(a) In
accordance with the provisions of sections 32515 and 34001 of the Food and
Agricultural Code, processes which have been demonstrated to be equally
efficient and approved by the Department are as follows:
(1) "Pasteurization", "pasteurized" and
similar terms shall mean the process of heating every particle of milk or milk
product, in approved equipment (as specified in Article 19), to one of the
temperatures given in the following chart and held continuously at or above
that temperature for at least the corresponding specified time:
Temperature
|
Time
|
63°C (145°F) (see
581(a)(1)(A))
|
30 minutes
|
72°C (161°F) (see
581(a)(1)(A))
|
15 seconds
|
89°C (191° F)
|
1.0 second
|
90°C (194°F)
|
0.5 seconds
|
94°C (201°F)
|
0.1 seconds
|
96°C (204°F)
|
0.05 seconds
|
100°C (212°F)
|
0.01 seconds
|
(A) If the
fat content of the milk product is ten percent (10%) or more, or if it contains
added sweeteners, or if it is concentrated (condensed), the specified
temperature shall be increased by 3°C (5°F). Provided, that eggnog, as
defined in 21 CFR, section
131.170 (2005), shall be heated to at least
the following temperature and time specifications:
Temperature
|
Time
|
69 C (155
F)
|
30 minutes
|
80 C (175
F)
|
25 seconds
|
83 C (180
F)
|
15 seconds
|
(b) Proposals must be submitted to the
Department of Food and Agriculture, Milk and Dairy Food Safety Branch, for
consideration of a process to be equally efficient to the pasteurization and
immediate cooling standards as specified in section 34001 of the Food and
Agricultural Code and subsections (a)(1) and (a)(1)(A) of this section. The
proposal shall be evaluated for equivalency, on a case-by-case basis, and the
proposal shall include, but is not limited to, the following information:
(1) Company name, address, contact
information, corporate address, and the facility location where the equipment
is proposed for use.
(2) Statement
of proposal, including the description of the process and an explanation why
currently approved methods cannot be used, or are less practical, for the
proposed application.
(3)
Identification of product(s) to be processed with the proposed
methodology.
(4) Diagram of the
process and product flow.
(5)
Process parameters, including temperature(s), pressure(s) and times, and
significant equipment or parameter changes from currently approved methods of
pasteurization.
(6) Equipment
material, design and finishes.
(7)
Statistically valid experimental data that compares the proposed process to
currently approved methods, and that relates the data to the conditions and
product formulations in California under which the product(s) is intended for
use.
(8) If available, written
approval from other state or federal dairy regulatory agencies, or published
conference actions of the National Conference on Interstate Milk Shipments
(NCIMS) supporting the proposed process.
(9) If available, technical reviews or
evaluations furnished by state or federal accredited and licensed, scientists,
engineers or other professionals that specialize in, or relate to the proposed
process.
(c) The
Department shall respond to written proposals within 30 business days to
acknowledge receipt of the proposal.
(d) Prior to issuing a decision regarding
equivalency, the Department may conduct site visits, may conduct a pilot
program to verify and study the results of the equivalency process, and may
perform any other tests or studies to verify equivalency as the Department
deems appropriate on a case-by-case basis.
Notes
Cal. Code Regs. Tit. 3, §
581
1. New
section filed 9-16-2005; operative 10-16-2005 (Register 2005, No.
37).
2. Editorial correction of subsection (a)(1)(A) (Register 2006,
No. 3).
Note: Authority cited: Section
407,
Food and Agricultural Code. Reference: Sections
32515
and
34001,
Food and Agricultural Code.
1. New section filed
9-16-2005; operative 10-16-2005 (Register 2005, No. 37).
2.
Editorial correction of subsection (a)(1)(A) (Register 2006, No.
3).