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| Letter to Industry - October 20, 1999 |
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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. You may access this Guide at
http://www.fsis.usda.gov/Regulations_&_Policies/
Compliance_Guides_Index/index.asp
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
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