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| Letter to Technical Center - August 12, 1998 |
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John Carlson, Director
Processing Operations
Technical Service Center, FO
Robert C. Post, Ph.D., Director
Labeling and Compounds Review Division
Processing Compounds Inquiries
As you know, we are moving to eliminate the processing compounds prior
authorization program. Guidance materials and instructions about processing
compounds, i.e., nonfood compounds and proprietary substances, will be addressed
in the final rule pertaining to sanitation requirements. In the interim, we have
received questions, and we understand you have too, from industry and inspectors
as to how compounds can enter inspected facilities since we have begun to
redirect the resources used to perform the reviews and authorizations of
compounds (July 13, 1998, letter enclosed).
We recommend that the response to such inquiries convey that (1)
the List of Proprietary Substances and Nonfood Compounds be consulted for
current authorizations of use, or (2) if there is no entry in the current List
(or the upcoming Supplement to the List), the establishment must have
documentation on file to certify the processing compound is safe and suitable
when used as instructed. For example, the documentation can be in the form of a
processing compound manufacturer's or supplier's guaranty or a third-party
authority's certification, that the compound is safe according to some
established safety criteria and, as proposed for use, will have no deleterious
effects on the meat or poultry being processed. The documentation should also
include clear use instructions for all applications for which the compound is
intended to be used.
There are no objections to the Technical Service Center conveying the information contained in this memorandum to inspectors or establishments. If you need additional information or assistance on technical issues about processing compounds, do not hesitate to contact me at (202) 205-0279.
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