200 C Street, S.W.
Washington, DC 20204
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