Section 345IAC8-2-2.5. Milk products plants cleaning frequency

  5. (a) As used in this section, "extended operation" means using equipment for longer than twenty-four (24) hours between cleaning.

  (b) A manufacturing grade milk plant may use equipment in extended operation up to seventy-two (72) hours if the plant qualifies its processes and equipment under this section.

  (c) A manufacturing grade milk plant that wants to qualify a process and the equipment used in that process for extended operation must submit a written request for approval to the state veterinarian. The request for approval must contain the following:

(1) The applicant's identity and the location of the plant.

(2) A brief description of the applicant's manufacturing process.

(3) A description of a proposed qualification plan that will demonstrate that producing products with the relevant equipment in extended operations will not create a public health hazard.

  (d) The state veterinarian shall review the proposed qualification plan and may approve it if the following requirements are satisfied:

(1) The request for approval meets the requirements in subsection (c).

(2) The qualification plan contains a qualification study designed to evaluate if the extended operation in the processes studied creates a public health hazard.

The state veterinarian and the applicant may agree to changes in the proposed qualification plan. The state veterinarian may approve changes in an approved qualification plan at any time if the amended plan meets the requirements in subdivision (2).

  (e) After the state veterinarian approves a qualification plan under subsection (d), the applicant may conduct the qualification studies in the plan. During the operation of a qualification study, the applicant must allow board personnel access to data collected pursuant to the qualification plan upon request.

  (f) After the qualification study is completed, the applicant may submit the study data to the state veterinarian for review. The state veterinarian may approve a manufacturing grade milk plant's extended operation if the following requirements are met:

(1) The qualification study was conducted according to the approved qualification plan.

(2) Data from the qualification study establish that extended operation in the processes that were studied does not create a public health hazard.

  (g) A plant that is utilizing extended operation must do the following:

(1) Make, keep, and allow board personnel access to the following records:

(A) An operational unit run time chart. The operational unit run time chart's content must be approved as part of the qualification plan.

(B) Cleaning charts.

(C) Pasteurization records.

(D) A summary that clearly shows:

(i) when an operational unit was placed in use;

(ii) when the equipment was cleaned; and

(iii) how long the equipment was in use.

(2) Provide finished product produced under the qualified process to board personnel for official testing upon request.

  (h) The state veterinarian may require that a process be requalified or revoke approval for an extended operation if any of the following occur:

(1) The equipment is operated outside the parameters of the approval.

(2) A plant fails to meet the requirements in subsection (g).

(3) There are significant changes in the qualified process.

(4) The extended run creates or appears to create a hazard to the public health.

  (i) The state veterinarian, in coordination with an industry representative organization, shall prepare and maintain a guidance document that contains a description of the qualification process and guidelines for qualification plans and qualification studies. (Indiana State Board of Animal Health; 345 IAC 8-2-2.5; filed Mar 23, 2000, 4:49 p.m.: 23 IR 1917; readopted filed May 2, 2001, 1:45 p.m.: 24 IR 2895; readopted filed May 9, 2007, 3:16 p.m.: 20070516-IR-345070037RFA; readopted filed Aug 7, 2013, 8:32 a.m.: 20130904-IR-345130236RFA)