Feasibility Study – WingMan Drug Detection Device (DDD)™ (patent pending) 1.1 Introduction Trace detection Raman spectroscopy is a powerful chemical analysis technique for stand-off and microscopic analysis of both organic and inorganic compounds. The WingMan DDD™ (patent pending) design utilizes Raman spectroscopy as its core technology in a novel application for upper respiratory drug examinations, forensic trace detection of latent fingerprint residues and toxin identification. A variety of Raman spectroscopy techniques have been successfully utilized for in vitro analysis of biological fluids. Non-invasive in vivo analysis of ocular fluid to determine blood glucose concentrations has been demonstrated by Pelletier, Lambert and Borchert utilizing an NIR Raman laser spectroscopy technology, and in vivo oral fluid analysis may be feasible utilizing an analogous methodology (Pelletier 2005). Detection of compounds with masses as low as approximately 1ng has been demonstrated by Dr. Ilana Bar utilizing a Raman microscope and an inexpensive excitation laser illuminator source (Malka 2013). A similar nanogram level trace detection capability has been demonstrated by Dr. Henric Ostmark, Swedish Defense Research Agency, utilizing stand-off Raman trace detection methodologies and an 11 inch telescope resulting in spectral acquisition times of less than 1 second (Ostmark 2012). Polish researchers have also successfully utilized an eye-safe Raman spectroscopy system to detect alcohol vapor in automobile cabins at stand-off distances (Młyńczak 2014). Though the three latter investigations were focused on the detection of explosive residues, vapor traces and latent fingerprints, there are a number of potential applications for Raman technology in the life sciences, emergency response and forensics spheres. Trace detection utilizing Raman spectroscopy at distances of 1-321mm will be feasible via a custom optical design, an intensified charge-coupled device (ICCD) and other filtration components (Ostmark 2011). The miniaturization of SSE Raman systems is a critical development for the feasibility of the WingMan DDD™ (patent pending) as an original equipment manufacturer (OEM) SSE Raman platform could be utilized as the core engine of the system and enable rapid development, trace detection optimization and commercialization (Tague 2015).

1.2 Executive Summary WingMan DDD™ (patent pending) – A Device and Method for Instantaneous Drug Testing in the Field Nicholas Wing and Dr. Brian Manhire, professor emeritus of electrical engineering, Ohio University, have conceptualized and designed the WingMan DDD™ (patent pending), a handheld Raman chemical analysis device for roadside drug/alcohol examinations, latent fingerprint residue detection and toxin identification in the field. Need: The paucity of effective roadside DUI/DUID drug testing solutions, and the total lack of an inexpensive and instantaneous field drug testing system, has led to a national crisis. On July 31st, 2014, Rep. John Mica stated that drug and alcohol impaired driving has been responsible for more than 50% of all fatal motor vehicle crashes (MVCs), or more than “a quarter of a million” fatalities, since 2000 (Statement 2014). According to the National Highway Traffic Safety Administration (NHTSA) 2007 National Roadside Survey (NRS), it is seven times more likely that an injured night and weekend driver will test positive for controlled substances than for alcohol alone (U.S. Dept. of Transportation 2008). Further, in 2009, 33% of fatal MVCs involved drugged driving, according to the NHTSA and the Fatality Analysis Reporting System (FARS) (U.S. Dept. of Transportation 2010). In the same report, it was estimated that nearly a half million Americans were injured in drugged driving MVCs, and the total annual cost attributed to these collisions is estimated to be upwards of $60 billion. Current drug testing technologies and legislation have lagged behind the problem. Whereas there are BAC standards for determining levels of intoxication for alcohol, no comprehensive standards exist for illegal and prescription controlled substances, and therefore, “per se” zero-tolerance legislation provides the greatest level of safety and an immediate enforcement capability. Due to a lack of comprehensive screening technologies, many DUIs are actually DUIDs; however, it is easier to successfully prosecute a DUI drunk driving vs. a DUID drugged driving charge (DuPont 2012). The adoption of technologies which can simultaneously screen for alcohol and illegal and prescription drugs utilizing a single biological sample will therefore result in more accurate data and an increase in successful DUI/DUID convictions. Solution: The WingMan DDD™ (patent pending) and the suite of spectroscopic chemical analysis products resulting from the original patent will provide law enforcement and EMS first responders with powerful new handheld in vivo and in situ drug screening and forensic trace detection chemical analysis devices. The WingMan DDD™ device and method of examination will be inexpensive, repeatable into the millions of testing iterations, and as accurate as laboratory scanning. It is also nonintrusive to the test subject and may more readily meet the Constitutional test under the IV Amendment as it does not require the “seizure” of a biological sample nor sample preparation. The WingMan DDD™ could also be utilized to scan target surfaces of the vehicle (e.g. steering wheel, door handle, trunk) for particle remnants of illicit and prescription drugs. Due in part to the infeasibility of developing BAC equivalency standards for the multitude of drugs and poly-abuse drug combinations, 18 states have adopted per se and “zero-tolerance per se” DUID legislation for the use of illicit and prescription drugs and the operation of a motor vehicle. Intoxication standards similar to BAC measures are infeasible for the myriad of illicit and prescription drugs and will

prove ineffective in poly-abuse drug & alcohol DUID cases (DuPont 2012). There are 18 states which have adopted zero-tolerance “per se” legislation for the use of licit and illicit controlled substances and the operation of a motor vehicle (U.S. Dept. of Transportation 2010). Therefore, a positive presumptive result would warrant arrest, confirmatory laboratory testing and prosecution under the law in those states, and will aid law enforcement in gaining a search warrant to impound and search the vehicle. Model successes in “per se” drugged driving legislation and enforcement operations could be adopted and duplicated in other states. Conclusions: It is our express purpose to ensure that these devices meet and exceed the requirements of the U.S. Department of Justice, and that the test results are accepted in U.S. and international courts in support of the laboratory toxicology necessary in order to gain a DUID drugged driving conviction. Unlike other testing methods our device will establish the presence of illicit drugs and alcohol in situ and in the upper respiratory system, thus proving immediate consumption without having to take a biological sample from the test subject. In partnership with OEM manufacturers and academic research institutions, we hope to make our devices widely available to local, state and federal law enforcement officers, forensic investigators and EMS first responders. 2.1 Background Why Raman Spectroscopy? Raman spectroscopy is a non-destructive chemical analysis technique that utilizes scattered light to identify organic and inorganic compounds. Raman techniques are well suited to in vitro chemical analysis and Lambert et. al., selected NIR Raman spectroscopy for investigations of human aqueous humor (HAH) as “Raman spectroscopy offers the possibility of remotely obtaining a measurement of glucose in vivo, because in contrast to infrared spectroscopy, its spectral signature is not obscured by water (Lambert 1998).” The Raman Scattering Effect was first observed by Sir Chandrasekhara Venkata Raman in 1928, the discovery of which resulted in his Nobel Peace Prize in Physics in 19301. Raman’s original research publications focused on the vibrational principles of stringed instruments, and this research translated to his study of the vibrational principles of matter when exposed to an excitation light source (Raman 1989). Sir Raman employed a spectrograph to record his observations of the unique scattering of light, and stated that, “The quantitative measurement and specification of colour is of scarcely less practical importance than simple photo-metry. The skill and judgment with which a trained [spectroscopist] discriminates between different shades and depths of colour is nearly as marvelous as the precision with which a trained musician can distinguish the finest differences in the quality or pitch of musical notes. As in the case of music, so also in the case of colour, our sensations may be analyzed in their constituent elements (Raman 1951).” Though the sophistication of the spectrograph has improved since 1930, the essential principles of Raman scattering remain the same, and following illumination by the excitation laser, the frequencies of the backscattered light can be recorded by a spectrometer and the data cross-referenced against a library of spectral signatures to accurately identify the compound(s) of interest (Eckenrode 2001). Similar to Pythagoras’ observations on the resonant frequency of matter, all chemical compounds respond uniquely to an excitation laser

1 Sir C.V. Raman was awarded the Nobel Peace Prize for Physics for his discovery of the “Raman Scattering Effect” (The Nobel Foundation 2014).

light source illuminator (Levin 1994). The stimulation of the molecules within the compound result in unique vibrations, stretches and rotations, which are bond and molecule specific, and as a result of these phenomena a unique frequency of light is emitted from the compound (Wilson 1955). Further, “Raman spectroscopy is very sensitive to chemical composition and structure. This is because Raman spectra are representations of the Raman active vibrational modes of a molecule. When a molecule is altered either by adding extra atoms or replacing atoms with a different element, it changes the vibrational frequencies of various modes. (Misra 3)” The resulting unique Raman scattered frequencies, or spectral signature, is then measured and recorded via the spectrograph (Eckenrode 2001). Wynn, et. al., note that “[t]his inelastic scattering process creates a spectral fingerprint of the material specific to its vibrational structure; thus it is expected to have reasonably low clutter (Wynn 4).” Raman spectroscopy is a powerful field chemical analysis technique and is gaining acceptance in field forensic applications (Bartick 2002). Raman spectroscopy is not only feasible, but ideal for the WingMan DDD™ (patent pending) presumptive chemical analysis applications. 2.2 Raman spectroscopy for in vivo analysis of biological fluids and vapors A variety of Raman spectroscopy techniques, methodologies and excitation wavelengths have been utilized to analyze biological fluids in vitro. Non-invasive in vivo analysis of ocular fluid to determine blood glucose concentrations in the aqueous humor (AH) has been demonstrated by Pelletier, Lambert and Borchert utilizing an NIR Raman laser spectroscopy technique, and in vivo oral fluid analysis may be feasible utilizing an analogous methodology (Pelletier 2005). In furtherance of the investigation of aqueous humor, La Via, et. al., utilized a Resonance Raman Spectroscopy (RRS) technique and a krypton-ion laser source to accurately measure Amphotericin B (AmB) concentrations in ocular fluid (La Via 2006). Lambert, et. al., further determined that Raman spectral signatures of metabolites found within the AH are “quite distinct” as water and ocular fluid are poor Raman scatterers (Lambert 1998). This research has important and sweeping implications for the development of novel Raman instruments for in vitro biological fluid analysis. Raman spectroscopy methodologies are repeatable, non-destructive and non-invasive, and are well suited to in vivo chemical analysis applications. La Via, et. al., concluded that their 406.7 nm Raman instrument could be utilized for the “measurement of actual drug levels in the AH. [And that] there is the potential to measure the ocular concentrations of other pharmaceutical agents with similar instruments (La Via 2006).” Therefore, Raman instruments could be designed for a variety of in vivo diagnostic and drug concentration monitoring applications. The study further notes that drug concentrations are often “too low to be detected with most spectroscopic techniques,” due in part to sample fluorescence which can overwhelm the weak Raman signal (La Via 2006). The issue of sample fluorescence was also a challenge in previous investigations. Raman spectroscopy remains a viable analytical technique as biological sample fluorescence can be overcome by a variety of methods. Lambert, et. al., demonstrated effective mitigation of “extraneous biological fluorescence” via the selection of the 785nm excitation wavelength and other methodologies (Lambert 1998). In subsequent studies, Dr. Lambert has utilized both Shifted Excitation Raman Difference Spectroscopy (SERDS) and Sequentially Shifted Excitation (SSE) Raman spectroscopy to mitigate sample fluorescence, thus improving signal to noise ratio and the sensitivity of his Raman instruments (Wise 2014). With the development of smaller SSE Raman instruments, the number of applications for higher sensitivity measurements has expanded.

On March 9th 2015, Bruker Optics Inc., released its new handheld Bravo™ SSE Raman instrument for bulk raw material identification and verification on the pharmaceutical production line to meet 21 CFR compliance standards (Tague 2015). This is the first miniaturized SSE Raman instrument of its kind and its patented dual excitation laser configuration offers a variety of advantages over previous handheld Raman instruments (Tague 2015). The miniaturization of SSE Raman systems is a critical development for the feasibility of the WingMan DDD™ (patent pending) as an original equipment manufacturer (OEM) SSE Raman platform could be utilized as the core engine of the system and enable rapid development, trace detection optimization and commercialization. Raman spectroscopy is also well suited to a variety of vapor-phase headspace and fluid-phase measurements, which could be beneficial in analyzing in vivo breath and oral fluid without taking a biological sample. David Tuschel has successfully utilized a HORIBA LabRAM HR Evolution Raman instrument to comparatively analyze fluid and vapor phase samples, including carbonated beverages (Tuschel 2014). Due to sample fluorescence the liquid phase of the beer sample was not analyzed at 532 nm, but the use of a 1064 nm excitation laser would have likely overcome this sample fluorescence and enabled the comparative analysis (Bakeev 2013). Tuschel demonstrated that Raman spectroscopy could be utilized to measure CO2 levels in both the fluid and vapor phases of the carbonated beverage sample, and that “The Raman spectra of the headspace and solvated CO2 demonstrate that Raman spectroscopy is well suited for the study of molecular interactions of solute and solvent (Tuschel 2014).” The utilization of similar Raman comparative analysis techniques to study in vivo breath and oral fluid may be advantageous. 2.3 Stand-off trace detection of organic and inorganic compounds Dr. Henric Ostmark, Swedish Defense Research Agency, has utilized novel approaches to stand-off Raman spectroscopy to achieve trace detection of bulk samples, vapor traces and residues of explosives and precursor chemicals (Ostmark 2011). Other photometric devices, including similar Coherent Anti-Stokes Raman Scattering (CARS), Laser Induced Breakdown Spectroscopy (LIBS), and stand-off Raman chemical analysis systems, intended for the trace detection of explosives, precursor chemicals and other threat materials have been assessed and verified by the U.S. Department of Homeland Security (DHS) for remote sensing applications at distances of up to 50m (U.S. Dept. of Homeland Security 2012). Dr. Ostmark selected Raman spectroscopy for stand-off detection applications as it offered the following advantages:

1. Raman spectroscopy delivers energy to the target with minimal losses 2. Allows for instant (spectral acquisition times of ~1sec) unique identification. 3. Databases of spectral signatures can be created and expanded (Ostmark 2012)

Stand-off trace detection of explosives has also been demonstrated against complex and noisy backgrounds by Dr. Marcos Dantus and Dr. Marshall T. Bremer of masses as low as 18ng at distances of up to 10 meters (Bremmer 2014). Dr. Dantus’ system utilizes a femtosecond stimulated Raman scattering (SRS) technique to identify trace levels of organic or inorganic compounds of interest. This system should be capable of detecting narcotics, precursors and explosives particles, though it is still within the zone of severe damage for force protection applications, and may therefore be better suited to narcotics detection and presumptive identification applications. Trace detection of alcohol vapor has also been demonstrated by Młyńczak et. al. utilizing a stand-off Raman system configuration and an eye-

safe excitation laser (Młyńczak 2014). This device, developed by Polish researchers, makes use of an intensified charge-coupled device (ICCD) to overcome the poor signal strength of the Raman scatter at stand-off distances (Młyńczak 2014). Dr. Ostmark’s systems have also been configured for stand-off trace detection utilizing an ICCD and additionally employ notch and bandpass optical filtration (Ostmark 2012). A device which is configured similarly to the aforementioned systems for the trace detection of narcotics, precursors and alcohol vapor could have a significant competitive advantage as a first-line drug detection and presumptive chemical analysis device. 2.4 Raman microscopy for trace detection of organic and inorganic compounds Dr. Ilana Bar, principal investigator and professor of physics, Ben-Gurion University of the Negev, has demonstrated a trace detection capability of target compounds with masses as low as ~1ng utilizing a Raman microscope and an inexpensive excitation laser light source/illuminator and a cooled ICCD detector (Malka 2013). Dr. Bar’s Raman system has been successfully utilized to chemically analyze latent fingerprint residues for explosives and explosives precursor chemicals. Among the benefits of utilizing Dr. Bar’s Raman microscopy method is that it offers a trace detection chemical analysis capability that is nondestructive, repeatable and requires little to no sample preparation (Malka 2013). Gas Chromatography/Mass Spectrometry (GC/MS) remains the “gold standard” for trace chemical analysis; however, this is a destructive chemical analysis process, and is both more expensive and time consuming for forensic laboratories (Kerrigan 2014). FBI forensic investigator, Edward Bartick, has emphasized that non-destructive Raman chemical analysis is gaining acceptance in forensic investigations and as evidence in criminal court cases, and that Raman scattering and infrared absorption spectroscopies are complementary chemical analysis techniques (Bartick 2002). DHS has also noted the potentiality that “complementary technologies may be combined,” advantageously such as LIBS and Raman spectroscopy (U.S. Dept. of Homeland Security 2012). Dr. Kenneth Busch, professor of chemistry at Baylor University’s Center for Applied Spectroscopy, has affirmed the virtues of non-destructive chemical analysis techniques which do not dissolve the sample and enable chemical analysis through clear glass containers and plastic forensic evidence bags (Marshall 2009). As Raman spectroscopy gains acceptance from forensic investigators the compass of its potential investigative and first responder applications will expand. 2.5 Feasibility of a millimeter range trace detection capability The investigations of Dr. Bar, Dr. Młyńczak and Dr. Ostmark, demonstrate the versatility of Raman spectroscopy as a laboratory and field chemical analysis tool, and each have demonstrated trace detection at the nanogram level. Each of these investigators have utilized Raman systems which employ a cooled intensified charge coupled device which significantly improves signal to noise ratio and thus trace detection. Dr. Bar has demonstrated trace detection utilizing Raman microscopy at distances of

court system (Ostmark 2012). These results are promising as Raman gains increasing acceptance as a viable forensic chemical analysis technique and becomes admissible as evidence to convict drug traffickers, drug dealers and the operators of clandestine laboratories. 2.6 Raman spectroscopy for presumptive chemical analysis There are currently 19,000 U.S. law enforcement agencies which submit controlled substances cases to forensic laboratories for chemical analysis, and of these cases 80% are for heroin, cocaine, methamphetamine and marijuana (Sylvester 2009). Due to diminished budgets and the closing of state forensic laboratories, backlogs of tens of thousands of drug cases pending analysis are now the norm and the State of Alabama alone had accumulated more than 30,000 drug cases as of 2013 (Associated Press 2013). The “ebb and flow” and the extent of the backlogs varies by state, and at the national level there were more than 774,000 drug evidence samples submitted for analysis in 2005 (Sylvester 2009). The U.S. Justice System and forensic laboratories are being overwhelmed by the high volume of these backlogged cases. Raman technologies are ideally suited for presumptive chemical analysis applications, and have been successfully utilized to reduce and eliminate drug case backlogs. The Thermo Fisher Scientific TruNarc™ handheld Raman chemical analysis device provides affordability and legal acceptability for presumptive testing in low level drug possession court cases. For example, the New South Wales (NSW) Police utilized the TruNarc™ to rapidly eliminate their backlog of more than one thousand drug cases in program year 2014, and have expanded the initiative with the procurement of nine TruNarc™ devices (Gallacher 2014). Calhoun and Etowah County, Alabama, have also successfully utilized the TruNarc to diminish their share of the state’s backlog of more than 30,000 drug cases pending presumptive chemical analysis at a rate of 250 cases per month (Thornton 2014). Further, the use of the TruNarc™, which retails at $21,000 was credited with $135,000 in additional cash seizures and fines & fees levied against convicted drug dealers (Lockette 2013). These cases might otherwise have been dismissed or plea bargained down due to a lack of presumptive and forensic laboratory chemical analysis of the evidence, and thus the device paid for itself nearly sevenfold. The South Australia Police (SAPOL) have also procured six TruNarc™ devices and emphasized the virtue of having in situ presumptive analysis results which create the incentive for the defendant to cooperate with investigators, as well as to enter a guilty plea, as “an accused person in possession of drugs may not know exactly what they do have” and will often wait for the forensic laboratory results before attempting to plea bargain (Schrader 2014). Chief Inspector John Schrader notes that this presumptive data is critical as it “gives us a firm direction in our investigation” in real-time, helps to prioritize samples to be sent to the forensic laboratory for further analysis and creates investigation efficiencies and speeds prosecution (Schrader 2014). Though technologies exist to effectively reduce these backlogs there has been a delay in their adoption and implementation. According to David Sylvester, director of the National Forensic Science Technology Center’s (NFSTC) Field Investigation Drug Officer (FIDO) program, based upon their focus groups and the evaluation of existing technologies in 2009, there was not yet an affordable presumptive chemical analysis device available to law enforcement for field deployment (Sylvester 2009); however, the TruNarc™, TacticID-N™ and ACE-ID™ Raman chemical analysis devices were not available at the time that the focus groups were conducted. Raman chemical analysis for presumptive identification may be

beneficial to the FIDO program as it is also not “intended to be confirmatory in nature, it was intended to be presumptive to assist with pre-arraignment or with plea bargaining. (Sylvester 2009)” 3.1 WingMan DDD™ (patent pending) applications By utilizing the same means and method to examine a human test subject or a target surface of interest, the WingMan DDD™ will have utility in the following applications:

1. Roadside DUID upper respiratory drug/alcohol examinations 2. Trace detection chemical analysis of latent fingerprint residues containing drugs, precursors and

other toxins on surfaces within the vehicle and/or at the scene of a crime2 3. Toxin identification for Homeland Security (HLS) 3, EMS and first responders during poison

control response calls in which the victim is unconscious or is a child and is unable to communicate with the responder (in inadvertent or intentional poisonings4)

Similar to Dr. Ostmark’s stand-off trace detection system, our WingMan DDD™ (patent pending) will utilize a combination of white light and Raman imaging during the targeting and spectral acquisition phases of analysis, and it is anticipated that via the composition of a custom optical design, a cooled ICCD and notch and bandpass optical filtration we will achieve a comparable detection capability of organic and inorganic compounds with masses as low as 9ng (Ostmark 2011). None of the existing handheld law enforcement Raman spectrometers offer trace particle and latent fingerprint analysis capabilities, which will perhaps represent the greatest strategic advantage to the WingMan DDD™ (patent pending). 3.2 Need for new technologies and updated laws The paucity of comprehensive roadside drug/alcohol screening technologies and effective legislation has led to a national crisis. Current enforcement methodologies within the U.S. rely primarily upon the judgment of a Drug Recognition Expert, or DRE (DuPont 2012). Dr. Robert DuPont, M.D. et. al. concluded that the low DRE screening rate is not scalable to the drugged driving problem, and is further complicated by time consuming recruitment processes, which can take years and are limited to an elite pool of eligible candidates (DuPont 2012). Whereas, handheld and mobile drug screening technologies including the Alere™ DDS®2 and Drager 5000® systems are scalable to any geographic jurisdiction or metro police force in real-time. The use of oral fluid roadside drug testing devices has proven more effective in this regard, which has led to its adoption by law enforcement organizations around the globe (Statement 2014). Australian Police forces have been utilizing oral fluid screening devices since

2In 2008, Italian investigators uncovered 1,400 illicit bread baking operations controlled by the Camorra Mafia, which employed the mafia’s ex-offender members who were in need of employment after being released from prison. According to the Naples Police, the bakers were intentionally “slowly poisoning” some customers, who relied on the low prices, with bread containing “dioxins and carcinogenic substances (Kington 2008).” 3Lone wolf Jihadists have been encouraged to utilize mafia-style tactics and poison targets (Abdulrahim 2014). 4 According to the Centers for Disease Control (CDC) the poisoning death rate has tripled over the past 30 years with more than 41,000 deaths as a result of intentional or unintentional poisoning in 2008; and the National Capital Poison Center reported that 59% of the 54,534 poison exposure consultations in the D.C. metro area involved children and teens (National Capital Poison Center 2014). *A field deployable trace chemical analysis capability will enable EMS first responders and forensic investigators to identify the toxicant(s) in vivo and in situ.

2004, and have found the greatest success when deployed in DUI checkpoints and direct patrols to augment their DRE certified officers; and the South Australia Police (SAPOL) have achieved 10,000+ detections and convictions over a seven year period (Cornish 2013). This achievement would not have been economically feasible via the use of DREs alone, and therefore an enforcement strategy which incorporates chemical analysis roadside drug testing devices with certified DREs would be advantageous. Zero-tolerance “per se” drugged driving laws will ensure the greatest level of safety and in situ oral fluid testing is complementary to this legislation. A national meeting of toxicologists, DREs and prosecutors organized by the NHTSA and National Safety Council concluded that DUID and drug involved vehicular assault and vehicular homicide cases were excessively difficult to prosecute due to a lack of legal clarity, and recommended that all states adopt zero-tolerance per se drugged driving laws and effective enforcement technologies (Logan 2007). As Sgt. Chris Prince, Sacramento Police Department, has noted, oral fluid screening devices such as the Alere™ DDS®2 are advantageous to officers in the field as they are capable of testing for a variety of illicit and prescription drugs by screening for “the active metabolites [of the drugs] present within the system of the individual that we’re testing (Sharp 2014).” Rep. John Mica (R-FL) has noted that there are no national standards for DUID enforcement, and emphasized European use of oral fluid roadside drug testing systems (Statement 2014). Oral fluid testing devices are gaining recognition as the most viable roadside drug testing solution available to law enforcement, and the WingMan DDD™ (patent pending) could complement these devices by screening the individual and/or target surfaces of the interior or exterior of the vehicle for the presence of trace amounts of illicit and prescription drugs. 3.3 Challenges to BAC equivalency and the “relative risk” alternative Though oral fluid screening devices are promising, they do not currently also screen for alcohol nor alcohol metabolites, and a new generation of devices are needed which can simultaneously screen for drugs & alcohol without having to collect multiple biological samples. Candace Lightner, Founder of MADD and We Save Lives, has highlighted the growing danger of drug & alcohol poly-abuse and reaffirmed her organization’s support of zero-tolerance per se laws, roadside oral fluid testing technologies and mandatory screening for drugs & alcohol following the occurrence of a fatal traffic accident (We Save Lives 2014). DuPont, et. al., states that due to the problem of poly-abuse and the infeasibility of establishing BAC analogous intoxication standards for all illegal and prescription drugs and the interminable number of drug combinations, that the relative risk standard is a more viable alternative (DuPont 2012). According to DuPont there is a strong correlation between crash culpability and poly-abuse, and in a 2004 study, “[it] was reported that drivers who were positive for Tetrahydrocannabinol (THC) and had a BAC ≥ 0.05 were 2.9 times as likely to be responsible for the crash when compared with drug-free drivers with BACs ≥ 0.05. Ogden and Morris (2010) reported on a culpability study of 442 drivers injured in crashes in Victoria and noted that though 51 percent of the drug-free drivers were responsible for their crashes, 75 percent of those with one drug, 77 percent of those with two drugs, 93 percent of those with 3 drugs, and 100 percent of those with 4 drugs were judged responsible (DuPont 35).” Guohua, et. al., also noted significant increases in fatal motor vehicle crash risk for poly-abuse drivers, which could be as much as 23 times greater for alcohol and drug combinations, based upon relative risk statistical comparisons, and recommended that roadside drug testing be expanded (Guohua 2013). Thus, the “relative risk standard” is more applicable to DUID enforcement and oral fluid testing methodologies, and negates the rationale for investing in research to

establish a BAC equivalency for drug impaired driving, poly-abuse drug combinations and individual drugs of abuse. Gathering accurate data on the physiological impairing effects of drugs and poly-abuse on driving is unlikely. The American Prosecutors Research Institute (APRI) notes that “For ethical and safety reasons, on-the-road driving studies using ‘real-world’ doses of drugs like cocaine and methamphetamine are not feasible (Kerrigan 27).” Therefore, zero-tolerance “per se” drugged driving laws are needed in order to more efficiently and effectively prosecute drugged driving cases. APRI defines “per se” laws as those which, “make it a criminal offense to have a specified drug or drug by-product (metabolite) in the body while operating a vehicle. Some states’ per se drug laws incorporate a ‘zero tolerance’ standard in which any detectable level of a specified drug or metabolite constitutes a violation while a few states list actual drug concentrations at which a violation occurs (Kerrigan 5).” Reisfield, et al. also states that BAC equivalency is infeasible as there is little correlation between drug blood concentrations and impairment, and that to fail to enact effective drugged driving legislation as a result is “tantamount to inaction (Reisfield 2012).” Per se drugged driving legislation resolves this issue and clearly defines the law. It is not economically nor scientifically feasible to establish BAC-analogous standards for all drugs of abuse nor to accurately account for the limitless combinations of illegal and prescription drugs and alcohol. Therefore, “per se” legislation and a zero-tolerance standard informed by “relative risk” assessments for poly-abuse would offer a more viable legislative option. The advantage of utilizing the WingMan DDD™ (patent pending), with an enhanced trace detection capability, would be the detection of the particle remnants of one or more parent illicit substances in the upper respiratory system, as well as alcohol vapor and the related drug metabolites, without having to remove an oral fluid sample. 4. Conclusions: Trace detection Raman spectroscopy is a powerful technology for stand-off detection and microscopic analysis of both organic and inorganic compounds of interest as demonstrated in the respective investigations of Dr. Ilana Bar, Dr. Jarosław Młyńczak and Dr. Henric Ostmark. Further, a variety of Raman spectroscopy techniques have been demonstrated in the determination of glucose and AmB concentrations in in vitro biological fluids. The WingMan DDD™ (patent pending) could have utility in a variety of applications including drug examinations, latent fingerprint detection & presumptive chemical analysis and toxicant identification. Trace detection utilizing Raman spectroscopy at distances of 1-321mm will be feasible via a custom optical design, an intensified charge-coupled device (ICCD) and other filtration components (Ostmark 2011). The miniaturization of SSE Raman systems is a critical development for the feasibility of the WingMan DDD™ (patent pending) as an original equipment manufacturer (OEM) SSE Raman platform could be utilized as the core engine of the system and enable rapid development, trace detection optimization and commercialization.

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