§ 1171a.39. Clarification of the requirements of § § 1171a.29(c) and 1171a.31(c)—statement of policy.
(a) This section clarifies § § 1171a.29(c) (relating to testing requirements) and 1171a.31(c) (relating to test results and reporting). The Department interprets ‘‘an approved laboratory other than the one that tested the harvest batch or lot’’ in § 1171a.29(c)(2) to be a separate and distinct approved laboratory that meets all financial and professional suitability requirements under this chapter independently from the approved laboratory that conducted the harvest batch or harvest lot test. The Department will consider the following factors to determine whether an approved laboratory is a separate and distinct laboratory:
(1) Separate, independent location from the other approved laboratory, such as no interest in the land or the building in which the other approved laboratory is located or part interest in any mortgage, deed, trust, note or the long-term liability secured in whole or in part by the land or building in which the other approved laboratory conducts testing. For clarification, this statement of policy does not impact the Department’s ability to approve laboratories with multiple locations, including those with shared finances, staffing or operations.
(2) Separate legal entity from the other approved laboratory.
(3) No shared financial ownership with the other approved laboratory, such as filing joint tax returns, shared Federal or Tax Identification Numbers, having direct or indirect ownership interest in another laboratory, commingling of funds or shared bank accounts.
(4) Separate ownership and management in terms of members of a board of directors, shareholders or partners that represent a controlling interest, or management, compliance staff or employees in common with the other approved laboratory.
(5) Separate accreditation from the other approved laboratory.
(6) Separate operations from the other approved laboratory, such as no shared policies or standard operating procedures, reliance on input or oversight of the other approved laboratory or reliance on the other approved laboratory to financially support the approved laboratory’s operations.
(7) No shared equipment or interest in any mortgage, deed, trust, note or other long-term liability secured in whole or in part by equipment used by the other approved laboratory.
(b) The Department will consider the factors in subsection (a)(1)—(7) with respect to determining approved laboratories to conduct confirming tests for re-testing of previously failed samples in § 1171a.31(c).
Authority The provisions of this § 1171a.39 added under sections 102(3)(ii), 301(a)(4) and 704(a) of the act (35 P.S. § § 10231.102(3)(ii), 10231.103(a)(4) and 10231.704(a)).
Source The provisions of this § 1171a.39 added March 3, 2023, effective March 4, 2023, 53 Pa.B. 1179.
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