WSR 01-17-009

PERMANENT RULES

STATE TOXICOLOGIST


[ Filed August 2, 2001, 9:44 a.m. ]

Date of Adoption: August 2, 2001.

Purpose: Amendments to rules to clarify intent in the areas of acceptable use of the external standard simulator thermometer, acceptable range for the external standard simulator result, severability, and the need to repeat the fifteen minute observation period following an invalid sample.

Citation of Existing Rules Affected by this Order: Amending WAC 448-13-040 and 448-13-060.

Statutory Authority for Adoption: RCW 46.61.506.

Adopted under notice filed as WSR 01-11-134 on May 23, 2001.

Changes Other than Editing from Proposed to Adopted Version: The following additional comments regarding the amendments and proposed new sections were received and considered; however, no changes to the proposed version have been made.

Two written comments were received regarding the adoption of this permanent rule, and oral comment was also taken at a hearing in Bellevue, Washington on June 26, 2001. The issues raised were considered, and consideration and response is given in this concise explanatory statement.

Why was the acceptable range for the thermometer reading not changed to 34 degrees plus or minus 0.1 degrees instead of 0.3 degrees? This question reflects a misunderstanding of the issue ruled on by judges in Renton and Bellevue district courts in King County. These courts found that there was no explicit recognition in the WAC of the limits of accuracy of the mercury in glass thermometers used in the breath test equipment, and that thus, any variability in the thermometer must be included within the acceptable range. By enlarging the acceptable range to 0.3 degrees centigrade, but continuing to require a thermometer reading of 34 degrees plus or minus 0.2 degrees in the operation of the program, the potential variance in the thermometer is explicitly recognized and allowed for. Changing this allowable range does not introduce any additional inaccuracy into the measurement of the subject's breath alcohol concentration.

Does this change in the allowable range introduce a more lax standard for the breath alcohol test? No, the limited accuracy of the thermometer and its potential to lose accuracy over time has not been demonstrated to introduce additional error into the subject's breath test. As such, maintaining the established practice for conducting the breath test, but adjusting the acceptable range to address the courts concerns with respect to admissibility, ensures continuity of accuracy and reliability in the test.

Does the lack of a savings clause create a problem for cases occurring prior to the change to the 0.08 simulator standard in 1999? The WAC change as published (WSR 01-11-134) does include a savings clause (see WAC 448-13-060(5)), which explicitly states that the validity of the test is determined with respect to the provisions in place at the time the test was administered. This is consistent with rulings from municipal and county courts of limited jurisdiction in 1999, which found that validity of the test would be determined with respect to the WAC in effect at the time.

There is no explicit definition of accuracy for the thermometer in the definitions section. The standard dictionary definition adequately conveys the meaning this term for the purpose of the WAC.

Is the thermometer certification protocol based on NIST standards? No, however, it is a reasonable protocol based on the design of the thermometer. There is no NIST protocol for certifying this custom thermometer. NIST recommends testing of thermometers at multiple temperatures, which is done during calibration at the time of manufacture. This is not an attempt to evaluate the actual variance for that thermometer, but simply a check to see if they meet a specified minimum standard for certification. Given that there is no demonstrated effect of the accuracy of this thermometer on the results of the subject's breath test, this is a reasonable standard.

Is the state toxicologist going beyond his statutory authority in adopting the WAC regarding the admissibility of the test? The administrative code provisions in chapter 448-13 WAC are simply setting out which elements are needed for a reliable and accurate test. The WAC does not mention admissibility, which is a determination made by the court. The state toxicologist is however concerned that the scientific standards of the test meet the court's threshold for admissibility.

There is no definition of the term "certified" with respect to the thermometer. Directions with respect to the certification of the thermometer are maintained in the policy and procedures manual of the Washington State Patrol Breath Test Section, and are available on request. Technicians will prepare a declaration indicating the date of testing, the thermometer serial number, the simulator serial number, and the DataMaster instrument serial number, along with an indication of whether the thermometer met the specified standard described in WAC 448-13-035 in order to be certified.

The language used in WAC 448-13-035 referencing "standards traceable to NIST" is vague. The concept of traceability to a reference standard is a common principle in measurement science. It describes the notion that there is an absolute standard for temperature, maintained by the National Institute for Standards and Testing (NIST), and that the reference thermometer used to certify the mercury in glass thermometers used in this program, must be compared against a thermometer which has been checked either directly or indirectly against that absolute standard, and can thus be "traced" to it.

Is this an emergency, and is it valid to change the WAC for purposes of admissibility? The purpose of the hearing conducted in Bellevue on June 26, 2001, was to consider the proposed permanent changes to the administrative code, not the propriety of the emergency finding. The reasons for the state toxicologist's finding of an emergency were described in WSR 01-10-007. The use of an emergency WAC filing under RCW 34.05.350 in 1999, to address a similar situation in which breath tests were being suppressed was upheld by the Thurston County Superior Court, in an administrative procedures action brought in Gober v. Logan (Thurston County Superior Court Cause No. 00-2-00442-4). Any challenge to the agency's current finding of an emergency should be brought in the same venue.

Does approval of the use of the simulators with a plus or minus 0.3 degree acceptable range go beyond what is approved on the NHTSA conforming products list, and as such does this invalidate that approval? Neither the manufacturer's manual for the Guth 34C simulator, the conforming products list, or the NHTSA protocol for testing (62FR43416) reference any range of allowable operation for the simulator. Although the amended WAC allows a range of plus or minus 0.3 degrees, the protocols in place still require an observed range of plus or minus 0.2 degrees. The additional allowable tenth of a degree has been adopted to account for the limits of accuracy to which the thermometer can be certified, which is specifically stated in WAC 448-13-035 to be a tenth of a degree.

Does the simulator manufacturer require regular checking of the accuracy of the thermometer in their manual? The manufacturer (Guth Laboratories) does not recommend in their manual that the thermometer be checked for accuracy.

Should operators be required to record the actual temperature of the solution? The WAC has never required operators to record the actual temperature of the solution, and the training given to the operators has simply instructed them in how to determine if the displayed temperature fell within the allowable range of 34 degrees plus or minus 0.2 degrees centigrade. While it is important for the operators to be able to make this determination, the actual temperature within the range is not relevant in determining the accuracy of the test.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 3, Amended 2, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 3, Amended 2, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 0, Repealed 0.
Effective Date of Rule: Thirty-one days after filing.

August 1, 2001

Barry K. Logan, Ph.D.

Washington State Toxicologist


NEW SECTION
WAC 448-13-035   Simulator thermometer certification.   The ability of the simulator to provide a reference ethanol vapor concentration is a function of its temperature. The thermometers used in the simulators shall be certified on an annual basis to have an accuracy of within plus or minus 0.1 degree centigrade. Such certification shall be made using a reference thermometer traceable to standards maintained by the National Institute of Standards and Testing (NIST), or its successor.

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AMENDATORY SECTION(Amending WSR 99-06-048, filed 3/1/99, effective 4/1/99)

WAC 448-13-040   Administration of breath test on the 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 p)) Prior to the start of the test ((must be)) the operator must verify that the thermometer, certified per WAC 448-13-035, indicates that the temperature of the simulator solution is thirty-four degrees centigrade plus or minus ((0.2)) 0.3 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. 99-06-048, 448-13-040, filed 3/1/99, effective 4/1/99; 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.]


NEW SECTION
WAC 448-13-056   Invalid sample message.   One of the causes of an "invalid sample" message being displayed by the DataMaster during the test is the presence of exogenous mouth alcohol, which could adversely affect the breath test reading. In the event that the DataMaster records an "invalid sample" result at any point during the subject's test, that subject's test should be readministered, after again checking the subject's mouth and repeating the fifteen minute observation period as required in WAC 448-13-040.

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AMENDATORY SECTION(Amending WSR 99-22-009, filed 10/22/99, effective 11/22/99)

WAC 448-13-060   Validity and certification of test results.   A test shall be a valid test and so certified, if the requirements of WAC 448-13-040, 448-13-050 and 448-13-055 are met, and in addition the following criteria for precision and accuracy, as determined solely from the breath test document, are met:

(1) The internal standard test results in the message "verified."

(2) In order to be valid, the two breath samples must agree to within plus or minus ten percent of their mean. This shall be determined as follows:

(a) The breath test results shall be reported, truncated to three decimal places.

(b) The mean of the two breath test results shall be calculated and rounded to four decimal places.

(c) The lower acceptable limit shall be determined by multiplying the above mean by 0.9, and truncating to three decimal places.

(d) The upper acceptable limit shall be determined by multiplying the mean by 1.1 and truncating to three decimal places.

(e) If the results fall within and inclusive of the upper and lower acceptable limits, the two breath samples are valid.

(3) The simulator external standard result must lie between ((.090 to .110 inclusive for tests conducted prior to April 1, 1999, and)) .072 to .088 inclusive ((for tests conducted on or after April 1, 1999. This provision is remedial in nature and applies to any judicial or administrative proceeding conducted after April 27, 1999)).

(4) All four blank tests must give results of .000.

If these criteria are met, then these and no other factors are necessary to indicate the proper working order of the instrument, and so certify it, at the time of the breath test.

(5) These criteria have changed over time, and the criteria applied to determine the validity of any test and so certify it, should be those provisions of the Washington Administrative Code in effect at the time the test is administered.

[Statutory Authority: RCW 46.61.506. 99-22-009, 448-13-060, filed 10/22/99, effective 11/22/99; 95-20-025, 448-13-060, filed 9/27/95, effective 10/28/95; 91-06-022, 448-13-060, filed 2/26/91, effective 3/29/91.]


NEW SECTION
WAC 448-13-225   Severability.   If any part or provision of these rules or regulations or the application thereof is held invalid, such invalidity shall not affect other provisions or applications of these rules which can be given effect without the invalid provision or application, and to this end any section, paragraph or sentence, is declared to be severable.

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Washington State Code Reviser's Office