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State v. Chun

February 13, 2007

STATE OF NEW JERSEY, PLAINTIFF,
v.
JANE H. CHUN, DARIA L. DE CICCO, JAMES R. HAUSLER, ANGEL MIRALDA, JEFFREY R. WOOD, ANTHONY ANZANO, MEHMET DEMIRELLI, RAJ DESIA, JEFFREY LOCASTRO, PETER LIEBERWIRTH, JEFFREY LING, HUSSAIN NAWAZ, FREDERICK OGBUTOR, PETER PIASECKI, LARA SLATER, CHRISTOPHER SALKOWITZ, ELINA TIRADO, DAVID WALKER, DAVID WHITMAN AND JAIRO J. YATACO, DEFENDANTS.



The opinion of the court was delivered by: King, P.J.A.D., Special Master

FINDINGS AND CONCLUSIONS OF REMAND COURT

On remand from the Supreme Court of New Jersey: December 14, 2005

Findings and Conclusions Submitted to Supreme Court: February 13, 2007

TABLE OF CONTENTS

I. PROCEDURAL HISTORY . . . . . . . . . . . . . . . . . 4

II. STANDARD OF PROOF . . . . . . . . . . . . . . . . .14

III. THE FACTS

1. CHEMISTRY AND PHYSIOLOGY . . . . . . . . . . . 19

2. HISTORY . . . . . . . . . . . . . . . . . . . 23

3. THE INSTRUMENT . . . . . . . . . . . . . . . . 33

IV. EXPERT TESTIMONY

1. HANSUELI RYSER . . . . . . . . . . . . . . . 47

2. THOMAS A. BRETTELL, Ph.D. . . . . . . . . . 73

3. SGT. KEVIN M. FLANAGAN . . . . . . . . . . . 103

4. EDWARD CONDE . . . . . . . . . . . . . . . . 134

5. ROD G. GULLBERG . . . . . . . . . . . . . . 143

6. SAMUEL E. CHAPPELL, Ph.D. . . . . . . . . . 156

7. BARRY K. LOGAN, Ph.D. . . . . . . . . . . . 162

8. J. ROBERT ZETTL . . . . . . . . . . . . . . 175

9. PATRICK M. HARDING . . . . . . . . . . . . . 185

10. NORMAN J. DEE . . . . . . . . . . . . . . . 196

11. STEPHEN B. SEIDMAN, Ph.D. . . . . . . . . . . 202

12. GERALD SIMPSON, Ph.D. . . . . . . . . . . . 210

13. MICHAEL PETER HLASTLA, Ph.D. . . . . . . . . 219

V. FINDINGS AND CONCLUSIONS OF LAW

1. IN THE WAKE OF DOWNIE . . . . . . . . . . . 228

2. ADMINISTRATIVE SAFEGUARDS . . . . . . . . . . 238

3. SOURCE CODES . . . . . . . . . . . . . . . . 241

4. RFI-EMI INTERFERENCE . . . . . . . . . . . . 248

5. FOUNDATIONAL EVIDENCE . . . . . . . . . . . 250

6. BREATH VOLUME AND FLOW RATE . . . . . . . . 251

7. CENTRALIZED DATA MANAGEMENT . . . . . . . . . 253

8. NON-OPERATOR DEPENDENT . . . . . . . . . . 254

9. BREATH TEMPERATURE SENSOR . . . . . . . . . 255

10. TOLERANCES FOR THE TWO BREATH TESTS . . . . 256

VI. CONCLUSION . . . . . . . . . . . . . . . . . . . 258

APPENDIX A - TRANSCRIPTS . . . . . . . . . . . . . . 260

APPENDIX B - BIBLIOGRAPHY

1. RECOMMENDED . . . . . . . . . . . . . . . . 262

2. ANCILLARY . . . . . . . . . . . . . . . . . 269

I. PROCEDURAL HISTORY

The case arises from quasi-criminal actions involving twenty defendants who were arrested in Middlesex County for driving while under the influence of alcohol in violation of N.J.S.A. 39:4-50. Defendants challenged the admissibility and reliability of breath test results obtained from the Alcotest 7110 MKIII-C, firmware version NJ 3.11 (Alcotest 7110).

On October 14, 2005 the Law Division granted the State's motion to consolidate the cases pending as of May 23, 2005 in several Middlesex County municipal courts. Among other things, Judge Cantor denied the State's motion to take judicial notice of the opinion in State v. Foley, 370 N.J. Super. 341, 359 (Law Div. 2003), which ruled that the Alcotest 7110 MKIII-C was scientifically accurate and reliable and that its reported readings would be admitted into evidence without the need for expert testimony. At the time of Foley, New Jersey was using firmware version 3.8.

In her written statement of November 10, 2005 Judge Cantor explained that the Alcotest 7110 MKIII-C was a new instrument adopted throughout New Jersey on a county-by-county basis on a sequential timetable. She emphasized that only the Camden County, Law Division in Foley had found it scientifically reliable and that Judge Orlando, in dictum, had concluded that New Jersey should make certain changes in the instrument's firmware and the instructions given to its users. Ibid. Because the Alcotest 7110 MKIII-C was a novel scientific instrument which had never been vetted by an appellate court or our Supreme Court, Judge Cantor concluded that its scientific reliability remained a justiciable issue.

On December 1, 2005 the Appellate Division granted the State's motion for leave to appeal and denied its motion for a summary reversal. The Appellate Division remanded the matter to the trial court for an accelerated hearing on the validity of breath tests for alcohol, obtained through the use of Alcotest instruments.

On December 14, 2005 our Supreme Court certified the appeal pending in the Appellate Division on its own motion pursuant to R. 2:12-1. The Court vacated the remand to the Law Division and remanded the matter to retired Appellate Division Judge Michael Patrick King, to preside as a Special Master. The Court ordered the Special Master to conduct a hearing and report his findings and conclusions on an accelerated basis.

The Court ordered the Special Master to:

1. Conduct a plenary hearing on the reliability of Alcotest breath test instruments, including consideration of the pertinent portions of the record in State v. Foley, 370 N.J. Super. 341 (Law Div. 2003), and the within matters in the Superior Court, Law Division, Middlesex County, together with such additional expert testimony and arguments as may be presented by the parties;

2. Determine whether the testimony presented by the parties should be supplemented by that of independent experts selected by the Special Master;

3. Grant, in the Special Master's discretion, motions by appropriate entities seeking to participate as amici curiae, said motions to be filed with the Special Master within ten days of the filing date of this Order;

4. Invite, in the Special Master's discretion, the participation of entities or persons as amici curiae or, to the extent necessary in the interests of justice, as intervenors to assist the Special Master in the resolution of the issues before him; and

5. Within thirty days of the completion of the plenary hearing, file findings and conclusions with the Clerk of the Court and contemporaneously serve a copy on the parties and amici curiae, which service may be effectuated by the posting of the report on the Judiciary's website . . . .

The Court also ordered the parties, and permitted all amici curiae who participated in the plenary hearing, to serve and file initial briefs within fourteen days of the filing of the Special Master's report as well as responses, if any, within ten days. It further ordered the Clerk to set the matter for oral argument on the first available date after completion of briefing by the parties. Finally, the Court ordered the stay of N.J.S.A. 39:4-50 proceedings pending in Middlesex County, and directed all Superior and Municipal Court judges before whom such proceedings were pending, to ensure strict enforcement of the Court's Guidelines for Operation of Plea Agreements in the Municipal Courts of New Jersey.

On January 9, 2006 the Special Master granted to the Association of Criminal Defense Lawyers of New Jersey (ACDL) leave to appear as amicus curiae. On January 23, 2006 the Special Master also admitted the New Jersey State Bar Association (NJSBA) as amicus curiae, under R. 1:13-9, in view of the matter's public importance.

On January 10, 2006 the Court sua sponte issued an order addressing issues that affected the prosecution of N.J.S.A. 39:4-50 offenses statewide. The Court ordered all prosecutions and appeals which did not involve the Alcotest 7110 to proceed in the normal course. The Court, however, ordered the stay of prosecutions and appeals involving repeat offenders and the execution of their sentences where the convictions were based solely on Alcotest readings. The Court also ordered that first-offender prosecutions proceed to trial based on clinical evidence when available and on Alcotest readings. It ordered, however, that the execution of sentences for all first offenders be stayed pending disposition of the Court's final decision on the Alcotest 7110's reliability, unless public interest required their immediate implementation.

As explained by the Administrative Director, Judge Carchman, in a clarifying memorandum to municipal court judges dated January 17, 2006, a court could admit evidence of an Alcotest reading, over the objection of defense counsel, without first holding a hearing on the instrument's scientific reliability. He further explained that under N.J.S.A. 39:4-50(a)(2) and (3), the penalty for repeat offenders was the same whether the finding of guilt was based on observation or blood alcohol levels. However, for first offenders, the penalty could vary, making the Alcotest reliability hearing of fundamental importance.

On March 15, 2006 the Court entered an order directing the Special Master to designate an independent expert or experts.

Upon deliberation and consultation with the parties and amici curiae, the Special Master determined that a court-appointed expert was not necessary for proof purposes, especially because of the quasi-criminal nature of the proceedings.

Meanwhile, discovery proceeded. On February 3, 2006 the Special Master entered an order directing the State to give defendants certain information, documents and materials pertaining to the Alcotest 7110's firmware, software, algorithms, electronic schematics, and source codes. Among other things, the discovery order recognized that the exchange of firmware and software might require a protective order to be submitted by the State or manufacturer for court approval. On February 17, 2006 the Special Master entered a supplemental discovery order directing the State to lend three Alcotest 7110s to defense counsel and one to counsel for the amicus NJSBA. Among other things, the supplemental discovery order also allowed the manufacturer Draeger Safety Diagnostics, Inc. (Draeger) to apply to intervene in this matter, especially because of the issue of "trade secrets."

Draeger objected to the discovery orders claiming that they permitted the release of trade secrets and proprietary information. On February 23, 2006 Draeger's intellectual property counsel prepared a proposed protective order and sent it to the State for submission to the court. Draeger's proposal included a request for indemnification from defense counsel. In response to defendants' objections to Draeger's initial draft -- especially to the request for indemnity -- and a revised proposal by the State, the Special Master requested defense counsel to submit a proposed protective order.

Draeger then offered to make copies of the Alcotest 7110's source codes available to the Special Master and explain them to him during an in camera session provided there would be no testimonial record and the data would be returned after his inspection and decision. Again, defense counsel objected, explaining that the purpose of requesting the source codes and algorithms was to allow their expert to review and test them.

On April 19, 2006 defendants submitted their proposed protective order. In anticipation of a court-issued protective order, the State provided to defense counsel and the amicus the four Alcotest 7110 instruments for their inspection.

On April 26, 2006 the Special Master entered a protective order which required all discovery information in which Draeger asserted an intellectual property right so marked. With regard to the marked discovery, the protective order required: (1) that the information could not be disclosed by parties or amici curiae, or by consultants and experts given access to it; and (2) that the information must be returned to Draeger following the conclusion of all litigation. The protective order also extended its terms and restrictions for three years from the termination of litigation or until such time as the marked discovery information entered the public domain, whichever came first, and stated that the violation or breach of any condition would be grounds for court contempt action, civil damages or other appropriate sanctions after a hearing where the accused would be afforded due process under R. 1:10. Additionally, if Draeger did not cooperate with discovery, the protective order allowed the Special Master to draw any appropriate negative inferences in his decision on the Alcotest 7110's reliability. The protective order did not include an indemnification provision.

Shortly after, on April 28, 2006, the State submitted comments on its revised proposed protective order. In part, the State explained that the indemnification provision would require those defendants who received the instruments to indemnify and hold harmless the State from any damage that might result from the firmware's use or installation.

On May 15, 2006 Draeger wrote to the State with its objections noting that it would not cooperate with discovery unless the court entered a "satisfactory" protective order. On May 22, 2006, after consideration of Draeger's expressed objections, the Special Master amended the protective order by: further limiting access to the information disclosed; extending the term and restrictions from three years to as long as the marked discovery information remained a trade secret or until it entered the public domain; and providing that other sanctions might be appropriate in cases where Draeger demonstrated at a hearing that it would suffer irreparable harm and there was no adequate remedy at law.

On June 15, 2006 Draeger wrote again to the State indicating that the amended protective order was an "improvement" but still did not provide adequate protection. Draeger continued to insist that the Special Master adopt an order substantially similar to its initial proposal. For example, Draeger contended: it should be provided with the identity of experts who would be given the marked information in discovery; it should not have to appear before the Special Master at a hearing to demonstrate irreparable harm; it should be allowed to demonstrate its intellectual property rights or prove its need for injunctive relief in a forum other than before Judge King; and it should not be forced to comply with an order essentially based upon a proposal by defendants who did not have any trade secrets or proprietary information to be protected.

Draeger also advised the Special Master and the State that it "recently" had adopted a "new policy" regarding confidential disclosure of the Alcotest 7110's source codes and other trade secrets to those individuals -- including parties involved in the Chun litigation -- who accepted the following conditions: (1) individuals who agreed to sign appropriate non-disclosure and confidentiality agreements prepared by Draeger; (2) individuals who agreed to review the information in a room at Draeger's offices in Durango, Colorado; (3) individuals who agreed to allow a Draeger representative to be present in the room when they reviewed the information; and (4) individuals who agreed not to take photographs, make copies by writing or other means, or make any recordings of the information. To maintain its "non-party status," Draeger again declined the Special Master's offer to meet with him or participate in any conferences. Incidentally, Draeger has no United States or foreign patent protection on the Alcotest 7110.

Neither the State nor defendants expressed any interest in complying with Draeger's fastidious conditions on the source codes' disclosure. The Special Master also declined to further amend the protective order. Consequently, discovery and the exchange of documents and expert reports proceeded without Draeger's participation. This created an anomalous situation: the manufacturer was not a party to the defense of its product. The State had to defend the Alcotest 7110 derivately.

Pursuant to N.J.R.E. 104, the Special Master held forty-one full days of evidentiary hearings which commenced on September 18, 2006 and concluded on January 10, 2007. The parties and amicus NJSBA submitted proposed findings of fact and conclusions of law regarding the scientific reliability of the Alcotest 7110. As further ordered by the Court, the Special Master has issued his findings and conclusions in this matter within thirty days of the completion of the hearings.

II. STANDARD OF PROOF

The key issue is whether the Alcotest 7110 is a scientifically reliable instrument for determining the alcohol content of the breath and blood. The resolution of this question will assist the Supreme Court in determining whether the results of Alcotest 7110 readings generally may be admitted in evidence and support convictions under N.J.S.A. 39:4-50 and cognate statutes.

Under New Jersey's statutory scheme, a driver of a motor vehicle is guilty of a so-called "per se" violation of N.J.S.A. 39:4-50(a) at a "blood alcohol concentration of 0.08% or more by weight of alcohol in the defendant's blood." Thus, New Jersey is a "blood" alcohol jurisdiction as opposed to a "breath" alcohol jurisdiction. See State v. Downie, 117 N.J. 450, 469-71 (1990) (Stein, J., dissenting). A person "under the legal age [twenty-one] to purchase alcoholic beverages" while operating a motor vehicle "with a blood alcohol concentration of 0.01% or more" is subject to special penalties imposed by N.J.S.A. 39:4-50.14 (the so-called "kiddie drunk" law). Operation of a commercial vehicle "with an alcohol concentration of 0.04% or more" is separately prohibited by N.J.S.A. 39:3-10.13. Interestingly, this latter statute defines alcohol concentration either by "blood" or "breath," not by "blood" alone, as does N.J.S.A. 39:4-50. See N.J.S.A. 39:3-10.11. All agree that this "commercial vehicle" section is rarely, if ever, invoked by the police.

The .08% blood alcohol level must be enforced by the several states under pain of withholding of federal highway-aid funds. See 23 U.S.C.A. §§ 163 and 410; 23 C.F.R. § 1225. We understand that New Jersey is in compliance with the federal mandate as of 2004. See L. 2004, c. 8 § 2 (amending N.J.S.A. 39:4-50(a), eff. April 26, 2004); State v. Chambers, 377 N.J. Super. 365, 371 (App. Div. 2005).

To allow the admission of scientific evidence in criminal cases, there must be general acceptance by the relevant scientific community. State v. Harvey, 151 N.J. 117, 169-70 (1997) (citing Frye v. United States, 293 F. 1013, 1014 (D.C. Cir. 1923); Romano v. Kimmelman, 96 N.J. 66, 80 (1984); State v. Johnson, 42 N.J. 146, 170-71 (1964); Foley, 370 N.J. Super. at 349. To establish general acceptance, test results must have "'sufficient scientific basis to produce uniform and reasonably reliable results [which] will contribute materially to the ascertainment of the truth.'" Romano, 96 N.J. at 80 (quoting State v. Hurd, 86 N.J. 525, 536 (1981)). "Proving general acceptance 'entails the strict application of the scientific method, which requires the extraordinarily high level of proof based on prolonged, controlled, consistent, and validated experience.'" Harvey, 151 N.J. at 171 (quoting Rubanick v. Witco Chem. Corp., 125 N.J. 421, 436 (1991)).

Given the rapidly changing nature of modern science, courts recognize that continuing research may affect the scientific community's acceptance of a novel technology. Id. at 167-68. Thus, newly-devised scientific technology essentially achieves general acceptance only after it passes from an experimental to a demonstrable technique. Id. at 171.

General acceptance, however, does not require unanimous agreement about the accuracy of the scientific test or the infallibility of its methodology, techniques or procedures. Ibid. Nor does it require the exclusion of the possibility of error. Ibid.; Romano, 96 N.J. at 80. Indeed, our courts recognize that "[e]very scientific theory has its detractors." Harvey, 151 N.J. at 171.

In a criminal case where defendants challenge the prosecution's attempt to introduce a novel type of scientific evidence, a court may conduct a hearing under N.J.R.E. 104 to determine whether the scientific evidence is generally accepted. Id. at 167. Proof of its general acceptance can be obtained through expert testimony, publications or judicial opinions. Id. at 172-76; Foley, 370 N.J. Super. at 350. The party offering the evidence has the burden to "clearly establish" each of these methods. Harvey, 151 N.J. at 170; Foley, 370 N.J. Super. at 349 ("To establish general acceptance within the scientific community the proponent must meet the clear and convincing standard of proof."). At a N.J.R.E. 104 hearing, however, proofs need not comply with the other rules of evidence, except that N.J.R.E. 403 may be invoked and valid rules of privilege are recognized. Biunno, Current N.J. Rules of Evidence, comment 4 on N.J.R.E. 104(a) (2006). Thus, hearsay evidence is admissible. Ibid. When a showing of general acceptability has been made, courts will take judicial notice of the scientific instrument's reliability. Romano, 96 N.J. at 80-82 (holding that the breathalyzer's general acceptance within the scientific community demonstrated its scientific reliability and that such reliability was the subject of judicial notice in all cases under N.J.S.A. 39:4-50).

The State must prove by clear and convincing evidence that the Alcotest 7110 is generally accepted in the relevant scientific community -- even if such acceptance is not unanimous -- for the purpose of determining the concentration of alcohol in the blood. If the Alcotest 7110 is a scientifically reliable instrument for measuring blood alcohol, the test results are admissible in evidence only in those cases where the State clearly establishes that: (1) the instrument was in proper working order; (2) the operator was qualified to administer the instrument; and (3) the test was administered in accordance with official instructions and New Jersey State Police protocol for the instrument's use. See Romano, 96 N.J. at 81.

III. THE FACTS

1. Chemistry and Physiology

Scientists have long known the presence of alcohol (ethanol) in the brain causes cerebral dysfunction leading to automobile accidents. The medium through which alcohol reaches the brain is the blood. If we could directly sample blood from the brain, the amount of alcohol it contains could be easily and accurately known. But we can not.

Alcohol comes into the human body through the stomach and passes to the small intestines. It is absorbed into the blood partly in the stomach but principally from the small intestines. Absorption can take place quite quickly or more slowly, depending on the contents of the stomach and the strength and quantity of the alcohol ingested. The alcohol-laden blood then passes to the liver and circulates through all parts of the body. It is found in all water in the body. Freshly formed urine, saliva or other body fluids receive alcohol in proportion to their water content. Blood from many parts of the body, taken after time allowed for absorption, will reflect the alcohol present throughout the body. Urine specimens and saliva samples are not particularly accurate and are difficult to obtain, especially on a repeat basis over a short period of time. They are unsatisfactory for field work.

The taking of blood samples poses some inconveniences but not of great magnitude. With blood the first issue is from what part of the body is the sample taken. The amount of alcohol present in the blood will vary between venous blood from the cubital or elbow vein in the arm, from fingertip capillary blood, or from arterial blood. Even arterial blood will provide different readings on the amount of alcohol present depending on the site where the blood sample is taken.

Arterial blood passes through the lungs into the heart and from there goes to the brain through the carotid arteries. On leaving the brain it travels through the venous system, goes back through the liver, and continues through the heart where it is again pumped into the arterial system and lungs.

Returning to the problem of determining how much alcohol is in the brain, the immediate source of blood supply to the brain is through the carotid arteries. If we could simply and safely draw a blood sample from one of those arteries this would be an excellent measure of alcohol in the brain. Such a procedure is neither simple nor safe.

Blood can be taken from other sites, commonly the finger tips or the cubital vein. Both sites are much more remote from the brain and do not give a precise indication of what is present in the brain at the time. The alcohol content of blood constantly changes as it circulates through the body. It is eliminated through various parts of the circulatory system but gains more alcohol from the small intestines so long as alcohol remains in the stomach.

For multiple tests, upon which the accuracy of blood readings depends, the fingertip blood or capillary blood is not satisfactory. The size of the sample is quite small and there is immediate danger of exposure to the air and evaporation of some of the alcohol, because alcohol is a very volatile substance. Venous blood is satisfactory as to quantity. However, it does not always give an accurate reflection of the alcohol in the brain, especially during the period during which alcohol is still being absorbed through the stomach and small intestines into the blood. All of this has been known to scientists for a long time.

Scientists also have long known that as the blood passes along the alveolar or honey-comb-like cells in the lungs, some of the volatile alcohol in the blood will escape into the breath chambers on the other side of the thin membrane which makes up those cells. This transfer of alcohol from blood to breath in the lungs proceeds, in general, at a fairly predictable rate for most, but probably in no two people is that rate precisely the same. This is because of biological variation.

Since arterial blood passing through the lungs is the most accessible practical spot for testing prior to going through the carotid arteries to the brain, it became apparent that if an accurate form of detecting the amount of alcohol in the breath could be developed and if the breath-alcohol level could be related to an assumed amount of alcohol in the arterial blood which produced it, a prediction could be made as to how much alcohol must be present in the blood flowing through the brain. Thus emerged the Breathalyzer and its progeny: all other breath-alcohol analyzing instruments.

In our view, there is really no problem at all with the technology for measuring the amount of alcohol present in a given sample of breath or vapor. The breathalyzer has been one of a number of scientifically-proven instruments. With proper working order and a trained operator, it can read alcohol in breath quite well and with satisfactorily scientific acceptability. Most all experts agree on this. The problem is converting that breath-alcohol reading or concentration (BrAC) into a blood alcohol concentration (BAC). This outcome depends on the process in the subject's lungs.

2. History

Evidential breath testers (EBTs) have been in use since Robert F. Borkenstein invented the breathalyzer in 1954. In 1984, National Draeger, Inc., the American subsidiary of Draegerwerk Aktiengesellschaft (Draeger AG), acquired Smith and Wesson, the breathalyzer's manufacturer, partially to gain access to the United State's market. Draeger AG was founded in 1887 in Luebeck, Germany.

Also in 1984, the National Highway Traffic Safety Administration (NHTSA), United States Department of Transportation (USDOT), issued a notice converting the mandatory standards for EBTs to model specifications and publishing a conforming products list (CPL) of such instruments to assist states in their purchasing decisions. 49 Fed. Reg. 48854 (Dec. 14, 1984). The model specifications also added an alternative laboratory method to test breath sampling capability, eliminating the need to test with human subjects. Ibid. NHTSA defined EBT's as "instruments that measure the alcohol content of deep lung breath samples with sufficient accuracy for evidential purposes." Ibid.

In 1993, NHTSA published the amended Model Specifications for Devices to Measure Breath Alcohol and an updated CPL to accommodate transportation workplace alcohol testing programs, to meet new zero tolerance laws for underage offenders, and to add testing for acetone interference. 58 Fed. Reg. 48705 (Sept. 17, 1993). The updated CPL listed the "Alcotest 7110." Ibid.

The USDOT Volpe National Transportation Systems Center (Volpe) in Cambridge, Massachusetts performs EBT testing for NHTSA on instruments submitted by manufacturers to determine their accuracy and precision. Ibid. NHTSA, through Volpe, also does special testing for end-users upon request. As Edward Conde explained, Volpe performs an "initial type approval" consisting of eight steps: accuracy and precision testing; acetone interference testing; blank testing; breath alcohol sample simulator (BASS) testing; power variation or voltage testing; temperature testing; post-vibration testing; and electrical safety inspection.

In 1994 Hanseuli Ryser, a key State's witness in this proceeding and Draeger's United States' principal, established the Breathalyzer Division in the United States. Eight years later, the Breathalyzer Division merged with Draeger Interlock, Inc., and the name changed from National Draeger to Draeger Safety Diagnostics, Inc. (Draeger). As vice president of Draeger's operations in Durango, Colorado, Ryser supervises the production, servicing and engineering of evidential breath-testing instruments.

In 1995 Draeger introduced to the United States market the Alcotest 7110 MKIII, which used a dual sensor measuring system consisting of infrared spectroscopy (IR) and electrochemical or fuel cell technology (EC), to analyze breath alcohol results. From November 1995 through February 1996, personnel from the Alcohol Drug Testing Unit (ADTU) of the New Jersey State Police along with then chief forensic scientist, Charles Tindall, Ph.D., and assistant chief forensic scientist, Thomas A. Brettell, Ph.D., performed various tests on four EBTs including the Alcotest 7110 MKIII. They conducted the tests for the purpose of selecting a new breath-testing instrument to replace the Breathalyzer Models 900 and 900A. As Brettell explained, breathalyzers produced "very good, reliable, precise, accurate" results when operated and maintained properly, but they were fast becoming dinosaurs since Draeger acquired the manufacturer and eventually stopped making spare parts, ampules and new instruments.

In addition to the Alcotest 7110 MKIII, the forensic scientists and ADTU members evaluated three other instruments: BAC Datamaster; Intoxilyzer 5000; and Intoximeter EC/IR. They performed validation studies including side-by-side testing for accuracy, precision, linearity, and specificity. They also qualitatively evaluated the instruments for such things as ease of operation, operator dependence, transportability, and printout information. Brettell testified that the results showed the Alcotest 7110 MKIII was capable of providing accurate and precise results. Brettell further testified that he recommended the State select the Alcotest 7110 with the wet bath simulator (Draeger CU34) and a laser-jet external printer, but without the detector for radio frequency interference (RFI) or the breath temperature sensor option.

In January 1996 Volpe successfully tested the Alcotest 7110 MKIII for accuracy and precision, among other things, and listed the instrument on the CPL. 61 Fed. Reg. 3078 (Jan. 30, 1996). Independent laboratories in the Netherlands (1994) and Paris, France and the German government (1998) also successfully tested the Alcotest 7110 MKIII for compliance with the more rigorous standards adopted by the Organisation Internationale de Metrologie Legale (OIML), an international treaty organization established in 1955 to address issues relating to the application of common legal measurements by its 113 members.

Draeger subsequently developed the Alcotest 7110 MKIII-C, which added an internal computer communications capability or modem as a standard feature. NHTSA did not re-test the instrument, concluding that the communication enhancement did not affect the instrument's accuracy or precision. In 1998 NHTSA amended the CPL to include, among others, the Alcotest 7110 MKIII-C. 63 Fed. Reg. 10066 (Feb. 27, 1998).

In 1998 the New Jersey Attorney General (AG) proposed the readoption, with amendments, of the Chemical Breath Testing Regulations, N.J.A.C. 13:51, which were scheduled to expire on September 16, 2001. 30 N.J.R. 4321(a) (Dec. 21, 1998). The proposed amendments addressed the introduction of new chemical breath testing methods and technology including the Alcotest 7110 MKIII as an improved instrument for testing a person's breath by chemical analysis. Ibid. After receiving no public comments, the AG approved the Alcotest 7110 MKIII for evidential breath testing in New Jersey. N.J.A.C. 13:51-3.5(a)(2); N.J.A.C. 13:51-3.5(a)(2)(i); N.J.A.C. 13:51-3.6(c). The regulations state in relevant part:

2. Infrared analysis and electrochemical analysis, when utilized in a single approved instrument as a dual system of chemical breath testing, is approved as a method of chemical breath testing.

i. The Alcotest 7110 MKIII, is a chemical breath test instrument which employs both infrared analysis and electrochemical analysis as a dual system of chemical breath testing and is an approved instrument for use in the testing of a person's breath by chemical analysis. [N.J.A.C. 13:51-3.5(a)(2)(i).]

The State subsequently commissioned Draeger to develop a version of the Alcotest 7110's firmware to meet its particular needs. In 1998 Draeger delivered the first instruments with firmware version 3.8 to the New Jersey State Police.

On September 6, 2002 Draeger, the licensor, and the State of New Jersey, Department of Treasury, Division of Purchase and Property, on behalf of the State Police, the licensee, entered into a Firmware/Software License Agreement. The license agreement recognized that Draeger owned the firmware and software, and that the State Police had a non-exclusive license to use the Alcotest 7110 MKIII-C under certain terms and conditions. One of the conditions required the licensee to agree not to "reverse engineer, decompile or disassemble the Firmware/Software or otherwise attempt to derive source codes from the Firmware/Software, not shall Licensee allow any other entity to do so."

Meanwhile, New Jersey reviewed and evaluated the operation of the Alcotest 7110, NJ 3.8 in the Pennsauken Township pilot program (pilot program) which took place from December 2000 through December 2001. Sergeant Kevin Flanagan, New Jersey State Police, testified that he loaned two instruments to the Pennsauken Township Police Department which then performed breath tests on 372 subjects suspected of operating a motor vehicle under the influence of alcohol. After the pilot program ended, the Camden County Prosecutor applied to the court for a consolidated proof hearing on the instrument's scientific reliability. Foley, 370 N.J. Super. at 345. The request related to cases pending before the Pennsauken Township Municipal Court which involved prosecutions for violation of N.J.S.A. 39:4-50, N.J.S.A. 39:3-10.13 or N.J.S.A. 12:7-46 (reckless boating). Ibid. The court granted the application and held an evidentiary hearing from September 8, 2003 to October 14, 2003. Id. at 345-46.

In 2003 New Jersey also requested Volpe to perform special testing of the Alcotest 7110, NJ 3.8, including informal RFI testing. Conde performed the tests and found that the instrument conformed to NHTSA's model specifications.

The Foley court also found that the Alcotest 7110 was a scientifically reliable evidential breath-testing instrument. Id. at 351. It found that the test readings produced by the Alcotest 7110 were accurate and admissible in evidence in a prosecution for violation of N.J.S.A. 39:4-50, N.J.S.A. 39:3-10.13 or N.J.S.A. 12:7-46 without the need for expert testimony. Id. at 359.

During the Foley hearings, however, it became apparent there were several functions or features of firmware version NJ 3.8 which required revision. For example, the judge expressed concern about the unusually high number of subjects in the pilot program who were unable to provide the minimum breath sample and were charged with refusal to submit to a breath test. Id. at 345. In response to the 28% refusal rate, the court directed the State to modify the firmware and change the instructions given to individuals who were about to use the instrument. Ibid. The court also ordered that no person who delivered a breath sample of at least 0.5 liters of air during a test on the Alcotest 7110 could be charged with refusal. Ibid.

After Foley, the State asked Draeger to make certain scientific and administrative changes to the firmware. From July through September 2004 Brettell and his laboratory staff performed validation testing on two beta or experimental versions of NJ 3.10. Brettell confirmed that Draeger made the requested changes to the instrument which included: giving operators the option simply to terminate the test rather than record it as a refusal; displaying "error" messages on the LED screen so operators could take them into consideration; automatically truncating the final blood alcohol result to two decimal places; instituting a two-minute lockout between breath tests; and allowing operators to observe the protocol for the twenty-minute observation period instead of locking the instrument preventing use during that period. Draeger also revised the alcohol influence report (AIR) to present all information on one page, including error messages, and New Jersey revised its blowing instructions to ask subjects for deep breaths.

Shortly thereafter, Flanagan and the ADTU operators discovered that four data fields could not be reviewed including the subject's drivers license number, the issuing state, the agency case number, and the summons number. Draeger made these changes, which Flanagan verified, and the State then received current firmware version NJ 3.11. Brettell did not perform additional testing and validation because he believed these changes did not affect the analytical operation.

New Jersey asked Volpe to perform special testing to determine if the Alcotest 7110, NJ 3.11 complied with NHTSA's model specifications. From December 2005 to February 2006, Conde performed tests on the Alcotest 7110, NJ 3.11, retaining only those AIRs which contained data needed for type approval or disapproval. Conde again concluded that the NJ 3.11 met the model specifications and was suitable for use in an evidential environment.

In January 2005 police departments in Middlesex County began to use the Alcotest 7110, NJ 3.11. By December 2005 thirteen of New Jersey's twenty-one counties were using the Alcotest 7110 in place of the breathalyzer for evidential breath testing. In April and June 2006, at the recommendation of the Division of Criminal Justice and the State Police, the roll-out of the Alcotest 7110 continued in several more counties including Atlantic, Cape May, Passaic and Sussex. The State Police had scheduled roll-outs in October 2006 for the remaining four counties -- Bergen, Hudson, Monmouth and Essex -- but ceased pending decision in this case. To date, New Jersey and its municipalities have bought about 480 instruments with extended four-year warranties for approximately $11,800 each.

At the time of the hearing, at least three other states (Alabama, New York and Massachusetts) and several countries including Germany, Finland, Austria, Italy, Spain, South Africa, Taiwan, Hong Kong, Bulgaria, Guam and the Northern Marianas were using the Alcotest 7110 for evidential breath testing.

3. The Instrument

The Alcotest 7110 is a breath alcohol analyzer used for evidential breath alcohol measurements. It weighs approximately 16.5 pounds and resembles a tool kit. The entire system includes the breath analyzer, a special organizer stand with a drawer, a standard keyboard, an external laser printer, a wet bath simulator, and a temperature probe.

The instrument fits in a metal case with a cover that is removed when in use. On its rear side, there are various interfaces including an exhaust port, an outlet port to deliver air to the simulator, and an inlet port to the IR absorption chamber (or cuvette). There also are power and start buttons, and a tag with the instrument's serial number. The top surface contains a flexible breath hose which is forty-six inches long and heated with two temperature sensors to 43 plus or minus 0.3 degrees Celsius to prevent condensation and overheating of the hose material. A disposable mouthpiece fits onto the breath hose to ensure a better seal, make it easier to exhale, and aid hygiene. The mouthpiece is changed after each breath sample.

The top of the instrument contains a forty-character light-emitting diode (LED) display screen which prompts the operator to take certain actions, describes the operation being performed, conveys error messages, and displays BAC results. The instrument operates in AC or DC modes. It contains an internal printer which uses paper 2 1/4 inches in width and approximately 22 inches in length, but is disabled in New Jersey in favor of an external printer.

While the Alcotest 7110 shares some of the same features as a computer, we find it best described as an embedded system with a very specific, dedicated purpose. The instrument has fairly limited interface sensors and operates by using a very reduced logic code which is sufficient to support its function. Like a computer, however, the Alcotest 7110 contains both hardware and software components.

Hardware components include the IR absorption chamber, EC sampling system, sensors (flow and pressure), a signal processing system, and a microprocessor. Software components include firmware for the microprocessor and software to handle data communications, data retrieval, and operator input.

The Alcotest 7110 is the only evidential breath-testing instrument which uses a dual system of IR absorption analysis and EC fuel cell technology to independently measure alcohol concentration in the same breath sample. Ryser explained that Draeger does not hold a patent for the dual technology because, among other things, it wants to avoid the disclosure of company "trade secrets." Draeger, however, does hold a trademark for the name "Alcotest."

The Foley court accurately described the IR and EC methods this way:

IR Analysis

Within the instrument a source emits an infrared light which is sensed by a detector. The infrared light from the source to the detector is established in the absence of alcohol as the baseline condition. When a breath containing alcohol is introduced into the chamber some of the infrared light is absorbed by the alcohol molecules and therefore does not reach the detector. The comparison between the presample IR and the sample IR transmission results in a lesser amount of infrared light with the sample present. The quantitative difference in the amount of infrared light reaching the detector is converted by the circuitry into a printed result which equates to the alcohol concentration of the person's breath.

EC Analysis

The instrument also contains a fuel cell which produces an electrical current. In the absence of alcohol the current is flat. When alcohol is introduced the electrons which flow between the anode and cathode on the fuel cell increase. This increase in the flow of electricity is interpreted by the [Alcotest] 7110 as the effect of alcohol in the breath. [Foley, 370 N.J. Super. at 346.]

While we adopt as fact the descriptions of these two methods as set forth in Foley, we find these additional facts about the Alcotest 7110 in connection with our decision.

IR technology has been available since 1974. In the Alcotest 7110, IR analysis observes a subject's breath from the beginning to the end of its presentation. The solid brass cuvette chamber holds approximately seventy milliliters which is small enough to avoid mixing old and new breath but large enough to absorb energy when alcohol is present. The chamber is heated to prevent condensation on its walls and internal parabolic mirrors. The mirrors are gold-plated to optimize energy reflection and placed at either end of the cuvette, where they deflect the emitted IR light a specific number of times until a detector receives it. Unlike the majority of breath-testing instruments which operate at the 3.4 or 3.5 micron range, the Alcotest 7110 detects alcohol in the 9.5 micron range of the IR spectrum. By only allowing energy at the higher wavelength to pass through the IR filter, the instrument is less susceptible to endogenous interfering substances such as acetone, acetaldehyde and ketones.

EC technology also has been available for many years, at least since the mid-1960s, but has not been used for evidential purposes until the mid-to-late 1980s when the introduction of microprocessors provided the necessary speed. Unlike IR absorption, however, EC analysis waits until the end of a subject's exhalation to take a breath sample out of the IR chamber for analysis.

The fuel cell consists of plastic housing with a vapor inlet port and an exhaust port, and its interior consists of a porous matrix of plastic materials filled with sulfuric acid. Platinum plates on both sides attach to two electrodes or wires which lead to the outside of the fuel cell housing. A small piston assembly draws in a sample approximately one cubic centimeter in volume from the same breath sample in the cuvette.

For a single breath sample to be acceptable, Draeger programmed the Alcotest 7110 with a preset tolerance which requires the IR and EC results to agree within .008 blood alcohol concentration (BAC) or 10% of the IR reading, whichever is greater. Draeger set that particular tolerance so the instrument would be compatible with OIML specifications.

To detect interfering substances, the Alcotest compares the IR and EC readings. Where only alcohol is present on the breath, the readings will be similar but where interferents -- endogenous and exogenous -- are present, the readings will diverge.

Another standard feature includes RFI shielding, which protects the instrument from outside interference which can affect its components. The RFI shielding consists of metal coating underneath the top lid and a metal bottom, both of which prevent electromagnetic waves from entering the instrument. The instrument's five-layer printed circuit board (or motherboard) also suppresses RFI influence. Because of the shielding and special design, Ryser did not recommend that New Jersey purchase the optional RFI detector offered by Draeger. He expressed concern that the RFI detector permitted undesirable penetration of the shield through a small hole. The Alcotest 7110 also successfully underwent informal RFI testing by NHTSA, by laboratories using OIML standards, and Brettell's staff at the State's forensic laboratory. Nonetheless, the ADTU instructs operators to keep portable radios and cell phones out of the room during breath testing.

The State also did not purchase the breath temperature sensor option. The sensor consists of a thermistor placed into the breath hose to measure a subject's breath temperature. For calibration, the temperature sensor requires substantial equipment including two large heated tanks which cost about $15,000 each and two automatic calibration devices which cost about $36,000 each. Draeger is the only manufacturer which offers the sensor. Alabama uses the optional sensor to make downward corrections in the software of 6.58% for each degree that the breath temperature exceeds the standard 34 degrees C; Germany uses it to make both upward and downward corrections.

Draeger designed the Alcotest 7110 to measure samples of alveolar or deep lung air. To provide a valid breath sample in New Jersey, a subject must meet five criteria: (1) minimum breath volume of 1.5 liters; (2) minimum blow duration of 4.5 seconds; (3) minimum flow rate of 2.5 liters per minute; (4) the breath sample must reach a plateau (equilibrium), meaning that the IR reading must not change by more than 1% per 0.25 second; and (5) no detection of mouth alcohol or interfering substances. When a subject fails to meet any of the criteria, the display screen will report an "error" message.

With regard to mouth alcohol, operators in New Jersey must continuously observe a subject for a full twenty minutes, without interruption, before they can begin the breath test. During that time, the subjects cannot have any substances in their mouths nor can they regurgitate or burp. If there are any interruptions, the twenty minutes must start over again. New Jersey also intended for the Alcotest 7110 to institute a two-minute lockout between breath samples to prevent mouth alcohol inside the cuvette from contaminating the second sample. However, Flanagan and Brettell recently became aware that the instrument was not uniformly adhering to the two-minute lockout by about a second or two, and have contacted Draeger about the problem. The instrument's slope detector also provides an additional safeguard against mouth alcohol.

After receiving two valid breath samples, the Alcotest 7110 compares the results of the four readings: two taken by the IR and two by the EC technologies. The two breath samples must be within a specific tolerance of each other for the tests to be considered reliable. If the two samples are not within the tolerance range, a third test is forced.

This court recognizes Brettell's testimony that firmware version NJ 3.11 requires the test results to be within plus or minus .01 or plus or minus 10% of the mean of the four readings (two EC and two IR), whichever is greater. The NJ 3.11 version allows the operator a maximum of eleven attempts to collect two valid breath samples. After the eleventh try, the operator may terminate the test and restart the sequence, terminate the test and report it as a refusal, or terminate the test and give an opinion that the subject was not capable of providing a proper sample. For example, both Flanagan and Brettell stated that women over age seventy would have trouble providing 1.5 liters of breath and should not be charged with refusal. In those cases, the officers may chose to take the women to a hospital for blood tests or issue a summons based solely on observations.

Draeger ships the instruments directly to the police departments which purchased them. Prior to shipping, Draeger calibrates the instruments, simulators, and temperature probes, and certifies their accuracy. Upon their arrival and before the instruments are placed into service, an ADTU coordinator from the State Police verifies the firmware version, calibrates them, sets the tolerances, conducts control and linearity tests, and performs a solution change.

Calibration of the Alcotest 7110 involves a wet bath simulator, the Draeger CU34, and one bottle of 0.10 ethanol alcohol solution. The ethanol alcohol solution is poured into the simulator jar where it is heated to 34 plus or minus 0.2 degrees C. A NIST-traceable temperature probe monitors the temperature of the simulator solution. NIST refers to the National Institute of Standards and Technology, which is responsible for establishing, maintaining and publishing basic standards of measurement consistent with their international counterparts. Each temperature probe has a probe value, which can be changed only by a coordinator using the "black-key" function. When the instrument determines that the simulator has reached the correct temperature, the coordinator hooks up the simulator to the back of the instrument through the rear port of the cuvette. The coordinator then hits the escape key, the function appears on the display screen, the coordinator types in calibrate, and follows the instrument's prompts.

The coordinator then performs a control test to verify that the instrument is properly calibrated to the .10 simulator solution. The linearity test then uses three different simulator solutions of .04, .08 and .16. The instrument performs two tests on each solution. Afterwards, the coordinator uses a bottle of solution from the local police department and generates a solution change report. At that point, the calibration test sequence is complete and the instrument prints a calibration record.

Draeger ships the simulator solutions in lots of 1000, but only after Brettell's laboratory has tested six bottles from each lot to make sure they are within tolerance. For the .10 solution change, Brettell set the tolerance at .005 or 5%. Draeger's default tolerance at .010 or 10%. Brettell's laboratory issues certificates of analysis stating that each simulator solution was within specifications of the target value for the particular concentration. New Jersey protocol requires bottles to be changed after thirty days or twenty-five subject tests, or sooner if the instrument gives an error message that the solution is depleted.

After the initial calibration, an ADTU coordinator will recalibrate the instrument every twelve months, after an instrument is returned for service after repairs, or whenever a coordinator considers it necessary. See N.J.A.C. 13:51-4.3(b). Draeger also annually recalibrates the simulators and temperature probes.

The Alcotest 7110 employs multiple steps in testing an individual's breath alcohol concentration. While the court accurately described the sequence in Foley, 370 N.J. Super. at 347-48, a brief review of the salient facts is presented here.

After the operator explains the process to the individual, the operator removes a new mouthpiece from a sealed plastic bag and inserts it onto the breath hose. The operator then starts the instrument and inputs basic identifying information such as the test subject's name, weight, age, and identifying documentation and license number. The instrument automatically inputs the time and date.

The breath test sequence adopted for New Jersey consists of the following steps: ambient air blank check; control test; ambient air check; breath test one; ambient air check; breath test two; ambient air check; control test; and ambient air check. The purpose of the ambient air checks is to ensure that the air in the instrument's chamber (or cuvette) is free of any interfering substances and registers an alcohol level of 0.00%.

For the breath test, the operator instructs the individual to take a deep breath and blow into the instrument. When ten asterisks appear on the LED screen, the subject has reached the minimum volume requirement of 1.5 liters. However, the ADTU trains operators to encourage subjects to blow up to 3.0 liters (or until twenty asterisks appear on the screen) in order to ensure that the subject has reached deep lung air. After registering at least the minimum volume of air required for testing, the operator instructs the individual to stop blowing.

Upon completion of the test sequence, the Alcotest 7110 prints an AIR on an 8.5 X 11 sheet of paper which contains the individual's identification, date, time, and test results for each stage of the procedure. If the results are within the acceptable tolerance, the AIR shows the successful BAC values to three decimal places. The AIR then shows the final BAC test results as the lowest of the four readings which the instrument truncates to two decimal places. The AIRs are sequentially numbered. The ADTU instructs operators to give one copy to the local police department, retain one copy, and give a copy to the subject.

The Alcotest 7110 has a modem capable of communicating with a central server. Such communication would allow for data to be uploaded daily or weekly from each instrument in the field to a central location for the purpose of data collection. The digital data would be maintained there for a period of time which this court believes should not be less than ten years. Draeger is willing to provide the State with a Microsoft Access database program at no cost.

New Jersey, however, does not use the standard modem. Brettell discussed the issue of centralized data management with the Porter Lee Corporation, the software company which created New Jersey's laboratory information management (LIM) system. In September 2005 Porter Lee gave Brettell an estimate of $9760 for the transfer of the Alcotest data to the LIM database. The State, however, never proceeded with the project.

As of the time of this hearing, ADTU coordinators download the electronic data in the field onto their laptops. Although the Alcotest 7110 has the option to store 1000 test results, New Jersey protocol requires coordinators to download data at or before 500 tests.

Finally, the Alcotest 7110 relies upon source codes which consist of its own language with syntax, specially named routines, and formatting conventions. An examination of the source codes presumably would reveal if the firmware was properly implementing the intended algorithms and computations, and if the data communication, retrieval and input software was subject to malicious manipulation.

We already have discussed Draeger's grudging attitude and non-cooperation about revealing the source codes during discovery. From the onset of this matter, the parties could not agree about terms for inspection of the source codes. We cannot fault the refusal of defense counsel to permit the Draeger interests to propagandize the court in an ex parte proceeding. See R. 1:2-2. Nor can we fault the defense's rejection of Draeger's proffer of an inspection in Durango, Colorado under very restrictive and sanitized conditions.

But we draw no negative inference against Draeger for its recalcitrant and less than forthright cooperation in discovery in this litigation, which centered upon the integrity of its Alcotest 7110 product. Indeed, Ryser's response to the subpoena served upon him and the Draeger interests during his cross-examination in this case on October 12, 2006, and at this court's suggestion, was substantial and very helpful to this court and the parties. We do not think that this dispute about the source codes has any substantial relevance to our ultimate conclusion, that the Alcotest 7110 instrument is very good at measuring breath alcohol. Further, we conclude that the under-resourced defendants and amici had no way of examining or testing the elaborate source codes at this late point in the litigation. Source code issues arise when the instrument fails to perform properly or its various components fail to interface with each other. We have seen no hint of source code problems or failure throughout this litigation.

IV. EXPERT TESTIMONY

1. Summary of Testimony of State's Expert and Draeger's Principal, Hansueli Ryser

Hansueli Ryser was born and raised in Zurich, Switzerland where he received an electrical engineering degree in 1973 from the Federal College of Technology (19T13).*fn1 After working several years as an engineer for Seeholzer AG in Zurich, Ryser joined CMI, Incorporated, the manufacturer of the Intoxilyzer (19T16-19T17;19T51). At CMI, he designed electronic circuitries for the Intoxilyzer series (1978-1979), established a quality assurance department (1979-1980), served as director of manufacturing (1980-1982), and ultimately became president when it came under new ownership (1982-1986) (19T16-19T18;19T25-19T26). He then accepted the position of Director and CEO at EyeMetrics Corporation in Switzerland, a firm which specialized in optics and electronic imaging analysis (19T16;19T18;19T27).

In early 1991, Ryser became President of Draeger Switzerland AG, a subsidiary of Draeger Safety AG (19T14-19T16;49T58). In mid-1994, Ryser established the Breathalyzer Division of National Draeger, Inc. in the United States (19T15;49T30-49T31). In 2002, the Breathalyzer Division merged with Draeger Interlock, Inc. (a separate company which sold breath analyzers for installation in cars) and the name changed from National Draeger to Draeger Safety Diagnostics, Inc. (Draeger) (19T14;49T30-49T31;49T104). Draeger has offices in Durango, Colorado (production, servicing and engineering) and in Dallas, Texas (sales and marketing, and the interlock business) (49T104). Ryser is vice president in charge of the Durango operations, where he supervises a staff of thirteen (19T15;49T143;50T9). He holds dual citizenship: Swiss and American (19T60).

Ryser ranked these Draeger entities in their hierarchy: (1) Draeger; (2) Draeger Safety, Inc. (DSI); (3) Draeger Safety AG (Draeger AG) in Luebeck; and (4) the holding company, Draegerwerk Aktiengesellschaft (Draegerwerk AG) in Luebeck (23T4;49T59;49T140;49T142;50T14). According to Ryser, Draeger remained under the "very tight control" of Draeger AG (19T59).

Ryser is a member of several professional organizations including the International Association of Chemical Testers (IACT), the National Safety Council's Committee on Alcohol and Other Drugs, and the National Commission for Alcohol and other Drugs (19T19). He previously testified in Florida on the scientific reliability of the Intoxilyzer 5000, in Colorado on the source code issue relating to the Alcotest 7410 handheld instrument, and in Foley (19T19-19T20;19T24-19T25). The State moved to qualify Ryser as an expert in electrical engineering and breath-testing devices (19T20). He testified over the course of seven days.*fn2

In 1984 the Draeger organization acquired Smith and Wesson, the manufacturer of the breathalyzer, partially to gain access to the United State's market (20T49-20T50;20T54). Ryser believed that the breathalyzer's once state-of-the-art technology still was "very proper and correct" (20T51;20T56-20T57). He explained, however, that the breathalyzer differed from the Alcotest 7110 in several major respects: (1) the breathalyzer was more susceptible to an operator's influence; (2) every thirty days, a trooper had to check the breathalyzer in the field; and (3) the breathalyzer recorded data by the operator's hand on a "little paper" (20T51-20T56;51T88).

In 1995 Draeger introduced to the United State's market the first Alcotest 7110 MKIII which was "built" in Durango (49T116). The instrument was tested successfully by NHTSA and by independent laboratories against OIML standards including the MNI Laboratory in the Netherlands (OIML draft three) (1994) and NLA (or NLE) the national laboratory in Paris (OIML draft four) (20T41-20T42). In 1998 the German government also tested the instrument against the OIML specifications, which provided the basis for Germany's switch from blood analysis to breath (20T43).

The Alcotest 7110, however, is not included on the OIML certification list (51T101). In fact, the list contained only one breath-testing device which was the Seres instrument made in France by a company that subsequently went bankrupt (51T102). Because of the cost of OIML testing, in excess of $45,000, and the fact that its requirements have been continuously diluted over time, Draeger has not submitted the Alcotest 7110, NJ 3.11 for OIML testing (51T102).

The Alcotest 7110 instrument costs approximately $7300 for the basic instrument or $10,000 for the entire system, excluding extended warranties or other services (19T62-19T63). At the time of the hearing, the Alcotest 7110 was used exclusively by the State Police in New York, New Jersey (except for four counties which are awaiting the changeover), Alabama, Massachusetts, and the Ramah Navaho Indian Reservation in New Mexico, and nonexclusively in California, Rhode Island, New Mexico, Oregon and Illinois (20T43-20T45;20T47;21T11;50T45-50T51).*fn3 It also is used exclusively in Guam, the Northern Marianas, Finland, Germany, Austria, Italy, Spain, South Africa, Taiwan, Hong Kong, and Bulgaria, and non-exclusively in various former Russian or Soviet countries, the Middle East, Australia, and Denmark (20T45-20T47;20T60). New Zealand also used an infrared table-top type instrument, although it was unclear from the testimony if Ryser was referring to the Alcotest 7110 (20T48).

In 1998 Draeger delivered the first instruments to the New Jersey State Police (22T72). In September 2002 Draeger and the State entered into a software licensing agreement (22T74). To date, New Jersey has bought 480 of the instruments with extended four-year warranties for approximately $11,800 each (19T63;21T12;26T34).

Ryser fully described the Alcotest 7110, NJ 3.11, including its various components (19T79-19T148). For a detailed discussion and visual demonstration, we refer the reader to the videotape produced during the hearing (S-26).*fn4 A brief overview follows.

The Alcotest 7110 analyzes alcohol vapor in the human breath according to an evidential protocol (19T80). The entire system includes a special organizer stand with a drawer, a breath analyzer, a standard keyboard, an external laser printer, a wet bath simulator used to introduce a known alcohol concentration for accuracy verification purposes, and a temperature probe (19T62-19T63;19T79-19T82).

The instrument's external features include: various interfaces on the back side including an exhaust port, an outlet port delivering air to the simulator, and an inlet port to the cuvette; a power button; a start button which engages a test or wakes up the instrument from standby mode; a forty-character backlit fluorescent display screen; a serial tag; a flexible breath hose which is forty-six inches long (so the subject does not have to bend forward to take the test) and heated with two temperature sensors to 43 degrees C plus or minus 3 degrees C to prevent condensation and overheating of the rubber hose; a mouthpiece for the breath hose which ensures a better seal, makes it easier to exhale, and aids hygiene; and an AC power cord (19T83-19T91;19T120;19T122;21T53-21T57).

The internal features include: an infrared (IR) absorption chamber or cuvette; an electrochemical sampling system (EC) which consists of a fuel cell, pump, and motor; a power supply for direct current (DC) low power voltage to the entire system; a DC pump which purges the air inside the cuvette after a test is completed and provides air to the simulator for control check purposes; a solenoid which sends air to either the cuvette or the simulator; a large printed circuit (PC) board or motherboard which contains all the electronic components including the microprocessor*fn5 and the electronically erasable programmable read only memory (EEPROM) which stores the firmware; an interface board which contains all the outside connections; an internal printer which prints data on register-type tape as opposed to the easier-to-read letter-size paper used by the external printer; electrical chokes; an AC compartment; a pressure sensor which provides information on breath volume; and a flow sensor which detects and measures the flow rate of a subject's breath (19T82-19T83;19T91-19T93;19T98-19T99;19T101;19T112-19T113). Ryser explained that the Bundesamt, the German governmental entity for legal metrology, required redundant sensors (19T99-19T100).*fn6

The Alcotest 7110 is the only breath-testing instrument using dual technology to quantify alcohol concentration in the same breath sample (19T175-19T176;20T21). Draeger does not hold a patent for the dual technology, but holds several patents for certain processes within the system (19T38;20T21-20T22). Ryser believed that Draeger did not aggressively pursue patents, desiring to avoid disclosure of company "trade secrets" (20T22;22T67). The name "Alcotest," however, is protected as a trademark (19T40).

IR technology has been available since 1974 (19T174). In the Alcotest 7110, IR technology acts as the "real time analyzer" because it observes breath from the beginning to the end of its presentation (19T174). The solid brass IR chamber is heated to prevent condensation on its walls and internal parabolic mirrors (19T94-19T95). The mirrors cover the front and back of the chamber, and are gold-coated to optimize IR energy reflection (19T95).*fn7 The mirrors deflect the IR energy within the chamber a specific number of times before the energy hits the IR detector (19T95).*fn8 The IR filter (which sits on top of the detector) allows only those parts of energy to pass through the filter that relate to 9.5 microns*fn9 on the IR spectrum (19T132;21T60). Unlike the majority of breath-testing instruments operating at the 3.4 or 3.5 micron range, the higher wavelength is less susceptible to endogenous interfering substances such as acetone, acetaldehyde and ketones (19T155-19T158;21T60-21T61). The chamber's inner volume is small enough at 70 ml. to avoid mixing old with new breath but large enough to absorb energy when alcohol vapor is present (19T93;19T153).

EC technology or fuel cells have been used since the mid-1960s for alcohol measurement (19T162). In the mid-to-late 1980s, the introduction of microprocessors provided the speed necessary to allow fuel cells to perform calculations for evidential purposes (19T162-19T163). Unlike IR technology, the fuel cell in the Alcotest 7110 waits until the end of exhalation to take a breath sample out of the IR chamber for analysis (19T175). The fuel cell consists of plastic housing about an inch in diameter with a vapor inlet port and an exhaust port leading to the pump (19T97-19T98;S-28). Its interior contains a porous matrix of plastic material filled with sulfuric acid (19T97). There are platinum plates on both sides which are attached to two electrodes or wires leading to the outside of the fuel cell housing (19T97). A small piston pump assembly draws in a sample approximately one cubic centimeter in volume from the same breath sample, which is already in the cuvette (19T134;19T161).*fn10

Another standard feature includes shielding for RFI, which can affect the instrument's components (19T104). RFI refers to interference which enters the instrument from the outside whereas electromagnetic interference (EMI) refers to interference which the instrument generates (23T39;61T19-61T20). Both RFI and EMI are subsets of electromagnetic compatibility (EMC) (23T39). The Alcotest 7110's shielding consists of metal coating underneath the top lid along with a metal bottom, which simulates a faraday chamber by preventing any electromagnetic waves from entering the instrument (19T106;19T129).*fn11 Ryser also explained that the instrument's five-layer PC board is designed specifically to suppress the influence of RFI (19T107-19T108;23T38-23T39).

Because of the shielding and special design, Ryser did not recommend that New Jersey purchase the optional RFI detector offered by Draeger (19T109;61T43-61T44). To the contrary, he expressed concern that the detector required a small hole in the faraday chamber to bring the signal into the processor (19T109).*fn12

Instead, Ryser recommended RFI testing in a special laboratory where the Alcotest 7110 would be exposed to different frequencies (19T109). For example, the National Laboratory for Metrology in Holland and the national laboratory in Paris performed RFI testing on the Alcotest 7110 in accordance with OIML standards (19T110;61T57-61T58). The tests were done in a special radiation chamber with an antenna source which allowed for the transmission of various frequencies and modulations (61T58). The tests exposed the instrument to radiation as strong as ten volts per meter and over a frequency span up to one gigahertz (61T58).

To detect interfering substances, the Alcotest 7110 compares the IR and EC readings (19T169). If only alcohol (ethanol) is present, the readings are similar (19T173). If another substance is present, however, the readings diverge (19T173). There is a preset tolerance that requires the results of both readings to be within .008% BAC or 10% of the IR reading, whichever is greater; if the two results exceed the tolerance, the instrument displays an interference message and aborts the test (19T168-19T169;19T173-19T174). Draeger set the tolerance to make the system compatible with OIML standards (19T169).

Ryser testified that the two samples or four tests (two IR and two EC) must agree within plus or minus .01 BAC of the average of the four measurements or plus or minus 10% of the average of the four measurements, whichever is greater (19T170). If the first two breath samples are not within acceptable tolerance agreement, the Alcotest 7110 requires collection of a third, valid breath sample (D-15 at 13). Recognizing that there had been confusion over the correct tolerance, Ryser explained there was no change between versions 3.8 and 3.11 -- the only two versions used in New Jersey -- but that the language in Draeger's operator's manual for version 3.8 was not correct (22T36-22T38;49T53). This language has been corrected for current use.

Draeger calibrated its evidential breath analyzers based upon the customer's request (19T73). Draeger calibrated the Alcotest 7110 in New Jersey to interpret a certain concentration of alcohol with reference to a blood/breath ratio of 2100:1 (21T70). Ryser understood the ratio in the population was higher and believed that the 2100 figure favored an average defendant (21T70;22T20-22T21). While he could not recall the exact percentage, he seemed to agree that the ratio favored at least 84% of the population (21T71-21T72). He also understood that the ratio differed between individuals and for the same individual from time-to-time based upon changing physiological conditions (21T70-21T71). Draeger recommended that the instrument be recalibrated every twelve months (50T21-50T23).

Ryser also reviewed New Jersey's testing protocol. New Jersey's control test verifies accuracy every time a breath test is done (50T26;50T30). Ryser considered this the most rigorous possible quality control regime.

First, an ambient air blank verifies that the air inside the chamber is free of any absorbing alcohol vapor (19T178-19T179). Essentially, the air blanks force ambient or room air through the chamber to produce a result of .000% alcohol levels (19T178-19T179).

Next, a control test verifies the instrument's accuracy by using a simulator with a known standard of water-ethanol solution (19T179). With a probe to monitor the solution's temperature, the simulator is heated to 34 degrees C to produce a reading equivalent to the targeted value labeled on the bottle (19T181-19T182). The testing protocol requires a bottle of known standard solution of .10, which must be changed every thirty calendar days or twenty-five subject tests (50T85). Periodic calibration inspections use standard solutions of .04, .08, .10, and .16 (50T84). Draeger produces the simulator and temperature probe, both of which are returned to Draeger for recertification and calibration every twelve months (19T67;19T183;19T185;19T189).

Draeger purchases the simulator solution from an independent laboratory called Plus Four Engineering in Colorado and then, sells it to New Jersey in batches of 1000 bottles (19T190-19T191;50T99;50T100-50T101). However, it first ships six bottles -- the first two from the lot, the middle two, and the last two -- to the State Laboratory where Brettell or his associates perform quality control testing (50T102). Each bottle has a "shelf life" of two years (50T103).

Ryser also testified about the margin of error determined by using freshly certified standard solution and a NHTSA-approved simulator (61T65). He explained that the margin of error was the same as the one employed by New Jersey for control testing, and recommended by the NHTSA and OIML specifications (61T65). For the Alcotest 7110, it was plus or minus .005 BAC (absolute tolerance) or plus or minus 5% (relative tolerance), whichever was greater (50T17-50T18;51T64;61T71-61T72).*fn13 The absolute tolerance applied to concentrations below .10 whereas the relative tolerance applied at or above .10 (50T18-50T19). Therefore, a subject who presented a reading of .08 would have a relative tolerance window from .076 to .084 (61T72).*fn14 However, that same subject would have an absolute tolerance window from .075 to .085 (61T72). Because the absolute tolerance window was greater, all readings would have to be within .075 and .085 (61T73). Ryser was unaware of any state program that automatically reduced an alcohol reading by the instrument's margin of error, although he noted that Alabama apparently recognized it by refusing to prosecute anyone unless they had result of at least .084 (50T19).

Regarding the actual tests, Draeger designed the Alcotest 7110 to measure samples of alveolar or deep lung air (19T191). To accomplish that task, Draeger proposed, and New Jersey accepted, four sampling criteria: (1) a minimum flow rate of 2.5 liters of breath per minute; (2) a minimum blow duration of at least 4.5 seconds; (3) a minimum breath volume of 1.5 liters; and (4) the use of a slope detector to ensure that the instrument waited until the IR absorption plateau is reached (19T191-19T192;20T77-20T79;D-7 at 21). If the sample did not meet all of the minimum criteria, the screen displayed an error message (20T5).

Draeger also designed the Alcotest 7110 to detect potential residual alcohol in the mouth cavity produced by regurgitation, burping, belching, or hiccups (20T5;21T99). Alcohol also can be retained in the mouth in cavities, under dentures or in certain absorbent materials such as chewing tobacco or food (21T99). Absent any direction from NHTSA or the states regarding the conditions under which mouth alcohol detection must occur, Draeger relied upon the OIML specifications to develop its safeguard routine (20T6).*fn15

The Alcotest 7110 is manufactured by the parent company in Luebeck (20T9). Draeger in Colorado customizes the instrument to the specific applications requested by each state (20T9). For example, the instrument by default is manufactured to accept a wet bath simulator that can attach to the back but can be modified if a state prefers to use a dry gas standard (20T9). Draeger follows a lengthy checklist to verify that the instrument is calibrated within the specified tolerance and that it is built with the correct firmware according to the customer's specifications (20T10). Draeger also verifies the serial number, performs temperature verifications for the breath hose and cuvette, checks the printer, and cleans the instruments (20T14-20T15). After it completes all the quality control and quality assurance steps, Draeger issues a twelve-month certificate of accuracy before it ships each instrument to the customer (20T10).

Draeger offers a standard twelve-month warranty (20T11). It also offers an extended four-year warranty which New Jersey chose to purchase (20T11). Draeger performs all warranty work at no charge for parts and labor (20T12). In 2005 New Jersey returned for repairs three instruments to Draeger from Middlesex County (20T12). The East Brunswick Police Department returned one instrument for replacement of the motherboard, which is manufactured by another company in Germany and delivered complete to Draeger (20T13-20T14;21T29-21T30;S-33). Because the motherboard basically held the "entire electronics real estate," Ryser acknowledged that anything stored on the random access memory (RAM) chip, mounted on the motherboard's surface, could be lost (20T15;50T42;50T59-50T61). He noted that the motherboard had been sent to Luebeck where it probably was undergoing repairs in the service department (50T63;50T80).

The East Brunswick police also returned an instrument for replacement of the printer cable, which essentially required a new connecting wire between the motherboard and the receptacle for the external printer (20T16;S-34). New Brunswick also returned an instrument which showed an error -- its memory was exceeding capacity (20T17-20T18;S-35). In the last case, Draeger cleared the memory and performed the requisite tests to confirm that the instrument was functioning properly (20T18).

The Alcotest 7110 consists of "core" software that has never been changed since the first units were built in Durango in 1995 (49T116;61T66). The core software contains the essential routines relating to how the instrument measures and analyzes alcohol vapor (23T58;24T55;24T58). These routines or critical functions include the IR and EC systems, the temperature sensors on the breath hose and cuvette, pressure sensor, flow sensor, AC/DC analysis, and general processor controls (24T58;24T60-24T65;D-99). Despite vague earlier testimony, Ryser insisted that the Alcotest 7110's core software was the same everywhere (49T119-49T120). Among other things, Ryser modified his earlier statements that the core software in Alabama's instrument had been changed for breath temperature sensing and fuel cell fatigue, claiming they were customized features which did not affect the way the unit read alcohol (25T17-25T18;49T119;61T66-61T68). We think this was no more than a dispute bout nomenclature.

The Alcotest 7110 also consists of customized software or firmware (20T18-20T19;24T55). Firmware consists of the binary code of the "compiled source code," and contains all the instructions or routines necessary for the instrument to operate according to precise guidelines and specifications (20T19). Ryser noted that firmware constantly changes (20T33). Such revisions can by initiated by the customer or the manufacturer (if laws or regulations change, or tolerances change) (20T33;49T81-49T82). For example, since 1998 Draeger has made approximately twenty-seven revisions to the Alcotest 7110's firmware in Alabama's program which Ryser described as very complex (25T12;25T15;25T29-25T30;D-100). As an aside, Ryser indicated that Draeger will have to update the firmware in 2007 to make its instruments compliant with the new daylight savings time structure (20T33;25T41-25T42). Draeger, however, will not make firmware changes that affect the measurement of alcohol (20T31-20T32). Draeger also will not make changes which may affect an instrument's compliance with the NHTSA specifications without first advising the customer (20T32).

Each time the firmware changes, Draeger assigns a new firmware number which initially is accompanied by a letter designation (20T33). After the engineering department performs a quality assurance test, the instrument is given to the technical writing department which runs control tests and writes a new manual (20T34). The instrument then goes to the service department where the instrument is checked again for quality control and assurance (20T34). Draeger then instructs its customers to perform all the necessary tests to assure that it has successfully embedded the requested changes (20T35). Only after the completion of successful testing by the customer will Draeger remove the letter designation (20T35). The new firmware version then is installed and recorded in the instrument's EEPROM (20T35).

Unlike Alabama and Germany, New Jersey did not purchase the optional breath temperature sensor (20T72;22T20). While Germany uses the sensor to make both upward and downward corrections, Alabama uses it to make downward corrections in the software of 6.58% for each degree that the subject's breath temperature exceeds the standard 34 degrees C programmed into the instrument (20T72;61T58). This rise in breath temperature causes the BAC reading to increase to this extent.

The sensor costs about $1300 if ordered at the time of manufacture or $1600 if retrofitted to the top of an instrument (19T64). For calibration, the temperature sensor requires substantial equipment including two large heated tanks which cost about $15,000 each and two automatic calibration devices which cost about $36,000 each (61T62).

While Draeger offered the sensor in its literature and Ryser admitted that it makes the Alcotest 7110 a better instrument, he does not "loudly" market it for several reasons:

(1) Draeger is the only manufacturer that offers the feature and if he pushed it too strongly, it might reflect on the reliability of other breath-testing instruments; and (2) the 2100:1 ratio already "took into account" this variability in breath temperature (22T23-22T28;61T40;61T58).

The Alcotest 7110 stores approximately 1000 tests (20T37). After the memory is full, the data can be removed by an upload procedure to a computer (20T37-20T38). If the tests are not removed, they will be erased on a first-in, first-out basis (20T38). New Jersey's instrument also has hardware capable of communicating with a remote computer -- similar to the Alcotest 7110 system used in Alabama -- but Ryser said the State claimed it did not have the financial resources to install dedicated telephone lines to allow frequent data uploads (20T38-20T39;49T87). If New Jersey did download data via computer or modem to a central computer, Draeger could provide a program that used Microsoft Access to "grab" the information relevant to New Jersey's breath-testing program in a readable format (20T40-20T41). The program would be limited to 255 fields, instead of the current 310 fields in New Jersey's current software (61T55-61T56).

The source codes for the Alcotest 7110 consist of 53,744 lines or approximately 896 pages (20T106;22T22;D42). Software engineers in Luebeck wrote the code in C or C computer language which is humanly viewable but only meaningful to a programmer (20T106-20T107;22T117;23T68). The codes, however, cannot be understood without access to the Alcotest 7110's algorithms and hardware (20T109). Because Draeger puts a "tremendous amount of effort" into the development of its breath-testing instruments, it views source codes as highly proprietary (20T20;22T113). Specifically, Draeger believes that release of its source codes would give its competitors a chance to duplicate its "state-of-the-art" technology (20T24). Ryser explained that Draeger was the technology leader in the breath-testing field as, for example, it was the first company to operate a breath-testing instrument at 9.5 microns in the IR spectrum and the only company to use a dual IR and EC system to quantify breath samples (20T20-20T21). Draeger keeps the source codes for New Jersey's Alcotest 7110 in its engineer's locked computer in Durango (49T135-49T136).

In April 2006 Ryser attended an IACT conference in Anaheim, California where he presented Draeger's new instrument, the Alcotest 9510 (20T113).*fn16 At the conference, he approached representatives of several competitors about their source code policies including CMI (which would not discuss the issue due to ongoing litigation), Intoximeter (which refused to release it), and National Patent (which invited attorneys to its factory in Ohio to examine the code) (20T27;20T112).

At Ryser's suggestion, Draeger changed its policy to adopt the approach taken by National Patent (20T28). Since then, it received one inquiry from attorneys in Massachusetts (20T28-20T29). To date, Draeger has not released source codes to any of its customers (20T30). Nor has Draeger apparently released the actual algorithms although it has provided customers with explanations of how the Alcotest 7110 determines mouth alcohol (20T20).

During the hearing, Draeger and defense counsel by negotiation reached a tentative agreement in principle relating to the source code issue and techniques to insure the Alcotest 7110's scientific reliability (61T5-61T6). Defense counsel agreed to forego further cross-examination of Ryser and to limit its direct case to concerns about hardware issues (61T7). In return, Draeger agreed to: (1) submit the source codes and algorithms for the Alcotest 7110, NJ 3.11 to a jointly acceptable independent software house for examination; (2) program the software to include a self-reporting tamper feature to prevent any modifications except for intentional ones which Draeger would report; (3) allow a laboratory in the United States to verify that the next revised firmware version of the Alcotest 7110 (possibly NJ 3.12) satisfied OIML specifications; and (4) sell the instrument to defense attorneys and experts on the same terms that they sell them to the State of New Jersey (61T8-61T11;61T14;D-232). Ryser understood that these terms would be included in the Special Master's recommendations and findings of fact (61T7;61T17). Of course, he recognized that Draeger's license agreement with the State required the latter's approval before the instrument could be used by someone other than a state representative (61T18).

Ryser also testified at length about the documents produced in response to a subpoena issued to him in court on October 12, 2006 addressed to Draeger and Draegerwerk AG (49T23;49T139-49T140;D-175;D-220). Draeger produced 578 pages of documents which referred to New Jersey's software (49T132). Draeger AG, the German "parent" company, did not respond to the subpoena, claiming that it did not have any offices or employees in New Jersey, and did not do any business or sell any products in the State (50T15). Ryser's testimony about these documents is incorporated where appropriate throughout this summary.

Finally, Ryser briefly addressed the "sucking" issue, i.e., where a subject sucks air back into the instrument (61T36;61T63). He was unaware of similar complaints from other users and was unable to duplicate the problem when Durango tested three instruments (61T38;61T64). Because the subjects in New Jersey apparently sucked the air into the instrument through the port by the breath hose, Ryser thought the problem could be a hardware issue (61T64). In the event, the "sucking" issue could not result in a wrongful conviction because the BAC reading is .000.

Based upon his training and experience, Ryser was 100% convinced that the Alcotest 7110 accurately read alcohol in human breath within the specified tolerances and was scientifically reliable (20T49).

This court finds that Ryser was a candid, forthright, and most cooperative witness. He seemed understandably uncomfortable at his company's secrecy and reluctance to disclose information. He was a very credible and thoughtful witness and the court could detect no evasive or deceptive quality in his testimony.

2. Summary of Testimony of State's Expert, Thomas A. Brettell

Thomas A. Brettell holds a Ph.D. in analytical chemistry from Villanova University (33T7). He is certified as a forensic laboratory director and a public manager by the State of New Jersey, and as a laboratory inspector by the American Society of Crime Laboratory Directors (33T8-33T9). He also is a certified Diplomate for the American Board of Criminalistics, which encompasses the collection, preservation and analysis of trace evidence (33T17). Brettell has certificates for breathalyzer and Alcotest 7110 training (33T9).

In March 1976 Brettell began working for the Office of Forensic Sciences, Division of the New Jersey State Police, as a forensic chemist and, in August 2001, became forensic laboratory director (33T9-33T10;33T13). At the time of the Alcotest hearing, Brettell supervised 250 personnel and had administrative and technical responsibilities for the State laboratory system, including: three regional laboratories for drug, toxicology and fire debris analysis; the criminalistics laboratory for drug and toxicology analysis; the full service laboratory for nuclear and mitochondrial DNA; and the equine testing laboratory (33T9-33T10;33T13). He planned to retire on December 31, 2006 (33T19;34T30).

Brettell is a member of the American Chemical Society, the International Association of Chemical Testing, and various forensic science associations, and has published numerous articles on basic chemistry, toxicology and drug analysis (33T15). He has testified as an expert more than seventy-five times in administrative, municipal and Superior courts in New Jersey on such subjects as drug analysis, forensic toxicology, and forensic chemistry, and testified on the scientific reliability of an evidential breath tester (EBT) in Foley (33T16-33T17). The State offered him as an expert in forensic chemistry and breath testing; the defense agreed that he was eminently qualified (33T17;33T35).

Over the years, Brettell worked closely with the Alcohol Drug Testing Unit (ADTU), which administers and manages the State's breath-testing program (33T13-33T14;33T36;34T109;41T43). While Brettell performed the scientific studies and validation of the instruments, the ADTU staff supervised the testing protocols, trained the operators, set up the instruments in the field, performed periodic testing including calibration and linearity checks, and gave testimony in court when needed (33T36;34T109). The ADTU, however, did not perform any actual maintenance on the Alcotest 7110 instruments, which were returned to Draeger for repairs (36T77;48T44).

From November 1995 through February 1996, Brettell assisted Dr. Charles Tindall (then chief forensic scientist) and members of the ADTU in the selection of an EBT to replace the breathalyzer in New Jersey (33T31;33T35-33T36;D-185). Brettell believed that the breathalyzer produced "very good, reliable, precise, accurate" results when operated and maintained properly, but explained that it was no longer produced and parts were increasingly difficult to find (34T23). The breathalyzer also depended upon operators to follow a checklist, perceive the movement of the pointer on the galvanometer, take a visual reading from the scale, and record the reading by pressing down the marker on carbon paper to make an imprint (34T23-34T24;39T20-39T21). We gather that this imprint was rarely used and produced in court. The visual reading usually was simply recorded by the operator.

The group selected four instruments which were considered "state-of-the-art" at the time, and had been successfully tested by NHTSA and placed on the conforming products list (CPL) (33T37). The instruments were the Alcotest 7110 MKIII, BAC Datamaster, Intoxilyzer 5000, and Intoximeter (33T36-33T37;D-185). They tested the instruments to determine which would fit best into New Jersey's program (33T38).

For each instrument, Brettell and Tindall performed validation studies including side-by-side testing for accuracy (how close the measurements were to the true value), precision (how close the measurements were to each other), linearity (how close the plotting of test results from solutions of increasing concentrations were to a straight line), and specificity (how the measurement of ethanol compared to other organic compounds) (33T38;33T41-33T42;33T49;34T35-34T37). The group also qualitatively evaluated the instruments for ease of operation, operator dependence, transportability, ticket printout information, computer compatibility, and integrity (D-185).

For accuracy, Brettell and Tindall took six known standards of simulator solutions ranging from .016 to .320 ethanol and ran twenty tests on the instruments (33T41;33T50). Using the same solutions, they also tested for precision by determining the standard deviations of the measurements, and for linearity by measuring the instruments' responses (33T41-33T42).

For specificity, they checked for interferents including acetone (a metabolite which appears on the breath of diabetics), isopropanol (rubbing alcohol), methanol (wood alcohol), and methyl tertiary butyl ether (MTBE) (an antioxidant found in oxygenated fuels and gasoline) (33T42-33T43;39T54-39T55). They checked for interferents by relying upon the instrument's use of dual technologies, EC or IR, to measure the same breath sample (33T45;42T14-42T15). If the two technologies deviated by more than .008 or the EC reading deviated 10% or more from the IR reading, the instrument signaled an interferent error (33T45;37T145).

For example, Brettell explained that the fuel cell did not respond to acetone, but that the IR spectrophotometer would detect acetone if the concentrations were high enough (33T46;39T52). By designing the Alcotest 7110 to detect IR absorption at the 9.5 micron range, Draeger eliminated the potential for acetone to interfere with the ethanol reading (39T52;39T57-39T58). Brettell said that his laboratory detected acetone at a frequency of maybe 10%, very infrequently detected isopropanol, and never detected methanol or MTBE (33T43-33T44).

Brettell found the Alcotest 7110 MKIII was reliable for breath testing, performed accurately with precision and specificity, and gave a good linear response up to .320 ethanol (33T48). He liked the dual detectors which produced two readings and the built-in safeguards against RFI and mouth alcohol, and the minimum blowing criteria (34T25-34T26). The evaluation group and the ADTU coordinators in particular found the instrument easy to operate, portable, essentially operator independent, computer compatible, and tamper-proof (33T48;D-185). The group also found it complied with the standards in OIML Draft III (47T54-47T55;D-185;D-186). Deputy Attorney General Hoffman represented to the court that the OIML historically had approved only one breath-testing instrument, which was made in France by the now-defunct Seres Company (47T57-47T58).

New Jersey selected the Alcotest 7110 with the wet bath simulator (33T52-33T53). The simulator contained the solution and vapor, was separately maintained, and was attached to the breath hose (41T126;45T73). The State also chose to use a laser-jet external printer so the AIRs would contain all the information customized to the State's program (33T53). Brettell explained that New Jersey did not select the RFI detector because the instrument already was shielded and had successfully been informally tested by NHTSA and OIML-approved labs (33T53-33T54). His lab also did some informal testing with walkietalkies, radios and "things like that," and found no variation from the expected outputs using known concentrations (33T54). Brettell was convinced there was no interference from radio frequencies (33T54).

Brettell decided that New Jersey did not need to purchase the breath temperature sensor option (33T55-33T56;35T72-35T73;35T119). The sensor consisted of a thermistor placed into the breath hose to measure the temperature of breath as the subject blew into the tube (33T56). In Brettell's opinion, the temperature sensor was not generally accepted in the breath-testing community based upon the lack of peer-reviewed scientific publications and the absence of its use in programs throughout the country, except in Alabama (33T56;35T73-35T74;35T120;35T122;44T70). Most vendors did not offer a similar option nor did they recommend setting the simulator temperature to anything other than 34 degrees C (33T56-33T57).

He mentioned that the purchase of sensors would impose additional costs on municipalities, but maintained that cost was not a factor in his decision (35T72-35T73).

Brettell was aware of research showing that changes in body temperature influenced the breath alcohol reading (37T186-37T187;51T55). As temperature increased, more ethanol molecules entered the breath, changing the partition coefficient (37T187-37T188;51T55-51T56). It was generally accepted that for every degree centigrade above normal body temperature, the alcohol reading in breath could vary by about 6.8% upwards, requiring an adjustment (33T60-33T61;51T55-51T56). Alabama used the sensor to make only downward corrections; Germany corrected both upwards and downwards (35T102;37T184). In Brettell's opinion, however, there was no need to correct for breath temperature (33T63). He explained that the important temperature was in the deep lungs, not the bronchial tubes (33T61).

Brettell further explained that the Alcotest 7110 took into account such temperature variation by using a blood-breath ratio of 2100:1, which was lower than the actual ratio of 2300 or 2400:1 reported recently by A.W. Jones (33T62;39T85).*fn17 By doing so, the instrument underestimated alcohol in the blood by 9 to 10% (33T62). The 2100:1 ratio was not programmed into the software but was based upon the fact that when the simulator solution turned from a liquid to a gas it would be in the ratio of one gram per 210 liters (34T106-34T107). If the State wanted to reduce the ratio to 2000:1 to benefit more defendants, Draeger would only need to change the solution (34T107-34T108).

Draeger subsequently developed the Alcotest 7110 MKIII-C, which added a communication port (33T51-33T52). The communication consisted of a modem, which allowed the instrument to obtain data over the telephone (44T44-44T45). New Jersey purchased the instruments and customized the firmware (33T64). Prior to its use in the field, the Alcotest 7110, NJ 3.8, was tested successfully by Brettell and Lt. Tom Cambria, now retired, and by NHTSA for accuracy and precision (33T88-33T89). Brettell did not recall working with firmware version 3.6 (39T9-39T10).

New Jersey then engaged in the Pennsauken pilot program which began in December 2000 and continued for one calendar year; this tested 372 subjects in the field (33T64;33T89;34T31;34T39-34T40). Brettell reviewed and analyzed the data, and testified about the results in Foley which raised several issues, including: the instrument was not reporting the lowest breath alcohol concentration when it went to a third test; the minimum volume of 1.5 liters possibly was too high and should be lowered; the operator did not have the opportunity to terminate the test without charging refusal, resulting in a high "automatic" refusal rate of 28%; the blowing instructions were "a concern" and should be changed; and an operator had to use the "black key" to set the instrument to truncate the final BAC result to two decimals (33T90-33T92;34T83).

There is a probe value on the black key which matches a particular temperature probe (35T47). The coordinator enters the probe value into the instrument (35T46-35T47). The probe values differ and are used to ensure that the simulator reads at the proper temperature (35T48;35T56;47T44-47T45). The probes are periodically returned to Draeger for recertification (36T70;36T72). Brettell was aware that Draeger also had a yellow key which apparently inhibited incrementing the sequential file numbers and setting the calibration file number, date of calibration, and storing of the calibration record (46T74-46T75; D-175 at DS168).

After the Foley decision, the State asked Draeger to make certain firmware changes to include more information on the AIR and add error messages, among other things (33T64;33T93). Draeger subsequently produced firmware version 3.9, which New Jersey never saw (33T65;47T79). Instead, in June 2004, Draeger gave the State a beta version 3.10Y for testing and validation (33T65;33T79;33T104;43T82;D-175 at DS174).*fn18 All requests for software changes -- scientific and administrative -- required Brettell's approval (43T88-43T89). And Brettell, not the ADTU, tested the firmware (43T117).

Among other things, NJ 3.10Y incorporated the following changes: (1) operators had the option to terminate the test, rather than record it as a refusal; (2) the instrument automatically truncated the final blood alcohol result to two decimal points; (3) the instrument added the safeguard of a two-minute lockout between breath tests; and (4) the instrument allowed the operator to follow protocol for the twenty-minute observation period, no longer automatically locking the instrument (33T96-33T99;33T102;42T71-42T72). With regard to the latter, if a subject regurgitated, burped or belched or was not continuously observed for twenty minutes, Brettell explained that the change allowed an operator to test another subject in the interim and restart the process again for the initial subject after a full twenty-minute observation period had elapsed (33T99;37T25;40T11). He further explained that local police departments had discretion to determine when the observation period began, either on arrest or on arrival at the station house (36T47;46T23-46T24).

At Brettell's request, the revised firmware also addressed the high refusal rate in Foley by displaying error messages on the screen so that operators could take them into consideration (33T96). The State also changed its training protocol to teach operators to instruct subjects to blow deep breaths (33T96). The new instruction stemmed from the assumption that breath at the end of a deep exhalation accurately reflected alveolar or deep-lung air (39T66). Additionally, Brettell requested changes in the AIR ...


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