1. (a) All breath alcohol testing techniques, methods and programs to be used for evidential purposes must have the approval of the scientific director.

2. (b) Prior to initiating a breath alcohol testing program, an agency or laboratory shall submit an application to the scientific director for approval. If the scientific director deems it appropriate, an on-site inspection may be made by the scientific director or a designated representative to assure compliance with the provisions of the application. An agency or laboratory applying for approval of a breath alcohol testing program must agree to:

   1. (1) conduct such analyses only for the purposes stated in subsection (c)(8) of this section;
   2. (2) allow access for inspection under subsection (d) of this section; and
   3. (3) comply with subsection (f) of this section.

3. (c) All breath alcohol testing techniques, in order to be approved, shall meet, but not be limited to, the following:

   1. (1) a period during which an operator is required to remain in the presence of the subject. An operator shall remain in the presence of the subject at least 15 minutes before the test and should exercise reasonable care to ensure that the subject does not place any substances in the mouth. Direct observation is not necessary to ensure the validity or accuracy of the test result;
   2. (2) the breath alcohol testing instrument and reference sample device must be operated by either a certified operator or technical supervisor and only certified personnel will have access to the instrument;
   3. (3) the use of a system blank analysis in conjunction with the testing of each subject;
   4. (4) the analysis of a reference sample, the results of which must agree with the reference sample predicted value within plus or minus 0.01g/210 L, or such limits as set by the scientific director. This reference analysis shall be performed in conjunction with subject analyses;
   5. (5) all analytical results shall be expressed in grams of alcohol per 210 liters of breath (g/210 L);
   6. (6) maintenance of any specified records designated by the scientific director;
   7. (7) supervision of certified operators and testing techniques by a technical supervisor meeting the qualifications set forth in §19.6 of this title (relating to Technical Supervisor Certification);

   8. (8) designation that the instrumentation will be used only:

      1. (A) for testing subjects that are suspected of violating any statute or codified rule that defines intoxication in terms of alcohol concentration; and
      2. (B) in compliance with §19.5(b), (c), and (e) of this title (relating to Operator Certification).
4. (d) The scientific director or a designated representative may at any time make an inspection of the approved breath alcohol testing agency or laboratory to ensure compliance with these regulations.
5. (e) Upon proof of compliance with subsections (a) - (c) of this section, approval will be granted by the scientific director.

6. (f) Approval of any breath alcohol testing program is contingent upon the applying agency or laboratory's agreement to conform and abide by any directives, orders, or policies issued or to be issued by the scientific director regarding any aspect of the breath alcohol testing program; this shall include, but not be limited to, the following:

   1. (1) program administration;
   2. (2) reports;
   3. (3) data, records and forms;
   4. (4) site location and security;
   5. (5) certified evidential instruments should not ordinarily be used for public information programs and dissemination of any such information should be carried out by a certified technical supervisor;
   6. (6) methods of operations and testing techniques;
   7. (7) instruments and reference sample devices;
   8. (8) purposes for which testing is conducted;
   9. (9) operators and technical supervision of operators.
7. (g) Approval of a breath alcohol testing program may be denied or withdrawn by the scientific director if, based on information obtained by the scientific director, a designated representative of the scientific director, or a technical supervisor, the approved agency or laboratory fails to meet all criteria stated in this section.
8. (h) Technical supervisors, when required, shall provide expert testimony by direct testimony or by written affidavit concerning the approval of techniques, methods and programs under their supervision.

Source Note:The provisions of this §19.4 adopted to be effective March 26, 2006, 31 TexReg 2189; amended to be effective June 26, 2013, 38 TexReg 3988.