
Letter to Industry - Nonfood Compounds - October 20, 1999
The guidance provides information about a change in FSIS regulations regarding the use of nonfood compounds and processing aids in Federally inspected meat and poultry establishments. It applies to official establishments and actions they may take to meet regulatory requirements for sanitation. It relates to 9 CFR 416.4.
Dear Sir or Madam:
The Compounds and Packaging Review Branch (CPRB) was responsible for authorizing nonfood compounds (cleaners, sanitizers, lubricants, etc.) for use in Federally inspected meat and poultry plants. However, this authorization program no longer exists. The CPRB was eliminated on September 30, 1998. Therefore, it is no longer possible to obtain an USDA authorization letter for a nonfood compound.
On October 20, 1999, USDA published in the Federal Register, a Final Rule entitled "Sanitation Requirements for Official Meat and Poultry Establishment". This rule consolidates the sanitation regulations into a single part applicable to both official meat and poultry plants, eliminates unnecessary differences between the sanitation requirements for meat and poultry processing, and converts many of the highly prescriptive sanitation requirements to performance standards. Among the prescriptive sanitation requirements that were eliminated was the regulation (Title 9, Code of Federal Regulations (CFR), Section 381.60) requiring the authorization of nonfood compounds by USDA, prior to their use in a Federally inspected meat or poultry establishment. The new sanitation regulations (9 CFR, Section 416.4) state that nonfood compounds and processing aids used by an establishment must be safe and effective under the conditions of use. The establishment must have documentation on file substantiating the safety of a chemical's use in a food processing environment and this documentation must be available to Food Safety and Inspection Service (FSIS) inspection program employees for review.
The documentation may be in the form of a manufacturer's or supplier's letter of 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 effect on meat and poultry being processed. A manufacturer's or supplier's letter of guaranty should contain the following information: 1) name and address of the supplier; 2) brand name, code name, or other designation; 3) statement of safety and efficacy; 4) statement of compliance with U.S. Federal regulations (if applicable); 5) use directions; and 6) signature of an authorized firm representative.
In order to assist meat and poultry establishments in making their own determinations concerning the appropriate use of nonfood compounds, FSIS has developed a compliance guide. Although the guide is directed mainly to the regulated meat and poultry establishments, chemical manufacturers may find it useful in developing and marketing their products. The Sanitation Performance Standards Compliance Guide is on the USDA Website.
If you have any additional questions concerning the subject of your inquiry, please contact Mr. Bill Jones at (202) 205-0279.
/s/
Robert C. Post, Ph.D., Director
Labeling and Consumer Protection Staff