Labeling and Consumer Protection
August 12, 1998
John Carlson, Director
Robert C. Post, Ph.D., Director
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 Area Code (202) 205-0279.