72-1
MANUFACTURING CHEMISTS’

ASSOCIATION,

INC.

MINUTES OF MEETING
FOOD,

DRUG,

AND COSMETIC CHEMICALS COMMITTEE

MCA Conference Room
June 13,

Washington,

D. C.

1967

*************

Members Present
W. E. McCormick, Chairman
V. H. Knoop, Vice chairman
T. R. Aalto
F. R. Barron, Jr.
R. N. Bell
C. P. Carpenter
Frank DiPrima (for J. M. Stocker)
T. W. Hanavan
James Hulse (for C. F. Hagan)
K. B. Kerr (for O. H. Peterson)
W. A. Knapp
J. A. Korth
K. E. Mulford
W. H. Meyer
A. M. Schnitzer (for R. P. Howard)
H. C. Spencer
G. P. Vincent
“w. G. White
Samuel Zuckerman
M. M. Hoover, Secretary

B. F. Goodrich Company
Mallinckrodt Chemical Works
Tenneco Chemicals, Inc.
American Cyanamid Company
Stauffer Chemical Company
Union Carbide Corporation
Merck & Co.
E. I. du Pont de Nemours & Company
Chas. Pfizer & Co.
Salsbury Laboratories
Allied Chemical Corporation
Corn Products Company
Atlas Chemical Industries
Procter & Gamble Company
Phillips Petroleum company
The Dow Chemical Company
Olin Mathieson Chemical Corporation
Shell Chemical Company
H. Kohnstamm & Company
MCA Staff

Guests Present
L. S. Harrow
Arthur Schramm
A. E. Settle

General Foods Corporation
Stange Company
MCA Staff

Members Absent
C. F. Hagan
R. P. Howard
J. G. Kuniholm
A. R. Marusi (Board Liaison)

Chas. Pfizer & Co.
Phillips Petroleum Company
Hercules Incorporated
The Borden Company

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Members Absent

(cont'd)

L. A. Miller
0. H. Peterson
H. L. Schulman
D. A. Seligman
J. M. Stocker

Monsanto Company
Salsbury Laboratories
Washine Chemical Corporation
Hoffman-LaRoche Inc.
Merck & Co.

*************
1.

Minutes of the Last Meeting

The minutes of the January 25,
distributed.
2.

1967 meeting were approved as

Membership

The committee welcomed W. A. Knapp of Allied Chemical Corporation
and J. A. Korth of Corn Products Company as new members of the committee.
Dr. Knapp replaces B. T. McMillan, and Mr. Korth replaces J. T. Seawell.
The secretary announced the resignation of R. G. Troup of j. T.
Baker Chemical Company.
3.

internal Liaison

MCA Public Relations Department - In response to the request of
the committee, Mr, Settle reviewed the activities of the MCA Public
Relations Department in the area of food additives.
The committee
expressed its thanks to Mr. Settle for an interesting presentation.
MCA Environmental Health Advisory Committee - The chairman announced
his recent appointment of N. G. White as representative of the FDCC
Committee to EHAC.
4.

External Liaison

FDA Advisory Committee - The
ment of T. W. Hanavan (chairman),
members of an ad hoc subconpitt^e
the FDCC Committee at its jufie^-ld

chairman announced his recent appoint­
H. C. Spencer, and T. R. Aalto as
to make specific recommendations to
meeting relative to the work of the

FDA Advisory Committee, specifically the Panels on Reproduction Studies,
Carcinogenicity, and Potentiation.

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It was voted unanimously that three groups be established under
the general direction of the ad hoc subcommittee, each to be staffed by
toxicologists, and each to develop an MCA position concerning one of
the panel subjects which would be presented orally and in writing to
the FDA Advisory Committee and to the respective panel.
There was
general agreement that the statements should be coordinated with those
of the NACA.
Dr. Carpenter agreed to head up the Reproduction Studies Group,
and Mr. Hanavan agreed to recruit two others outside of the FDCC Committee
to head up the Carcinogenicity and the Potentiation groups.
Codex Alimentarius Commission - Mr, Mulford reported that his task
group (including Messrs. Hanavan and Kuniholm) has recommended that
Dr. Spencer be nominated as MCA's choice for an industry advisor to
attend the next session of the Codex Alimentarius Commission in Rom
next January.
The task group took into account the advisability of
rotating this assignment, but felt that Dr, Spencer should again be
nominated because of the need for continuity in the face of the changes
in U.S. Government representation, and because of his excellent work
in the past.
The committee unanimously accepted the recommendation of the
task group, and the secretary was requested to make this action known
to the chief U.S. delegate, expressing the hope that it will be re­
ceived favorably.
Dr. Spencer said that the committee should give
thought to rotation in future nominations of industry advisors.
The secretary agreed ro advise MCA member companies of the need
for establishing a continuing liaison with the government people
serving as U.S. delegates to the CAC.
He also agreed to inform them
of Dr. Spencer’s nomination to serve as an industry advisor, and to
urge that any comments and suggestions they may have regarding the
work of the CAC be sent in prior to the January session.
Members of
the FDCC Conmittee were urged to send in their thoughts as well.
Food Chemicals Codex - Dr. Spencer reported that the Food Pro­
tection Committee of the NAS-NRC is implementing the matters of
supplementation and reissue of the Food Chemicals Codex.
5.

Carcinogenicity Task Group

No action was taken at the June 13, 1967 meeting to implement the
May 15, 1967 recommendations of the task group.

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Various suggestions were made as to the course to follow which
included sponsoring a symposium, collecting papers and other infor­
mation, and meeting with government experts at the Tri-City center.
Thoughts were expressed as to the need for stimulating positive and
constructive statements to offset the negative, the need for more
research to establish the facts before spending further time on this
subject, the need to find out what experience has been gained so far,
and the need for further thinking as to what action to take.
6.

Plant Inspections Task Group

The committee voted unanimously to accept the draft questionnaire
of the task group with two minor revisions, subject to approval of
the MCA Staff.
7.

Other Items

Indirect Food Additives - The secretary was requested to ascertain
from Dr. Frawley what data he now has so that the FDCC Committee can
decide about its recommendation regarding his proposal.
Micro-Organisms - Mr. Lee Harrow of General Foods explained his
company's philosophy and practice re controlling microbiological
contamination, which was received with considerable interest by the
committee.
Economic Poison Disclaimers - Discussion of this item was tabled
until the next meeting of the committee.
Cosmetics Legislation - The secretary was requested to try again
to obtain from TGA its thoughts.
Unsolicited Drug Samples Legislation - Messrs. Mulford and
McCormick were requested to draft an appropriate letter on this subj ct.
Animal Care Legislation - The secretary was requested to continue
to keep the committee advised of developments in this area.
H.R. 8458
was mentioned specifically.
8.

Next Meeting

It was decided to hold the next meeting of the committee on
September 12, 1967 in the MCA Conference Room in Washington.

MMH:sjg
June 14,

1967

M. M. Hoover, Secretary
FDCC Committee

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-LIED CHEMICAL CORPORA!
LEGAL

N

DEPARTMENT

June 9, 1967

MR. KNAPP:
Re:

Manufacturing Chemists Assoc. Inc.
Food, Drug & Cosmetic Chemicals Committee

We think that Allied Chemical should help the MCA
as much as possible on the formulation of FDA plant inspection
procedures.
As you are aware, our attitude has been to cooperate
with the FDA inspectors unless they want information to which
they are apparently not entitled.
We have insisted that requests for such information
be made in writing. It is then evaluated by the Legal Depart­
ment and others. Generally, the inspectors stay within the
scope of legitimate inquiry.

John H. Lehnert

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T

June 9, 1967

Hr. Morgan M. Hoover
Manufacturing Chemists Association, Inc.
1825 Connecticut Avenue, N.W.
Washington, D. C. 20007
Dear Hr. Hoover;
I regret delay in replying to your letters of February 28
and March 21, 1967 concerning supporting data for thesis
presented by Dr. Frawley in his A.C.S. paper of last September.
We have one compound (a pesticide), phenyldlmethyl urea,
CgH^NHC0N(CH^)2» for which chronic feeding study was not published.
Phenyldimethyl urea has oral LD_Q to rats intubated as 20X
w/v suspension in IX aqueous Methocelu) of 3.9 ±0.2 g/kg.
A three-months feeding study at 0, 40, 200, 1000, 2500 and 5000
ppm in the diet produced no histopathology but did produce sig­
nificantly increased liver weights in female rats at 2500 and
5000 ppm in the diet.
In the two-year chronic feeding study,
rats were fed at 0, 10, 50, 250, 1250 and 2500 ppm in the diet.
No significant effect was observed as judged by growth rate,
mortality, blood studies or histopathology.
With respect to migration studies on actual food samples,
we have worked only with olive oil in contact with fluorine
containing polymer films. Here, migration was very low not
approaching that of rosin size. This work can be abstracted
if desired.
Very truly yours
Original Sign'd
K& A. Knapp

W. A. Knapp
Consultant-Toxicology
WAK:dmk

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