WSR 99-01-012

PROPOSED RULES

STATE TOXICOLOGIST

[Filed December 4, 1998, 2:08 p.m.]



Original Notice.

Preproposal statement of inquiry was filed as WSR 98-17-095.

Title of Rule: Administration of breath test program, chapter 448-13 WAC.

Purpose: To clarify language and make rule consistent with changes in statute.

Statutory Authority for Adoption: RCW 46.61.506.

Statute Being Implemented: RCW 46.61.506.

Summary: Issues have been raised in court regarding oral jewelry, changing of simulator solutions, and interpretation of test results. These changes are designed to clarify these issues.

Reasons Supporting Proposal: The per se limit for alcohol intoxication has been changed to 0.08g/210L of breath, and program changes are being made for consistency.

Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Barry K. Logan Ph.D., 2203 Airport Way South, Seattle, WA 98134, (206) 343-5435.

Name of Proponent: State Toxicologist, governmental.

Rule is not necessitated by federal law, federal or state court decision.

Proposal Changes the Following Existing Rules: These changes would define oral jewelry as a physical limitation to providing a breath test, and would require its removal; change the simulator external standard value to 0.08g/210L; define purpose of truncation of lower BAC result; remove confusing "approaching" language regarding changing of simulator solution; place in code provisions regarding expiration of breath test operator certification; and other minor changes regarding personnel responsibilities.

No small business economic impact statement has been prepared under chapter 19.85 RCW. No anticipated impact on small business, since rule affects agency only.

RCW 34.05.328 does not apply to this rule adoption. Agency compliance is not required per subsection (5)(a)(i).

Hearing Location: Washington State Toxicology Lab, 2203 Airport Way South, Seattle, WA 98134, on January 26, 1999, at 9:00 a.m.

Assistance for Persons with Disabilities: Contact Linda Collins, (206) 343-5435 by January 20, 1999.

Submit Written Comments to: Barry K. Logan Ph.D., 2203 Airport Way South, Seattle, WA 98134, fax (206) 731-8564, by January 20, 1999.

Date of Intended Adoption: February 28, 1999.

December 4, 1998

Barry K. Logan Ph.D.

Washington State Toxicologist

OTS-2631.2

AMENDATORY SECTION (Amending WSR 95-20-025, filed 9/27/95, effective 10/28/95)



WAC 448-13-030  Definitions. (1) "Accuracy" means the proximity of a measured value to a reference value.

(2) "Alcohol" means the unique chemical compound ethyl alcohol.

(3) "Blank test" means the testing of a DataMaster instrument to ensure that no alcohol from a previous test can interfere with a person's breath test.

(4) "Breath alcohol analysis" means analysis of a sample of a person's expired breath, using a breath testing instrument designed for this purpose, which instrument is approved by the state toxicologist, in order to determine the alcohol concentration in that breath sample.

(5) "Breath test document" means the form which is printed by the DataMaster on the completion of a breath alcohol test.

(6) "Calibration" means the process of standardizing the DataMaster using a certified simulator solution to allow by proportion, the measurement of the alcohol concentration of a person's breath. Calibration will be performed periodically as required and at least once a year during quality assurance.

(7) "Certified" when used in conjunction with breath test personnel means an operator, instructor, solution changer or technician possessing a valid permit.

(8) "Certified simulator solution" means an alcohol/water solution prepared and tested by an approved protocol, and meeting the criteria specified therein.

(9) "Certified test" means a test conducted in accordance with WAC 448-13-040 and 448-13-050. A test which meets these requirements as determined from the breath test document is a certified test.

(10) "Concentration" means the weight amount of alcohol, expressed in grams, contained in two hundred ten liters of breath or alcohol/water vapor.

(11) "DataMaster" means BAC Verifier DataMaster, instruments including those carrying the designation BAC Verifier DataMaster II, and the BAC DataMaster. These are the only approved breath test instruments in the state of Washington.

(12) "Data base" means information collected primarily for the purposes of statistical analysis of patterns of drinking and driving in the state of Washington.

(13) "Data entry" means the process of providing information through a keyboard to the DataMaster for the purposes of (a) identifying a breath test document to an individual, and (b) statistical analysis.

(14) "Interference" means a test result whose infrared absorbance properties are not consistent with ethanol.

(15) "End expiratory breath" means the last portion of breath to be delivered to the DataMaster once the appropriate sample acceptance criteria have been met.

(16) "External standard test" means the use of a simulator containing a certified simulator solution, to provide a known alcohol vapor concentration to test the accuracy and proper working order of the DataMaster and confirm its calibration at the time of a person's breath test. This test of the function of the DataMaster is performed with every breath test. The external standard test does not calibrate the DataMaster.

(((16))) (17) "Internal standard test" means the use of a quartz filter to provide a check that the instrument has maintained calibration since the last time calibration was performed and is in proper working order at the time of the test.

(((17))) (18) "Precision" means the ability of a technique to perform a measurement in a reproducible manner.

(((18))) (19) "Procedure" and "method" are used interchangeably to indicate a series of steps which, when carried out as directed, constitute the means by which a given task is performed in a reproducible manner.

(((19))) (20) "Protocol" means the written record of any method or procedure.

(((20))) (21) "Quality assurance program" means an ongoing program designed to perform preventative maintenance and identify potential defects before they affect the operation of the instrument.

(((21))) (22) "Simulator" means a device which when filled with a certified simulator solution, maintained at a known temperature, provides a vapor sample of known alcohol concentration.

(((22))) (23) "Software" means the computer program stored in the DataMaster which allows it to operate.

(((23))) (24) "Valid breath sample" means a sample of a person's breath provided in such a manner to be accepted for analysis by the DataMaster.



[Statutory Authority: RCW 46.61.506. 95-20-025, § 448-13-030, filed 9/27/95, effective 10/28/95; 91-06-022, § 448-13-030, filed 2/26/91, effective 3/29/91.]



AMENDATORY SECTION (Amending WSR 91-21-040, filed 10/11/91, effective 11/11/91)



WAC 448-13-040  Administration of breath test on the ((BAC Verifier)) DataMaster. The following method for performing a breath test is approved by the state toxicologist pursuant to WAC 448-13-130 and includes the following safeguards to be observed by the operator prior to the test being performed. It must be determined that: (1) The person does not vomit or have anything to eat, drink, or smoke for at least fifteen minutes prior to administration of the test; and (2) the subject does not have any foreign substances, not to include dental work, fixed or removable, in his or her mouth at the beginning of the fifteen minute observation period. Such determination shall be made by either an examination of the mouth or a denial by the person that he or she has any foreign substances in mouth. A test mouthpiece is not to be considered a foreign substance for purposes of this section. If a subject is wearing jewelry or ornamentation pierced through their tongue, lips, cheek, or other soft tissues in the oral cavity, they will be required to remove this prior to conducting the breath test. If the subject declines, they will be deemed to have a physical limitation rendering them incapable of providing a valid breath sample and will be required to provide a blood sample under the implied consent statute, RCW 46.20.308.

The temperature of the solution in the simulator prior to the start of the test must be thirty-four degrees centigrade plus or minus 0.2 degrees centigrade. During the test the person will be required to provide at least two valid breath samples. A refusal to provide a valid breath sample at any point during the test will constitute a refusal. The results of the test will be provided in the form of a printout on a breath test document. These results will indicate the grams of alcohol per two hundred ten liters of breath.



[Statutory Authority: RCW 46.61.506. 91-21-040, § 448-13-040, filed 10/11/91, effective 11/11/91; 91-06-022, § 448-13-040, filed 2/26/91, effective 3/29/91.]



AMENDATORY SECTION (Amending WSR 95-20-025, filed 9/27/95, effective 10/28/95)



WAC 448-13-050  Test defined. The test of a person's breath for alcohol concentration using the DataMaster shall consist of the person insufflating end-expiratory air samples at least twice into the instrument, sufficient to allow two separate measurements. There will be sufficient time between the provision of each sample to permit the instrument to measure each sample individually. Two valid breath samples, provided consecutively, will constitute one test.

The DataMaster will perform this test according to the following protocol when being employed to measure an individual's breath alcohol concentration. Any test not performed according to the following protocol is not a valid test. Successful compliance with each step of this protocol is determined from an inspection of the breath test document. These steps are necessary to ensure accuracy, precision, and confidence in each test.



Step 1. Data entry.

Step 2. Blank test with a result of .000.

Step 3. Internal standard verified.

Step 4. First breath sample provided by subject.

Step 5. Blank test with a result of .000.

Step 6. External standard simulator solution test. The result of this test must be between ((.090)) .072 and ((.110)) .088 inclusive.

Step 7. Blank test with a result of .000.

Step 8. Second breath sample provided by subject.

Step 9. Blank test with a result of .000.

Step 10. Printout of results on a breath test document.



[Statutory Authority: RCW 46.61.506. 95-20-025, § 448-13-050, filed 9/27/95, effective 10/28/95; 91-06-022, § 448-13-050, filed 2/26/91, effective 3/29/91.]



AMENDATORY SECTION (Amending WSR 95-20-025, filed 9/27/95, effective 10/28/95)



WAC 448-13-065  Interpretation of breath test results for purposes of sentencing. ((Once it is determined that a breath test has met all the above criteria and is valid,)) The ((person's)) subject's presumed breath alcohol content for the purposes of ((the interpretation of civil and criminal statutes)) sentencing shall be determined by taking the lower of the two subject sample breath test results, and truncating this to two decimal places. (E.g., if a person's two breath test results were 0.106 and 0.121, the person's presumed breath alcohol content would be 0.10 g/210L.)

The trier of fact must however inspect and consider the results of the tests of both breath samples as they appear on the breath test document, to ensure that the requirements of WAC 448-13-060 are met.



[Statutory Authority: RCW 46.61.506. 95-20-025, § 448-13-065, filed 9/27/95, effective 10/28/95.]



AMENDATORY SECTION (Amending WSR 95-20-025, filed 9/27/95, effective 10/28/95)



WAC 448-13-070  External standard simulator solution. In order to validate and certify the proper working order of the DataMaster at the time of a person's breath test, the vapor from a certified external standard simulator solution will be tested, separated by blank tests, between the two valid breath samples provided by the subject per WAC 448-13-050. This test of the vapor from the certified external standard simulator solution concentration, by the infrared technique employed by the DataMaster, will confirm the certification of the person's test results as they appear on the breath test document, provided that the results of such analysis also meet the criteria of WAC 448-13-060. ((At such time as the concentration of the vapor from the external standard simulator solution measured by the DataMaster approaches the lower acceptable limit of .090, the solution will be discarded and replaced with a new solution which meets the criteria of WAC 448-13-080. In any event,)) The solution will be replaced no more than sixty days from the date of its installation. As there is no meaningful way to interpret data resulting from reanalysis of the simulator solution following its removal after use on a DataMaster instrument, collection and reanalysis of such solutions is neither recommended nor approved by the state toxicologist. The internal standard test conducted with every breath test provides a check that the instrument has remained in calibration while in use in the field.



[Statutory Authority: RCW 46.61.506. 95-20-025, § 448-13-070, filed 9/27/95, effective 10/28/95; 91-06-022, § 448-13-070, filed 2/26/91, effective 3/29/91.]



AMENDATORY SECTION (Amending WSR 95-20-025, filed 9/27/95, effective 10/28/95)



WAC 448-13-080  Preparation and certification of external standard simulator solution. The external standard simulator solutions shall be prepared by the forensic toxicology staff or by persons certified as technicians in the state toxicology laboratory, using standard laboratory procedures, in such a manner that when heated to 34C ± 0.2C it will produce a vapor with an ethanol concentration of between ((.090)) .072 and ((.110)) .088 inclusive, at the time of the test. The principle used for the preparation of the simulator solutions is that a ((0.123)) 0.0984g/100mL solution will give a vapor ethanol concentration at 34C of ((0.100)) 0.080g/210L. The protocol which shall be followed for the preparation and certification of the external standard simulator solution will be that protocol currently approved and authorized by the state toxicologist according to WAC 448-13-130 and conforming to WAC 448-14-010. Details of the currently approved and authorized protocols are available upon request from the office of the state toxicologist. Sworn statements regarding the preparation, testing, and certification of the simulator solution are available under the provisions of CrRLJ 6.13. The simulator solution shall have an expiration date of one calendar year following the date of its preparation. Alternatively, simulator solutions may be purchased from a vendor approved by the state toxicologist.



[Statutory Authority: RCW 46.61.506. 95-20-025, § 448-13-080, filed 9/27/95, effective 10/28/95; 91-21-040, § 448-13-080, filed 10/11/91, effective 11/11/91; 91-06-022, § 448-13-080, filed 2/26/91, effective 3/29/91.]



AMENDATORY SECTION (Amending WSR 95-20-025, filed 9/27/95, effective 10/28/95)



WAC 448-13-140  Instructors. The state toxicologist shall certify persons found by him to be competent and qualified, as "instructors." Instructors are authorized to administer breath tests for alcohol concentration using the DataMaster and are further authorized to train and certify as operators, according to outlines approved by the state toxicologist, those persons the instructor finds qualified to administer the breath test utilizing the DataMaster breath test instrument. Instructors who are also certified as PBT technicians may instruct other individuals as PBT technicians according to the approved outlines. Details of persons certified as instructors shall be maintained by the state toxicologist and available upon request.

If an instructor fails or refuses to demonstrate to the state toxicologist or to his representative, that they have the ability to adequately perform their responsibilities as an instructor, then the state toxicologist will suspend their permit.



[Statutory Authority: RCW 46.61.506. 95-20-025, § 448-13-140, filed 9/27/95, effective 10/28/95; 91-06-022, § 448-13-140, filed 2/26/91, effective 3/29/91.]



AMENDATORY SECTION (Amending WSR 95-20-025, filed 9/27/95, effective 10/28/95)



WAC 448-13-170  Technicians. The state toxicologist shall certify as "technicians" such persons found by him to be competent and qualified to maintain the proper working order of the DataMaster infrared breath testing instrument, through adjustment, repair, and regular service. Further, technicians are authorized by the state toxicologist to prepare simulator external standard solutions and to perform the procedures approved for periodic quality assurance of the DataMaster instruments as required pursuant to WAC 448-13-110. Details of persons so certified shall be maintained by the state toxicologist and available upon request.

Technicians are authorized to perform maintenance, calibration and instruction in the use of the portable breath test devices.

Technicians are also authorized to instruct persons otherwise qualified as "instructors," "operators," and "solution changers" according to training outlines approved by the state toxicologist. Certified technicians are themselves authorized to perform the duties of "instructors," "operators," and "solution changers."

Electronics technicians who repair component parts of the DataMaster, and who are not certified as technicians under this section, are not authorized to conduct quality assurance, conduct training, or perform duties in the above categories.

If a technician fails or refuses to demonstrate to the state toxicologist or his representative, that he or she has the ability to adequately perform his or her responsibilities as a technician, then the state toxicologist will suspend their permit.



[Statutory Authority: RCW 46.61.506. 95-20-025, § 448-13-170, filed 9/27/95, effective 10/28/95; 91-21-040, § 448-13-170, filed 10/11/91, effective 11/11/91; 91-06-022, § 448-13-170, filed 2/26/91, effective 3/29/91.]



AMENDATORY SECTION (Amending WSR 91-06-022, filed 2/26/91, effective 3/29/91)



WAC 448-13-180  Permit cards. The state toxicologist shall authorize the issuance to persons deemed qualified as "instructors," "operators," "solution changers" or "technicians," a wallet-sized card bearing his or her name and designation. Permit cards shall bear the signature or facsimile signature of the state toxicologist. Such permit cards shall expire three years after the date on the card, unless renewed for a like three-year period. Operators whose authorization expires may take recertification training within ninety days following expiration of their prior certification, but are not certified to perform any evidential breath tests during that period. Once ninety days have elapsed after the expiration of authorization, the operator must repeat the basic certification training.



[Statutory Authority: RCW 46.61.506. 91-06-022, § 448-13-180, filed 2/26/91, effective 3/29/91.]



AMENDATORY SECTION (Amending WSR 95-20-025, filed 9/27/95, effective 10/28/95)



WAC 448-13-210  Address for correspondence. Information regarding instrument records, or the certification of operators, instructors, solution changers, and technicians should be obtained from the Washington State Patrol, Breath Test Section, 811 E. Roanoke, Seattle, WA 98102.

Persons seeking information regarding ((currently approved protocols and procedures, or information regarding those persons currently authorized as operators, instructors, solution changers, or technicians for the DataMaster,)) other aspects of the breath alcohol testing program shall direct their request initially to the State Toxicologist, State Toxicology Laboratory, University of Washington, Department of Laboratory Medicine, 2203 Airport Way S., Seattle, WA 98134.



[Statutory Authority: RCW 46.61.506. 95-20-025, § 448-13-210, filed 9/27/95, effective 10/28/95; 91-06-022, § 448-13-210, filed 2/26/91, effective 3/29/91.]

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