Document 9L8JNkX64vj9kvmYrNE79q25

FILE NAME: CTFA (CTFA) DATE: 1977 CTFA032 DOC#: CTFA032 DOCUMENT DESCRIPTION: Articles from Trade Journal { together with their requested classification. The German Dyestuff Commission already has our safety data for these colors and, I feet that in the interest o f international coop eration, and i f the toxicological data supports it, we can expect early listing o f such colors as FD&C Green 3, D&C Red 17, D&C Red 31, D&C Red 33, D&C Red 6, D&C Blue ,6, D&C Orange 17 and External D&C V iolet 2. Further more, the Commission can be requested to broaden allowed uses o f such colors as FD & C Blue 1. The meeting closed with a call fo r continued Interna-, tional exchange o f scientific information. The success o f this meeting was made possible by a large number o f people, too many to name here. However, three men deserve special thanks. Dr. Opdyke's contribution was enormous in magnitude. His many months o f work in studying data and in develop ing strategy fo r the meeting, as well as his fantastic per formance throughout the meeting doubtlessly had a great effect on its outcome. Dr. Goswin Van Ham o f Margaret Astor Cosmetics in Germany, and Dr. Otto Jacobi o f Kolmar Laboratories, came to the U.S. for the express purpose o f painstakenly examining our data and translating it into tables in German for consideration by the Commission. The cosmetic industry owes these men and our friends in Germany a debt o f gratitude for their efforts on its behalf. CTFA-FDA -- Scientific Liaison Dr. Harold Schwartz* Since the last Scientific Conference, three meetings o f : the CTFA-FDA Scientific Liaison Committee were held. I t has been most interesting and certainly gratifying in many ways; interesting because each meeting brought forth new questions, problems, and occasionally even resolutions o f some o f those problems; gratifying because I believe for the first time, sound scientific discussion represented the atmosphere at our meetings. I t is my recollection that approximately thirty different subjects were thoroughly discussed. From our ingredient survey to such widely diverse subjects as chloroform use in toiletries, bubble baths, color petitions, mercury in cosmet-* *The Mennen Company, Morristown, N .J, 07960 ics, microbiology, etc., were discussed. When requjl problems were studied in separate sessions. Very o fte n j J subject matter became so deep and so Important to f one, that a special committee o f scientists was required, we brought in people from outside In order to assist \ necessary. For example, when the question of asbestos in talc c up, people who were Interested in talc and who werej perts in the field o f analysis o f talc were brought in so fl the subject could be thoroughly handled on a scieni basis. Dr. George Wolcott mentioned how a group \ formed in order to study chloroform in toiletries, espei in dentrifices. Hexachlorophene and other subjects 1 discussed at these joint meetings held by scientists and I, by compliance people. I really have to emphasize this cause I think our biggest hang-up when we first started to determine that this committee would meet and dis only on a scientific basis and certainly not on a legal or o f compliance basis. I believe, certainly in the last year, t we have been conducting our business in that manner. Much o f the success o f our committee is due to | participants. Through the leadership o f Commissioner Edwards! his staff, Dr. Wodicka, Dr. Schaffner, and all other F | participants, a willingness to deal with scientific pro] on a scientific basis has been demonstrated. Additionally, accolades must go out to all the membL o f the CTFA participating in this joint venture. They iilj worked diligently, controlled their tempers for the 1 part, and I believe have performed a noteworthy service.-! Certainly much o f the uneasiness about discussing p Jems with FDA has noticeably decreased and, I say thfe| the face o f what I believe are the most trying times. N ot only our industry, but FDA is feeling great press v from such sources as consumer groups, Congress, and so.i| and yet, the discussions have been kept on a rather eS keel. The best way to describe the kinds o f activities tha t| group has participated in would be to just read the a_ o f our last meeting which was held in Washington 1 August 18th. I t represents a far cry from the sparring i took place some two-and-a-half years ago at the first i f sion. This Agenda reads as follows: -- 1 . CTFA Petitions 2. Color Additives ] 3. Hair Coloring Research j 4. Chronic Eye Studies j 5. Hexachlorophene J 6. Feminine Deodorant Sprays i i 7. Aerosols ! j 8. Asbestos in Talc j 9. Chloroform I 10. Shampoos 11. Microbiology ;T2. Mercurials 13. Hypoallergenic Cosmetics ,14 . Organic or Natural Cosmetics This agenda certainly covers a wide gamut that affects a ll| us, I hope that we continue to approach scientific probli affecting our industry w ith forthrightness, without vindj 10 8 CTFA COSMETIC JOURNAL, VOL. 3, NO. 4 r? DEFENDANT'S EXHIBIT DC 3- QE-CPC00001182 requifi often &j to I uired, a sist \ is, and w ith an openness dedicated to resolving probj r p f the present and avoiding problems o f the future. | ^ l i , v e the FDA-CTFA Scientific Liaison Committee || .continue to approach problem solving with those cri| in mind. talc c > were 1 in so that! scientiM roup especial ' Discussion of sets we<L :s and n -J e this -.I arted m i id discu$J al o- oni f e. , thatJ le . Voluntary Petitions James H. M erritt, Moderator Dr. Murray Berdick Dr. Harold Schwartz John C. Warley, Jr. to tlx I /ards and| es H. M erritt :her FDA| problemsl sr :|i membersi hey haw! the i rv ice. ing prob-l ly this in i s subject o f our discussion this morning, our Petireally has its genesis a couple decades ago when there first Introduced in Congress legislation to require pre ice o f cosmetics before they were marketed. That Jon has been introduced repeatedly. Congress, in its i, has not enacted it. I t has felt, and I th in k right* y so, there are more pressing problems fo r the Food and ig Administration. Wth the knowledge tha t pre-clearance legislation had pressures | nd so on;| :her even j j' introduced several times and w ith the knowledge too in the color additives suit there were efforts made to ret the regulations as including pre-clearance, this Asciation, then known as TGA, met and decided to develop thatour| e: igton on ring that j first sei f promulgate, i f possible, a system o f self-regulation on a iSitary basis. |W e contend that self-regulation w ill be just as effective, ||,b e much more economical than mandatory regulation, 'w ill provide the consumer an adequate level o f protecso that the consumer w ill be protected against those ties or th a t harm which might come from unsafe prod- firs t tw o steps in the program o f self-regulation J filed w ith the Food and Drug Administration several ilUhs ago. They involved tw o petitions, to be promul* I under the Food, Drug and Cosmetic A ct as voluntary is. They have since been published in the Federal r fo r comment. |p w , firs t on our office staff team, I am going to call on j Warley, a lawyer, who w ill discuss the concept inp d in the tw o petitions filed; the first, or voluntary htration o f manufacturers; the second, for the voluntary ure o f ingredients. cts a ll robl t vindlft| ^C. Warley. Jr. )':jn going to be discussing some o f the legal and regula rs overtones to these petitions; and, I won't get very |nU fic fo r obvious reasons. T w o items --where cosmetics P w de and what is in them -- have been a top prio rity on FD A's list for some while; and, they are now a top priority on the CTFA and the cosmetic industry's list, as welt. In considering the steps by which information could be submitted to FDA on the location o f manufacturers and the ingredients in cosmetics, there were basically two paths open to the industry; One was mandatory regulation. The other was voluntary regulation. The mandatory regulation seemed at first, i suppose, to be the most obvious way to go because voluntary regulation in this context had never really been attempted by an In dustry before. Therefore, the petitions which we submitted, and the Steps which we are taking in subm itting this information to the government is, I thin k unprecedented in the field o f statutory regulation. For that reason perhaps there are few precedents fo r us to follow and the regulatory road might be a b it rocky for a while, but we are sold on the concept. For a number o f reasons we chose the voluntary regula tion route. First and foremost was our conviction that this industry would cooperate in supplying the information to the government; that it did not have to be coerced into submitting the information and that it would be something o f a grand gesture on industry' s part to comply fu lly and to show the government and the consumer that there Is a con scientious soul in industry which is going to cooperate where cooperation is needed. We submitted two petitions. Most o f you, l feel sure, have seen them by now. I f you haven't had a chance to scrutinize them, you at least know o f their existence. The firs t calls for the registration o f manufacturers and packagers o f cosmetic products. You will be asked to file w ith the Food and Drug A d ministration a registration for all o f your plants, factories, etc. In return, you w ill receive from them a plant registration number which you w ill use w ith future correspondence w ith the agency. The second petition is fo r the filin g o f cosmetic ingred ients in classes. By classes I mean between fifty and a hun dred per cent, twenty-five and fifty percent, etc. on down. So, it is not a completely quantitative formulation but it is completely qualitative, w ith the exception of flavors and fragrances, whose composition, due to their complexity and the great number o f ingredients involved, is not requested. The information w ill be submitted in order o f decreasing predominance and there is a very strict legally binding con fidentiality provision by which the FDA w ill be precluded from revealing this information submitted on the product ingredients statement to anyone, except under very certain spelled out and defined conditions. In our grounds fo r submission to the Food and Drug Administration we stated that in our belief the information we were providing was necessary for FDA to do its job under the Food, Drug, and Cosmetic A c t and to carry out the responsibility that the public has charged that agency with, and since we have acknowledged the fact that the information is necessary fo r FDA to do its job, it puts us in a very paradoxical position not to give them the informa tion that we have spoken of. We are encouraging support fo r these. We think support w ill be forthcoming and i f fo r some reason i t is not, then it QE-CPC00001183 CPC-FISHBAINTRSCPT00000798 Pharmacology & Toxicology Robert Giovacchini, Ph.D.* 1972 CO M M IT T E E REPORT I should like to begin by firs t discussing the In te rin d u s try aerosol testing program, w hich was formed as a subcom m itte e under the pharmacology and toxicology com mittee. This program involves the safety evaluation o f propellants and several contracts have been le t in this area. The firs t one is to Dr. Richard Stewart o f the Medical College o f Wisconsin. This is an evaluation o f the absorp tio n , excretion, and physiological effects, both under acute and subacute exposure in humans using a wide range o f propella nt concentrations and exposure times. There is an associated study going along w ith this w hich is being funded com pletely by the du Pont Company, w hich is an evaluation o f propellant levels under conditions o f use. This study is being done to insure th a t the concen trations u tiliz e d in the Stewart study w ilt be more than that seen under norm al use conditions. The second study has been funded and is in progress at the University o f Maryland College o f Pharmacy under Dr. David Blake. This study examines the biotransform ation and m etabolic fate o f propellants, the study beginning firs t in rats moving on to dogs and later to humans. The th ird study has been funded at the Medical College o f Georgia w ith D r. Nancy Flowers. I t 's a study which is exam ining the early changes in the electroconduction system o f the heart fo llo w in g exposure to propellants; dogs are u tilized in this study. On Wednesday the Inter-Industry Aerosol Subcommit tee w ill meet to discuss three additional areas where protocols have been made available. One deals w ith the effects o f propellants on the m ucocilliary system, a second area deals w ith the effects o f propellants on pulm onary cytolo gy, and the th ird deals w ith health status surveys o f people exposed to propellants. The Pharmacology and Toxicology Com m ittee has had task forces w orkin g in basically 17 other areas, and I w o n 't cover all 17, Q u ic k ly I 'd ju s t like to summarize a couple o f them. One is a task force under D r. G uido Battista (WarnerLam bert) which is dealing w ith ways and means o f handling poison c o n tro l in fo rm a tio n . In ad dition w e've been w orkin g w ith the com m ittee th a t D r. Berdick referred to w hich is looking fo r m ethodol ogy fo r the safety evaluation o f eye-are colors. We're look ing in to the area o f antim icrobials as well as - a program fo r dermatologists, and additional guidelines fo r the safety evaluation o f cosmetic products. ' Gillette Medical Evaluation Laboratories, Rockville, Md. 20850 10 C TF A COSMETIC JO URNAL, V O L. 5, NO. 2 One thing tha t has come up and I 've been dire ctly in volved w ith is the OTC-FDA A ntim icro bial Review. I need not say what this review panel has done up to now, 1 th in k everyone w ho reads the newspapers is aware o f w h a t's happening. We are scheduled to meet again this week to deal w ith the safety and efficacy o f TBS, TCC, and DP 300. 1973 CO M M IT T EE REPO RT This year has been a busy and progressive year fo r the members o f the Pharmacology and Toxicology Comm ittee. I th in k there have been times when we fe lt like we were like the last group to leave D unkirk or members o f the Charge o f the Light Brigade. In spite o f all this, we've worked in several very definitive areas. I'd like to cover them in the order that I've got them on my lis t - which is n o t neces sarily the order in which they were handled. One o f the m ajor problems th a t we concentrated on this year was the Poison C ontrol Center Program. This was a p ro ya m th a t was developed w ith the -- then the poison control center w ith in the Food and Drug A dm inistration. This u n it a t this m om ent is part o f the Consumer Product Safety Agency. The thrust o f the program was (1) how does one handle Poison C ontrol calls fo r cosmetic type products, and (2) how can such a program be placed in the CPSC Poison Center com puter in an all-encompassing procedure fo r the members o f the industry. Dr. Guido Battista, headed this task force o f Pharmacology and Toxicology and w ith his task force group p u t together a list of, if you w ill, generic type form ulations, and the types o f antidote proce dures that m ight o r m ight not be required. This document, at the present time, has gone to the S cientific Advisory Com m ittee and w ill be moving its way up through C TF A before being sent ou t to the industry fo r comment and review. The second program tha t we're w orking on is en title d the Program fo r Dermatologists. I f a physiciandermatologist were to contact you w ith respect to patch testing, or a consumer w ith respect to an alleged, allergic reaction, how should one handle It? This program w ill shortly be reviewed by the Pharmacology and Toxicology Com m ittee and then w ill also begin w orking its way up through C TFA fo r review. It describes various ways in which the industry can handle these types o f situations prudently and scientifically. The third m ajor program we have been w orking on fo r the year have been guidelines fo r Prognostic Safety Evalua tion o f Cosmetic and Toiletries Products. We are tryin g to develop the safety guidelines based on product categories. Thus, you w ill have a checklist, n o t a lita n y o f tests. As you develop a product w ithin a certain product category, you can use the checklist to see the areas o f possible concern. The table can be used as a review. As you examine you r product vs. the checklist do you believe there may or may no t be a problem w ith respect to, fo r example, ophthalm ic irritancy, dermal irrita ncy, etc. Then you can decide i f addi tional studies are needed. Also, you may conclude that no studies are required. We w ant to be very clear on the fact tha t in going through this checklist, you m ight conclude tha t you have sufficie nt evidence in yo u r files that you don' t have to do a specific test. There may be sufficient evidence from the medical literature tha t lets you conclude that you d o n 't have to do a test. It's the sort o f review to go through to ascertain whether or n o t you have sufficient QE-CPC00001184 CPC-FISHBAINTRSCPT00000799 inform ation fo r the safety o f that particular product before The Microbial Content Subcommittee under the chair you go to market. Other areas th a t the Pharmacology and T oxicology manship o f Dr. S. Mark Henry (Bristol-Myers) has prepared a document entitled The M icrobial L im it Guidelines fo r com m ittee task forces have been involved in - include ophthalm ic pigm entation; D r. Costello and his group are w orking on a review o f saccharin fo r use in oral products; a aq chloroform safety review; eye anesthesia and shampoos; asbestos and talc; support to the color additives com m ittee; and, a review o f the EEC lists w ith respect to ingredients. A n area that we're going to be moving into , w ith Dr. Lanman, in charge o f this task force, and now th a t D r. Estrin has the funds to hire staff, w ill be a review o f the medical literature w ith respect to antim icrobial ingredients. We shall be requesting fro m companies any internal in fo r m ation they may have on the safety o f antim icrobial in gredients. cosmetics and toiletries. This docum ent was recently ap proved by the board fo r distribution to CTFA member companies. This subcommittee also has sent o u t form s fo r the com pletion o f a CTFA study on the microbiological status o f products produced by C TFA member companies. The study w ill encompass a total o f 4,000 products. A prelim inary p ilo t study covering 100 products has been conducted by cooperating laboratories. The subcommittee is continuing to study methodology w ith regard to the classification and isolation o f various types o f microorganisms. Mr. John Yablonski (Avon) o f this subcommittee is coordinating the w ork on a sim plified methodology fo r classifying microorganisms. This is in tended fo r use by qu ality control microbiologists. This subcommittee is also functioning in the area o f maintaining the file o f m icrobiological cultures which can be used fo r preservation tests and other testing procedures. The list o f cultures w ill be made available to those member companies w ho subm it a lis t o f cultures in their own cul ture collections. Microbiology Committee Our Education and in fo rm a tio n Subcommittee has completed a slide presentation which can be seen in the e xh ib it area. The professional qu ality o f this presentation is the best trib ute which can be given to the efforts o f this committee. This slide presentation w ill be made available to member companies. This subcommittee also played a most vital role in plan ning and coordinating a Raw Materials Seminar w hich was Charles Goldman, Ph.D.* held in Saddlebrook, New Jersey last June. This was the firs t meeting o f its kind covering this most im portant area 1972 CO M M IT T E E REPORT The M icro biolog y Com m ittee has been very active during this past year. AH o f you in this room have been caught up in the various pressing problems w hich beset our industry today. The fa c t th a t there are v irtu ally no pressing, m icrobiological crises w hich are facing our industry is the best measure o f our com m ittee accomplishments. The members o f this com m ittee, and the various sub committees, deserve recognition fo r their c o n trib u tio n to the cosmetic and to ile try industry. This has o n ly been possi ble because o f the support and the c om m ittm e nt o f the various member companies o f the C TF A . Our Preservation Subcommittee, w hich is under the chairmanship o f Dr. John S m ith o f Chesebrough-Pond's, has completed a col laborative study involving microbial challenge o f cosmetic form ulations, w ith pure and m ixed cultures and using both qualitative and qu antita tive methods fo r assessment. This paper w ill be published in the near future. This subcom m it tee also has com piled a list o f m icrobial cultures in order to facilitate the exchange among various C TFA member com panies. James Rodgers (Mennen) w ho is a member o f this sub com m ittee, is c u rrently investigating a standardization pro cedure using d io x in as the reference. I f this approach proves feasible, a larger collaborative study w ill be done. C urrently member laboratories arc starting another collaborative study to evaluate the rechallenge method demonstrating the efficacy o f a preservative in a test cosmetic form ulation. in the microbiology o f cosmetic products. The M icrobiological Aspects o f Q uality Assurance Sub com mittee during the past year has completed a document entitled Q uality Assurance Procedures fo r the Management o f Process Water. The C TFA Board o f Directors has recently approved this docum ent fo r distrib ution to the C TFA membership. The entire subcommittee participated in the discussion and participation on the management o f demineralized water systems at the Raw Materials Seminar held at Saddlebrook last June. The subcommittee has also completed pre lim inary drafts o f a docum ent entitled Cleaning and Sanitizing E quipm ent This was subm itted to the Q uality Assurance Comm ittee whose chairman Is Mr. W illiam Fead. A draft o f a document entitled a Check List for Inplant Inspections was prepared and submitted to the M icro biology Committee. The Raw Materials Subcom m ittee consists o f tw o branches, one is located on the West Coast and is under the direction o f Dr. David Anderson o f Max Factor. The other is located on the East Coast and is headed by James Rodgers o f the Mennen Company. During the past year, this subcommittee participated in the symposium on the m icrobial content o f raw materials. Various raw material categories fo r round robin testing were selected and technical conferences were held w ith invited suppliers on the particular raw materials which were under study. Th is group is to be congratulated for the w ork tha t was done, and a very fine conference in which they Avon Products, Jnc., Suffern, N.Y. 10901 participated. -3 C TF A COSMETIC JO U R N A L , V O L. 5, NO.. 2 1.1 QE-CPC00001185 CPC-FISHBAINTRSCPT00000800 dlnforught to at. Obnd will .cation ly been thodollited to s, have analytiver the ble for es that menta- } appli<years, jhysics aretical practlmeans ty and nt very ch e m i- ingreusively / techials do pectrod In the greater tiled to way is signififor the jce the oscopy analyrumeni which itlon to ed that t aid in cation, remely iversity workers was of t impeonably nt of a met for duced. and now NMR equipment is available in the same price range as infrared equipment. The particular significance of NMR for identifi cation is that the structure of an organic mole cule could readily be deciphered from its NMR spectrum. This cannot be done easily by infrared and this is what makes NMR very attractice for identification purposes. We are using NMR primarily for identification of those compounds which are quite indistin ,guishable by IR such as a homologous series, which differ only by a methylene or an oximethylene group. The polyoxyethylene sorbitanes all give a very similar IR spectra, while the NMR spectra can readily distinguish these closely related com pounds. As simple identifications have become more and more instrumental, the assay procedures have also followed the same path. The Introduc tion of ultraviolet spectrophotometry about 25 years ago completely altered analytical proce dures and made possible many accurate ana lyses where before then only semi-quantitative determinations were possible. The great change in our day was the expan sion of the use of all forms of chromatography. Gas chromatography has been of particular Im, portance to our Industry. The Instrumentation is relatively inexpensive, simple, and Is capable of analytical separations unheard of previously. It Is * now possible fo r the first time to determine in detail the composition of many raw materials. ** Fatty acid analysis has become a routine procedure and enables us to have a greater control over our products. Gas chromatography has been applied to all types of raw materials and finished products, and its use is growing at a very rapid rate. We have been introducing GC methods into our standards and quite a number are to be found in the latest edition of the CTFA manuals. A very recent development in chromatography , -i,has been the introduction of high speed liquid chromatography. The manual column procedure in use for many years has been revitalized, and with the application of high pressure pumps, the speed of separation has been greatly acceler ated. Separations that previously took hours or days can now be accomplished in a matter of minutes. Heat sensitive bio-materials which can not be handled by gas chromatography can readily be separated by high pressure liquid ; chromatography at room temperature. The ' ""`growth of this technique parallels that of GC in the '60's, and there is no doubt that we will be ' publishing methods using this technique in fu ture editions o f the CTFA manuals. In all areas of analysis the tendency has been to be increasingly concerned with the m inor trace components of the materials. We have been testing for arsenic and lead for many years, using the classical laborious wet chemical procedures. As the need for testing trace metals became more apparent, the technique for accomplishing this was also developing. This last decade saw the introduction of atomic absorption spectro photometry and made it possible to analyze for most trace metals in the parts per million range. What was once a horrendous analytical prob lem can now be performed on a routine basis. This new method has already been incorporated in one of our standard methods of metal analysis, and In the future many more trace metals will be tested in this way. With the application of computers to analytical chemistry, it is now possible to combine all the data obtained from the new instrumentation and to automate many of these procedures. The next decade will show even more growth as th e available technology is absorbed and becomes common practice. We no longer can resist the influx of this developing methodology. The only rational approach is to accept the inevitable changes that are almost upon us and take advantage of the new opportunities th a t are now available. T jj Bhe CTFA Talc Subcommittee was es- < tablished in September 1973. Its first assignment SQ was for to the evaluate the optical microscope method detection and estimation of asbestos minerals in talc used for foods and drugs, which was published in the Federal Register of Sep tember 28,1973, as an FDA proposal. The miner als were identified by the use of refractive index mounting liquids. Talc George W. Sandland Bristol-Myers Company Based on the application of the published method to the analysis of seven different talc samples, ten scientists presented data which indicated lack of reliability and reproducibility in the method. Four of the investigators disqualified themselves due to uncertainty and lack of confi dence in their interpretations. A report describing the round robin was filed with the Hearing Clerk in December 1973, along with a recommendation to delay finalizing the proposed regulation until further work could be 16 21 CTFA COSMETIC JOURNAL, VOLUME 8, NUMBER 1. JANUARY/MARCH1976 21 t. * * QE-CPC00001186 CPC-FISHBAINTRSCPT00000801 done either to modify the optical microscopic method or to develop more satisfactory metho dology. The subcommittee agreed to form an Ad Hoc Methodology Committee to be headed by Dr. Robert Rolle of Johnson & Johnson. Scientists from government and industry were invited to participate on this committee. Every known me thod was considered by the committee, including refinement of the optical microscopic method to include the use of dispersion staining. The mi croscopic method was finally abandoned as a general procedure due to the lack of confidence in the sample size, and the inability to resolve particles which are submicron in size. The mi croscopic method was found to have some value, however, when used with dispersion staining, for the confirmation of fibrous amphibole. The work of the Ad Hoc Methodology Com mittee eventually led to the selection of differen tial thermal analysis (DTA) for the detection of chrysotile, but this method has the disadvantage o f iack of specificity for chrysotile since it detects other serpentine minerals as well. The only known backup method for a positive identifica tion in this event, is transmission electron mi croscopy with selected area diffraction. This equipment is very expensive and is not readily available. It was also agreed, though, that despite many efforts, the committee had been unable to find a sample of cosmetic talc containing natu rally occurring chrysotile, and that indeed there may not be such an entity; therefore, a backup method would not be necessary anyway. If this be true then, it was asked, "Why should we test fo r chrysotile if there isn't any?" This resulted in a survey of the industry wherein data were accumulated for a total of 3397 analyses of cosmetic talc. Incidentally, the manufacturers and suppliers of cosmetic talc have been monitoring for chrysotile since 1971 and some have done so since 1968. Not one single sample analyzed in this total, showed a positive detection o f chrysotile. Based on these data, the Talc Subcommittee has recommended that it should not be necessary to monitor cosmetic talc for chrysotile. The Ad Hoc Methodology Committee has developed a method for the detection of fibrous amphibole using continuous scanning X-ray dif fraction plus optical microscopy with dispersion staining. The latter procedure is necessary in the case of a positive result by X-ray. The method has a detection lim it of about 0.5 percent and offers the advantage of a more statistically valid sample size, at two grams compared with the optical microscopic method which examines a portion o f a one milligram sample. The Talc Subcommittee has recommended to the CTFA Standards Committee that a revised standard for cosmetic talc be issued, with updat ing to include specifications fo r Fibrous Amphi bole at "none detected," Free Crystalline Quartz at "As specified by buyer," and X-ray as an alter nate to IR for identification. Since some perfectly good cosmetic talcs contain dolomite or caicite, which are acid soluble, the lim it for acid soluble has been increased to 6.0 percent. The Standards Committee has accordingly updated the standard for cosmetic talc and the recommended methods will be included. At this moment the new standard has been edited and submitted for printing. Future plans include further study of trace impurities in cosmetic talc and the standard will be further modified, when, and as found neces sary. Another very important phase of our work involves the motivation of the cosmetic talc suppliers to label their containers in such a manner so as to identify cosmetic talc as CTFA Grade and thereby signify that it has been ade quately monitored to conform with the published CTFA Standard. Considering that CTFA members buy 85 to 90 percent of the cosmetic talc used in this country, and that the major suppliers o f cosmetic talc participated in the development of this standard, its issue should do much to provide adequate control, and ensure that a suitable grade is furnished to the market. We are indebted to Bob Rolle of Johnson & Johnson and all the other dedicated scientists who participated in this work. P ro d u c in g quality products is a very ob vious goal of all cosmetic manufacturers. Suc cess in achieving this goal has helped to make the cosmetic industry one that is dynamic and fast growing. This rapid growth, coupled with increasing consumer pressure and legislative demands, has made the CTFA guideline program more valuable and more necessary. The work of creating these guidelines demands a meaningful technical dialogue among participating compan ies. Quality Assurance Alayne Zatulove Estee Lauder, Inc. There are 16 different firms represented on our Quality Assurance Committee, and during CTFA COSMETIC JOURNAL. VOLUME 8. NUMBER 1, JANUARY/MARCH 1976 the tica rest in ti 1 pac proi asp- V conr pro< pen A plin rials proi Ir forf met disc tiom ager weig ent man usee upd QE-CPC00001187 CPC-FISHBAINTRSCPT00000802 The CTFA Standards Committee has the responsibility for establishing up-to-date chemical and physical specifications for ingre dients used in cosmetic products. The standards, w h ich c o n s is t of a six-volume set: Specifications, Methods, Spectra and three volumes of Cosmetic Ingredient Descriptions (CID's), are continu ously being added to and updated. The Stand ards Committee relies upon its members to con tribute laboratory time to the initial testing of raw materials and the statistical establishment of specifications for the parameters studied. Standards Monroe Messinger Chesebrough-Pond's Inc. This past year has been a particularly difficult one fo r our laboratory testing activity. However, in spite of external obstacles, there has been significant progress. As of May 1975 we had Issued a total of 130 CTFA specifications, 123 CTFA spectra and 141 CTFA methods. Since March 1976 approximately 25 methods have been completed, as well as a corresponding number of spectra. The Cosmetic Ingredient Description subcom mittee of the Standards Committee, under the chairmanship of Dr. Fred Lowman, has prepared and approved for publication, 90 CID's, since the last printing and distribution of the CID list. Approximately 20 CID's are being prepared by several members of the subcommittee, and an additional 25 materials have been identified as cosmetic ingredients currently in use from the FDA list of ingredients of cosmetics and drugs. The Talc subcommittee, with George Sandland as its chairman, has completed a revised standard which Is designed to control the quality of cosmetic grade talc. It will help to assure that talc used by our membership will meet the high standards of our industry. Among the revisions and improvements in this standard are the inclu sion of limits for fibrous asbestiform amphibole and quartz minerals, along with suitable method ology for quality assurance applications. An alter nate method for identification has also been added in the use of an X-ray defraction procedure. There is much work that remains, in the con tinuing activity of the Standards Committee, in reviewing the cosmetic ingredient descriptions and converting them into standards. The emer gence of the Cosmetic Ingredient Review pro gram will certainly increase the participation of the Standards Committee and/or its subcomml^l tees. ' We extend our appreciation to ail members o il the Standards Committee and to its subcommifc! tees for their valued participation in the stan ards program. The Microbiology Committee composed of the main committee and five su b fji committees: Education and Information, chain ' by Frank Wertalik; Microbial Content, chaired byM Warren Mulston; Quality Assurance, chaired b yff Jack Bachelor; Preservation, chaired by Emily! Owen; and Raw Materials, chaired by Margaret! Dolan. There are approximately 30 companies o r| their divisions represented, with 45 microbioli _ gists participating in the various activities. 11 would like to update you to their accompli* ments and future objectives. Microbiology James Rodgers The Mennen Company Education and Information. You have u n rll doubtedly noticed our booth in the Exhibit Area The first preview of the latest slide/tape presents-5 tion, entitled, "Cleaning and Sanitation of Manu-1 facturing Equipment," is being shown. Also o i r f j display are our previously c o m pleted slide/tape ! presentations: "Microbes, Sanitary Practices and You," "Determination of the Microbial Content of Cosmetics and Toiletries," "Treatment and Han dling of Process Water," and "Speciation of Yeasts, Molds and Staphylococci." The Education and Information subcommittee $ is also preparing for the industry debut of "Wally and Wanda Whitehat." This is a new poster program series, designed to help stimulate greater awareness of good sanitary practices. In.^ addition, the "Microbiology Forum," presented in each issue of the CTFA Cosmetic Journal, ls || spearheaded by this subcommittee. Microbial Content. The joint papers, " Method*! ology for Microbial Content of Finished Pro*! ducts National Survey" and the " National Micros biological Survey of Cosmetics and Toiletries,;J 1972-1975," have been completed and made?' available for publication by the CTFA. 12 CTFA COSMETIC JOURNAL, VOLUME 9, NUMBER 1. JANUARY/MARGH 1977 Quam cal guid process been coi from the and the joint effe Commitl as an in< The g of manu dustry is Prese the guid Liquid a also sut Use of 1 tion Tes group is preserva tries. Raw I categori ing mici and the the exai tent, Rc some tic from var these st metic Jt Curre generai niques t raw ma Microbi* Journal rum." In De determii bacteria croorga oratorie Micrc Advisor propose and app 1. T h e . metic tee r and aspe multi pack opmi nel. 13 REDACTED QE-CPC00001188 CPC-FISHBAINTRSCPT00000803 1977Annual Meeting Reports CTFA's scientific department in! 1976 again demonstrates its flexibility in meeting i new challenges and responding to long-range needs of the industry. Scientific Advisory Committee Dr. Robert Giovacchinni The Gillette Company 1 Time does not permit me to do more than list a few typical committee accomplishments for 1976: TECHNICAL GUIDELINES: Two new ones --safety substantiation and manufacturing cod ing--were added to an already substantial number available to manufacturers to assist them in developing their own quality assurance pro grams. VISUAL AIDS: The fifth in a series of audio visuals--this one on "Cleaning and Sanitization o f Plant Equipment" has been prepared to help you in your training programs, and is now in production. DICTIONARY: New edition covering double the number of ingredients in the 1973 edition w ill be in the mails in March. STANDARDS: A major supplement will be pub lished in 1977. Here's a sampling of activities of the newer task forces set up to meet specific problems: EYE AREA SAFETY: This task force has drafted proposals aimed at minimizing potential risks to consumers through misuse of eye area cosmetic products. The task force is also initiating roundrobin testing of methodology involving FDA and Dr. Louis Wilson, an ophthalmologist under con tract to FDA, GMP's: A good manufacturing practices task force has prepared comments on the proposed drug GMP's and w ill meet with FDA to discuss FDA plans for publishing cosmetic GMP's. GLP's: A good laboratory practice task force has j drafted comments fo r submission to FDA by the <) March 21 deadline. i Talc: A task force has just concluded a round! robin test of methodology fo r detection of asbes tos with FDA and Mt. Sinai Hospital scientists. This methodology has just been published by CTFA as part of a revised Standard for Talc. The results o f the study are expected to affirm the purity of current talcum products. OTC Panel Reviews: CTFA has several active,; OTC task forces open to all interested manufac turers and suppliers. The OTC panels have been occupied since January 1,1977 on learning how to live with "open meetings" under the new Sunshine Law. Panels of concern to our in d u stry; are: antiperspirant oral cavity topical analgesic miscellaneous external dentrifice and antimicrobial II Contact Jim McNerney of CTFA staff if you have questions in any of these areas. CTFA is also active in the safety research area. Murray Berdick w ill discuss color additive testing requirements in a few moments. In addition, CTFA has initiated Phase III of its long-term studies on temporary semi-permanent and oxi dation-type hair dyes, and, through the Inter industry Aerosol Safety Committee, is complet ing design of protocols fo r testing particulate, ingredients as well as its exploration of possible alternative propellants. SAC Organization: Finally the Scientific Advisory Committee, the body that coordinates the activi tie s of th e s c ie n tific d e p a rtm e n t, is undergoing a further reorganization designed to ensure effi cient handling of scientific programs. You may recall that the first phase of the reorganization opened up membership on the scientific advisory committee to all chief scientists of active member companies. That change considerably strength- 22 CTFA COSMETIC JOURNAL. VOLUME 9, NUMBER 2. APRIL/JUNE 1977 QE-CPC00001189 CPC-FISHBAINTRSCPT00000804 has been updated, and the guidelines for clean Microbiology ing and sanitization of equipment are in develop Frank Wertalik Schering-Plough mental stages. Guidelines for evaluating shelf life stability of product preservation systems are under discussion. Determination of a panel se lection and product testing protocols for in-vitro I'd like to go through some of the activities of land in-vivo correlation testing are being dis- the subcommittees and task forces of the Micro- ; cussed for performing this correlation evalua- biology Committee. g jtio n . They have a joint CTFA Mutagenicity Task < i On October 10, 1976, the present Force with the CTFA Pharmacology and Toxicol- J ' ' CTFA Standard for Cosmetic Talc was pub ogy Committee. The joint committee was formed lished. It marked a notable step forward in In 1977 to review, evaluate, report on published controlling the quality of the talc used by the and unpublished testing methods and scientific CTFA membership, by guarding against the information. presence of asbestiform impurities in the talc The Eye Area Safety Task Force, an industry products sold by CTFA membership. As a result task force was formed in 1977 to review this area. of the efforts of the ad hoc Methodology Com The task force membership is technically diversi mittee under the chairmanship of Dr. Robert fied and affords an excellent cross-section of Rolle, it reflects the most up-to-date technology management for full development of each se available in the greatest number of laboratories lected topic. available to the CTFA membership. It also util The Microbiological Methods Task Force was izes the largest and most significant sampie size formed to develop more uniform microbiological of any method for the evaluation of a talc ship methods for the evaluation of materials. We have ment which may be small, or carload in size. been working on a revision of the Microbiologi cal Guidelines for Process Water, recognizing new technical information, developments and Talc Subcommittee advancements. We have the "Microbiological Forum." I'm Chairman of the Information Education Subcom George Sandiand Bristol-Myers Company*12 mittee, and the "Forum" is one of the things that we use. It's a very important vehicle. We'd like The new Cosmetic Talc Standard is a modifi nore contribution from the membership. The cation of the old TGA/CTFA Talc Standard with " Forum" is in the CTFACosmetthiceJfooullornwailn, ganmdajor additions; % includes short articles relating to the field of 1. An Optional identification procedure using microbiology. X-ray diffraction. We have produced a new slide-tape presenta- 2. The addition of a " none detected'' limit for |;"fion entitled, " Cleaning and Sanitation of fibrous amphiboles, using CTFA Method J ^Manufacturing Equipment." We have continued 4-1. In this method, the following steps are our efforts for informing and educating industry required: %members by completing this fifth slide-tape pres (a) A primary detection of amphiboles by entation. X-ray diffraction, is employed as the rtWe are developing a poster series. Two of the posters are posted at the exhibit booth, in rough first step. (b) When a positive detection of amphi The Committee has in mind a series of sters for plant and personal hygiene for the " anufacture of high-microbiological quality cosjjrtics. te're planning a workshop on decontamina- boles is indicated, a secondary proce dure using light microscopy along with dispersion staining is applied to deter mine whether or not any amphiboles !pn technology and sanitization technology in Phi. We have some information at the booth on Ve have developed the Microbiological Lanolin? Sidelines for Sampling Cosmetic Raw Materials th in process and finished goods. This guide" has been approved and should be published the near future. We have developed the micro- 51 M a d is o n A v e n u e , N e w York, N.Y. 10010 (212) 683-3089 `ogical aspects of quality assurance, which CTFA COSMETIC JOURNAL, VOLUME 9, NUMBER 4, OCTOBER/DECEMBER 1977 QE-CPC0Q001190 CPC-FISHBAINTRSCPT00000805 detected by X-ray diffraction are asbestiform in nature. 3. Optional procedures are given fo r the esti mation of quartz or crystalline silica: (a) Method J 5-1, using DTA, is capable of detecting 0.5 to 1.0% of quartz. (b) Optional Method J 6-1, using X-ray diffraction, is capable of detecting 2.0% of quartz. A round robin was conducted early this year using Method J 4-1 on samples from seven different brands representing 90% of the sales volume o f talcum products on the market. The results showed inconsistencies of data among some of the participants, particularly in the use of the Part II Optical Microscopy and Dispersion Staining Method. Because of this, a more com prehensive version of the optical method was written. It has been sent to ail participants for a second round robin, along with another set of 'ontrols plus those samples from the market which seemed to be associated with the incon sistent data. As of this writing, the testing is in c o m p le te . It must be emphasized that the Optical Micro scopic Method Part II section of Method J 4-1 is not an easy procedure. It requires the expertise of a very competent microscopist, who also has experience in mineralogy. Since scientists meet ing these qualifications are not numerous, we are considering a program under the sponsorship of CTFA, designed to train microscoplsts specifi cally in the required discipline. In the meantime, we have every confidence that Method J 4-1 is practical, and can be suc cessfully used by properly trained scientists. O ur future plans include a refinement of the optical microscope procedure to make it usable by as many scientists as possible. Now fo r just a few points of interest: A Workship on Asbestos was conducted on July 18 to 20, 1977, at the National Bureau of Standards. Close to 400 participants, primarily from industry,, government agencies and the research community, attended. The workship did not result in recommenda tions for the definition and measurement of asbestos, which may be correlated with biologi- M ttyakohob? 51 M a d is o n A v e n u e . N e w Y ork , N .Y . 10010 (212) 6 8 3 -3 0 8 9 cal activity. There was overwhelming opinion that there is a dose-effect relationship for asbes tos and an expected threshold. Without doubt, if there were agreement as to a definition of asbes tos for regulatory purposes, there are techniques for detection and quantitation. However, some of these techniques are extremely sophisticated, require highly specialized training; are research- based, and are impractical fo r routine control purposes. There were no allegations against the safety of cosmetic talc, however, the Food and Drug Ad ministration expects to promulgate regulations for cosmetic talc in the future, to guard against the use of impropoer talcs for cosmetic pur poses. The history of use of cosmetic talc indicates that it is safe, and it has been placed in Category I for efficacy and safety by the OTC Antimicro bial II and External Products Panels. I wish to extend sincere thanks to Dr. F.R. Rolle who served as Chairman of the ad hoc Talc Methodology Committee and to Dr. J.P. Schelz, Chairman of the CTFA Talc Task Force. We are also grateful fo r the time and effort put forth by members of the Food and Drug Administration, of the academia, and of industry, to assist in this important project. Last year at this time, CTFA had submitted the galley proofs of the second edition of the CTFACosmetic Ingredient Dictionary to the FDA and received some recommendations from them for changes. To a large extent, we modified various CTFA Adopted Names and monographs to conform with their suggestions in March of this year, the second edition was published. The Dictionary has been well re ceived. Over 3,000 copies have been sold both here and abroad. N om en clatu re Griffin Shay Avon Products, Inc. In the October issue of Cosmetics and Toile tries Ed DeNavarre gave the Dictionary a gener ally positive review. Other reviewers have been equally complimentary. On Friday, October 28, FDA proposed to rec ognize the second edition of the Dictionary, providing 60 days fo r comment. There are a number of ingredients fo r which FDA feels the monographs in the Dictionary disclose neither the chemical configurations nor, where appro priate, the substances of origin. FDA has pro posed continued adoption of the names for some 30 CTFA COSMETIC JOURNAL. VOLUME 9. NUMBER 4, OCTOBER/DECEMBER 1977 Q E -C P C 0 0 0 0 1 191 CPC-FISHBAINTRSCPT00000806