1. (a) All breath testing instruments to be used for evidential purposes must have the approval of and/or be certified by brand and/or model by the office of the Scientific Director, Alcohol Testing Program, Texas Department of Public Safety (hereinafter referred to as the scientific director).

   1. (1) The scientific director will establish and maintain a list of approved instruments certified by brand and/or model for use in the state.
   2. (2) If application is made for approval or certification of an instrument by brand and/or model not on the approved list, the scientific director shall examine and evaluate the instrument to determine if it meets the criteria for approval or certification. A manufacturer or designated manufacturer's representative requesting approval of an instrument must submit a production model of the instrument, along with a written request for approval. It shall be the responsibility of the manufacturer or the designated manufacturer's representative to incur costs of mailing or shipping of the instrument to and from the department. It shall also be the responsibility of the manufacturer or the designated manufacturer's representative to submit a certified check or money order in the amount of $500 payable to the Texas Department of Public Safety (this is an administrative approval processing fee and is nonrefundable).

2. (b) In order to be certified each brand and/or model of breath testing instrument must meet the following criteria:

   1. (1) Breath specimens collected for analysis shall be essentially alveolar in composition.
   2. (2) The instrument shall analyze a reference sample, such as headspace gas from a mixture of water and a known weight of alcohol at a known temperature, the result of which must agree with the reference sample predicted value within plus or minus 0.01g/210L or such limits as set by the scientific director.
   3. (3) The specificity of the procedure shall be adequate and appropriate for the analyses of breath specimens for the determination of alcohol concentration for law enforcement.
   4. (4) Any other tests deemed necessary by the scientific director to correctly and adequately evaluate the instrument to give correct results in routine breath alcohol testing and be practical and reliable for traffic law enforcement purposes.

3. (c) Upon proof of compliance with subsection (b) of this section an instrument will be certified by brand and/or model and placed on the list of certified instruments.

   1. (1) Inclusion on the scientific director's list of approved and/or certified instruments will verify that the instrument by brand and/or model meets subsection (b) of this section.
   2. (2) The scientific director may suspend or revoke the certification of a brand and/or model of instrument and remove it from the list of certified instruments for cause.
4. (d) The technical supervisor, as the field agent of the scientific director, shall determine if the individual instrument by serial number is the same brand and/or model that is shown on the scientific director's approved list and meets the criteria for certification as stated in subsection (b)(2) of this section and when required, shall provide direct testimony or written affidavit of this information in accordance with §19.7(y)(7) of this title (relating to Explanation of Terms and Actions).
5. (e) After approval and/or certification if it is determined by the scientific director, or a designated representative or technical supervisor, that a specific instrument is unreliable and unserviceable, the specific instrument will be removed from service and certification and/or approval may be withdrawn.

Source Note:The provisions of this §19.1 adopted to be effective January 1, 1976; amended to be effective April 4, 1984, 9 TexReg 1701; amended to be effective September 8, 1986, 11 TexReg 3800; amended to be effective November 30, 1990, 15 TexReg 6602; amended to be effective August 4, 1998, 23 TexReg 7842.