July 2, 2001
NOTE: A draft of this document was originally posted. The text as it currently appears is the final version. We apologize for any inconvenience this may have caused.
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Visual Test Protocol and Notice of M-I-00-3 Rescinded
NOTE: With issuance of this memorandum, M-I-00-03 is rescinded.
The NCIMS and FDA have agreed to the following protocol for the evaluation of analyst's ability to conduct visually read animal drug residue tests under Section 6 and Appendix N of the Grade A Pasteurized Milk Ordinance.
This protocol is to be used with animal drug residue test kits that are based on visual readings and is to be in place by March 1, 2002.
- The LEO will conduct an initial onsite evaluation of each analyst including Appendix N, Industry Analysts.
- The LEO will submit a written narrative report to the LQAB listing each approved analyst.
- Analyst requirements:
- Each analyst must demonstrate the ability to detect the beta-lactams at safe/tolerance level per kit label claim (Pen G, Cloxicillin, Ceftiofur, and Cephapirin) using blind samples with duplicate negatives. LQAB will supply the concentrates for this program.
- Each Analyst certified to perform visual drug residue test will participate in annual proficiency tests* to demonstrate ability to detect the beta-lactams at safe/tolerance level per kit label claim (Pen G, Cloxicillin, Ceftiofur, and Cephapirin), using blind samples with duplicate negatives. LQAB will supply the concentrates for this program. Results must be satisfactory.
- The current certification and proficiency programs for Official Laboratories, Officially Designated Laboratories and Certified Industry Supervisor programs will not change with the exception of the annual proficiency tests* described above.
*These proficiencies are to be separate from normal annual proficiencies and are to be test kit specific.
Analyst(s) will not be allowed to perform visual animal drug residue testing if ANY of the following conditions are determined:
- There is a lack of documentation with reference to analyst training;
- The analyst(s) is testing after March 1, 2002 without having passed an on-site evaluation;
- The analyst(s) fails the on-site performed by LEO (the analyst must identify all drugs correctly); or
- The analyst(s) fails the annual proficiency testing.
Additional copies of this memorandum are also enclosed for your distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Milk Rating Officers and State Laboratory Evaluation Officers in your region. This memorandum is available on the FDA Web Site at http://www.cfsan.fda.gov (Updated Web Address) and should be widely distributed to representatives of the dairy industry and other interested parties.
Steven T. Simms, Acting Chief
Milk Safety Team