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M-I-02-8: Laboratory Tests Not Approved For Specific Dairy Products May Not Be Used As "Official Regulatory Tests"

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HHS:PHS:FDA:CFSAN:OFP:DCP:MSB

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-I-02-8

June 21, 2002

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

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Laboratory Tests Not Approved For Specific Dairy Products May Not Be Used As "Official Regulatory Tests"

At the January 16, 2002 NCIMS Executive Board meeting, held in Reno, Nevada, it was suggested that FDA issue an M-I that addresses concerns cited by board members pertaining to the use of laboratory tests, which are not approved for specific dairy products being used as "Official Regulatory Tests". Problems occur with laboratory analysis whenever products are analyzed for regulatory purposes using evaluated/approved tests on dairy products that have not been evaluated/approved with those tests or when unevaluated/non-approved tests are used to analyze dairy products.

BACTERIAL COUNT

It is more appropriate to test the base or raw milk of the following dairy products: cultured products, acidified products, condensed products, ultra-filtered (UF) milk, whey, and powdered whey.

For regulatory purposes, the above cited dairy products must not be assayed using existing evaluated/approved bacterial count test methods as those methods have not been evaluated and approved using the above cited dairy products.

Unevaluated/non-approved tests cannot be used to determine the bacterial count of a sample. These tests include: direct microscopic count (DMC), RedigelTM, etc. However, if a Regulatory Agency chooses an inappropriate product to be tested or uses an unapproved test for "Official Regulatory" testing and the result is violative, regulatory officials must act on the result. Appropriate action and a follow-up investigation are required to resolve the results.

DRUGS

It is more appropriate to test the base or raw milk except for individual cow samples, of the following dairy products: aseptic milk, cultured products, acidified products, condensed products, UF milk, whey and whey products, dried milk and dried products, eggnog and flavored (non-chocolate) products. (Refer to M-a-72)

For regulatory purposes, the above cited dairy products, including individual cow samples, must not be assayed using existing evaluated/approved animal drug residue test kit methods as those assays have not been evaluated and approved using the above cited dairy products or individual cow samples.

Unevaluated/non-approved test kits cannot be used to determine if animal drug residues are present. However, if a Regulatory Agency chooses an inappropriate product to be tested or uses an unapproved test for "Official Regulatory" testing and the result is violative, regulatory officials must act on the result. Appropriate action and a follow-up investigation are required to resolve the result.

PHOSPHATASE

It is not appropriate to test the following dairy products for phosphatase activity: aseptic products, ultra-pasteurized products, ESL (extended shelf life) products, and condensed products. The verification of the process is proof of pasteurization.

For regulatory purposes, the above cited dairy products must not be assayed using existing evaluated/approved phosphatase test methods, as those methods have not been evaluated/approved using the above cited dairy products.

Unevaluated/non-approved phosphatase tests cannot be used to determine if products were properly pasteurized. However, if a Regulatory Agency chooses an inappropriate product to be tested or uses an unapproved test for "Official Regulatory" testing and the result is violative, regulatory officials must act on the result. Appropriate action and a follow-up investigation are required to resolve the result.

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

Larry Maturin, PhD, Chief
Laboratory Quality Assurance Branch

CAPT Robert F. Hennes, RS, MPH, Chief
Milk Safety Branch