Current through Register Vol. 48, No. 9, September 27, 2024
A. Sampling
criteria.
1. Samples of MANUFACTURED GRADE
DAIRY PRODUCTS shall be collected by the manufacturer or the DEPARTMENT, as
directed, at a frequency that is deemed appropriate by the DEPARTMENT based on
the level of RISK of the product.
2. Samples may be taken while in the
possession of the manufacturer and/or distributor, retail stores, cafes,
restaurants, and other places where MANUFACTURED GRADE DAIRY PRODUCTS are sold
and shall be taken and examined as often as the DEPARTMENT may
require.
B. Sampling
enforcement.
1. Upon receipt of
unsatisfactory samples, as specified in (a) and (b) below, the DEPARTMENT shall
send a written notice thereof to the PERMIT HOLDER of the MANUFACTURED GRADE
DAIRY PRODUCTS PLANT or MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTION STATION.
a. For FROZEN DESSERTS this notice shall be
sent when two (2) of the last four (4) consecutive bacterial counts (except
those for ASEPTICALLY PROCESSED MIX), coliform determinations, or cooling
temperatures, taken on separate days, exceed the limit of the standard for
FROZEN DESSERTS. An additional sample shall be taken within twenty-one (21)
days of the sending of such notice, but not before the lapse of three (3) days.
The DEPARTMENT shall suspend the manufacturer and/or distributor's PERMIT in
accordance with Section III and/or take court action as necessary whenever the
additional sampling results indicate that three (3) of the last five (5)
bacterial counts (except those for ASEPTICALLY PROCESSED MIX), coliform
determinations, or cooling temperatures exceed the limit of the standard for
FROZEN DESSERTS.
b. For CHEESE and
BUTTER, this notice shall be sent when a sample is confirmed to be positive for
PATHOGENIC organisms. A positive finding of PATHOGENIC organisms in a sample
shall be considered an IMMINENT HEALTH HAZARD, and the product involved shall
not be offered for sale. The DEPARTMENT shall immediately suspend the PERMIT
and the PERMIT shall remain suspended until a minimum of two (2) consecutive
representative samples are found to be free of PATHOGENIC organisms.
2. Whenever a phosphatase test is
positive, the cause shall be determined by the PERMIT HOLDER. Where the cause
is improper PASTEURIZATION, it shall be corrected, and any MANUFACTURED GRADE
DAIRY PRODUCT involved shall not be offered for sale.
3. Whenever a pesticide residue test is
positive, an investigation shall be made to determine the cause, and the
product involved shall not be offered for sale. The cause shall be corrected.
An additional sample shall be taken and tested for pesticide residues and no
MANUFACTURED GRADE DAIRY PRODUCT shall be offered for sale until it is shown by
a subsequent sample to be free of pesticide residues or below the actionable
levels established for such residues.
4. Whenever a DRUG residue test is positive,
an investigation shall be made to determine the cause, and the cause shall be
corrected in accordance with the provision of Section II of this
regulation.
5. Whenever a container
or containers of ASEPTICALLY PROCESSED MANUFACTURED GRADE DAIRY PRODUCT is
found to be unsterile due to under processing, the DEPARTMENT shall consider
this to be an IMMINENT HEALTH HAZARD and shall suspend the PERMIT of the
MANUFACTURED GRADE DAIRY PRODUCT plant for the sale of ASEPTICALLY PROCESSED
MANUFACTURED GRADE DAIRY PRODUCT. No ASEPTICALLY PROCESSED MANUFACTURED GRADE
DAIRY PRODUCT shall be sold until it can be shown that the processes,
equipment, and procedures used are suitable for consistent production of a
sterile product. All products, including MANUFACTURED GRADE DAIRY PRODUCT,
manufactured in or from the lot found to contain one (1) or more unsterile
units shall be recalled and disposed of as directed by the DEPARTMENT.
C. Sampling methods.
Samples shall be analyzed at an official or appropriate
OFFICIALLY DESIGNATED LABORATORY. All sampling procedures and required
laboratory examinations shall be in substantial compliance with the Standard
Methods for the Examination of Dairy Products of the American Public Health
Association, and the certification of sample collectors, and examinations shall
be evaluated in accordance with the United States Public Health Service/FDA
Evaluation of MILK Laboratories. Aseptically processed MANUFACTURED GRADE DAIRY
PRODUCTS packaged in HERMETICALLY SEALED CONTAINERS shall be tested in
accordance with the FDA's Bacteriological Analytical Manual. Examinations and
tests to detect adulterants, including pesticides, shall be conducted as the
DEPARTMENT requires.