U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection

HHS:PHS:FDA:CFSAN:OC:DCP:MSB
 
                                        200 'C" Street, SW
                                        Washington, DC 20204
 
                                        M-I-92-12
 
                                        November 20, 1992
 
TO:       All Regional Food and Drug Directors
          Attn:  Regional Milk Specialists
 
FROM:          Milk Safety Branch  (HFF-346)
 
Subject:  Reiteration of Regulatory Agency Monitoring
          Requirements of Industry Drug Residue Screening.
 
 
We have been requested by industry representatives and regulatory
agencies to elaborate more on the first, second and third
questions from M-a-79.  They are:
 
     What is the required frequency for regulatory agencies to
     make unannounced on-site inspections to collect samples from
     bulk milk pickup tankers and to review industry records of
     the industry sampling program?
 
     Answer from M-a-79:  This should be done at least quarterly.
 
This frequency was developed to enable regulatory agencies to
incorporate this activity in their regular (unannounced)
inspections of milk plants and receiving stations.  It may entail
an additional inspection each six months for transfer stations
that are required to be inspected every 6 months.
 
The next question and answer was:
 
     How many samples should be collected and analyzed during
     these unannounced on-site inspections?
 
     Answer from M-a-79 was:  Samples should be collected and
     analyzed from at least 10% of the bulk milk pickup tankers
     scheduled to arrive on the day of inspection.
 
This means that on the day the inspector arrives at the site
(plant, receiving or transfer station), 10% of the bulk milk
tankers due to arrive during that 24 hour period should be
collected and analyzed.  This is not equal to 10% of the total
bulk milk tankers arriving at that site during the quarter.  For
example if a site would receive 1.7 million lbs of milk per day
from 50 - 34,000 lb. bulk milk tankers, 10% of 50 or 5 samples
would be collected and analyzed.
 
The next question and answer was:
 
     Can this be done as a part of an unannounced regulatory
     inspection of a plant, receiving station or transfer
     station?
 
     Answer from m-a-79 was:  Yes.
 
This question and answer was presented to emphasize that separate
trips to these sites are not required if the regulatory
inspection of the facility is unannounced.
 
 
 
                              Johnnie G. Nichols