Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 32 - Milk-Testing Laboratories › Section 19 CSR 25-32.010 - State Approval of Milk-Testing Laboratories

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: Laboratories which perform examinations of
				  milk required by the "Grade A Pasteurized Milk Ordinance" and by the
				  cooperative State-United States Public Health Service/Food and Drug
				  Administration Program for Certification of Interstate Milk Shippers must be
				  approved by the Department of Health, which is the official agency for approval
				  of milk-testing laboratories. This rule establishes up-to-date minimum
				  requirements for laboratory approval, using the current recommendations of the
				  federal Food and Drug Administration.
PUBLISHER'S NOTE: The secretary of state has
				  determined that publication of this rule in its entirety would be unduly
				  cumbersome or expensive. The entire text of the rule has been filed with the
				  secretary of state. Section (2) of this rule-the only part of the rule not
				  published in its entirety-requires that laboratories be in compliance with the
				  publication,
Evaluation of Milk Laboratories
, and the official
				  Milk Laboratory Education Forms (FD-2400 series); these have been filed with
				  the secretary of state. The entire text of the rule is also available at the
				  office of the director, State Public Health Laboratory, Department of Health
				  and is available to any interested person at a cost established by state
				  law.
(1) Application for
				evaluation and approval of a laboratory must be made to the director, section
				of laboratory services, Department of Health by the director of the applying
				laboratory. To be eligible for evaluation, a laboratory must routinely analyze
				samples for either interstate or intrastate milk shippers.
(2) To be eligible for approval, a laboratory
				must be in substantial compliance with the United States Public Health
				Service/Food and Drug Administration's
Evaluation of Milk
				Laboratories
and official Milk Laboratory Evaluation Forms (FD-2400
				series).
(3) An on-site evaluation
				of the applying laboratory shall be made by the state milk laboratory
				evaluation officer for a review of facilities, equipment, materials,
				procedures, test results and records. The evaluation shall be made using the
				official Milk Laboratory Evaluation Forms (FD-2400 series). The evaluation
				officer shall determine whether the laboratory techniques of analysts of the
				applying laboratory are in compliance with the procedures as described on the
				official Milk Laboratory Evaluation Forms (FD-2400 series). An on-site
				evaluation to determine compliance of a laboratory shall be made at least every
				two (2) years.
(4) Analysts must
				participate at least annually in the examination of split samples for those
				specific procedures for which they are certified. Failure without cause to
				participate in this annual Proficiency Testing Program or failure to meet
				established performance criteria will result in an analyst being placed on
				provisional certified status. Failure of analysts on provisional certified
				status to participate in the examination of split samples or to meet
				satisfactory performance levels on the next set of split samples will result in
				withdrawal of certification.
(5) An
				analyst who has lost certification must participate in a training program
				acceptable to the state milk laboratory evaluation officer before requesting
				recertification.
(6) The Department
				of Health shall issue a certificate of approval to each official laboratory and
				officially designated laboratory which has been approved. The certificate shall
				be returned to the Department of Health upon expiration or
				revocation.
(7) Approval of a
				laboratory may be revoked or suspended for failure to successfully participate
				in the Proficiency Testing Program as described in section (4) of this rule,
				for lack of certified analysts, for changes in quarters, personnel, equipment
				or supplies, which result in procedures and practices not in compliance with
Evaluation of Milk Laboratories
or for other
				reasons.