Document 3Qq7E238VB58anvpjzGJM6pa
D O M ESTIC W ffftA TrN G CO M PANY
j .n e w B r u n s w i c k , n ,
Nbvenfcer 28, 1977
Mr. Say Kranmes Whittaker,Clark & Daniels, Inc. 1000 Coolidge Street South Plainfield, N.J. 07080
Dear Task Force Member;
Hie results for the CTF round robin retest of coded talc samples bave now been received from all participating laboratories. We should like to urge you to attend a meeting of our Task Force on December 6, 1977, beginning at 5:30 p.m. in the CTFA Conference Boom. This meeting baa been scheduled so as not to conflict with technical sessions being presented at the conference of The Society for Occupational and Environ mental Health. This conference, "Occupational Exposures to Fibrous and Particulate Dust and Their Extension into the Environment' is being held at the Mayflower Hotel in Washington, December 4-7, 1977.
The main purpose of the Task Force meeting, as outlined in the attached agenda, will be to discuss in some detail an inter-laboratory comparison of data and to determine whether or not we have met our objectives. Hopefully, our meeting will conclude by 7 p.m. Please contact me (201/524-5518) if you cannot be present, Thank you for your continued support.
Sincerely,
Bound Robin Testing of Consumer Talcun Products
Central Analytical Laboratories Johnson & Johnson Research Center
New Brunswick, N. J. 08903
JPS/gm Enclosure
cc: Dr. N. F. Estrin Vice President-Science, CTFA Mr. G. Sandland
Bristol-Myers Products
PLAINTIFFS EXHIBIT
WCD-419
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CEFA Talc Sdxrocndttee Task Force on Round Robin Testing of Major Consumer
TflirtraProducts for AsbestifdnnAmphibole Minerals
ifeetingDate: Tuesday, December 6, 1977 Time: 5:30 p.m. Place: CTFA Offices 1133 15th Street, N.W. Washington, DX.
AGENDA
X. Discussion of Partial Pound Robin Retest data. II. Refinement of CTFA Method J4-1
A. Part I 1. Specific sensitivity for fibrous vs.massive treooolite. 2, Specific sensitivity fop anthophyllite.
B. Part II, Tentative Revision III, Interaction with Mt. Sinai Environmental Sciences Laboratory IV. Possible CTFA Response to NIOSH Request for Establishing
Safe and TWithfrfl Criteria Relative to Occupational Exposure to Talc.
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^ D istrib u te d (1) CTFA, SAC Committee on 3 /18776" (2) CTFA Talc Sub-Committee on 3/31/76
SUMMARY REPORT OF
CTFA TALC SUB-COMMITTEE
CTFA Talc Sub-Committee met on March 11, 1976 to review recent press report pertaining to analysts o f talcum powder products.
As a re s u lt of information collated from the attending company rep resen tatives, the following fa cts were ascertained:
1. The samples were analyzed by Sinai in 1973,
2. Samples were confirmed as pre-1971 production with one product which has not been manufactured since the end of World War I I ,
3. The asbestos a n a ly tica l re s u lts of Sinai are in c o n f lic t with those determined on the same samples by Dr. Pooley, a C a rd iff s c ie n t is t of world renov/n. Mt. Sinai reported ten samples as containing up to 20% asbestos, whereas Pooley detected asbestiform mineral in only fiv e samples and a t considerably lower le v e ls .
Based on the above situ a tio n the cornmittee f e l t that i t would be important to put th is situ a tio n in proper perspective by:
1, Presenting summary data to FDA to affirm the responsible action which has been pursued by our industry since 1972 when the asbestos concern f i r s t surfaced - Plan "A"
2, Considering a sampling of current industry production and submitting th is to a n a ly sis by FDA, Mt. Sinai and inde pendent a n a ly tica l lab oratories - Plan "B" - to be carried out only i f Plan "A" were found to be in s u f f ic ie n t.
Action taken to date has been the follow ing:
1. Plan HA" was executed immediately over the weekend and on March 15, le t t e r s were received from the following companies and c r i t i c a l l y reviewed:
Avon Chesebrough Ponds Colgate Palmolive Coty Cyprus Minerals Faberge Johnson & Johnson Walter FicCrone A ssociates S te rlin g Drug Whittaker, Clark S Daniels
Approximately 4,000 analyses have been reviewed covering the period as early as 1971,
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2. The t a lc sub-committee met with Dr. Schaffner and his s t a f f on the afternoon of March 15 to summarise and present these documents, FDA was su ita b ly impressed but urged consideration fo r the in clu sio n of a sampling plan in the CTFA Talc Standard. In consideration of the voiced p ra c tic a l d if f ic u lt ie s , due to individual s itu a tio n s , Dr. S chaffner, as an a lte rn a tiv e , suggested the voluntary submission of periodic reports, on t a lc analyses. We were advised that the FDA has analyzed seventy s ix samples of t a lc products In 1975 and has not detected asbestos, according to th e ir methods of a n a ly s is , "DTA and Optical Microscopy", Samples of these products implicated by S in ai have been offered by the FDA to Mt. Sinai laboratories for their analysis.
The Revised T a lc Standard was submitted to the CTFA headquarters on March 18, 1976 fo r p ub lication. Another meeting o f the Talc Sub-Committee has been scheduled for March 31, 1976 to discuss the follow ing:
1, D iscussion o f further CTFA stra te g y , v is a v is , Mt. Sinai e .g , - data exchange, methodology o f a n a ly sis.
2. CTFA a n a ly sis of FDA pick-up samples from th e ir 1975 survey,
6, Sandland, Chairman T a lc Sub-Committee
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Meeting Date: December 4, 1974 Release Date: December 19, 1974
MEETING NOTES 01 CTFA TALC SUBCOMMITTEE
PRESENT;
Mr. George Sandland, Chairman Dr. George Cohen Mr, Alan M. Harvey Mr. Ray Krammes Mr. George Lee Dr. F. Robert Rolle Mr. Joseph Simko Mr. Harold Stanley, JrDr. John Travers
COPY:
Dr. Murray Berdick Dr. Christopher Costello Mr. Salvatore DiBianca Dr. John Menkart Dr. Norman Estrln Mr. Eugene 1. Lambert Mr. Fred Roesch Dr. C. S. Thompson Mr. Ronald Yakupcin
Bristol-Myers Products rietol-Myers Products R. T. Vanderbilt Whittaker, Clark & Daniels Johnson & Johnson Johnson & Johnson Colgate-Palmolive Pfizer Avon Products
Chesebrough-Ponds
- Colgate-Palmolive
Hennen Co.
Clairol
CTFA
Covington & Burling
Whittaker, Clark & Daniels
R. T. Vanderbilt
Kolmar Laboratories
The meeting was held In the Bristol-Myers Technical Services Conference Room at Hillside, N. J, G.'Sandland presided.
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The committee discussed the results of the round robin testing of talc samples to evaluate the DTA/optical microscope procedure for chrysotlle and the x-ray diffraction/optical microscope procedure for amphibole, developed by the Ad Hoc Methodology Committee,
It was concluded that we can recommend x-ray diffraction
1%with the optical microscope as back-up for the detection of amphibole
at a level.
, Only 2 members supplied data using the DTA procedure for serpentine. The use of the optical microscope as back-up to differentiate non-fibrous serpentine (aritigorite) from fibrous serpentine (chrysotlle) was shown to be unreliable based on results from 3 investigators.
Coded Sample
Investigator and Results
StLucy Walter McCrone H. Stanley
McCrone Associates Pfizer
D. Hamer &Johnson Johnson
A - Talc Sample from Pfizer containing chrysotlle and Antigorlte
none detected pass
chrysotlle
Chrysotlle found
found - fail
fail
B-1% Chrysotlle in Talc prepared by a simulated industrial milling process
chrysotlle found none found
fail
pass
Chrysotlle found fail
C-l.2% fibrous talc in platy talc
none found pass
none found pass
none found pass
The only other back-up procedure would be TEM which theoretically is satisfactory, but which has the following disadvantages:
1. Lack of availability to most talc users. 2. Its ultra sensitivity could be a problem. 3. A statistically significant sample size cannot be examined within
a reasonable time frame. 4. Hot amenable or compatible in a Quality Assurance environment.
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Since we do not have a readily available back-up for DTA, it was agreed that we would have to depend solely on it, knowing that it will detect both fibrous and non-fibrous serpentine. However, since no one to our knowledge has ever detected chrysotile or antigorite by DTA in any cosmetic talc, it is our opinion that the risk involved, without a back-up method, is extremely small.
The committee concurred, though, that we should obtain additional data to confirm the reliability of DTA. Avon and Johnson & Johnson already have contributed data. The following additional sources of data will probably be available within the next few weeks:
<
H. Stanley (Pfizer) - expects delivery of new DTA (Mettler) this week and will do samples.
S. DiBianca(Mennen) - expects receipt of 1200 cell very soon and will do as soon as possible. Has duPont DTA.
R. Krammes (Whittaker, Clark & Daniels) - will have samples analyzed by De Bel and Richardson Testing Institute, Enfield, Conn.
J. Simko (Colgate-Palmolive) - expects to purchase DTA, but will attempt to have samples run by the Instrument supplier prior to purchase. Mr. Simko feels that tests could be completed within next 2 months.
Dr. Rolle will furnish coded samples to each of the above participants as required.
One of the original aims of our Ad Hoc Methodology Committee was to work collaboratively with the technical staff at PDA, and at first, it appeared that John Stuart would be the contact. However, he has been deluged with assignments to the extent that he has been unable to be an active participant on the Methodology Committee. This is unfortunate, since such a divisive arrangement has made it virtually impossible to approach our goal on a common ground with FDA.
It was suggested that we attempt to set up a liaison meeting with Dr. Shaffner or Mr. Eiermann in order to establish a collaborative approach to the problems involved in this project.
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Mr. Sandland pointed out that CTFA meets with FDA routinely by means of the Government Liaison Committee, and agreed to discuss the matter with Dr. Estrin in order to determine the best way to resolve the problem.
Mr. Harvey called the attention of the committee to an entry in the Federal Register of Monday, July 1, 1974, pertaining to Department of the Interior, Bureau of Mines and defining Health and Safety Standards in Metal and Nonmetallic Open Pit Mines. Threshold limit values are stated for "asbestos" which is defined to include only ehrysotlle, amoslte, crocidolite, anthophylite asbestos, tremolite asbestos and actinolite asbestos. The word "asbestos" is included in naming the last 3 materials in order to differentiate them from the non-asbestiform types of these materials, such as tremolite of a nonasbeetiform, which occurs in talc deposits, and is not mentioned in the definition, and, therefore, is not covered in the regulation.
The S-hour time weighted average airborne concentration of asbestos dust to which employees are exposed shall not exceed 5 fibers per milliliter, greater than 5 microns in length. Mo employee shall be exposed at any time to airborne concentrations of asbestos fibers in excess of 10 fibers longer than 5 microns, per milliliter of air, as determined by the membrane filter method over a minimum sampling time of 15 minutes.
Mr. Harvey also stated that NXOSH is considering the establishment of a standard for talc which will be separate from the asbestos standard. This will require a joint overview study to determine the nature of all talcs and will probably take 2 to 3 years to complete from the time It is started.
Mr. Krannr.es circulated to the committee a Field Information Memorandum #74-92, to all OSHA Assistant Regional Directors and Area Directors on the subject of Tremolite and Talc, A copy of the memorandum is attached.
A significant feature which is apparent in both of the above government publications is a change in the definition of a fiber and an apparent deviation from the previous 3 to 1 aspect ratio definition.
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The next meeting will be held on February 4, 1975 at 10:00 A.M. at the Bristol-Myers Technical Services Conference Room, 225 Long Avenue, Hillside, N. J.
The agenda will include: 1, Consideration of all available data on the DTA analysis
for Chrysotile. 2. Finalization of our proposal for presentation to FDA.
Y. W. Sandland Chairman, CTFA Talc Subcommittee
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