ML19331A420

Discusses Proposed Quality Std to Permit Radionuclides in Process Steam Used in Mfg of Food,Drugs & Cosmetics. Concludes That Addition of Carcinogenic Matl Is Undesirable

ML19331A420
Person / Time
Site:	Midland
Issue date:	10/28/1968
From:	Kirk J FOOD & DRUG ADMINISTRATION
To:	Spencer H DOW CHEMICAL CO.
References
NUDOCS 8007160970
Download: ML19331A420 (2)

Text

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! DEPARTMENT OF HEALTH EDUCATION AND %LFARE I

PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION WASHINGTON, D. C. 20204 t

October 28, 1968 Dr. Howard C. Spencer Biochemical Research Laboratory Building 1803 '

The Dow Chemical Company ,

Midland, Michigan 48640 Re: Food Additive Master File 100

Dear Dr. Spencer:

This refers to your conference on July 30, 1968, with our Bureau of Science personnel concerning the establishment of a " Quality Standard" to permit the presence of small amounts of radioactivity uninten-tionally added to steam used in the processing of products subject to th'e Federal Food, Drug, and Cosmetic Act. We acknowledge also

. receipt of the various written materials and letters provided on this suoject.

l We have designated the information provided as Food Additive Master File 100. Additional material and correspondence should bear this number for ease cf reference.

The basic issue appears . to be whether or not FDA can establish a

regulation permitting the unintentional addition of radionuclides i to process steam, the use of which may add minute amounts of the

' radioactive materials to foods, drugs, and cosmetics produced with

, the contaminated steam.

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Recognizing that there are certain differences in the law as it '

covers these different products, we think that we cannot authorize

the deliberate addition of carcinogenic materials to any f them.

Certainly in the case of food additives, the law itself proscribes the issuance of any regulation as requested, because radionuclides are recognized as being carcinogenic. We think that the addition of such material to drugs and cosmetics is also undesirable.

Dr. Beamer's letter of August 26, 1968, gives some information on the frequency of leaks in existing steam generating reactors. However, it is still not clear that it is uneconomic to repair the facility as soon as a suitably sensitive detecting instrument registers radio-activity in,the process steam circuit. Certsinly any food or drug 8007160 i20 g .

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Dr. Howard C. Spencer

The Dow Chemical Company .

manufacturing plant ordinarily shuts down to correct any situation that leads, or may lead, to contamination of the product. We can

• find no basis for a conclusion that in this case some health risk should be accepted with known carcinogenic materials.

, Sincerely yours, J. K. Kirk

~ Associate Commissioner for Compliance 9

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