STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

GARY LANOUE, )

)

Petitioner, )

)

vs. ) Case No. 98-4571RX

) DEPARTMENT OF LAW ENFORCEMENT, )

)

Respondent. )

)

SUPPLEMENTARY FINAL ORDER

This cause came on for consideration pursuant to a Mandate from the District Court of Appeal of Florida, First District, dated February 14, 2000, requiring further proceedings in accordance with Lanoue v. Florida Department of Law Enforcement,

25 Fla. L. Weekly D76 (Fla. Dec. 29, 1999), before the Division of Administrative Hearings, by its designated Administrative Law Judge, Suzanne F. Hood.

APPEARANCES

For Petitioner: Chris H. Bentley, Esquire

Diane D. Tremor, Esquire

Rose, Sundstrom and Bentley, LLP 2548 Blairstone Pines Drive Tallahassee, Florida 32301

David M. Robbins, Esquire Epstein and Robbins

1125 Blackstone Building

Jacksonville, Florida 32202

For Respondent: Richard D. Courtemanche, Jr., Esquire

Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32302

Lee Ann Gustafson, Esquire Department of Legal Affairs The Capitol, Plaza Level 01

Tallahassee, Florida 32399-1050

STATEMENT OF THE ISSUE

The issue in this case is whether Rules 11D-8.002(1) and 11D-8.006(2), Florida Administrative Code, and FDLE/ATP Form 16 constitute invalid exercises of delegated legislative authority.

PRELIMINARY STATEMENT

On October 12, 1998, Petitioner Gary Lanoue (Petitioner) filed a "Petition Seeking an Administrative Determination of Violations of Section 120.54(1)(a), and the Invalidity of Existing Rules." Said petition raised two issues pursuant to Sections 120.56(3)(a) and 120.56(4)(a), Florida Statutes, respectively. The first issue was whether existing

Rules 11D-8.002(1) and 11D-8.006(2), Florida Administrative Code, and FDLE/ATP Form 16, which is incorporated by reference in

Rule 11D-8.003(7), Florida Administrative Code, constituted invalid exercises of delegated legislative authority as defined in Section 120.52(8), Florida Statutes. The second issue was whether FDLE's unpromulgated policies were "rules" as defined by Section 120.52(15), Florida Statutes, in violation of

Section 120.54(1)(a), Florida Statutes. As to the unpromulgated policies, Petitioner challenged the following: (a) FDLE's statements concerning the procedures, criteria and standards for the approval of all alcohol reference solutions (ARS) used to inspect evidential breath test instruments; and (b) FDLE's

statements concerning the procedures, criteria and standards for selection and approval of the source of ARS, as well as the identification of the current sole source of ARS.

A Notice of Hearing dated October 17, 1998, scheduled the case for final hearing on November 19, 1998. The case proceeded to trial on November 19 and 23, 1998.

During the hearing, Petitioner testified on his own behalf and presented the testimony of Richard Courtemanche, Tom Wood, and Dr. Elton Scott, accepted as an expert in mathematics and statistics. By way of deposition, Petitioner also presented the testimony of Richard Lober. Petitioner's exhibits one through eight were received into evidence.

Respondent Florida Department of Law Enforcement (FDLE) presented the testimony of Kenneth J. Guthrie, Robert D. Thomason, Tom Wood, and Dr. Bruce Goldberger, accepted as an expert in forensic toxicology, including testing for alcohol in breath. FDLE's exhibits one through eight were received into evidence.

The court reporter filed the transcript of the formal hearing with the Division of Administrative Hearings on November 25, 1998. The parties filed their post-hearing submittals ten days thereafter.

The undersigned entered a Final Order on December 24, 1998.

The Final Order dismissed the petition based on a finding that Petitioner lacked standing.

On January 22, 1999, Petitioner filed a Notice of Appeal with the Florida District Court of Appeal, First District. After hearing oral arguments on November 2, 1999, the Court issued an opinion in Lanoue v. Florida Department of Law Enforcement, 25 Fla. L. Weekly D76 (Fla. Dec. 29, 1999). The Court affirmed the Final Order with regard to Petitioner's lack of standing to challenge FDLE's unpromulgated rules, but reversed the Final Order with regard to Petitioner's standing to challenge the existing rules. The Court remanded for further proceedings to determine whether the existing rules constitute an invalid exercise of delegated legislative authority.

The Court denied FDLE's Motion for Rehearing on January 27, 2000. On February 14, 2000, the Court issued a Mandate requiring further proceedings in accordance with its opinion referenced above.

On February 16, 2000, the undersigned entered an Order Reopening File and Requiring Report. On February 23, 2000, Petitioner filed a Motion to Reopen the Record for Receipt of Newly Discovered Evidence and Motion to Extend the Time for Filing Response to Order Reopening Record and Requiring Report. A Notice of Rule Development as set forth in Florida Administrative Weekly, Volume 25, Number 13, April 2, 1999, was attached to Petitioner's motions as Exhibit A. FDLE filed a response to Petitioner's motions on February 28, 2000.

Petitioner filed a reply to FDLE's response on March 3, 2000.

On March 10, 2000, the undersigned entered an Order granting Petitioner's motion to reopen the record. This order also gave the parties an opportunity to file supplementary proposed final orders.

On March 17, 2000, Petitioner filed an unopposed Motion for Extension of Time. The undersigned granted this motion by order dated March 21, 2000. The parties filed their supplementary proposed final orders on March 31, 2000.

On April 10, 2000, the Florida District Court of Appeal, First District, returned the record and exhibits in this case to the Division of Administrative Hearings.

On May 3, 2000, the undersigned entered an Order Officially Recognizing Rules 11D-8.002(27) and 11D-8.0035, Florida Administrative Code. This order also advised the parties that the undersigned sua sponte requested and received a copy of FDLE/ATP Form 32 (7-6-99) from FDLE on May 2, 2000.

FINDINGS OF FACT

1. In Florida, it is unlawful to drive or to be in actual physical control of any motor vehicle while under the influence of alcoholic beverages when affected to the extent that the normal faculties are impaired. Section 316.193(1)(a), Florida Statutes.

2. Any person who accepts the privilege of operating a motor vehicle within Florida is deemed to have given consent to submit to a breath test for the purpose of determining the

   alcohol content of his or her breath if lawfully arrested for DUI. Failure to do so results in the suspension of a person's driver's license and the failure to consent is admissible into evidence in any criminal proceeding. Section 316.1932(1)(a), Florida Statutes.

3. Tests determining the weight of alcohol in a person's breath must be administered in accordance with FDLE's rules. Section 316.1932(1)(f), Florida Statutes. Breath test results are considered valid if performed substantially according to methods approved by FDLE. Section 316.1932(1)(b)(2), Florida Statutes. The results of breath tests administered in accordance with Chapter 316, Florida Statutes, are admissible in any civil or criminal proceeding arising out of acts alleged to have been committed by any person while driving under the influence of alcohol. Section 316.1934(2), Florida Statutes.

4. The Florida Legislature has established certain presumptions and incremental penalties, which are dependent upon the results of breath-alcohol tests administered pursuant to Chapter 316, Florida Statutes. A breath-alcohol level of 0.08 or more grams of alcohol per 210 liters of breath (g/210L) is prima facie evidence that the person was "driving under the influence" (DUI) of alcoholic beverages to the extent that his or her normal faculties were impaired. Moreover, a person who has a breath- alcohol level of 0.08 g/210L or higher is presumed guilty of DUI. Sections 316.1934(2)(c) and 316.193(1)(c), Florida Statutes. A

   breath-alcohol level of 0.05 g/210L or less creates a presumption that the person was not under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired. Section 316.1934(2)(a), Florida Statutes. If a

   breath-alcohol level is in excess of 0.05 g/210L but less than

   
   

   0.08 g/210L, no presumption arises; however, the level may be considered with other competent evidence in determining whether the person was under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired. Section 316.1934(2)(b), Florida Statutes. Persons with breath-alcohol tests of 0.20 g/210L or higher are subject to greater fines and terms of imprisonment than persons with breath-alcohol tests of

   0.08 g/210L. Section 316.193(4), Florida Statutes.

   
   

5. The penalties for being found guilty of the offense of DUI are set forth in Section 316.193, Florida Statutes. These penalties include fines of $250 to $5,000, terms of imprisonment from six months to one year, and terms of probation and the performance of public service or community work projects. The driver's license of a person who is arrested for a violation of Section 316.193, Florida Statutes, or a person who has refused to submit to a breath test, is suspended, pursuant to Section 316.2615, Florida Statutes.

6. FDLE has adopted Chapter 11D-8, Florida Administrative Code, to implement the statutory Alcohol Testing Program (ATP), formerly known as the Implied Consent Program. The purpose of

   these rules, in part, is to establish procedures, techniques, approved methods, criteria, and standards to ensure the accuracy and reliability of the evidential breath-testing instruments utilized to test the alcohol content of the breath of persons suspected or charged with DUI. To that extent, FDLE adopted rules specifying the method of breath-testing (infrared), the specific machine approved for evidential use (CMI, Inc.

   Intoxilyzer 5000 Series), and the criteria by which other manufacturers could receive approval for a different type or model instrument for use in Florida. Rule 11D-8.003, Florida Administrative Code. In order to ensure that individual breath- test results are reliable and accurate, FDLE established rules requiring that each machine be inspected when initially received, when moved to a different agency, and on an annual and a monthly basis. Rules 11D-8.004 and 11D-8.006(1), Florida Administrative Code.

7. An FDLE inspector conducts the annual inspections of the breath-testing machines. A local law enforcement inspector conducts the monthly inspections. In each instance, a simulator solution is used to replicate a human's breath at each of the three statutorily specified alcohol concentrations--0.05 g/210L,

   0.08 g/210L, and 0.20 g/210L. The instrument is deemed accurate and reliable, thus remaining in service, if the inspection results fall within the ranges described in Rule 11D-8.002(1),

   Florida Administrative Code. The ranges set forth in the rule are discussed below.

8. On February 17, 1998, a police officer stopped Petitioner while he was operating a motor vehicle. Petitioner was arrested and administered a breath test to determine the amount of alcohol in his breath. Petitioner provided two breath samples indicating a breath-alcohol level of 0.09 g/210L for each sample. He was charged with DUI. Subsequently, Petitioner pled not guilty. At the time of hearing, Petitioner's criminal trial was pending.

9. Officer Kenneth Guthrie is employed by the Jacksonville Sheriff's Office as a correctional officer. He has been a certified breath-test operator for approximately two years. Officer Guthrie follows FDLE/ATP Form 23, Operational Procedures Checklist, when he performs a breath test on a subject. He has followed that procedure for every individual that he has tested.

10. Officer Guthrie performed a breath test on Petitioner after he was arrested on February 17, 1998. Officer Guthrie used the Intoxilyzer 5000 Series instrument, serial number 66-002726, to perform this test. Officer Guthrie completed steps one through twelve of the checklist when he performed Petitioner's test.

11. Officer Robert Thomason has been employed by the Jacksonville Sheriff's Office for eight years. Officer Thomason is certified by FDLE to perform the monthly inspections on the

    Intoxilyzer 5000 Series instruments in the custody of the Jacksonville Sheriff's Office. In performing the monthly inspections, Officer Thomason follows a step-by-step procedure set forth in FDLE/ATP Form 16. The form is adopted by reference in Rule 11D-8.003(7), Florida Administrative Code. Its use is required in Rules 11D-8.004(1) and 11D-8.006(1), Florida Administrative Code.

12. FDLE/ATP Form 16 requires Officer Thomason to "[p]repare simulators for tests using Department provided or approved alcohol reference solution and/or Department provided or approved alcohol stock solution" in making his inspections. "Source" means the entity from which the agencies must order alcohol reference solution (ARS). However, FDLE/ARP Form 16 does not define "approved ARS."1

13. Officer Thomason is required to perform the following five series of tests on each Intoxilyzer 5000 Series instrument using a simulator: (1) one set of tests with distilled water only; (2) one set of tests with three milliliters of acetone; and

    (3) three sets of tests with ARS that replicate the target concentrations of 0.050, 0.080, 0.200 g/210L. Officer Thomason is required to perform three tests with each solution. If any one of the tests using any level of ARS is outside of the ranges set forth in Rule 11D-8.002(1), Florida Administrative Code, Officer Thomason removes the instrument from service.

14. Officer Thomason does not perform any test on the ARS prior to its use in the simulator. He does not usually receive anything in writing from FDLE indicating that it has approved a lot of ARS. However, Officer Thomason may request a Certificate of Assurance (COA), discussed below, from FDLE indicating that it has approved the ARS.2

15. Typically, the Intoxilyzer 5000 Series instrument is calibrated by a manufacturer or its authorized repair facility after major maintenance. FDLE's inspectors are trained to calibrate the instruments, but do not routinely perform that duty.

16. In order to comply with Rule 11D-8.002(1), Florida Administrative Code, the monthly tests of the Intoxilyzer 5000 Series instruments must yield results, which fall within acceptable ranges. "Acceptable range" is defined in the rule as follows:

    1. Acceptable Range -- Shall mean the observed values must fall within the following ranges at each alcohol target concentration: 0.05 g/210L range is 0.045 -- 0.055 g/210L; 0.08 g/210L range is 0.075 -- 0.085 g/210L; 0.20 g/210L range is 0.190 --

       0.210 g/210L.

       
       

       Rule 11D-8.002(1), Florida Administrative Code.

       
       

17. Officer Thomason performed an agency inspection of the Intoxilyzer 5000 Series instrument at issue here, on February 1, 1998. He used ARS from lot numbers 97180, 97190, and 97200 to

    perform the tests at the target levels for 0.050, 0.080, and

    
    

    0.200 g/210L respectively.

    
    

18. All of the results of the monthly tests that Officer Thomason performed on the subject instrument on February 1, 1998, were within the requirements of Rules 11D-8.002(1) and 11D-8.006, Florida Administrative Code, to keep the instrument in service. The results of these tests performed with ARS to create a

    0.05 g/210L simulated breath-alcohol level were 0.049, 0.048, and

    
    

    0.048 g/210L. The results of the tests performed with ARS to create a 0.08 g/210L simulated breath-alcohol level were 0.081, 0.80, and 0.081 g/210L. The results of the test performed with ARS to create a 0.20 g/210L simulated breath-alcohol level were 0.197, 0.197, and 0.194 g/210L.

19. Officer Thomason performed a second agency inspection of the subject Intoxilyzer 5000 Series instrument on February 27, 1998. Once again he used ARS from lot numbers 97180, 97190, and 97200 to perform the tests at the target levels for 0.050, 0.080, and 0.200 g/210L respectively. The results of these tests performed with ARS to create a 0.05 g/210L simulated breath- alcohol level were 0.050, 0.049, and 0.048 g/210L. The results of the tests performed with ARS to create a 0.08 g/210L simulated breath-alcohol level were 0.079, 0.080, and 0.078 g/210L. The results of these tests performed with ARS to create a 0.20 g/210L simulated breath-alcohol level were 0.198, 0.200, and 0.198 g/210L.

20. When Officer Thomason prepares a simulator with ARS, he pours the ARS from its bottle into a 500-milliliter flask, then pours the contents of the flask into the jar of the simulator. He does not pour the entire bottle into the flask; there is usually a small amount of ARS left in the bottle.

21. In order to verify the calibration of an Intoxilyzer 5000 series instrument, the operator must provide a vapor to the instrument to simulate human breath, which includes moisture and an alcohol content. A simulator is a device designed to simulate a person's breath, providing a sample of air to the instrument, which contains the alcohol vapor of a known concentration.

22. The operator places an ARS solution into the simulator device. ARS is defined in Rule 11D-8.002(8), Florida Administrative Code, as a mixture of a known mass of ethanol and a known volume of water, the headspace above which will have a known ethanol concentration at a specified temperature. The ARS is used to assure the accuracy, precision, and reliability of the Intoxilyzer 5000 Series instrument.

23. The simulator device heats the ARS to a temperature of

    
    

    34 degrees centigrade, plus or minus (+/-) two degrees. Air is pumped into the bottom of the simulator and bubbled through the ARS, collecting as a vapor above the water. Back pressure is applied to the simulator and the vapor travels from the simulator to the Intoxilyzer 5000 Series instrument, which measures the alcohol content.

24. An ARS containing 0.0605 grams of alcohol per deciliter of water (g/dL) replicates a breath-alcohol level of 0.05 g/210L. An ARS containing 0.0968 g/dL replicates a breath-alcohol level of 0.08 g/210L. An ARS containing 0.2420 g/dL replicates a breath-alcohol level of 0.20 g/210L.

25. The conversion factor for converting g/dL to g/210L is

    
    

    1.21. For example, 0.0605 g/dL divided by 1.21 equals 0.05 g/210L.

26. Alcohol is completely miscible in water; it mixes in all proportions. When a small amount of ethanol is mixed with a large amount of water, it is readily distributed and becomes homogeneous within a very short time. Once the ARS is mixed, it will stay miscible until some heroic measure is taken to separate the alcohol and water.

27. Alcohol stock solution is concentrated alcohol solution, which must be mixed with a known quantity of water to create ARS. If FDLE did not provide law enforcement agencies with an approved ARS source, it could produce and provide the local agencies with stock solution. As a matter of practice since January of 1997, FDLE no longer prepares alcohol stock solution or provides it to the local agencies. Instead, FDLE arranges for the supply and purchase by all law enforcement agencies of a premixed ARS from an approved source.

28. Selection of the source of ARS is an important part of FDLE's ATP. At the time of the hearing, FDLE's criteria and

    standards for the selection of the source included the following:

    
    

    (1) the size of the ARS lots available; (2) standards related to the entity's facilities, personnel, product, manufacturing protocol, quality assurance/control practices, and customer relations with existing accounts; and (3) whether the entity is regulated by the Food and Drug Administration. These criteria and standards are not included in Rule 11D-8.006(2), Florida Administrative Code.3

29. Thomas Wood has been employed with FDLE in the ATP since November of 1993. At the time of the hearing, Mr. Wood had the responsibility to evaluate and recommend selection of an approved source for ARS. Using the criteria and standards set forth above, Mr. Wood recommended that FDLE contract with Guth Laboratories (Guth) as the approved source of ARS.

30. Guth is a distributor or vendor of ARS manufactured by Steiffel Research Institute, Inc. (Steiffel). At the time of the hearing, Steiffel produced ARS in lots of 250 gallons and dispensed it in individual bottles containing 500 milliliters. The Jacksonville Sheriff's Office purchased the ARS at issue here from Guth.

31. Based on Mr. Wood's recommendation, FDLE contracted with Guth as the sole source of ARS for the state of Florida. Mr. Wood's selection of Guth as the approved source was based primarily upon the qualifications of Steiffel.

32. The contract between FDLE and Guth required Guth to provide lots of ARS that are within approximately 3 percent of the target value for each ARS ethanol level. FDLE had the right to reject any lot that did not meet the contract specifications. If Guth consistently provided lots of ARS that FDLE rejected, the agency could have contracted with another source.

33. One of Mr. Wood's duties is to determine the known amount of ethanol in the ARS. Prior to the distribution of ARS for use by the local agencies, Mr. Wood analyzes each lot to determine if it is in compliance with the department's specifications, using specified procedures, criteria, and standards. Guth supplies the samples for this pre-distribution analysis, ten bottles from each lot.

34. After each lot is distributed to law enforcement agencies, Mr. Wood acquires ten bottles of each lot from various local law enforcement agencies for a post-distribution analysis, using the same procedures, criteria, and standards as the pre- distribution analysis. Each ARS sample in the pre-distribution analysis and the post distribution analysis is analyzed using gas chromatography ("GC").

35. The ARS used to test the accuracy, precision, and reliability of breath-testing instruments in Florida is one of the foundations of the ATP. It is extremely important for the ARS to replicate the statutory target values of 0.05, 0.08, and

    0.20 g/210L. The accuracy of the breath-testing machine depends in large part upon the accuracy of the ARS.

36. At the time of the hearing, FDLE had no promulgated rule setting forth the procedures, criteria, or standards for the approval or rejection of ARS.4 Companies other than Guth, who wished to become a source of ARS for Florida, would have had to contact FDLE to determine these procedures, standards and criteria.

37. Mr. Wood created and used COAs to analyze each lot of ARS. The COAs contained the following information: (a) the methodology used to analyze sample bottles from each new lot of ARS; (b) the criteria that samples of ARS had to meet before a lot could be approved; (c) acceptable ranges of alcohol content within which samples had to fall before a lot of ARS could be approved; and (d) the data collected during a GC analysis of a lot of ARS.

38. The COAs described FDLE's practice requirement regarding the criteria and specifications for accepting or rejecting each ARS lot. FDLE had followed this practice without deviation since the ATP started in January of 1997.

39. As noted above, ARS is defined in Rule 11D-8.002(8), Florida Administrative Code, as a "mixture of a known mass of ethanol and a known volume of water, the headspace above which will have a known ethanol concentration at a specified temperature." At the time of the hearing, there was no way to

    determine the meaning of the word "known" without reference to the COAs and the ranges of acceptability described therein.

    Thus, the COAs were very important and necessary in order to determine the meaning of the rule.

40. At the time of the hearing, FDLE approved ARS to replicate a 0.05 g/210L breath-alcohol level if the average test results of that solution fell between 0.0565 g/dL and 0.0645 g/dL, a range of 0.008 g/dL. The allowed variation around the target ARS concentration of 0.0605 g/dL was +/- 0.004 g/dL, which yields a 6.6 percent variation or percentage of error.5

41. At the time of the hearing, FDLE approved ARS to replicate a 0.08 g/210L breath-alcohol level if the average test results of that solution fell between 0.0928 g/dL and 0.1008 g/dL of ethanol, a range of 0.008 g/dL. The allowed variation around the target ARS concentration of 0.0968 g/dL is +/- 0.004 g/dL, which yields a 4.1 percent variation or percentage of error.6

42. At the time of the hearing, FDLE approved ARS to replicate a 0.20 g/210L breath-alcohol level if the average test results of that solution fell between 0.2320 g/dL and 0.2520 g/dL of ethanol, a range of 0.020 g/dL. The allowed variation around the target ARS concentration of 0.2420 g/dL is +/- 0.010 g/dL, which yields a 4.1 percent variation or percentage of error.7

43. Mr. Wood set the percentage of error for FDLE to accept or reject lots of ARS based on scientifically accepted practice.

    He set a range that would provide accurate, precise, and reliable results for breath testing in the state of Florida.

44. The variation in the selection range in Guth's contract specification (3 percent for all three target concentrations) was less than the variation in FDLE's selection range (6.6 percent for 0.05 g/210L and 4.1 percent for 0.08 and 0.20 g/210L) to better assure that the solution would remain within the department's approval range.

45. There is a difference of opinion within the scientific community regarding the acceptable variation or percentage of error for the alcohol content of ARS that is used to inspect breath-testing machines for accuracy. The National Safety Council, Committee on Alcohol and Other Drugs, recommends the use of a percentage of error of 2 percent. Dr. Bruce Goldberger, an expert in forensic toxicology, recommends setting the percentage of error for ARS at 3 percent.

46. At the time of the hearing, Mr. Wood acknowledged that he could have set the percentage of error for ARS provided by Guth and approved by FDLE at 2 percent or 3 percent, or whatever he felt was appropriate. If the allowable range of error were too large, and a machine were inspected with an ARS that has an alcohol content at the extreme low-end of that range, an improperly calibrated machine might be approved for use. Nevertheless, the percentages of error that Mr. Wood set for Guth (3 percent) and FDLE (6.6 percent and 4.1 percent) were

    scientifically reasonable and would not have had a significant impact on the validity and reliability of breath-test results.8

47. The COAs require ten bottles of a lot of ARS to conduct a GC analysis. Ten bottles are necessary to get a proper sample representation and to permit the rejection of some bottles without invalidating the test results.

48. In preparation for GC analysis, three sub-samples from each simulator solution bottle must be combined in a GC vial. Three vials must be prepared from each ARS bottle.

49. According to the COAs in use at the time of the hearing, the GC vial ethanol concentrations from each analyzed simulator solution bottle were averaged to yield an estimated concentration for each bottle. The sample bottles received and the data obtained had to meet the following criteria for a lot of simulator solution to be approved for use in Florida: (1) Eight or more of the ten simulator solution bottles received had to be suitable for analysis; (2) Two of the three GC autosampler vials had to provide an analytical result for each bottle; (3) The difference between any two analytical results for a bottle had to be 0.0040 g/dL or less for 0.05 and 0.08 g/210L solutions and 0.0100 g/dL or less for 0.200 g/210L solution; (4) Six or more of the analyzed simulator solution bottles had to provide an average result; and (5) All average results had to fall on or between the ARS acceptable range for each target level.

50. When Mr. Wood performs a pre- or post-distribution analysis, he uses reliable calibrator solution from more than one vender to calibrate the GC. He performs this calibration by injecting a known amount of alcohol into the GC and noting the response. He then injects a different known amount of alcohol into the GC and notes the response. Finally, he constructs a calibration curve, drawing a line through the curve to determine the amount of alcohol for an unknown concentration.

51. To calibrate the GC, Mr. Wood uses reliable known alcohol concentrations from commercial vendors. The solutions meet the standards of the National Institute of Standards and Technology (NIST). The scientific community considers these solutions to be highly accurate.

52. The GC analysis is a very specific, very accurate, precise test to certain limits within a relatively small standard deviation. This means that a GC analysis of 30 vials of an ARS solution will result in slightly different readings of the amount of ethanol content in each vial, even though the actual ethanol content in each vial is the same. Analytical variation is built into the GC measurement process. The GC's ability to make fine distinctions in the amount of alcohol, together with its sensitivity to other testing variables or errors accounts for the range of variation.

53. In a GC analysis, the exact or actual concentration of alcohol in ARS depends upon the limits that are established to

    make that determination. Determining a mean, which is an average value for a series of tests, and calculating the standard deviation sets the limits.

54. It is possible in the scientific community to obtain exact concentrations of alcohol in ARS. NIST has the ability to make such determinations. The extreme measures taken by NIST cost tens of thousands of dollars. NIST uses a multitude of techniques that are not commonly available. Such extreme measures are not necessary to verify the alcohol content of ARS used to inspect the Intoxilyzer 5000 Series instrument.

55. ARS is not used to calibrate the breath test machines. It is used to verify their calibration.

56. The Intoxilyzer 5000 Series instrument has a limit on its ability to measure the alcohol content of a person's breath at any given time. It is not intended to measure exactly a person's breath-alcohol concentration at a specific time; the machine measures a person's breath-alcohol level within a range. In order to ensure the validity of a breath test, Rule 11D- 8.002(16), Florida Administrative Code, states as follows:

    (16) Breath Alcohol Test -- Shall mean, the analyses of a minimum of two samples of breath collected within fifteen minutes, and the results reported as the alcohol level based upon grams of alcohol per 210 liters of breath. To be acceptable as a valid breath test, the two results shall be within +/-

    0.020 g/210L and taken within fifteen (15) minutes of each other. If the results of the first and second sample are more than +/-

    0.020 g/210L apart, a third sample shall be analyzed. To be acceptable as a valid breath

    test, any two of three results shall be within +/- 0.020 g/210L and taken within fifteen (15) minutes of each other. In the event the person tested refuses or fails to provide the required number of valid breath samples, than this event shall constitute a refusal. Notwithstanding the foregoing sentence, the result(s) obtained, if proved to be reliable, shall be acceptable as a valid breath alcohol level.

57. The manufacturer sets the limits of the Intoxilyzer 5000 Series instrument as accurate to +/- 0.005 g/210L of a breath-alcohol concentration or 5 percent of the breath-alcohol concentration, whichever is greater. The manufacturer's specifications are consistent with the limits set by the National Highway Traffic Safety Administration (NHTSA).

58. NHTSA is the federal agency that approves evidential breath-test devices. NHTSA publishes its standards and a list of approved devices in the Federal Register. The definition of "Acceptable Range" set forth in Rule 11D8.002(1), Florida Administrative Code, coincides with the NHTSA standards. Persuasive evidence indicates that not even NHTSA has a device to measure the exact breath alcohol concentration in a person's breath at a specific time.

59. During the pre-distribution analysis of ARS lot number 97180, the target value was 0.0605 g/dL. The minimum average observation for any sample bottle was 0.0604 g/dL. The maximum average observation for any sample bottle was 0.0622 g/dL. The mean of the samples was 0.0612 g/dL.

60. During the pre-distribution analysis of ARS lot 97190, the target value was 0.0968 g/dL. The minimum average observation for any sample bottle was 0.0965 g/dl. The maximum average observation for any sample bottle was 0.0980 g/dL. The mean of the samples was 0.0972 g/dL.

61. The difference between the mean concentration and the target concentration of the samples of ARS lot 97190 is

    +0.0004 g/dL. If one divides 0.0004 g/dL by the target value of 0.0968 g/dL, the quotient is 0.0041 g/dL, which is equivalent to a 0.41 percent variation from the target concentration.

62. The difference between the average minimum observed concentration and the target concentration of the samples of ARS lot 97190 is 0.0003 g/dL. If one divides 0.0003 g/dL by the target value of 0.0968 g/dL, the quotient is 0.0031 g/dL, which is equivalent to a 0.31 percent variation from the target concentration.

63. During the pre-distribution analysis of ARS lot 97200, the target value was 0.2420 g/dL. The minimum average observation for any sample bottle was 0.2420 g/dL. The maximum average observation for any sample bottle was 0.2453 g/dL. The mean of the samples was 0.2438 g/dL.

64. If a precise 0.080 g/210L ARS is used in a monthly inspection, and the machine produces a result of 0.085 g/210L, the machine would remain in service. A person with an actual breath-alcohol level of 0.08 g/210L could receive a result of

    0.085 g/210L on that machine. Likewise, a person with an actual breath-alcohol level of 0.075 g/210L could produce a reading of

    0.08 g/210L on the machine. These results are theoretically possible.

65. Additionally, assuming that a precise 0.080 g/210L ARS is used to perform monthly inspections, the following hypothetical results could be obtained. If the machine reads

    1. g/210L when inspected, a person with an actual breath- alcohol of 0.076 g/210L could produce a reading of 0.080 g/210L. A machine with a reading of 0.083 g/210L at the time of inspection could produce a result of 0.080 g/210L on a person having an actual 0.077 g/210L breath-alcohol level. A machine with a reading of 0.081 g/210L could produce a reading of 0.080 g/210L on a person tested who has an actual breath-alcohol level of 0.079 g/210L. These results are mathematically possible.

66. If the value of an ARS used to perform a monthly inspection is higher than the target value, the results of the Intoxilyzer 5000 Series instrument can be less than the range of accuracy of the instrument.

67. On the other hand, if an ARS used to perform a monthly inspection is lower than the target value, the results of the Intoxilyzer 5000 Series instrument can be more than the range of accuracy of the instrument. For example, the lowest average value of the acceptable range in the COA (in use at the time of the hearing) for 0.08 g/210L simulator solution was 0.0928 g/dL,

    which equates to 0.077 g/210L. If that ARS produced a result of

    
    

    1. g/210L on a high reading machine, there was a variation of

    
    

    0.008 g/210L, while the machine range rule allows a variation of only +/- 0.005 g/210L.9

68. Under the circumstances described in the paragraph above, a person with an actual breath-alcohol level of 0.077 g/210L could receive a breath-test result of 0.085 g/210L.10 Such an occurrence is only a remote possibility. There is no evidence that an ARS has been responsible for producing such results. Moreover, Petitioner's breath-test result of 0.09 g/210L under these facts would mean that his actual breath- alcohol level was 0.082 g/210L.

69. The sampling methodology set forth in the COAs used by Mr. Wood at the time of the hearing provided for the averaging of sample results. In those COAs, an individual ARS sample could result in a GC measurement of alcohol content below the lowest average value of the range established by the COAs. For example, the COA for ARS with an alcohol content of 0.08 g/210L allowed a lot to be approved if one or more of the individual samples measured as low as 0.0908 g/dL on the GC. However, Mr. Wood would not have approved a lot of ARS unless the average results were 0.0928 g/dL or higher.

70. The facts of this case are clearly different from the facts set forth in the paragraphs above. There is no evidence that the machine used to test Petitioner's breath-alcohol level

    was improperly calibrated, yielding breath-alcohol readings of

    
    

    0.08 g/210L or higher when his actual breath-alcohol was below that level. There is no evidence that the ARS used to inspect that machine had an alcohol content at a sufficiently low level of the acceptable range for 0.08 g/210L simulator solution to result in a reading of 0.08 g/210L or higher when the actual breath-alcohol was below that level.

71. The highest Intoxilyzer 5000 Series instrument readings using ARS lots 97180, 97190, and 97200, and therefore in the best light of the Petitioner, were 0.050, 0.081, and 0.200 g/210L respectively. The mean values of the ARS were 0.0612, 0.0972, and 0.2438 g/dL, respectively.

72. Using the mean values of the ARS and the highest actual machine readings, the actual breath-alcohol level that could result in a recorded breath-test result of 0.09 g/210L would be 0.091, 0.089, and 0.091 g/210L respectively.

73. Using the minimum observed average ARS values (0.0604, 0.0965, and 0.2429 g/dL) and the highest actual machine readings, the actual breath-alcohol levels that could produce a recorded breath-test result of 0.090 g/210L, would be 0.090, 0.089, and

    0.090 g/210L.

    
    

74. One does not arrive at a different result using the lowest individual sample values at each level and the highest actual machine readings. The lowest individual sample values of ARS were 0.0602, 0.0960, and 0.2421 g/dL. The actual breath-

    alcohol levels that could produce a recorded breath-test result of 0.090 g/210L, would be 0.0898, 0.0883, and 0.0901 g/210L.

75. The result is the same when one uses the lowest individual sample values at each level (0.0602, 0.0960, and 0.2421 g/dL) and the highest possible machine readings (0.055, 0.085, and 0.210 g/210L. With a recorded breath-test result of

    0.090 g/210L, the actual breath-alcohol level that could produce that result would be 0.084, 0.0843, and 0.0809 g/210L.

76. Similarly, the facts of this case do not indicate that the GC analysis of ARS lot 97190 yielded results for 0.08 g/210L simulator solution which exceeded the allowable ranges set forth in Rule 11D-8.002(1), Florida Administrative Code. According to the COA in use at the time of the hearing, the lowest average value for that solution was 0.0928 g/dL, which converts to 0.0767 g/210L. The highest actual machine reading, and therefore in the best light of Petitioner, was 0.081 g/210L. The difference between 0.0767 g/210L and 0.081 g/210L is 0.0043 g/210L, which is well within the rule's allowable range of 0.005 g/210L.

77. The same holds true when one uses the value for the lowest individual sample in ARS lot 97190 and the highest actual machine reading. The lowest individual sample was 0.0960 g/dL, which converts to 0.0793 g/210L. The highest actual machine reading was 0.081 g/210. The difference between the two is 0.0017 g/210L, which is less than 0.005 g/210L. The results are

    no different when the same calculations are performed for ARS lots 97180 and 97200.

    CONCLUSIONS OF LAW

    
    

78. The Division of Administrative Hearings has jurisdiction over the subject matter and the parties to this proceeding pursuant to Sections 120.56 (3), Florida Statutes.

79. Pursuant to Sections 120.56(1)(a) and 120.56(3)(a), Florida Statutes, a substantially affected person may seek an administrative determination of the invalidity of an existing rule.

80. Section 120.52(8), Florida Statutes, states as follows in pertinent part:

    (8) "Invalid exercise of delegated legislative authority" means action which goes beyond the powers, functions, and duties delegated by the Legislature. A proposed or existing rule is an invalid exercise of delegated legislative authority if any one of the following applies:

    
    

    * * *

    
    

    1. The agency has exceeded its grant of rulemaking authority, citation to which is required by s. 120.54(3)(a)1.;

    2. The rule enlarges, modifies, or contravenes the specific provisions of law implemented, citation to which is required by s. 120.54(3)(a)1.;

    3. The rule is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency;

    4. The rule is arbitrary or capricious;

    5. The rule is not supported by competent substantial evidence . . . .

81. Petitioner asserts that all or part of Rules 11D- 8.002(1) and 11D-8.006(2), Florida Administrative Code, and FDLE/ATP Form 16, which is incorporated by reference in Rule 11D- 8.003(7), Florida Administrative Code, constitute invalid exercises of delegated legislative authority. Petitioner has standing to challenge these rules. Lanoue v. Florida Department of Law Enforcement, 25 Fla. L. Weekly D76 (Fla. Dec. 29, 1999).

82. Petitioner bears the burden of establishing the invalidity of existing rules by a preponderance of the evidence. Cortes v. State Board of Regents, 655 So. 3d 132, 135-136 (Fla. 1st DCA 1995).

83. Section 316.193, Florida Statutes, states as follows in relevant part:

    1. A person is guilty of the offense of driving under the influence and is subject to punishment as provided in subsection (2) if the person is driving or in actual physical control of a vehicle within this state and:

       1. The person is under the influence of alcoholic beverages . . . when affected to the extent that the person's normal faculties are impaired;

          
          

          * * *

          
          

          (c) The person has a breath-alcohol level of

          0.08 or more grams of alcohol per 210 liters of breath.

          
          

84. Section 316.1932, Florida Statutes, states as follows in pertinent part:

    (1)(a) Any person who accepts the privilege extended by the law of this state of operating a motor vehicle within this state is, by so operating such vehicle, deemed to

    have given his or her consent to submit to an approved chemical test or physical test including, but not limited to, an infrared light test of his or her breath for the purpose of determining the alcoholic content of his or her blood or breath. . . .

    
    

    * * *

    
    

    (b)1. . . . The breath-alcohol level must be based upon grams of alcohol per 210 liters of breath.

    
    

    * * *

    2. An analysis of a person's breath, in order to be considered valid under this section, must have been performed substantially according to methods approved by the Department of Law Enforcement. For this purpose, the department may approve satisfactory techniques or methods. Any insubstantial differences between approved techniques and actual testing procedures in any individual case do not render the test or test results invalid.

    * * *

    
    

    (f)1. The tests determining the weight of alcohol in the defendant's . . . breath shall be administered at the request of a law enforcement officer substantially in accordance with the rules of the Department of Law Enforcement. Such rules must specify precisely the test or tests that are approved by the Department of Law Enforcement for reliability of result and ease of administration, and must provide an approved method of administration which must be followed in all such tests given under this section. . . .

85. Section 316.1934, Florida Statutes, states as follows in pertinent part:

    1. It is unlawful and punishable as provided in Chapter 322 and in s. 316.193 for any person who is under the influence of alcoholic beverages . . . when affected to

       the extent that the person's normal faculties are impaired . . . to drive or be in actual physical control of any motor vehicle within this state. . . .

    2. At the trial of any civil or criminal action or proceeding arising out of acts alleged to have been committed by any person while driving, or in actual physical control of, a vehicle while under the influence of alcoholic beverages . . . when affected to the extent that the person's normal faculties were impaired . . . the results of any test administered in accordance with s. 316.1932 or s. 316.1933 and this section are admissible into evidence when otherwise admissible, and the amount of alcohol in the person's . . . breath at the time alleged, as

       
       

       shown . . . by chemical or physical test of the person's breath, gives rise to the following presumptions:

       1. If there was at that time a . . .

          breath-alcohol level of 0.05 or less, it is presumed that the person was not under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired.

       2. If there was at that time a . . .

          breath-alcohol level of 0.05 but less than 0.08, that fact does not give rise to any presumption that the person was or was not under the influence of alcoholic beverages .

          . . but may be considered with other competent evidence in determining whether the person was under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired.

       3. If there was at that time a . . .

       breath-alcohol level of 0.08 or higher, that fact is prima facie evidence that the person was under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired. Moreover, such person who has a breath-alcohol

       level of 0.08 or higher is guilty of driving, or being in actual physical control of, a vehicle, with an unlawful breath-

       alcohol level. The presumptions provided in this subsection do not limit the introduction of any other competent evidence bearing upon

       the question of whether the person was under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired.

    3. . . . a physical test of a person's breath, in order to be considered valid under this section, must have been performed substantially in accordance with methods approved by the Department of Law Enforcement and by an individual possessing a valid permit issued by the department for this purpose. Any insubstantial differences between approved techniques and actual testing procedures or any insubstantial defects concerning the permit issued by the department, in any individual case do not render the test or test results invalid. The Department of Law Enforcement may approve satisfactory techniques or methods, ascertain the qualifications and competence of individuals to conduct such analyses, and issue permits that are subject to termination or revocation in accordance with rules adopted by the department.

86. Rule 11D-8.002, Florida Administrative Code, states as follows in relevant part:

    1. Acceptable Range -- Shall mean the observed values must fall within the following ranges at each alcohol target concentration: 0.05 g/210L range is 0.045 -- 0.055 g/210L; 0.08 g/210L range is 0.075 -- 0.085 g/210L; 0.20 g/210L range is 0.190 --

       0.210 g/210L.

       
       

       * * *

       
       

       (8) Alcohol Reference Solution (commonly referred to as simulator solution) -- Shall mean a mixture of known mass of ethanol and a known volume of water, the headspace above which will have a known ethanol concentration at a specified temperature.

       
       

       * * *

       (11) Approved Breath Test Instrument -- Shall mean any type of instrument approved by the Department; and listed in 11D-8.003.

       
       

       * * *

       
       

       1. Breath Alcohol Level -- Shall mean the alcohol concentration by weight in a person's breath based upon grams of alcohol per 210 liter of breath.

       2. Breath Alcohol Test -- Shall mean, the analyses of a minimum of two samples of breath collected within fifteen minutes, and the results reported as the alcohol level based upon grams of alcohol per 210 liters of breath. To be acceptable as a valid breath test, the two results shall be within +/-

       0.020 g/210L and taken within fifteen (15) minutes of each other. If the results of the first and second sample are more than +/-

       0.020 g/210L apart, a third sample shall be analyzed. To be acceptable as a valid breath test, any two of three results shall be within +/- 0.020 g/210L and taken within fifteen (15) minutes of each other. In the event the person tested refuses or fails to provide the required number of valid breath samples, than this event shall constitute a refusal. Notwithstanding the foregoing sentence, the result(s) obtained, if proved to be reliable, shall be acceptable as a valid breath alcohol level.

       * * *

       
       

       (21) g/210L -- Shall mean grams of alcohol per 210 liters of breath.

       
       

       * * *

       
       

       1. Precision -- Shall mean, for the purpose of Department inspections, using the same tests used for acceptable range, the average standard deviation shall be no more than 0.0042 g/210L, truncating the fifth decimal place.

       2. Reference Sample Device (simulator) -- Shall mean a device that contains and delivers a temperature controlled headspace alcohol/water gas sample to a breath test

          instrument, a device that artificially simulates the alveolar breath of a human being.

          
          

          * * *

          
          

       3. Source Approved by the Department -- Shall mean any vendor or manufacturer of Alcohol Reference Solution or Alcohol Stock Solution selected by the Department to provide or distribute Alcohol Reference Solution or Alcohol Stock Solution to one or more agencies.11

87. Rule 11D-8.003, Florida Administrative Code, states as follows in pertinent part:

    1. Evidential breath testing involves methods which measure the alcohol level of deep lung breath samples. Breath test methods for determining breath alcohol level shall be approved by the Department in accordance with section (7) of this rule. The Department approves the following method(s) for evidential breath testing: Infrared Light Test, also known as Infrared Light Absorption Test.

    2. The Department approves the following breath test instrument(s) for evidential use: CMI, Inc. Intoxilyzer 5000 Series . . .

       * * *

       
       

       (7) When conducting an evaluation for approval of breath test instruments in accordance with this rule, the Department shall conduct a minimum of 50 tests at each concentration for acceptable range, precision, and alcohol-free reading in accordance with the Inspection Procedures FDLE/ATP Form 16 January, 1997, which is approved by the Department and is incorporated by reference.

88. Rule 11D-8.004, Florida Administrative Code, states as follows in relevant part:

    1. All breath test instruments when initially received from a manufacturer and prior to being placed into evidentiary use, shall be inspected for acceptable range, precision, and alcohol-free reading in accordance with the Inspection Procedures FDLE/ATP Form 16. . . .

    2. When conducting an inspection in accordance with this rule, the Department inspector shall conduct a minimum of 10 tests at each concentration for acceptable range, precision, and alcohol-free reading, in accordance with Inspection Procedures FDLE/ATP Form 16 and shall report such test on a form provided by the Department.

    3. Breath test instruments shall be inspected by the Department at least once each calendar year (January 1 through December 31).

89. Rule 11D-8.006, Florida Administrative Code, states as follows in pertinent part:

    1. Breath test instruments shall be inspected by the agency at least once each calendar month by an agency inspector. The agency inspector shall conduct a minimum of 3 tests at each alcohol concentration for acceptable range and alcohol free reading in accordance with the Inspection Procedures FDLE/ATP Form 16. . . .

    2. The agency must use alcohol reference solution and/or alcohol stock solution prepared by the Department, or alcohol

       
       

       reference solution and/or alcohol stock solution from a source approved by the Department.

       
       

90. FDLE/ATP Form 16 sets forth the inspection procedures for tests using approved ARS. It requires inspectors to "[p]repare simulators for tests using Department provided or approved alcohol reference solution and/or Department provided or

    approved alcohol stock solution." The form also states as follows in relevant part:

    1. Simulator test results must fall within the acceptable ranges stated in rule 11D- 8.002(1). . . .

    2. If the instrument LED readings(s) or a value printed on the print card(s) falls outside the acceptable range, perform additional tests to identity the source of the out of range reading. Remember that an out of range reading has four possible origins: The simulator may not be working properly (including the connections between the simulator and instrument); the simulator solution may not be mixed properly; the simulator solution may not have the proper concentration; or the instrument may not be working properly. Additional testing may include remising simulator solutions or using another alcohol reference solution.

91. Rule 11D-8.0035, Florida Administrative Code, states as follows in relevant part:

    1. The Department will approve sources of alcohol reference solution for use by agencies in the State of Florida. A source approved by the Department may be a single entity that manufactures and distributes alcohol reference solution, or may be two entities, one which manufactures the alcohol reference solution and one which distributes the alcohol reference solution. A source approved by the Department must meet the following requirements:

       1. The source must prepare alcohol reference solution using only distilled or deionized water;

       2. The source must use reagent grade or

          U.S.P. Punctilious grade ethanol in the preparation of the alcohol reference solution;

       3. The source must be capable of producing a minimum batch volume of 800 bottles, each containing at least 500 milliliters, to produce the following vapor alcohol

          concentration: 0.05 g/210L, 0.08 g/210L,

          0.20 g/210 L;

       4. The source must have performed and documented a shelf-life study justifying an expiration date of at least 365 days from the date of manufacture.

    2. The Department shall approve each lot of alcohol reference solution provided by a source approved by the Department prior to the distribution of the alcohol reference solution for use in agency or Department inspections. The source approved by the Department will only supply alcohol reference solution previously approved by the Department for use in agency or Department inspections.

       1. Prior to Department approval of a lot of alcohol reference solution, a source approved by the Department shall provide to the Department a minimum of ten (10) sample bottles selected from each lot.

       2. The Department shall determine the ethanol concentration in a minimum of ten

          (10) sample bottles of alcohol reference solution using gas chromatography or other scientifically accepted method. Three tests will be performed on each sample bottle of alcohol reference solution, yielding a minimum of 30 tests results for each lot. All test results shall fall within +/- 3% of the target ethanol concentration.

          1. Upon approval of a lot of alcohol reference solution by the Department, the Department will notify the source approved by the Department that a lot may be distributed to agencies for use in agency inspections. The Department will prepare a Certificate of Assurance, FDLE/ATP Form 32 -- 7-6-99, which is approved by the Department and is incorporated by reference. The Certificate of Assurance contains a summary of the laboratory analysis performed on the lot of alcohol reference solution, and shall be made available upon request.

          2. The Department shall perform a post- approval laboratory analysis of alcohol reference solution previously approved by the Department for use by the agencies.

             1. The Department shall select a minimum of three (3) agencies to provide bottles of alcohol reference solution from a lot previously approved by the Department.

             2. The sample bottles received and the data obtained from the post-approval analysis must be consistent with the procedures set forth in subsection (2)(b). . . .

92. FDLE/ATP Form 32 is entitled Certificate of Assurance. It states as follows in relevant part:

    The Florida Department of Law Enforcement Alcohol Testing Program (Department) assures that Florida Citizens are provided with accurate, precise, and reliable breath alcohol tests for use in traffic court proceedings. Alcohol Reference Solution (ARS) used in Florida is prepared by the Department or by a source approved by the Department, and is an important part of the Department's assurance to Florida citizens and courts.

    
    

    The Department tests newly manufactured ARS by gas chromatography to determine accuracy of preparation and uniformity within the lot. Lots meeting Department standards are approved for use in Florida. The gas chromatographic testing consists of the analysis of at least ten bottles of ARS in triplicate. Analysis of all ARS bottles must produce three valid test results. Individual test results are an estimate of the ARS ethanol concentration, and the average of the results is the best estimate of the ARS ethanol concentration.

    
    

    Lots having 30 analytical determination within the following acceptable ranges will be accurate and uniform within the lot and are approved for use in the State of Florida.

    
    

    * * *

    
    

    [The following data relates to Vapor Alcohol Target Concentration in g/210L, ARS Target in g/100mL, and ARS Acceptable Range in g/100mL respectively]

    
    

    0.050	0.0605	0.0586 to 0.0623
    0.080	0.0986	0.0938 to 0.0997
    0.200	0.2420	0.2347 to 0.2492

    
    

    A lot meeting the above criteria has an alcohol concentration indistinguishable from an alcohol target concentration of XXX b/100mL. It will provide a vapor alcohol reading at or between XXX g/210L to XXX g/210L when tested by a properly calibrated breath test instrument operated in compliance with Chapter 11D-8, F.A.C. . . .

93. Petitioner claims that Rule 11D-8.002(1), Florida Administrative Code, constitutes an invalid exercise of delegated legislative authority because it enlarges, modifies or contravenes the specific alcohol target levels established in Chapter 316, Florida Statutes. This argument is without merit.

94. Theoretically, an individual with an actual breath- alcohol level below 0.08 g/210L (if such can be determined) could test above that level if the Intoxilyzer 5000 is not properly calibrated. Similarly, an individual with an actual breath- alcohol level above 0.08 g/210L could test below that level if the machine is not properly calibrated. These hypothetical results are remotely possible because Rule 11D-8.002(1), Florida Administrative Code, allows a breath test machine to remain in service as long as its most recent inspection yields results within the acceptable ranges set forth in the rule for all three target alcohol concentrations. The mathematical calculations that support these hypothetical results do not take into

    consideration all of the other safeguards in the ATP, which ensure the validity and reliability of breath-alcohol tests.

95. In order to avoid the hypothetical results described in the paragraph above, every machine in service would have to read exactly 0.050, 0.080 and 0.200 g/210L during every inspection, which would have to be performed using a precise 0.050, 0.080 and

    0.200 g/210L ARS respectively. FDLE cannot scientifically guarantee such results given the limitations on the capabilities and precision of the statutorily approved breath test instrument, without regard to possible variations in the alcohol content of ARS used during inspection.

96. Section 316.1932(1)(a), Florida Statutes, requires persons who accept the privilege of driving in this state to submit to an approved test, including, but not limited to an infrared light test of their breath, if lawfully arrested for any offense committed while driving or in physical control of a motor vehicle. Section 316.1934(2), Florida Statutes, sets forth the acceptable, debatable, and unacceptable levels of alcohol in breath respectively as follows: 0.05 g/210L or less; in excess of 0.05 g/210L but less than 0.08 g/210L; and 0.08 g/210L or higher.

97. Rule 11D-8.003(1), Florida Administrative Code, designates the infrared light test as the approved method for evidential breath testing. Rule 11D-8.003(2), Florida Administrative Code, approves the Intoxilyzer 5000 as the

    approved instrument for evidential use. Both sections in the rule are consistent with Section 316.1932(1)(a), Florida Statutes.

98. The Intoxylizer 5000 is not intended to precisely measure the alcohol content of a person's breath. Instead, it measures the breath-alcohol content within the parameters established by its manufacturer, +/- 0.005 g/210L or 5 percent of each target concentration, whichever is greater. The acceptable ranges set forth in Rule 11D-8.002(1), Florida Administrative Code, coincide with the manufacturer's specifications, NHTSA standards, and the statutory target breath-alcohol levels within the capabilities and precision limitations of the machine.

99. Rule 11D-8.002(1), Florida Administrative Code, serves the purpose of informing the public that the method of testing breath alcohol, recognized by the Legislature and chosen by FDLE operates within a range of accuracy.

100. Petitioner admits that the capabilities and the precision of the breath testing machine are not at issue.

101. The COAs in use at the time of the hearing set a range of average results from GC analysis that had to be met before a lot of ARS could be approved for use in inspections of breath test instruments. A range of average results is necessary because GC analysis, as with any measurement process, has limitations in its ability to measure the exact alcohol concentration in a lot of ARS. These limitations are unrelated

     to the actual alcohol content of an individual sample or lot of ARS, which has a homogenous alcohol content.

102. Theoretically, the allowable ranges for approval of ARS in the COAs, in combination with the acceptable ranges in the machine range rule, could produce results which exceed the acceptable ranges in Rule 11D-8.002(1), Florida Administrative Code. This is mathematically possible only if an ARS, with an alcohol content at the extreme lower limits of the allowable range for ARS, is used to inspect a machine that is operating at the upper operational parameters for instrument accuracy. There is no evidence that ARS and a high reading machine has ever produced this result. Moreover, Petitioner provided no statistical evidence showing the probability of such an extreme result.

103. Persuasive testimony indicates that the ranges for allowable average values of ARS in the COAs at issue here were based on scientifically accepted practice. A lot of ARS meeting the criteria in the COAs had an alcohol concentration that is scientifically indistinguishable from its respective target level. There is no persuasive evidence to the contrary.

104. The inspection procedures set forth in Rules 11D-8.004 and 11D-8.006, Florida Administrative Code, and FDLE/ATP Form 16 are not designed to calibrate the breath test machines. The manufacturer or its authorized repair facility calibrates the machines. The purpose of ARS and the inspection procedures is to

     verify the accuracy of the machines within their specified range of accuracy. FDLE/ATP Form 16 requires an inspection at each of the statutory target concentrations, with ARS from three different lots, lowering the probability that an improperly calibrated machine will be placed in service.

105. FDLE has created an inspection process that is designed to ensure reliability of result and ease of administration, providing a method of administration to be followed in every inspection. See Section 316.1932(1)(f)1., Florida Statutes. FDLE could not guarantee the precision that Petitioner demands even if FDLE furnished a GC machine and an analytic chemist for each Intoxilyzer 5000 during each inspection.

106. NIST has the ability to obtain exact alcohol concentrations in ARS. The tests performed by NIST cost thousands of dollars and require equipment not commonly available. Requiring FDLE to verify the alcohol content in ARS using NIST standards would place an "extremely expensive and difficult burden . . . on the state." State v. Friedrich, 681 So. 2d 1157, 1163 (Fla. 5th DCA 1996).

107. The acceptable ranges set forth in Rule 11D-8.002(1), Florida Administrative Code, and the standards, criteria, and procedures that FDLE uses to verify the calibration of the Intoxilyzer 5000 pursuant to Rule 11D-8.006, Florida Administrative Code, and FDLE/ATP Form 16 are supported by

     competent evidence and are not arbitrary and capricious.

     
     

     Absolute accuracy in the process of verifying the alcohol content of ARS and in the process of verifying the calibration of breath test machines is not necessary to ensure the validity and reliability of breath test results.

108. Since the hearing, FDLE has adopted Rule 11D-8.0035, Florida Administrative Code and FDLE/ATP Form 32. This new rule and form set forth the standards, criteria, and procedures for approving ARS and establish the percentage of error for all three levels of ARS at 3 percent. Moreover, the Court in Lanoue v. Florida Department of Law Enforcement, 25 Fla. L. Weekly D76 (Fla. Dec. 29, 1999), held that Petitioner did not have standing to challenge the non-rule policies and statements in the COAs that FDLE was using at the time of the hearing to analyze ARS.

109. In 1996, the legislature amended Sections 316.1932 and 316.1934, Florida Statutes. Chapter 96-330, s. 4, Laws of Florida. FDLE adopted Rule 11D-8.002(1), Florida Administrative Code, in 1997 prior to the most recent amendment of the statutes in 1998. See Chapter 98-27, S. 1, Laws of Florida. Therefore, the Legislature is presumed to have adopted the Department's interpretation of Sections 316.1932(1)(b)2. and 316.1932(1)(f)1., Florida Statutes. Cole Vision Corporation v. Department of Business and Professional Regulation, Board of Optometry, 668 So. 2d 404, 408-409 (Fla. 1st DCA 1997).

110. Petitioner argues that Rule 11D-8.006(2), Florida Administrative Code, and FDLE/ATP Form 16 are vague and ambiguous, fail to establish adequate standards, and vest unbridled discretion in FDLE, and thus allow arbitrary and capricious results. Specifically, Petitioner asserts that the rule fails to define a "source approved by the Department." According to Petitioner, the rule does not identify the source by name or establish standards, criteria, and procedures for selection of the source. Petitioner also claims that the form fails to define "approved ARS" or to establish standards, criteria, and procedures for approving ARS. These arguments are without merit.

111. The term "source" means:

     
     

     That from which any act, movement, information, or effect proceeds. A person or thing that originates, sets in motion, or is a primary agency in producing any course of action or result. An originator; creator; origin. A place where something is found or whence it is taken or derived.

     
     

     Black's Law Dictionary, (5th ed. 1979).

     
     

112. During the trial, Petitioner elicited testimony indicating that FDLE's approved source of ARS was the entity, manufacturer or vendor, from which local law enforcement agencies could procure ARS. At that time, FDLE had established standards and criteria for selection of the source that were established before FDLE contracted with Guth, but which were not set forth in the rules. Based on these standards and criteria recommendation,

     FDLE approved Guth as the sole source of ARS. The standards and criteria were not arbitrary and capricious.

113. It is not necessary to identify the name of the existing approved source or to include the details of the process used in selecting the source in the rules. The identity of the source is subject to change from time to time. The process of selection, whether by bid or sole source procedures, is controlled by the rules of the Department of Management Services.

114. At the time of the hearing, FDLE had established standards, criteria and procedures for approving a lot of ARS, which had not been promulgated as rules. These standards, criteria and procedures were set forth in the draft COAs in use at that time. As stated above, competent evidence indicates that the standards, criteria and procedures for approving ARS were not arbitrary and capricious.

115. Second, since the hearing, FDLE adopted Rule 11D- 8.002(27), Florida Administrative Code, which defines a "source approved by the Department." Rule 11D-8.0035, Florida Administrative Code, and FDLE/ATP Form 32 set forth further description of an approved source, list the requirements that must be met by a source approved by FDLE, and describe the standards, criteria, and procedures for the selection of an approved ARS. These rules were promulgated without challenge.

116. The terms "source approved by the Department" and "approved ARS" as used by FDLE in Rule 11D-8.006(2), Florida

     Administrative Code, and FDLE/ATP Form 16 did not constitute an invalid exercise of delegated legislative authority at the time of the hearing. The new rules provide additional support for this determination and eliminate any ambiguity or vagueness that might have existed in the rules prior to their adoption.

117. Finally, Petitioner does not have standing to challenge the non-rule statements and policies that further explain the meaning of "source approved by the Department" and "approved ARS" by virtue of the Court's holding in Lanoue v. Florida Department of Law Enforcement, 25 Fla. L. Weekly D76 (Fla. Dec. 29, 1999).

ORDER

Based on the foregoing Findings of Fact and Conclusions of Law, it is

ORDERED:

That the petition for administrative hearing in this case is dismissed.

DONE AND ORDERED this 23rd day of May, 2000, in Tallahassee, Leon County, Florida.

SUZANNE F. HOOD

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675 SUNCOM 278-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us

Filed with the Clerk of the Division of Administrative Hearings this 23rd day of May, 2000.

ENDNOTES

1/ Rule 11D-8.0035, Florida Administrative Code, which was adopted on July 6, 1999, sets forth the procedures, standards and criteria for approving ARS.

2/ Rule 11D-8.0035(3), Florida Administrative Code, approves a Certificate of Assurance, FDLE/ATP Form 32, and incorporates it by reference, effective July 6, 1999.

3/ Rule 11D-8.002(27), Florida Administrative Code, which was adopted on July 6, 1999, defines a "source approved by the Department.

4/ See Endnote 1 above.

5/ FDLE/ATP Form 32 approves ARS to replicate a 0.05 g/210L breath-alcohol level if the average test results of that solution fall between 0.0586 g/dL and 0.0623 g/dL of ethanol, a range of 0.0037 g/dL. The allowed variation around the target ARS concentration of 0.0605 g/dL is +/- 0.00185 g/dL (3.05 percent variation or percentage of error).

6/ FDLE/ATP Form 32 FDLE approves ARS to replicate a 0.08 g/210L breath-alcohol level if the average test results of that solution fall between 0.0938 g/dL and 0.0997 g/dL of ethanol, a range of 0.0037 g/dL. The allowed variation around the target ARS concentration of 0.0968 g/dL is +/- 0.00295 g/dL (3.04 percent variation or percentage of error).

7/ FDLE/ATP Form 32 FDLE approves ARS to replicate a 0.20 g/210L breath-alcohol level if the average test results of that solution fall between 0.2347 g/dL and 0.2492 g/dL of ethanol, a range of 0.0145 g/dL. The allowed variation around the target ARS concentration of 0.2420 g/dL is +/- 0.00725 g/dL (2.99 percent variation or percentage of error).

8/ FDLE/ATP Form 32 sets the variations or percentages of error at 3.05 percent for 0.05 g/210L ARS, 3.04 percent for 0.08 g/210L

ARS, and 2.99 percent for 0.20 g/210L ARS. See endnotes 5, 6,

and 7 above.

9/ The lowest average value of the acceptable range in FDLE/ATP Form 32 for 0.08 g/210L ARS is 0.0938 g/dL, which equates to 0.07752 g/210L. If that ARS produces an inspection result of

0.085 g/210L on a high reading machine, there is a variation of 0.00748, a result that exceeds the limit of +/- 0.005 g/210L established by the machine range rule.

10/ The lowest average value of the acceptable range in FDLE/ATP Form 32 for 0.08 g/210L ARS is 0.0938 g/dl, which equates to 0.07752 g/210L. If a machine is inspected with 0.07752 g/210L ARS and produces a reading of 0.085 g/210L, a person with an actual breath-alcohol level of 0.077 g/210L would receive a reading of 0.08448 g/210L.

11/ See endnote 3 above.

COPIES FURNISHED:

Chris H. Bentley, Esquire Diane D. Tremor, Esquire

Rose, Sundstrom and Bentley, LLP 2548 Blairstone Pines Drive Tallahassee, Florida 32301

David M. Robbins, Esquire Epstein and Robbins

1125 Blackstone Building

Jacksonville, Florida 32202

Richard D. Courtemanche, Jr., Esquire Department of Law Enforcement

Post Office Box 1489 Tallahassee, Florida 32302

Lee Ann Gustafson, Esquire Department of Legal Affairs The Capitol, Plaza Level 01

Tallahassee, Florida 32399-1050

James T. Moore, Commissioner Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32399-1489

Michael Ramage, General Counsel Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32399-1489

Carroll Webb, Executive Director

Joint Administrative Procedure Committee

120 Holland Building Tallahassee, Florida 32399-1300

Liz Cloud, Chief

Bureau of Administrative Code The Elliott Building Tallahassee, Florida 32399-0250

NOTICE OF RIGHT TO APPEAL

A party who is adversely affected by this final order is entitled to judicial review pursuant to Section 120.68, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing one copy of the notice of appeal with the Agency Clerk of the Division of Administrative Hearings and a second copy, accompanied by filing fees prescribed by law, with the District Court of Appeal, First District, or with the District Court of Appeal in the Appellate District where the party resides. The notice of appeal must be filed within 30 days of rendition of the order to be reviewed.

Docket for Case No: 98-004571RX

Orders for Case No: 98-004571RX