# Procedures for Transportation Workplace Drug and Alcohol Testing Programs

- **operation:** document
- **citation:** 75 FR 49850
- **title:** Procedures for Transportation Workplace Drug and Alcohol Testing Programs
- **source type:** rulemaking
- **agency:** Office of the Secretary
- **status:** historical
- **official:** true
- **published on:** 2010-08-16
- **effective on:** 2010-10-01
- **summary:** The Department of Transportation (the Department or DOT) is amending certain provisions of its drug testing procedures dealing with laboratory testing of urine specimens. Some of the changes will also affect the training of and procedures used by Medical Review Officers. The changes are intended to create consistency with many, but not all, of the new requirements established by the U.S. Department of Health and Human Services.
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- **source url:** https://www.federalregister.gov/documents/2010/08/16/2010-20095/procedures-for-transportation-workplace-drug-and-alcohol-testing-programs
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Federal Register, Volume 75 Issue 157 (Monday, August 16, 2010) [Federal Register Volume 75, Number 157 (Monday, August 16, 2010)] [Rules and Regulations] [Pages 49850-49864] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 2010-20095] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 [Docket OST-2010-0026] RIN 2105-AD95 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of the Secretary, DOT. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Department of Transportation (the Department or DOT) is amending certain provisions of its drug testing procedures dealing with laboratory testing of urine specimens. Some of the changes will also affect the training of and procedures used by Medical Review Officers. The changes are intended to create consistency with many, but not all, of the new requirements established by the U.S. Department of Health and Human Services. DATES: This rule is effective October 1, 2010. FOR FURTHER INFORMATION CONTACT: Mark Snider, Senior Policy Advisor (S- 1), Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey Avenue, SE., Washington, DC 20590; telephone number 202-366-3784 (voice), 202-366-3897 (fax), or [email protected] (e-mail). SUPPLEMENTARY INFORMATION: Background and Purpose On November 25, 2008 (73 FR 7185), the U.S. Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) issued a Final Notice of Revisions to the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Mandatory Guidelines) that included changes to the procedures for collection and testing of urine specimens, creation of and requirements for the certification of Instrumented Initial Test Facilities (IITFs), collection site oversight requirements, and changes to the role of and standards for collectors and Medical Review Officers (MROs). The HHS Mandatory Guidelines were to become effective May 1, 2010, but on April 30, 2010 (75 FR 22809), HHS postponed implementation until October 1, 2010. On February 4, 2010, DOT published a Notice of Proposed Rulemaking (NPRM) (75 FR 5722) seeking comments about changing part 40 to be consistent with certain aspects of the HHS Mandatory Guidelines. The final rule responds to the comments and makes a number of changes to the existing rules governing the Department's drug testing program. Principal Policy Issues Requirements of the Omnibus Transportation Employee Testing Act of 1991 Several commenters questioned whether and to what extent the Department must follow the HHS Mandatory Guidelines. Some commenters urged the Department to choose a different approach from the HHS regarding the drugs for which testing occurs, the initial testing of all specimens for 6-Acetylmorphine (6-AM), and the use of IITFs. Although since its passage, the Department has cited the Omnibus Transportation Employee Testing Act of 1991, 49 U.S.C. 31300, et seq., 49 U.S.C. 20100, et seq., 49 U.S.C. 5330, et seq., and 49 U.S.C. 45100, et seq. (Omnibus Act), as the definitive authority for our reliance on the HHS Mandatory Guidelines for scientific testing issues, several of the commenters have challenged this or otherwise asked the Department to clarify what the Omnibus Act requires. Even before the Omnibus Act, the Department looked to the HHS Mandatory Guidelines for guidance on scientific matters. In a 1988 Interim Final Rule (IFR) the Department relied upon the HHS for testing methodologies to determine the drugs for which testing would be done and which laboratories to use. Specifically, the Department noted that under ``the HHS Guidelines, a Federal agency may test a urine sample only for certain specified drugs. The Department's Procedures echo this requirement.'' (53 FR 47002, Nov. 21, 1988; emphasis in the original) In the same IFR, the Department required regulated transportation employers to use only laboratories certified under the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs. While deciding to utilize many aspects of the HHS Mandatory Guidelines, the Department acknowledged ``that the Guidelines, as written by HHS to apply to testing by Federal agencies, do not fit perfectly the circumstances of employers regulated by DOT * * *. Obviously, the circumstances of industries regulated by DOT are very different from those of Federal agencies.'' (53 FR 47002) Thus, the Department began to lay the foundation for using the technical expertise of the HHS for the scientific aspects of DOT's testing program while relying upon the Department's own authority and that of DOT agencies to tailor many procedural aspects of DOT testing to fit the transportation industries. In a 1989 final rule, we discussed the applicability of the Fourth Amendment of the United States Constitution to both the Federal agency programs covered by the HHS Mandatory Guidelines and the testing that transportation employers would conduct in response to the Department's requirements. The Department acknowledged that the HHS Mandatory Guidelines had passed Constitutional scrutiny by the Federal courts, all the way up to the Supreme Court of the United States. The Federal courts concluded that HHS had met the Fourth Amendment balancing of the Federal need to ensure safety by drug testing versus individuals' strong interests in their right to privacy. The HHS Mandatory Guidelines had set up a testing system with sound methodology that ensured privacy and accuracy. Given these considerations, the Department decided to rely on HHS for the science of DOT's testing program and for the drugs for which we test, the testing methodologies, and the integrity of the HHS certified laboratories. (54 FR 49854, Dec. 1, 1989) Congress endorsed the Department's decision by explicitly directing, in the Omnibus Act, the Department to incorporate the HHS scientific and technical guidelines for laboratories and testing procedures for controlled substances. The Omnibus Act specifically requires that we incorporate the HHS scientific and technical guidelines that ``establish comprehensive standards for all aspects of laboratory controlled substances testing'' in order to ensure full reliability and accuracy in testing. [49 U.S.C. 31306(c)(2)(A), 49 U.S.C. 20140(c)(2)(A), 49 U.S.C. 5331(d)(2)(A) and 49 U.S.C. 45104(2)(A)] The legislative history for the Omnibus Act indicates the following intent: ``Incorporating the HHS [[Page 49851]] guidelines relating to laboratory standards and procedures for testing controlled substances, as proposed by the reported bill and as DOT has done in part 40 of title 49 CFR, as it exists at this writing, is an essential component of the procedural safeguard.'' Senate Report 102- 54, Omnibus Transportation Employee Testing Act of 1991, Report of the Senate Committee on Commerce, Science and Transportation on S.676, 102nd Congress, 1st Session, May 2, 1991, page 26 (Senate Report 102- 54) (emphasis added). The Omnibus Act also requires the Department and DOT agencies to look to the HHS for laboratory certification, the procedures for reviewing laboratories for certification, and the procedures for the revocation of such certification. In addition, the Department must follow the HHS Mandatory Guidelines regarding establishing the list of drugs for which we test and the procedures for use of the Federal Drug Testing Custody and Control Form (CCF) to establish the chain of custody of specimens. The legislative history of the Omnibus Act indicates that Congress wanted the Department and DOT agencies to continue use of the HHS scientific and technical guidelines and the HHS certified laboratories to ensure accuracy, fairness, and the constitutionality of DOT's drug testing program. While the Omnibus Act was being drafted, opponents of drug testing warned that employees were in danger of ``false positives'' that would result from initial screening of urine that might indicate levels of illegal drugs. The Senate noted that it had addressed this concern: ``By incorporating laboratory certification and testing procedures developed by HHS and DOT and by providing for the subdivision of specimens and the opportunity for an independent test of positive samples, the Committee has taken affirmative steps to ensure accuracy.'' Senate Report 102-54, pages 6-7. The legislative history for the Omnibus Act makes numerous additional references to the understanding that the Department would work with HHS to ensure testing accuracy. There is also clear indication in the legislative history that Congress recognized that the HHS standards were likely to be modified over time. The Omnibus Act itself explicitly refers to incorporating the HHS ``scientific and technical guidelines dated April 11, 1988, and any subsequent amendments thereto * * *'' 49 U.S.C. 31306(c)(2), 49 U.S.C. 20140(c)(2), 49 U.S.C. 5331(d)(2) and 49 U.S.C. 45104(2). Allowing for subsequent amendments, however, did not mean that Congress wanted to lower the standards for testing. ``Realizing that these guidelines possibly are subject to future modification, the Committee has acted to specify that the basic elements of certain provisions now in effect are mandated, including the need for comprehensive standards and procedures for all aspects of laboratory testing of drugs, the establishment of a minimum list of controlled substances for which employees may be tested, the establishment of standards and procedures for the periodic review of laboratories, and the development of criteria for laboratory certification.'' Senate Report 102-54, pages 21-22, 26 and 32. When the Omnibus Act requires the Department to follow HHS on specified scientific matters, we adhere to the requirements. When the Omnibus Act allows the Department the option of following HHS, we have always and will continue to weigh the costs and benefits of following HHS in light of our mission. However, when the Omnibus Act specifically requires the Department to take a direction different from that which HHS takes, then the Department is prohibited from following HHS on such matters. In reviewing the Omnibus Act, its legislative history, and the regulatory history of the Department's testing program, it remains clear that, since the inception of our program, the Department has been tied to HHS for the scientific methodology, for identification of the drugs for which we will require testing; the certified laboratories we are to use; and the technical expertise for certifying and decertifying laboratories. These are the core scientific laboratory functions necessary for the Department's program. However, it is important to note that the Department has discretion concerning many other aspects of the regulations governing testing in the transportation industries' regulated programs. As far back as 1988, our regulations established the fundamental roles and concepts for the current DOT regulated industry testing program. Our early regulations established how collections were to be done, who could be an MRO or a Substance Abuse Professional (SAP), and the respective training for and responsibilities of these important gatekeepers. While relying on HHS for certain scientific efforts, we did not necessarily follow HHS regarding collection issues, laboratory reporting requirements, how MROs handle certain test results, the rehabilitation and the return-to-duty process, and other areas covered by the HHS Mandatory Guidelines. The Department's regulation and the regulations of DOT agencies set their own processes and procedures for all aspects leading up to and through specimen collection and then picking up from what processes and procedures would occur after a laboratory confirmed a drug test result, including the return-to-duty process for individuals who have non-negative test results. In shaping our program to fit the needs of the transportation industries, the Department and DOT agencies have made adaptations to meet the changing needs of the transportation industries. In some cases we have consequently chosen a different path from the one chosen by HHS on the same or similar non-scientific issues. The Omnibus Act acknowledged that such Departmental and DOT agency regulations were in place with respect to non-scientific issues. Congress explicitly allowed these regulations to continue in effect, with the option for the Department and DOT agencies to amend or further supplement their respective regulations in the future. 49 U.S.C. 31306(i), 49 U.S.C. 20140(f), and 49 U.S.C. 45106(c). One example of the Department's divergence from HHS on non- scientific matters covered in the HHS Mandatory Guidelines is the issue of how to conduct direct observation collections. On June 25, 2008, the Department issued a final rule (73 FR 35961) that, among other amendments, modified 49 CFR part 40 at section 40.67(b) and added a new paragraph 40.67(i) to improve direct observation procedures to better address known adulteration and substitution threats. Although HHS addresses direct observation collections in the HHS Mandatory Guidelines, the Department chose to use a different procedure because of evidence regarding cheating and our experience in regulating the transportation industries. In explaining our rationale, we noted that the use of direct observation collections is ``a very significant tool the Department employs to combat attempts by employees to cheat on their tests.'' (74 FR 37949, July 30, 2009) In addition, we stated in the final rule reinstating the direct observation provisions after the court victory, ``the Department remains convinced that conducting all return-to-duty and follow-up tests under direct observation is the most prudent course from the viewpoint of safety.'' (74 FR 37950, quoting the October 22, 2008 final rule preamble at 73 FR 62918) The Department's regulations concerning direct observation procedures were affirmed by a unanimous court. (BNSF Railway Company v. Department of [[Page 49852]] Transportation, 566 F.3d 200 (DC Cir. 2009) In upholding the rule, the U.S. Court of Appeals for the D.C. Circuit noted that the Department had experience, comments, and evidence to support the need to make the improvements to the direct observation procedures. BNSF Railway Company v. Department of Transportation, 566 F.3d at 204. The Court further found that the improved procedures were constitutional, stating, ``[g]iven the combination of the vital importance of transportation safety, the employees' participation in a pervasively regulated industry, their prior violations of the drug regulations, and the ease of obtaining cheating devices capable of defeating standard testing procedures, we find the challenged regulations facially valid under the Fourth Amendment.'' Id. at 208. Hence, the Department chose a different approach from HHS on direct observation procedures, tailored them to the needs identified, and the Court upheld this approach as constitutional. Some of the commenters asked the Department to consider deviating from the HHS Mandatory Guidelines regarding the drugs for which testing is required. Some commenters want the Department to exclude Methylenedioxymethamphetamine (MDMA) from the list of drugs, while others want the Department to include synthetic opiates, and others want alternative testing methodologies to be employed. It is not unusual for the Department to receive requests from commenters to move away from the illegal drugs for which HHS has set the protocols; however, the Department has remained consistent in our responses and our reliance upon HHS as the scientific experts in these matters. What the Department stated in response to similar requests in the late 1990s to move beyond the HHS minimums still remains true: ``This is a long-standing issue in the program, and DOT continues to take the position that we ought not to go beyond the testing that HHS has authorized and for which HHS has certified laboratories.'' (65 FR 79484, Dec. 19, 2000) In response to those who have urged DOT to go beyond the drugs for which HHS tests, we have consistently stated: ``we believe the stability and reliability of the program are well served by limiting testing to the `HHS five.' HHS has established testing protocols and cutoffs for these drugs, and laboratories are subject to HHS certification for testing of these five drugs. This is not true for other drugs.'' (65 FR 79491, Dec. 19, 2000) Although the HHS has now expanded its panel to include an additional amphetamine, MDMA, the same reasoning holds true and the Department will continue to follow the HHS testing protocols for the reasons we explained in 2000. Also in 2000, the Department explained, ``With respect to alternative testing technologies such as hair testing, saliva testing, and on-site testing, which commenters recommended in context of several sections of the NPRM, the Department will wait upon the action of HHS before proposing to incorporate additional methods. Approval of these or other methods, and establishment of requirements and procedures for them, are matters primarily within the expertise of HHS.'' (65 FR 79489, Dec. 19, 2000) Furthermore, in the preamble to our Specimen Validity Testing final rule in 2008 (SVT Final Rule), we stated that the Omnibus Act ``provides only one way to determine that an employee has tested positive for illicit drug use--a drug test confirmed by an HHS-certified laboratory using HHS scientific and testing protocols and verified by an MRO.'' (73 FR 35966, June 25, 2008) The Department, as required by the Omnibus Act, has consistently specifically followed HHS on laboratory certification matters, but we have also created responsibilities for laboratories under part 40 that do not impinge upon the scientific and technical aspects of drug testing. As the Department stated in 2000, ``laboratories have responsibilities under part 40 independent of their HHS responsibilities (e.g., with respect to relationships with MROs, release of information, and validity testing), and laboratories must be accountable to DOT in those matters.'' (65 FR 79484, Dec. 19, 2000) At times, we have had to adapt certain aspects of technical drug testing matters to fit the needs of the transportation industries. For example, in 2003, the Department issued an interim final rule (2003 IFR) concerning laboratory substitution criteria. (68 FR 31624, May 28, 2003) In the 2003 IFR, we did not, and could not, change the HHS- established laboratory testing substitution criteria, but instead addressed how laboratories were to report out their findings to the MROs on the CCF, what subsequent actions would be required of the MROs with respect to the reported result, and whether to tell the employer to send the employee back in for a direct observation collection. In short, we said that specimens reported by laboratories as substituted with creatinine concentration in the 2-5 ng/mL range would not be considered by MROs to be refusals to test. Instead, transportation employees with such results would require immediate recollections under direct observation. In a July 2008 interpretation, which is being incorporated in this final rule at section 40.159, the Department instructed MROs on how to ``handle laboratory results reported as invalid because of pH greater than or equal to 9.0 but less than or equal to 9.5.'' This is another example of how the Department has adapted the HHS scientific requirements established for laboratories to the needs of the transportation industries. In fact, the HHS Mandatory Guidelines have adopted our MRO provisions for invalids due to pH in the 9.0-9.5 range. We read the Omnibus Act to require the Department to follow the HHS on the drugs for which we test and the testing protocols, but the Omnibus Act allows us to, and we have chosen to, diverge from the HHS and the HHS Mandatory Guidelines on collections, MROs, and what laboratories can report. As we said in our 2008 SVT Final Rule preamble, ``Since Congress specifically limited the scientific testing methodology upon which DOT can rely in making its drug and alcohol testing regulations; we follow the HHS scientific and technical guidelines, including the amendments to their Mandatory Guidelines.'' (73 FR 35961, June 25, 2008) In the 2008 SVT Final Rule, we also explained that the ``Omnibus Act requires the DOT to incorporate the HHS scientific and technical guidelines, and we do not have the authority to impose additional scientific and technical requirements upon the laboratories.'' (73 FR 35963, June 25, 2008) In response to the commenters who would like us to consider alternative specimens such as hair testing and point of collection testing, we reiterate what we said in response to comments on our direct observation final rule in late 2008: ``The Department is not opposed to the use of alternative, less intrusive, testing methods as a means of accomplishing the safety purposes of the program while preventing individuals from cheating. Under the Omnibus Transportation Employee Testing Act of 1991, however, the Department is authorized to use only testing methods that have been approved by the Department of Health and Human Services (HHS). To date, HHS has not approved any specimen testing except urine.'' (73 FR 62917, Oct. 22, 2008) Therefore, we cannot consider alternative specimens at this particular point in time. In fact, DOT would not desire to do so without the HHS [[Page 49853]] scientific and laboratory certification processes being in place. Several commenters have asked us to explain how the Omnibus Act affects the Department's determination of whether it will and will not follow HHS. In response, as we explained above, where the Omnibus Act requires the Department to follow the HHS--for the laboratory and testing procedures, the Department will follow the scientific and technical aspects prescribed by the HHS. Where the Omnibus Act limits or otherwise prohibits the Department from following the HHS, the Department must decline to follow the lead of the HHS. For example, when HHS did not embrace a split specimen requirement, the Department departed from the HHS Mandatory Guidelines due to the Omnibus Act's requirements for split specimens. Where the HHS takes a position that we are neither required to follow nor prohibited from following, the Department will continue to view the HHS position as optional. We recognize that the HHS has expertise in the Federal employee testing program for these optional matters, but the Department has its own expertise as the regulator of the largest workplace drug and alcohol testing program in the world. As such, we will consider the optional matters in light of transportation safety, the costs and benefits to our regulated industries, and scientific and forensic considerations. Use of Instrumented Initial Test Facilities In our NPRM, we proposed allowing DOT employers to choose between full service laboratories and IITFs. An IITF would be able to provide results to employers only for negative and certain negative dilute specimens, as well as specimens they reject for testing. All other specimens would be forwarded to an HHS certified, full service laboratory. We requested comments as to how this process would impact the industry, specifically employers. The majority of commenters felt that use of IITFs would be detrimental to the turnaround time for reporting of non-negative results and most did not favor use of IITFs. Other commenters believed IITFs would be very useful, accurate, and afford the ability for a rapid turnaround time for their negative results. DOT Response The Omnibus Act actually prohibits the Department from following HHS on the issue of IITFs. The Omnibus Act requires ``that all laboratories involved in the controlled substances testing of any individual under this section shall have the capability and facility, at such laboratory, of performing screening and confirmation tests.'' (49 U.S.C. 31306(c)(3), 49 U.S.C. 20140(c)(3), 49 U.S.C. 5331(d)(3) and 49 U.S.C. 45104(3)) An IITF can conduct the initial screening for drugs in a urine specimen, but is not certified to provide a confirmation test. Since IITFs do not have any confirmation testing capabilities, the Department must not use them in part 40. The Senate Report for S. 676, the bill that subsequently became the Omnibus Act, indicates the intent behind this requirement was to ensure that ``[a]ny testing program would be required to include procedures to protect individual privacy, incorporate laboratory certification and testing procedures developed by [HHS] * * * require that all laboratories involved in testing for drugs have the capability of performing screening and confirmation tests at such laboratory.'' Senate Report 102-54, pages 10-11. Because IITFs do not offer confirmation testing, the Department is prohibited by the Omnibus Act from using laboratory facilities that lack the capability to perform both screening and confirmation tests. Therefore, DOT employers do not have the option of using IITFs. For this reason there are no provisions in this final rule for IITFs, and they will not be authorized for use in DOT's program by our regulated employers. MDMA Testing In the NPRM, we proposed to incorporate testing for MDMA into part 40. Comments A majority of commenters favored testing for MDMA. A few commenters indicated that their data showed that there would be relatively few positive test results, creating an unnecessary cost burden to employers. One laboratory group opposed the inclusion of MDMA and suggested the Department test instead for ``hydromorphone, hydrocodone, oxycodone, and oxymorphone.'' Those who favored testing MDMA represented a wide range of interests--MRO groups, third-party administrators, a major employer association, a major service agent association, among them. Most who supported testing for MDMA said that many employers were already testing for MDMA in their non-DOT testing programs. They supported putting MDMA testing into the Federal testing arena. Some commenters presented information about the use of MDMA, saying that MDMA was no longer a threat; MDMA is strictly a drug for younger persons; MDMA is a ``club'' drug that is not being used by transportation employees. Others presented data showing that MDMA use is on the rise and the implication is that the threat of MDMA use will become greater as the current transportation population is replaced via attrition by a younger population. DOT Response In this rulemaking, we are adopting the HHS laboratory testing requirements of conducting initial testing for MDMA, conducting confirmatory testing for MDMA, Methylenedioxyamphetamine (MDA), and Methylenedioxyethylamphetamine (MDEA). As we stated in our NPRM, regarding such matters, ``past experience has shown that DOT has never deviated from HHS on laboratory testing matters--the drugs for which we test, the specimens we test, specimen validity testing values, initial and confirmatory cutoff values, and laboratory testing processes and procedures, among others. The DOT is required by the Omnibus Transportation Employee Testing Act of 1991 to adhere with the HHS on these important laboratory testing matters.'' (75 FR 5722-5723, Feb. 4, 2010) We can provide additional guidance to MROs, as appropriate, so that these changes fit the transportation industries. However, we do not read our authority as allowing us to depart from HHS on this subject. Aside from the fact that the Omnibus Act requires us to test the drugs for which HHS labs are certified to test, we note that, as some commenters said, MDMA is not just a ``club drug'' any more, it is being marketed to a much larger population in American communities. The Department of Justice National Drug Intelligence Center's 2010 National Drug Threat Assessment ( http://www.justice.gov/ndic/pubs38/38661/38661p.pdf ) supports DOT's conclusion with regard to MDMA availability, finding: ``Asian DTOs [Drug Trafficking Organizations] are responsible for a resurgence in MDMA availability in the United States, particularly since 2005. These groups produce large quantities of the drug in Canada and smuggle it into the United States across the Northern Border. The smuggling of MDMA into the United States from Canada fueled an increase in the availability of the drug that began in 2005, although availability appears to be stabilizing. Data regarding MDMA availability are limited; nonetheless, analysis of National Forensic Laboratory Information System (NFLIS) data shows a 76 percent increase in the number of MDMA submissions from 2005 to 2008, although [[Page 49854]] MDMA submissions make up a much smaller percentage of submissions than other illicit drugs, including cannabis, cocaine, methamphetamine, and heroin. National Drug Threat Survey (NDTS) data also provide an indication of MDMA availability. The percentage of state and local law enforcement agencies that reported moderate or high availability of MDMA in their areas increased from 47.2 percent in 2005 to 51.5 percent in 2009. Seizure data show that the amount of MDMA seized along the U.S.[dash]Canada border increased 156 percent from 2007 to 2008 and that more MDMA was seized at the Northern Border in 2008 than in any year since 2005. MDMA seizure totals declined in 2009 but still exceeded 2007 totals. Although most Northern Border seizures occur at POEs (Points of Entry), the amount of MDMA seized between POEs appears to be increasing, likely because increased scrutiny at POEs has forced smugglers to develop new routes and smuggling methods in an attempt to circumvent law enforcement. For example, in 2008, more than 243,000 dosage units of MDMA were seized between POEs, compared with none the previous year; seizures between POEs in 2009 exceeded those in 2008. MDMA seizures along the Southwest Border and through commercial air have also increased, albeit on a much smaller scale. Seizures at or near the Southwest Border show an increase from 114,286 dosage units in 2006 to 387,143 dosage units in 2009. Furthermore, commercial air seizures spiked in 2008, with a 91.4 percent increase from 2007 to 2008 (433,571 dosage units to 829,857 dosage units); MDMA commercial air seizure totals for 2009 decreased, resulting in levels comparable to 2007 levels. Ready availability of MDMA has enabled distributors to expand their customer base to include new user groups, most notably African American and Hispanic users. Asian DTOs have begun distributing MDMA to African American and Hispanic street gangs, which distribute the drug along with other illicit drugs in markets throughout the United States, most notably in the Southeast, Southwest, and Great Lakes Regions. Moreover, MDMA is no longer exclusively viewed as a ``rave'' or club drug, which also aids distributors in selling it to nontraditional abusers.'' One laboratory group urged DOT to require testing prescription medications and synthetic drugs, rather than MDMA. While DOT shares the group's concern about unauthorized use of the prescription medications and the use of synthetic drugs, testing for prescription medications and synthetic drug and testing for MDMA are separate issues. As part of their non-DOT testing programs, regulated employers can test for prescription medications or synthetic drugs and in many instances it may be appropriate to do so. Some DOT agencies and the United States Coast Guard (USCG), for instance, have medical qualification standards--for Commercial Drivers License holders, certified pilots and aviation mechanics, and licensed mariners--that focus upon the underlying medical conditions that would require use of prescription medications. Evaluating medical professionals are trained to seek information that would shed light on an individual's use of medicines and their qualification to perform safety sensitive duties. It is also important to note that employers can expand upon the Department's regulatory requirements, as long as they do not represent the test as being required by DOT. Under their non-DOT testing programs, DOT-regulated companies may test for other drugs of their choosing. Therefore, companies are not prohibited by DOT from testing for additional drugs that may be of concern within their communities and companies. Lowering Laboratory Cutoff Criteria for Cocaine and Amphetamines The Department proposed, in the NRPM, to adopt the HHS-lowered laboratory testing cutoffs for cocaine and amphetamines. Initial test cutoffs for cocaine metabolites would go from 300 to 150 ng/mL, while confirmation test cutoffs would go from 150 to 100 ng/mL. For amphetamines, initial test cutoffs would go from 1000 to 500 ng/mL, while confirmation tests for amphetamines and methamphetamines would go from 500 to 250 ng/mL. Comments Most commenters support the Department's conforming to the HHS Mandatory Guidelines in lowering the cutoffs for both cocaine and amphetamines. Most believe doing so will enhance the safety of the traveling public because more users of illicit drugs and more users of non-prescribed medications will be identified. There was no controversy about the new screening and confirmation test levels for cocaine. Some commenters believed that there could be ``false positive'' drug tests stemming from the new cutoffs for amphetamines. Some others believed the amphetamine cutoffs could even cause laboratories to report over-the-counter (OTC) medications as confirmed positive test results. Some others believed that lowering the screening cutoffs for amphetamines will provide little value in the confirmation process, serving only to increase the cost of the program. Some commenters cited the data from one of the laboratories-- Clinical Research Laboratory (CRL)--as reason to support the new cutoffs, while others cited the same data as reason to oppose the new cutoffs. DOT Response As stated earlier in this document, the Department must follow the laboratory testing protocols and standards that are established by HHS. Therefore, we must and will adhere to the screening and confirmation drug testing cutoffs that HHS has established for the laboratories and for which the laboratories are certified. In addition, taken with the comment data from Quest Laboratories, we believe the laboratory data sets from both Quest and CRL lead likely to some, but not all, of the same conclusions. Regarding cocaine, based upon data provided by both Quest and CRL, we can expect a marked increase in cocaine users identified using the new screening and confirmation cutoffs that HHS has established. The Department, like the overwhelming number of commenters, considers this to be a beneficial change. In 2009, there were nearly 13,000 positive DOT drug test results reported by laboratories as having confirmed positives for cocaine. Quest and CRL data show that we can expect a significant number of confirmed positive test results for cocaine using the new cutoffs. These new lower cutoffs should result in the Department identifying more cocaine users, further assuring the traveling public that the transportation system is the safest it can be. Doing so will also permit us to continue to further deter drug use in the transportation industries and get those identified as using drugs referred for evaluation and treatment. Regarding amphetamine and methamphetamine, the Quest data report on 68,000 regulated and 132,000 non-regulated specimens and indicate that a 40% increase in screening and a 30% increase in confirmation rates are expected; hence, a large number of currently non-detected users would be identified. A second submission of amphetamine and methamphetamine test data, this from CRL, includes the reanalysis of a much smaller number of regulated specimens. Several important facts about the CRL study protocols and results were not fully explained or clarified in their data submission. As a result, we are concerned that other commenters may have misinterpreted the CRL data as meaning that there will be ``false positive'' tests results for amphetamines and that some OTC medications--ephedrine, pseudoephedrine, and phenylpropanolamine--will be confirmed and reported as positives by laboratories. [[Page 49855]] We want to address these commenters' statements that testing at the new amphetamine screening cutoffs will yield ``false positive'' test results. Neither CRL nor Quest even alluded to there being a ``false positive'' testing issue with the new amphetamine cutoffs. Concerns about the risks of ``false positive'' test results are not supported by the available data. In fact, no reportable positive test results were identified in the CRL and Quest data on specimens that did not, in fact, screen and confirm positive for a drug for which DOT tests. In addition, we want to clarify that no OTC medication that CRL chose to test for--ephedrine, pseudoephedrine, and phenylpropanolamine--would confirm positive on a DOT test and would be reported on a DOT test. We are concerned that the CRL confirmation testing on these specimens may have proven misleading to the groups who read the data and believed that our tests for amphetamines would identify these particular OTC medications. It is our opinion that CRL's inclusion of this confirmation test data does not support CRL's conclusion. Laboratories simply will not conduct confirmation testing for or identify these OTC medications in DOT's program. It is also important to note that only confirmed positive drug tests are reported to the MRO as positive. No results screened positive are reported as positive until and unless they are also positive on a laboratory confirmation test and for the drugs for which we test. And, no test result is reported to the employer until the MRO properly verifies the result by determining if the employee has a legitimate medical explanation for the positive. If the employee has a legitimate medical explanation, the MRO will report the result to the employer as a negative test. These are ``due process'' steps that have always been an integral part of DOT's testing program. We realize that laboratories will certainly screen specimens for amphetamines at the new HHS cutoffs and will not realize the same return rate on confirmed positive testing as they observe now, as CRL points out effectively in their data. CRL is concerned that the cost of confirming the increased number of screened positive tests does not warrant the expense for such a small number of confirmed positives, as shown by their data. It is important to note that the confirmation rates for opiates and amphetamines is now generally less than that for THC, cocaine, and PCP. Therefore, it is not unusual to see a disparity between screening rates and subsequent confirmation rates, especially for opiates and amphetamines. However, we will urge HHS to closely monitor this screening issue for amphetamines during the first year the new cutoffs are in place. We believe that the issue will be properly evaluated by HHS with DOT, the Center for Substance Abuse Prevention Drug Testing Advisory Board (CSAP DTAB), and laboratories in determining if the screening cutoffs for amphetamine would need to be modified upward if the added cost largely outweighed the benefits. The CSAP DTAB provides advice to the Administrator, SAMHSA, regarding the drug testing laboratory certification program. Laboratory Testing for 6-Acetylmorphine (6-AM) In the NPRM, we proposed to incorporate new HHS criteria for initial testing for 6-AM, a marker for heroin. We also asked if there were factual, evidence-based concerns about the need to show morphine with a 6-AM confirmed positive result. Al
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