§ 59a.5. Standards for Pennsylvania-approved dairy laboratories, official laboratories and other laboratories; reports of results.
(a) General standards. A Pennsylvania-approved dairy laboratory, an official laboratory or another laboratory that conducts sampling or laboratory examinations for purposes of this chapter shall conform that sampling or testing to the applicable standards and procedures set forth in the Standard Methods for the Examination of Dairy Products or the current edition of the Official Methods of Analysis of the Association of Official Analytical Chemists. Procedures, including laboratory examination procedures and the certification of sample collectors, shall be evaluated in accordance with the current Evaluation of Milk Laboratories, Recommendations of the United States Public Health Service/Food and Drug Administration and the Grade ‘‘A’’ PMO and operate in accordance with current FDA 2400 Laboratory Series forms.
(b) Reports of results. If a Pennsylvania-approved dairy laboratory issues a report of the results of laboratory examinations for purposes of this chapter, the report shall be signed by a Pennsylvania-approved dairy laboratory director or a person designated by a laboratory director to sign these reports. If an official laboratory issues a report of the results of laboratory examinations for purposes of this chapter, the report shall be signed by the laboratory director, a person designated by the laboratory director, the person who performed the tests described in the report or the Director of the Department’s Bureau of Food Safety and Laboratory Services.
(c) Pennsylvania-approved dairy laboratory director.
(1) A person may apply to the Department to be certified as a Pennsylvania-approved dairy laboratory director. This approval may be sought for one or more of the following categories of dairy testing procedures:
(i) Sampling.
(ii) Cultural procedures.
(iii) Coliform count (media or PetrifilmTM).
(iv) Standard plate count (media or PetrifilmTM Count).
(v) Drug Residue Testing/Appendix N of the Grade ‘‘A’’ PMO.
(vi) Direct microscopic somatic cell count or electronic somatic cell count, or both.
(vii) Phosphatase: Electronic Fluorophos or Charm methodologies, or both.
(2) The Department will consider the written application of a dairy laboratory director to be certified as a Pennsylvania-approved dairy laboratory director. The application may be made by letter or on a form the Department will provide upon request. A prospective applicant shall meet two or more of the following requirements to be eligible to apply:
(i) The applicant shall have at least 1 year of experience or the equivalent of that experience conducting analysis at a dairy laboratory.
(ii) The performance of the applicant with respect to the category for which certification is sought has been evaluated onsite by Department personnel and been satisfactory.
(iii) The performance of the applicant in a Department-conducted milk split sample proficiency program with respect to the category for which certification is sought has been satisfactory.
(iv) The applicant has attended and completed a training session offered by the Department or the FDA addressing the category for which certification is sought.
(3) The Department will provisionally certify a dairy laboratory director to be a Pennsylvania-approved dairy laboratory director with respect to one or more specific categories of testing procedures if the applicant meets the qualification standards in paragraph (2), submits an application and does the following:
(i) Completes a Department-administered written examination and attains a score of at least 80%. The examination must have the following parts:
(A) A general section addressing sampling and culturing procedures.
(B) A section addressing the specific categories of dairy testing procedures with respect to which the applicant seeks certification.
(ii) Passes an onsite performance and facilities evaluation by a laboratory evaluation officer from the Department.
(4) After the provisional certification in paragraph (3), the Department will certify a dairy laboratory director to be a Pennsylvania-approved dairy laboratory director with respect to one or more specific categories of testing procedures if the provisionally-certified person submits a split sample to the Department for analysis, retains and analyzes the other portion of the split sample, and the results of analysis are consistent between the Department and the provisionally-certified person.
Cross References This section cited in 7 Pa. Code § 59a.2 (relating to definitions).
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