlaauea). The anawer to thia queation will help determine whether a per eon who haa awailowed keroaene ahould be lavagcd. The Academy of Pediatrica, the American Public Health Aeaociation and the American Medical Aaaoctation preaently are conducting a clinical atudy in an effort to anawer the queation of how to treat a patient who haa ingeated keroaene. It ie our purpoae, by uaing rabbita, m ice and rata, to determ ine if keroaene ia abaorbed from the gnatro-inteatinal tract and ii keroaene can be detected in the blood and varioua organa - auch ae lung, liver and kidney - after ingeation. It ia alao our purpoae to determ ine if change a from the norm al occur in iheae organa and tieeuea where keroeene may be detected. API 07562 h U f r M aad M.tJuj, J-7 2 For oar atady a *4 karaaaaa furaiahad ky tka Hamkla OU ad Rafiaiag Campaay u i kavlag tka iaUaviag spacLAeadsaat lui Gravity. API rUak Patmt, *7, Mia. laykalt Calar. Ilia. Carraaiaa S kra. at 122* 7. Max. aa AITI! acal* Doctor Teat luroag Taat, koara. Mia. DiatUladaa* *7. BP. Ma. 10% Raeavarad 99% Raaavarad, la. Bai. Potai, Max. aliar, art. %, Max. Limita 41-44 120 29 1 vast 24 IM 141-429 441 IM 0. Il Tost Matkad AJTM D 297 AJTM D 94 AlT M D 194 AfTM D 110 7SM 9203 AJTM D 147 AJTM D90 KahMt, rato aad l u war* u* u last Miaula. Ki t m m vai gWam ta nkklta iatravaaoaaly u i by tausch taka la doaaga y ta Mee par Kg. tta rata toyatamaak taka ia aaagaa varylag iram 9 to 2k ce par Kg. ;aad ta alca ia aaagaa ai t.S cc aaak via atamack take. Tka klsad waa drawa aitar S miaataa (ar laagtr) aad aa laag aa 24 koara altar tka admiaistratiaa i tka karaaaaa. W k M tka aaimaia ara aurificad or ieaatfdati, a aam#1ata patkalsgical arala*tira (graaa lai mieroseapte) aa -- ada. Stacs karaaaaa ia aaiacikla ia lao-aataaa, tkla autarial (spactrsgrada aa faraiskad ky tka milita Patrolaaaa Campa* y) as aad aa tka astraet&ag vakicia. It raaaavaa karaaaaa iroaa klood *ff*ctivly. API 07563 t J- 3 A caacaatratloa earva nud far kotk # tka karoaana p w ki aimea lt vaa faaatt tkat kareaaaa mixatt vitti ia*oetaaa prottueaa a skarp paak at v tv t laagtk 221 ullliaiicro a, aatt a alifllt paak at v ara laagtk 273 nlllim lcroa vkaa raatt oa a Backmaa Mattai DU Spactropkotaaaatar. Tka aatractatt aampla vaa raatt fram arava laagtk 294 aitlllaiicroa tkrougk arava laagtk 490 nailllm lcraa aalag tka altraviolat ligkt. Balk poaitira aa wall aa aagatlaa "ceatrol kleotta" vara raatt. (Saa flgara kalow). Aa agaal volwaaa al klaad aatt iao-octaaa v ara aaatt far 4 aalaaiaa al axtractioa. API 07564 ) J-9 4 L&rf dosages of kerosene ware employed la rabbit and rata; comparable doaea ia man would bar been beyond what one might ex pect a peraon to coaaume. Therefore, It waa decided to have karoaeae labelled with radio-active tritium by the New In gland Nuclear Corpora tion and to uae autoradiography to demonatrate gaetrolnteatinal ab sorption and cellular dapoeitlon of thie radioactive material given in minute doaea to mice. Autoradiographic permeable baae tripping film (emulaion No. JI-1906) and permeable baae emulaion (NTB^) were furniahed by the Kastman Kodak Company for our uae. Thirty mice, atarved for 1Z hour a. were aneathetiaed using odium araytal intraperitoneally An incision waa made below the left coatal arch from the xiphoid process to the poaterior axillary fold. The expoaed muscle was cut carefully with sharp aciaaora 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 kerosene could be regurgitated and aspirated into the lunge. Using a fine hypodermic needle, 11 (eleven) millicure of radioactive kerosene (0. J cc kerosene) was injected into the stomach. Following thia ingeation the stomach waa placed bacx into normal position and the muscle and skin were sutured. Six hours later the mice were anesthetized, killed and the anterior part of the thoracic wall waa rvmoved and each mouse waa immersed m isopentane cooled down to 1b0 F ov mear.a of liquid nitrogen. Freeaing waa instantaneous API 07565 ) r-io 5 The mic* war removed from the leopeubuie mad placed 1 dry Ice. Later the desired orgeat were chipped oat with a pick aad hammer and stored at t C. aatil needed. Later, wader very low temperature, 4 micro sections were cat using a sliding microtome. These sections were lifted with a camels hair brush into a beaker filled with cold methyl alcohol and stored at C. for one day. The following day the methyl alcohol suspended sections were allowed to stand in the methyl alcohol at room temperature for one-ball hour end then floated onto egg albumin * glycerol smeared elides, allowed to dry in a 17* C. oven overnight. Blood smears were treated in a similar manner. The elides were then dipped in 1% celloldie solution in 100% ethyl alcohol to eliminate artifacts and then into subbing fluid (5% solution of gelatin and 0.05% chrome alum) to effect good emulsion binding. The elides were then covered with the emulsion from the stripping film and stored in lig^bk proof bokelite bones for sufficient length of time to expose the film adequately to any radioactive material. Tallowtug such exposure the elides wore developed end examined. The mixture of kerosene and lso~octane "peaked" at wave length 221 millimicron With a Slight peek at 273 m illim ic ro n K exam ined w ith the Beckman DU Spectrophotometer. The curve obtained from API 07566 l ) J-ll b mtAii g rat biooo w.`h iso-octane 'peaked" at wave length 209 m illi micron and .'-adily dined to wave length 400 millimicron. The curve altar 1 rc of kerosenawee given 18 rate via atomach tuhe. the ra: killed and blood drawn from the inferior vena cava, the blood extracted with iso-octane and thl* examined wi.h the DU Spa<tro photometer - peaked" at 21 and 273 millimicron. The greatest amount of kerosene found In the blood after 1 cc v n given via etomach waa detected l to 4 hour* after the adminletration of the keroeene. Calculation wee made aging the formula of H. W, Gerarde. P P M Cl hrm:i>aampv^lyew'waerigohmat t(i3cp magt. eorif abllomold XX vvonlulmu mea) of a a m p l a X 1Q6 The largest amount of kerosene detected in the blood of our rate four hours after piar ing the kerosene into the etomach was 142 ppm. Twenty-four hours later, no kerosene was detected in the rats' blood When rabbits were used, keroeene wee detected in the urine 24 hours after administration of tbs keroeene via stomach tube. X-rays of the cheet of rebbits given keroeene revealed increased densities In those animals m which keroeene was detected in the blood. Groee and microscopic examination of the tiesuea revealed areas of i onsolldatlon in the lung, degenerative changes in the liver, tubular cells of the kidney and heart T'.ete manges were always found when keroeeae was date , ted in the blood and ware not ((served in our roatrol animals. API 07567 > A J-12 ' Examination of tit radio-autog raphic elides reveals the presence of the '`tm e d '' kerosene in the following organs and tissues: 1. Stomach z3.. PLluansgme a 4. Liver 65.. KUridinnaeyry bladder 7. Heart muscle The spectrophotometric evaluation of the kerosene in the blood of a rat given k. rosene via stomach is hereto attached. See page 3. Conclusions 1. Kerosene can be disseminated rapidly by hematogenous routes from the stomach to many organs and tissues and can be detected in the blood by spectrophotometric methods. Positive chest x-ray findings are found \n those rabbits in which karosane ia found in the blood. i Significant pathological changes are observed in the lunge, liver, kidney and heart of animals in which kerosene is placed into the stomach and left there. 3. Radioactivity in kerosene administered to mice via stomach tube in minute dotages can subsequently be detected in the blood and various organs by autoradiography. API 07568 ) J-13 I Acknowledgements This study * 1 1 financed in pert by the American Petroleum Institutes Medical Advisory Committee through its sob-committee oo Specialty Petroleum Products. J. W. Oabora, M. D .. Chairman. The assistance and advice of Colvin H. Agnew, M. D. and L. B. Beentjes. Ph. D .. of the Department of Radiology is acknowledged with gratitude. API 07569 t STANDARD OIL COMPANY (INDIANA) 910 South Michigan Avenue Chicago So, Illinois October 20, 1959 J-14 j, W. OSBORN, M.D. Standard Oil Company (Ohio) ^dland Building Cleveland 15, Ohio ear Dr Osborn: At your request, I attended the Second Annual meeting of the American Association 9f Poison Control Centers at the Palmer House in Chicago, on October 6, 1959 Following la a brief auanary of what took place. I am also enclosing material tnat was distributed. Ute meeting was 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, i quorum was not present until late in the meeting. By-lav changes have taken care of thla matter. Tba duea have been $2.00 per member but due to a change in the by-laws, voted at this meeting, the dues will be $5*00. Many of the members present were pediatricians and pharmacologists. By-lav changes were made with which they expect to broaden their membership to other organisations. In the committee reports, there was a request for educational material for dis tribution-- pamphlets, etc. on poisonous drugs-- which could be handled through Baalth Department contacts. It was recommended that an Bducatloc Committee be formed and 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 miles. Some centers are for information only, while others are for both information and treatment. It was emphasised that adequate training should be given to persons giving out information and recognise the advis ability of getting legal series on matters that may arise as the result of giving out information. Tbs Research Committee has no funds to date. A film lending library and a national clearing house for poison control centers is under the Bureau of State Services, Public Health Service, Department of Public balth, Education and Welfare, Washington 25, D.C. They are now getting Information from the control centers. Sixty centers report every case treated. At the present line, they have 15,000 poison cases reported on the epidemiological survey and of tbls 15,000 cases, there are 631 cases of kerosene poisoning. A control of alter nating lavage and not-lavags treatment was made on 198 cases. It was reported that *54 of those receiving lavage had complications and 634 of those not lavaged had 'Plications. It was the concensus of opinion at this meeting that lavage was Indicated. Dr. R. K. Richards of Northwestern recommended lavage. API 07570 J-15 -2,, Leslie Corsa stated that it was doubtful that centers were saving many lives they were pensitting an excellent epidemiological survey of poisons and it was ^jo educating both the public and the doctors in regard to poison control. ,feel that it might be worthwhile for the A.P.I. to become a member of this organlLtion in order that they may be in touch with what is taking place and they should able to add something, pertaining to petroleum products, to the control center. Yours truly, /s/ B.B. Reeve, M.D. Medical Director BiR:rl &cl. API 07571  t APPENDIX K-l REPORT OF SUBCOMMITTEE ON TOXICOLOGICAL REVIEWS H. W. Gerarde, M. D., Chairman- 1. The second editions of the Toxicological Reviews on Butadiene, Naphthenic Acids, Copper Naphthenate, and Naphthalene have been published. 2. Final drafts have been prepared on Benzene, Toluene, and Xylene. Publication is expected in early I960 3. A large nuaiber of first drafts of Toxicological Reviews have been received from Dr. Phillip Drinker. k. It is anticipated that $5,000 will be needed for re vision of the Toxicological Reviews during the coming year. 5. The first drafts of the Toxicological Reviews will be circulated in groups of four to the members of the Medical Advisory Comnittoe- for eonmenta and suggestions. Respectfully submitted, H. W. Gerarde, M. D., Chairman Subcommittee on Toxicological Reviews API 07572 $ f APPENDIX L-l REPORT OF SUBCOMMITTEE ON INDUSTRIAL HYGIENE ~ J. A. Spence, Chairman This subcommittee met 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 Dusts and Gases, Z-k 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 will be presented at the April i960 meeting of the .62 Committee. Work on the petroleum catalyst project has been completed. The sub committee submits to the Medical Advisory Committee the report "Some Catalysts Used in Petroleum Refining" with the recommendation it be used for distribution vithin API only. The subcommittee has begun the preparation of Industrial hygiene mation on various petroleum refining processes. Initial attention will be to the following processes: l) reforming, 2) cracking, 3) alkylation, and isomerization. Members have accepted the following assignments. Alkylation - Mr. Spence Cracking - Messrs. Daniels, Pabst, and Wllkening . Isomerization Messrs. Dooley and Renes Reforming - Messrs. Halley and Hendricks Mr. Wllkening will be project leader. infor given k) Deadline for completion of the first draft is March 1, i960. Following completion of this first phase, attention will be given to l) polymerization, 2) solvent refining, 3) treating, and if) selected refining processes. Present work by the Cg - C-[p 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 hygiene problems will be available to supplement the final findings of the Cg - C1 2 subcommittee. J. A. Spence, Chairman Subcommittee on Industrial Hygiene API 07573 I ( APPENDIX M-l SUBCOMMITTEE CN ATMOSPHERIC POLLUTANTS LIAISON REPORT 1)0 SMOKE AND FUMES C&jMITTEE The Subcommittee of the Medical Advisory Committee of API which concerns itself with atmospheric pollutants brings greeting to you gentlemen here through me g its liaison. You gentlemen are well aware that the Petroleum Industry has been accused of being responsible for certain pollutants found in the air and that these pollu tants have been alleged to arise from the manufacture, refining, production, storage, transportation, sale cued use of petroleum and petroleum products. When you have dis cussed and analyzed these air pollutants, you find they a considerable list which includes - SOg and its variants, O3, CO and oxidents such as hydrocarbons, HO2 with its olefins, etc. Because the public, or people, have at times complained of eye irritation, decreased visibility, coughing, etc., all of the pollutants I have mentioned have been accused of injuring our health. It was presumed and supposed that air pollu tion was a menace to public health and that anyone coming in contact with polluted sir, as we have it in our urban areas, would become a cancer victim, might die of tuberculosis, would acquire a continuous bronchitis, would lose their eyesight or finally might suffocate to death. Our newspaper and feature writers and the people themselves blamed our industry for causing this terrific nuisance, this nuisance that might hill, this nuisance that has been caused by a large, prosperous industry, worldwide in its operations, and which is accepted in the lives of each one of us for our comfort and existence. We, as people, are very anxious to abate air pollution and parti cularly if we find we are responsible for it. As we learn the answers we have attempted to meet the problems. If there are still problems, we may still find answers as we are still working at it. In the past years, the petroleum industry has spent many millions of dollars and, to quote Mr. McAfee, during years 1956, 1957 and 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 has been a redesigning of storage tanks 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 we hope will solve, eventually, the problem of air pollution. Much of this technical money Is 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 Donors, Meuse Valley and London incidents are examples of medical hazards. Communication has been bad, especially through newspapers and other articles published by individuals in scientific magazines. These articles con cerning "smog" often stress unproved facts and many of them are deleterious to the Petroleum Industry. Politicians have become very 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 laws 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", affects the health of API 07574 m.  f -2 - M-2 the individual, both physically and mentally, we have found no case, nor have we 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 effect. This is complicated by age and state of health of the individual and indirectly by his activity or inactivity. Hence, in establishing standards we must establish standards at an extremely low level so that the pollutants 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 ve think it might barm him. To date in our urban communities, 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. Pour 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 number of people are affected it is a public nuisance, other wise with one person it becomes a private nuisance. When we have an obnoxious odor it is an aesthetic nuisance and may cause damage by reducing the price of real estate, but it certainly is not a medical hazard because it has not made anyone sick. It could be a medical nuisance because it makes you sneeze or it might annoy you because your eyes 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 Conmittee will differentiate, in its research and in its reporting and evaluation of constituents of air pollution, between medical hazard and nuisance and not presume that all are medical hazards. As true Americans we do not like to have our rights infringed upon, whether it is the inability to see as far as we 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 talk I recently gave to a combined two-day meeting of my Subcomnittee and members of the Automobile Manufacturers Association, the American Association of Railroads API 07575 i - 3 - M-3 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 5Ubcommittee on Atmospheric Pollutants, hosted this meeting vhich was the first of its hind to be held. Representatives of your Committee who were present and who participated in the program were Mr. W. T. Gunn and Mr. Jerry McAfee. In addition -to this, the Medical Advisory Committee has received to date two parts of Dr. M. W. Goldblatt's fined report. His contract with the API con cerning Project MC-k terminated on July 1, 1959 and he informs us we can expect three more portions of this report before it is concluded. The Medical Advisory Committee is requesting that this report be printed, multilithed or reproduced in hook fora for distribution to members of your Committee, the various oil companies vithin the Institute and others interested in this 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 petroleum products. Respectfully submitted, John C. Ruddock, M. D., Chairman Subcommittee on Atmospheric Pollutants, Medical Advisory Committee, American Petroleum Institute API 07576 t APPENDIX N-l f REPORT OF LIAISON MEMBER TO THE A.M.A. COMMITTEE ON TOXICOLOGY AND THE DiTKH-INDUSTRY GROUP ON LABELING ^ status of Hazardous Substances Labeling Legislation A. Federal Level - The first session of the 86th Congress adjourned in September without taking any action on S.1263 and H.R.5260 (identical bills 8ponsored by the Inter-Industry Group "to regulate the interstate distribution and sale of packages of hazardous substances intended or suitable for household use"), ijke Senate Committee on Interstate and Foreign Commerce held one hearing August 13 at which time the API was represented by M. D. GJerde and J. W. Osborn, M. D. Dr, Osborn read a prepared statement on behalf of the API supporting the position of the Inter-Industry Group. No hearings were held on H.R.U260. Likewise, no hearings yere held on H.R.7352, a bill sponsored by the American Medical Association "to jugulate the labeling of hazardous substances for non-manufacturing purposes." Dr. Osborn is in touch with Mr. GJerde, Chairman of the API Interdivisional Committee on Labeling, and with Mr. Ackerly, counsel for the C.S.M.A. Labeling Ccnmittee, 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 No. was enacted by the Ohio General Assembly to become effective November U, 1959- As of October 20, the Ohio Department of Health had not promulgated any regulations for the administeratlon 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 slowly in promulgating regulations and adopting enforcement procedures but emphasized that they would expect the lav to be complied with. The above information is the gist of that supplied by Mr. Addison E. Dewey, Director of the Ohio Petroleum Council in Columbus in his Information bulletin dated October 20, 1939* A printed copy of the Ohio lav was sent to Mr. E. 0. Mattocks on October 22 for duplication and distribution to interested API members. 2. Illinois Senate Bill No. 911 -- As of June 11, 1959 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 passed March 1959 is expected to take effect January 1, i960. Likewise, no rules or regulations for its enforcement have been made available to this member to date. U. City of New York -- Revision of the Sanitary Code, Title IVj Environmental Sanitation, Article 211: Hazardous Substances. Presumably, this new lav announced last February as being passed went into effect in New York City on or about October 1, 1959* No further information on any rules or regulations or en forcement procedures has been received by this member to date. 5> Vermont H. 263 -- This bill introduced March 13 1959 was essentially the same as the Inter-Industry Group draft of January 5 1999* Subsequently, on April 1 , 1959 Vermont H.B.k6o was 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 Committee 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 a API 07577 TI -2 - N-2 .ceived on the subsequent fate of either of these bills. 6. Washington - H.B. No. ^37 passed the House with minor amendments but v9S killed by a Senate Committee on March 5 The State legislature adjourned on 4arch 12 with no opportunity to revise the bill at that session. There may be billB before other State assemblies during 1959 but this member has no information on other than the above. J. W. Osborn, M. D. Vice Chairman, Medical Advisory Committee API 07578 REPORT ON ACTIVITIES OF THE API INTERDIVISONAL C C M H l J W Q M EBLING APPENDIX 0-1 During the past year the API Interdlvisiooal Committee on Labeling has continued its work to determine requirements for precautionary labeling of petroleum products In accordance with the policy established by API, we have 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 Glycol Anti-Freeze, Methanol Anti Freeze, Aromatic Petroleum Oils (with fraction boiling over 700F.), Cut-Back Petroleum Asphalts (flash 20F. - 80F.), and Cut-Back Petroleum Asphalts (flash 80OF. - 120F.). The above will be included in 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 promulgated 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 alcohol, and others, if needed. Prepared by M. D. GJerde and Dr. C. H. Hine. I APPENDIX P-1 WAX RESEARCH ADVISORY COMMITTEE The wax research project, under the direction of Dr. P. Shubik of the Chicago Medical School, is proceeding most satisfactorily. To date, no known carcinogen had been found in any of the waxes examined. The limit of sensitivity of the test is 0.01 p.p.m. Of the five waxes subjected to extensive biological testing (mouse skin painting, rabbit skin painting, injection into mice, and feeding at a 10$ 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 1959 unfavorable publicity, attributed to a National Cancer Institute specialist, appeared in a great number of newspapers throughout the United States. Through the efforts of Dr. Shubik and many of the members of the Wax Research Advisory Committee, the immediate crisis was met. Ultimately, on June 29, 1959, representatives of the Committee and Dr. Shubik met with Secretary Flemming of the Department of Health, Education, and Welfare, Surgeon General Burney of the U. S. Public Health Service, Commissioner Larrick of the Food and Drug Administration, and Dr. Major, Associate Director of the National Cancer Institute. The results of this meeting was the attached statement by Secretary Flemming at his news conference on June 30, 1959 As a result of the work sponsored by the Wax Research Advisory Committee, Mr. Frank Porter has written to Secretary Flemming requesting an extension of time for wax for one year beyond March 6, i960, the date on which, under Public Law 85*929 a decision on the suitability of wax as a food container coating would otherwise have had to be rendered. Mr. Porter has received the attached reply from Mr. Larrick, Commissioner of the Food and Drug Administration. The 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 at this time with petroleum wax competitors undermining the public confidence in petroleum wax. The Wax Research Advisory Committee plans to request the Medical and Health Committee to recommend to the API Board of Directors that they instruct their Committee on Public Affairs to undertake this task immediately and to form a Wax Advisory Committee to assist them in their program. The Committee would like to cosmend Mr. B. 0. Mattocks for his invaluable guidance and assistance throughout the year. Respectfully submitted in behalf of the Wax Research Advisory Committee R. E. ECKARDT, M. 3., Chairman REB:Mev Attach.: Statement by Secretary Flemming, June 30, 1959 API 07580 I / riU RELEASE AT CONCLUSION p _2 JJEWS CONFERENCE ` Statement* by Arthur S. 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 in wax used for milk carbons and other food containers. I think ve should try to clarify the situation with respect to these waxes. 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 as* geobled about kO waxes for further chemical and biological analysis and sent them to : tbe National Cancer Institute. In June 1957, 2U of these waxes were sent for study I to Dr. Philippe Shublk, Division of Chemistry, Chicago Medical School. Dr. Hueper I provided Dr. Shublk with suggestions for the work and data on the economic, chemical, sod biological aspects of dairy waxes. A representative ample of each of these ! waxes was retained by the National Cancer Institute's Environmental Cancer Section of which Dr. Hueper is chief. In tbe fall of 1957 Dr. Hueper received a report from Dr. Shublk on results of preliminary tests of the 2k waxes. The studies were performed by Dr. William Lijlnsky, an associate of Dr. Shubik's. It was demonstrated in these studies that one of the waxes contained a known carcinogen (cancer producing agent), 1,2,5*6,-dibenzanthracene. Three additional waxes were suspected but no carcinogen could be identified. It should be noted that while this compound has produced csncer in laboratory animals, 1 ,2,5*6,-dibenzanthracene has not been shown to pro duce cancer in man. A report of the results of this investigation was communicated to Mr. Ernest Kellogg, Secretary of the Milk Industry Foundation. As a result, Mr. Kellogg asked the American Petroleum Institute for assistance in investigating tbe problem. Dairy industry representatives also met with Public Health Service milk and food personnel to map out a program to assure that the waxes used were free from Impurities. In November, 1957 the American Petroleum Institute made available $100,000 a year far five years to support additional studies by Dr. Shublk (Dr. Shublk has indicated that the resulta will be published as the studies are completed.) Accordingly, Dr. Shublk was supplied an additional sample of 26 represent ative waxes by the petroleum Industry. By tbe time these new samples vers received, Dr. Shublk had improved his analytical techniques to the point where he could identify as little as one part of 1,2,5,6,-dibenzanthracene in one-half billion parts of wax. In the earlier experiments, sensitivity was one part of 1,2,5,6, -dibenzanthracene in one million parts of wax. With the high sensitivity of the new techniques, no dl- benzaathracene has been found in any of the 26 samples. Released at News Conference, Washington, D. C., June 30, 195$. API 07581 i 9 Meanwhile, in 1958, samples of the 2k waxes sent to Dr. Shubik by Dr. 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. II&-85). . The Kotin investigations confirmed the Shubik findings that one wax con tained between 0.5 and 1.0 micrograms per gram of l,2,5/8/~dlbenzanthracene. The Kotin investigations demonstrated, in addition, that 1,2,5,6,-dibenzanthracene added to dairy waxes for experimental purposes was extracted from thin layers of wax by mili. The results of these studies have been reviewed by scientists of both the Public Health Service and the Food aTV^ Drug Administration. 1 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 and 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. API 07582 American Petroleum Institute SO W E S T S O tm S T R E E T New York 20. N. Y. fran k M. RORTER. MIHIOIWT 15# i m Ir* 8 AMriLiif I m t n y M l i r M t * f SMUfc* t w t l i i i , mk m m rn M h u c t e 19, . 8. Ml 1 W m S?*'N FREEDOM PROGRESS Copy Froa 1. 0. Jfattocka For Informtloa Of Naabon Of: Advisory CcMlttoo to tha Vfcx Rasosreh Projoet sad CAtaarvanj Iatordivlaiooal Coanlttoa on Patrolaua Food Additives 10/15/ API 07583 UN ) f department of HEALTH. EDUCATION. AND WELFARE FOOD AND DRUG ADMINISTRATION W A S H IM O T O N 2. D . C. October 27, 1959 Mr. Frank M. Porter American Petroleum Institute 50 West 50th Street Nov York 20, New York Deer Mr. Porter: Secretary Flecming has asked that we reply to your letter of October 15, 1959, in which you requested an exteusion of time under the Food Additives Amendaient, permitting the continued use of pe troleum waxes pending completion of the current research program. The Food and Drug Administration has not, as yet, granted ex tensions as authorized by the Food Additives Amendment. Wc have adopted the policy that such extensions will be granted where there is a showing that the material to be covered by an exemption has been used without apparent injury to consumera and data is avail able demonstracing that continued use would be without hazard to the public health and that the extensions are necessary. We recog nize that the studies on petroleum waxes ere in progress, were started seasonably, and further, that they cannot be completed prior to March 5, 1960. Thus, wc may be in a position to grant an extension in this instance of up to one year, which, incidentally, is the rnaxlaum period of time which we can grant under the exiating lav. We have no statutory authorization ior granting exten sions beyond March 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 the food uses to which they will be put. We would also need for th record a summary of the work completed indicating chat the woxea to be covered by the extension may be safe and a status report on the investigations still in progress, it may be that it would be advisable first to have these scientific matters discussed at a conference between the scientists 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. API 07584  Mr. Frank H. Forcer - October 27, 1S59 n Aa indicated above, if the data which you furnish us in Janu ary indicates chat continued use of the petroleua waxes does not present a hazard co the public health, we will be agreeable to an extension for whatever additional time is necessary, up to March 5, 1961. Sincerely yours George P. Larrick Commissioner of Pood and Drugs API 07585 ) ) API MAC QUARANTINE SERVICE APPENDIX 3-1 Miss Regina Bums 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 w ill be Chief of the Epidemiology and Domestic Operations Branch. In the meantime, Miss Burns will continue to act as liaison vlth us in the field of quarantine. O. M. Saunders, M. D. API 07586 > INDUSTRIAL ) AFPBfPIX R-l HYGIENE BULLETIN M S T A N D A R D OIL C O M P A N Y OT C A L IT Q R N IA 1958 FOOD ADDITIVE AMENDMENT Typical InffoorrmPateitoitnioWnhiincgh MFDaAy be Needed Tbe moat significant feature of tbs 1956 Food Additive Amendment to tba federal food, Drug and Cosmetic Ant is that it places the responsibility on the user and manufacturer to sbov affirmatively that the produet to be used is safe and presents no hazard to its consvaer. Tbe lav requires that the user now file a petition for use^ of his food additive under conditions of intended use. If he can prove it is safe, tbe FDA will approve its intended use. "The term 'food Additive1 means any substance the in tended uae of vhlch results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food including any substance intended for use in producing, manufacturing, peeking, processing, preparing, treating, packaging, transporting or holding food." ' To assist those vho wish to seek clearance of Company products under the Food Additive Amendment, the following infor mation should be Included in the petition: A. Food additive identification and composition B* Food additive use C. Rtysieal and technical effects establishing the food additive as affecting the food D. Methodology B. Safety of the food additive API 07587 > R-2 1. IMTORMATIOW REQUIRED FCB PETITIONIRQ FDA A. FOOD ADDITIVE IDBflTPICATIOW 1 . Heme of Product a) ccoaon name b) other names, including trade naae c) cheaioal naae following the ncaenclature accepted by Cbeaical Abstracts 2. Formula a) Bapirlcal foraula b) Structural formula c) Molecular weight 3 Definition of food additive A. Coaponents Wt. Brief description of manufacturing process B. Include equations for chemical reactions Involved API 07588 2. 1*. Dtaesstcer,ipstitoanbioliftyproduct: liquid, solid, crystalline, amorphous, color, odor, 5. ffeysical, chemical and/or biological properties Solubility Cold vater Hot vater Alcohol &acids, etc Melting point Soiling point Specific gravity Refractive index ' Viscosity Optical rotation Pfa Ash HgO content Iodine number Saponification number Alkoxyl content Volatile matter Vater*insoluble matter Other extrectables API 07589 i Biological activity Absorption spectra in ultraviolet and infrared Fluorescence spectra Readily carbonizable substs. Readily oxidizable substs. Stability, etc. R-k 3- 6. Purity. Specification prescribing the minima content of desired components. 7. uImndpeusriritaibesle. rSeapcetcioifnicabtyipornosdulcimtsitoirngiJ^arusreintiicesa. ndDleeatadilasndofaslsuoitaobthleerteknsotwsn for checking the specifications. (Wnohtersehsouucldh binefosrumbmatiitotnedi)s not available, a statement as to why it is API 07590 8. Identification tests 9. Assay procedure 10. Other pertinent data ) i. FOOD AODITIVi USE 1. The Mount of the food additive proposed for use 2* Purpose for vhich it is proposed R-6 5. a. Directions, recaonendationa and suggestions regarding the proposed use b. Include saagple of proposed label for the food additive .. "If the additive results or nay expect to result f r a the use of packaging aaterial, the petitioner shall show bow this nay occur and what residuals aay reasonably be anticipated." a. Determine quantity of each residue on various foods and identify residua. API 07592 * (1) Calculated maximum contaminations, include sample calculations R-7 6. (2) 8olvent extraction using 5 solvents at 135F for one week (water, 20)1 sucrose, l citric acid, yft acetic acid, 3 sodiua chloride, edible oil or lard) - with solubility curves if indicated. (3) Quantity and transfer data and description of method used. k. Suggested tolerance limitation on food C. PHYSICAL AHD TECHNICAL EFFECTS E3TABLISHDO THE FOOD ADDITIVE AS AFFECTIMQ THE food -- 1. Is the additive stable or unstable 2. Will it be expected to become a component. If yes, bow mucbt What products are formedt 3. Will it affect the characteristics of the food directly or indlrectlyT If yes, how? Mote: These data should include information in sufficient detail to permit evaluation with control data. API 07593 a-8 7. U. What if the sliest quantity of the additive necessary to produce effect expected? Data from carefully controlled experiments shoving the degree of effect accomplished by the additive at several different levels of concentration in food Bust be obtained. The number of levels of concentration will depend upon a number 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. METHODOLOGY 1. "A, description of practical analytical methods to determine the amount of food additive in rav, processed and/or finished food or any substance formed in or on such food 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, farther, the validation data must demonstrate that the method is applicable to each food in vhich the additive is to be used. The method should generally be accurate to vlthin at least lOJl st ths tolerancs level sad be sensitive to about 100 of the tolerance level. The blank on a food containing no additive should be reasonably reproducible and should not exceed 10^ of the tolerance." "The test proposed shall be one that can be used for food-control pur poses end that can be applied vith consistent rsult by any properly equipped end trained laboratory perse,nel." API 07594 8 * R-? . IKVESnOATIQH MADE OH THE S A im OF TEE FOOD ADDITIVES 1. aReetshuoldtas) of aniaal tolerances (detailed results and description of a) Acute oral LD^q Rats b) Acute deraal LD^q Rabbits c) 30 or 90 Day Subacute Feeding Rats d) 2-year Feeding Rats e) 2-Year Feeding Dogs 2. Rfoeopdoratds doiftivinevestigation that would bias a "safe" evaluation of the 3. Check for presence of known carcinogens, i f expected. API 07595 *> I f, FR0P06BP TOLERANCES FOR THE FOCO ADDITIVI PCB SPECIFIC USES (A petitioner u y includa * propoMd regulation) R-10 9. IStSOHSEL DEPT. - CORPORATIOH SAFETY DIVISIOH BULLETIN NO. 1 8/H /59 API 07596