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M-I-92-12: Reiteration of Regulatory Agency Monitoring Requirements of Industry Drug Residue Screening

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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 xample 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