Document 8VQ13BXL5ad7xqyDawQJXQOR5

FILE NAME Talc TALC DATE 1973 Aug 31 DOC TALC458 DOCUMENT DESCRIPTION Letter to FDA from M 8/31/73 | . ALEXANDER M. SCHMIDT " COMMISSIONER , FOOD AND DRUG ADMINISTRATION * 5600 FISHERS LANE ROCKVILLE , MARYLAND 20852 , JOHNS MANVILLE APPRECTATES YOUR PROMPT|. RESPONSE TO MR PERRY MARTINSON'S | TELEGRAM OF 8-24-73 MAY I REITERATE THAT IF FINAL FDA REGULATIONS ARE ADOPTED PROHIBITING THE USE OF TALC CONTAINING ASBESTOS IN FOOD AND FOOD PACKAGING MATERIALS UNLESS THE TALC IS 99.9 FREE OF AMPHIBOLE ASBESTOS FIBERS AND 99.99 FREE OF CHRYSOTILE ASBESTOS FIBERS THE MERE PUBLICATION OF SUCH REGULATIONS IN THE FEDERAL REGISTER WILL CAUSE IRREPARABLE . AND IRREVERSIBLE HARM TO MANVILLE AND OTHER COMPANIES IN THE TALC INDUSTRY UNDERSTAND WE THAT FDA IS PROPOSING TO USE A TEST METHOD EN- TITLED MICROSCOPIC DETECTION OF ASBESTOS IN TALC FORMULATED | BY ARNOLD E. SCHULZE AND WILLIAM V. EISENBERG TO DETECT THE PRESENCE OF ASBESTOS IN TALC PURSUANT TO THE CONTEMPLATED REGULATIONS AND THAT FDA IS OF THE OPINION THAT ALL FOOD GRADE TALC WILL PASS THIS TEST USING THE DESCRIBED METHOD - MANVILLE'S RESEARCH CENTER HAS ANALYZED OUR TALC USING NOT THIS TEST METHOD AND OUR TALCDOESDOES MANY OTHER WILL THE TALC PRODUCED BY PASSPASS THISTEST NOR COMPANIES PASS THIS TEST CRMC WE HAVE OBSERVED MARKED AND SERIOUS INCONSISTENCIES BETWEEN THE PROPOSED SPECIFICATION AND THE PROPOSED TEST PROCEDURE IN THE INTEREST OFFDA AND THE INDUSTRIES INVOLVED THESE INCONSISTENCIES SHOULD BE ANALYZED AND RESOLVED PRIOR TO PUBLICATION OF ANY REGULATIONS THE PROPOSED TEST WOULD REQUIRE A DEGREE OF PURITY WHICH EVEN THE FINEST GRADE OF a ANALYTICAL REAGENTS CANNOT BE ASSURED OF MEETING OBVIOUSLY WE ARE NOT COMMUNICATING EFFECTIVELY ON TECHNICAL AND SCIENTIFIC PROCEDURES SUCH COMM NICATIONS ARE ABSOLUTELY ESSENTIAL IF WE ARE TO AVOID INADVERTANTLY CAUSING IRREPARABLE HARM DUE TO A LACK OF UNDERSTANDING WE RESPECTFULLY SUGGEST THAT THE MEDICAL AND SCIENTIFIC LITERATURE IS DEVOID OF ANY EVIDENCE WHATSOEVER OF A CAUSAL RELATION- - SHIP BETWEEN THE INGESTION OF TREMOLITE THE MOST COMMON- ASBESTOS CONSTITUENT OF COMMERCIAL TALC AND ANY INCREASED INCIDENCE OF GASTROINTESTINAL CANCER AMONG INDIVIDUALS EXPOSED FOR PERIODS IN EXCESS OF 25 YEARS TO TALC CONTAINING UP TO 70 TREMOLITE WE SPECIFICALLY INVITE YOUR CAREFUL ATTENTION TO THE EPIDEMIO- LOGICAL STUDIES CONDUCTED BY DR MORRIS KLEINFELD ET AL 1967 MORTALITY AMONG TALC MINERS AND MILLERS IN NEW YORK STATE ARCHIVES OF ENVIRONMENTAL HEALTH 14 663-667 AND TO DR KLEINFELD'S KLEINFELD'S TO LETTER JOINS MANVILLE JANUARY DATED | 24 1973 A COPY OF WHICH WAS ATTACHED TO MANVILLE'S COMMENTS TO FDA DATED APRIL 20 1973 AS EXHIBIT G. -2- -2- 000090 THE SOLE EPIDEMIOLOGICAL OF STUDY WORKERS OCCUPATIONALLY EX- TO TREMOLITE WAS CONDUCTED BY DR KLEINFELD POSED | HE CONCLUDED AS FOLLOWS : WITH REGARD |TO CANCER OF THE GASTROINTESTINAL TRACT AND PERITONEUM AMONG THE TALC WORKERS WE DID NOT FINAD NY SIGNIFICANT DIFFERENCES BETWEEN THE OBSERVED AND EXPECTED VALUES IN THE OVERALL AND SPECIFIC AGE GROUPS STUDIED THESE FINDINGS DIFFER FROM THOSE OBSERVED IN INSULATORS ASBESTOS A INCREASE IN THE OBSERVED IN- SIGNISFIGINCIFAICNANTT CIDENCE OF GASTROINTESTINAL MALIGNANCY WAS FOUND OVERALL IN THE AND SPECIFIC AGE GROUP STUDIED BY ' US PREVIOUSLY ASBESTOS THE DUST EXPOSURE AMONG INSULATORS IS CHIEFLY CHRYSOTILE OUR FINDINGS AMONG ASBESTOS INSULATORS WAS TO SIMILAR THOSE REPORTED BY SELIKOFF , , HAMMOND AND CHURG STUDIES CONDUCTED BY SELIKOFF AND AS OTHERS TO BIOLOGICAL EFFECT OF CROCIDOLITE AMOSITE AND CHRYSOTILE CANNOT BE VALIDLY RELATED TO TREMOLITE WHICH IS PHYSICALLY AND CHEMICALLY DIVERGENT FROM THOSE MINERALS IT WOULD BE SCIENTIFICALLY IRRESPONSIBLE TO INCRIMINATE TREMOLITE AS A HEALTH HAZARD ON THE BASIS OF THE SELIKOFF STUDIES AND FINDINGS OF THE SOLE SCIENTIFIC STUDY ON TO THE GENERAL PUBI IN THE FACE OF THE THE QUESTION WHICH CANCER AMONG WORKERS CONCLUDED NO EXCESS OF GASTROINTESTINAL OCCUPATIONALLY EXPOSETDO TREMOLITE TALC IT MUST BE NOTED en -3- CRMC 0091 GASTROINTES THAT ALL THE STUDIES INDICATING ANY SORT OF EXCESS AMOSITE CANCER RELATED TO CROCIDOLITE TINAL CONCLUDED NOT TOTREMOLITE | AS DR GEORGE WRIGHT ATTACHED AS EXHIBIT E TO OUR COMMENTS , IT AND CHRYSOTILE AND IN HIS PAPER WOULD BE MOST UNSCI- CHRYSOTILE ENTIFIC AND IN FACT NOT AT ALL CORRECT TO ASSUME THAT TRCERMOO-LITP - HAS THE SAME PROPERTIES IN THIS REGARD AS DO CIDOLITE AND AMOSITE IN AVAILABLE AT WRIGHT STATES IN HIS PAPER THE EVIDENCE AS DR ASBESTOS INDICATES THAT THE ROLE OF THIS TIME CLEARLY VARIES FROM IMPORTANT TO EXISTENT | DEPENDENT CARCINOGENESIS FIBER IS AND ESPECIALLY UPON THE CIRCUMSTANCES UPON THE VARIETY OF IN ALL EXPOSURE THE ASSUMPTION THAT ASBESTOS OF OCCUPATIONAL OF ITS VARIED FORMS AND USES IS UNIFORMLY CARCINOGENIC NOT TREMOLITE VALID BOTH AND ANTHOPHYLIHTAVEE BEEN SHOWN TO OF EITHER MESOTHELIOMA BE FREE OF ASSOCIATION WITH AN EXCESS OR GASTROINTESTINAL CANCER TO YOU WE ARE SENDING DR KLEINPELD'S PAPER . BY MAIL COPIES OF DR WRIGHT'S AND LETTER TO JOHNS MANVILLE ) PAPER AND BELIEVE WE FIRMLY THAT A THOROUGH ANALYSIS OF THE MEDICAL AND LITERATURE LEAD SCIENTIFIC ON ASBESTOS AND HEALTH WILL FDA TO_ FURTHER REGULATIONS OF THE USE OF TALC THE CONCLUSION THAT NO MATERIAL IS CONTAINING TREMOLITE IN POOD AND FOOD PACKAGING WARRANTED CRMC re Ue PAE IMPORTANT YOU ARE NO DOUBT AWARE OF THE JOINT SYMPOSIUM OF THE | EPA AND NETUIS CALLED BY DR SELIKOFF FOR NOVEMBER 19 AND 20 ON THE EFFECTS OF INGESTION OF INORGANIC PARTICALS AT WHICH ALL LEADING SCIENTISTS IN THIS FIELD WILL BE EXPECTED TO ATTEND MANVILLE RESPECTFULLY REQUESTS THE FOLLOWING ACTION BY THE FDA , FIRST THE FDA ISREQUESTED TO INVITE QUALIFIED SCIENTIFIC MANVILLE PERSONNEL OF AND OTHER INDUSTRY LEADERS TO MEET WITH SCIENTISTS IN THE FDA TO ESTABLISH REASONABLE _ LIMITATIONS ON TREMOLITIC TALC AS AN INCIDENTAL FOOD ADDATIVE AND TO FORMULATE RESPONSIBLE TEST METHODS IN THAT REGARD SECOND THE FDA PARTICIPATE IN THE JOINT SYMPOSIUM OF THE NEIHS AND EPA REGULATIONS THIRD . NO FINAL OR PROPOSED ON THE USE OF TALCIN FOOD PROCESSINOGR PACKING BE DISSEMINATEDISSEMINATED UNTIL THE RESULTS OF THOSE SYMPOSIUM DELIBERATIONS ARE KNOWN - OR FOURTH IN THE EVENT ACTION DETRIMENTAL TO JOHNS MANVILLE THE TALC INDUSTRY IS PROPOSED OPPORTUNITY TO DISCUSS SUCH ACTION WITH THE FDA BE AFFORDED JOHNS MANVILLE PRIOR TO PUB- LICATION 000093 | I WOULD GREATLY APPRECIATE YOUR SYMPATHETIC CONSIDERATION OF THESE REQUESTS | AND YOUR RECOGNITION OF THE GENUINE CONCERN _ HAS _ MANVILLE THAT RUMORED ACTIONS BY THE FDA IF TRUE , WOULD ON THE BASIS OF HIGHLY SUSPECT DATA UNNECESSARILY INDUSTRY DESTROY AN WITH A LONG HISTORY OF OPERATIONS FREE o OF HEALTH HAZARDS WE AGAIN PLEDGE FULLCOOPERATION WITH THE FDA IN CONDUCTING WHATEVER STUDIES MAY PE REASONABLY REQUESTED TO ESTABLISH THE BIOLOGICAL EFFECTS OF TREMOLITE ON HUMANS WHEN INGESTED I WOULD APPRECIATE HAVING A RESPONSE FROM YOU TO THIS TELEGRAM AND AM AT YOUR DISPOSAL IN THE EVENT FURTHER DISCUSSIONS WOULD BE HELPFUILN REACHING A RESPONSIBLE CONCLUSION TO THIS MATTER SINCERELY YOURS ; FREDRICK L. PUNDSACK , PH.D.PH.D. _ . SENIOR VICE PRESIDENT RESEARCH AND DEVELOPMENT _ MANVILLE CORPORATION a 000094