• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

M-I-05-3: Updated Official Laboratory Evaluation Forms (FDA-2400 Series)

<< Back to Index of Memoranda of Information (M-I) Main Page

June 2, 2005

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Updated Official Laboratory Evaluation Forms (FDA-2400 Series)

Sixteen (16) Official Laboratory Evaluation Forms (FDA-2400 Series) utilized in the evaluation of milk labs, certified industry supervisor (CIS) facilities or screening facilities as required by the National Conference on Interstate Milk Shipments (NCIMS) Program have been updated and are attached in PDF format (2400, 2400a, 2400b-1, 2400b-3, 2400d, 2400h, 2400h-1, 2400h-2, 2400h-3, 2400h-4, 2400j-1, 2400j-2, 2400m, 2400n [App. N Gen Requirements], 2400n-x [Charm SL/SL-6] and 2400n-x [Idexx New Snap]).

All required evaluations cited above shall be conducted using these most recently updated and approved FDA-2400 Series evaluation forms. Federal or state laboratory evaluation officers (LEOs) shall determine if the laboratory, equipment, records and techniques of analysts are in compliance with these FDA-2400 Series evaluation forms beginning 6 months from the issue date of this memorandum, December 1, 2005, with the exception of 2400 (Cultural Procedures), 2400n-x [Charm SL/SL-6] and 2400n-x [Idexx New Snap] which remain in effect due to lack of substantive changes.

An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Rating Officers in your region. The electronic version should be widely distributed to representatives of the dairy industry and other interested parties and will also be available on the FDA Web site at http://www.fda.gov/food at a later date.

If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to robert.hennes@fda.hhs.gov or larry.maturin@fda.hhs.gov.

/s/

Larry Maturin, PhD, Chief
CAPT Robert F. Hennes, RS, MPH, Chief
Laboratory Quality Assurance Team Milk Safety Team


Attachments:

  1. APPENDIX N BULK MILK TANKER SCREENING TEST FORM IDEXX - New SNAP® BETA LACTAM For Raw Bovine Milk GENERAL REQUIREMENTS
  2. ELECTRONIC SOMATIC CELL COUNT Bentley Somacount 150/300/500
  3. STANDARD PLATE COUNT, COLIFORM, AND SIMPLIFIED COUNT METHODS
  4. DETECTION OF INHIBITORY SUBSTANCES IN MILK Bacillus stearothermophilus Disc Assay, Charm Tablet Method For Raw and Finished Cow and Goat Milk
  5. DETECTION OF INHIBITORY SUBSTANCES IN MILK DELVOTEST 5 PACK/Visual & DelvoScan Reader For Raw and Finished Cow and Goat Milk
  6. DIRECT MICROSCOPIC SOMATIC CELL COUNT
  7. ELECTRONIC SOMATIC CELL COUNT Foss 250/300/360/400
  8. ELECTRONIC SOMATIC CELL COUNT Fossomatic 5000
  9. ELECTRONIC SOMATIC CELL COUNT Somascope MKII
  10. ELECTRONIC SOMATIC CELL COUNT Foss 90
  11. PHOSPHATASE TEST - FLUOROPHOS ALP TEST SYSTEM
  12. PHOSPHATASE TEST - CHARM PASLITE - ALKALINE PHOSPHATASE TEST USING CHARM II 6000/6600 AND LUMINOMETER/LUMINATOR
  13. DAIRY WATERS (Coliform Group)
  14. APPENDIX N BULK MILK TANKER SCREENING TEST FORM GENERAL REQUIREMENTS
  15. APPENDIX N BULK MILK TANKER SCREENING TEST FORM Charm SL (raw bovine and caprine) and SL-6 (raw bovine) Beta-Lactam Tests GENERAL REQUIREMENTS
  16. CULTURAL PROCEDURES - GENERAL REQUIREMENTS