Document 3J0OvEbERzZ4kvzD7Vvpyxr0

/ HAZLETON LABORATORIES AMERICA, INC. 9 2 0 0 Leesburg Turnpike Vienna. Virginia 22180 U.S.A. Telex: 8 9 9 4 3 6 (Hazlabs Vina) Phone: (703) 893-5400 Cable: Haz/abs Wash.D.C. Richard R. Bates, M.D. - . Chairman, Toxicology Advisory Committee Acting Associate Commissioner for Science Food and Drug Administration 560 0 Fishers Lane Rockville, Maryland 20852 June b , 1976 Dear Dr. Bates: x . On May 8, at the Toxicology Advisory Committee Meeting On "Lead . in Bahy and Infant Food," I had the privilege of meeting you and presenting an abbreviated summary of some of the investigative work that I have carried Out in the area of human body burden of lead and other trace metals. I feel very privileged to have heard Commissioner Schmidt's talk to the Committee, and I also realize that the time he took to make his remarks changed the plans scheduled for the meeting. Perhaps if we were able to - have maintained the presentations as scheduled, I would not have been frus trated by my concern that the Committee was not able to consider. the many scientific concerns in this complex area of allowable exposure to lead. In my frustration I attempted to present a rather hurried summary of a number of points salient tothe objectives of this Committee. As I indicated, some of these points related to my published data, but a good many related to the Kehoe data which X presented orally last spring at the Society of Toxicologists meeting. Dr. Kehoe's data represents 21,000 days of measured ` exposure to lead in eighteen individuals, four of which were involved in the measurement of oral lead balance and fourteen of which were involved in both oral and inhaled, lead balance. Since the report on the Kehoe data will not be available in published form for many months, I would like to summarize some of the findings for the Committee either through a presen tation or perhaps through communications with Dr. Mahaffey. As you may know, I observed at the meeting that none of the members of the Committee were from industry. I was told that this was because of the problem of "conflict of interest." Having spent a considerable amount of my training and experience in the academic circles, I feel that there are a number of toxicologists (hopefully including myself) in the research in dustry (such as Hazleton Laboratories) and especially in the chemical inCs? dustries who can present important views which go beyond the usual academic perspectives. KE 00004 Having been associated with a large number of different individuals who have been active in lead research for the last eight years, I have come to appreciate the fact that those who depend solely on the written literature for their information on the health hazards of lead will automatically end up with an alannist position. This is because of the nature of the infor mation which tends to be acceptable for publication. That is, negative European Laboratories Phone: (0423) 67265 Bichard B. Bates, M.D. June 4, 1976 page 2 . . - results (lack of toxicity) rarely attract enough attention for finanical support or for publication purposes. Thus there are a very large number of people who read such literature in contrast to the very few people who have extensive experience in evaluating the effects of lead exposure in humans. One of my close associates, Dr. Kehoe, more than anybody else I know, has had more experience in observing the health effect of lead in humans. Since the Committee members did'not seem to include an individual with direct experience in lead, I hope that it Will avail themselves of the few lead specialists who have such experience. I am enclosing my curriculum vitae for your information and will be glad to address the Committee or present my data in any way that may be of help. ' Sincerely, Stanley B. Gross, Ph.D. Senior Besearch Scientist enclosure cc: Trs. Schmidt, Mahaffey, Kehoe and Mr. Donald Neilson 0000426