Cal. Code Regs. tit. 3, § 581 – Pasteurization Requirements and Equivalency.

(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. (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:
  1. (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
  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
(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. (1) Company name, address, contact information, corporate address, and the facility location where the equipment is proposed for use.
2. (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. (3) Identification of product(s) to be processed with the proposed methodology.
4. (4) Diagram of the process and product flow.
5. (5) Process parameters, including temperature(s), pressure(s) and times, and significant equipment or parameter changes from currently approved methods of pasteurization.
6. (6) Equipment material, design and finishes.
7. (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. (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. (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.

Note: Authority cited: Section 407, Food and Agricultural Code. Reference: Sections 32515 and 34001, Food and Agricultural Code.

History

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).