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REVOCATION OF AUTHORIZED USE OF DIETHYL PYROCARBONATE
Proprietors of distilled spirits plants, bonded wine cellars, breweries, and others concerned:
This circular is issued to inform you that the Food and Drug Administration has published an order in the Federal Register of August 2, 1972 (37 F.R. 15426), which amended 21 CFR Part 121 by revoking § 121.1117 Diethyl pyrocarbonate. The notice of proposed rule making to withdraw approval of diethyl pyrocarbonate for use in the production of still wines, beer, noncarbonated soft drinks and fruit-based beverages was published in the Federal Register of February 11, 1972 (37 F.R. 3060) and announced in Industry Circular 72-3, dated February 29, 1972.
Comments on the proposal were received from 36 consumers, the Government of Venezuela, the Center for Science in the Public Interest and the Environmental Defense Fund. In view of these comments and other material available to the Food and Drug Administration, the Commissioner has concluded that the usage of diethyl pyrocarbonate is theoretically capable of producing urethan, a byproduct which may be hazardous to the health, when combined with other ingredients in beverages.
Accordingly, formulas and other requests calling for the use of diethyl pyrocarbonate will not be approved by the Director, Bureau of Alcohol, Tobacco and Firearms. Existing approved formulas, which provide for the use of the additive, must be amended by submission of a new formula or by a rider deleting diethyl pyrocarbonate or bringing products containing this ingredient into conformity with Food and Drug additive regulations. The provisions of 26 CFR 240.1051 will be amended to delete the authorized use of diethyl pyrocarbonate.
Inquiries regarding this circular should refer to its number and be addressed to the Director, Bureau of Alcohol, Tobacco and Firearms.
Rex D. Davis
Acting Director |
