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

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.cfsan.fda.gov at a later date and should be widely distributed to
representatives of the dairy industry and other interested parties.
 
 
 
Larry Maturin, PhD, Chief		      CAPT Robert F. Hennes, RS, MPH, Chief
Laboratory Quality Assurance Branch	      Milk Safety Branch
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M-I-02-8	1	    June 21, 2002