WORLD HEALTH Kinde ORGANISATION MONDIALE
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ORGANIZATION Yee DE LA SANTE
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CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER
INTERNATIONAL AGENCY FOR RESEARCH ON CANCER

150, COURS ALBERT-THOMAS ~ 69372, LYON Cédex2— FRANCE
Tal.(78)75 8) 81- Télégr. Unicancer Lyon — Telex 380023—

In reply please refer to : C2/12/11 26 ‘May 198]

Priere de rappeler Ja reférance :

Dear Dr Infante
Thank you for your letter of 12 Mey 1981.

I was Surprised by some of your remarks, especially
those suggesting both that the Working Group was not familiar
with IARC criteria, and further, intimating that the members
of the Working Group did not follow these criteria when
reviewing data on formaldehyde.

While we are grateful for comments on the activities of
such working groups, since they help IARC to improve the
quality of evaluations, I would like to Teessure you, however,
that not only were the members of this working group scientists
of experience and wide knowledce, but also, they were
perfectly aware of all the elements which are required in making
an evaluation. ,

I appreciate your willingness to provide us with new
information; however, you will be awere that it is TARC policy
when evaluating chemicals included in the Monograph Series, to
consicer only data that has appeared, or will be published, in
the peer-reviewed scientific literature. No exception is mede
to this rule, es past experience has shown that making
exceptions, such as using the Feéeral Recister, reports from the
Regulatory Agency, etc., may lead to misinéerstandincs, error
anc complaints, es was the case, Zor examnDle, with beryvilicun.
Only ‘for information related to che production end use of
substances Go we Gepart from that rule, because such Gata ere
not taken into consideration in builéing up an evaluation, end
because most are not published normally in the scientific
literature.

Dr P.F. Infante

Director
ffice of Carcinogen Identification
and Classification

U.S. Department of Lebor

Occupational Safety end Health
Acministration

washington, D.C. 20210
Dr P.F. Infante Page 2

I would add that your letter, its content ana style,
also its wide Gessemination, could be interpreted as an attempt
by OSHA to influence a working party of the Agency, and to cast
espersions on the scientific integrity ané objectivity of its
members whose reputations are internationally recognized.
Purther, it has serious political implications @éS attacking the
Objectivity of the Agency's Scientific and Governing Councils.
I should point out that the United States is officially represent-
ed on the latter. Perhaps Dr Kang, being on his first visit, was
unfamiliar with the work and scientific background of the
Committee. His views. unfortunately lend Support to the views of
some of the working group members that he wes not appearing es an
incependent scientist es is the practice.

While this may not have been your intention, I am sure you
realize that it is my immediate duty to Protect the autonomy of
the working group members, whose scientific integrity I have no
reason to doubt.

. Finally, I have the impression that your letter originates
trom your having received partial or incomplete information.

The Working Group egreed that if the monograph on formaldehyde
WweS to be published in Volume 27, its evaluation had to be
formulated on the basis of the published information. For th
reason, and unless further Gata on this compound eppear in
press or it has been officially confirmed that new Gata heve been
eccepted for publication, the Working Group decided that the
evaluation should be that there is limited evidence of
carcinogenicity. The Working Group, incluGing Dr Kang, left to
the IARC Secretariat the Option, however, of GecidGing whether the
monograph on formaldehyde should be printed in its present form,
Or whether it should be Geleyed pending the publication of new
Gata. It wes also agreed that if new Gata heve appeared in press
before the monograph is due to be sent to the printer, the
evéluation woulé@ be revised.

t

Su

Cories of your letter ane my reply will be circulated +o
é1l members of the Working Party.
Yours sincerely, .
—
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John EieSinson, M.D.
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Director
cc: Dr T.G. Auchter, Waeshincton D C., USK
Dr L. Tomatis, IARC
All members of the TZRC Working Group