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6 Return-to-duty Before sending the specimen for analyses, the collec- tor divides the specimen into two bottles, the first con- Drug and alcohol testing (alone or in combination) must be taining at least 30 ml of urine, the second containing conducted prior to an employee's return to a safety-sensitive at least 15 ml of urine. The two bottles are then sealed, position following a positive test. dated, and sent to the laboratory for analyses with a copy of the completed CCF. Follow-up Initial Test and Confirmation Test Drug and alcohol testing (alone or in combination) must be conducted at unannounced bases at least six times in the first On arrival at the laboratory, each urine specimen must 12 months following the return to a safety-sensitive position be tested twice. The initial immunoassay test is used to after a positive test. eliminate negative urine specimens from further consid- eration and to identify the presumptively positive speci- mens that require confirmation or further testing. The DRUG TESTING confirmatory test uses gas chromatography/mass spec- trometry (GC/MS) or liquid chromatography interfaced Specimen Collection to (tandem) mass spectrometry (LC/MS or LC/MS/MS) to identify and quantify the presence of a specific drug Subpart E of 49 CFR Part 40 is dedicated to the collection or metabolite. of specimens. It is a detailed set of instructions, from the preliminary steps in the collection process to the shipping of Common Methods Used to Defeat the Drug-Testing the specimen to the laboratory. Program A urine specimen must be collected using chain of cus- As discussed earlier, the DOT drug-testing program has tody procedures documented with the Federal Drug Test- measures to determine whether the specimen is urine and ing Custody and Control Form (CCF). Specimen collection whether the urine presents normal characteristics or has must be conducted by a trained individual using a standard been adulterated. At the collection site, the urine is checked collection kit. for proper temperature and unusual appearance. In some cases, direct observation of the specimen collection is The collection begins with the collector completing Step required. At the laboratory, specimen validity testing is con- 1 of the CCF. Precautions the collector must take to prevent ducted to determine whether the specimen is consistent with tampering include dyeing the toilet water and asking the normal human urine. employee to show the contents of his or her pockets. The collector then instructs the employee to wash and dry his or In spite of these precautions, however, products aimed at her hands. The employee is not allowed to wash his or her "beating the test" continue to proliferate. In August 2010, hands again until after delivering the specimen. Employees a Google search on the phrase "beat a drug test" yielded are not allowed access to water or to materials that can be 1,500,000 results. As of May 2005, the National Laboratory used to adulterate or dilute a specimen. A sealed or wrapped Certification Program identified more than 400 products collection container is selected with both the employee and that are marketed to beat a drug test. the collector present. The employee is then directed to go to the room used for urination and provide a specimen of at Earlier methods of beating the tests were crude and often least 45 ml, not flush the toilet, and return the specimen as ineffective. Over time, however, methods improved and a soon as he or she has completed the void. The collector must cottage industry developed, especially through the Internet. pay careful attention to signs that the employee is attempt- In general, many new products work when first introduced, ing to tamper with the specimen. To prevent substitution, the but as they are detected, identified, and ultimately tested for, room used for urination has a toilet tank with a blue dye in it. their use wanes, and they are replaced with newer formula- tions, repeating the cycle. The collector inspects the specimen to ensure that it is of sufficient volume and acceptable temperature range Drug users can use three general approaches to beat the (32C-38C or 90F-100F). The collector also checks for urine test: dilution, adulteration, and substitution. Each is signs of tampering, such as unusual color, appearance, and discussed in the following sections, which, unless otherwise odor of the specimen. If the collector suspects tampering, he noted, are based in large part on the following publications: or she may request that the employee provide a new speci- Jambor (2000), Caplan (2007), Dasgupta (2007), Bush men under direct observation. Follow-up and return-to-duty (2008), and Jaffee et al. (2008). The reader is encouraged to tests require direct observation. refer to these publications for additional material.

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7 Dilution increase the probability of false negatives. Some act by inter- fering with the immunoassay detection scheme, others by The dilution and cleansing products are aimed at diluting converting the target drug to compounds that do not bind the urine in the bladder (in vivo) to such an extent that the to the antibodies used in the immunoassay or that produce concentrations of tested illicit drugs fall below the estab- negative results in confirmation testing (Wu et al. 1999). lished cutoffs. Dilution and cleansing products are available through various Internet sites, and even large retailers sell The first type of adulterants were common household them, usually with product descriptions that tout the prod- items such as bleach, vinegar, hand soap, drain cleaner, ucts' purported abilities without mentioning their likely eye drops, lemon juice, table salt, and golden seal tea. Mik- purposes. These products--sold as teas, pills, gel caps, kelsen and Ash (1988) set up an experiment to determine drinks, and chewable tablets--are usually to be consumed how these common household items affected urine drug with large amounts of water 1 to 5 h before providing a tests. Solutions of several illegal and medicinal drugs were urine specimen. added to urine from a healthy drug-free individual. The results indicated that with the exception of lemon juice, all In addition to selling products, some Internet sites also adulterants produced some false negatives, depending on the provide advice on how to beat the test. Drug users are type of drug and adulterant concentrations. With the excep- advised to drink as much water as possible before the test tion of eye drops, however, all adulterants could be detected and to take high dosages of aspirin, presumably because it because they shifted urine characteristics outside of normal may reduce the sensitivity of some urine tests. Donors are human range. Salt produced specific gravity values greater advised to never give the first urine of the morning. Taking than 1.035; drain cleaner, bleach, and vinegar shifted pH val- of vitamin B-2 is advised to color the urine, likely to be clear ues; golden seal caused a dark appearance in the urine; and from drinking the great quantity of water. Taking diuretics is hand soap produced cloudiness in the specimen. also advised, from weak diuretics such as coffee, cranberry juice, certain health food products, and over-the-counter The effects of eye drops on urine drug tests were fur- pills for premenstrual water retention, to potent diuretics ther examined by Pearson et al. (1989). Solutions of several like furosemide, which are available only with a prescription illegal and medicinal drugs in isotonic saline were added to in the United States but can be purchased over-the-counter drug-free urine. Eye drop solution was added in various con- in Mexico. According to some websites, the diuretics can centrations to each specimen before analyses. Eye drop solu- be detected in urine, but analyses of these drugs are rarely tion produced false negatives only for marijuana and only included in drug-testing programs not aimed at athletes. in some concentrations, and it was not detectable by rou- tine urine analyses. The lowering of tetrahydrocannabinol There is evidence that ingestion of large quantities of (THC) in the specimen could be accounted for by two com- water can produce false negatives. Cone et al. (1998) exam- ponents, benzalkonium chloride and borate, which reduced ined the effectiveness of two herbal products (Naturally the availability of the drug to be tested by increasing the Klean Herbal Tea and golden seal root), a diuretic medication attraction of 9-carboxy-THC to the walls of the glass tubes. (hydrochlorothiazide), and water (1 gal, 12 oz) as a means of passing a drug test. Subjects smoked a marijuana cigarette Glutaraldehyde was the active ingredient in some of the and insufflated cocaine and were randomly assigned to one first commercially available products marketed to beat the of the treatments. Twenty-two hours after taking the drugs, urine drug tests (UrinAid, Clear Choice). It interferes with subjects consumed their respective treatment. The herbal screening immunoassays by producing final absorbance products, the diuretic medication, and the 1 gal of water were rates readings for amphetamines, cocaine metabolites, can- served in four 1-qt drinks at 1-h intervals. By the time the nabinoids, opiates, and phencyclidine that are lower than subjects drank 2 qt of any fluid, they were generally produc- true negative urine specimens (Goldberger and Caplan 1994; ing false negatives. The ingestion of large quantities of water Wu et al. 1994). produced dilute specimens (creatinine concentration less than 20 mg/dl and specific gravity less than 1.003). Negative Products with hydrochloric acid, such as Amber 13, THC marijuana results rarely returned to positive after drinking Free, and an early version of Urine Luck, were marketed the 1-gal treatments, but cocaine results reverted to positive next. They did interfere with some immunoassays, often after the dilution effects disappeared. resulting in false negatives. However, because of their acid- ity, they could be easily detected. Adulteration In late 1996, products with nitrates became common Adulteration additives are chemical compounds that are (Klear, Whizzies, Randy's Clear). Nitrates did not appear to added to the urine after it is provided in the collection cup have a large effect on immunoassays, but they did produce (in vitro). Types of additives range from common house- false negatives for marijuana in the confirmatory (GC/MS) hold items to special formulations purposely developed to tests (Tsai et al. 1998; Wu et al. 1999). Nitrates can naturally

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8 occur in human urine, but at much lower levels than those The Whizzinator received media coverage in May 2005 resulting from adulteration (Urry et al. 1998). after a professional football player was caught with one in an airport. A month later, the player was suspended by the NFL Pyridinium chlorochromate (PCC) was the active ingredi- for substance abuse. In October 2008, federal prosecutors ent of the next generation of adulterants (Urine Luck). Wu et won a 19-count indictment against the maker of the Whizzi- al. (1999) conducted a series of studies to determine the condi- nator for fraud and selling drug paraphernalia. Prosecutors tions under which PCC interfered with the screening and con- alleged that by manufacturing and selling the Whizzinator, firmation analyses of illegal drugs. PCC was added at three the company's president and vice president conspired to concentrations to urine specimens positive for methamphet- defraud the Substance Abuse and Mental Health Services amine, cocaine, opiates, phencyclidine, and marijuana. The Administration. adulterated specimens were tested with two immunoassays and GC/MS. Results indicated that PCC affected response In November 2008, the two individuals pleaded guilty rates as a function of immunoassay, type of drug, and PCC in federal court to one count of conspiracy to defraud the concentration. In general, however, intermediate and high government and one count of conspiracy to sell drug para- concentrations of PCC resulted in lower detection of opiates phernalia. In April 2010, one man was sentenced to 6 months and marijuana with both immunoassays and GC/MS. in federal prison followed by 3 years of supervised release; the other was sentenced to 3 years' probation (Burris 2010). Urine Luck was reformulated by dropping the pyridinium Their company was forced to shut down and the website ion, making chromium (VI) (chromate) the active ingredi- used to sell the product has been closed. The next generation ent. The new formulation had effects similar to the previ- of the Whizzinator, however, can still be purchased online. It ous one, a positive screen and negative confirmation result has been marketed as paraphernalia for urolagnia. for THC. Paul and Jacobs (2002) investigated the effects of chromate and other oxidizing agents on the GC/MS test for It can be noted, however, that to combat substitution under tetrahydrocannabinol carboxylic acid (THCA). They found observed collection, the observer gives instructions to the that, when treated with chromate, THCA was lost com- donors to raise their clothing above the waist, lower clothing pletely in the specimen. Another chromium-based product and underpants, and to turn around to permit the observer to is Ultra Kleen. determine the presence of a prosthetic or other device that could be used to interfere with the collection process. In 2001, Cody and Valtier reported the effects of Stealth, an adulterant sold in two vials, one containing peroxidase Specimen Validity Testing (SVT) and the other peroxide. The user pours the content of one vial into the collection cup, adds urine, and then adds the con- In the DOT drug-testing program, measures are in place to tents of the second vial. The combination of the two chemi- determine whether a specimen is urine, whether the urine cals creates a strong oxidant in the urine. Stealth was found presents normal characteristics, or whether it has been to cause immunoassay false negatives for marijuana, LSD, adulterated. and morphine. Normal Urine Characteristics The effects of several oxidants, including iodine (a halo- gen, with fluorine, chlorine, and bromine) were examined In healthy humans, urine has specific physical characteris- by Paul and Jacobs (2005). Iodine was found to destroy tics: temperature, color, clarity, odor, and foaming proper- morphine and 6-acetylmorphine almost immediately. The ties. It also has specific chemical characteristics: creatinine, effects were less evident on THCA. specific gravity, and pH. Substitution Urine temperature is typically 90F100F (32C38C) within 4 min of collection. Temperatures outside this range Some donors substitute their urine, which would presumably may be an indication that a substitute sample was used. result in a positive test, with urine that is clear of drugs and that, if undetected, would result in a negative test. The drug- The color of urine depends on several factors. A first free urine, natural or synthetic, is sold in containers and can morning void has a deep yellow color. After hydration, the be frozen for up to 1 year. At the time of collection, the drug- urine becomes dilute, and it is a pale yellow. Very dilute free urine must be warmed to body temperature and trans- urine is almost colorless. ferred to the collection cup. To avoid detection even under direct observation, the drug-free urine is transferred through A normal urine specimen is clear and transparent. Bac- a hose (the Urinator) or fake penis (the Whizzinator), which teria, blood, sperm, crystals, or mucus can make urine can be purchased to match the color of the skin of the donor. look cloudy.

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9 Typically, dilute urine has little to no odor. The smell of A specimen is substituted when urine can be affected by the consumption of foods and bev- erages such as asparagus, curry, alcohol, coffee, turkey, and The creatinine concentration is less than 2 mg/dl and onion. Abnormal urine odors can be caused by urinary tract the specific gravity is less than or equal to 1.0010 on disorders, diabetes, and E. coli bacteria infection. both the initial and confirmatory tests on two separate aliquots, or Urine foaming can be a sign of protein in the specimen. The creatinine concentration is less than 2 mg/dl and Normal urine foaming does not have the rainbow appear- the specific gravity is greater than or equal to 1.0200 ance that is typical of soap adulteration. on both the initial and tests on two separate aliquots. Creatinine is a waste product formed by the break- A specimen is adulterated when down of creatine, a nitrogenous organic acid that helps to supply energy to muscle. Creatinine is filtered out of the The pH is less than 3 or equal to or greater than 11; blood by the kidneys and then is passed out of the body in The nitrite concentration is equal to or greater than 500 urine. Normal creatinine concentrations are greater than mcg/ml (two different tests required); 20 mg/dl. The chromium (VI) concentration is equal to or greater than 50 mcg/ml (two different tests required); Specific gravity assesses the amount of substances in the The presence of halogen (e.g., bleach, iodine, fluoride) urine. The higher the specific gravity, the more solid material is detected and confirmed, with a specific halogen con- is in the urine. Normal values are between 1.0020 and 1.0200 centration equal to or greater than the limit of quanti- (Caplan 2007), depending on fluid intake and hydration. tation (LOQ) of the confirmatory test on the second aliquot (two tests required); pH is a measure of urine acidity or alkalinity. A urine pH The presence of glutaraldehyde is detected and con- of 4 is strongly acidic, 7 is neutral, and 9 is strongly alkaline. firmed, with the glutaraldehyde concentration equal to or greater than the LOQ of the confirmatory test on the Types of Validity Tests second aliquot (two tests required); The presence of pyridine (pyridinium chlorochromate) Laboratories must conduct the following validity testing of is detected and confirmed, with a concentration equal to the specimen: or greater than the limit of detection (LOD) of the con- firmatory test of the second aliquot (two tests required); Determine the creatinine concentration on each pri- The presence of a surfactant is detected and confirmed, mary specimen. Determine its specific gravity if the with a concentration equal to or greater than 100 mcg/ creatinine concentration is less than 20 mg/dl. ml dodecylbenzene sulfonate-equivalent cutoff con- Determine the pH of each primary specimen. centration on the second aliquot (two tests required); or Perform one or more validity tests for oxidizing adul- The presence of any other nonspecified adulterant is terants on each primary specimen. verified using an initial test on the first aliquot and a Perform additional validity tests on the primary speci- different confirmatory test on the second aliquot. men when the following conditions are observed: Abnormal physical characteristics, A specimen is invalid when Reactions or responses characteristic of an adulter- ant obtained during initial or confirmatory drug tests Creatinine concentration and specific gravity are (e.g., nonrecovery of internal standards, unusual inconsistent with normal human urine; response), or pH is equal to or greater than 3 and less than 4.5; Possible unidentified interfering substance or pH is equal to or greater than 9 and less than 11; adulterant. The nitrite concentration is equal to or greater than 200 If it is determined that specimen is invalid, send to a mcg/ml but less than 500 mcg/dl; second laboratory for additional analyses. There is general oxidant activity that cannot be accounted for by identifying a specific agent; or Validity Tests Criteria A urine specimen does not meet the criteria for dilute, substitute, or adulterated but clearly is not normal. A specimen is dilute when Detection of Tampering The creatinine concentration is greater than or equal to 2 mg/dl but less than 20 mg/dl, and An important distinction must be made at this point between The specific gravity is greater than 1.0010 but less than detection of tampering and prevalence of tampering. Detec- 1.0030 on a single aliquot. tion of tampering is obtained through SVT. If SVT were

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10 100% effective in detecting tampering, then the prevalence TABLE 1 of tampering would equal the rate of detection. In reality, ANNUAL NONNEGATIVE RATES (%) BY VALIDITY of course, SVT is not 100% effective in detecting tamper- TESTING CATEGORY ing, and the true measure of prevalence of tampering is Specimen Validity 2005 2006 2007 2008 2009 unknown. It can be noted that as part of a report on motor Test Category carrier safety by the U.S. Government Accountability Office Acid-Base 0.01 0.00 0.01 0.020 0.03 (GAO 2008), eight undercover investigators provided spec- Invalid 0.12 0.12 0.11 0.11 0.09 imens that were adulterated or substituted, and none was Oxidizing Adulterants 0.00 0.00 0.00 0.00 0.00 detected with SVT. Substitution 0.05 0.05 0.05 0.05 0.06 The relationship between the detection of tampered specimens and the prevalence of tampered specimens can be viewed in two competing ways. The first is that drug test TABLE 2 takers are becoming more sophisticated and more successful SPECIMENS BY TAMPERED OR REJECTED STATUS FOR in their methods of beating the test. The second view is that U.S.DOT SAFETY-SENSITIVE WORKFORCE SVT has become increasingly effective in detecting tam- Test Category 2008 2009 (Full 2010 pered specimens. In this report, this view of the relationship (JulyDecember) Year) (JanuaryJune) was adopted. Thus, when a reduction in detection is referred Total Results 2,850,106 5,163,165 2,662,335 to, it also implies a reduction in prevalence. Tampered 5,106 8,421 3,948 Percentage Tampered 0.18 0.16 0.15 Table 1 reports the annual nonnegative rates by validity Rejected 4,636 7,106 3,484 testing category for the federally mandated, safety-sensitive Percentage Rejected 0.16 0.13 0.13 workforce from one large-scale laboratory (Quest Diagnos- tics, September 2010). Table 2 reports the annual tampered or rejected specimens for the DOT safety-sensitive work- Vulnerabilities of DOT Drug Testing force (Swart, personal communication, Nov. 22, 2010). A 2007 GAO report described an undercover operation that Figure 1 shows the adulterated, substituted, and invalid revealed significant vulnerabilities in the DOT's drug-testing specimens as a percentage of tampered specimens (Swart, program. GAO investigators created two fictitious trucking personal communication, Nov. 22, 2010). Note that the per- companies and produced bogus commercial drivers' licenses centage of invalid specimens has declined over the past 3 using software and hardware available on the market to the years, whereas the percentage of substituted and adulterated general public. The undercover investigators reported to urine specimens has increased. collection sites pretending to have been selected by their FIGURE 1 Substituted, adulterated, and invalid specimens as a percentage of all tampered specimens for the U.S.DOT safety-sensitive workforce.

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11 companies for drug testing. Twenty-four sites were selected combat adulteration and substitution, it would be useful throughout the United States. At each collection site the inves- to conduct similar undercover investigations on a regular tigators tested 16 specific DOT protocols. Eight of the 24 urine basis to determine whether failure rates are decreasing over specimens were either adulterated or substituted. time. Table 3 reports the failure rates for the DOT protocols included in the investigation. The results indicated that 22 of the 24 sites showed varying degrees of failure to comply with DOT protocols. In addition, Classes of Drugs none of the eight adulterated or substituted specimens were detected. Interestingly, the GAO did not count these instances Laboratories must test for the following five drugs or classes as violations of protocol because the collectors were not of drugs in a DOT drug test. DOT specimens cannot be required to validate the identity of the employees, but only to tested for any other drugs. ensure that employees presented identification (GAO 2007). Marijuana metabolites, Cocaine metabolites, TABLE 3 Amphetamines, FAILURE RATES FOR SELECTED DOT PROTOCOLS Opiate metabolites, and TESTED BY GAO Phencyclidine (PCP). Selected DOT Urine Specimen Collection Protocol Percentage of the 24 Collection Cutoff Concentrations Sites That Failed Secure the facility from all substances that could be 75 used to adulterate or dilute the specimen In 2010, to harmonize DOT drug-testing requirements with those of DHHS, DOT amended certain provisions of its drug- Secure all sources of water in the restroom 67 testing procedures. In general, among other changes, DOT Ask the employee to empty his/her pockets and dis- 42 procedures now require initial testing for methylenedioxymeth- play items to ensure that no items are present that could be used to adulterate the specimen amphetamine (MDMA); confirmatory testing for MDMA, methylenedioxyamphetamine (MDA), and methylenedioxyeth- Check the temperature of the specimen 19 ylamphetamine (MDEA); initial testing for 6-acetylmorphine; Place a bluing agent in the toilet or secure it with tape 17 lower initial test and confirmatory test cutoff concentrations for amphetamines; and lower initial test and confirmatory test Although the GAO investigation is now 3 years old, cutoff concentrations for cocaine. Table 4 reports the current and new procedures have been implemented since then to cutoff concentrations for initial and confirmation tests. TABLE 4 CURRENT CUTOFF CONCENTRATIONS FOR INITIAL AND CONFIRMATION TESTS Initial Test Analyte Initial Test Cutoff Confirmatory Test Analyte Confirmatory Test Cutoff Concentration (ng/ml) Concentration (ng/ml) Marijuana Metabolites 50 THCAa 15 Cocaine 150 Benzoylecgonine 100 Opiate Metabolites Codeine/Morphineb 2,000 Codeine 2,000 Morphine 2,000 6-Acetylmorphine 10 6-Acethylmorphine 10 Phencyclidine 25 Phencyclidine 25 Amphetaminesc Amphetamine/Methamphetamined 500 Amphetamine 250 Methamphetaminee 250 MDMAf 500 MDMA 250 MDAg 250 MDEAh 250 a Delta-9-tetrahydrocannabinol-9-carboxylic acid. b Morphine is the target metabolite for codeine/morphine testing. c Either a single initial test kit or multiple initial test kits may be used, provided the single test kit detects each target analyte independently at the specified cutoff. d Methamphetamine is the target analyte for amphetamine/methamphetamine testing. e To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 100 ng/ml. f Methylenedioxymethamphetamine. g Methylenedioxyamphetamine. h Methylenedioxyethylamphetamine.