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February 13, 1975

SUBJECT:

CTFA Talc SUbCOITLllittee MeetiTlg
with Food and DrQg A~~inistration
t'!ashinqton, D_~~ Febn.!<JTv 7, 1975

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This ~eeting was ne1d in Dr. R.N. Schaffner's office on
February 7. 1975 at 1: 00 PH. Represe~ting FDA \,'ere:
Dr. R. Schaffner, Mr. H. Eierillann, Mr. H_ Davis, Dr. W.
HorO\vitz and Dr. Yates. The CTFA ,.,as represented by:
Dr. N. Estrin. Mr. G. Sandl~nd. Dr. M. Berdick, Dr. R.
Rolle ana G. Lee.
Dr. Estrin introduced ttr. Sandland as chairman of the CTFA
Talc Subcommittee and indicated that the purpose of our
meeting was to pres ant the analytical methodology \vhich
had been developed by the CTFA Task Force as applicable
to cosmetic tales.
FDA indicated that there had been no eminent plans to
publish new proposed methodology in this regard and did
not give us the impression that this matter was being
assigned any urgency. They reported no furthe~ work with
the optical microscopy method. Dr. Horowitz was asked by
Dr. Schaffner to elaborate on the only apparent area of
analytical activity whieh is being directed towards Food
Regulatory. This is being carried out under contract by
the Franklin Institute, who are investigating an SEM method.
They're attempting to develop methodology for detecting low
levels of asbestos contamination and have experienced
difficulty in presenting a uniform sample to the SEM. It's
expected that this study may take one to two years. Any
further steps to be taken with regards to Food Regulation
will therefore have to wait on developffients from the
Franklin Institute.
When questioned as to FDA efforts and progress in the
approach of "concentrating asbestos" to increase the level

Plaintiff's
Exhibit
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of sensitivity, Dr. Yates"~eplied in a tone of frustration
that all attempts nave met with failure; they had investigated heavy density liquid separation. Dr_ Yates did not
state that efforts ~ould be continu~d in this direction,
but we volunteered help in evaluating methodology should
they develop something.
Dr. Rolle outlined tnG p~o~os~a CTPA ~ethoas and t~e
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in cos~etic talc 8XC8pt Professor Lewin. At this poi~t,
Dr. Schaffner asked us what Professor Lewin was doing
(if any thin;) in talc analysis. Dr. Rolle outlined a
conversation he had had with Professor Le~in the day
before and Dr. Schaffner directed Dr. Horowitz to interview
Professor Lewin for his most current views regarding
chrysotile in talc. Dr. Berdick made the point that if
chrysotile is not expected to be found in talc, then the
FDA should not propose regulations to cover chrysotile.
After an exchange of philosophy, where Mr. Eierrnann took
a strong stand for chrysotile in talc regulation, Dr.
Schaffner suggested that if the CTFA would submit
supporting data attesting to the absence of chrysotile
in talc the FDA would take the matter under consideration.
Mr. Sandland indicated that the CTFA will be proposing
self-regulatory action by amending its present CTFA Talc
Standard to include the asbestiform tremolite proposal.
G. Sandland stated that a regulation of 1% asbestos
in talc was not only achievable by throughly tested methods,
but also gave a safety factor of" 48,300 (Sivertson calculation). Mr. Eiermann bluntly said that the calculation was
wrong since the standard of 2 fibers/cc. is not a time
weighted average. Before we had a chance for rebuttal
Dr. Schaffner said that the Sivertson calculation was
foolish 'since no mother was going to powder her baby with
1% of a kno,~ carcinogen irregardless of the large safety
factc~.
Because of Dr. Schaffner's strong stand we did
not correct t1r. Eiermann's misunderstanding of the
calculation.
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Dr. Schaffner emphasized that there is an ultimate and
more important need for talc clinical safety data in
order to satisfy the consumerist advocates. The writer
assured him that this would be forthcoming from J&J.
Copies of the DTA and X-Ray Diffraction Detection
Procedures together with the Sivertson Report "An Estimate
of a Safe Level of Asbestos in Baby Powder Talc" were
distributed to the FDA representatives and the meeting
was closed with Dr. Estrin thanking the FDA for the
opportunity of exchange and discussion.
The general impression received by the writer was that
the FDA was not anxious to publish further proposals
relative to "asbestos-in-talc" pending outcome of the
Franklin Institute Study, as long as the consumerist
advocates remain quiescent.
It is also evident that the
FDA would depend on clinical data to defend the safety
of talc.
In a post-meeting caucus of the CTFA attendees, it was
agreed that the CTFA would proceed to compile information
from consultants and manufacturers which attest to the fact
that chrysotile has never been found in cosmetic tales
and submit this to the FDA.

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