Document R5vggzn2vEVYzjgzp7waJGBE

The Cosmetic Toiletry and Fragrance Association Inc. 1133 15th STREET N.W. WASHINGTON D.C. 20005 - 331-1770 - TELEX 89-2673 - James H. Merritt President March 1 1977 . ; Norman F. Estrin Ph.D. Vice President E. Edward Kavanaugh Vice PresidentCongressional Relations MINUTES Margaret W. Smith . Executive Secretary . PHARMACOLOGY & TOXICOLOGY INDUSTRY AEROSOL SAFETY COMMITTEES joint A meeting of the Pharmacology & Toxicology and the Inter- Industry Aerosol Safety Committees was held on Februar 1y6 1977 at the CTFA offices Washington D. .. Those in attendance were Yale Gressel Avon Products Tom Anthony Dow Chemical Inc. CHAIRMAN CHAIRMAN Brad Arthur Frank Baker Eli Lilly Procter & Gamble Co. Richard Bourne Lehn & Fink John Clayton Plough Inc. Neal Corbin Armour Salvatore DeSalva Palmolive John McClement New York University Francis Mina Hoffmann Theodore Myers Vick Divisions Research Richard Schnetzinger Revlon Henry Trochimowicz DuPont Leonard Vinson Lever Bros. Kenneth Vos S. C. Johnson & Son John Willson Johnson & Johnson Inc. Richard Witkowski Faberge Inc. George Wolcott John H. Breck Ronald Wulf Wallace Ernst Zander Sterling Drug Norman Estrin CTFA James McNerney CTFA . I. Opening Remarks Chairman Gressel welcomed attendees who were new to the the members group and introduced ; three . Theodore Myers Vick Chemical Company - who recently the CTFA Pharmacology and Toxicology Committee joined John Clayton Marlowe Plough Inc. - who . recently replaced Edward Neal Corbin Armour Research Center who represented Joseph Hiddemen Protected Document to Protective Order 0099052 JNJ 000684352 Page 2 The minutes immediately Dr. DeSalva city test of the January 20 1977 meeting were distributed prior to this meeting The only comment was from who requested information on an vitro mutageni- II Report on SAC and TAC Meetings Chairman Gressel discusse thde highlights of the Scientific Advisory Committee February 2 and the Technical Advisory Committee February 1 meetings Mr. McNerney will distri- bute copies of minutes this was done under separate cover III Eye Area Cosmetic Safety Dr. Estrin reported on the status of the work of Wilson and Aherne who are investigating cases of possible blindness alledgedly due to the use of eye area cosmetics Heinz Eierman of FDA considers the problem to be the result of in- adequate preservatives FDA has a list of injury complaints companies and batch numbers See SAC Minutes referred to above and it has been heard that FDA is considering seizure of products directly implicated in the blindness cases IV A meeting of the CTFA Eye Area Cosmetic be held at CTFA on February 17 1977 Safety Task Force will Bubble Bath Warning Statements Dr. Estrin reported on the FDA proposal to require a caution statement on labels of cosmetic bubble bath products which was published in the Federal Register of January 28 1977 Comments are due on or before March 29 1977. Dr. Lapides an internationally known urologist from the University of Michigan has offered his services to refute FDA A CTFA task force is being organized by Mr. Edward Kavanaugh and will have their first meeting in New York City on February 1977. They have a need for scientific input and the Pharma- 22 cology and Toxicology Committee was asked for liaison partici- pation Dr. DeSalva Dr. Vinson and Mr. Bourne volunteered and Dr. Wolcott recommended Dr. Coscarelli who will contact Mr. McNerney will so inform Mr. Kavanaugh and obtain meeting arrangement details for the volunteers V. Color Additive Research Program Chairman Gressel briefly reviewed the research requirements for the continued provisional listing of 32 color additives which are referred to in the February 4 1977 Federal Register and which were discussed in detail with the FDA during a meeting with the Industry Color Task Force on February 14 1977 The research program will entail lifetime feeding studies in mice and lifetime utero feeding studies in rats for 16 color additives In order to cope with this enormous under- taking the Industry Color Task Force has asked the Pharmacology and Toxicology Committee for assistance in monitor- ing the program , , Protected Document to Protective Order 0099053 JNJ 000684353 ? ave ve. V. Cont'd There were no volunteers however the members will determine if there are any of their staff personnel who could and would participate Interested parties should contact Mr. McNerney as soon as possible Chairman Gressel has volunteer- ed a member of his staff VI Several members of be given to hiring toxicologists the Committee suggested that consideration consultants for this task possibly retired Aerosol Safety A. Propellants 1 Proposed MCA Technical Panel - Mr. McNerney reported that Dr. Daly was not able to attend but had given him a brief report via telephone There has been little progress with establishing the alternate propellant toxicity research program See Minutes of January 20 1977 Meeting which has been proposed by DuPont for joint funding by suppliers through MCA Approximately half of the proposed funding has been committed DuPont apparently intends to carry out the program with whatever joint support that can be mustered Dr. Trochimowicz reported on a seminar that Dr. Bruce Ames presented at Haskell Laboratories Representatives of Allied Chemical and ICI participated and the details of the Modified for vapors Ames Test on propellants were discussed with Dr. Ames who said the data appeared alright Modified Dr. Ames Trochimowicz also Test as conducted reported that in the there was a plateau in the number of revertants between 24 and 48 hours and a marked increase at 72 hours indicating that an extraneous toxic effect may be occurring at 72 hours and perhaps the test should be limited to 48 hours The protocol for the Modified Ames Test will be presented at the forthcoming Environmental Mutagen Society Meeting to determine its acceptability by the Society members In response to the studies conducted at Frederick Cancer Research Center which were noted during the January 20 meeting Dr. Trochimowicz reported that the investigator had exposed the culture media for hours and then in- troduced the bacteria thereby making the test and the negative results suspect 2 Hydrocarbon Toxicity Task Force - In the absencoe f Task Force Chairman McDermott Mr. McNerney reported that several members of the task force met informally with Dr. Carrol Kerwin Toxicologist for Phillips Petroleum Company at the Toxicology Forum conference February 7-9 Protected Document to Protective Order 0099054 JNJ 000684354 J - . Page 4 VI Cont'd 2. Cont'd A tentative meeting tatives of Phillips upon Mr. McNerney between task force and represenand possibly Aeropres was agreed will coordinate the meeting In a subsequent conversation with Dr. Kerwin Mr. McNerney learned that Phillips primarily concerned with occupational exposures to hydrocarbons and would only be interested in sponsoring toxicity studies which could be related to worker exposure not product ex- posure by consumers The committee discussed this limited interest on the part of a supplier and agreed that a close liaison between both groups would still be mutually beneficial Chairman Gressel reported that both regular 6 hour modified 72 hour Ames Tests on butane propane and and isobutane which Avon had sponsoreadt SRI were negative He will distribute the report when issued He also will distribute the list of 130 chemicals which were studied by ICI Ltd. in their battery of six short term tests for carcinogenicity 3 Methylene - Chloride Jessie Norris was not able to attend In her absence Tom Anthony of Dow Chemical U.S.A. pre- methylene sented an update on toxicity studies on ide A list of studies was distributed and it is chlor- being sent the committee under separate cover Mr. Anthony presentation included the following a Dow's month inhalation studiys several weeks from the 12 month sacrifice Animals are being exposed to 500 1500 and 3000 ppm 6 hours per day 5 days per week_ b The National Coffee Association NCA is sponsoring long term feeding studies Methylene Chloride is the only chemical used for decaffination c The NCI studies at Gulf South Research Institute have been terminated and the histopathology evaluations are underway d Dr. Shimken has conducted a pulmonary adenoma screen- ing study in susceptible mice for NCI are equivocal The results e Dow suspects the positive results that SRI has obtained with the Ames Test are due to a questionable sample that they have been using A pure sample was shipped from Dow to SRI approximately two weeks ago Protected Document to Protective Order 0099055 JNJ 000684355 Page 5 3. Cont'd f A Russian paper on the lack of a mutagenic effect paper in drosophila was referred to A copy of the is being distributed under separate cover g Methylene chloride doesn't have sufficient vapor pressure to be used alone as a propellant However many manufacturers are mixing it with hydrocarbon and propellant systems e.g. 15-20 in hairsprays 10-21 in antiperspirants B. Particulate Testing Program In the absence of Task Force Chairman Hardy Mr. McNerney reported that the task force had met on January 14 1977 to review each member's suggested protocols and comments and had developed the essential componants of a draft Dr. Hardy and Mr. McNerney met on February 10 1977 and prepared the initial draft which was distributed to the committee at this meeting A copy is being sent to each member under separate cover The committee discusstehde study of household products in this program Dr. Mina informed the committee that the CSMA Aerosol ing on March Divisions Scientific Committee would be meet1 1977 and could consider participating in the program at that time Mr. McNerney supplied Dr. Mina with sufficient numbers of copies of the draft protocol for CSMA's considerations up fol ow follow fosltloawtus Chairman Gressel informed the committee that he had discuss- ed the possibility of studying talc in the particulate test- ing program with Dr. Petterson of Johnson & Johnson Dr. Petterson believes we should further since based upon the not consider testing talc any extensive data on hand the OTC Antiperspirant Panel has placed cosmetic talc into : Category I. He is going to send Dr. the submission that was presented to be available for distribution Gressel a the Panel copy of and it will Mr. McNerney and Dr. Wulf noted that there is still a need by the task force for data on the concentration of active ingredientisn hairsprays and antiperspirants to which consumers are exposed during normal use conditions These appropriate data will be helpful to the task force in setting dosage levels C. Research Program Status Reports 1. University of Washington Epidemiology Study -Mr McNerney reported that he had discussed the status of the final report with Carrie Hall via telephone on February 11 and was informed that a It will take Ms. Hall approximately two weeks to pre- pare and ship requested the computer runs that Dr. Discher had Protected Document to Protective Order 0099056 JNJ 000684356 , Page 6 . b She estimates that she will have between 3,000 of remaining funds after supplying with the computer runs 2,500 and Dr. Discher c Dr. Discher estimates it will cost 3,500 to set print 20 copies of a draft of a final report plus another 2,500 to prepare the polished final report Ms. Hall and Mr. McNerney agreed that considering the costs involved perhaps a typewritten very rough first draft could be submitted and CTFA could prepare and distribute copies to the committee for review d Ms. Hall requested the committee's recommendation on whether the final report should include data on preg- nancy history Apparently this section of the ques- tionnaire was added by the investigator when the results of a study which indicated a greater incidence of miscarriages among operating room personnel than the general Wolcott nor public any of were published Neither Dr. the attendees could recall any discussion or agreement with the investigator to explore this area Dr. Wolcott will determine the circumstances surrounding the acquisition of these data and report on it at the next meeting Dr. Estrin noted that he was concerned about the committee's decisioonn the sputum cytology problem He is aware of Dr. Saccamanno's strong feeling concerning the poor quality of the specimens but believes both the Schweide and Sacca- manno interpretations should be presented in the report together with the investigator's evaluation Mr. McNerney reported that following a phone discussion between Dr. Discher and Dr. Lanman he had written a letter to Dr. Discher informing him of the committee's deliberation on this matter raising the possibility of a third party review . See Attachme1 nt Dr. further and report back Wolcott will ve explore : the problem 2 Medical College of Wisconsin Hydrocarbon Study - Mr. McNerney reported that the contractual status of this project had been determined as requested by committee at the January 20 1977 meeting and Mr. Merritt issued an appropriate letter See Attachment 2 The letter apparently was effective because Dr. Stewart presented Dr. Vos with three copies of the draft final report Acute and Repetitive Human Exposure to Isobutane and Propaneoriginal Dr. Vos reported that Dr. Stewart had suggested that the original task force review the draft and that the review expedited because he would like to publish it as soon as possible To the best of the attendees recollection the task force consisted of George Kitzke Paul Finkelstein and Jessie Norris Two of the copies were given to Dr. Willson and Mr. Anthony who would deliver them to Dr. Finkelstein and Ms. Norris respectively Mr. McNerney will make a copy of the third report and send it to Dr. Vos for his and Dr. Kitzke's review Protected Document to Protective Order 0099057 JNJ 000684357 Page 7 3 Lovelace Foundation Propelled Cosmetics Study Mr. McNerney reported that the Particulate Testing Protocol Task Force was unable to visit Lovelace at the time of the Scottsdale <_): meeting because it coincided with an FDA site visit Another visit is being planned for March prior to the Society of Toxicology meeting Mr. McNerney will arrange the visit and contact the task force members 4 Aviado Studies - Dr. Wulf reported on a visit that he Mr. Troy and Mr. McNerney had made to Dr. Aviado's laboratories at the University of Pennsylvania on January 25 1977 Dr. Aviado's contract with FDA for the study ofpropellants will terminate in July or August and no future work is of planned He and his staff are conducting studies correlating the chemical properties chemicals with their biological effects in vitro and vivo systems Dr. Aviado does not have the chronic inhalation testing capability that would be applicable to the needs of the particulate testing program VII Pharmacology and Toxicology A. Good Laboratory Practices Task Force Chairman John Willson reported that FDA was yester- holding public hearings on this proposed regulation yesterday and today Since CTFA management wanted comments this week the task force met after dinner last night and finished a rough draft The draft will be reviewed by the CTFA Government Relations Committee at the Boca Raton meet- ing Copies will be distributed to the Pharmacology and . Toxicology Committee for their review and and the Scientific Advisory Committee comment The final comments will be submitted to FDA on or before March 21 1977 B. Safety Testing Guidelines In the absence of Task Force Chairman Mark Taylor Mr. McNerney reported that the January 10 1977 meeting of the task force was cancelled because of snow and it has not met since The committee discussed the original purpose test procedures for reference by OTC Panels and current needs assistance to CTFA member companies in safety substantiation of their products It was agreed that the current need was pressing and a deadline of six weeks should be set to have a draft in the hands of the committee Chairman Gressel will so inform Mr. Taylor C. Mutagenicity Task Force Chairman Gressel reported that Drs McDermott Trochimo- wicz and Gilman would represent the committee on the joint task force with members of the Microbiology Committee The Microbiology Committee has appointed four members one being from Clairol therefore Mr. Burnett will not represent the Pharmacology and Toxicology Committee Dr. Gressel will contact Chairman Rodgers of the Microbiology Committee and arrange the initial meeting : Protected Document to Protective Order 0099058 JNJ 000684358 Page 8 D. Toxicology Forum - Short Term Tests for Carcinogenicity . Mr. McNerney summarized the conference which was held at Hunt Valley Maryland from February 7-9 1977 E. OTC Drug Review 1. Antiperspirant Panel - Dr. Baker reported that the pertinent developments at the February 3-4 1977 Panel meeting included a The original dose levels for the long term animal inhalation test should be changed from 10x 100x and 1000x to 1X use dose 10x and 100X b There were no changes of products and categories c The new CTFA nomenclature was adopted d No final decision on the criteri foar extra strength claims but probably will be tied to perception e The Panel has cancelled its next meeting which was scheduled for March 31 - April 1 1977. They requested that the preliminary draft as changed be retyped and sent to all members for their review Following this a meeting would be scheduled 2. Topical Analgesic etc. Panel It was reported that several companies are participating in a collaborative study to determine company variability in testing sunscreen lotions F. Cosmetic Ingredient Review Program Chairman Gressel led a discussion of the Pharmacology and Toxicology Committee's role in the CIR program In summary the committee wishes to participate but would need more information before a role could be defined e.g. how many in- gredients are to be reviewed concurrentl anyd what will be the procedure to be followed after an ingredient is placed in Category III by the Panel Dr. Estrin discussed procedures that he has proposed as an industry response to the CIR program These are currently being reviewed by CTFA staff and legal counsel G. Society of Toxicology Meeting Dr. Trochimowicz The and his staff submitted abstracts of two papers which are presenting Dr. Vos submitted an abstract of a paper by the staff of the Medical College of ~ Wisconsin and S. C. Johnson Company Copieosf stracts were distributed at the meeting and are sent to each member under separate cover these ab- also being Protected Document to Protective Order 0099059 JNJ 000684359 Page 9 G. Cont'd Mr. McNerney offered to committee's task forces with the meeting coordinate would like any meetings that the to hold in conjunction H. New Business 1. Bismuth Oxychloride - It was reported that based upon| an article on the toxicity of bismuth in Lancet Japan is considering regulatory action against bismuth oxy- chloride VIII Future Meetings Adjournment March 16 April 20 May 18 June 15-16 July 20 August . September 21 October 16-18 November 16 December 14 Bristol NYC CTFA Washington D.C. Palmolive Research Center Piscataway New Jersey DuPont Wilmington Delaware Avon NYC No Meeting CTFA Washington D.C. CTFA Scientific Conference Dallas Meeting date to be arranged CTFA Washington D.C. Bristol NYC Texas Note 2 days Meeting on 15th tour of Haskell Laboratories on 16th - additional details later There being no further business the meeting was adjourned James M. McNerneyToxicology Director of Toxicology JMM Attachments Protected Document to Protective Order 0099060 JNJ 000684360