U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection

HHS:PHS:FDA:CFSAN:OC:DCP:MSB
 
                                                200 `C' Street, S.W.
                                                Washington, DC 20204
 
                                                M-I-92-11
 
                                                November 20, 1992
 
TO:         All Regional Food and Drug Directors
            Attn:  Regional Milk Specialists
 
FROM:             Milk Safety Branch (HFF-346)
 
Subject:          Chloramphenicol Screening Test Methods
 
 
FDA has completed an evaluation of the CHARM II Test for
Chloramphenicol in Milk Using Tablet Reagents and EDI EZ-Screen
KWIK-KARD~  .
 
A summary of this evaluation and a more detailed description of
the method is available from the Milk Safety Branch, HFF-346, 330
"C" St. SW, Washington DC 20204.
 
The FDA Laboratory Quality Assurance Branch is developing
laboratory evaluation procedures to certify laboratories to use
these methods.  They will notify states when that process has
been completed.  Once state laboratories have been certified,
these official methods may be used for regulatory actions.
 
These evaluations were done in response to the submission of
these methods by these companies to a December 13, 1990 FEDERAL
REGISTER announcement.  The primary objective of the study was to
evaluate the test kits' performance at the level of 1 ppb.
 
This Charm II method is available from:  Charm Sciences Inc., 36
Franklin Street, Malden, MA 02148.
 
The EZ-Screen method is available from:  Environmental
Diagnostics, Inc., 1238 Anthony Road, Burlington, NC 27215.
 
These methods were evaluated using ten different experiments,
including a pilot study, ruggedness test, freeze/thaw test, cross
reactivity or interference test, controls from different parts of
the country, effect of various common bacterial strains and of
varying somatic cell counts on test kit performance, stability
and lot to lot variation of the kits, and the effect of incurred
residues on test kit performance.
 
Following the provisions of PMO Section 6, these methods have
been evaluated and accepted by FDA for use by the states and
industry.
 
Copies of this memorandum are provided for distribution to State
Milk Sanitation Regulatory Agencies, State Milk Sanitation Rating
Officers and District Milk Specialists in your region.  It should
be made readily available to the dairy industry.
 
 
 
                                    Johnnie G. Nichols