§ 159.010-7 Recognized independent laboratory: Memorandum of Understanding.

(a) Only laboratories that have entered into an MOU with the Coast Guard may perform the functions of a recognized laboratory under this chapter. (b) An independent laboratory seeking to become a recognized independent laboratory must submit a signed MOU to the Commandant that includes— (1) A statement of purpose; (2) An identification and description of the parties involved; (3) A description of the problem resolution and appeals processes; (4) A description of the process for measuring effectiveness and efficiency of the program under the MOU; (5) The effective date of the MOU and terms for its termination; (6) A statement to the effect that the MOU is not an exclusive agreement between the recognized independent laboratory and the Coast Guard; (7) An agreement to conduct comparison testing with other recognized laboratories as directed by the Coast Guard, no more often than twice each year, with the laboratory bearing the cost of sample acquisition and testing; (8) A statement as to how the costs of implementing the MOU will be borne; and (9) A description of each party's responsibilities for— (i) Equipment review and approval; (ii) Coast Guard oversight of the recognized independent laboratory's procedures and processes; (iii) Coordination between the parties; (iv) Developing and maintaining regulations and standards; (v) Handling review and approval of new and novel items not anticipated by existing regulations and standards; (vi) Testing and inspection facilities and procedures; (vii) Production quality control; and (viii) Maintenance of records. (c) The signature on the MOU required by paragraph (b) of this section must be that of the chief officer of the independent laboratory or the chief officer's representative. The Commandant or an authorized representative of the Commandant will review the MOU to ensure that it contains the information required by paragraph (b) of this section, and that the substantive provisions submitted in compliance with that paragraph are equivalent to those contained in other MOUs signed by the Commandant. If the Commandant determines that the MOU is acceptable and the independent laboratory is capable of carrying out the equipment approval functions identified in the MOU in accordance with all appropriate requirements, the Commandant or authorized representative may at his discretion sign the MOU. Where qualitative tests or determinations are required for approval or follow-up, provision must be made for conducting comparison tests with other recognized laboratories. (d) Copies of MOUs signed by the Commandant in accordance with this part and of lists of independent laboratories which have been accepted as recognized laboratories but which have not yet been added to the lists included in this subchapter may be obtained at the address listed in § 159.001-5.