Current through August 26, 2024
(1) GENERAL. The division shall test and seal
pasteurization systems according to this section. Except as provided under sub.
(6), no person may use any pasteurization system to pasteurize grade A or grade
B dairy products unless that system bears the unbroken seals applied by the
department under sub. (5).
(2) TEST
PROCEDURE. The division shall test grade A and grade B pasteurization systems
according to the procedure specified in Appendix I of the PMO.
Note: PMO Appendix I is on file with the
division and the legislative reference bureau. Copies may be obtained from the
division at cost or online at
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Milk.
(3) TEST FREQUENCY; GRADE A
PASTEURIZERS. The division shall test each grade A pasteurization system at the
following times:
(a) Before the
pasteurization system is first put into operation.
(b) At least once every 3 months, except that
a holding time test may be conducted at least once every 6 months.
(c) Whenever a seal, under sub. (5), is
broken.
(4) TEST
FREQUENCY; GRADE B PASTEURIZERS. The division shall test a grade B
pasteurization system at the following times:
(a) Before the pasteurization system is first
put into operation.
(b) At least
once every 12 months.
(c) Whenever
a seal, under sub. (5), is broken.
(5) DEPARTMENT SEALS. When the division's
test confirms that a pasteurization system is operating correctly, the division
shall apply seals that prevent any alteration of the system that would allow
any unpasteurized milk or dairy product to flow through the system.
(6) BROKEN SEAL.
(a) A dairy plant operator shall notify the
division by telephone, electronic mail, or facsimile (FAX) transmission within
2 hours after the dairy plant operator breaks a seal applied by the division
under sub. (5), or within 2 hours after a pasteurizing system malfunctions to
the possible detriment of public health or safety. The dairy plant operator
shall also notify the department in writing, on a form provided by the
division, within 5 business days after the seal is broken or the system
malfunctions.
(b) A dairy plant
operator may not operate a pasteurizer after breaking a seal applied by the
department under sub. (5), unless all of the following conditions are met:
1. The dairy plant operator notifies the
department under par. (a).
2. The
dairy plant operator determines and documents that pasteurization time and
temperature requirements under s.
ATCP 65.58 are met, and that the pasteurization system is
repaired and functioning properly. Time and temperature records required by s.
ATCP 65.66
shall be retained for at least 6 months.
3. The dairy plant operator conducts
phosphatase tests, under par. (d), if the pasteurizer is used to pasteurize
milk without added flavors or ingredients other than vitamins. Phosphatase
testing shall confirm that pasteurized milk without added flavors or
ingredients other than vitamins contains less than 350 milli-units of
detectable alkaline phosphatase per liter.
4. A pasteurizer operator qualified under s.
ATCP 65.54(3) is present to operate the
pasteurizer, or to supervise its operation.
(c) A dairy plant operator may not operate a
pasteurizer for more than 10 calendar days after breaking a seal applied by the
department under sub. (5), unless any of the following occurs:
1. The division tests the pasteurizer and
replaces the broken seal.
2. A
dairy plant operator or employee certified under sub. (7), tests the
pasteurizer and replaces the broken seal on an interim basis, pending retesting
and resealing by the department.
(d) Phosphatase testing, under par. (b) 3.,
shall comply with all of the following requirements:
1. The dairy plant operator shall collect and
analyze a test sample, directly from the pasteurizer system, at least once
during every 4 hours of pasteurizer operations.
2. The dairy plant operator shall store each
test sample at a temperature below 45º F. (7º C.) until it is tested
and shall analyze each sample within 48 hours after it is collected.
3. The dairy plant operator shall analyze
each sample using the Fluorophos ALP method, the Charm Paslite Alkaline
Phosphatase method, or another test method approved in writing by the
division.
4. Tests shall be
performed by an individual who is trained to conduct phosphatase tests on milk.
If the dairy plant is a grade A dairy plant, tests shall be performed by a
laboratory that the department has certified under ch. ATCP 77 or the
PMO.
(7)
EMERGENCY TESTING AND SEALING.
(a) The
division may certify a dairy plant operator or employee to test and seal a
pasteurization system in that dairy plant on an emergency basis under par. (b).
To be certified under this paragraph, a dairy plant operator or employee shall
have successfully completed a training course approved by the division. The
division may suspend or revoke certification for cause.
(b) A dairy plant operator or employee
certified under par. (a) may test and seal a pasteurization system in that
dairy plant on an emergency basis, pending retesting and resealing by the
division, under par. (c), if emergency testing and sealing is necessary to
continue pasteurizing operations after the department's seal is broken. Testing
under this paragraph shall comply with the procedure specified under sub.
(2).
(c) The division shall
promptly retest and reseal a pasteurization system after the division receives
notice, under sub. (6) (a), that its seal applied to that system has been
broken. The division shall retest and reseal a pasteurization system, under
this paragraph, regardless of whether the pasteurization system has been tested
and sealed under par. (b). The division need not retest or reseal a
pasteurization system that is withdrawn from service.
