Current through Register 1531, September 27, 2024
(A)
Raw Milk to be Used in Frozen Desserts, Frozen Dessert Mixes,
Butter, or Cheese.
(1)
Drug Residues.
(a)
All manufacturers shall test for drug residues, or have evidence of a previous
test for drug residues, on all incoming unpasteurized milk and milk products
received for processing into frozen desserts, frozen dessert mixes, butter, or
cheese.
(b) Drug residue tests
shall be performed as required by the Department's administrative guidelines
based on the PMO.
(c) The
manufacturer shall not use any item tested until it receives a negative test
result, provided that when drug residues have been found in a second sample of
raw milk or a raw milk product, the manufacturer shall destroy such milk or
milk product.
(d) Any positive drug
residue test shall be reported to the Department of Agricultural
Resources.
(e) Whenever a drug
residue test is confirmed positive, the manufacturer shall investigate to
determine the cause, and shall correct the cause in accordance with the
guidelines.
(2)
Pesticide Residues.
(a) Pesticide residue tests are performed by
federal agencies on a non-routine basis.
(b) Whenever a pesticide residue test is
positive, the manufacturer shall investigate to determine the cause, and shall
correct the cause. No product shall be offered for sale until it is shown by a
subsequent sample to be free of pesticide residues or below the levels
established by law for such residues.
(B)
Finished Products Testing
Requirements for Manufacturers of Frozen Desserts.
(1)
Phosphatase.
(a) Phosphatase tests are performed by the
Department on samples that are collected routinely.
(b) Whenever a phosphatase test is positive,
the manufacturer shall investigate to determine the cause. Where the cause is
improper pasteurization, it shall be corrected and any product involved shall
not be offered for sale.
(2) All manufacturers manufacturing finished
frozen dessert products by means other than a soft-serve machine shall have the
tests specified in 105 CMR 500.083(F) performed by a laboratory approved by the
Department of each of the following categories of finished products at least
once a month:
(a) Plain frozen dessert
(vanilla, chocolate, coffee, etc.);
(b) Fruits and variegated (strawberry, frozen
pudding, raspberry royale, etc.);
(c) Nuts and candy (maple walnut, butter
crunch, etc.);
(d)
Sherbet;
(e) Novelties (spumoni,
dixies, sandwiches, etc.);
(f) Seasonal products (products manufactured
during only part of the year); and
(g) Frozen yogurt, except that if live
cultures have been added to the product after pasteurization, the test for
bacterial limit shall not be required.
If the flavors listed in each of these categories can be
practically rotated, the tests shall be made on that basis.
(3)
New
Products. Any new frozen dessert product, including a new flavor
of any frozen dessert, shall be placed in the appropriate category specified in
105 CMR 500.082(B)(2) and shall have priority for testing.
(4) All manufacturers of frozen desserts
produced in a soft-serve machine shall have the tests of its finished product
specified in 105 CMR 500.083(F) performed by a laboratory approved by the
Department at least once a month.
(5)
Copies to be Submitted by
In-state Manufacturers. The manufacturer shall ensure that copies
of all test results for required tests are submitted directly to the board of
health by the laboratory within three business days of completion of the
tests.
(6)
Notification
Regarding Laboratory. Each manufacturer of a frozen dessert or
frozen dessert mix shall notify the board of health in writing of the name and
address of the laboratory where the tests required by 105 CMR 500.083 are done.
When the manufacturer ceases to use a particular laboratory, he or she shall
immediately notify the board of health in writing of the name and address of
the new laboratory that is to be used.
(C)
Sampling and Testing after a
Bacterial Violation is Found: Frozen Desserts Produced by Means Other than a
Soft-Serve Machine. Whenever any sample tested pursuant to 105 CMR
500.082(B)(1), (2) or (3) is found to be in violation of the bacterial limit or
coliform standard in 105 CMR 500.083(F), the manufacturer shall re-sample and
retest each subsequent production run of the finished product originally found
in violation (e.g. vanilla, chocolate, etc.)
until three consecutive non-violative samples are obtained.
(D)
Enforcement of Bacterial
Standards: Frozen Desserts and Frozen Dessert Mixes.
(1) Whenever two of the last four consecutive
tests for bacterial limit counts or coliform determinations (except those for
aseptically processed products), taken on separate days (different production
days), exceed the limit of the standard specified in 105 CMR 500.083(D), (E),
or (F), the board of health or the Department, as appropriate, shall send a
written notice thereof to the licensee. This notice shall also inform the
licensee of the provisions of 105 CMR 500.082(D)(2), and shall remain in effect
as long as two of the last four consecutive samples exceed the limit of the
standard.
(2) Whenever a standard
specified in 105 CMR 500.083(D), (E), or (F) has been violated by three of the
last five consecutive tests for bacterial limit or coliform determinations
(except those for aseptically processed products), taken on separate days
(different production days), the board of health or the Department, as
appropriate, shall immediately suspend the license or one or more particular
operations, or the sale of one or more particular products, without prior
notice or hearing, in accordance with 105 CMR 500.207(B).
(3) When the license or operation(s) are
suspended as provided in 105 CMR 500.082(D)(2), the following procedures shall
be followed.
(a) The manufacturer shall
provide to the board of health and the Department documentation showing:
1. The cause of the violative condition;
and
2. The plan of correction used
to correct the violative condition.
(b) After receipt of the documentation
specified in 105 CMR 500.082(D)(3)(a):
1. The
Department shall collect samples and conduct laboratory analyses to determine
if the conditions(s) have been corrected, and
2. An inspection shall be made. If it is
determined that the condition(s) responsible for the violation(s) has been
corrected, the board of health or Department shall reinstate the license, or
allow the resumption of operation(s), or the sale of suspended
product(s).
(E)
Violation of Standards:
Soft-serve Machines. Whenever any sample from a soft-serve machine
tested pursuant to 105 CMR 500.082(B)(2)(a) is found to be in violation of the
bacterial limit or coliform standard in 105 CMR 500.083(F), the machine
operator shall thoroughly clean, rinse, and sanitize the machine and shall test
the first product produced by the machine after cleaning. The machine may be
operated until the result of the confirmatory test is received. If such test
shows a violation, production must stop and further cleaning, sanitizing, and
testing must be done. No product may be sold or distributed in any way until
the result of the subsequent test meets the standards in 105 CMR
500.083(F).
