73-1
Manufacturing Chemists'

Association,

Inc.

MINUTES OF MEETING
FOOD,

DRUG,

AND COSMETIC CHEMICALS COMMITTEE

MCA Conference Room
September 12,

Washington,

D. C.

1967

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

Members Present
W. E. McCormick, Chairman
V. H. Knoop, vice Chairman
T. R. Aalto
R. N. Bell
C. P. carpenter
Frank DiPrima (for J. M. Stocker)
Carroll Fentress (for R. P. Howard)
J. P. Frawley (for J. G. Kuniholm)
T. W. Hanavan
James Hulse (for C. F. Hagan)
w. A* Knapp
J. A. Korth
K. E. Mulford
Thomas Shotwell (for 0. H. Peterson)
H. C. spencer
G. P. Vincent
N. G. White
M. M. Hoover, Secretary

The B. F. Goodrich Company
Mallinckrodt Chemical Works
Tenneco Chemicals, inc.
Stauffer Chemical Company
Union Carbide Corporation
Merck & Co..
Phillips Petroleum Company
Hercules incorporated
E. I. du Pont de Nemours & Co.
Chas. Pfizer & Co.
Allied Chemical Corporation
Corn Products Company
Atlas Chemical Industries
Salsbury Laboratories
The Dow Chemical Company
Olin Mathieson Chemical Corp.
Shell Chemical Company
MCA Staff

Guests Present
Daniel Badia
R. F. Philpitt
Joseph Treon

Chas. (Pfizer & Co.
Olin Mathieson Chemical Corp.
Atlas Chemical Industries

Members Absent
F. R. Barron, Jr.
C. F. Hagan
R. P. Howard
J. G. Kuniholm
A. R. Marusi,
W. H. Meyer
L. A. Miller

Board Liaison

American Cyanamid Company
Chas. Pfizer & Co.
Phillips Petroleum Company
Hercules Incorporated
The Borden Chemical Company
Procter & Gamble Company
Monsanto Company

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O. H. Peterson
H. L. schulman
D. A. Seligman
J. M. Stocker
Samuel Zuckerman

Salsbury Laboratories
Washine Chemical Corp
Ho f fman-LaRoche
Merck & Co.
H. Kohnstamm & Co.
******************

1.

Minutes of the Last Meeting

The minutes of the June 13,
distributed.
2.

1967 meeting were approved as

Membership

The secretary reported that no new members were added to the
committee since the last meeting.
3.

Liaison With FDA Advisory Committee

Mr. Hanavan reviewed what has been done by the FDCC Committee up
to this time for the purpose of presenting its views regarding
protocols to the Panels on Reproduction Studies, Carcinogenicity, and
Potentiation of the FDA Advisory Committee.
Corresponding task
groups have been established within the FDCC Committee to prepare
recommendations.
Dr. Carpenter reported on the response to the questionnaire for
reproduction data, which indicates that the three-generation test
is no more sensitive than the two-year feeding test.
He cautioned
that it could be more sensitive, however, depending on how it was
conducted, and that the raw data may have to be presented for
examination by the Panel on Reproduction Studies.
Dr. Frawley
reported that the single study performed by a university, which
indicated that the three-generation test is more sensitive, is being
repeated and may take a year.
It was unanimously voted that MCA prepare a statement for the
consideration of the Panel on Reproduction Studies which points out
that our data for approximately 17 compounds supports the recommen­
dation made previously by NACA based on approximately 48 compounds.
Dr. Treon summarized the draft position paper prepared by his
task group for consideration of the Panel on Carcinogenicity.
This
paper states in part that carcinogenicity is only one aspect of
testing for chronic toxicity, that it should be conscientiously
looked for in the course of all tests performed to evaluate the
chronic toxicity of a substance, and that if a chemical food or cos­
metic additive produces no hint or suggestion of carcinogenicity in

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the course of all the tests currently required for the evaluation
of the safety of such chemical additives, additional tests by other
techniques or different routes of administration (other than in­
gestion) appear to be an unnecessary burden unlikely to produce
results of practical significance.
It was unanimously voted that the position paper (with an
editorial revision) be presented to the Panel on Carcinogenicity,
and that a modification be made if subsequent developments indicate
a need for this.
The editorial revision is to correct the impression
in the third paragraph that the FDCC Committee feels that the Delaney
amendment to the Food, Drug, and Cosmetic Act is sound.
The chairman
requested Dr. Treon and Mr. Mulford to make this revision.
Dr. Frawley reported that there is as yet no protocol covering
the broad aspects of potentiation for the Panel on Potentiation to
evaluate, and that a recommendation in favor of deleting a require­
ment (F.R. 120.35) regarding the testing of organic phosphate
pesticides has apparently been accepted.
He agreed to keep the FDCC
Committee informed regarding protocols involving potentiation.
The secretary reported that the scheduled early October meetings
of Panels on Reproduction Studies and Carcinogenicity have been
postponed, one reason being that the list of questions to be sent
out by the Panel on Carcinogenicity has not yet been prepared.
He
was informed by Dr. Nelson that we will be advised as soon as the
meetings are re-scheduled.
4.

Liaison With Codex Alimentarius Commission

Dr. Spencer reported that the second meeting of the Codex Committee
on Food Additives is being held this week in The Hague, that a
meeting of the Codex Committee on Pesticide Residues is to be held
next week, and that the next session of the Codex Alimentarius
Commission will be held next January in Rome.
With regard to the latter. Dr. Spencer (who has been nominated by
MCA as an industry advisor to the Chief U.S. Delegate) indicated he
will work out a plan so that his efforts in Rome will be coordinat d
with those of Messrs. Ruark, Frawley, and Meyer who are industry
advisors to the U.S. Delegates to the Codex Committees on Food
Additives, Pesticide Residues, and Food Labeling respectively.
Dr. Frawley reported that there have been innumerable
difficulties
in obtaining data, and that no one is happy about the decisions being
made by the Expert Committees.
He will recommend a change in the
relationship of the Expert Committees to the Codex Committees, and a
change in the method of establishing acceptable daily intakes to take
into account variations in the amounts of individual foods consumed
in various countries.

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Dr. Frawley said also that the FDA will probably yield to the
Codex standards as they emerge, and that customers will demand con­
formance with them even if FDA doesn't.
It was brought out that a
food manufacturer will not wish to produce two types of each food,
one for domestic and another for foreign consumption.
The secretary commented that the chemical industry's methods for
dealing with such an important subject as international food standards
appear to be much too haphazard, and that something should be done to
correct this.
After discussion of this point, the committee voted
unanimously to request the chairman to appoint a task group to study
the matter and to give a report at the next meeting.
Mr. Mulford
expressed the opinion that the group should include in its work con­
sideration of what this country should do when Codex standards are
submitted for adoption.
5.

Proposed Revision to FDA Food Additives Procedural Regulations

After a discussion of the proposed revision, the committee voted
unanimously to request an extension of 60 days in the time permitted
to file written comments.
This request is to include the reason for
requesting the extension, which is that the complexity and farreaching implications call for it.
It was also voted unanimously to request the chairman to appoint
a task group to review the sets of comments already prepared (as

(

well as those to come) and make a recommendation as to what MCA
should do.
The chairman then appointed Dr. Knapp (chairman),
Mr. Hulse, and Dr. Vincent to the task group.
He also requested the
secretary to send a letter to the committee requesting comments to
be sent to the task group within two weeks.
The recommendation of
the task group is to be sent to the committee for letter ballot.
6.

Other Items

MCA Environmental Health Advisory Committee - Dr. White reported
on the recent EHAC meeting at which guidelines for further activity
were developed, and announced that a meeting of EHAC will be held
September 14 to implement them.
^

c

Indirect Food Additives Proposal - The secretary reported that

Dr. Knapp's data has been turned over to Dr. Frawley, and that
Dr. Frawley has expressed the belief that we will be in a better
position to request action by FDA on his proposal once the information
is in the scientific literature which will be soon.

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Plant Inspections - It was voted unanimously to table action
on the survey reported in previous minutes unless and until a
greater demand for it arises.
Based on comments made at recent
meetings, it had been decided that a survey was needed.
Microbiological Contamination in Pood Chemical Plants - It was
concluded that the answers given at the last meeting with respect
to food plants suffice.
Economic Poison Disclaimers - It was concluded that this subject
is not too much of a problem at the moment.
Cosmetics Legislation - Because of concern over possible undue
restrictions on the number of permissible cosmetic chemicals, the
secretary was requested to contact TGA and possibly PMA and others
to find out what is being done in the area of cosmetics legislation.
Unsolicited Drug Samples Legislation - Mr. Mulford reported that
a draft recommendation has been prepared which can be brought into
final shape without much effort should H.R. 3954 come up again.
Recordkeeping Legislation - Mr. Knoop reported that H.R. 11804
is of interest only to those products covered by the Drug Abuse
Control Act.
Purpose of the bill is to remove from the law the
provision vhich stipulates that ordinary business records will
suffice.
Since there is nothing to suggest any activity, Mr. Knoop
recommended no action.
Food Supplements Definition Legislation - Mr. Knoop reported
that H.R. 11837 is designed to negate FDA regulations on food
supplements, that the administration will probably oppose the bill
if it acts, but that the bill is of little practical importance.
Animal Care Legislation - The secretary reported that no con­
sideration of H.R. 8458 by the House Interstate and Foreign Commerce
Committee has been scheduled and probably won't be in this session
of Congress.
7.

Next Meeting

It was decided that the next meeting of the FDCC Committee will
be held February 20, 1968 in the MCA Conference Room in Washington.

M. M. Hoover,
MMH:sjg
September 15,

Secretary

1967

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