Document evXzZLzw1mwMj6XE2K9Mm2mw4

FILE NAME: Oil Industry and American Petroleum Institute (API) DATE: 1961 Apr 8 DOC#: API046 DOCUMENT DESCRIPTION: Minutes from API Medical Advisory Committee Meeting with Attachments mmitize use > AMERICAN PETROLEUM INSTITUTE X T FCR PUBLICATION MEDICAL ADVISORY COMMITTEE 31ST MEETING 9:00 A. M. Saturday, April 8, 1961 Denver Hilton Hotel, Denver, Colorado PRESENT: J. W. Osborn, M. D., Chairman Leo J. Wade, M. D., Vice Chairman (Represented by N. J. Roberts, M. D.) L. E. Renes, Secretary 10. Armstrong, M. D. ' c. Baird, M. D. Represented by R. W. Pipkin, M. D.) , H. Baylor, M. D. <, F. Boys, M. D. j. Collings, M. D. f g. Curtis, M. D. f g. Eckardt, M. D. /Represented by T. G. Rigney, M. D.) i.'m . Frank, M. D. i,D. Gassaway, M. D. j,7. Henson, M. D. CBNICAL ADVISORS PRESENT: ,V. Adams ,I. Barcus l A. Burhouse l E. Chalfant lX. Daniels to. Entwistle ,tf. Gerarde, M. D. '.Represented by T. G. Rigney, M. D.) LM. Adams, M. D. BEERS ABSENT: :.B. Allen, M. D. tf. Crookshank, M. D. effer Davis, M. D. IR. Fourcher, M. D. E. K. Linder, M. D. C. R. Miller, M. D. T. H. Mitchell, M. D. M. R. Plancey, M. D. J. C. Ruddock, M. D. C. L. Samuelson, M. D. G. M. Saunders, M. D. Ralph Schneider, M. D. (Represented by N. J. Roberts, M. D.) G. A. Sinclair, M. D. W. Wayne Stewart, M. D. P. D. Halley N. V. Hendricks P. K. Kuhne C. A. Neilson J. B. Rather, Jr. J. A. Spence R. Emmet Kelly, M. D. T. J. Kelly, M. D. E. P. Luongo, M. D. B. S. Miller, M. D. R. J. Potts, M. D. 3ERS PRESENT: .Jtf. Philip Drinker, R. Dugan, M. D. JO- Mattocks Tan Raalte, M. D. B. Simon, M. D. Consultant Harvard University Continental Oil Company American Petroleum Institute Royal Dutch Shell, Netherlands Esso Standard, Paris API 07673 OPENING REMARKS J, W. Osborn, M. D., Chairman of the Medical Advisory Committee, welcomed hi i embers present. He thanked each one for his effort in attending the meeting. INTRODUCTION OF HEW MEMBERS AND GUESTS G. A. Sinclair, M. D. and E. V. Henson, M. D. were appointed new members of the Xedical Advisory Committee. The following new technical advisors have been appointed since the last meeting: A. Burhouse, W. E. Chalfant, A. W. Lindert, and T. J. Smith, M. D. The following guests were introduced: R. R. Dugan, M. D., assistant to j. 0. Armstrong, M. D.; R. W. Pipkin, M. D. representing V. C. Baird, M. D.j T. G. Rigney, !(. D. representing R. E. Eckardt, M. D. and H. W. Gerarde, M. D.; N. J. Roberts, M. D. re presenting R. F. Schneider, M. D. and Leo J. Wade, M. D.j K. B. Simon, M. D., from Esso Standard of Paris; and H. van Raalte, M. D., from Royal Dutch Shell, Netherlands. 'JI. APPROVAL OF NOVEMBER ik, i960 MINUTES ACTION: It was regularly moved, seconded, and unanimously passed that the minutes of the 30th Meeting of the Medical Advisory Committee, held ; November 1^, i960, in the Conrad Hilton Hotel, Chicago, Illinois, j be approved as distributed. y. SUBCOMMTl'lkK REPORTS 1, Operating Subcommittee The minutes of the Operating Subcommittee are attached as Appendix A. The following recommendations of the Operating Subcommittee were considered and cted upon by the Medical Advisory Committee: (1) Hazleton Laboratories wrote R. E. Eckardt, M. D. requesting that he deterdne if the API would be interested in contributing to a program, costing about $37>000, x prepare a monograph of data on control rats used in long-term studies. ACTION: It was regularly moved, seconded, and unanimously passed that the request from the Hazleton Laboratories for financial assistance to prepare a monograph on data on control rats used in long-term studies be denied. . (2) R. E. Eckardt, M. D., Chairman of the Subcommittee on Carcinogenicity, re:onmended previously that the subcommittee be discontinued and that no subcamnittee dealing mtirely with cancer matters be set up. ACTION: It was regularly moved, seconded, and unanimously passed that no subcommittee of the Medical Advisory Committee be set up solely to handle matters relating to carcinogenicity and if any subcommittee has a problem dealing with carcinogenicity, it obtains such assist ance as is needed or they request the Medical Advisory Committee to help them. ACTION: The report of the Operating Subcommittee was accepted. API 07674 ) > ^ Atmospheric Pollutants Mr. Herman Barcus, Secretary cf the Subcommittee on Atmospheric Pollutants, gave e report of this group. The recommendations of the subcommittee that copies of Dr. joidblatt's Summary be sent to the U. S. Public Health Service, to the API Air and Water pcservation Committee, and that Dr. Goldblatt's data be sent to the American Documentation Institute, Washington, D. C., the Medical Advisory Committee raised considerable objections. ACTION : It was regularly moved, seconded, and unanimously passed that the references C., D., and E., relating to the Goldblatt report, be deleted from the subcommittee's report. Likewise, several editorial and clarification changes to the subcommittee's report rere approved. ACTION : It was regularly moved, seconded, and unanimously passed that the amended report of the Subcommittee on Atmospheric Pollutants be approved. The amended report is shown in Appendix B. ;. C9 - C12 Aromatics ... ... r" T. M. Frank, M. D. gave the report of this subcommittee. His report appears as jppendix C. i I ACTION : It was regularly moved, seconded, and unanimously passed that the report of the Subcommittee on C9 - Ci9 Aromatics be adopted. } Certificates of Appreciation > J. W. Osborn, M. D. reported that the Subcommittee on Certificates of Appreciation jst with three members present. They have several suggestions which will be processed rough the Operating Subcommittee and, with its approval, to the Medical and Health Com- ttee with a request for approval to issue Certificates of Appreciation at the November eeting of the Medical Advisory Committee. ACTION : It was regularly moved, seconded, and unanimously passed that the report of the Subcommittee on Certificates of Appreciation be approved. 1. Dermatology ' C. H. Baylor, M. D. gave the report of this subcommittee for Leo J. Wade, M. D., Chairman. A copy of his report is attached as Appendix D. ACTION*: It was regularly moved, seconded, and unanimously passed that the report of the Subcommittee on Dermatology be adopted. Epidemiology G. M. Saunders, M. D. reported that his group is working on a proposed pilot study 3f truck drivers. It is hoped that this will be available by the November meeting. . ACTION : It was regularly moved, seconded, and unanimously passed that this report be accepted. API 07675 ) -4 - Medical Policies and Administrative Practices N. J Roberts, M. D. reported, for R. F. Schneider, M. D., the Chairman of the ..^committee. There was no new or old business to be considered by the subcommittee at ,-'S meeting. ACTION: It was regularly moved, seconded, and unanimously passed that the report be accepted, - ^ Physical Agents G. H. Collings, M. D., Chairman, reported on the activity of his subcommittee, jis report is given as Appendix E. ACTION: It was regularly moved, seconded, and unanimously passed that the report be accepted. % Specialty Petroleum Products C. H. Baylor, M. D., Chairman, reported on the activity of this group. His re- 5ort is attached as Appendix F. ACTION: It was regularly moved, seconded, and unanimously passed that the report be adopted. j. Toxicological Reviews T. G. Rigney, M. D. reported for H. W. Gerarde, M. D., Chairman, on the activities :f the Subcommittee on Toxicological Reviews. Dr. Gerarde's report is attached as Appendix G. ACTION: It was regularly moved, seconded, and unanimously passed that the report be accepted. I Industrial Hygiene Dr. Jack Spence reported on the activities of the Subcommittee on Industrial iygiene. His report is attached as Appendix H. . ACTION: It was regularly moved, seconded, and unanimously passed that the . report of the Subcommittee on Industrial Hygiene be accepted. V. REPORT OF LIAISON MEMBERS A. Air and Water Conservation Committee C. L. Samuelson, M. D. reported that since he has just taken over the chairmanship ,of the Subcommittee on Atmospheric Pollutants, he has had no direct contact, as yet, with the Division of Refining's Air and Water Conservation Committee. B. First Aid Training T. M. Frank, M. D. reported that there was considerable study being given to the various methods of resuscitation. Three methods have been listed by the Central Committee on Accident Prevention in its First Aid Manual. API 07676 T > i -5- . Interdivisicnal Committee on Labeling >--------------------------------------- C H. Baylor, M. D. reported for Mr. A. E. Dooley, Chairman of the Interdivisional jomfflittee on Labeling. A copy of Mr. Dooley's report is attached as Appendix I. i. Oil Mist Advisory Committee N. V. Hendricks' report is attached as Appendix J. K, Petroleum Food Additives L. E. Curtis, M. D. reported that petitions had been filed for white oil, al white oil, and odorless light petroleum hydrocarbons. An extension has been asked for petrolatum. Dr. Curtis explained that Congress had passed a new law permitting the use of food additives, under an extension, to June 30, 1964. techni y. Quarantine Service G. M. Saunders, M. D. presented a report of his activities. His report is given ss Appendix K. The group indicated that they appreciated very much the information which jr. Saunders was distributing to them. S. Wax Committee Kieffer Davis, M. D., one of the liaison members from the Medical Advisory Conanittee the Advisory Committee to the Wax Research Project, prepared a report on the activities of the Wax Committee. The report was given for Dr. Davis by G. M. Saunders, M. D. The report is attached as Appendix L. I, Asphalt Study Committee J. W. Osborn, M. D. reported that Mr. Charles E. Spahr, Chairman of the Medical and Health Committee, had appointed a Special Asphalt Study`Committee, composed of seven Bribers, of which Dr. J. A. Spence was chairman. In addition to Dr. Spence, E. V. Henson, X. D. and C. H. Baylor, M. D., members of the MAC, are alsjf'on the study committee. Chairaan Osborn explained that this special study committee reports directly to the Medical and Health Committee. He pointed out, however, that Mr. Spahr had asked the Medical Advisory Committee for an opinion as to whether such a study committee was desirable. The Medical Advisory Committee had answered him in the affirmative last November. 1 71. 1962 BUDGET .. . "TM ... . A proposed budget for 1962, as compared with the approved 1961 budget, is as follows : BUDGET C9 - C12 Aromatics Physical Agents Specialty Petroleum Products Toxicological Reviews Consultant Atmospheric Pollutants .lead Survey Proposed 1962 $10,000 2,500 - 2,000 55,000 15,000 $84,500 Approved 1961 $10,000 2,500 15,000 5,000 3,000 5,000 $10,500 Change from -0 -0 -15,000 - 5,000 - 1,000 +50,000 +15,000 1961 +44,000 API 07677 T ) The various icems for the proposed expenditures of the subcommittees vere Resented in the appropriate subcommittee report. ACTION : It was regularly moved, seconded, and unanimously passed that the $3h,500 proposed budget for 1902 be presented to the Medical and Health Committee for its approval. HI. NEW BUSINESS L. Invitation to James G. Telfer, M. D. In the report on liaison with the Quarantine Service, given by G. M. Saunders, (. D., it was recommended that the Medical Advisory Committee approve inviting Dr. James G. felfer, of the U. S. Public Health Service, Quarantine Division, to attend a future meeting }f the Medical Advisory Committee. ACTION: It was regularly moved, seconded, and unanimously passed that the Chairman of the Medical Advisory Committee invite James G. Telfer, M. D. to the next Medical Advisory Committee meeting, or same future one which would be mutually agreeable. 3, Federal Hazardous Substances Labeling Law G. H. Collings, M. D. presented to the Operating Subcommittee the need for con sideration of necessary toxicological studies by API to comply with the recently enacted federal Hazardous Substances Labeling Law. The Operating Subcommittee requested that Jr. Collings present his recommendations to the Medical Advisory Committee. ACTION: It was regularly moved, seconded, and unanimously passed that the ; Chairman of the Medical Advisory Committee contact the Interidivisional ' Committee on Labeling to determine whether it has considered the I possible merit of action on the part of the API to conduct toxi cological investigations on standard types of petroleum products for | the purpose of clearing such products with the Food and Drug Admini stration, with reference to the requirements of the Federal Hazardous Substances Labeling Act. If the Interdivisional Committee on Label l ing has not done this and is not interested in this aspect of the | problem, it is further moved that the chairman of the Medical Advisory Committee appoint a study group, within the Medical Advisory Committee, to consider appropriate action by the Medical Advisory Committee. I Till. NEXT MEETING The question of when to have the next Medical Advisory Committee meeting and its subcommittees was discussed quite extensively. The question of whether to have the sub committee meetings on Friday and Saturday, with the Medical Advisory Committee meeting on Monday, as against possibly having the subcommittee meetings on Thursday and Friday and the Medical Advisory Committee meeting on Saturday, was discussed at length. ACTION: It was regularly moved, seconded, and unanimously passed that the Medical Advisory Committee subcommittees meet on Friday and Saturday, . November 10 and 11, at the Conrad Hilton Hotel in Chicago, the Operating Subcommittee to meet on Saturday evening, November 11th, ; and the Medical Advisory Committee to meet on Monday morning, < November 13th. API 07678 T ) ^ ADJOURNMENT The meeting was adjourned at 11:00 A. M. -proved: * W. Osborn, M. D. pril 26, 1961 Chairman L. E. Renes, Secretary Reported by E. 0. Mattocks API 07679 ) - 2 A-2 ,-^cer.cia'icr.s 3.* ve " 'be Goidbla-t report vhich they planned to present to the & ,izi~ Advisory Ccnnn ttee for action. They, likewise, were planning to recommend the ir.g o f a te c h n ic a l consultant to assist the Atmospheric Pollutants Subcommittee in er to keep a b r e a st of current literature. ' - Dr. Samueison stated that his group was going to propose the initiation of a ,,search proposal on the determination of the medical aspects of nitrogen oxides and '."fur oxides and particulate matter which occur in atmospheric pollution. They had ;.,,ree possible laboratories 'under consideration and expected to have a final recom^r.dation as to the place by the November meeting. Considerable discussion resulted '.,cni the recommendations which were to be presented to the Medical Advisory Committee. 5, C9 - C]_2 Aromatics T. M. Frank, M. D. reported on the activities of this subcommittee for effer Davis, M. D., Chairman, who was unable to be present. Dr. Frank indicated iiat they planned to ask for $10,000 for the year 1962 to continue the work on Cg - C ^ jjomatic toxicity being conducted currently at The University of Texas. He indicated, -cvever, that there was some uncertainty as to the future of the project. A study ;C30ittee is to be appointed to review the findings of this project. Definite recom- e'dations will be made at the November meeting. . Certificates of Appreciation Chairman Osborn stated that only four Certificates of Appreciation had been ivarded by the Medical and Health Committee to members of the Medical Advisory Comjittee up to date. This subcommittee had met and vas planning to make recommendations x the Operating Subcommittee at a later date. Dermatology C. H. Baylor, M. D. reported for Leo J. Wade, M. D., Chairman. Dr. Baylor educated that there were no further developments in the problem of dermatitis in the etroit Area. 1. Epidemiology George M. Saunders, M. D. indicated they were endeavoring to find practical sans to implement the recommendation, made last November concerning the making of a jr.udy of truck drivers. Medical Policies and Administrative Practices N. J. Roberts, M. D. reported for Ralph Schneider, M. D. 'at there were no current problems. It was indicated i Physical Agents G. H. Collings, M. D., Chairman of this subcommittee, reported that they going to request $2,500 for 1962 for continuing the contribution to the Noise Jttdttee, under Dr. Glorig. He indicated further that the group thought that there ^uld be some criteria of noise. They were developing a uniform standard which would '* suggested to the Medical Advisory Committee fcr use by the petroleum industry. ^Specialty Petroleum Products API 07681 C. H. Baylor, M. D. reported on the activity on kerosine poisoning at the versi.ty of Vermont and at Baylor University. Because of the inability to successfully T ) APPETIT ZC A NOT FOR PUBLICATION AMERICAN PETROLEUM INSTITUTE MEMBERS PRESENT: MINUTES GF THE MEDICAL ADVISORY COMMITTEE'S OPERATING SUBCOMMITTEE Friday, April 7, 1961 Denver Hilton Hotel Denver, Colorado J. W. Osborn, M. D., Chairman Leo J. Wade, M. D., Vice Chairman (Represented by N. J. Roberts, M, D.) L. E- Renes, Secretary V. C. Baird, M. D., Past Chairman (Represented by R. W. Pipkin, M. D.) C. H. Baylor, M. D. (}. H. Collings, M. D. I, E. Curtis, M. D. (PFA) Kieffer Davis, M. D. (Represented by T. M. Frank, M. D.) E. Dooley (ICL) (Represented by C. H. Baylor, M. D.) S. E. Eckardt, M. D. (Wax) (Represented by T. G. Rigney, M. D.) I. INTRODUCTORY REMARKS H. W. Gerarde, M. D. (Represented by T. G. Rigney, M. D,) N. V. Hendricks (Oil Mist) E. 0. Mattocks (ex-officio) C. L. Samuelson, M. D. G. M. Saunders, M. D. Ralph Schneider, M. D. (Represented by N. J. Roberts, M. D.) J. A. Spence J. W, Osborn, M. D . , Chairman of the Operating Subcommittee, welcomed all present. He introduced the following: R. W. Pipkin, M. D. who was representing 7. C. Baird, M. D.j T. G. Rigney, M. D. representing R. E. Eckardt, M. D. and 3. W. Gerarde, M. D.; N. J. Roberts, M. D. representing R. F. Schneider, M. D. and Leo J. Wade, M. D.j T. M. Frank, M. D. representing Kieffer Davis, M. D. The chairmen explained that Mr. Chenles E. Spahr, Chairman of the Medical and Health Committee, had. appointed a Special Asphalt Study Committee composed of seven sembers, with Dr. J. A. Spence, Chairman, and with two other Medical Advisory Committee members - C. H. Baylor, M. D. and E. V. Henson, M. D. The Chairman explained that this aonmittee reports directly to the Medical and Health Committee. It was appointed 'following a request for a recommendation from the Medical Advisory Committee, which was riven to Mr. Spahr, recommending the appointment of such a group. il. APPROVAL OF MINUTES ACTION: It was regularly moved, seconded, and unanimously passed that the minutes of the Operating Subcommittee meeting, held Sunday, November 13, I960, in the Conrad Hilton Hotel, Chicago, Illinois, be approved as distributed. 3l. REPORT OF SUBCOMMITTEE CHAIRMAN h Atmospheric Pollutants API 0768c C. L. Samuelson, M. D., Chairman of the Subcommittee on'Atmospheric Pollutants, T> A-5 ,aiy-e :=r -V-~- arbors ir. human bleed, very little had been done during the past iiar- ^ W . Gera: he, M. D. has agreed to run the blood analyses in his laboratory. *v,g T3C55iC*_* >y --'.1 C. A. Nau, M. D. using the sane analysis as he has employed on his I'g - C]_2 aromatic for blood analysis was discussed. It was reported that the money ''-ren -ly apprcpr: ated through 1961 will be sufficient to carry through the year 1962. Toxicological Reviews T. G. Rigr.ey, M. D. reporting for H. W. Gerarde, M, D., Chairman, stated there ,,as Q0 ac*ivity to be brought to the attention of the Operating Subcommittee. Industrial Hygiene Dr. J. A. Spence reported that last November his subcommittee recommended to .jje Medical Advisory Committee, which approved, contributing $25,000 to assist the apartment of Public Health in making a lead survey. It was agreed subsequently that his request should be channeled through the Division of Refining's Air and Water jonservation Committee. The Division of Refining did not report whether they agreed or disagreed with this suggestion. The industrial hygienists feel very strongly that the jpl should cooperate with the U. S. Public Health Department insofar as possible. By ;ooperating, the Public Health people are willing to listen to industry people's suggestions and tell them what their plans are. Failing to cooperate in this manner results in the API beling labeled as uncooperative not only in this venture but other rentures. The industrial hygienists are recommending that $15,000 be placed in the ',962 budget to assist in the lead survey. r. Oil Mist Liaison Group Chairman Osborn explained that following the report from the Oil Mist Task ;roup of the industrial hygienists, he had set this group up as a special liaison task force since they were primarily to act as liaison with other groups who are conducting jresearch work on oil mists. y. 1962 BUDGET ^ A proposed budget for 1962 is as follows: C9 - C ^2 Aromatics Physical Agents Consultant Atmospheric Pollutants Lead Survey $10,000 2,500 2,000 55,000 15,000 $84,500 ACTION: It was regularly moved, seconded, and unanimously passed that the proposed budget of $84,500 for 1962 be recommended to the Medical Advisory Committee for approval. 4 INVESTIGATION OF AUTOMDBILE EXHAUSTS C. L. Samuelson, M. D., Chairman of the Subcommittee on Atmospheric Pollutants, ^ r t e d that a conference is to be arranged with the Automobile Manufacturers Association ^ical people to explore possible mutual problems. 4. CARCINOGENICITY A P I 07 68 2 R. E. Eckardt, M. D., Chairman of the former Subcommittee on Carcinogenicity, A- -- .j -;2z:er.de3. jir.c ir.r.a" '.^committee ".Iccnmended 'hey are per. ere ucrplecicn cf the verb at Kettering Laboratory ac The university > that this subcommittee be discharged. He further recommended that no be given the charge cf handling the broad subject of carcinogenicity. He hat each subcommittee should handle its own carcinogenicity problems and cable to do so, to request assistance from the Medical Advisory Committee. ACTION: It was regularly moved, seconded, and unanimously passed that the recommendation of R, E.'Eckardt, M. D. be presented to the Medical Advisory Committee. .rrr. HAZLETON LABORATORIES1 REQUEST R. E. Eckardt, M. D. received a request from the Hazleton Laboratories to assist in defraying a proposed budget of $37,000 to prepare a monograph of data on con sol rats used in long-term studies, The request is attached as Exhibit A. The -estion was raised as to whether any useful information for the future would be pro vided by such a study. It was indicated that perhaps this would be a proper project -0r the U. S. Public Health Service, ACTION: It was regularly moved, seconded, and unanimously passed that the request from Hazleton Laboratories for financial assistance be disapproved, Till, NOVEMBER 1961 MEETING Considerable discussion took place as to whether the Medical Advisory Com-ittee and its subcommittees should meet on Friday, Saturday, and Monday in the Conrad Hilton Hotel in Chicago, in November 1961, during the Annual API Meeting, or wether they should meet on Thursday, Friday, and Saturday. ACTION: It was regularly moved, seconded, and unanimously passed that the Operating Subcommittee recommend to the Medical Advisory Committee that the Medical Advisory Committee subcommittees meet on Friday and Saturday, November 10th and 11th, 19 6 1, In the Conrad Hilton Hotel, Chicago, Illinois, the Operating Subcommittee to meet Saturday night, November 11th, and that the Medical Advisory Committee meet Monday morning, November 13th. 3. NEW BUSINESS L Chairman Osborn reported that the Division of Refining had decided not to mve an air pollution session at their midyear meeting this year and, therefore, the request for a paper from the Medical Advisory Committee did not materialize. -. The Air Pollution Control Association had requested a paper on air pollution, '0be given at Its June 1961 meeting. The chairman declined this invitation since he is 'unable to comply with the requirement that the paper must be completed and furnished b them by March 15 th. Sometime ago, R. E. Eckardt, M. D. was appointed the API representative to '-e Liaison Panel of the Food Protection Committee of the National Academy of Science, 'ional Research Council. Dr. Eckardt had requested to be relieved of this assign at. While he was an API representative, he reported to the Medical Advisory Committee. API Upon his resignation, it was the suggestion of J . W. Osborn, M. D,, Chairman ;* the Medical Advisory Committee, that the responsibility be given to the Inter visional Committee on Petroleum Food Additives which appeared, to be more reasonable assigning it to the Medical Advisory Committee. This suggestion was transmitted I - 5 ) A-5 L. S. Curtis, M. D. by J . W. Osborn, M. D. Dr. Curtis, Chairman of the Interdivisional ^jBiittee on Petroleum Food. Additives, suggested that Mr. Charles M. Shaw, of the Caiidard Oil Company of California, who currently represents this company on the Liaison also represent API Interdivisional Committee on Petroleum Food Additives. A ',,eStion was raised as to whether the representative on the Food Protection Committee ^ jUld be a physician. It was generally agreed that the current arrangement appeared be satisfactory. t j Federal Hazardous Substances Labeling Act. - G. H. Collings, M. D. wished the g i to consider the advisability of undertaking a joint toxicological study of common ^troleum products which are required to be labeled. He indicated that requests were eing received from customers to certify that the material being sold was in compliance "_th the Federal Hazardous Substances Labeling Act, for subsequent labeling. The work the Interdivisional Committee on Labeling was discussed. While it was recognized .jjjt a large number of products are definitely an individual company problem, neverthe less, there appeared to be places where a joint activity by the API might be highly desirable. The Operating Subcommittee suggested that Dr. Collings present this to the Indicai Advisory Committee at its meeting on the following day. j. a d j o u r n m e n t The meeting adjourned at 11:15 P- M. L. E. Renes, Secretary- Reported by E. 0. Mattocks Approved: j. W. Osborn, M. D., Chairman API 07684 V Box 30 Church ginia EXHI3IT A HAZLETON LABORATORIES Incorporated Falls Church J anuary 20, 1961 Dr- R, E. Eckardt Director, Medical Research Division Esso Research and Engineering Co. P. 0 . Box ^5 Linden, New Jersey Dear Bob: The staff at Hatleton Laboratories is planning a program in which we hope you will be interested. This is the preparation of a monograph of data on control rats used in long-term studies. Our data cover a period of 1^ years and we feel this is an untapped, rich source of information useful to our clients and colleagues in toxicology. A systematic survey and analysis will be made of the following criteria which have been used in the classical evaluation of stress in toxicological investigations: Survival Body Weight Gains (Growth) Food Consumption and Utilization Water Consumption Clinical Values Hematology Biochemistry _ Urine Analyses Organ Weights and Organ/Body Weight Ratios Reproduction Pathology Gross and Microscopic Tumor Incidence and Disposition Behavioral Characteristics Data as outlined above will not be complete on all rats but will be typical of the era of toxicology in which it was obtained. API 07685 Dr. R. ka -P - I n. " January 20, 1961 Data will be taker, from ohe records of cur 2300 control rats cf the following strains: STRAIN NO. OF RATS Carworth Farms Wistar Charles River Wistar Charles River Sprague-Dawley HoItzman Sprague-Dawley 1200 +00 350 350 2300 According to type and duration of the study, data are available as follows: Dietary Feeding Six Months One Year Two Years 11+50 1000 700 Oral Administration Three .Months Six Months One Year 500 UOO 150 Reproduction Studies 350 The estimated cost for the entire program is approximately $37,000. The Procter and Gamble Company has generously made an initial subscription to the support of this program. We are writing you in the chemical industry to ask your support in this undertaking. It is, of course, our intention to acknowledge each subscription in the publication of the data. Please be assured that no monetary profit to either Hazleton Laboratories or the contributors is to be realized from this project. We hope you will agree with us that dissemination of a monograph containing standard laboratory values on the rat would be a significant contribution to the science of toxicology. If you have any questions, please contact me personally, or in my absence, either Tom Tusing or John Keller. In any event, we would like to hear from you concerning this program. As usual, your comments will be appreciated. With best personal regards. Sincerely yours, LWH:cLh L. W. HAZLETON, Ph.D. API 07686 REALISTS FCR SUPPORT CF PUBLICATION CF MONOGRAPH ON CONTROL RAT SENT TO FOLLOWING PERSONS -^jr. Z. Saunders '[: paohclcgy ar.d Toxicology Seccicr. -0 jcir.e ar.d French Laboratories % Spring Garder. Street . J;.Delphi a 1, Pennsylvania P'' * v 5. Feenstra Department of Pathology rjrjohn Company I- Henrietta Street aaiazoo, Michigan ' Elmer P. Wheeler '.gistant Director, Medical Department tr.santo Chemical Company Kg North Lindbergh Boulevard C. Louis 66, Missouri Bernard F. Daubert '.rector of Scientific Research eneral Foods Corporation ;5 South Broadway jrrytown, New York Robert L. Gates .rector, Research and Development tod Machinery and Chemical Corporation Cagara Chemical Division tddleport, New York John P, Frawley lief Toxicologist ircuies Powder Company, iilmington 9 9 i Delaware Inc. M r . V * K . Rowe Biochemical Research Department 12-63^ Building The Dow Chemical Company Midland, Michigan Dr- C. Boyd Shaffer Director of Environmental Health Central Medical Department American Cyanamid Company 30 Rockefeller Plaza New York 20, New York Dr. David W. Fassett Eastman Kodak Company Kodak Park Works Rochester L, New York Mr. William G. Whitehouse Philips Roxane, Incorporated 2hOO Frederick Avenue . St. Joseph, Missouri Mr. Donald H. Kirby Research and Development Laboratory John H. Breck, Inc. II5 Dwight Street Springfield 3> Massachusetts Dr. Frank M. Berger President Wallace Laboratories ' Half Acre Road Cranbury, New Jersey 1, Floyd P. Hallett usistant Director rsduct Development - Medicinal feilinckrodt Chemical Works Louis 7, Missouri Mr. Hobart 0. Thomas Assistant to Vice President, Stauffer Chemical Company 380 Madison Avenue New York 17, New York Research John A. Zapp irector Haskell Laboratory 2. I. duPont de Nemours 'ilmington 98, Delaware & Co., Inc. Dr. Louis Lykken Manager, Technical Service Shell Chemical Company 110 West 51st Street New York 20, New York Department John W, Ward * H. Robins Co., Inc . -<07 Cummings Drive "-chmond, Virginia Dr. Fred Coulston Sterling- Winthrop Research Institute Rensselaer, New York API 07687 T _ ^ -a**, --CX---'-- --..n p-' ^c. Denarcr-er.": -:"'r?cwder Ccmpar.y -''goon 99, Delaware jcseph Marrus f!..,al Departner.-: F'l- ov'.araaaeurieal ^ 3ox ^30 .-iers, New York CoEoany * , George R Boyd, Jr. '1-ion Leader, Inorganic .eared and Development Department ,,ginia-Carolina Chemical Corporation .'yiond, Virginia , Leo R . Gardner i-ager, Research and Development ifornia Spray-Chemical Corporation -as Street & Ortho Way ';>3iond, California Ralph C. Wands jiied Research Section esota Mining & Manufacturing Co. <1 Hudson Road Paul 19, Minnesota R. C. Anderson iad, Department of Toxicology Lilly Research Laboratories 1 Lilly and Company dianapolis 6 , Indiana Henry F. Smyth Lion Institute 00 Fifth Avenue "sburgh 13; Pennsylvania R. E. Eckardt rector, Medical Research Division -sc Research and Engineering Co. 0. Box L5 nien, New Jersey George F. Rugar lociate Director 'arch Department ;-asond Alkali Company 'L Box 'lesville, Ohio Dr. Edward Eagle Head, Division of Physiology and Toxicology Swift & Company Union Stock Yards Chicago 9, Illinois Dr. John F. Mahoney Manager, Technical Service Chemical Division Merck Sharp & Dohme, Inc, Rahway, New Jersey Dr, Charles S. Delahunt Chas. Pfizer & Co., Inc. Research Division Groton, Connecticut Dr. Douglas V, Frost Head, Nutrition Research Department Abbott Laboratories North Chicago, Illinois Dr. Harold Wittcoff Director of Chemical Research General Mills, Inc. 9200 Wayzata Boulevard Minneapolis 26, Minnesota Dr. J. P. Dailey Director of Research Armour Pharmaceutical Kankakee, Illinois Company Mr. Kenneth B. Nash Insecticide Products Department Olin Mathieson Chemical Corporation Mathieson Building Baltimore 3, Maryland Dr. H. Douglas Tate Manager, Agricultural Chemicals Research and Development Naugatuck Chemical Naugatuck, Connecticut Dr. Theodore King Ortho Research Foundation Division of Ortho Pharmaceuticals Raritan, New Jersey API 07688 I T H E STANDARD OIL COMPAIFY (An Ohio Corporation) Midland Building Cleveland, Ohio February 17, 1961 Mr. Elmer 0. Mattocks, Director Department of Technical Services American Petroleum Institute 1271 Avenue of the Americas New York 20, New York Subject: Hazleton Laboratories Proposed Monograph of Data on Controlled Rats Dear Elmer: Confirming our telephone conversation of today, I have reviewed Dr. Eckardt's letter of February 3, 1961, to Dr. L. W. Hazleton in re ply to Dr. Hazleton's letter of January 20 to Dr. Eckardt. I agree with Dr. Eckardt that the Public Health Service ought to give a substantial contribution to this project and perhaps support the project in total. On the other hand, the API Medical Advisory Committee would have a definite interest in the results of this proposed study. Thinking in terms of the entire program approximately $37,000 in cost, the Medical Advisory Committee might do well to consider an amount in the neighborhood of $1,000 or perhaps $2,000 at the most. Will you please reproduce Dr. Eckardt's and Dr. Hazleton's letters for distribution to the Members of the Operating Subcommittee. Each member should come to the Operating Meeting in December prepared to express his opinion. In the meantime, those who are chairman of subcom mittees or liaison committees may put this matter before their respec tive committee members as each chairman sees fit. Sincerely yours, /s/ J. W. Osborn J. W. OSBORN, M. D. Chairman, API - MAC JWO/sjf c c : Dr. R. E. Eckardt API 07689 r c 0 ? ESSO RESEARCH AND ENGINEERING COMPANY P. 0. Box +5, Linder., N. J. Research Division February 3, 1961 , Dr L. W. Hazleton iI Hazleton Laboratories, Inc. p. 0. Box 30 Falls Church, Virginia Dear Lloyd: We have your letter of January 20, 1961 concerning the contribution to a publication which will bring together the data on a group of normal animals maintained in your laboratories. Rest assured that I believe this is an extremely important project and one which ought to be supported. However, in looking through the group of individuals to whom you have written, asking for support, it occurs to me that with the exception of the Shell Chemical Company, we are the only oil company that you have approached. In view of this, and the fact that I believe such information would be of value to any of the oil companies, I would feel that the contribution toward your publi cation ought to come from the American Petroleum Institute. In view of this, I am sending a carbon copy of my letter to you, and also a copy of your letter to me, to both Jim Osborn, who is Chairman of the Medical Advisory Committee of the API, and to Mr. Elmer Mattocks, who is head of the Technical Services Division of the API, and serves as Executive Secretary of our Medical Advisory Committee. Rest assured, that I believe your project is an excellent one and one that very much needs to be done and is very deserving of support. I would cer ! tainly feel that you ought to be able to get a substantial Public Health Service grant in support of such a project, since such a project is of extreme importance to the Public Health Service, and in particular, the Food and Drug Administration whose responsibility it is under the law to interpret the significance of biological data. Lacking good data on normal controls, I find it extremely difficult to understand how they can adequately interpret what may be developing in the experimental animals. I simply propose that they ouggit to give a substantial contribution to this project, and in all likelihood, ought to support the project in toto. It seems to me that this is an excellent expenditure of public funds which after all are made up of API 07690 4 2 February 3, 1961 , ,v.g -axes cf all of the corporations that are represented and might be in- .a-&sted tn thus cnfomatocn. ! " " I - presume that you will probably hear either from Dr. Osborn or Mr. Mattocks, 1 although it may be that you will not hear from them until after the next meeting of the Medical Advisory Committee which is scheduled for April 8th, I believe, in Denver, Colorado, In any event, this information will be in their hands in time for their coming meeting, In the event, that they do not support you, I hope you will contact me again, and because it may be that we would sup port you ourselves even though they migfct not choose to do so. . sincerely yours, r . E. ECKARDT, M. D. Director SEE-.WK cc: Mr. E.O, Mattocks - w/atts. - L.W.Hazleton ltr. of l/20/6l Dr. J.W. Osborn - " " " " API 07691 * APPSITDIX 3 HI?i?.T C? THE 3T3C CMMZT'-'kn C" ATMOSPHERIC PCIlLTAhTS l7 I. Samuelscn, M. D., Cr.airr.ar. ~ ,'zcczz.izzee, ir. addition zo closed sessions on Wednesday evening, and Thursday afternoon, convened formally at 9:00 A. M. on Thursday , 19oi. Seven of she nine members were present. Since .'--cnate in hav icussion. .er neecir.gs scheduled for the same time were cancelled, we were ; a large delegacin of visitors who took an active part in the The recommendations being presented reflect the thinking of the subcommittee, ,>e discussion at the meeting, and verbal and written suggestions presented. With regard to Dr. Goldblatt's work, the subcommittee makes the following -eccmmendations: A. That Goldblatt's reports I, II, III, and Summary be accepted. B. That the Goldblatt project be terminated; that Dr. Goldblatt be notified; that the MAC express its appreciation to Dr. Goldblatt for his work. C. That consideration for publication of Goldblatt's Summary, as it was received or after editing, be tabled. D. That Dr. Goldblatt's Summary be studied further in an effort to make it publishable. The last recommendation is being feasible, at this time, to attempt to make Summary which would result in a manuscript clude the possibility of some such attempt ation at some future date. made as it did not appear practical nor any recommendations as to editing the acceptable to the MAC. This does not pre being made by the subcommittee for consider As to the matter of research in the field of air pollution and its effect or. health, the subcommittee feels that this is a proper and timely undertaking for the MAC. The subcommittee recommends: A. That the MAC request $50,000 for 1962, and possibly to continue for a period of from three to five years, for investigating any possible relationship between pulmonary carcinoma and exposure to petroleum and petroleum pro ducts resulting from their use. Particular reference to be made to the roles of polycyclic aromatics, oxides of nitrogen, sulfur and its compounds, and particulate matter as they may arise from the use of petroleum and petroleum products. B. That the MAC authorize the subcommittee to contact various individuals, groups, or laboratories to develop a research program along the lines mentioned in A above.(Exhibit l) C. That the subcommittee develop a specific study and select the proper per sonnel and facilities to carry out such a study and present these to the MAC for final approval and permission to proceed. API 07692 ) 2 The r.avare of the study reflects the general feeling of those making .-j-estior.s and also reflects the opinion of the subcommittee. Investigation as to facilities available and costs have been very limited -gcause of the tire the subcommittee has had. The subcommittee has not wished to pro ved too far without seme specific approval by the MAC. Based on the limited infor mation at hand, we feel that a program which will be acceptable to the MAC can be 7eVeloped for the amount requested. While we have recommended that the Goldblatt project be terminated, the sub..'BHiittee believes that the work should be continued and that a review of current "iterature be made. In order to accomplish this, to be of help to this subcommittee *3,i to the MAC, the following recommendations are presented for MAC consideration: A. That $5,000 be budgeted for the services of a technical consultant. B. That the $5,000 available for the year 1961 be used for the services of a technical consultant, for the year July 1, 1961 to June 30, 1962. C. That, pursuant to adoption of A above, Dr. Philip Drinker be engaged as this technical consultant. As a matter of information, agreement has been reached for the subcommittee to meet with a comparable group of the Automobile Manufacturers Association. The subcommittee will report on this meeting in November. C. L. Samuelson, M. D., Chairman API 07693 T :EC?C- 1 --1 'OR TES RESEARCH AND EDUCATIONAL PROGRAM RELATING CO PETROLEUM PRODUCTS AND AIR POLLUTION Charles Hir.es, M. D., Hire Laboratories, Sar. Francisco, California In August, I960, a report of the surgeon general's ad hoc task group on air _.-U'ior. research goals was published. Recommendations were to the effect that research is needed in sene ter. different fields of endeavor relative to the general problem ;Vo.ir pollution, it crier tc solve on a national basis the problems confronting the ;..,-ry regarding air pollution. Goal number one was concerned with the effects of air ution on man, and was stated to embrace determination of the effects of air pollution \ --nan health, the establishment of the identity of agents and mechanisms involved in >e production of these effects, and the identification of pollutants which produced desirable sensory response in human beings together with mechanism of their reaction. joint role and responsibility for research was defined in this report, and it was inT-ated that in order to realize a maximum return both government and industrial resources >ou!d be directed towards the problem and information obtained by industry should be made vailahle for integration with the general fund of knowledge. In addition to public funds -ich will probably exceed one million dollars, funds from other private sources such as '.search fundations and philanthropic organizations were indicated as necessary. The 'die Health Service, at both national and at the State level, have moved ahead rapidly - this area, assuming the role not only as monitor of epidemiological effects and con stant to different administrative units, but also have assumed leadership in initiating search to an extent which has not heretofore been approached. In 1957 the Subcommittee on Atmospheric Pollutants, in order to assess the Erection in which medical research was needed, obtained the services of a consultant, r, Goldblatt (recommended by me), and have subsequently received suggestions regarding .suitable program. Dr. Goldblatt's conclusions are known to you and need not be referred to 'nther here. My group is in agreement with the general areas in which he has indicated m* work could profitably be carried out, and believe that these can be well summarized zto four general areas : I. II. III. IV. Epidemiology Education Toxicological evaluations Chemical research I am proposing that you might wish to consider support of studies along these lr.es insofar as they seem to pertain to the problems of the petroleum industry. 1 Epidemiology The objective of this phase of the study would be to determine what variations --aorbidity and mortality may occur in specific geographic areas according to the use specific fuel sources. We would propose that a professional epidemiologist be re cited for purposes of working out a satsifactory experimental design and implementing a ' study which would be pertinent to geographic areas concerned with oil production and ^cessing, and areas of heavy use of petroleum products in comparison with areas in <5<-5h Dther sources of energy are utilized, and petroleum products are utilized to a esser extent. We would also recommend that an evaluation be undertaken of all the ~rer.t epidemiological studies now being carried Out under U. S. Public Health Service ;;ppcrt as an essential phase of the study in order to evaluate the data and conclusions **-rapo_ated from it with special attention being given to preparation of a report "-ideally assessing these studies. API 07694 glue at ter. The object of this phase of the activity would be to outline a broad scope edu- -ior.al program for the medical profession and the general public with regards to the ^va0ir.ship between the activities of the petroleum industry and the general air Dollutior tw'bls- fsel that it would be desirable to prepare a series of informative, |\lc.jaented articles which would be published in national scientific journals, in different !-'-cad county medical society bulletins, and in state medical journals. We also feel a IEjected educational program should be carried out in critical areas such as Los Angeles I'^i New Orleans, through personal contact of physicians, and repeated meetings with county Ledical society groups. Finally, a series of articles should be prepared for release to 'e newspapers and popular magazines relative to this problem indicating the exact extent If iuiowledge, and the extent to which speculation is engaged in regarding the long term Effects on health. ,-Tl, Toxicological Studies , The objective of this plan of the study would be to obtain additional toxicologic '.nfonnation as regards a number of long term problems. j A. We propose first, a program relative to the long term effects of nitric (;)dde and its possible conversion in situ to N02 in the pulmonary tract in the presence ;f ozone or an oxidant atmosphere. While standard texts state that nitric oxide is of .ittle importance because of its rapid conversion to nitrogen dioxide, the environmental iata obtained in the Los Angeles basin indicates that the preponderant oxide of nitrogen s NO, and that the ratio may vary as much as ten to one in favor of this form. We would suggest setting up a series of experiments using air-way resistance measurements accord ing to the Amdur technique, and/or the uptake of CO or nitrous oxide as a sensitive index f pulmonary exchange. B. A second problem would have for its objective the determination of the ffects of low levels of oxidants of oxides of nitrogen and/or SO2 on absorption and re- :ention of pulmonary carcinogens of the polyaromatic hydrocarbon type. We would suggest :omparison of uptake from the respiratory tract of these compounds both in the intact mimai and one from whom the trachae has been partially isolated, utilizing suitable .racer technique. C. Finally we would propose a project to determine the effects of low levels :f nitric oxide, nitrogen dioxide and sulfur dioxide on specific segments of the popula tion with known deficit in pulmonary function. We would propose to expose suitable jroups of subjects of up to 100 individuals to realistic air levels of these substances and determine pulmonary function by appropriate techniques. J. Chemical Research Our goals in this area would be as follows: A. Study of the formation of sulfuric acid mists from S02- Several studies cave been conducted in this area; however definitive answers are not yet available. The objective of these studies would be to evaluate factors which are important relative to inversion of sulfur dioxide to sulfuric acid mist to determine to what extent this con version may occur. ' B. Persistence of polycyclic carcinogens in the atmosphere. The objective of study would be to determine factors affecting the stability and disappearance of poly cyclic hydrocarbons in the air; also to determine the half-life of these substances under Carious conditions. API 07695 \V \>` TV 3-5 We would be pleased to develop a comprehensive experimental design if your w,,,p is interested in any of these areas in which we have indicated that we believe father work is needed, or other problems. If there are other specific problems on :^ch you would like a recommendation as to research, we would be happy to consider A and cooperate with you in any way possible. ESTIMATED BUDGET REQUIREMENTS X. $25,000 per annum IX. $25,000 per annum j;iX. A. $30,000 B. $15,000 1 C, $18,000 17. A. $20,000 B. $25,000 I i API 07696 I APPENDIX : REPORT OF THE SUBCOMMITTEE ON C9 - Cl2 AROMATICS Kieffer Davis, M. D., Chairman The Subcommittee on C9 - C]_2 Aromatics met in the Denver Hilton Hotel, Denver, Colorado, on Thursday, April 6 , and Friday, April 7, with 15 members or representatives and 25 guests present. A report was received from C. A. Nau, M. D. The work of the past six months has been chiefly on injection of the materials after techniques were worked out. Peripheral blood and bone marrow studies showed significant changes in general, similar to those produced by inhalation. The work was of limited duration and needs to be augmented somewhat, both in time and with respect to tests performed (e.g., pathology of body tissues). Dr. Nau developed a blood test for detection of C ^ i o blood levels v-.ich shows great promise of practical value, both in future experiments and possibly in clinical application. Action was taken to instruct Dr. Nau to extend the work by injection of C ^ i O i-n point of time and the use of at least one other species of animal, and that similar work be undertaken on the Cll,12 sample. Budget requirements for 1 9 6 2 seem adequate in the amount of $10,000 which amount is requested from the MAC. It was proposed that the chairman of the subcommittee appoint a study group to explore the possibility for more precise identification of the compounds in the C9 - C12 aromatic group and the preparation of smaller fractions of these mixtures for future study. T. M. Frank, M. D., Acting Chairman i J I AFI 07697 APPENDIX D REPORT OF THE SUBCOMMITTEE ON DERMATOLOGY Leo J. Wade, M. D., Chairman April 7, 1961 9:00 A, M, MEMBERS PRESENT: W. 0. Armstrong, M. D. C. H. Baylor, M. D, (Acting Chairman) MEMBERS ABSENT: Leo J. Wade,.M. D,, Chairman F. D. Gassaway, M. D. A. E. Dooley B. S. Miller, M. D. T. J. Smith, M. D. I. Prior to the Denver meeting the chairman, Leo J, Wade, M. D., requested Dr. Baylor to preside, in the chairman's absence, and reported to him that no important inquiries, develop ments, or information concerning subcommittee work had occurred since the subcommittee met in Chicago in November, I960. II. III. There have been no further developments in the CIO-UAW matter discussed with Mr. Van Atta by Dr. Wade, Mr. M. D. Gjerde, and Mr. A. E. Dooley 6n October 3, I960. No funds are requested by the subcommittee for 19 6 2. IV. No new business was reported by the members present and, in the absence of a quorum, no action was taken. C. H. Baylor, M. D. Acting Chairman API 07698 APPENDIX E RSPCRT OF THE SUBCOMMITTEE ON PHYSICAL AGENTS G. H. Collings, M. D., Chairman 1- The subcommittee has reviewed a paper by Jones and Church, entitled "A Criterion fz Evaluation of Noise Exposures," published in the American Industrial Hygiene Association Journal, 21:#6:Wl:1960. The subcommittee con siders the method presented here for the evaluation of noise exposures to have possible merit as a guide for standardized practice in the petroleum industry. The subcommittee recognizes that this method has some inherent imperfections ! under certain conditions but these would be offset by advantages to be gained i f from more uniform practice in measuring and evaluating noise throughout the 1- industry and no better method which might be used for this purpose is known to the subcommittee. ' It is our plan, therefore, to recommend to the MAC in November 1961 the publication of this method for noise evaluation as a recommended guide for the petroleum industry. Prior to that time, members of the MAC will be requested to review and try out the method and comment upon its acceptability. The Industrial Hygiene Subcommittee will also be requested to furnish an opinion. 2. The subcommittee recommends that $2,500 be budgeted in 1962 for continued support of Dr. Glorig's work on noise and deafness. G. H. Collings, M. D., Chairman API 07699 APPENDIX ? Z T .- 3 2 ^pCOMMIZTBE_aR SPPPT,r W PT7TR0LEUM PBODUCTS ^ p. M>; A p ril PRESENT: j^tjTw T Adams g, Entwistle 2 , V. Henson, M. D. . R. Miller, M. D. j. H. Mitchell, M. D. ip, G. Rigney, M. D. (rep, H. W. Gerarde, M. D.) p, F. Schneider, M. D.(rep. by N.J.Roberts, M. j/, W. Stewart, M. D. C. S. Baylor, M. D., Chairman ^ D.) ggRS ABSENT: R - C. Cole J ' W. Hammond -SIT0RS: Osborn, M. D. p. 0. Mattocks j, B. Simon, M. D. (Guest of Standard Oil (N.J.) of Paris, France) r . W. Pipkin, M. D. t. The minutes of the meeting of November 12, i960 were approved as submitted. 2 , In an effort to define more clearly the category of specialty petroleum products the Chairman reported replies from the Secretary, Mr. A. A. Mulliken, of the Chemical Specialties Manufacturers Association and the Chairman of the API Petroleum Products Committee, Mr. C, B, Gale - American Oil Company (formerly Standard Oil Company (Indiana)). The situation is not much clearer but apparently the API committee understands the term as a ''marketing expression" and it does not include any petroleum product that sells in large quantities. Exactly what should be included is less well defined. II. In order to keep abreast of the knowledge accumulated by the American Association of Poison Control Centers the Subcommittee now has a member (the chairman) belong ing to that organization. 1. The long-awaited report of Dr. Edward Press on cases of kerosine ingestion has not yet been published as far as the subcommittee can learn. 7. Progress of the Medical Advisory Committee - API Kerosine Project (to determine the best method of treating patients who have ingested kerosine or products containing it with special emphasis on the wisdom of gastric lavage) The study was reactivated in early 1961 when Dr. Gerarde generously agreed to analyze the blood samples sent to him by Dr. Mintz and Dr. McKay from their clinical cases. Dr. Mintz has succeeded Dr. Daeschner as head of Pediatrics at Baylor University, Houston, Texas. Dr. McKay reports that he has observed only 2 cases cf kerosine ingestion so far this year. He attributes the drop in the number of cases to publicity given the subject in his area. Dr. Mintz did not get his project started until March 1. To date, he has submitted no blood samples to Dr. Gerarde. Some are expected shortly. Dr. Nau plans further studies beginning in June and will have 2 or 3 research students working on one or more of the following projects under his supervision: 1. Development of a satisfactory method for determining kerosine levels in blood, He has a method for measuring C9 compounds and hopes it can be adopted to kerosine. API 07700 2 - F-2 2. Try zo correlate blood levels with tissue changes in rats. 3. To determine the reversibility of these changes, 4 . To test the ability of various household substances to delay the absorption of kerosine from the G.I. tract, e.g. olive oil, corn starch, egg white, etc. Dr. Nau expects to work at Galveston (University of Texas) until September 1 and 3t Oklahoma City after that date. ^ Budget - In view of the funds already available to the 3 investigators and the amount of clinical material which will likely be available for study within the next 18 months, the subcommittee requests no additional funds for 1962. *2 No new business was presented and the subcommittee adjourned. C. H. Baylor, M. D., Chairman dendum: Since the above meeting took place, the proposed regulations implementing the Federal Hazardous Substances Labeling Act were published in the Federal Register, April 29, 1 9 6 1 . The Food and Drug Administration proposes that kerosine be labeled as "highly toxic - Poison" with the skull and cross-bones included as part of the label. API 07701 HEPCRT Z? Tn5 SUBCOMMITTEE ON TOXICOLOGICAL REVIEWS H. V. Gerarde, M. D., Chairman Since the November meeting of the Medical Advisory Committee, second drafts of the Toxicological Reviews on Sulfur Dioxide and Sulfuric Acid have been circulated for comment and approval, For Sulfuric Acid, there were 20 approvals, 3 qualified approvals, and k disapprovals. Also circulated were third drafts of Styrene and Cyclohexane. For Styrene there were 16 approvals, 12 qualified approvals, and 2 dis approvals; for Cyclohexane there were 15 approvals, 13 qualified approvals, and 2 disapprovals. The review on Cumene has been rewritten by Professor Drinker and is currently being reviewed by members of the subcommittee. The third draft on Sulfur Dioxide and Sulfuric Acid and the fourth draft on Styrene and Cyclohexane will soon be ready for duplication and re-circulation for approval for publication. H. W. Gerarde, M. D., Chairman Presented by: T. G. Rigney, M. D. * {. \ API 07702 The subcommittee met on April " , 1 9 6 1 , with six members, Prof. Drinker jS -nsultant, and eight guests present. Mr. Eer.dricks, as liaison member, reported no recent activity for the ,,52 Committee of the American Standards Association.` Attached is Mr. Dooley's teport on the Z-37 and Z-U Committees' activities. In Mr. Wilkening's absence, the chairman summarized the subcommittee's progress on the project "Industrial Hygiene Aspects of Petroleum Refining Pro cesses-" Mr. Wilkening is compiling the contributions of the subcommittee members will distribute to them a composite draft in May. It is planned, as was done vith the "Catalyst Project," that the final report will be submitted to the Medical Advisory Committee at the November 1961 meeting, with the recommendation that it be distributed only within the petroleum industry. In Mr. Hammond's absence, the chairman reviewed the liaison activities vlth the Subcommittee on Cg - Cip Aromatics. As yet, no reports have been received from the industrial hygienists on environmental studies. The members were urged to investigate potential problem areas and follow the analytical techniques for air and. blood analyses used by Dr. Nau. The results would supplement the research findings of the C9 - Cp2 subcommittee and so guide the Medical Advisory Committee on this important problem. Mr. Hendricks reported that the Air and Water Conservation Committee has decided against the proposal that the API give financial support to the co operative lead-in-air study being undertaken by the U. S. Public Health Service and participating industrial groups. In view of this development, the question was re-evaluated by the subcommittee. It is the subcommittee's unanimous recommendation that, in view of the Medical Advisory Committee's responsibility on health matters, they seek API participation in this program in the amount of $15,000 total. Next, the chairman mentioned that the Medical and Health Committee had appointed a Special Asphalt Study Committee to evaluate the need to study health problems associated with asphalt. The Industrial Hygiene Subcommittee was instructed to direct to the chairman any ideas or information which would be of value to the asphalt group in their assignment. J. A. Spence, Chairman API 07703 t H-2 Attachment Report to the API Medical Advisory Committee The Z-3T Committee on Maximum Allowable Concentrations of Toxic Dusts and Gases is sponsored by the American Industrial Hygiene Association. Standards have been published for 13 sub stances: carbon monoxide, hydrogen sulfide, carbon bisulfide, manganese, chromic acid and chromates, mercury, lead and certain inorganic compounds, nitrogen dioxide, methanel, formaldehyde, carbon tetrachloride, methyl chloride, and trichloroethylene. The standards for benzene, toluene, and xylene are being printed and will be available in early May. Drafts of standards for tetra- 1 chloroethylene (200 ppm), methylene chloride (500 ppm), methyl bromide (20 ppm), methyl chloroform (500 ppm), and paradichloro- benzene (75 ppm), chlorine (2 ppm), Styrene monomer (UOO ppm), and ethylene dichloride (200 ppm) are in circulation among the sponsor and the various ASA committees which must act on them. The Z - k Comnittee on Industrial Sanitation is being reactivated under its new sponsor, the American Conference of Governmental Industrial Hygienists. This committee published its American Standard on Minimum Requirements for Sanitation in Places of Employment in 1955- A. E. Dooley API 07704 APPENDIX i ZiTERDIVTSIOIIAL COMMITTEE ON LA3ELING - LIAISON REPORT TO MEDICAL ADVISORY COMMITTEE Bulletin 2511 - Letter ballots have been returned, from practically all yners of "cine Ir.terdivisional Committee on Labeling. Some members have suggested that are more than editorial ones and a second letter ballot will be necessary, ^fl'^etter ballot will be sent to the committee members during the latter part of I Federal Labeling Law - Enforcement of the Act for hazardous substances ',-,er than "extremely flammable," "flammable," "highly toxic" has been deferred until 1, 1961. Proposed regulations to implement the Act did not appear in the -deral Register on April 3 or k as expected but should be published within a day or [ Interested persons will be given 60 days to file comments. This time was a ionpromise between the 90-day period requested by industry and the 30-day period imposed by the Food and Drug Administration. The FDA leans toward an oral LD/50 of "grams per hilogram as the top figure for toxic substances rather than the 1 gram , 'ilogram suggested by industry. The FDA will probably insist that the pre- *al.ionary label appear on the front panel of the package. Inter-Industry Association Labeling Committee - Dr. Horace Gerarde has .een made a member of the Toxicity Committee of the Chemical Specialties Manufacturers Association. The CSMA had previously ashed the API to designate a toxicologist with -oviedge of petroleum products to act as a consultant to this committee and Dr. shorn selected Dr. Gerarde last November. The next meeting of the Inter-Industry fflimittee is tentatively set for the middle of May. MCA Labeling Manual - The fifth revision of Manual L-l will probably be ready .'or distribution sometime during this month. State Labeling Legislation - Bills have been introduced in the legislature :f several states this year. The Washington bill was not enacted and the passage of -jje Michigan bill appears doubtful at this time. Leaded Gasoline Labels - Ethyl Corporation has made a sign for use on gaso line storage tanks. It is a 7-inch diamond shaped enameled sign with black letters :n a yellow background. The wording is: "This tank has contained leaded gasoline aming - Do not enter without fresh air mask, special clothing, rubber gloves and r:bber boots." These signs can be obtained from the Ethyl Corporation at twenty-four :ents each. Allan E. Dooley, Chairman Interdivisional Committee on Labeling Presented by: C. H. Baylor, M. D. API 07705 CIL MIST LIAISON C O M M U T E Acting on approval given by the MAC in Novemb Committee is proceeding, as follows: the Oil Mist REPORT PUBLICATION The committee report previously sent to you will be put in proper form for publication and submitted to an appropriate journal, Credit to API will be shown. 2. EPIDEMIOLOGICAL STUDY ' In an effort to set up an epidemiological study of workers exposed to oil mist, the following approaches will be explored: (a) Selected industrial organizations will be contacted. These will be chosen on the basis of those having large groups of potentially exposed workers and having medical records available, and their willingness to cooperate in such a study. (b) Contact will be made with those labor unions whose members work in jobs offering exposure, such as the Machinists' Union, and where sickness or similar records may be available. (c) This will be discussed with the Public Health Service where con siderable interest in the overall problem of oil mist exposure . is evidenced by animal studies now being conducted by Dr. Stockinger. 3. CARCINOGENIC PROPERTIES OF OIL MIST For the time being, this will be followed through epi demiological study that is set up and through the animal inhalation studies now under way b y Dr. Stockinger and those planned by Dr. Vorwald and Prof. Urban. A meeting is to be arranged with Dr. Stockinger to discuss his study methods in terms of evaluating carcinogenic potency. The Oil Mist Committee requests approval of this report. Respectfully submitted, N. V. Hendricks API 07706 1 d APPETTOIX X REPCRT Cl! LIAISON WITH QUARANTINE SERVICE TO MEDICAL ADVISCRY COmi'lT'EE ;3-'5on with the Epidemiology and Domestic Operations Branch, Division of Foreign f^antine of the U.S.P.H.S. has continued. Dr. James G. Telfer remains as Chief of the !-ar,chj with Miss Regina B u m s in charge of the epidemiology and immunization program. i.^e the last report to the MAC, on lb- November i960, there have been numerous communi- .jrions from the Branch concerning disease occurrence, quarantine regulations and immuni3-ion requirements. Some of the information was felt to be of sufficient importance to tje API members to pass on to MAC. Some was not. chronological listing of events is given below: c Jan. 1961 Telephone call from the Branch to inform that as of 15 Jan. 1961 any one entering U.S.A. from Cuba must be in possession of a valid Smallpox vac cination certificate. The MAC was notified through Mr. Mattocks' office. 3 Jan. 1961 ' Telephone call from the Branch informing about an outbreak of influenza (Type A) in England and reported cases in American Samoa and Hawaii (type undetermined). The MAC was informed by letter of 1 Feb. 1961 from Mr. Mattocks. 3 Feb. 1961 Information from the Branch concerning reported outbreak of in Brasil in the Rio area and that quarantine officers were apply "strick surveillance" rules to all arrivals in the U. The MAC was informed through Mr. Mattocks. mild Smallpox requested to S. from Brasil. ;3 Feb. 1961 News articles and radio newscasts of previous few days reporting serious outbreak of human plague in Venezuela prompted a call to the Branch for clarification. The Branch investigated through their intelligence sources and reported back that there was no basis for the rumor which probably had been started as a political maneuver. T Mar. 1961 A memorandum of this date from Miss Regina Burns reporting an outbreak of Smallpox in Madrid and reconmending that all travellers to Madrid have a successful smallpox vaccination within one year prior to departure was transmitted to Mr. Mattocks who, in turn, transmitted the information to the MAC. 23 Mar. 1961 Your liaison representative, while in Washington, had the opportunity to meet for discussions with Dr. Telfer, Miss B u m s , and Dr. Holly, Quarantine Officer at Idlewild. Dr. Telfer would welcome an invitation to meet with the MAC members at some future date. 30 Mar. 1961 Miss Burns called to report that a case of smallpox had been imported into Frankfurt, Germany, on 11 March 1961 on a Pan American flight from Karachi. The patient was taken ill on 19 March, entered hospital on 25 March when the diagnosis was confirmed. No secondary cases had been reported in Germany. The Pan American flight continued on from Frankfurt and entered the U.S. on 11 March. The U.S.P.H.S. was to check the passenger list and investigate all contacts. Recommendations API 07707 It io recommended that: (l) This report be accepted by the MAC and (2 ) Dr. James G. Telfer be invited to meet with the MAC at some future date. G. M. Saunders, M. D., MAC Liaison r 1 APPENDIX L ADVISORY COMMITTEE TO THE WAX RESEARCH PROJECT - LIAISON REPORT TO MEDICAL ADVISORY COMMITTEE ~ In the absence of Dr. Eckardt, Chairman, I am happy to submit a brief report of the activities of the API Wax Research Project. In accordance with the new Food Additives Law, a petition | was filed in February this year with the Food and Drug Administration for a regulation which would permit the use of certain waxes in connection with food, In a sense, the petition was incomplete because (l) some of the two-year animal studies have not been com pleted and the data submitted on this portion of the work, although factual, undoubtedly will not be accepted before the two-year period is up; and (2) a very short and proper analytical method for testing waxes has not yet been devised. The method submitted as a part of the petition is a lengthy one requiring days for completion. From past experience, the Food and Drug people will desire to have an analytical method that will require only a few hours for completion. On the basis of a letter from the Food and Drug Administration, petroleum waxes are now eligible for an extension of time, since the enactment of the transitional amendment to the Food Additives Law. We are confident that the data already developed, plus that which will result from the long-term animal experimental work and a concise analytical method for testing waxes which will be resolved before long, will allow this research group to present a completed petition that will be accepted by the Food and Drug Administration, to the end that a regulation will be written for the use of certain waxes in connection with food. Presented by: George Saunders, M. D. MAC Liaison Member I i API 07708