Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part I - General Health
Chapter 5 - CLINICAL LABORATORIES
EQUIPMENT TO DETERMINE BLOOD ALCOHOL CONTENT UNDER THE VEHICLE CODE AND THE FISH AND BOAT CODE
Section 5.104 - Prearrest breath tests for blood alcohol content

Universal Citation: 28 PA Code ยง 5.104

Current through Register Vol. 54, No. 44, November 2, 2024

(a) Equipment approval requirements.

(1) The Department will approve prearrest breath testing devices for use by police officers in conducting preliminary alcohol determinations on persons suspected of driving while under the influence of alcohol. Until performance standards for prearrest breath testing devices are promulgated by regulation, manufacturers who desire interim approval of their devices shall file the following information with the Department:
(i) A complete description of the device, including its principle of operation.

(ii) An operator's manual for the device.

(iii) A maintenance and repair manual for the device, if applicable, including diagrams and lists of component parts.

(iv) Performance data derived from studies conducted by or for the manufacturer to support claims relating to the reliability of the device.

(v) The names and addresses of law enforcement agencies in this Commonwealth who have purchased the device. Manufacturers shall provide to the Department, on an annual basis, the names and addresses of new purchasers to whom the devices are sold.

(vi) A list and complete description, including applicable manuals, for breath simulators or other accessories intended for use with the prearrest breath testing device.

(vii) A list of authorized distributors and service representatives for the prearrest breath testing device.

(viii) The data and results of reviews or studies conducted by other State or Federal agencies, including certification or approval, if available.

(2) When the filing requirements in paragraph (1) have been met and the Department is satisfied that the information supplied by the manufacturer is complete, adequate and responsive; that the device has been properly tested; that the device is reliable and readily available; and that the device can be adequately serviced, the device will be issued an interim approval for use in this Commonwealth. The interim approval will remain in effect until performance standards are promulgated by regulation, or until unsatisfactory performance is demonstrated.

(b) Approved equipment list. Prearrest breath testing devices which meet subsection (a) will be placed on a list of approved equipment for preliminary breath alcohol testing purposes. This list will be revised semiannually. A certified copy of the list will be available upon request at the Bureau of Laboratories.

(c) Application for approval. Manufacturers of prearrest breath testing devices who are seeking approval from the Department for their instruments to be used by law enforcement officials shall submit information specified in subsection (a)(1) to: Division of Chemistry and Toxicology, Bureau of Laboratories, Department of Health, Pickering Way & Welsh Pool Road, Lionville, Pennsylvania 19353, (215) 363-8500.

This section cited in 28 Pa. Code § 5.101 (relating to purpose); and 58 Pa. Code §51.51 (relating to chemical tests); and 58 Pa. Code § 131.5 (relating to chemical tests).

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