2 Ra!o

MAY
BABY PRODUCTS COMPANY

April 26, 1973
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To:

D. D. Johnston

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Bill Ashton and I visited with Roger Miller and Vernon Zeitz
on April 18th. We covered a number of points of considerable
concern.
1.

It is our joint conclusion that we should not rely on the
"Clean Mine" approach as a protective device for Baby
Powder in the current Asbestos or Asbestos-Form controversy.
We believe this mine to be very clean; however, we are
also confident that fiber forming or fiber type minerals
could be found.
The usefulness of the "Clean Mine" approach
for asbestos only is over.

2.

It is

possible that the

technique

of

identification

for asbestos or asbestos-farm materials will be an optical
approach. It probably will be some variation of the MCCrone
method. This method with appropriate concentrating techniques will permit a good laboratory to identify asbestos
or tremolite in a talc sample.
The current medical research is confirming that it is
particle shape, not chemical substance which is harmful
as such fiber-like materials ~ill be suspect. The argument rages as to whether an aspect ratio of 3/1, 5/1, or
10/1 will be adopted.
The problem then is two fold,
Baby Powder.
a.

one for Windsor and one for

At Windsor the mine is currently under the jurisdiction
of the Bureau of Mines. The inspections of the mine
indicate that we are well within the limits presently
accepted for non-fibrous dust. Roger Miller feels
that they could live within the current TLV values
for fibrous talc of 5 parts per million. We don't
know the impact of a TLV of 2 fibers per cubic meter.
The May 8th meeting will primarily be an information
.. meeting on mine and manufacturing safety. We would
not expect standards to be set, however, there will
be agitation probably by OSHA, NIOSH, and the Consumer
Groups
(5elikoff), to lower the standards for the
industrial exposure to the same level as asbestos.

Plaintiff's
Exhibit
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Windsor is currently cooperating heavily with the
local Bureau of ~lines man out of Albany and in fact
teaching him how to use microscopic techniques to
identify the presence or absence of fibers.
We recommend that Windsor have a representative at
the May 8th meeting as observers and that no other
J&J representation should be had at the Bureau of
Mines meeting. We will review this strategy next
week after a meeting with the Johns Manvill people.

b.

J

5.

As for Baby Powder, the entire thrust of our communications with the FDA has concentrated on asbestos as
harmful fiber-like material. Sophisticated techniques
have been proposed to make sure that fiber-form materials
present in samples~re identified as being asbestos.
The implic_ati,on2:5._t)"!at _.~;Ll.. _9.th~x:~r- form~ __ i f
p:resent, were talC__ OI other minerals ~nd these-were
safe:-fhis posture will no longer oesatisfactory.
If the FDA Fo6C"1r5ivislon, ··whIch ~s moving more rapidly
than the cosmetic Division, publishes a standard, it
will probably be to ban asbestos-form or fibrous material
in talc. That could eliminate the current uses of talc
in packaging materials. These talcs contain widely
varying amounts of tremolite or fibrous talc. Our
Baby Powder contains talc fragments classifiable as
.fiber. Occasionally sub-trace quantities of tremolite
or actinolite are identifiable (optical Microscope)
and these might be classif~ed_as asbestos fiber.

We have been pursuing several alternatives to better protect our powder franchise. These include:

a.

An improvement in the flotation technique to better

select platy talc, and
perhaps
reduce any trernolite or talc shards. The work is still in the lab
and the timetable for commercialization is unknown.
It is, however, a chemical procedure and therefore
would probably not require major- equipment change.
b.

A program investigating two different ways of removing a large portion of the very fine particles
presently found in talc. We have demonstrated the
feasibility of both approaches. The equipment and
process development would take between 9 and 12 months
on a crash basis. Other approaches which might be
less expensive or more effective, have only been
talked about. A crash engineering program could be

J&J-0145686
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undertaken with a good chance of success in this
area.
It should be cautioned, however, that no
final product will ever be made which will be
totally free from respirable particles. tve are
talking about a significant reduc~ion in fine
particle count but not 100% clean-up.
c.

Corn Starch is obviously another answer. The
product by its very nature does not contain fibers.
Furthermore, it is assimilated by the body.

We would reconunend that items "a" and "c" receive top
priority. The Corn Starch program is primarily one of
merchandising ana the development of explosion proof
facilities. We would recomme~d this program be spearheaded by a task force under Jim Dettre.
The flotation program is currently being worked on at
Windsor by vernon Zeitz. We would propose a task force of
Zeitz, Gocd~an, and Ashton and Rolle,
to identify the·
opportunities in removing fiber-like materials from the
beneficiated talc, with a recommendation to Management in
30 days.

6.

If we are agreed with the above,
toen the Battelle
Program should be restudied to include cells of animals
on a, b, and c. We might wish these to be new cells, or
to delete certain cells now in the program.

D. R. Petterson
DRP/mm
cc: ~]. Ashton
R. t-liller
File

J&J-0145687

Protected Document--Subject to Protective Order

JNJMX68_000013466