LAW offices

Keller and Heckman
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•JOSEPH

E. KELLER

JEROME

H.HECKMAN

CHARLESi H

MEEHAN

iris JJ STREET. R. W.

WASHINGTON, D. C. EOO30

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WILLIAM H. BOROHESANI, JR.

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ROBERT R. TIERNAN
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bUUI ADDRESS "EMJUs"

BLACK

January 8,

1968

To the Members of the SPI Pood Packaging Materials Committee

Gentlemen:
Mr. Heckman is presently away from his
Washington desk on a brief vacation.
In his absence
he has requested that I
inform the full Committee of the Food and Drug
Administration's proposed "National Conference on
Indirect Additive Problems" tentatively scheduled
for the thirteenth and fourteenth of February.
We
have obtained permission from Mr. Louis Rothschild
to reproduce the enclosed article bearing on the
conference which appeared in the January 8, 1968
edition of Food Chemical News.
I am sure that all of you will appreciate
the significance of this FDA proposal in terms of
its potential impact on the entire indirect additives
regulatory scheme.
As soon as more definitive informa­
tion becomes available as to the subject matter to be
covered as well as the industry representatives to be
invited, we shall be contacting you further.
In the meantime, I know Mr. Heckman will
want to give you his comments and observations on
this matter as soon as he returns to his desk early
next week.
Cordially yours,

Thomas J. Hughes,
for Jerome H. Heckman

ASI-PR 0000605

Page 24
January 8,

1968

FOOD CHEMICAL NEWS

The Food and Drug Admin stration did issue a § 121. 1210 to set a zero tolerance
for residues of carbomycin in the edible tissues of chickens. The agency said that
residues of oxytetracycline in chickens from use of the combination will not
exceed the tolerances already set in § 121„ 1946
These tolerances are ’ p. p, m.
in uncooked kidney, and 1 p. p. m. in uncooked muscle, liver, fat and t i ,n. FDA
revised § 121, 1046 so that the residues in chickens can result from use of
oxytetracycline-medicated drinking water as well as feed.
There were two Food Additive Orders issued last week (See following story).
O
STANNOUS CHLORIDE CLEARED FOR ASPARAGUS UP TO 20 P.P.M.
(

A Food Additive Order was issued Jan. 4 to clear use of stannous chloride for
color retention in asparagus packed in glass, with lids lined with an inert '
material, in an amount not to exceed 20 p. p. m. calculated as tin (Sn).
The Petition was filed by P. J. Ritter (See FOOD CHEMICAL NEWS, Sept. 4,
Page 33), which also proposed an amendment to the food standard for canned
vegetables other than those specifically regulated to permit use of stannous
chloride in asparagus up to 20 p. p. m.
The canned asparagus standard permits use of stannous chloride in a quantity
not to exceed 15 p. p m. The Ritter proposal was designed to increase the
permitted level to 20 p, p. m. in glass-packed asparagus with lids lined with an
inert material. Stannous chloride is "generally recognized as safe" as a
preservative up to 0. 0015% and no Food Additive Order was needed. The new
§ 121. 1213 was required to clear the higher level.
Simultaneously with issuance of the Food Additive Order, FDA republished the
food standards amendment providing "that in the case of asparagus packed in
glass containers with lids lined with an inert material the quantity of stannous
chloride added may exceed 15 p. p m. but not 20 p. p. m. calculated as tin (Sn). "
The amendment will become effective in 60 days unless it is stayed because of
objections filed within 30 days. Ritter's food standards proposal had been
endorsed in a comment submitted to FDA by H. P. Cannon & Son (See FOOD
CHEMICAL NEWS, Oct. 9, Page 17).

SCHEDULES NATIONAL CONFERENCE ON INDIRECT ADDITIVE PROBLEM
The Food and Drug Administration has tentatively scheduled a National Conference
on Indirect Food Additives for Feb. 13 and 14 to discuss, among other topics,
a proposal by Hercules' Dr. John P. Frawley that indirect additives - - except
for pesticides and heavy metals - - used in accordance with good manufacturing
practices at 0. 2% or less be exempted from FDA's procedural food additive
requirements.
ASI-PR 0000606

January 8, 1968

Page 25
FOOD CHEMICAL NEWS

The Frawley proposal was a major topic at both the FDA-Food and Drug Law
Institute and Food Protection Committee meetings in Washington last month
(See FOOD CHEMICAL NEWS, Dec. 4, Pages 8 and 18).
A general review of FDA's proposed changes in the food additive procedural
regulations (See FOOD CHEMICAL NEWS, Aug. 14, Page 3) will also be on the
program, which will cover a day-and-a-half in three separate three-hour
sessions at the Department of State auditorium in Washington.
Dingell Subcommittee Relays Complaints About FDA's Indirect Regulations
I

The proposal by Frawley, who is expected to be one of several industry speakers
at the conference, has drawn considerable scientific support. FDA's revised
procedural regulations have also come in for comment and criticism, and led
to complaints to Chairman Dingell's (D-Mich.) Small Business subcommittee
on Regulatory Agencies in the House. Dingell's staff reportedly carried the
complairt s of unnecessary paperwork and unnecessary testing requirements
to FDA.
One of the purposes of the conference will be to get a public airing of the com­
plaints before there is a Congressional hearing, FDA began whipping up the pro­
gram shortly before Christmas. A report to Dingell from FDA is due shortly.
Representatives of the adhesives, can manufacturing, glass container, paper,
petroleum, plastics, rubber, and other industries whose indirect additives are
regulated by FDA will be invited to participate and attend the conference.
The first session which FDA's L. L. Ramsey, the Bureau of Science's Assistant
Director for Regulatory Programs, will keynote will be devoted to chemistry
and migration of indirect additives.
The afternoon session of Feb. 13, which will cover toxicological problems,
will hear Dr. W. H. Summerson, Bureau of Science director.
The following morning's wrapup will be an open forum, and will include, among
the topics, discussion of FDA's new administrative regulations (See FOOD
CHEMICAL NEWS, Sept. 18, Page 12,r Oct. 2, Page 10; Oct. 9, Page 14;
Oct. 17, Pages 2 and 3; Oct. 23, Page 8; Oct. 30, Page 3; Nov. 6, Page 20;
Nov. 13, Page 16; and Nov. 20, Page 4).

FDA EASES RESTRICTIONS ON DISCLOSURE OF DATA FROM CONTRACTS

j

The Food and Drug Administration last month took steps to make information
obtained from agency contracts more freely available to the public.
First public disclosure of the new FDA policy was made by Assistant Commis­
sioner for Education and Information Theodore O. Cron in a speech Dec. 27
in Washington to the American Marketing Association meeting.

ASI-PR 0000607