STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
WILLIAM LANE, | ) ) | |||
Petitioner, | ) ) | |||
vs. | ) | Case | No. | 07-4495RX |
) | ||||
DEPARTMENT OF LAW ENFORCEMENT, | ) | |||
) | ||||
Respondent. | ) | |||
| ) |
FINAL ORDER
Pursuant to notice, Lawrence P. Stevenson, Administrative Law Judge, Division of Administrative Hearings, conducted a formal hearing in the above-styled case on October 29, 2007, and April 30, 2008, in Tallahassee, Florida.
APPEARANCES
For Petitioner: Robert R. Berry, Esquire
Eisenmenger, Berry & Peters, P.A. 5450 Village Drive
Viera, Florida 32955
For Respondent: Sharon S. Traxler, Esquire
Department of Law Enforcement 2331 Phillips Road
Tallahassee, Florida 32308-5333 STATEMENT OF THE ISSUE
Whether Florida Administrative Code Rules 11D-8.011, 1D-8.012, 11D-8.013, and 11D-8.014 constitute an invalid exercise of delegated legislative authority.
PRELIMINARY STATEMENT
On September 28, 2007, Petitioner William Lane filed a "Petition Challenging Florida Department of Law Enforcement's Failure to Comply with the Requirements of Chapter 120, Florida Statutes, as They Relate to Promulgation of FDLE Rules Regarding Blood Alcohol Testing in DUI Cases" (the "Petition") at the Division of Administrative Hearings ("DOAH"). The case was scheduled for hearing on October 29 and 30, 2007, in Tallahassee.
At the outset of the final hearing, the parties agreed that there were no factual matters in dispute and that the case could be tried entirely through written legal argument. The parties agreed to an appellate-style briefing schedule whereby Petitioner would file an initial brief on November 19, 2007, Respondent Florida Department of Law Enforcement ("FDLE") would file an answer brief on December 3, 2007, and Petitioner would file a reply brief on December 13, 2007. The undersigned would then prepare a final order within 20 days of the reply brief.
Two extensions were granted to the parties during the briefing period. The reply brief was filed on December 20, 2007. As the undersigned commenced work on the final order, it became apparent that some fact-finding would be necessary in order to resolve the issues raised by Petitioner. Specifically, one of Petitioner's chief allegations concerned FDLE's improper reliance
on the "generic classifications" of blood alcohol testing known as alcohol dehydrogenase and gas chromatography. In its answer brief, FDLE maintained that these tests are not vague or "generic" but are "specific, definite and explicit methodologies of scientifically determining the amount of alcohol in a blood sample." The undersigned convened a teleconference with the parties to suggest that expert testimony would be necessary to determine the nature of these tests and therefore the sufficiency of the challenged rules. The parties agreed and the continued hearing was scheduled for April 30, 2008.
At the hearing, Petitioner offered the testimony of Lawrence W. Masten, an expert in the field of toxicology. FDLE offered the testimony of Bruce Goldberger, an expert in the field of forensic toxicology, and of Laura Barfield, the manager of FDLE's Alcohol Testing Program. Neither party offered any exhibits into evidence.
A one-volume Transcript of the hearing was filed at the Division of Administrative Hearings on May 15, 2008. By order dated May 27, 2008, Petitioner's motion to extend the time for filing proposed orders was granted, and the parties were given until July 6, 2008, to file their proposed orders. Both parties timely filed their proposed final orders. Both parties' proposals have been given careful consideration in the preparation of this Final Order.
Unless otherwise indicated, all statutory references in this Final Order are to the 2007 version of the Florida Statutes and all references to Rules are to the current version of the Florida Administrative Code.
FINDINGS OF FACT
Based on the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made:
FDLE is the state agency responsible for the regulation of blood analysts who conduct blood testing for purposes of
the driving and boating under the influence and related provisions of Chapters 316, 322, and 327, Florida Statutes.
§ 316.1932(1)(a)2., Fla. Stat. Among FDLE's enumerated powers under the Alcohol Testing Program (the "program") are the authority to approve the "type" of blood test utilized and the authority to "specify techniques and methods" for blood testing utilized under the driving and boating under the influence and related provisions of Chapters 316, 322, and 327, Florida Statutes. § 316.1932(1)(a)2.n., and o., Fla. Stat.
Petitioner, William Lane, has been charged with DUI manslaughter and is awaiting trial on that charge in the 18th Judicial Circuit, in and for Brevard County, Florida. Petitioner was subjected to a blood alcohol test that purported to be conducted in compliance with Sections 316.1932, 316.1933,
and 316.1934, Florida Statutes. FDLE has not contested the standing of Petitioner to initiate this proceeding.
Petitioner has challenged Florida Administrative Code Rules 11D-8.011, 11D-8.012, 11D-8.013, and 11D-8.014 as invalid exercises of delegated legislative authority.1 Florida Administrative Code Rule 11D-8.011 provides:
11D-8.011 Approval of Blood Alcohol Test Methods.
The Department approves the following test methods for determining blood alcohol level:
Alcohol Dehydrogenase (Enzymatic).
Gas Chromatography.
Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3., (d) FS. Law Implemented 316.1933(2)(b), 316.1934(3),
322.63(3)(b), 327.352(1)(e), 327.353(2),
327.354(3) FS. History–New 10-31-93.
Florida Administrative Code Rule 11D-8.012 provides: 11D-8.012 Blood Samples - Labeling and
Collection.
Before collecting a sample of blood, the skin puncture area must be cleansed with an antiseptic that does not contain alcohol.
Blood samples must be collected in a glass evacuation tube that contains a preservative such as sodium fluoride and an anticoagulant such as potassium oxalate or EDTA (ethylenediaminetetraacetic acid). Compliance with this section can be established by the stopper or label on the collection tube, documentation from the manufacturer or distributor, or other evidence.
Immediately after collection, the tube must be inverted several times to mix the blood with the preservative and anticoagulant.
Blood collection tubes must be labeled with the following information: name of person tested, date and time sample was collected, and initials of the person who collected the sample.
Blood samples need not be refrigerated if submitted for analysis within seven (7) days of collection, or during transportation, examination or analysis. Blood samples must be otherwise refrigerated, except that refrigeration is not required subsequent to the initial analysis.
Blood samples must be hand-delivered or mailed for initial analysis within thirty days of collection, and must be initially analyzed within sixty days of receipt by the facility conducting the analysis. Blood samples which are not hand-delivered must be sent by priority mail, overnight delivery service, or other equivalent delivery service.
Notwithstanding any requirements in Chapter 11D-8, F.A.C., any blood analysis results obtained, if proved to be reliable, shall be acceptable as a valid blood alcohol level.
Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3., (d) FS. Law Implemented 316.1933(2)(b), 316.1934(3),
322.63(3)(b), 327.352(1)(e), 327.353(2),
327.354(3) FS. History–New 10-31-93,
Amended 7-29-01.
Florida Administrative Code Rule 11D-8.013 provides: 11D-8.013 Blood Alcohol Permit - Analyst.
The application for a permit to determine the alcohol level of a blood sample shall be made on a form provided by the Department and shall include the following information:
Name and address of applicant;
A copy of state license if licensed, or college transcript;
Name and address of employer and laboratory facility where applicant performs analyses;
Identify at least one Agency for which blood analyses are to be performed pursuant to Chapters 316, 322, and 327, F.S.; and,
A complete description of proposed analytical procedure(s) to be used in determining blood alcohol level.
Qualifications for blood analyst permit
- To qualify, the applicant must meet all of the following requirements:
Department approval of analytical procedure(s). All proposed analytical procedures will be reviewed and a determination of approval will be made by the Department;
Satisfactory determination of blood alcohol level in five proficiency samples provided by the Department using the proposed analytical procedure. Satisfactory determination shall be made by reporting results for blood alcohol proficiency samples within the acceptable range for the samples. For blood alcohol testing, acceptable ranges shall mean the calculated proficiency sample mean + or - 3 standard
deviations iterated twice. The mean and standard deviations will be calculated using the results reported by the analysts and reference laboratories;
Identify at least one Agency for which blood analyses are to be performed pursuant to Chapters 316, 322, and 327, F.S.; and,
Meet one of the following:
Possess a clinical laboratory license in clinical chemistry as a technologist, supervisor or director, under Chapter 483, F.S.; or
Be a licensed physician pursuant to Chapter 458, F.S.; or
Complete a minimum of 60 semester credit hours or equivalent of college, at least 15 semester hours of which must be in college chemistry.
The department shall approve gas chromatographic analytical procedures and enzymatic analytical procedures based on alcohol dehydrogenase which meet the following requirements:
Includes the approved method used and a description of the method, and the equipment, reagents, standards, and controls used;
Uses commercially-prepared standards and controls certified by the manufacturer, or laboratory-prepared standards and controls verified using gas chromatography against certified standards. For commercially-prepared standards and controls, the manufacturer, lot number and expiration date must be documented for each sample or group of samples being analyzed. For laboratory-prepared standards and controls, date, person preparing the solution, method of
preparation and verification must be documented;
A statement of the concentration range over which the procedure is calibrated. The calibration curve must be linear over the stated range;
Uses a new or existing calibration curve. The new calibration curve must be generated using at least three (3) standards: one at 0.05 g/100mL or less, one between 0.05 and 0.20 g/100mL (inclusive) and one at 0.20 g/100mL or higher, and must be verified using a minimum of two (2) controls, one at 0.05 g/100mL or less and one at 0.20g/100mL or higher. The existing calibration curve must be verified using a minimum of two (2) controls, one at 0.05 g/100mL or less and one at 0.20g/100mL or higher;
Includes the analysis of an alcohol- free control, and the analysis of a whole blood or serum control. The whole blood or serum control may be used to satisfy the control requirement(s) in paragraph (d);
A gas chromatographic analytical procedure must discriminate between methanol, ethanol, acetone and isopropanol and employ an internal standard technique;
An enzymatic analytical procedure based on alcohol dehydrogenase must use the procedure recommended by the instrument manufacturer/test kit vendor for whole blood alcohol analysis, and the enzyme used must have sufficient selectivity to provide negligible cross-reactivity towards methanol, acetone and isopropanol.
The permit shall be issued by the Department for a specific method and procedure. Any substantial change to the method, analytical procedure, or laboratory
facility must receive prior approval by the Department before being used to determine the blood alcohol level of a sample submitted by an agency. The Department shall determine what constitutes a substantial change.
An analyst shall only use a Department- approved procedure to determine the blood alcohol level of samples submitted by an agency. Approval of blood alcohol analysis methods and procedures shall be based on rule requirements in effect at the time they were submitted for approval.
Specific Authority 316.1932(1)(a)2., (f)1., 316.1933(2)(b), 316.1934(3) 322.63(3)(b),
327.352(1)(b)3. FS. Law Implemented 316.1932(1)(b), 316.1933(2)(b), 316.1934(3),
322.63(3)(b), 327.352(1)(b), (e),
327.353(2), 327.354(3) FS. History–New 10-
31-93, Amended 4-1-94, 2-1-95, 1-1-97, 11-5-
02, 12-9-04.
Florida Administrative Code Rule 11D-8.014 provides: 11D-8.014 Blood Alcohol Permit - Analyst: Renewal.
Permits to conduct blood alcohol analyses shall remain valid until otherwise suspended or revoked by the Department. In order to remain qualified for such permit, an analyst must satisfactorily determine the blood alcohol level of at least two (2) proficiency samples provided by the Department each annual quarter. Satisfactory determination shall be made by reporting results for blood alcohol proficiency samples within the acceptable range for the samples. For blood alcohol testing acceptable ranges shall mean the calculated proficiency sample mean + or - 3 standard deviations iterated twice. The mean and standard deviations will be calculated using the results reported by the analysts and reference laboratories.
An analyst, who is in good standing, may elect to not participate in one proficiency test cycle each calendar year.
The analyst must notify the Department in writing, of his/her election prior to the date the proficiency test results must be reported to the Department.
Upon notification by the Department that an analyst has failed to satisfactorily determine the blood alcohol level on any set of proficiency samples, the analyst shall be required to satisfactorily determine the blood alcohol level of a second set of five proficiency samples provided by the Department.
Upon notification by the Department that an analyst has failed to satisfactorily determine the blood alcohol level on a second set of proficiency samples, the analyst shall not perform any duties authorized by the analyst’s permit until the analyst satisfactorily determines the blood alcohol level of a subsequent set of proficiency samples provided by the Department. This section shall not preclude the Department from taking further action in accordance with Rule 11D-8.015, F.A.C.
Failure to satisfactorily determine the blood alcohol level of any six (6) sets of proficiency samples provided by the Department within a twelve (12) month period shall result in revocation of the blood analyst permit.
Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3. FS. Law Implemented 316.1932(1)(b), 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.352(1)(e),
327.353(2), 327.354(3) FS. History–New 10-
31-93, Amended 1-1-97, 11-5-02.
Subsections 316.1932(1)(a)2. and (f)1., Florida Statutes, cited as specific authority for all four rules, provide:
(2) The Alcohol Testing Program within the Department of Law Enforcement is responsible for the regulation of the operation, inspection, and registration of breath test instruments utilized under the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327. The program is responsible for the regulation of the individuals who operate, inspect, and instruct on the breath test instruments utilized in the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327. The program is further responsible for the regulation of blood analysts who conduct blood testing to be utilized under the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327. The program shall:
Establish uniform criteria for the issuance of permits to breath test operators, agency inspectors, instructors, blood analysts, and instruments.
Have the authority to permit breath test operators, agency inspectors, instructors, blood analysts, and instruments.
Have the authority to discipline and suspend, revoke, or renew the permits of breath test operators, agency inspectors, instructors, blood analysts, and instruments.
Establish uniform requirements for instruction and curricula for the operation and inspection of approved instruments.
Have the authority to specify one approved curriculum for the operation and inspection of approved instruments.
Establish a procedure for the approval of breath test operator and agency inspector classes.
Have the authority to approve or disapprove breath test instruments and accompanying paraphernalia for use pursuant to the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327.
With the approval of the executive director of the Department of Law Enforcement, make and enter into contracts and agreements with other agencies, organizations, associations, corporations, individuals, or federal agencies as are necessary, expedient, or incidental to the performance of duties.
Issue final orders which include findings of fact and conclusions of law and which constitute final agency action for the purpose of chapter 120.
Enforce compliance with the provisions of this section through civil or administrative proceedings.
Make recommendations concerning any matter within the purview of this section, this chapter, chapter 322, or chapter 327.
Promulgate rules for the administration and implementation of this section, including definitions of terms.
Consult and cooperate with other entities for the purpose of implementing the mandates of this section.
Have the authority to approve the type of blood test utilized under the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327.
Have the authority to specify techniques and methods for breath alcohol testing and blood testing utilized under the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327.
Have the authority to approve repair facilities for the approved breath test instruments, including the authority to set criteria for approval.
Nothing in this section shall be construed to supersede provisions in this chapter and chapters 322 and 327. The specifications in this section are derived from the power and authority previously and currently possessed by the Department of Law Enforcement and are enumerated to conform with the mandates of chapter 99-379, Laws of Florida.[2]
* * *
(f)1. The tests determining the weight of alcohol in the defendant's blood or breath shall be administered at the request of a law enforcement officer substantially in accordance with 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. However, the failure of a law enforcement officer to request the withdrawal of blood does not affect the admissibility of a test of blood withdrawn for medical purposes.
Subsection 316.1933(2)(b), Florida Statutes, cited as specific authority for Rule 11D-8.0133, provides:
(b) A chemical analysis of the person's blood to determine the alcoholic content thereof 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. 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 at the discretion of the department. Any insubstantial differences between approved methods or techniques and actual testing procedures, or any insubstantial defects concerning the permit issued by the department, in any individual case, shall not render the test or test results invalid.
Subsection 316.1934(3), Florida Statutes, is cited as specific authority for Rule 11D-8.013.4 Section 316.1934, Florida Statutes, provides, in relevant part:
316.1934 Presumption of impairment; testing methods.—
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 or controlled substances, when affected to the extent that the person's normal faculties are impaired or to the extent that the person is deprived of full possession of normal faculties, to drive or be in actual physical control of any motor vehicle within this state. Such normal faculties include, but are not limited to, the ability to see, hear, walk, talk, judge distances, drive an automobile, make judgments, act in emergencies, and, in general, normally perform the many mental and physical acts of daily life.
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 or controlled substances, when affected to the extent that the person's normal faculties were impaired or to the extent that he or she was deprived of full possession of his or her normal faculties, 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 blood or breath at the time alleged, as shown by chemical analysis of the person's blood, or by chemical or physical test of the person's breath, gives rise to the following presumptions:
If there was at that time a blood- alcohol level or 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.
If there was at that time a blood- alcohol level or breath-alcohol level in excess 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 to the extent that his or her normal faculties were impaired 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.
If there was at that time a blood- alcohol level or 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 blood-alcohol level or breath-alcohol level of 0.08 or higher is guilty of driving, or being in actual physical control of, a motor vehicle, with an unlawful blood-alcohol level or 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.
A chemical analysis of a person's blood to determine alcoholic content or a chemical or 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. . . .
For purposes of this proceeding, the remaining provisions cited as specific authority for or as laws implemented by the challenged rules are redundant to the provisions set forth above.5
11. Sections 316.1932, 316.1933, and 316.1934, Florida Statutes, are collectively referred to as the implied consent law. See Robertson v. State, 604 So. 2d 783, 789 n.4 (Fla.
1992). In Robertson, the Court, citing its earlier analysis in State v. Bender, 382 So. 2d 697 (Fla. 1980), discussed the implied consent law and its relation to earlier common law evidentiary principles as to the admissibility of expert testimony in a DUI prosecution.
The implied consent law "includes an exclusionary rule prohibiting the use of blood-test results taken contrary to its core policies." Robertson, 604 So. 2d at 789. However, "this exclusionary rule does not prohibit the use of all evidence obtained contrary to the implied consent law, but only such evidence obtained in a manner that is contrary to the core policies of the statute: ensuring scientific reliability of the tests, and protecting the health of test subjects."
Id. at 789 n.5.
Prior to the adoption of the implied consent law, scientific tests for intoxication were admissible if a proper predicate established that (1) the test was reliable, (2) the test was performed by a qualified operator with the proper equipment, and (3) expert testimony was presented to explain the meaning of the test. Robertson, 604 So. 2d at 789. The Court explained the implications of this common law rule:
This predicate had to be established in each and every case. If the state failed to do so, the evidence was not admissible.
Moreover, when the state attempted to establish the necessary predicate, the defense enjoyed an opportunity to rebut all of this evidence. If the defense introduced sufficient evidence to rebut any one of the elements of the predicate, then once again the expert evidence was not admissible.
Perhaps most significantly of all, the former procedure required the trial court to be the arbiter of what often was a dispute over arcane scientific principles.
Id. (citation omitted).
The implied consent law altered this practice by creating a presumption that the evidence is admissible, provided the state shows that the person conducting the test was properly licensed and has substantially complied with the governing regulations. "In other words, the state's burden of establishing a predicate is simplified in the sense that the state no longer has to guess what factors a particular trial judge will require the state to prove before admitting the test results; nor is the trial court required to wade into a morass of arcane scientific challenges and counterchallenges. If the state follows the HRS[6] 'checklist,' then the trial court's determination that the predicate has been established is clothed in a presumption of correctness." Robertson, 604 So. 2d at 789.
In the instant case, Petitioner contends that the challenged rules do not provide a "checklist" in the area of
blood alcohol testing sufficient to entitle the state to the presumption of correctness under the implied consent law.
According to Petitioner, Robertson dictates that blood alcohol tests conducted under the challenged rules are not entitled to any presumption of correctness, and must be subjected to the three-step common law test for admissibility.
Petitioner complains that the rules do not provide a checklist at all. Florida Administrative Code Rule 11D-8.011 simply approves alcohol dehydrogenase and gas chromatography as test methods for determining blood alcohol level, without setting forth a procedural checklist by which a judge could verify that the testing has been conducted in a scientifically reliable manner.
In fact, the challenged rules do not prescribe a specific step-by-step procedure for the conduct of blood alcohol testing. Rather, blood alcohol permit applicants are required to propose analytical procedures that comport with the requirements set forth in Florida Administrative Code Rule
11D-8.013(3). If the application is approved by FDLE, then a permit is issued that allows the analyst to conduct testing only for the specific method and procedure described in the application, and only in the specific laboratory facility named in the application. Any substantial changes in the test method,
analytical procedure, or in the laboratory facility itself must be approved by FDLE. Fla. Admin. Code R. 11D-8.013(4).
Petitioner takes the position that in order to be consistent with the statutes as interpreted by Robertson, FDLE's rules must impose a uniform, step-by-step procedure for the administration of alcohol dehydrogenase and gas chromatography blood alcohol testing. FDLE takes the position that imposing such a procedure on every laboratory in the state would be absurdly expensive, scientifically unnecessary, and is not required by the governing statutes.
Gas chromatography is the only test method currently used in Florida laboratories. "Headspace analysis" is the general procedure employed.7 Laura Barfield, the manager of the Alcohol Testing Program, explained that gas chromatography is a separation technique used to analyze blood samples for their alcohol (specifically, ethanol) content. Gas chromatography separates a compound into its individual components, using gas as the mode for separation.
Petitioner's toxicology expert was Lawrence W. Masten, a former professor of toxicology at the University of Mississippi and currently a toxicology consultant. Dr. Masten explained the method in layman's terms. A small sample of blood is diluted with an internal standard, which is a chemical (usually a molecule similar to ethyl alcohol) of a known
concentration. The diluted sample is placed into a vial, sealed, then heated to a constant temperature. The air sample in the head space above the heated liquid is analyzed in the gas chromatograph to derive findings as to the level of alcohol in the blood sample.
Dr. Masten explained that the internal standard is included so that a ratio may be established between the molecules of alcohol in the blood sample and those in the standard. The inclusion of an internal standard also makes it less important to precisely measure the volume of the blood sample.
Bruce Goldberger is a forensic toxicologist and is the director of toxicology at the University of Florida College of Medicine. In 1999-2000, Dr. Goldberger chaired a committee of scientific and legal experts who made recommendations to FDLE resulting in the current form of the challenged rules.
Dr. Goldberger testified that the committee discussed the procedures needed to produce a reliable and accurate result from a gas chromatograph. He believed that the most important aspect of the rules is the requirement that the procedure be able to differentiate between ethanol and other volatiles in the specimen. Dr. Goldberger also cited the specific criteria for the calibration and control of the method as important factors
in ensuring the reliability of tests performed pursuant to FDLE permits.
Dr. Goldberger explained that, because there is the possibility of other alcohols in the blood specimen, the testing method must be able to differentiate between ethanol, which humans consume in alcoholic beverages, and acetone, isopropanol, methanol, and any other possible interferent.
Dr. Goldberger agreed with Dr. Mastin on the importance of requiring the use of an internal standard.
Dr. Goldberger testified that the use of an internal standard is always necessary in modern day quantitative analysis. While acknowledging the difficulties that these concepts pose to laymen, Dr. Goldberger stated that anyone trained in the area of quantitative analysis would understand the role of an internal standard. He explained that Florida Administrative Code Rule 11D-8.013(3)(f) does not prescribe one specific internal standard because there are two such standards that are commonly used throughout the world, and that either one, n-propanol or butanol, is accepted by scientists in the field of forensic toxicology.
Dr. Goldberger testified that different laboratories may use different standards without affecting the accuracy and reliability of their tests, provided their testing methods are validated and provided the lab where the chemist is performing
the test employs the calibrators and controls that are noted in Florida Administrative Code Rule 11D-8.013.
Dr. Goldberger believes that it would be poor science to write rules that "get down to the nitty-gritty of a method." The rules should not prescribe the precise chemical composition of the internal standard, the temperature used to heat samples, or the column8 used. Different laboratories have different equipment, and the rules should provide some leeway to allow the analysts to perform their work in their own setting.
As an example, Dr. Goldberger cited Florida Administrative Code Rule 11D-8.013(3)(c), which addresses the concentration range over which the procedure is calibrated. The calibration curve must be linear over the stated range.
Dr. Goldberger noted that the range varies between laboratories, and even from day to day within a single lab. In Dr. Goldberger's lab, the range may be linear from 0.01 to 0.5 one day, and from
0.01 to 0.4 the next day. This variability is why the lab runs calibrators to verify the range, and includes the current range on the worksheet along with the testing data. Dr. Goldberger concluded that the variations make it impossible for FDLE to require a specific number for the range.
As another example, Dr. Goldberger cited Florida Administrative Code Rule 11D-8.013(3)(d), which discusses the constitution and use of a calibration curve. Calibration curves
also vary from lab to lab, and the rule allows for that variation. Dr. Goldberger stated that it would be possible to specify an exact concentration, but it would not be good practice and could not be done without retooling the labs.
Dr. Goldberger conceded that it would be possible to develop a detailed checklist in a rule, but asserted that to do so would not be good science. If the rules dictated every aspect of the equipment and procedures to be used in the lab, then nearly every lab in the state would have to retool and purchase new gas chromatographs. The expense would be prohibitive and unnecessary in scientific terms.
Dr. Goldberger asserted that there is no need for a detailed checklist in the rules because the labs performing blood alcohol testing in Florida all use validated methods and are adequately calibrated and controlled. The data verifying the labs' methods, calibrations and controls is available for expert review. Florida Administrative Code Rule 11D-8.014 establishes a proficiency testing program, requiring every analyst to undergo quarterly testing to make sure their work is satisfactory.
Dr. Goldberger testified that he has worked in several labs during his 25-year career. The methods employed in each lab were essentially the same. The instruments vary from lab to lab, but the technique is the same. Some technological
improvements have been made in newer gas chromatographs, but have not altered the essential techniques of gas chromatography, which have not changed in 30 to 40 years.
Dr. Goldberger stated that, while a layman might not be able to look at the rules and know all the steps necessary to perform a valid blood alcohol analysis, an analyst would. Further, persons reviewing the analyst's work in the lab would know the steps because each analyst is required to file with FDLE a "standard operating procedures" ("SOP") document that is several pages long and minutely details the procedures used by the analyst. Dr. Goldberger testified that "SOP" is a term of art in the industry. He acknowledged that the challenged rules do not employ that term, but testified that the language in Florida Administrative Code Rule 11D-8.013(2)(a) requiring FDLE approval of "analytical procedure(s)" is understood to mean that applicants must file their SOPs. The SOP is the "analytical procedure" to be approved by FDLE.
The SOP contains all the analytical parameters necessary to perform gas chromatography, including the temperature, column, and column length. The SOP sets forth the steps employed by the analyst. Dr. Goldberger gave examples of the initial steps in a typical SOP: step one would call for removing the batch of specimens from the refrigerator, step two would be a review of the specimen identification information on
the tubes, and step three would call for preparation of the dilution standard for that day's work. As the analysis goes forward, the analyst prepares a worksheet documenting each step in the process. The worksheet is used as part of the validation process for that batch and also for the calibration and control of that batch. An expert reviewing the analyst's work can combine the SOP, the worksheet and the raw data of the analysis to reconstruct exactly what occurred in the lab. Thus,
Dr. Goldberger concluded that a "checklist" of sorts is provided under the challenged rules by way of each analyst's analytical procedure, which FDLE initially approves and periodically reviews.
Dr. Goldberger concluded that the current standard of practice in forensic toxicology labs is to use head space gas chromatography for the analysis of blood alcohols. The standard of practice allows for differences in methodology from one lab to another, assuming the methodology is performed correctly. These variations do not prevent a qualified analyst from knowing what is required to conduct a gas chromatograph blood alcohol analysis.
Ms. Barfield, the manager of the Alcohol Testing Program, testified as to the program's duties. The program grants permits only to the analysts, not to laboratories. Approximately 66 analysts are currently permitted in Florida,
and 11 Florida labs are used for this work. Some analysts hold two permits, because they use two different analytical procedures and a separate permit is required for each procedure.
A potential applicant may obtain an application from the program's office or download it from the program's web page. The application requires the applicant to identify her employer, the lab facility to be used, and at least one agency for which the analyst will perform blood alcohol analysis. The applicant must identify the method to be used and must include a copy of her SOP. Once filed, the SOPs are maintained by the Alcohol Testing Program as a public record. The program releases permitting and proficiency test information upon request.
Ms. Barfield stated that the "method" referenced by the rules is the type of test, i.e., gas chromatography or alcohol dehydrogenase. The "procedure" contemplated by the rule is the SOP, the actual set of steps that the blood sample will go through when that analyst performs a blood alcohol analysis. Ms. Barfield testified that this "procedure" equates to the statutory term "method of administration" found at Subsection 316.1932(1)(f)1., Florida Statutes. The "method of administration" is spelled out at Florida Administrative Code Rule 11D-8.013(3)(a)-(g).
Ms. Barfield personally reviews the applications for blood alcohol analyst permits. When reviewing an application
and its accompanying analytical procedures, Ms. Barfield uses Florida Administrative Code Rule 11D-8.013 as a checklist to ensure that all requirements have been met. She checks off each requirement of the rule that the application meets. If the proposed procedure discriminates between methanol, ethanol, acetone and isopropanol, she gives it a check. If it uses an internal standard, it gets a check. If it employs appropriate levels of standards and controls, it gets a check. The steps described in the analytical procedure become requirements of that analyst's permit and must be performed each time the analyst conducts a blood alcohol analysis.
Ms. Barfield also gives proficiency tests pursuant to Florida Administrative Code Rule 11D-8.013(2)(b). In a proficiency test, the applicant must use the proposed procedure to correctly determine the blood alcohol level in five proficiency samples provided by the Alcohol Testing Program.
Ms. Barfield testified that the rules do not prescribe the specific steps to be used in the analytical procedure because there are many different laboratories and many different ways to achieve an accurate and reliable blood alcohol result. As an example, she described her own procedure in comparison to that of the lab at the University of Miami:
I'm in the FDLE laboratory and I'm using a PerkinElmer gas chromatograph . . . and I'm going to prep my samples, meaning taking the
blood vial that I receive, and I'm going to aliquot for a sample 50 microliters of that blood and put it in the correct container to be able, to be analyzing it. The head space gas chromatography has a special little container. You do not stick the blood vial on the autosampler. Anyway, you're aliquoting 50 microliters, and I'm going to do that twice because my procedure says I have to do it twice and the rule says I have to do it twice, and . . . I'm going to dilute it with n-propanol internal standard and I'm going to dilute it with a thousand milliliters of internal standard, and my
n-propanol internal standard is at a .02 concentration. I put it on the gas chromatograph, and it's a head space autosampler, and I'm going to heat that bottle up to 60 degrees [Celsius] in order for equilibriation to occur between the alcohol in the blood and the alcohol in the head space above it, and I'm going to inject my needle into that. I'm going to leave the needle in there .02 seconds. I'm going to withdraw for .05 seconds. I'm going to put it on a transfer line that's 90 degrees C, and I'm going to run it through a gas chromatograph whose column on the inside is heated up to 55 C, and I'm going to detect it with a flame ionization detector. That's all great. That's the steps. That's the FDLE laboratory. We get a good result, a valid, reliable result. . . .
The University of Miami, they use a Hewlett- Packard gas chromatograph. It has an autosampler on it, too, and to prep their samples, they don't have an automatic sampler to get the blood out where they can automatically sample 50 microliters and dilute it with 1,000 milliliters of internal standard. They're going to use pipettes.
They're going to manually do it. Their sample size is 500 milliliters of blood. They automatically pipette their 500 milliliters of blood, put it in the special container for the autosampler. They're only
diluting with 500 milliliters of internal standard, and their internal standard concentration is a .04. They seal off their bottle. They put it on the autosampler.
They decide to equilibrate for 22 minutes at
50 C. The other lab was at 60. Their
transfer line is-— they're going to inject for .05 seconds and withdraw for .05 seconds, and they're going to use their transfer line heated to 85 Celsius, and their gas chromatograph was heated to 50 Celsius, and they use a flame ionization detector, because most everybody does.
Those are all little different parameters, right, but I just described two procedures, and the end result is they get the same answer. All the little minute things are laboratory-specific for the equipment that they have, everything from how they pipette the sample out of [the] blood tube to how they analyze it and the temperatures and the pressures and the operating parameters, transfer line temperatures, things like that, those are all individualized to a laboratory, and just because they're different doesn't make it wrong.
To further go along with the description of their method and the overall requirements of the procedure that we're looking at,
I proficiency test the analysts from the University of Miami. They're using different temperatures. They're doing things a little bit differently. Granted, everything's about-— generally, it's the same, but the temperatures are different and things like that. I proficiency test them before I even give them a permit, and both of their procedures provide accurate and reliable results, and that's why it's not detailed down to the minutia in that particular section [of the rule], because there are differences that can occur in the grand scheme that don't affect the overall end result.
Ms. Barfield agreed that it would be possible to write a rule to encompass every detail for each of the labs, but stated that it is not scientifically necessary to enact such a rule. She further stated that such a rule would not be feasible because it would require every lab to have the same equipment and procedures, from pipetting the blood sample to the gas chromatograph to the autosampler to the same gases, operating at the same temperatures. Ms. Barfield testified that it would not be feasible to impose the same criteria for every procedural step in every lab without incurring an enormous outlay of money. She noted that a gas chromatograph alone costs around $50,000.
Ms. Barfield acknowledged that Florida Administrative Code Rule 11D-8.003(2) specifically approves two, and only two, instruments for the conduct of breath tests: the Intoxilyzer 8000 and the Intoxilyzer 5000. FDLE rules also call for the Alcohol Testing Program to register and conduct validation inspections of particular breath testing machines. Fla. Admin. Code R. 11D-8.004.
When questioned as to why FDLE did not regulate gas chromatographs in the same manner, Ms. Barfield replied that any comparison between breath and blood testing is "apples to oranges." There is no need for the rules to identify "approved" gas chromatographs because all of the commercially available machines do the job for which they are designed. Breath testing
is complicated by the fact that law enforcement personnel are operating scientific equipment; having a multitude of different testing instruments could jeopardize accuracy. It is preferable to train all breath test operators on the same equipment. In contrast, the gas chromatographs used in blood testing are being operated by professional analysts who have their own standards of practice. Thus, there is no need to standardize the equipment used in blood testing.
Ms. Barfield failed to note that Subsection 316.1932(1)(a)2., Florida Statutes, states: "The Alcohol Testing Program within the Department of Law Enforcement is responsible for the regulation of the operation, inspection, and registration of breath test instruments." (Emphasis added.) The statute charges the program with responsibility for the regulation of persons who operate, inspect and instruct on the breath test instruments, and for analysts who conduct blood testing, but nowhere does it specifically authorize the Alcohol Testing Program to regulate blood testing instruments. The apparent lack of statutory authority to regulate the gas chromatographs used by blood testing labs convincingly supplements Ms. Barfield's more practical reasons for the lack of a rule on this subject.
Dr. Masten testified for Petitioner that it is possible to create a checklist for performing a gas
chromatographic analysis of blood alcohol content. He also stated that a checklist such as those used by quality assurance auditors might be a desirable way to standardize operations and lessen the potential for error.
However, Dr. Masten also conceded that alternate methods can achieve reliable, accurate results, and that proficiency testing can assure such results. Two analysts in different labs may use variations on the gas chromatography method, such as different temperatures and pressures during the testing. Dr. Masten knew of differences in instrumentation between FDLE's labs in Tallahassee and Orlando. However, if each analyst passes proficiency testing, then each analyst's processes are validated.
Dr. Masten testified that there are a number of different manufacturers of gas chromatograph instruments, which vary in terms of their capacity but otherwise achieve reliable results in blood testing. Different gas chromatographs use different materials in their columns. There are also several internal standards that are acceptable.
Dr. Masten defined a methodology as a set of specific conditions, some of which are columns, temperature, pressure of the gas flow or rate of the gas flow, and the type of machine. These are all different parameters that are normally addressed in the SOP. Reasonable scientists can disagree as to certain
parameters, such as the amount of dilution. Dr. Masten stated that the prime criterion for any set of conditions is to prove they work. Because gas chromatography has so many variables, there is a large matrix of different conditions that potentially achieve correct results. These conditions vary from lab to lab, and to a lesser degree from analyst to analyst within a lab. If an analyst's method is validated, it can be used to reach an accurate and reliable test result.
The greater weight of the expert testimony at the instant hearing established that a perfectly uniform manner of performing either gas chromatography or the alcohol dehydrogenase analysis would not be scientifically sound nor economically feasible. Dr. Goldberger reasonably opined that a defendant is provided with the equivalent of the "checklist" desired by Petitioner: the SOP, the analyst's worksheet, and the raw data of the analysis provide a reviewing expert with all the necessary information to contest the analyst's work. The fact that all SOPs are not perfectly uniform in accordance with the idealized rules envisioned by Petitioner is less important than the fact that all SOPs and analysts' test results are available as public records and may be reviewed for their accuracy and reliability.
The evidence at hearing established that blood alcohol testing is dissimilar to breath testing. Specific instruments
must be approved for breath testing because law enforcement personnel operate the instruments. Uniformity of equipment helps to simplify the permitting process and helps to ensure accuracy in testing. Also, Ms. Barfield at least suggested that there may be breath instruments on the market that are themselves unreliable. In contrast, the expert testimony at hearing established that all commercially available gas chromatographs perform their intended functions, and that blood alcohol analysts are trained professionals able to operate according to their labs' SOPs, without detailed, step-by-step instruction imposed by FDLE rules.
The evidence established that Florida Administrative Code Rules 11D-8.011 and 8.013 substantially comply with their statutory authorities. Test methods are established by Rule 11D-8.011. Methods of administration are found in the uniform permitting criteria set forth in Rule 11D-8.013(3)(a)-(g).
Dr. Goldberger testified at length regarding the development of the rules, and Ms. Barfield described the application of the rules during the permitting process and in the laboratory. Both of these experts agreed that it would be poor science to require every analyst in the state to perform testing according to the standards of a single laboratory. The science of gas chromatography in blood alcohol testing simply does not require such rigidity.9 The challenged rules reasonably set forth
permitting criteria and proficiency testing that insure the scientific reliability of the blood alcohol testing carried out by analysts operating under permits issued by the Alcohol Testing Program of FDLE.
No evidence was offered by either party regarding the necessity to specify the types or amounts of preservatives and anticoagulants that must be contained in the glass evacuation tubes used to collect blood samples. No evidence was offered by either party as to the necessity to specify a range of temperatures for the refrigeration of blood samples collected pursuant to the implied consent law.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and the subject matter of this proceeding according to Subsections 120.56(1) and (3), Florida Statutes.
Section 120.56, provides in pertinent part:
GENERAL PROCEDURES FOR CHALLENGING THE VALIDITY OF A RULE OR A PROPOSED RULE.--
Any person substantially affected by a rule or a proposed rule may seek an administrative determination of the invalidity of the rule on the ground that the rule is an invalid exercise of delegated legislative authority.
The petition seeking an administrative determination must state with particularity the provisions alleged to be
invalid with sufficient explanation of the facts or grounds for the alleged invalidity and facts sufficient to show that the person challenging a rule is substantially affected by it, or that the person challenging a proposed rule would be substantially affected by it.
* * *
CHALLENGING EXISTING RULES; SPECIAL PROVISIONS.--
A substantially affected person may seek an administrative determination of the invalidity of an existing rule at any time during the existence of the rule.
Petitioner William Lane, who has been charged with DUI manslaughter and was subjected to a blood alcohol test pursuant to Sections 316.1932, 316.1933, and 316.1934, Florida Statutes, is an affected persons with standing to challenge the validity of Rules 11D-8.011, 11D-8.012, 11D-8.013, and 11D-8.014. See Lanoue v. Florida Department of Law Enforcement, 751 So. 2d 94 (Fla. 1st DCA 1999).
As the moving party asserting the affirmative by attacking the validity of an existing agency rule, Petitioner in this case retains the burden of proof throughout the entire proceeding. Espinoza v. Department of Business and Professional
Regulation, 739 So. 2d. 1250, 1251 (Fla. 3d DCA 1999); Balino v. Department of Health and Rehabilitative Services, 348 So. 2d 349 (Fla. 1st DCA 1977); § 120.56(3), Fla. Stat.
The party attacking an existing rule has the burden to
prove that the rule constitutes an invalid exercise of delegated legislative authority. Cortes v. State Board of Regents, 655 So. 2d 132 (Fla. 1st DCA 1995). The standard of proof is a preponderance of the evidence. See Subsection 120.56(3).
An administrative law judge may invalidate an existing rule only if it is an invalid exercise of delegated legislative authority. See § 120.56(1)(a) and (3)(a), Fla. Stat.
Subsection 120.52(8) defines "invalid exercise of delegated legislative authority" to mean:
[A]ction 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:
The agency has materially failed to follow the applicable rulemaking procedures or requirements set forth in this chapter;
The agency has exceeded its grant of rulemaking authority, citation to which is required by s. 120.54(3)(a)1.;
The rule enlarges, modifies, or contravenes the specific provisions of law implemented, citation to which is required by s. 120.54(3)(a)1.;
The rule is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency;
The rule is arbitrary or capricious. A rule is arbitrary if it is not supported by logic or the necessary facts; a rule is
capricious if it is adopted without thought or reason or is irrational; or;
The rule imposes regulatory costs on the regulated person, county, or city which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives.
A grant of rulemaking authority is necessary but not sufficient to allow an agency to adopt a rule; a specific law to be implemented is also required. An agency may adopt only rules that implement or interpret the specific powers and duties granted by the enabling statute. No agency shall have authority to adopt a rule only because it is reasonably related to the purpose of the enabling legislation and is not arbitrary and capricious or is within the agency's class of powers and duties, nor shall an agency have the authority to implement statutory provisions setting forth general legislative intent or policy. Statutory language granting rulemaking authority or generally describing the powers and functions of an agency shall be construed to extend no further than implementing or interpreting the specific powers and duties conferred by the same statute.
Petitioner specifically alleges that Florida Administrative Code Rule 11D-8.011 sets forth merely two "generic classifications" of blood alcohol testing rather than the "precise methods" required by the following passage from Mehl v. State of Florida, 632 So. 2d 593, 595 (Fla. 1993):
Notwithstanding our conclusion that HRS has sufficiently met the statutory requirements, we believe that the public as well as those who may wish to obtain a testing permit should be apprised in advance of all approved methods of administering the test.
Therefore, beginning at 12:01 a.m. on April 1, 1994, the State shall not be allowed the benefit of the presumptions established in section 316.1934, Florida Statutes (1989), unless (a) the State has established reasonably definite rules specifying the precise methods of blood
alcohol testing that are approved for use in this State, and (b) the State and its agencies substantially comply with these rules. Of course, even when the presumption is not available, the State should still have the benefit of the Robertson analysis, upon a proper request.
Petitioner goes on to allege that FDLE has attempted to satisfy the Mehl Court's concerns through Florida Administrative Code Rule 11D-8.013. Petitioner argues that the public cannot read the challenged rules and come away knowing what one must do to perform an approved blood test. Thus, Petitioner contends, the rules are vague and do not comply with the Florida Supreme Court's ruling in Mehl.
Petitioner's argument conflates two issues that Mehl treated as separate and distinct. The Mehl Court's analysis dealt with two matters seriatim: first, the compliance of the HRS rules with statutory requirements; then, the state's prospective entitlement to the presumptions established in Section 316.1934, Florida Statutes. In the paragraphs immediately preceding the passage quoted above, the Court held that the rules were valid:
Rule 10D-42.028 authorizes two procedures for the testing of blood for alcohol
content: alcohol dehydrogenase and gas chromatography. This clearly meets the statutory requirement of specifying the approved test. However, Mehl contends that the regulations do not provide an approved method of administration. The State responds that under the rules a technician who wishes to qualify for a permit must submit to HRS the complete description of the procedure to be used and must satisfactorily analyze proficiency samples. The tests may only be performed by the permittee in a designated laboratory facility. Every three months, the permittee is given control samples to test to insure the accuracy of testing equipment and methodology. Each permit must be renewed annually, and unsatisfactory test results mandate termination of the permit.
Because HRS approves the methodology of the applicant and tests proficiency before issuing a permit, we conclude that HRS has met the statutory requirement of providing an approved method of administration.
Therefore, the results of Mehl's blood test are not subject to suppression.
Mehl, 632 So. 2d at 595.
Thus, the Court upheld the statutory validity of the rule, but established prospective criteria that HRS would be required to follow in order for the state to enjoy the presumptions established in Section 316.1934, Florida Statutes.10 The rule's statutory validity would not expire on April 1, 1994; the undersigned is aware of no adjudicatory principle by which the Court could hold a rule valid today but invalid tomorrow under the same statutory scheme. Rather, the Court decreed that, as of April 1, 1994, compliance with the still-valid rule
would no longer be sufficient for the state to enjoy the benefit of the presumptions established in Section 316.1934 in trial courts established pursuant to Article V of the Florida Constitution. The Mehl Court was announcing a prospective evidentiary ruling, not the future invalidation of the rules themselves.11
The Division of Administrative Hearings is a creature of the Legislature and an agency of the executive branch, thus not a proper forum in which to seek enforcement of the Florida Supreme Court's directive in Mehl. It is not the jurisdictional role of this tribunal to determine whether an agency's rule has complied with a Florida Supreme Court directive related to the manner in which the Article V courts of this state will receive evidence.
The issue in the instant proceeding is whether the challenged rules are an invalid exercise of delegated legislative authority. The question of the applicability of the statutory presumption is not directly before this tribunal, independent of the question of the rules' validity under Subsection 120.56(3), Florida Statutes. Mehl does not establish an independent basis for a conclusion of law that Rule 11D-8.011 or Rule 11D-8.013 is valid or invalid.
Petitioner argues that Robertson v. State, 604 So. 2d 783, 789 (Fla. 1992), mandated that the FDLE rules provide a
"checklist" for the blood alcohol analysis sufficient to permit a layman to understand each step in the process. Robertson was not a rule challenge12 but a case dealing with the admissibility of blood alcohol test results where the requirements of Section 316.1933 have not been met. The Court's language regarding a "checklist" was descriptive, a summation of its earlier statement that the presumption is invoked "once the state shows that the person conducting the test was licensed by HRS and substantially complied with the applicable regulations." Id.
The Court was not criticizing the agency's existing rules or demanding rulemaking to satisfy some newly identified "checklist" requirement. Robertson does not establish an independent basis for a conclusion of law that Rule 11D-8.011 or Rule 11D-8.013 is invalid.
Even if Robertson were directly prescriptive regarding the necessity of a "checklist" to ensure the rules' validity, Florida Administrative Code Rules 11D-8.011 and 8.013 combine to satisfy any reasonable interpretation of the Robertson criteria. Rule 11D-8.011 clearly sets forth the two approved test methods, and Rule 11D-8.013 sets forth the detailed information that an applicant must submit in order to receive a blood analyst's permit. Robertson does not demand a rule drawn with such precision that a defense attorney could base his entire cross examination of the state's blood analysis expert on the text of
the rule, or so precisely that a presiding judge could perfectly understand the scientific nuance behind each step of the gas chromatography process from a reading of the rule. Petitioner demands a literal checklist, whereas the Robertson Court envisioned a blood test conducted by a licensed analyst in accordance with reasonable regulations.
Petitioner's vagueness claim is brought pursuant to Subsection 120.52(8)(d), Florida Statutes, and is therefore properly before this tribunal. While not directly stated as such, Petitioner's arguments also tend to raise the issue that the rules are arbitrary and capricious pursuant to Subsection 120.52(8)(e), Florida Statutes.
The test for vagueness of a rule or statute is "whether men of common understanding and intelligence must guess at [the provision's] meaning" and differ as to its application. Department of Health and Rehabilitative Services v. Health Care and Retirement Corporation of America, 593 So. 2d 539, 541 (Fla. 1st DCA 1992), quoting State v. Cumming, 365 So. 2d 153, 156 (Fla. 1978) and State v. Rodriguez, 365 So. 2d 157, 159
(Fla. 1978). See also Witmer v. Department of Business and
Professional Regulation, 662 So. 2d 1299, 1302 (Fla. 4th
DCA 1995).
Subsection 120.52(8)(e), Florida Statutes, provides: "A rule is arbitrary if it is not supported by logic or the
necessary facts; a rule is capricious if it is adopted without thought or reason or is irrational." Similarly, case law provides that an "arbitrary" decision is one not supported by facts or logic, or despotic, and a "capricious" decision is one taken irrationally, or without thought or reason. Board of Clinical Laboratory Personnel v. Florida Association of Blood Banks, 721 So. 2d 317, 318 (Fla. 1st DCA 1998); Board of Trustees of the Internal Improvement Trust Fund v. Levy, 656 So. 2d 1359, 1362 (Fla. 1st DCA 1995). In undertaking this analysis, the undersigned is mindful that these definitions:
add color and flavor to our traditionally dry legal vocabulary, but do not assist an objective legal analysis. If an administrative decision is justifiable under any analysis that a reasonable person would use to reach a decision of similar importance, it would seem that the decision is neither arbitrary nor capricious.
Dravo Basic Materials Company, Inc. v. Department of Transportation, 602 So. 2d 632, 635 n.3 (Fla. 2d DCA 1992).
As noted in Findings of Fact 7 through 9 above, the following relevant Florida Statutes are cited by FDLE as specific authority for Rule 11D-8.013: Subsection 316.1932(1)(a)2 and (f)1; Subsections 316.1933(2)(b); and Subsection 316.1934(3).
Subsection 316.1932(1)(a)2., Florida Statutes, provides, inter alia, that the Alcohol Testing Program shall:
establish uniform criteria for the issuance of permits to blood analysts; have the authority to permit blood analysts; promulgate rules for the administration and implementation of the program, including definitions of terms; have the authority to approve the "type of blood test" utilized under Chapters 316, 322, and 327; and have the authority to "specify techniques and methods" for blood testing utilized under Chapters 316, 322, and 327.
Subsection 316.1932(1)(f)1., Florida Statutes, provides that the rules must "specify precisely the test or tests that are approved by [FDLE] 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."
Subsection 316.1933(2)(b), Florida Statutes, provides, inter alia, that the blood alcohol analysis "must have been performed substantially in accordance with methods approved by [FDLE]" and by an individual possessing a valid FDLE permit. FDLE "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 at the discretion of the department."
Subsection 316.1934(3), Florida Statutes, provides that the blood alcohol analysis "in order to be considered valid
under this section, must have been performed substantially in accordance with methods approved by [FDLE]" and by an individual possessing a valid FDLE permit. FDLE "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."
Petitioner argues that Rule 11D-8.013 does not provide the "approved method of administration" required by Section 316.1932(1)(f)1., Florida Statutes. Rather, Petitioner contends, the rule "outlines a set of criteria for an approved method of administration," and leaves it to the applicant for an analyst's permit to set forth the precise method, which may vary from analyst to analyst. This variation in methods gives the public no notice of the precise blood analysis method used in any given case.
Petitioner believes that FDLE should treat blood alcohol testing in the manner it treats breath testing. FDLE's rules specify the methods of breath testing and approve the specific instruments to be used in breath testing. See Fla. Admin. Code R. 11D-8.003. FDLE registers and inspects each breath test instrument prior to its being placed in service by an agency, and sets forth specific inspection procedures. See Fla. Admin. Code R. 11D-8.004. After being placed in use,
approved breath test instruments are inspected by an agency inspector once a month. See Fla. Admin. Code R. 11D-8.006. FDLE approves the sources of alcohol reference solutions and dry gas standards for breath test instruments, and further must approve each lot of reference solution prior to its distribution in the state. See Fla. Admin. Code R. 11D-8.0035 and 8.0036.
FDLE cannot treat the blood and breath testing programs identically because its statutory authority is more limited as to the blood testing program. Subsection 316.1932(1)(a)2., Florida Statutes, specifically grants the Alcohol Testing Program responsibility for the "regulation of the operation, inspection, and registration of breath test instruments." The Alcohol Testing Program is given no such authority to regulate blood alcohol testing instruments, but is limited to the regulation of the analysts who conduct blood testing.
An argument similar to Petitioner's was considered and dismissed by the court in Wissel v. State of Florida, 691 So. 2d
507 (Fla. 2d DCA 1997). In Wissel, appellant challenged his DUI conviction on the basis that FDLE's breath test rules failed to define "vapor mixture," failed to specify the procedures for mixing a simulator vapor solution, failed to specify the type of glassware used or how the glassware was to be cleaned, and failed to define the source from which the stock solution should
be obtained. 691 So. 2d at 508. The court addressed appellant's argument as follows:
The certified question posed to us essentially asks whether every step, aspect or procedure employed in the simulation tests used to inspect breath test instruments pursuant to Florida Administrative Code Rules 11D-8.005 and
11D-8.006 must be expressly prescribed by rule or regulation required by section 316.1932(1)(f)1 and adopted pursuant to chapter 120, The Florida Administrative Procedures Act. We hold that procedures that are implicit and incidental to procedures otherwise explicitly provided for in a properly adopted rule or regulation do not require further codification by a further adopted rule or regulation. In our opinion, to hold otherwise belies statutory intent and/or common sense.
* * *
ppellant's attack, based on the lack of a rule or regulation to cover every step of the testing procedures for breath test instruments, is not only speculative and theoretical, but also hyper-technical.
Wissel, 691 So. 2d at 507, 508.
In the instant case, Petitioner's argument amounted to no more than an assertion that Robertson requires a checklist, and that the term "checklist" means a step-by-step description of the blood alcohol testing procedure that would enable a layman, such as a judge or defense attorney, to ascertain at a glance whether the analyst complied with the applicable statutes and rules. As noted above, Robertson provided no such
definition of a "checklist." Subsection 316.1932(1)(a)2., Florida Statutes, clearly indicates that the blood alcohol testing program is to be regulated via the permitting process for analysts, not through the absolute standardization of equipment and procedures urged by Petitioner. The rules allow for some variation in method from one analyst to the next, but the rules also provide for an adequate paper trail by which each analyst's method may be reviewed. Though the rules do not meet Petitioner's vision of a perfect courtroom situation, Petitioner has not demonstrated that the statutes require them to meet that ideal.
Petitioner has failed to establish that Florida Administrative Code Rules 11D-8.011 and 8.013 are vague. "Men of common intelligence" may not fully understand the science behind gas chromatography, but neither must they guess at the rule's meaning or differ as to its application. The concept of "vagueness" in cases such as Cole Vision Corp. v. Department of Business and Professional Regulation, 668 So. 2d 404, 410 (Fla. 1st DCA 1997), references the idea that a man of common intelligence is unable to read the rule and understand what he is supposed to do to comply with it, or what he must avoid doing in order not to violate the rule. The evidence at hearing established that Rules 11D-8.011 and 8.013 sensibly set forth the permitting criteria in sufficient detail for applicants and
analysts to fully understand their requirements and restrictions. As the Wissel court stated, it is not necessary for the agency to include in its rule "every step, aspect or procedure" of the scientific process at issue. It is doubtful that a rule could ever include sufficient detail to make an untrained layman completely conversant on the subject of gas chromatography; it is certain that the implied consent law does not require FDLE to undertake such a seminar in its permitting rule.
Petitioner has failed to establish that Florida Administrative Code Rules 11D-8.011 and 8.013 are arbitrary or capricious. The evidence at hearing established that the rules are reasonable and are based on solid, long-established scientific principles.
As to Florida Administrative Code Rule 11D-8.012, Petitioner alleges that this rule regarding the collection and storage of blood samples fails to meet the requirements of State of Florida v. Miles, 775 So. 2d 950 (Fla. 2000), which considered an earlier version of the rule. In Miles, the state was found not entitled to the statutory presumptions of impairment under the implied consent law because "the absence of maintenance standards renders rule 11D-8.012(3) inadequate and inconsistent with the purpose of the implied consent law as it relates to ensuring the reliability of test results."
775 So. 2d at 955. Petitioner contends that the current rule fails to state how much anticoagulant and preservative must be in the vial, and fails to define the term "refrigeration" in terms of the range of temperatures required in storing samples, and therefore continues to violate the standard set forth in Miles.
FDLE points out that Miles predates the current rule, which was amended in 2001 to add language requiring anticoagulant, preservative, and refrigeration. FDLE states that industry standard is for the manufacturer to place the preservative and anticoagulant in the glass evacuation tubes in amounts sufficient for their intended use. Thus, there is no need for a rule to provide further detail than that set forth in Florida Administrative Code Rule 11D-8.012(2), which requires that blood samples be collected in a glass evacuation tube that contains a preservative and an anticoagulant, and provides that compliance with this requirement may be established by the stopper or label on the tube, by documentation from the manufacturer or distributor, or by "other evidence."
At the hearing, neither party presented evidence regarding the question of anticoagulants, preservatives, and refrigeration of blood samples. Petitioner's challenge was not to the facial inconsistency of the rule with its purported statutory authority or the statutes it purports to implement.
By its nature, Petitioner's challenge required some evidence regarding the need for the rule to specify amounts of preservatives and anticoagulants, or to specify temperature ranges for refrigeration. The undersigned simply has nothing on which to base a conclusion as to this rule. Petitioner's challenge regarding the entirety of Florida Administrative Code Rule 11D-8.012 thus fails for lack of proof.
Finally, Petitioner contends that FDLE lacks statutory authority for its pronouncement in Rule 11D-8.012(7):
(7) Notwithstanding any requirements in Chapter 11D-8, F.A.C., any blood analysis results obtained, if proved to be reliable, shall be acceptable as a valid blood alcohol level.
Petitioner interprets the quoted language to mean that such "reliable" results are therefore admissible as evidence at trial, and argues that FDLE has no statutory authority to make such a statement.
FDLE responds that the rule merely reflects the language of Subsection 316.1934(3), Florida Statutes:
A chemical analysis of a person's blood to determine alcoholic content or a chemical or 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. (Emphasis added.)
FDLE further argues that Rule 11D-8.012(7) reflects the settled law of this state that blood alcohol tests that do not comply with Florida Administrative Code Chapter 11D-8 are nonetheless admissible under the traditional predicate test discussed in Robertson. See Findings of Fact 12 through 14, supra. FDLE's argument is supported by the plain text of the rule, which implements Subsection 316.1934(3), Florida Statutes. Petitioner's argument might carry more weight if the rule were somehow binding on the courts, rather than a restatement of the courts' and the legislature's directives to FDLE. Florida Administrative Code Rule 11D-8.012(7) could fairly be termed superfluous, but Petitioner has failed to demonstrate that it is an invalid exercise of delegated legislative authority.
Though Petitioner cited Florida Administrative Code Rule 11D-8.014 in the Petition, he offered no argument or evidence regarding the validity of that rule.
ORDER
Based upon the foregoing Findings of Fact and Conclusions of Law, it is
ORDERED that the Petition is dismissed.
DONE AND ORDERED this 25th day of August, 2008 in Tallahassee, Leon County, Florida.
S
LAWRENCE P. STEVENSON
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 25th day of August, 2008.
ENDNOTES
1/ Petitioner has not challenged Florida Administrative Code Rule 11D-8.002, which sets forth the definitions for terms used in the challenged rules. The definitional rule provides:
11D-8.002 Definitions.
Acceptable Range – the results of alcohol reference solutions and dry gas standard analyses which fall within the following ranges at each alcohol vapor concentration: 0.05 g/210L range is 0.045 to 0.055 g/210L; 0.08 g/210L range is 0.075 to 0.085 g/210L; 0.20 g/210L range is 0.190 to
0.210 g/210L; or the Alcohol Reference Solution gas chromatographic results which fall within the following ranges:
0.0605 g/100mL range is 0.0586 to 0.0623
g/100mL; 0.0968 g/100 mL range is 0.0938 to 0.0997 g/100mL; 0.2420 g/100mL range is
0.2347 to 0.2492 g/100mL.
Accuracy – the nearness of a measurement to a known concentration.
Acetone Stock Solution – a mixture of acetone and distilled or deionized water provided by the Department.
Agency – a law enforcement agency other than the Department, or an entity which conducts breath tests or submits blood samples for alcohol testing pursuant to these rules, or a civilian entity performing such duties on behalf of a law enforcement agency.
Agency Inspection – the periodic testing of the calibration and operation of a breath test instrument, including all required preventive maintenance, in accordance with Rule 11D-8.006, F.A.C., and performed by a person authorized by the Department.
Agency Inspector – a person who has been issued an Agency Inspector permit by the Department.
Alcohol – ethyl alcohol, also known as ethanol.
Alcohol Free Test – a result of 0.000 g/210L when using distilled or deionized water.
Alcohol Reference Solution – a standard used to verify the calibration of a breath test instrument consisting of a mixture of alcohol and distilled or deionized water that will produce a known alcohol vapor concentration at a specific temperature.
Analyst – a person who has been issued a permit by the Department to conduct blood alcohol analyses.
Approved Blood Alcohol Test – the analyses of two separate portions of the same blood sample using a Department- approved blood alcohol test method and a Department-approved procedure, with results within 0.010 grams of alcohol per 100 milliliters of blood (g/100mL), and reported
as the blood alcohol level.
Approved Breath Alcohol Test – a minimum of two samples of breath collected within fifteen minutes of each other, analyzed using an approved breath test instrument, producing two results within
0.020 g/210L, and reported as the breath alcohol level. If the results of the first and second samples are more than
0.020 g/210L apart, a third sample shall be analyzed. Refusal or failure to provide the required number of valid breath samples constitutes a refusal to submit to the breath test. Notwithstanding the foregoing sentence, the result(s) obtained, if proved to be reliable, shall be acceptable as a valid breath alcohol level.
Authorized Repair Facility – the Department, the breath test instrument manufacturer, an entity authorized by the breath test instrument manufacturer to service and repair such breath test instrument.
Blood – whole blood.
Blood Alcohol Level – the alcohol concentration by weight in a person’s blood based upon grams of alcohol per 100 milliliters of blood (g/100mL).
Breath Alcohol Level – the alcohol concentration by weight in a person’s breath based upon grams of alcohol per 210 liters of breath (g/210L).
Breath Test Instructor – a person who has been issued a Breath Test Instructor Certification by the Criminal Justice Standards and Training Commission.
Breath Test Operator – a person who has been issued a Breath Test Operator permit by the Department.
Department – the Florida Department of Law Enforcement.
Dry Gas Standard – a standard consisting of a mixture of alcohol and gas which produces a known alcohol vapor
concentration used to verify the calibration
of a breath test instrument.
Evidentiary Breath Test Instrument – a breath test instrument approved by the Department under Rule 11D-8.003, F.A.C., and used primarily to conduct alcohol breath tests pursuant to Florida law.
Methods – types of alcohol analyses approved by the Department to conduct chemical or physical tests of blood or breath.
Mouth Alcohol Solution – a mixture of alcohol and distilled or deionized water provided by the Department.
Permit – when issued by the Department, certifies that the holder has met all necessary qualifications, remains in full compliance with these rules and is authorized to perform all related duties. A permit is issued only to a qualified applicant and remains valid and in full effect until determined otherwise by the Department.
Reference Sample Device – a device, also known as a simulator, that produces a known vapor concentration by the passage of air through a liquid.
Target Concentration – a gas chromatographic result equivalent to the following known alcohol vapor concentrations of alcohol reference solution: for
0.05 g/210L the target concentration is 0.0605 g/100mL; for 0.08 g/210L the target concentration is 0.0968 g/100mL; for
0.20 g/210L the target concentration is 0.2420 g/100mL.
2/ Section 2 of Chapters 99 through 379, Laws of Florida, amended the Administrative Procedure Act to clarify that agencies may not adopt rules pursuant to its "class of powers and duties" and that an agency's rulemaking authority extends no further than "implementing or interpreting the specific powers and duties" conferred by the statute. In 2000, the quoted subparagraph 2 was added to Subsection 316.1932(1)(a) to make explicit the rulemaking authority of the Alcohol Testing Program in light of the limitations expressed in Chapters 99 through
379. See § 1, Chs. 2000 through 2026, Laws of Florida.
3/ Subsection 316.1933(2)(b), Florida Statutes, is also cited as a law implemented by all four challenged rules.
4/ Subsection 316.1934(3), Florida Statutes, is also cited as a law implemented by all four challenged rules.
5/ Section 322.63, Florida Statutes, deals with alcohol and drug testing of commercial motor vehicle operators. Petitioner offered no evidence to show that he is a commercial motor vehicle operator and made no arguments based on this provision of the statutes. Subsection 322.63(3)(a), Florida Statutes, is cited as specific authority for Rules 11D-8.011, 8.012, and
8.014. Subsection 322.63(3)(b) is cited as specific authority for Rule 11D-8.013. Subsection 322.63(3) is virtually identical to Subsection 316.1932(1)(a)2., Florida Statutes.
Section 327.352, Florida Statutes, relates to alcohol and drug testing for the operators of vessels. Petitioner was not accused of operating a vessel under the influence. Subsection 327.352(1)(b)3 and Subsection 327.352(1)(d), Florida Statutes, are cited as specific authority for Rules 11D-8.011 and 8.012. Subsection 327.352(1)(b)3., Florida Statutes, is also cited as specific authority for Rules 11D-8.013 and 8.014. Again, these provisions are virtually identical to Subsection 316.1932(1)(a)2., Florida Statutes.
Section 327.354, Florida Statutes, deals with the presumption of impairment at a civil or criminal trial arising out of acts alleged to have been committed by a person while operating a vessel under the influence of alcoholic beverages or controlled substances. Subsection 327.354(3), Florida Statutes, cited as a law implemented by all four challenged rules, is virtually identical to Subsection 316.1934(3), Florida Statutes.
6/ Prior to 1992, the former Department of Health and Rehabilitative Services was responsible for breath and blood testing compliance under the implied consent law. Sections 20 through 22 of Chapters 92 through 58, Laws of Florida, transferred that responsibility to FDLE.
7/ Alcohol dehydrogenase ("AD") is an analytical laboratory method in which a reactive enzyme, AD, is used to detect and measure alcohol in a blood sample. Neither party presented testimony regarding this method.
8/ The column is the narrow tube in the gas chromatograph through which the sample is passed in a gas stream. It
separates and quantifies the mixtures of volatiles that pass through it.
9/ It should be recalled that Robertson identified "ensuring scientific reliability of the tests" as one of the two "core policies" of the implied consent law. 604 So. 2d at 789 n.5.
10/ After the statutory authority for breath and blood alcohol testing was transferred to FDLE (see endnote 6, supra), that agency adopted Florida Administrative Code Chapter 11D-8 in October 1993.
11/ The future usefulness of the rules would certainly be limited by the Florida Supreme Court's pronouncement, but the text of Mehl clearly distinguished between the rules' validity under the statutes and the changes to those rules the Court found necessary for the continued application of the statutory presumptions.
12/ In fact, in a footnote to the "checklist" statement, the Court suggested that a defendant seeking to rebut the statutory presumption "might challenge the HRS regulations themselves as being scientifically unsound...." Robertson, 604 So. 2d at 789 n.6.
COPIES FURNISHED:
Gerald M. Bailey, Commissioner Florida Department of Law Enforcement Post Office Box 1489
Tallahassee, Florida 32302
Michael Ramage, General Counsel Florida Department of Law Enforcement Post Office Box 1489
Tallahassee, Florida 32302
Robert R. Berry, Esquire Eisenmenger, Berry & Peters, P.A. 5450 Village Drive
Viera, Florida 32955
Sharon S. Traxler, Esquire Department of Law Enforcement - 7100 Post Office Box 1489
Tallahassee, Florida 32304
THE NOTICE OF RIGHT TO JUDICIAL REVIEW
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 the original Notice of Appeal with the agency Clerk of the Division of Administrative Hearings and a 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.
Issue Date | Document | Summary |
---|---|---|
Aug. 25, 2008 | DOAH Final Order | Petitioner failed to demonstrate that FDLE rules regarding blood alcohol testing under the implied consent law were an invalid exercise of delegated legislative authority. |
JOHN GOODMAN vs FLORIDA DEPARTMENT OF LAW ENFORCEMENT, 07-004495RX (2007)
DEPARTMENT OF HEALTH, BOARD OF NURSING vs BENJAMIN DALLAS STOE, R.N., 07-004495RX (2007)
DONALD MYERS vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 07-004495RX (2007)
ROBERT R. BERRY AND JILL HUMPHREY vs DEPARTMENT OF LAW ENFORCEMENT, 07-004495RX (2007)
DEPARTMENT OF HEALTH, BOARD OF NURSING vs B.J. WALPER PENANSKY, A.R.N.P., 07-004495RX (2007)