[Federal Register: April 4, 1997 (Volume 62, Number 65)] [Rules and Regulations] [Page 16369-16431] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr04ap97_dat-29] [[Page 16369]] _______________________________________________________________________ Part III Department of Transportation _______________________________________________________________________ Federal Highway Administration _______________________________________________________________________ 49 CFR Chapter III Regulatory Guidance for the Federal Motor Carrier Safety Regulations; Rule [[Page 16370]] DEPARTMENT OF TRANSPORTATION Federal Highway Administration 49 CFR Chapter III Regulatory Guidance for the Federal Motor Carrier Safety Regulations AGENCY: Federal Highway Administration (FHWA), DOT. ACTION: Regulatory guidance. ----------------------------------------------------------------------- SUMMARY: This document presents interpretive guidance material for the Federal Motor Carrier Safety Regulations (FMCSRs) now contained in the FHWA's Motor Carrier Regulation Information System (MCREGIS). The FHWA has consolidated previously issued interpretations and regulatory guidance materials and developed concise interpretive guidance in question and answer form for each part of the FMCSRs. These questions and answers are generally applicable to drivers, commercial motor vehicles, and motor carrier operations on a national basis. All prior interpretations and regulatory guidance of the FMCSRs issued previously in the Federal Register, as well as FHWA memoranda and letters, may no longer be relied upon as authoritative insofar as they are inconsistent with the guidance published today. Many of the interpretations of the FMCSRs published on November 23, 1977, and the interpretations of the Inspection, Repair, and Maintenance regulations published on July 10, 1980, have been revised. These revisions are reflected in the new questions and answers. This document also includes regulatory guidance issued since November 17, 1993, when the agency last published a collection of such guidance. Future regulatory guidance will be issued within the MCREGIS which will be kept current in the FHWA's Office of Motor Carrier Standards. The MCREGIS will be updated periodically and published in the Federal Register so that interested parties may have ready reference to official interpretations and guidance regarding the FMCSRs. This guidance will provide the motor carrier industry with a clearer understanding of the applicability of many of the requirements contained in the FMCSRs in particular situations. EFFECTIVE DATE: May 4, 1997. FOR FURTHER INFORMATION CONTACT: Mr. Neill L. Thomas or Mr. Nathan C. Root, Office of Motor Carrier Standards, (202) 366-1790, or Mr. Charles E. Medalen, Office of the Chief Counsel, (202) 366-1354, Federal Highway Administration, Department of Transportation, 400 Seventh Street, SW., Washington, DC 20590. Office hours are from 7:45 a.m. to 4:15 p.m., e.t., Monday through Friday, except Federal legal holidays. SUPPLEMENTARY INFORMATION: This document is an update of the notice of regulatory guidance for the FMCSRs issued by the FHWA November 17, 1993 (58 FR 60734). This notice contains previously issued, revised, and new regulatory guidance pertaining to Title 49, Code of Federal Regulations (CFR), Parts 40, 325, 382, 383, 384, 386, 387, 390 to 393, 395 to 397, and 399 of the FMCSRs. In some instances, old regulatory guidance has been removed. The information published in this document supersedes all previously issued interpretations and regulatory guidance, to the extent they are inconsistent with the guidance published today, including that published on November 23, 1977, at 42 FR 60078, and on July 10, 1980, at 45 FR 46425. To the maximum extent possible, all valid prior opinions have been incorporated into this document. This notice is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, March 29, 1996). The FHWA issued a final rule on March 8, 1996, which codified most of the regulatory guidance for CDL waivers under Sec. 383.3 (61 FR 9546). Guidance concerning CDL waivers had been issued under Sec. 383.7. From the 1993 Regulatory Guidance notice for Sec. 383.7, only questions 7(a), 8, 9, 10, 16, 17, 21, and 22 still remain. These questions and guidance are now listed as guidance for Sec. 383.3, where the CDL waivers have been codified. Guidance for question 3 under Sec. 383.5 has been changed to reflect a more expansive version of the same guidance in existence prior to the November 1993 Notice. Guidance for question 2 under Sec. 383.93, as it appeared in the 1993 notice, has been revised to clarify the existing guidance. Guidance for question 1 under Sec. 390.31 has been expanded to include guidance derived from a Final Order issued by the Department (58 FR 62467). Guidance for question 1 of Sec. 391.1 has been changed to remove a reference to part 391 subpart H. Guidance for question 6 under Sec. 391.11 has been moved to Sec. 392.9. Guidance for question 2 under Sec. 391.27 has been removed: violations of size and weight laws are not considered violations of motor vehicle traffic laws. Question 1 for Sec. 391.41 has been changed for clarity. Guidance for question 1 under Sec. 391.43 has been expanded for greater clarity. Guidance for Sec. 392.62 has been moved to Sec. 391.41. Guidance for question 1 of Sec. 393.51, question 1 of Sec. 393.65, question 1 of Sec. 393.75, question 5 of Sec. 393.100, and question 1 of Sec. 393.106 have been amended for clarity. Guidance for question 1 under Sec. 393.95 has been incorporated into the regulations (58 FR 34708) and is therefore removed from this document. Guidance for Sec. 395.1 has been reordered to consecutively follow the paragraphs within the section. Question 15 under Sec. 395.2 was expanded by guidance issued June 11, 1995. Question 20 under Sec. 395.2 has been revised to reflect an interpretation previously issued August 15, 1991, treating the same issue in a more explicit manner. Question 1 under Sec. 397.1 has been changed to more accurately explain who must comply with part 397. The 1994 Regulatory Guidance booklet, which reprinted the interpretations issued in the Federal Register in 1993, is available in the public docket on this rulemaking for reference The FHWA issued an advance notice of proposed rulemaking on November 5, 1996 (61 FR 57252) concerning the hours of service regulations (49 CFR part 395). On page 57258 of the notice, the FHWA erroneously indicated that an interpretation which allowed CMVs to be driven from motels to restaurants in the vicinity as ``off-duty time'' had recently been rescinded. The FHWA intended to rescind recent interpretations that describe conditions under which a CMV may be used as a ``personal conveyance'' (issued August 10, 1995), and address the entire issue of personal conveyance through notice and comment rulemaking. Question 8 under Sec. 395.2 has been expanded by guidance issued November 18, 1996, and placed more appropriately under Sec. 395.8 (see Sec. 395.8, question 27). All prior interpretations of personal conveyance are invalid. Since 1993, new interpretive guidance has been issued for, or existing guidance has been removed from, the following sections: 49 CFR Part 40 Secs. 40.3, 40.21, 40.23, 40.25, 40.29, 40.31, 40.33, 40.35, 40.39, 40.69, 40.81, 40.93, Special Topics--Requirements for Random Testing, Special Topics--Procedures for Handling and Processing a Split Specimen 49 CFR Part 382 Secs. 382.103, 382.105, 382.107, 382.109, 382.113, 382.115, 382.204, 382.205, 382.213, 382.301, 382.303, 382.305, 382.307, 382.401, 382.403, 382.405, 382.413, 382.501, 382.507, 382.601, 382.603, 382.605, Subpart B--Prohibitions, Special Topics--Responsibility for Payment for Testing, Special Topics-- [[Page 16371]] Multiple Service Providers, Special Topics--Medical Examiners Acting as MRO, Special Topics--Biennial (Periodic) Testing Requirements 49 CFR Part 383 Secs. 383.3, 383.5, 383.7, 383.31, 383.71, 383.73, 383.91, 383.93, Special Topics--International 49 CFR Part 384 Secs. 384.209, 384.211 49 CFR Part 387 Secs. 387.9, 387.15, 387.39 49 CFR Part 390 Secs. 390.3, 390.5, 390.15, Special Topics--Serious Pattern of Violations 49 CFR Part 391 Secs. 391.1, 391.11, 391.27, 391.41, 391.43, 391.49, 391.51, 391.63 49 CFR Part 392 Secs. 392.5, 392.9, 392.62 49 CFR Part 393 Secs. 393.11, 393.42, 393.48, 393.51, 393.65, 393.75, 393.89, 393.95, 393.100, 393.106, 393.201 49 CFR Part 395 Secs. 395.1, 395.2, 395.8, 395.13, 395.15 49 CFR Part 396 Secs. 396.11, 396.17, 396.23 Additional guidance will continue to be published in future issues of the Federal Register. The FHWA will be modifying or removing numerous regulations as part of President Clinton's Regulatory Reform Initiative. Many of these changes will have an impact on the regulatory guidance in this document. These changes will be reflected in future issues of the Federal Register. Members of the motor carrier industry and other interested parties may access the guidance in this document through the FHWA's Electronic Bulletin Board System (FEBBS) using a microcomputer and modem. The FEBBS is a read-only facility. Access numbers for FEBBS are (202) 366-3764 for the Washington, DC area, or toll-free at (800) 337-3492. The system supports a variety of modem speeds up to 14,400 baud line speeds, and a variety of terminal types and protocols. Modems should be set to 8 data bits, full duplex, and no parity for optimal performance. Once a connection has been established, new users will have to go through a registration process. Instructions are given on the screen. FEBBS is mostly menu-drive and hot keys are indicated with ``< >'' enclosing the hot key. After logging on to FEBBS and arriving at the MAIN MENU, select for Conference; then for Motor Carrier; then either again for MCREGIS Questions and Answers, or for Information (more detailed help). For Technical Assistance to gain access to FEBBS, contact: FHWA Computer Help Desk, HMS-40, room 4401, 400 Seventh Street, SW, Washington, DC 20590 (202) 366-1120. Specific questions addressing any of the interpretive material published in this document may be directed to the contact persons listed above, the FHWA Regional Offices, or the FHWA Division Office in each State. For ease of reference, the following listing of acronyms used throughout this document is provided: Appendix G--The Minimum Periodic Inspection Standards published as an appendix to the Federal Motor Carrier Safety Regulations BAT--Breath Alcohol Technician CDL--Commercial Driver's License CDLIS--Commercial Driver's License Information System CFR--Code of Federal Regulations CMV--Commercial Motor Vehicle CMVSA--Commercial Motor Vehicle Safety Act of 1986 COE--Cab-over-engine truck tractor C/TPA--Consortium or Third-Party Administrator CVSA--Commercial Vehicle Safety Alliance DHHS-SAMHSA--Department of Health and Human Services, Substance Abuse Mental Health Services Administration DOT--U.S. Department of Transportation DVIR--Driver Vehicle Inspection Report DWI--Driving While Intoxicated EAP--Employee Assistance Program EPA--U.S. Environmental Protection Agency FHWA--Federal Highway Administration FMCSRs--Federal Motor Carrier Safety Regulations FMVSS--Federal Motor Vehicle Safety Standards (developed and issued by the National Highway Traffic Safety Administration) FR--Federal Register FRSI--Farm-Related Service Industries GCWR--Gross Combination Weight Rating GVW--Gross Vehicle Weight GVWR--Gross Vehicle Weight Rating HM--Hazardous Materials HMRs--Hazardous Materials Regulations HMTUSA--Hazardous Materials Transportation Uniform Safety Act of 1990 ICC--Interstate Commerce Commission Forms MCS-90 and MCS-90B--Endorsements for Motor Carrier Policies of Insurance for Public Liability Under Sections 29 and 30 of the Motor Carrier Act of 1980 issued by an insurer MCSA--Motor Carrier Safety Act of 1984 MPH--Miles Per Hour MRO--Medical Review Officer NDR--National Driver Register NHTSA--National Highway Traffic Safety Administration within DOT RDMC--Regional Director of Motor Carriers SAP--Substance Abuse Professional SSN--Social Security Number STAA--Surface Transportation Assistance Act of 1982 STT--Screening Test Technician U.S.C.--United States Code Table of Contents Part 40--Procedures for Transportation Workplace Drug and Alcohol Testing Programs Part 325--Compliance With Interstate Motor Carrier Noise Emission Standards Part 382--Controlled Substances and Alcohol Use and Testing Part 383--Commercial Driver's License Standards; Requirements and Penalties Part 384--State Compliance With Commercial Driver's License Program Part 386--Rules of Practice for Motor Carrier Safety and Hazardous Materials Proceedings Part 387--Minimum Levels of Financial Responsibility for Motor Carriers Part 390--Federal Motor Carrier Safety Regulations; General Part 391--Qualifications of Drivers Part 392--Driving of Motor Vehicles Part 393--Parts and Accessories Necessary for Safe Operation Part 395--Hours of Service of Drivers Part 396--Inspection, Repair and Maintenance Part 397--Transportation of Hazardous Materials; Driving and Parking Rules Part 399--Employee Safety and Health Standards Regulatory Guidance Part 40--Procedures for Transportation Workplace Drug and Alcohol Testing Programs Sections Interpreted 40.3 Definitions 40.21 The Drugs 40.23 Preparation for testing 40.25 Specimen collection procedures 40.29 Laboratory analysis procedures 40.31 Quality assurance and quality control 40.33 Reporting and review of results 40.35 Protection of employee records 40.39 Use Of DHHS-certified laboratories 40.69 Inability to provide an adequate amount of breath 40.81 Availability and disclosure of alcohol testing information about individual employees 40.93 The screening test technician Special Topics--Requirements for random testing Special Topics--Procedures for Handling and Processing a Split Specimen Section 40.3 Definitions Question 1: May a Doctor of Chiropractic, holding a Certified Addiction Professional degree, serve as an MRO? Guidance: A Doctor of Chiropractic, holding a Certified Addiction Professional degree, is not considered to be a licensed medical doctor or doctor of osteopathy and, therefore, cannot serve as an MRO. Question 2: What are the qualifications and responsibilities of the MRO? Are MROs required to be certified? Guidance: Section 40.3 defines the qualifications for an MRO and Sec. 40.33 specifies the MRO's responsibilities. An MRO is defined as a licensed physician (medical doctor or doctor of osteopathy) responsible for receiving laboratory [[Page 16372]] results generated by an employer's drug testing program who has knowledge of substance abuse disorders and has appropriate medical training to interpret and evaluate an individual's confirmed positive test result together with his or her medical history and any other relevant biomedical information. An MRO is responsible for reviewing and interpreting confirmed positive test results obtained through the employer's testing program. The DOT does not require any certification of MROs at the present time. However, there are several national professional organizations which provide MRO certification. Section 40.21 The Drugs Question 1: Is testing for additional drugs authorized? Must a separate specimen be obtained? Guidance: Under part 40, an employer must test for the following drugs: marijuana, cocaine, amphetamines, opiates, and phencyclidine. An employer may not test for any other substances under DOT authority. Part 40 does not, however, prohibit an employer from testing for other controlled substances as long as that testing is done under the authority of the employer. Employers in the transportation industry who establish a drug testing program that tests beyond the five drugs currently required by part 40 must also make clear to their employees what testing is required by DOT authority and what testing is required by the company. Additionally, employers must ensure that DOT urine specimens are collected in accordance with the provisions outlined in part 40 and that a separate specimen collection process including a separate act of urination is used to obtain specimens for company testing programs. Question 2: Should labs conduct tests for five (5) drugs even if the drug testing custody and control form fails to indicate what tests are to be performed? Guidance: Part 40 indicates that DOT agency drug testing programs require that employers test for marijuana, cocaine, opiates, amphetamines, and phencyclidine (Sec. 40.21). All DOT specimens, therefore, must be tested for the above five categories of drugs even if the accompanying drug testing custody and control form fails to indicate this. While the DOT does not view this type of collection site error as a fatal flaw, it nevertheless jeopardizes the integrity of the entire collection process and could lead to a challenge and subsequent third party review. These errors should be addressed with the site supervisor in the hope of preventing future mistakes. Section 40.23 Preparation for Testing Question 1: On the testing of a split specimen, is it necessary to maintain anonymity of a person, at the laboratory level, when both the primary laboratory and the laboratory testing the split may have fees and could directly bill the employee? Guidance: Section 40.23(a) addresses mandatory use of the Federal Drug Testing Custody and Control Form in DOT urine collection and testing. This paragraph states, in part, that ``* * * personal identifying information on the donor (other than the social security number or other employee ID number) may not be provided to the laboratory.'' If circumstances arise in which the MRO orders a test of the split specimen, at the request of the employee, no additional identifying information on the employee may be provided to the laboratory that will be testing the split specimen. As directed by Sec. 40.33(f), ``* * * The MRO shall direct, in writing, the laboratory to provide the split specimen to another DHHS-certified laboratory for analysis.'' This request would reference only items contained on the face of the Drug Testing Custody and Control Form (e.g., Specimen Identification No., SSN or Employee ID No., Collection Date, etc.); the MRO would not specify the employee's name. Should a personal check (bearing the employee's name) accompany the request (e.g., a letter from the MRO), the MRO should not make any particular reference linking the split request with the person signing the check. In actuality, the primary laboratory will most likely bill the employer for the cost of sending the split specimen to the split laboratory; the split laboratory will normally require a cashier's check, money order, or an account to be set up (generally by the employer) prior to initiating processing. Question 2: In a case where an employee is providing a urine specimen and a breath test is conducted at the same time, may a laboratory receive both the Federal Drug Testing Custody and Control Form (with the specimens for testing) and the employer's copy of the Breath Alcohol Testing Form (with the test results) from the collection site? Guidance: The DOT provided clarification in its Guidance on the Role of Consortia and Third-Party Administrators in DOT Drug and Alcohol Testing Programs published on July 25, 1995 in the Federal Register which stated in part ``* * * MROs and BATs must send final individual test results directly to the actual employer as soon as the results are available * * * results may be maintained afterwards by the C/TPA * * * while there is no objection to the MRO or BAT transmitting results simultaneously both to the employer and to the C/TPA, it is not appropriate for the MRO or BAT to send the results only to the C/TPA, which subsequently retransmits them to the employer.'' A laboratory, regardless of what type of arrangement it has with the employer, is prohibited from receiving the employer's copy of the Breath Alcohol Testing Form together with the Federal Drug Testing Custody and Control Form(s) which accompany the urine specimen. The breath testing form contains individual identifying information. The DOT rule specifically states that this information may not be provided to a laboratory. However, a laboratory functioning as a C/TPA may receive the employer's copies of the Federal Drug Testing Custody and Control Form and the employer's copy of the Breath Alcohol Testing Form from the collection site under the following conditions: a. The employer's copy of the Federal Drug Testing Custody and Control Form (Copy 7) must not be included with the laboratory copies (Copies 1 and 2) which accompany the urine specimen. b. The employer's copies of the Federal Drug Testing Custody and Control Form and the Breath Alcohol Testing Forms must not be received by the accession/receiving (testing) section of the laboratory. These procedures should prevent that portion of the laboratory which conducts the drug analysis from having access to the identity (from the alcohol testing form) of the donor. The DOT rule requires the BAT immediately to transmit the results to the employer, regardless of what procedures have been established for providing to the employer or the C/TPA, the employer's copy of the breath testing form. In all instances, it is the employer (not the C/TPA) who designates in writing to the BAT or the BAT's company, who the employer's agent is and the procedures that the employer wants the BAT to use for transmission of data and forms. Question 3: Is a specific MRO name required in Step 1 on the Federal Drug Testing Custody and Control Form, or may a clinic, hospital, health care organization, or MRO company name appear in the MRO Name and Address area? Guidance: The DOT has determined that a specific physician's name and address is required in Step 1 of the [[Page 16373]] Federal Drug Testing Custody and Control Form as opposed to only a generic clinic, health care organization, or company name. The name should be that of a responsible physician rather than an administrative staff member or other company official. However, a company name may appear as part of the address, provided it is followed by or includes the MRO's name. Collection sites send copies of the MRO's custody and control form to this address, and drug testing laboratories use it to submit laboratory results to the MRO. The use of the MRO name will preclude potential compromises of confidentiality. In many cases, where only the name of a clinic, hospital or company appears on the mailing address, the laboratory results are sent to the clinic or hospital and are either circulated through numerous departments or, in some cases, never reach the MRO. The physician named in Step 1 may be the MRO who will actually perform the verification review or the name of a physician within the practice (company), but not necessarily the one who will actually perform the verification (in those cases where there is more than one MRO working in that office or company). Question 4: Is the collector's signature required on the chain of custody section of drug testing custody and control form? Guidance: The collector's signature is required in both the ``received by'' and the ``released by'' spaces in Step 6 of the drug testing custody and control form. Part 40 Appendix A specifies that the form shall provide both ``received by'' and ``released by'' entries of the collector's signature and printed names (see the instructions on the back of Appendix A, copy 7, Step 6. Combining these entries is not authorized by the rule. Question 5: May the drug testing custody and control form be used for non-DOT tests? Guidance: Employee drug testing conducted under local, State, or private authority must not be represented to the employee as being Federally mandated or required. The use of the custody and control form required under 49 CFR part 40 conveys that the testing is being conducted in accordance with applicable Federal regulations. A ``look- alike'' form that deletes references to DOT, Part 40, and Federal requirements may be used for non-DOT testing. Question 6: Is collection of blood authorized? May blood specimens be supported by the drug testing custody and control form? May blood test results be used to take DOT-required administrative actions? Guidance: The collection of blood for alcohol or drug testing under DOT authority is not authorized. Therefore, while a company, under its own authority, may require a blood specimen to be collected and tested for drugs and/or alcohol under certain circumstances, it is not acceptable for the company-required blood specimen to be supported by the same custody and control form that accompanies a DOT-required urine specimen. If a urine specimen for a DOT reasonable suspicion test is rejected for testing at the laboratory, results from a blood specimen collected in accordance with a company policy could be used to take action against an employee depending upon the drug testing policy established by that company. Under no circumstances, however, may the results of the blood test be used to take administrative or disciplinary action against an employee using DOT authority, for the reasons cited above. Question 7: Is the collector required to sign or initial the shipping container label? Guidance: Sections 40.23(c) and 40.25(h) describe the requirements for packaging the specimen and custody and control form in preparation for shipment to the laboratory. Section 40.23(c) states that the shipping container must be sealed and initialed to prevent undetected tampering. Section 40.25(h) states that the collection site person shall sign and enter the date specimens were sealed in the shipping containers for shipment. The DOT has determined that initialing and dating the seal by the collection site person is sufficient to meet the intent of the regulation. Question 8: How and to whom are copies of drug testing custody and control forms distributed? Guidance: The historically acceptable procedures for handling the custody and control form have been as follows: Parts 1, 2, and 3 must accompany the urine specimen in a sealed shipping container to the laboratory; Part 3 (Split Specimen) must be retained by the laboratory in case the split specimen must be sent to a second laboratory; Part 4 must be sent from the collection site directly to the physician (MRO); Part 5 is given to the donor at the collection site; Part 6 is retained by the collection site personnel; and Part 7 is provided to the employer representative. It is unacceptable for the MRO copy of the form to accompany the urine specimen to the laboratory. Clearly the intent of the regulation is for the urine specimen and Parts 1, 2, and 3 of the Federal custody and control form to be sent directly from the collection site to the laboratory, and the MRO (Part 4) copy of the custody and control form to be sent directly to the physician. There is no need to maintain a chain of custody tracking the handling of the sealed shipping container. In fact, the August 19, 1994 Federal Register (59 FR 42996) expressly notes this fact in changes to Sec. 40.25 to clarify this point. Question 9: Should a specimen be rejected by a lab if the donor- identifying information is erroneously provided? Guidance: The intent of the DOT procedures is to limit the amount of personal identifying information that is recorded on the specimen bottle and those copies of the drug testing custody and control form that accompany the specimen bottle to the laboratory. The rule only requires that a donor initial the specimen bottle label/seal and provide an SSN or employee identification number to be recorded on the laboratory copies of the drug testing custody and control form. The rule does not allow for additional personal information to be provided to the laboratory. In fact, the intent was to prevent the donor's identity from being routinely disclosed to the laboratory. It was never intended, however, that the inadvertent or erroneous disclosure of the donor's identity (i.e., name or signature) on the specimen bottle or laboratory copies of the drug testing custody and control form be a justification, in and of itself, for a laboratory to reject the specimen for testing or for an MRO to invalidate the test results. Furthermore, all accessioning procedures at laboratories certified by the DHHS-SAMHSA requires that specimens be identified by specimen identification number, donor identification number, and laboratory accession number only. Even though laboratory accessioning personnel may have access to a donor's name in these cases, the analytical personnel will not. Therefore, the donor's identity is still protected during the actual testing process. Question 10: Must the collector provide a real name on the collector certification section of drug testing custody and control form? Guidance: The intent of the DOT drug testing custody and control form is to provide complete documentation of the specimen collection process including the name of the collector and the location of the collection site. The collection site person who receives the urine specimen from the donor should be identified by name on the block specifying ``collector's name.'' Use of a ``code name,'' collector I.D. number, or [[Page 16374]] other substitution for the collector's name is not acceptable. The collector's name should be the same as that appearing on the identification each collector is required to make available to the donor, if so requested. Section 40.25 Specimen Collection Procedures Question 1: Under what circumstances must an employee be observed while submitting a urine sample? Under what circumstances is observation an optional choice of the employer? Guidance: A direct-observation collection is mandatory only when the collection site person observes behavior clearly indicating an attempt to tamper or when the specimen temperature is outside the normal range and an oral body temperature reading is refused or is inconsistent with the specimen temperature. The collection site person would contact a higher-level supervisor, or a designated employer representative, to relay the circumstances which require the observed collection. The supervisor or representative would review the circumstances for compliance with Part 40 requirements, and finding such, would approve in advance the decision to do the observed collection. The collection site person--of the same gender as the employee--would immediately conduct the observed collection. The employer has the discretion to require the employee to provide a specimen under direct-observation collection procedures for the return-to-duty test and any subsequent follow-up tests. The employer also has the authority to require an employee to provide a specimen under direct-observation procedures when the specific gravity and creatinine content of the employee's previous sample are below the regulatory standards. In the latter case, the MRO would receive the test results from the laboratory (i.e., positive, negative, or in the case where no immunoassay result is reported) along with information that the specimen had a specific gravity of less than 1.003 and creatinine concentration less than 0.2g/L. The MRO would inform the employer of the laboratory findings. The employer would make the decision to do a direct-observation collection on the employee on the next DOT test that the employee is required to take. It would be the employer's responsibility to notify the employee of the decision to exercise the option to do the collection(s) under the direct-observation procedure. The employer would authorize the collection site person to do the observed collection(s), as applicable. Directly observed collections are always performed by a collector of the same gender as the employee. Question 2: In a ``shy bladder'' situation, if the physician conducting the medical examination is not the MRO, may that physician report his/her conclusions directly to the employer? Also, if a company has a corporate or contract physician, may that physician perform the examination? Guidance: The rule does not preclude the MRO from performing this medical evaluation if the MRO has the expertise and is willing to conduct this evaluation. The DOT's requirement that the MRO review the results of the medical evaluation is related to the fact that the MRO may have additional information on the circumstances surrounding the attempt to provide the urine specimen, other pertinent information regarding the collection process, problems or lack of problems during previous collections, etc. All reporting to the employer regarding the final determination on the results of a urine specimen is accomplished by the MRO. This includes the findings and conclusions of the medical examination. If a company has a physician on the staff or has a contract physician, this individual may perform the medical examination if he/ she has the required expertise. The company should ensure that the MRO is informed of this arrangement and makes the referral to that particular physician. However, the requirement still exists to submit the findings of the evaluation to the MRO, who then reports his/her conclusions to the employer. A company may also designate its staff physician or contract physician as the MRO if that individual meets the regulatory criteria. Question 3: In a ``shy bladder'' scenario, may an employer require an individual to provide a specimen within three hours, and if the individual doesn't provide a specimen, is the inability considered to be a refusal? Guidance: The individual must provide the specimen within three hours. The inability to provide does not automatically mean that the individual being tested will be deemed to have refused testing. The required medical evaluation would produce the information which the MRO will use to draw final conclusions. If the finding by the MRO is that there was no legitimate medical reason for the individual's inability to provide the sufficient quantity of urine, then this finding constitutes a refusal. A refusal to provide a specimen has the same sanctions under the DOT rule as a positive test. Once it has been determined that the employee has violated a DOT rule (e.g., verified positive test, refusal), the employee must be immediately removed from performing any safety-sensitive duties. The employee may not again perform safety-sensitive duties until he or she has met the conditions of the applicable operating administration (e.g., Federal Highway Administration) rule for return to duty. The DOT rule does not address employer policies on subsequent personnel actions. Question 4: In a ``shy bladder'' scenario, does DOT consider a company's ordering the donor back to work prior to completion of the time and fluid intake period an obstruction of the collection process? Or, is the donor's failure to complete the collection, after having been compelled by the employer to leave the collection site, considered a refusal to test if no medical reason is provided for donor's failure to provide the required amount of urine? Guidance: A company's ordering the employee to return to work prior to the expiration of the time period, with no provisions for personal observation or for ensuring the employee's return to the collection site, appears to be in clear violation of DOT rules. The employer is not authorized to discontinue a test or to conduct a subsequent collection at a later time in lieu of a current collection. The employer could order the employee back to work while waiting for the three-hour period to elapse, but the employer must ensure that the employee drinks the prescribed amount of liquids, is under observation during the entire period of time, and returns to the collection site prior to the expiration of the three hours. It should be noted that because the donor was not afforded the full time period during which to provide a specimen, the donor's inability to provide the required amount of urine does not constitute a refusal to test but is the result of employer hindrance with the collection process. The MRO should advise the employer of its violation of 49 CFR part 40 and propose corrective action accordingly (i.e., establish correct policy). In addition, the MRO may report the violation to the appropriate DOT operating administration or may request that the DOT Drug Enforcement and Program Compliance office report the matter. The company is required to maintain, in accordance with the appropriate governing regulation, a record of this ``test'' for review by a DOT operating administration in the event of an audit. [[Page 16375]] Question 5: Is a current and valid picture/photo identification required before a urine collection takes place or may a physical description verification by telephone by an employer representative suffice? Guidance: The rule does not address if the photo identification is current nor does it prohibit telephonic verification of identity. The intent of the rule was that if the employee did not have proper identification, an employer's representative would be on site to identify that employee. There is no requirement that the representative sign any type of form, although procedures should be established to ensure the true identity of the representative. If telephonic identification is used, specific procedures should be in place to ensure that the employer representative is fully identified to the collection site person and that reasonable procedures exist to ensure that the employer's representative can truly identify the employee. If the employee's identification cannot be established to the satisfaction of the collection site person (or based on the collection site protocol for identification), the collection should not be completed. Additionally, any identification procedure allowed under specific DOT operating administration's rules is also permissible. Exception: If the donor is self-employed and has no photo identification, the collector should notify the collection site supervisor and record in the remarks section that positive identification is not available. The donor must be asked to provide two items of identification bearing his/her signature. Proceed with the collection. When the donor signs the certification statement, compare the donor's signature with signatures on the identification presented. If the signatures appear consistent, continue the collection process. If the signature does not match signatures on the identification presented, make an additional note in remarks section stating that ``signature identification is unconfirmed'' and continue the collection process. When this (self-employed) donor does not have appropriate identification this should not be considered a refusal. The collector should remember that his/her primary function is to obtain a specimen that can be tested for drugs under DOT rules. The collector should provide sufficient information in the remarks section to help the MRO make a determination regarding the merit of the collection process or for the employer to determine if there are systemic problems or other shortfalls in its policy/program. Question 6: May a urine specimen collection site be constructed to have two or more collectors or must each collection ``station'' be physically separated by a barrier or wall to ensure modesty and privacy of the donor? Guidance: In specifying privacy and security of the collection site, the DOT was concerned that the act of urination by a donor would have maximum privacy under most circumstances and that the specimen sample would be under sufficient security to prevent any allegation of tampering. Additionally, the regulatory requirement exists that the collection site person have only one donor under his/her supervision at any one time. In other words, one collection site person may not process the paperwork or collect a specimen from more than one donor at a time. There are collection sites, particularly at health clinics, that may have ``stations'' or booths which are partially partitioned from each other or from the rest of the clinic. The collection site person usually gathers relevant information from the donor at the booth, completes the necessary paperwork, and escorts the donor to a toilet area where the donor can provide a specimen in privacy. The rule does not permit unauthorized personnel in any part of the designated collection site where urine specimens are collected or stored. In the multiple booth situation, another collection site person would not be considered an unauthorized person. However, when other donors are present in a waiting area or another donor is being processed by another collection site person, the integrity of the specimen must be ensured. During the collection process, the collection site person must ensure that the specimen is under his or her direct control from the time the specimen is provided by the donor to the time it is sealed in the mailer. Additionally, regardless of the physical configuration of the collection site, there is the expectation that the donor will have some semblance of aural and visual privacy. For example, a donor may tell the collector that he/she is suffering from a particular illness, is on medication, or that he/she has an indwelling catheter, and wonder if this will impact on the test results. The donor should be able to make these statements without embarrassment or concern that another individual (i.e., another collector or donor) may overhear or see what the donor is providing to the collector. Question 7: May donors be required to remove all clothing, wear a hospital gown, or empty pockets? Guidance: The DOT's procedures for transportation workplace drug testing programs contained in Sec. 40.25(f)(4) states: ``The collection site person shall ask the individual to remove any unnecessary outer garments such as a coat or jacket that might conceal items or substances that could be used to tamper with or adulterate the individual's urine specimen. The collection site person shall ensure that all personal belongings such as a purse or briefcase remain with the outer garments. The individual may retain his or her wallet.'' (Emphasis added.) While it is clear that the rule does allow for collectors to request that donors remove unnecessary outer garments in order to ensure the integrity of the collection, the rule does not authorize collectors to require or request that donors remove other garments as well, e.g. shirts, blouses, pants, or skirts, thereby ensuring a modicum of privacy and reducing potential embarrassment. Additionally, donors may not be required or requested to wear hospital or examination gowns when providing a specimen. There is an exception to the above. The DOT has determined that if a urine specimen is being collected as part of a DOT-required physical examination (i.e., Sec. 391.43 Medical examination; certificate of physical examination) in which an individual is required to disrobe and wear a hospital or examination gown, the collection may be completed with the donor so attired. It should also be noted that if a collection site person, during the course of a collection procedure, notices an unusual indicator that an individual may attempt to tamper with or adulterate a specimen as evidenced by a bulging or overstuffed pocket for example, the collector may request that the donor empty his or her pockets, display the items, and explain the need for them during the collection. This procedure may be done only when there is a suspicion that an individual may be about to tamper with or adulterate a specimen. Otherwise, requiring donors to empty their pockets as a common practice is also prohibited under the current rules. Question 8: Please clarify donor identifying information requirements on the drug testing custody and control form. Guidance: In accordance with Sec. 40.25(f)(20), the donor/employee is required to initial the specimen bottle seal/label. The employee/ donor's identification number or SSN is to be [[Page 16376]] provided on the custody and control form and shall not be included on the specimen bottle seal/label. Other donor identification (i.e., name, signature) should not be provided on the copies of the custody and control form that accompany the specimen to the laboratory. However, disclosure of the donor's name/signature does not, in and of itself, require that the specimen be rejected for testing by the laboratory. Question 9: Is a consent form authorized? Guidance: Section 40.25(f)(22)(ii) states, ``When specified by DOT agency regulation or required by the collection site (other than an employer site) or by the laboratory, the employee may be required to sign a consent or release form authorizing the collection of the specimen, analysis of the specimen for designated controlled substances, and release of the results to the employer.'' The purpose of this statement is to allow collection sites or laboratories, of their own accord, or when required by a DOT agency regulation, to utilize consent or release of information forms for the collection, analysis, and release of specimen results to the employer. Sec. 40.25(f)(22)(ii) continues, ``The employee may not be required to waive liability with respect to negligence on the part of any person participating in the collection, handling, or analysis of the specimen or to indemnify any person for the negligence of others.'' The intent of this statement is to prevent anyone who participates in either the collection, handling, or analysis of the specimen from trying to require the employee to exempt them from liability arising from their actions. This pertains not only to collection site and laboratory personnel, but also to MROs, their staff, if applicable, and to the employer. Failure of an employee to sign the consent form does not equal a refusal to test and the test must proceed in all circumstances. The DOT also intends that this interpretation shall be followed for alcohol testing requirements. Question 10: Is the donor's presence required when the collector prepares a specimen for shipment? Guidance: The tamper-proof seal placed on the specimen bottle must be affixed in the presence of the donor, but the regulation is clear that the donor does not have to be present when the specimens are prepared for shipment to the laboratory. The collection site person is the only person required to sign or initial the seal on the shipment container. In fact, the rule allows the use of shipment containers that accommodate multiple specimen bottles. It would be impossible to have more than one donor witness the sealing of their specimen bottles in one shipment container when collectors are required by rule to deal with only one donor at a time. Question 11: In a post-accident situation requiring both a company test and a DOT test, which should be conducted first? Guidance: In a post-accident situation in which drug/alcohol testing is required under company authority or policy, and DOT-mandated tests are required, the DOT tests must be conducted first. Question 12: Please address the issue of low specific gravity/ creatinine. Guidance: Laboratory reports. The laboratory may report in the laboratory remarks section of the custody and control form that specific gravity is less than 1.003 and creatinine is less than 0.2 grams per liter. Actual values of specific gravity and creatinine should not be reported. Medical Review Officer Interpretations MROs shall report the laboratory findings (positive, negative or not tested (canceled)) to the employer and that specific gravity and creatinine are below 1.003 and 0.2 g/l, respectively. Employer Actions The employer shall not require the driver to submit to another specimen collection under FHWA authority. A dilute specimen does not constitute reasonable suspicion of controlled substance use. The employer may require the next specimen, required by DOT regulations, submitted by the driver to be collected under direct observation. Question 13: What should donors do if specimen collection procedures are not being followed? Guidance: Under DOT agency regulations, the employer is responsible for ensuring that specimens are collected in accordance with part 40. If the employees subject to DOT-mandated drug testing regulations believe that part 40 collection procedures are not being followed, they should so inform the employer. If the employer does not respond to the complaints and take appropriate corrective actions, the employees may seek resolution of their complaints through a DOT agency that has regulatory authority over the employer. Question 14: Is failure to check the temperature box on the drug testing custody and control form considered a fatal flaw? Guidance: In accordance with Sec. 40.29, the collector is to check the temperature of the specimen to ensure the integrity of the specimen. The fact that it was checked should be marked appropriately on the custody and control form. Inadvertently not marking the temperature-taken box, in and of itself, does not constitute a ``fatal flaw'' in the DOT chain of custody process. Question 15: What are the collection site requirements? Guidance: Section 40.25(a)-(b) outlines employer requirements for designating and maintaining the security of collection sites. To summarize the contents of this section, a collection site must at a minimum provide: (1) An enclosure where privacy for urination is possible; (2) A toilet for urination (unless a single use, disposable container is used with sufficient capacity to contain the entire void); (3) A source of water for washing hands; (4) A suitable writing surface for completing the required paperwork (custody and control form); and (5) Restricted access so that the site is secure during collection. Any facility, including a physician's office, that meets the minimum requirements may be used as a collection site for DOT-required drug tests. It is the employer's responsibility to not only designate and ensure that collection sites meet these minimum requirements, but also to ensure that collection site personnel at these locations are properly trained and/or qualified to collect urine specimens in accordance with the provisions outlined in 49 CFR part 40. Question 16: Are middle names required on the drug testing custody and control form? Guidance: Section 40.25(a) specifies that the custody and control form used to document DOT mandated drug testing shall provide space for collector, donor, and laboratory certifying scientist names and signatures. The regulation does not specify that a middle name or initial must be used. The intent of the regulation is to provide for the identification of the person(s) signing the certification statements. The use of supplemental instructions on the custody and control form (e.g. further defining name to include first, middle, last), does not impact on the security, identification, or integrity of the urine specimen and should not be used as a basis for invalidating the specimen results. Section 40.29 Laboratory Analysis Procedures Question 1: May a laboratory provide ``one-stop shopping'' to an employer by including the services of a MRO or a list of MROs (which the laboratory does not employ) from which the employer or client could select a specific MRO? Guidance: Under current DOT interpretation of the rule, a laboratory [[Page 16377]] would be prohibited from supplying a limited list of MROs from which the employer would select individuals that would provide MRO services. In this circumstance, there is a clear financial advantage to the MROs who appear on the laboratory list, since this makes them among the candidates for use by that laboratory's clients. This advantage could readily be viewed as providing these MROs an incentive to maintain a good relationship with the laboratory, so as to ensure that they remain on the list, which is in their financial interest. The existence of this incentive could, in turn, call into question the objectivity and independence of the MROs in the review of the test results and the reporting to relevant officials of any potential errors in test results or procedures. The regulatory prohibition is not limited to actual, demonstrated conflict of interest. It includes matters that ``may be construed as a potential conflict of interest''. The DOT position is that the above described laboratory arrangement presents the appearance of a conflict of interest. Question 2: May a laboratory continue to submit monthly summary reports to the employer/consortia or is the laboratory limited to quarterly reports only? Guidance: The DOT changed the requirement for a monthly statistical report to a quarterly report to provide cost savings to the industry without substantially decreasing the effectiveness of the report. Although the original regulatory language appears to require reporting only on a quarterly basis, the intent of this change was to require, as a minimum, a quarterly report, but not to limit those employers or laboratories who desired monthly reports. Monthly reports may be generated provided the reports do not contain personal identifying information or other data from which it is reasonably likely that information about individuals' tests can be readily inferred. If a laboratory provides monthly reports, there is no requirement to additionally provide a quarterly aggregate report. Likewise, the regulatory requirement to prevent individual identifying information remains for both monthly and quarterly reports. If a report is withheld for this reason, the laboratory will notify the employer. Question 3: Explain the requirements for quarterly lab summaries. Guidance: Section 40.29(g)(6) requires each laboratory to ``provide the employer an aggregate quarterly statistical summary of urinalysis testing of the employer's employees. Laboratories may provide the report to a consortium provided the laboratory provides employer- specific data and the consortium forwards the employer-specific data to the respective employers within 14 days of receipt of the laboratory report.'' The above reference also contains the following information: ``Quarterly reports shall not contain personal identifying information or other data from which it is reasonably likely that information about individuals' tests can be readily inferred. If necessary, in order to prevent disclosure of such data, the laboratory shall not send a report until data are sufficiently aggregated to make such an inference unlikely. In any quarter in which a report is withheld for this reason, or because no testing was conducted, the laboratory shall so inform the consortium/employer in writing.'' As referred to above, the DOT has held that during a quarter in which there was ``no activity'' the laboratory is still required to inform the employer, in writing, of the negative activity. This provision is necessary to assist Federal auditors during inspections of employers that are required by an Operating Administration to conduct a drug testing program. Unless the auditor has a complete quarter-by- quarter history and record of drug testing results from a laboratory, there is nothing to preclude an employer, for example, from destroying a quarterly summary that does contain a confirmed positive result and claim that there simply was no activity during the month. This, of course, would allow the company to continue to use that individual in a safety-sensitive function with no evidence that there was a confirmed positive drug test result. In effect, the negative lab report serves as an important check and balance used by auditors in their compliance and enforcement efforts. Question 4: May labs transmit results to an MRO by faxing Part 2 of drug testing custody and control form? Guidance: Laboratory test results may be provided to the MRO via facsimile transmission of the custody and control form. However, the ``true copy'' of the custody and control form must also be sent to the MRO. The purpose of permitting facsimile transmission of the custody and control form is to facilitate a quicker administrative review of test results by the MRO. The MRO may complete verification of a negative result based on the facsimile of the custody and control form; however, the verification of a positive result cannot be completed until the ``true copy'' of the custody and control form bearing the original signature of the laboratory's certifying scientist is received by the MRO. Question 5: May a lab certifying scientist use a ``signature stamp''? Guidance: In accordance with Sec. 40.29(g)(5), ``in the case of a positive report for drug use [the drug testing custody and control form (part 2)], shall be signed (after the required certification block) by the individual responsible for day-to-day management of the drug testing laboratory or the individual responsible for attesting to the validity of the test reports.* * *'' In accordance with Sec. 40.29(g)(1), ``Before any test result is reported (the results of initial tests, confirmatory tests, or quality control data), it shall be reviewed and the test certified as an accurate report by the responsible individual.'' The DOT's opinion is that negative reports must be reviewed and the test certified as an accurate report by the laboratory's responsible individual. This certification must be accomplished by a signature for positive test results while a signature stamp with initials for negative test results on the custody and control form may be used. Question 6: Does the regulation require lab ``batch reporting'' of drug test results? Guidance: The laboratory may report results to the MRO as soon as the results have been reviewed by the appropriate laboratory personnel. There is no requirement for ``batch reporting,'' or reporting simultaneously all results for specimens received in a given shipment. Nor does part 40 require ``batch reporting'' of results by the MRO to the employer. Batch reporting, which causes the transmission of negative results before positive results have been verified, may create a problem by leading an employer to make premature assumptions about a particular test result. However, the rule provides no authority for an employer to take any adverse action against an employee whose test result is pending. The differences in reporting time of test results may be due to a variety of circumstances including laboratory processing time, MRO administrative review processes for negatives, or the verification process for positives. Question 7: Is a lab required to send results directly to the MRO? Guidance: Yes. Section 40.29(g) requires confidentiality and limited access to laboratory test results, and the laboratory must send only to the MRO the original or a certified true copy of the drug testing custody and control form (Part 2). Furthermore, Sec. 40.33(b)(3) states: ``The role of the MRO is to review and interpret confirmed positive test results obtained through the employer's [[Page 16378]] testing program.'' Section 40.33(c)(2) states: ``The MRO shall contact the individual directly, on a confidential basis, to determine whether the employee wishes to discuss the test result. A staff person under the MRO's supervision may make the initial contact, and a medically licensed or certified staff person may gather information from the employee.'' Given the above, it should be clear that the intent of the current regulations is that all laboratory test results be sent directly to the MRO. When the test result is positive, the MRO must make the verification determination; when the test result is negative, the MRO may delegate to a person under his/her direct supervision the administrative review of the negative results. Question 8: Does the regulation allow the MRO to disclose to the employer the drug(s) involved in a positive test? Guidance: Section 40.29(g)(3) requires MROs to report to employers whether the drug test was positive or negative. It also allows the MRO to report the drug(s) for which there was a positive test. Section 40.31 Quality Assurance and Quality Control Question 1: Please explain the timing of blind performance test specimens. Guidance: Section 40.31(d) delineates employer and consortia blind performance test requirements. The intent of these requirements is to test the laboratory's ability to correctly identify positive and negative samples. These samples are to be unidentifiable as blind samples by the laboratory. The regulation does not specify the distribution or the timing of the submissions except to stipulate in Sec. 40.31(d)(2) that each ``employer shall submit three blind performance test specimens for each 100 employee specimens it submits, up to a maximum of 100 blind performance test specimens submitted per quarter.'' This is the basic requirement. The optimum program would be to evenly space the submission of blind samples throughout the period. Section 40.33 Reporting and Review of Results Question 1: Does the MRO have to personally conduct the verification of a positive drug test result? Guidance: The DOT requirement that the MRO be a licensed physician with knowledge of substance abuse disorders (Sec. 40.33(b)(1)) indicates the importance that the DOT placed on this function. The regulatory requirement is that prior to making a final decision to verify a positive test result, the individual is given an opportunity to discuss the test result directly with the MRO. An appropriately medically trained staff person (e.g., a nurse with substance abuse training) may gather information from an employee about the employee's explanation for a positive result. In every case, however, the MRO must talk to the employee before making the decision to confirm a laboratory positive as a verified positive drug test result. No staff person may make this decision for the MRO. Question 2: Does the DOT drug testing rule permit the use of a second and different MRO to whom the results of the split specimen can be sent by the second laboratory? Guidance: There is no appropriate role for a second and different MRO to whom the results of the split specimen would be submitted. The DOT's interpretation is that this procedure is not permissible under the DOT rule. The laboratory results of the split specimen are for the presence of the drug or drug metabolite and the rule text does not authorize a ``second'' verification process of the split results. Therefore, the use of a second MRO does not add to the overall verification process required by the rule. Additionally, if the split specimen fails to reconfirm or is not available for testing, it is the responsibility of the (original) MRO to cancel the test and provide notification of this cancellation to the appropriate parties. It would be inappropriate for the second MRO to cancel the test nor would the second MRO have the appropriate information to accomplish the cancellation notification. Question 3: If the MRO determines that a donor has a legitimate prescription for Marinol, would this be reported as a negative result? What if in the MRO's opinion, the use of the prescribed medication may compromise safety? Guidance: Section 40.33(a)(1) states in part, that `` * * * A positive test result does not automatically identify an employee/ applicant as having used drugs in violation of a DOT agency regulation. An individual with a detailed knowledge of possible alternate medical explanations is essential to the review of the results.'' The DOT's interpretation has been that if the MRO can determine that the donor has a legitimate prescription, the positive result would be ``down graded'' to a negative. This would apply to any legitimately prescribed drug, including Marinol. If the MRO determines that the use of that particular prescription/substance may compromise safety in the performance of a transportation related safety sensitive function (whether or not the substance is prescribed for the appropriate condition), the MRO should discuss this with the donor's (prescribing) physician. The donor's physician may decide to prescribe an alternate substance that may not have adverse effects on the donor's performance of his/her duties. Section 40.33(i) states in part, that ``(1) The MRO may disclose such [medical] information to the employer, a DOT agency * * * or a physician responsible for determining the medical qualification of the employee * * * if * * * (iii) * * * the information indicates that continued performance by the employee * * * could pose a significant safety risk. (2) Before obtaining medical information from the employee as part of the verification process, the MRO shall inform the employee that information may be disclosed to third parties as provided in this paragraph * * * ''. If after talking to the prescribing physician, the MRO still determines that a safety risk exists, he/she may inform the employer, DOT, or the employer's physician of the existence of a medical condition that could preclude the donor from performing a safety sensitive function. However, the MRO must ensure that he/she informed the employee prior to the verification process that this (medical) information may be provided to a third party. Question 4: Is there such a thing as an MRO management company or does the law specify that a single certified MRO review each lab result from tested employees and personally transmit the test results to the specific employer? Does the law require that the owner of an MRO management company be a physician? Do negative test results have to be handled by a physician MRO, or may the results be handled by the MRO management company administrators? Guidance: While part 40 makes no mention of an ``MRO management company'' the regulations do address the role of the C/TPA. The rules do not permit the C/TPA to receive drug testing results directly from either the laboratory or from the MRO. The laboratory results are reported directly to the MRO, and the MRO results are reported directly to the employer. Through interpretation of Sec. 40.33(a), the DOT has permitted the administrative review to be conducted by staff persons working under the direct supervision of the MRO. While allowing this delegation of MRO responsibility, the DOT never intended nor can it condone a practice which allows for MROs to appoint outside ``agents'' to perform this review. The [[Page 16379]] MRO should have a direct supervisory relationship with the reviewer and not simply have access to the ``process'' of the administrative review. Conversely, a C/TPA cannot contract for the MRO to review only positive drug test results, leaving the review or processing of negatives to the C/TPA. Question 5: May a C/TPA act as an agent of the MRO for the purpose of conducting administrative reviews of all negative urine drug test results and receive drug testing results directly from the laboratory? Guidance: No. The DOT never intended nor can it condone a practice which allows MROs to appoint outside agents to conduct such reviews. Additionally, Sec. 40.29(g) requires that all drug test results be transmitted by the laboratory directly to the MRO. Transmission to the MRO means to the MRO's place of business and not to a subsidiary or contractor for the MRO. There is also the requirement that, regardless of what forms/records a consortium or third party administrator maintains for an employer, notification of all positive results will be performed by the MRO and not through or by anyone else. Question 6: What are the MRO's review requirements during the verification process when the MRO copy of the custody and control form is not available? Guidance: The MRO may complete the verification process if the MRO's copy of the custody and control form is not available for review. The MRO needs to review a copy of the chain of custody which contains the employee's signature. A copy may be obtained from the employee, the collector, or the employer. These copies have the employee's signature. The preamble to part 40 (Medical Officer Issues) published on December 1, 1989 requires the MRO not to declare a verified positive result until he or she receives the hard copy of the original chain of custody form from the laboratory. This is because, prior to determining that the test is a verified positive, the MRO verifies the identifying information and the facial completeness of the chain of custody (i.e., determines that, on the face of the document, all the sign-offs are in the right places). Question 7: Does the MRO have to verify each drug when the laboratory reports a multiple positive drug test results for the same individual under the DOT drug and alcohol rule? Guidance: Section 40.33(a) states ``Medical review officer shall review confirmed positive results.'' The DOT drug rule requires analysis of urine for five drugs. Multiple drug positive results for the same specimen (donor) require the MRO to verify each reported drug to determine if there is a medical explanation for each positive result. Additionally, the DOT drug and alcohol management information system requests information on multiple drug results (for each individual). The intent is to capture this information. However, in the preemployment process, it would appear that with the employer's consent, the MRO may report a verified positive result for one drug out of several laboratory positive results (for one individual) without continuing to seek verification for the other drugs reported by the laboratory. The MRO may need to use his/her professional judgement to determine if verification of the other drugs may be accomplished expeditiously. Regardless of the number of drugs that are reported as verified for one individual, that individual cannot perform safety-sensitive work until he/she provides a urine specimen that is negative. In the case where the MRO verifies and reports only one drug, the other drugs should not be reported to the employer if they have not been verified. The MRO may document these unverified positive results in his/her records as unverified and unreported results. Question 8: Is a company obligated to pay for the processing of a split urine specimen when the primary specimen is positive? Does a company have to pay for testing the split specimen if it was a pre- employment test? Guidance: The split sample procedure is a statutory requirement of the Omnibus Transportation Employee Testing Act of 1991 for employers in the aviation, highway, rail, and transit industries, as well as the DOT rules. Section 40.3 states, in part: ``Employee. An individual designated in a DOT agency regulation as subject to drug testing and/or alcohol testing. As used in this part ``employee'' includes an applicant for employment.'' And Sec. 40.33(f) states, in part: ``If the employee requests an analysis of the split specimen within 72 hours of having been informed of a verified positive test, the MRO shall direct, in writing, the laboratory to provided the split specimen to another DHHS-certified laboratory for analysis.'' In other words, if the applicant or employee makes the request within this time period, the split specimen must be tested. This is true of all types of tests, including pre-employment. The employer is responsible for ensuring that the test occurs, including taking responsibility for paying for it. The employer may arrange with the applicant or employee for reimbursement, but in no case does the refusal by the applicant or employee to contribute to the cost of the test excuse the employer from ensuring that the test takes place. A previous agreement negotiated between the employee and employer or a labor-management agreement that specifies payment arrangements, could dictate the ultimate payment source. The split specimen testing process, initiated by the MRO's written request, should not be delayed while awaiting payment to come from the applicant or employee. If there is a dispute, the fall-back position would be for the employer to be billed (by either the primary laboratory for sending the split specimen, or the receiving laboratory for testing the split specimen) and then for the employer to settle the matter after-the-fact with the applicant or employee. Question 9: When may the MRO notify an employer of a positive drug test result? Guidance: The MRO may not notify the employer of a positive test until he/she has verified the test as positive. Verification requires that the MRO review the chain of custody documentation, contact the employee, review any documentation of a legitimate medical explanation for a positive test, and determine that the positive resulted from unauthorized use of a controlled substance. The MRO is not required to delay verification pending the outcome of the reanalysis or the split specimen. Only upon verification shall the MRO notify the employer of the positive result, and the employer shall then remove the employee from the safety-sensitive duties/position. Once having received notice of a verified positive result from the MRO, the employer shall not delay removal of the employee from safety-sensitive duties pending the outcome of the reanalysis or the split specimen. Question 10: Must the MRO report to employers be in writing Guidance: Part 40 does not require the MRO to provide written notification to employers of verified drug test results. The FHWA, however, does require MROs to forward a signed, written notification to the employer within three business days of the completion of the MRO's review for both positive and negative results. A legible photocopy of the fourth copy of the Federal Drug Testing Custody and Control Form required by part 40 appendix A may be used to make the signed, written notification to the employer for all test results (positive, negative, canceled, etc.), provided that the controlled [[Page 16380]] substance(s) verified as positive, and the MRO's signature, shall be legibly noted in the remarks section of step 8 of the form completed by the MRO. Question 11: May an MRO use part 2 of drug testing custody and control form to report negative results? Guidance: No. The MRO should not provide the employer with a copy of the custody and control form bearing the results from the laboratory. Often, positive results reported by the laboratory are determined by the MRO to be explained by authorized medical use of a substance, and thus are verified and reported negative. Employers are not permitted to have the laboratory information, only the MRO's determination. Question 12: Please explain an MRO's review of negative results. Guidance: The duties of the MRO with respect to reviewing negative urine drug test results are strictly administrative, but must include a review of the drug testing custody and control form prior to releasing the results to the employer. This is necessary to substantiate that the reported negative result is correctly identified with the donor and to ensure that the form is complete and sufficient on its face (Sec. 40.33(a) (1-2)). While the DOT, through interpretation, has permitted the administrative review to be conducted by a staff person working under the direct supervision of the MRO, the requirement to conduct the review in accordance with current regulations remains in effect. Question 13: Please explain MRO verification of opiate positives. Guidance: The MRO verification process of any positive laboratory report requires several specific actions. These include a review of the drug testing custody and control form for completeness and accuracy, notifying and providing the donor an opportunity to discuss the results, reviewing the donor's medical history and medical records, and investigating other biomedical factors that may account for the positive result. The above actions are especially important when the MRO is confronted with an opiate positive, as the result may be caused by the use of a legally prescribed medication or an ingested substance, such as poppy seeds. Using the above steps as a guide, the MRO first ensures that the drug testing custody and control form is complete and accurate on its face. Next, the MRO notifies the donor of the positive test result and offers the individual an opportunity to discuss the results. If the donor expressly declines the opportunity to discuss the test results, or fails to contact the MRO within five days after being notified by a designated employer representative to do so, the MRO may verify the laboratory test result as a positive. This includes results that are positive for opiates. If the donor accepts the opportunity to discuss the results with the MRO, the MRO must review any medical records provided by the donor to determine if the opiate positive resulted from a legally prescribed medication. If the donor is unable to produce medical evidence and admits to unauthorized use of an opiate, the MRO should verify the result as a positive. However, if the donor is unable to produce medical evidence, denies unauthorized use of an opiate, or denies using another individual's medication, the MRO must determine that there is clinical evidence--in addition to the urine test--of unauthorized use of any opium, opiate, or opium derivative before verifying the test result as positive. Examples of clinical evidence include recent needle tracks or behavioral or psychological signs of acute opiate intoxication or withdrawal. If a laboratory confirms the presence of 6- acetylmorphine (6-AM) through a GC/MS test, no clinical evidence is necessary, since 6-AM is a direct deacetylated metabolite of heroin, detectable within minutes, and its presence proves the recent use of heroin. If 6-AM is not found, clinical evidence will be required to verify a positive opiate result whether or not the donor claims poppy seed ingestion as a defense for the positive result. The verification process for an opiate positive result can be a very complex and very difficult task for the MRO and should be undertaken with a great deal of caution. Question 14: Please clarify the MRO/lab relationship. Guidance: Section 40.29(n)(6) states: ``The laboratory shall not enter into any relationship with an employer's MRO that may be construed as a potential conflict of interest or derive any financial benefit by having an employer use a specific MRO.'' Section 40.33(b)(2) further states: ``The MRO shall not be an employee of the laboratory conducting the drug test unless the laboratory establishes a clear separation of functions to prevent any appearance of a conflict of interest, including assuring that the MRO has no responsibility for, and is not supervised by or the supervisor of, any persons who have responsibility for the drug testing or quality control operations of the laboratory.'' Therefore, the rule prohibits an employer-employee or contract relationship between the laboratory and the MRO, and it is obvious that there must be a clear separation of functions between the MRO and the laboratory. Question 15: In what situations may an MRO reopen a verification of a drug test? Guidance: Section 40.33 specifically allows the reopening of an MRO's verification of a confirmed positive drug test in only two situations. When a donor provides documentation that serious illness, injury, or other circumstances unavoidably prevented the employee from timely contacting the MRO, the MRO may conclude from the documentation that there is a legitimate explanation for the employee's failure to contact the MRO (see Sec. 40.33(c)(6)). The second situation is if neither the employer nor the MRO is able to contact the employee and the MRO declares the test result to be positive, and the employee subsequently provides documentation that serious illness, injury, or other circumstances unavoidably prevented the employee from contacting the MRO in a timely manner, the MRO may conclude from the documentation that there is a legitimate explanation for the employee's failure to contact the MRO (see Sec. 40.33(g)). Section 40.35 Protection of Employee Records Question 1: Please clarify release of alcohol and drug test results with or without written authorization. Guidance: The rules governing release of employee test results (Secs. 40.35 and 40.81) permit disclosure to persons other than the employee, employer, or decision-maker in a lawsuit or grievance action, only with the written authorization of the employee. The authorization must be an informed consent, in that the employee fully understands the intended use and disclosure of the test results. Each entity's request for test results would require a separate authorization and must be specific. Specific items including the purpose of the release, specific test(s) to be released, the party(ies) to whom these specific results will be released must be included. Question 2: May employees be required to sign release forms for third-party disclosures? Guidance: The intent of (Secs. 40.29(g)(3), 40.35 and 40.37) is to ensure confidentiality of employee drug test results. Employees cannot be required to sign release or consent statements for third-party disclosure as part of the drug testing process. Information concerning the drug test may be released by the employer in [[Page 16381]] unemployment or workmen's compensation proceedings, or other situations in which the employee is seeking a benefit or challenges an action taken by the employer as a result of a drug test. It should be noted, however, that employers are required to request written authorization from CMV drivers to obtain past verified positive drug test results, refusals to test, and alcohol concentrations of 0.04 or greater over the past 2 years of driving a CMV (Secs. 382.405(f) and 382.413(a)). Section 40.39 Use of DHHS-Certified Laboratories Question 1: May additional testing be conducted on a DOT specimen reported by the laboratory as negative? Guidance: Section 2.4(e)(3) of the Department of Health and Human Service's Mandatory Guidelines for Federal Workplace Drug Testing Programs states, ``Specimens that test negative on all initial immunoassay tests shall be reported as negative. No further testing of those negative specimens for drugs is permitted and the specimens shall be either discarded or pooled for use in the laboratory's internal quality control program.'' The DOT requires use of DHHS-certified laboratories to do all DOT- required testing. Therefore, the above DHHS requirement is a DOT requirement as well. When a DOT specimen is reported as negative by the laboratory, no additional testing of the specimen is permissible. Question 2: Why use DHHS-certified laboratories? Guidance: The DOT requires that all drug testing mandated under the provisions of its drug testing rules must be conducted in DHHS- certified laboratories. The DOT decision to use DHHS-certified laboratories for drug testing is mandated by statute (Omnibus Transportation Employee Testing Act of 1991). The DHHS standards for certification and the proficiency testing requirements comprise the most stringent laboratory accreditation program available in analytical forensic toxicology for urine drug testing. Additionally, the DHHS certification program provides for standardization of laboratory methodology and procedures, ensuring equal treatment of all specimens analyzed. Finally, the use of DHHS-certified laboratories provides a standard that has withstood the test of legal challenges in Federal drug testing. Section 40.69 Inability To Provide an Adequate Amount of Breath Question 1: If an employee is unable to provide an amount of breath sufficient to permit a valid breath test, but does not allege that such inability is due to a medical condition, what actions must follow? Guidance: The rules prohibit a covered employee from refusing to submit to required alcohol tests. Post-accident, random, reasonable suspicion, or follow-up tests must be taken when those tests are required. Section 40.69 sets forth the procedures to be followed when an employee is unable to provide an adequate amount of breath for any reason. These procedures apply to the employee who claims a particular medical condition is creating the inability to provide breath; they also apply to the employee who claims to have no idea as to the cause of the inability, or to the employee who says nothing at all. It is imperative that the employee understands that during the required follow-on medical evaluation, the physician will concentrate solely on finding a medical condition to explain the inability. Paragraphs (d)(2)(i) and (d)(2)(ii) of Sec. 40.69 dictate that the only acceptable reason for an employee to be unable to provide an adequate amount of breath for testing is a medical condition. If a medical condition is not found, the employee will be deemed to have refused testing. Section 40.81 Availability and Disclosure of Alcohol Testing Information About Individual Employees Question 1: If there is one or more BAT working for a company, does the BAT supervisor have the right to review (have access to) the Breath Alcohol Testing Forms for purposes of supervisory control? Likewise, may this form be passed along by the BAT or the employer to billing personnel? Guidance: The rule holds employers responsible for implementation of the total program. This includes confidentiality of information and maintenance of records (including BAT and MRO records). Individuals such as supervisors of BATs and billing personnel with a ``need to know'' are considered authorized company personnel and are permitted to have access to breath alcohol testing documentation. Access to information would be for a specific purpose and necessary for the employer's successful implementation of the program. This would include review of the forms for completion, obtaining specific billing data from the forms, filing the forms, etc. Individuals with access to these forms are under the same regulatory requirements for maintaining confidentiality of these records as are employers and BATs. Breath Alcohol Testing Forms should not be duplicated for purposes of supervision or billing as this would create additional ``data bases'' or files with potential problems of disclosure of confidential information. Access to these records by unauthorized personnel would be difficult to control. This does not preclude use of input forms filled out by the BAT or other personnel that would contain appropriate billing data and which could be maintained as backup documentation. When the employer uses a C/TPA to act as the agent of the employer, then that C/TPA could have access to the Breath Alcohol Testing Form or the authority to obtain a copy of the form. Likewise, the employer's copy of the form may be submitted to the C/TPA by the employer or by the BAT when the employer has directed the BAT in writing to do so. In all cases of positive results at or above the .02 BAC level, the employer must be notified immediately, and prior to notification of the C/TPA. Positive results may not be sent from the BAT to the C/TPA and then submitted to the employer. Section 40.93 The Screening Test Technician Question 1: May an STT become trained to proficiency on an evidential breath tester (EBT) for the purposes of conducting screening tests on that device? Guidance: No. Section 40.93 only authorizes the STT to operate an alcohol screening device (ASD); it does not authorize the STT to operate an EBT. This was by design. Likewise, the STT training manual does not address the use of an EBT by the STT. This is in contrast with the training manual for the BAT which concentrates solely on the EBT; in fact, an entire unit in the BAT training manual is devoted to ``EBT Methodology.'' Additionally, the proficiency requirements for the ASD, as contained in the STT manual, are different from the proficiency requirements for the EBT, as contained in the BAT manual. When an EBT is used to conduct a DOT alcohol test, the operator must be a BAT. An STT is limited to conducting only the alcohol screening test, and the only instrument the STT may use is an ASD. Special Topics--Requirements for Random Testing Question 1: Please explain the random testing rates for alcohol and drugs. Guidance: The DOT drug testing rules require employers initially to conduct [[Page 16382]] random drug testing at a rate equal to 50 percent of their covered employees. Thus, if an employer has 100 covered employees, the employer must administer 50 random drug tests. The number of random tests is determined by the covered employee population, while the number of employees randomly tested varies depending on the random selection process. It is possible that 50 random tests may be conducted on less than 50 employees, some employees being tested two or more times due to the random selection of donors. The highway industry may be allowed to reduce the annual rate to 25 percent in calendar year 1998 based on the highway industry's performance in calendar years 1995 and 1996. The rate may be lowered to 25 percent based on two years of data reported to FHWA indicating a positive rate of less than 1.0 percent use of drugs by CMV drivers. The rate may increase again, however, to 50 percent based on one year of data reported to FHWA indicating a positive rate equal to or greater than 1.0 percent use of drugs by CMV drivers. The alcohol testing rules require employers initially conduct random testing at a rate equal to 25 percent of their covered employees. Thus, if an employer has 100 covered employees, the employer must administer 25 random drug tests. The number of random tests is determined by the covered employee population, while the number of employees randomly tested varies depending on the random selection process. It is possible that 25 random tests may be conducted on less than 25 employees, some employees being tested two or more times due to the random selection of donors. The highway industry may be allowed to reduce the annual rate to 10 percent in calendar year 1999 based on the highway industry's performance in calendar years 1996 and 1997. The rate may be lowered to 10 percent based on two years of data reported to FHWA indicating a violation rate of less than 0.5 percent use of alcohol by CMV drivers. The highway industry would be required to raise the annual rate to 50 percent in calendar year 1998 or later years based on the highway industry's performance in calendar year 1996 or later years. The rate may increase to 50 percent based on one year of data reported to FHWA indicating a violation rate of is equal to or greater than 1.0 percent use of alcohol by CMV drivers. Question 2: Is use of a consortium to conduct random testing allowed? Guidance: The FHWA requires individual owner-operators to be in a random testing pool of two or more persons. This, in effect, requires an individual owner-operator to be in a consortium for random testing purposes. The DOT allows and even advocates the use of a consortium to assist smaller companies in complying with the alcohol and drug testing regulations. While it is true that in a combined employer pool, some employers will have a higher percentage of their employees selected for testing than others in a given 12-month period, over time this will even out. Additionally, the DOT believes that the deterrent effect of random drug testing remains as powerful in a combined employers pool as it would be in a stand-alone single company pool. With this in mind, the DOT has determined that combining employer pools within a consortium meets the spirit and intent of the alcohol and drug testing regulations and is, therefore, permissible. Question 3: May an employer combine DOT and non-DOT random pools? Guidance: No. While it would seem to be advantageous for an employer to combine all employees into one random testing pool, this move could dilute the number of DOT-covered employees who would actually be tested. For example, in a pool that is comprised of 50 DOT- covered employees and 50 non-DOT-covered employees, and assuming a testing rate of 50 percent, it is possible that no DOT-covered employees would be tested (100 employees, 50 tests, all 50 tests conducted on non-DOT employees). The likelihood of this happening, albeit remote, is possible under a truly random scheme. On the other hand, keeping the above two classes of employees in separate pools assures that at least 25 of the tests conducted by the company will be conducted on DOT-covered employees. It is this assurance that ultimately mandates that DOT-covered employees remain in separate random pools. Question 4: May an employer combine employees covered by different operating administration rules into a single pool for random testing? Guidance: The DOT has determined that it is, indeed, permissible for an employer to combine covered employees from different operating administrations (e.g. Research and Special Programs Administration, Coast Guard, and FHWA), into a single selection pool for the purpose of conducting random drug testing under DOT authority. When exercising this option, however, the employer must ensure that the random testing rate is at least equal to the highest rate required by each of the operating administrations. Question 5: Is it permissible to separate union and non-union employees, both covered by DOT, into stand-alone pools? Guidance: The DOT has determined that it is permissible for an employer to separate union and non-union employees into separate pools for the purpose of random drug testing. If using this approach, the employer must ensure that employees from each pool are tested at equal rates. For example, if pool ``A'' consists of 50 non-union employees and pool ``B'' consists of 300 union employees, the employer must ensure, if testing is done at a 50 percent rate, that 25 tests are conducted annually on employees from pool ``A'' and that 150 tests are conducted annually on employees from pool ``B.'' Special Topics--Procedures for Handling and Processing a Split Specimen Question: Describe the proper handling and processing of a split specimen. Guidance: ``Where the employer has used the split sample method, and the laboratory observes that the split sample is untestable, inadequate, or unavailable for testing, the laboratory shall nevertheless test the primary specimen. The laboratory does not inform the MRO or the employer of the untestability, inadequacy, or unavailability of the split specimen until and unless the primary specimen is a verified positive test and the MRO has informed the laboratory that the employee has requested a test of the split specimen.'' (Sec. 40.29(b)(1)(ii)) ``In situations where the employer uses the split sample collection method, the laboratory shall log in the split specimen, with the split specimen bottle seal remaining intact.'' (Sec. 40.29(b)(2)) ``When directed in writing by the MRO to forward the split specimen to another DHHS-certified laboratory for analysis, the second laboratory shall analyze the split specimen by GC/MS to reconfirm the presence of the drug(s) or drug metabolite(s) found in the primary specimen.'' (Sec. 40.29(b)(3)) ``If the employee requests an analysis of the split specimen within 72 hours of having been informed of a verified positive test, the MRO shall direct, in writing, the laboratory to provide the split specimen to another DHHS-certified laboratory for analysis. If the analysis of the split specimen fails to reconfirm the presence of the drug(s) or drug metabolite(s) found in the specimen, or if the split specimen is unavailable, inadequate for testing or untestable, the MRO shall cancel the test and report cancellation and the [[Page 16383]] reasons for it to the DOT, the employer, and the employee.'' (Sec. 40.33(f)) If the primary laboratory does not receive a split specimen with the primary, or the split specimen is leaking, or the split specimen's seal is broken, or has any other problem that would make it unavailable for testing, the primary laboratory must still process the primary specimen as if there were no problems with the split specimen. The laboratory should not bring any split specimen deficiency to the attention of the MRO at this time. (Sec. 40.29(b)(1)(ii)) The seal on the split specimen must remain intact--just as the split specimen was sealed at the collection site. (Sec. 40.29(b)(2)) The MRO will direct the primary laboratory to forward the split specimen to a second DHHS-certified laboratory. At the second DHHS- certified laboratory, the split specimen shall only be used to reconfirm the presence of the drug(s) or drug metabolite(s) found in the primary specimen. (Sec. 40.29(b)(3)) Only a request from the employee can authorize the MRO to initiate the forwarding of the split specimen to the second DHHS-certified laboratory for analysis. (Sec. 40.33(f)) PART 325--COMPLIANCE WITH INTERSTATE MOTOR CARRIER NOISE EMISSION STANDARDS Sections Interpreted 325.1 Section 325.1 Scope Of The Rules In This Part Question 1: What noise emission requirements are applicable to auxiliary generators? Guidance: Auxiliary generators which normally operate only when a CMV is stopped or moving at 5 mph or less are ``auxiliary equipment'' of the kind contemplated by EPA and are, therefore, exempt from the noise limits in Part 325. However, noise from generators that run while the CMV is moving at higher speeds would be measured as part of total vehicle noise. Question 2: Do refrigeration units on tractor-trailer combinations fall within the exemption listed in part 325, subpart A of the FMCSRs? Guidance: No. PART 382--CONTROLLED SUBSTANCES AND ALCOHOL USE AND TESTING Sections Interpreted 382.103 Applicability 382.105 Testing Procedures 382.107 Definitions 382.109 Preemption of State and Local Laws 382.113 Requirement for Notice 382.115 Starting Date for Testing Programs 382.205 On-Duty Use 382.213 Controlled Substances Use 382.301 Pre-employment Testing 382.303 Post-accident Testing 382.305 Random Testing 382.307 Reasonable Suspicion Testing 382.401 Retention of Records 382.403 Reporting of Results in a Management Information System 382.405 Access to Facilities and Records 382.413 Release of Alcohol and Controlled Substances Test Information by Previous Employers 382.501 Removal From Safety-Sensitive Functions 382.507 Penalties 382.601 Motor Carrier Obligation to Promulgate a Policy on the Misuse of Alcohol and Use of Controlled Substances 382.603 Training for Supervisors 382.605 Referral, Evaluation, and Treatment Subpart B--Prohibitions Special Topics--Responsibility for Payment for Testing Special Topics--Multiple Service Providers Special Topics--Medical Examiners Acting as MRO Special Topics--Biennial (Periodic) Testing Requirements Section 382.103 Applicability Question 1: Are intrastate drivers of CMVs, who are required to obtain CDLs, required to be alcohol and drug tested by their employer? Guidance: Yes. The definition of commerce in 382.107 is taken from 49 U.S.C. Sec. 31301 which encompasses interstate, intrastate and foreign commerce. Question 2: Are students who will be trained to be motor vehicle operators subject to alcohol and drug testing? Are they required to obtain a CDL in order to operate training vehicles provided by the school? Guidance: Yes. Section 382.107 includes the following definitions: Employer means any person (including the United States, a State, District of Columbia or a political subdivision of a State) who owns or leases a CMV or assigns persons to operate such a vehicle. The term employer includes an employer's agents, officers and representatives. Driver means any person who operates a CMV. Truck and bus driver training schools meet the definition of an employer because they own or lease CMVs and assign students to operate them at appropriate points in their training. Similarly, students who actually operate CMVs to complete their course work qualify as drivers. The CDL regulations provide that ``no person shall operate'' a CMV before passing the written and driving tests required for that vehicle (49 CFR 383.23(a)(1)). Virtually all of the vehicles used for training purposes meet the definition of a CMV, and student drivers must therefore obtain a CDL. Question 3: Are part 382 alcohol and drug testing requirements applicable to firefighters in a State which gives them the option of obtaining a CDL or a non-commercial class A or B license restricted to operating fire equipment only? Guidance: No. The applicability of part 382 is coextensive with part 383--the general CDL requirements. Only those persons required to obtain a CDL under Federal law and who actually perform safety- sensitive duties, are required to be tested for drugs and alcohol. The FHWA, exercising its waiver authority, granted the States the option of waiving firefighters from CDL requirements. A State which gives firefighters the choice of obtaining either a CDL or a non- commercial license has exercised the option not to require CDLs. Therefore, because a CDL is not required, by extension part 382 is not applicable. A firefighter in the State would not be required under Federal law to be tested for drugs and alcohol regardless of the type of license which the employer required as a condition of employment or the driver actually obtained. It is the Federal requirement to obtain a CDL, nonexistent in the State, that entails drug and alcohol testing, not the fact of actually holding a CDL. Question 4: An employer or State government agency requires CDLs for drivers of motor vehicles: (1) with a GVWR of 26,000 pounds or less; (2) with a GCWR of 26,000 pounds or less inclusive of a towed unit with a GVWR of 10,000 pounds or less; (3) designed to transport 15 or less passengers, including the driver; or (4) which transport HM, but are not required to be placarded under 49 CFR part 172, subpart F. Are such drivers required by part 382 to be tested for the use of alcohol or controlled substances? Guidance: No. Part 382 requires or authorizes drug and alcohol testing only of those drivers required by part 383 to obtain a CDL. Since the vehicles described above do not meet the definition of a CMV in part 383, their drivers are not required by Federal regulations to have a CDL. Question 5: Are Alaskan drivers with a CDL who operate CMVs and have been waived from certain CDL requirements subject to controlled substances and alcohol testing? Guidance: Yes. Alaskan drivers with a CDL who operate CMVs are subject to controlled substances and alcohol [[Page 16384]] testing because they have licenses marked either ``commercial driver's license'' or ``CDL''. The waived drivers are only exempted from the knowledge and skills tests, and the photograph on license requirements. Question 6: Do the FHWA's alcohol and controlled substances testing regulations apply to employers and drivers in U.S. territories or possessions such as Puerto Rico and Guam? Guidance: No. The rule by definition applies only to employers and drivers domiciled in the 50 states and the District of Columbia. Question 7: Which drivers are to be included in a alcohol and controlled substances testing program under the FHWA's rule? Guidance: Any person who operates a CMV, as defined in Sec. 382.107, in intrastate or interstate commerce and is subject to the CDL requirement of 49 CFR part 383. Question 8: Is a foreign resident driver operating between the U.S. and a foreign country from a U.S. terminal for a U.S.-based employer subject to the FHWA alcohol and controlled substances testing regulations? Guidance: Yes. A driver operating for a U.S.-based employer is subject to part 382. Question 9: What alcohol and drug testing provisions apply to foreign drivers employed by foreign motor carriers? Guidance: Foreign employers are subject to the alcohol and drug testing requirements in part 382 (see Sec. 382.103). All provisions of the rules will be applicable while drivers are operating in the U.S. Foreign drivers may also be subject to State laws, such as probable cause testing by law enforcement officers. Section 382.105 Testing Procedures Question 1: What does a BAT do when a test involves an independent, self-employed owner-operator with a confirmed alcohol concentration of 0.02 or greater, to notify a company representative as required by Sec. 40.65(i)? Guidance: The independent, self-employed owner-operator will be notified by the BAT immediately and the owner-operator's certification in Step 4 notes that the self-employed owner-operator has been notified. No further notification is necessary. The BAT will provide copies 1 and 2 to the self-employed owner-operator directly. Question 2: A driver does not have a photo identification card. Must an employer representative identify the driver in the presence of the BAT/urine specimen collector or may the employer representative identify the driver via a telephone conversation? Guidance: Those subject to part 382 are subject first, generally, to part 383. Part 383 requires all States, with an exception in Alaska for a very small group of individuals, to provide a CDL document to the individual that includes, among other things: the full name, signature, and mailing address of the person to whom such license is issued; physical and other information to identify and describe the person including date of birth (month, day, and year), sex, and height; and, a color photograph of the person. Except in these rare Alaskan instances, the FHWA fully expects most employer's to require the driver to present the CDL document to the BAT or urine collector. A driver subject to alcohol and drug testing should be able to provide the CDL document. In those rare instances that the CDL or other form of photo identification is not produced for verification, an employer representative must be contacted and must provide identification. The FHWA will allow employer representatives to identify drivers in any way that the employer believes will positively identify the driver. Question 3: Will foreign drug testing laboratories need to be certified by the National Institute on Drug Abuse (NIDA)? Will they need to be certified by the Department of Health and Human Services (DHHS)? Guidance: The NIDA, an agency of the DHHS, no longer administers the workplace drug testing laboratory certification program. This program is now administered by the DHHS' Substance Abuse and Mental Health Services Administration. All motor carriers are required to use DHHS-certified laboratories for analysis of alcohol and controlled substances tests as neither Mexico nor Canada has an equivalent laboratory certification program. Question 4: Particularly in light of the coverage of Canadian and Mexican employees, how should MROs deal, in the verification process, with claims of the use of foreign prescriptions or over-the-counter medication? Guidance: Possession or use of controlled substances are prohibited when operating a CMV under the FHWA regulations regardless of the source of the substance. A limited exception exists for a substance's use in accordance with instructions provided by a licensed medical practitioner who knows that the individual is a CMV driver who operates CMVs in a safety-sensitive job and has provided instructions to the CMV driver that the use of the substance will not affect the CMV driver's ability to safely operate a CMV (see Secs. 382.213, 391.41(b)(12), and 392.4(c)). Individuals entering the United States must properly declare controlled substances with the U.S. Customs Service. 21 CFR 1311.27. The FHWA expects MROs to properly investigate the facts concerning a CMV driver's claim that a positive controlled substance test result was caused by a prescription written by a knowledgeable, licensed medical practitioner or the use of an over-the-counter substance that was obtained in a foreign country without a prescription. This investigation should be documented in the MRO's files. If the CMV driver lawfully obtained a substance in a foreign country without a prescription which is a controlled substance in the United States, the MRO must also investigate whether a knowledgeable, licensed medical practitioner provided instructions to the CMV driver that the use of the ``over-the-counter'' substance would not affect the driver's ability to safely operate a CMV. Potential violations of Sec. 392.4 must be investigated by the law enforcement officer at the time possession or use is discovered to determine whether the exception applies. Sections 382.107 Definitions Question 1: What is an owner-operator? Guidance: The FHWA neither defines the term ``owner-operator'' nor uses it in regulation. The FHWA regulates ``employers'' and ``drivers.'' An owner-operator may act as both an employer and a driver at certain times, or as a driver for another employer at other times depending on contractual arrangements and operational structure. Section 382.109 Preemption Of State And Local Laws Question 1: An employer is required by State or local law, regulation, or order to bargain with unionized employees over discretionary elements of the DOT alcohol and drug testing regulations (e.g., selection of DHHS-approved laboratories or MROs). May the employer defer the 1995 or 1996 implementation dates for testing employees until the collective bargaining process has produced agreement on these discretionary elements, or must the employer implement testing as required by part 382? Guidance: The FHWA provided large employers 45 weeks and small employers 97 weeks collectively to bargain the discretionary elements of [[Page 16385]] the part 382 testing program. An employer must implement alcohol and controlled substances testing in accordance with the schedule in Sec. 382.115. If observance of the collective bargaining process would make it impossible for the employer to comply with these deadlines, Sec. 382.109(a)(1) preempts the State or local bargaining requirement to the extent needed to meet the implementation date. Section 382.113 Requirement For Notice Question 1: Must a notice be given before each test or will a general notice given to drivers suffice? Guidance: A driver must be notified before submitting to each test that it is required by part 382. This notification can be provided to the driver either verbally or in writing. In addition, the FHWA believes that the use of the DOT Breath Alcohol Testing Form, OMB No. 2105-0529, and the Drug Testing Custody and Control Form, 49 CFR part 40, appendix A, will support the verbal or written notice that the test is being conducted in accordance with Part 382. Section 382.115 Starting Date For Testing Programs Question 1: In a governmental entity structured into various subunits such as departments, divisions, and offices, how is the number of an employer's drivers determined for purposes of the implementation date of controlled substances and alcohol testing? Guidance: Part 382 testing applies to governmental entities, including those of the Federal government, the States, and political subdivisions of the States. An employer is defined as any person that owns or leases CMVs, or assigns drivers to operate them. Therefore, any governmental entity, or a subunit of it that controls CMVs and the day- to-day operations of its drivers, may be considered the employer for purposes of part 382. For example, a city government divided into various departments, such as parks and public works, could consider the departments as separate employers if the CMV operations are separately controlled. The city also has the option of deeming the city as the employer of all of the drivers of the various departments. Section 382.205 On-duty Use Question 1: What is meant by the terms ``use alcohol'' or ``alcohol use?'' Is observation of use sufficient or is an alcohol test result required? Guidance: The term ``alcohol use'' is defined in Sec. 382.107. The employer is prohibited in Sec. 382.205 from permitting a driver to drive when the employer has actual knowledge of the driver's use of alcohol, regardless of the level of alcohol in the driver's body. The form of knowledge is not specified. It may be obtained through observation or other method. Section 382.213 Controlled Substances Use Question 1: Must a physician specifically advise that substances in a prescription will not adversely affect the driver's ability to safely operate a CMV or may a pharmacist's advice or precautions printed on a container suffice for the advice? Guidance: A physician must specifically advise the driver that the substances in a prescription will not adversely affect the driver's ability to safely operate a CMV. Section 382.301 Pre-Employment Testing Question 1: What is meant by the phrase, ``an employer who uses, but does not employ, a driver * * * ?'' Describe a situation to which the phrase would apply. Guidance: This exception was contained in the original drug testing rules and was generally applied to ``trip-lease'' drivers involved in interstate commerce. A trip-lease driver is generally a driver employed by one motor carrier, but who is temporarily leased to another motor carrier for one or more trips generally for a time period less than 30 days. The phrase would also apply to volunteer organizations that use loaned drivers. Question 2: Must school bus drivers be pre-employment tested after they return to work after summer vacation in each year in which they do not drive for 30 consecutive days? Guidance: A school bus driver whom the employer expects to return to duty the next school year does not have to be pre-employment tested so long as the driver has remained in the random selection pool over the summer. There is deemed to be no break in employment if the driver is expected to return in the fall. On the other hand, if the driver is taken out of all DOT random pools for more than 30 days, the exception to pre-employment drug testing in Sec. 382.301 would be unavailable and a drug test would have to be administered after the summer vacation. Question 3: Is a pre-employment controlled substances test required if a driver returns to a previous employer after his/her employment had been terminated? Guidance: Yes. A controlled substances test must be administered any time employment has been terminated for more than 30 days and the exceptions under Sec. 382.301(c) were not met. Question 4: Must all drivers who do not work for an extended period of time (such as layoffs over the winter or summer months) be pre- employment drug tested each season when they return to work? Guidance: If the driver is considered to be an employee of the company during the extended (layoff) period, a pre-employment test would not be required so long as the driver has been included in the company's random testing program during the layoff period. However, if the driver was not considered to be an employee of the company at any point during the layoff period, or was not covered by a program, or was not covered for more than 30 days, then a pre-employment test would be required. Question 5: What must an employer do to avail itself of the exceptions to pre-employment testing listed under Sec. 382.301(c)? Guidance: An employer must meet all requirements in Sec. 382.301(c) and (d), including maintaining all required documents. An employer must produce the required documents at the time of the Compliance Review for the exception to apply. Question 6: May a CDL driving skills test examiner conduct a driving skills test administered in accordance with 49 CFR part 383 before a person subject to part 382 is tested for alcohol and controlled substances? Guidance: Yes. A CDL driving skills test examiner, including a third party CDL driving skills test examiner, may administer a driving skills test to a person subject to part 382 without first testing him/ her for alcohol and controlled substances. The intent of the CDL driving skills test is to assess a person's ability to operate a commercial motor vehicle during an official government test of their driving skills. However, this guidance does not allow an employer (including a truck or bus driver training school) to use a person as a current company, lease, or student driver prior to obtaining a verified negative test result. An employer must obtain a verified negative controlled substance test result prior to dispatching a driver on his/ her first trip. Section382.303 Post-Accident Testing Question 1: Why does the FHWA allow post-accident tests done by Federal, State or local law enforcement agencies to substitute for a Sec. 382.303 test even though the FHWA does not allow a Federal, State or local law [[Page 16386]] enforcement agency test to substitute for a pre-employment, random, reasonable suspicion, return-to-duty, or follow-up test? Will such substitutions be allowed in the future? Guidance: A highway accident is generally investigated by a Federal, State, or local law enforcement agency that may determine that probable cause exists to conduct alcohol or controlled substances testing of a surviving driver. The FHWA believes that testing done by such agencies will be done to document an investigation for a charge of driving under the influence of a substance and should be allowed to substitute for a FHWA-required test. The FHWA expects this provision to be used rarely. The FHWA is required by statute to provide certain protection for drivers who are tested for alcohol and controlled substances. The FHWA believes that law enforcement agencies investigating accidents will provide similar protection based on the local court's prior action in such types of testing. The FHWA will not allow a similar approach for law enforcement agencies to conduct testing for the other types of testing. A law enforcement agency, however, may act as a consortium to provide any testing in accordance with parts 40 and 382. Question 2: May an employer allow a driver, subject to post- accident controlled substances testing, to continue to drive pending receipt of the results of the controlled substances test? Guidance: Yes. A driver may continue to drive, so long as no other restrictions are imposed by Sec. 382.307 or by law enforcement officials. Question 3: A commercial motor vehicle operator is involved in an accident in which an individual is injured but does not die from the injuries until a later date. The commercial motor vehicle driver does not receive a citation under State or local law for a moving traffic violation arising from the accident. How long after the accident is the employer required to attempt to have the driver subjected to post- accident testing? Guidance: Each employer is required to test each surviving driver for alcohol and controlled substances as soon as practicable following an accident as required by Sec. 382.303. However, if an alcohol test is not administered within 8 hours following the accident, or if a controlled substance test is not administered within 32 hours following the accident, the employer must cease attempts to administer that test. In both cases the employer must prepare and maintain a record stating the reason(s) the test(s) were not promptly administered. If the fatality occurs following the accident and within the time limits for the required tests, the employer shall attempt to conduct the tests until the respective time limits are reached. The employer is not required to conduct any tests for cases in which the fatality occurs outside of the 8 and 32 hour time limits. Question 4: What post-accident alcohol and drug testing requirements are there for U.S. employer's drivers involved in an accident occurring outside the U.S.? Guidance: U.S. employers are responsible for ensuring that drivers who have an accident (as defined in Sec. 390.5) in a foreign country are post-accident alcohol and drug tested in conformance with the requirements of 49 CFR parts 40 and 382. If the test(s) cannot be administered within the required 8 or 32 hours, the employer shall prepare and maintain a record stating the reasons the test(s) was not administered (see Secs. 382.303 (b)(1) and (b)(4)). Question 5: What post-accident alcohol and drug testing requirements are there for foreign drivers involved in accidents occurring outside the United States? Guidance: Post-accident alcohol and drug testing is required for CMV accidents occurring within the U.S. and on segments of interstate movements into Canada between the U.S.-Canadian border and the first physical delivery location of a Canadian consignee. The FHWA further believes its regulations require testing for segments of interstate movements out of Canada between the last physical pick-up location of a Canadian consignor and the U.S.-Canadian border. The same would be true for movements between the U.S.-Mexican border and a point in Mexico. For example, a motor carrier has two shipments on a CMV from a shipper in Chicago, Illinois. The first shipment will be delivered to Winnipeg, Manitoba and the second to Lloydminster, Saskatchewan. A driver is required to be post-accident tested for any CMV accident that meets the requirements to conduct 49 CFR 382.303 Post-accident testing, that occurs between Chicago, Illinois and Winnipeg, Manitoba (the first delivery point). The FHWA would not require a foreign motor carrier to conduct testing of foreign drivers for any accidents between Winnipeg and Lloydminster. The FHWA does not believe it has authority over Canadian and Mexican motor carriers that operate within their own countries where the movement does not involve movements into or out of the United States. For example, the FHWA does not believe it has authority to require testing for transportation of freight from Prince George, British Colombia to Red Deer, Alberta that does not traverse the United States. If the driver is not tested for alcohol and drugs as required by Sec. 382.303 and the motor carrier operates in the U.S. during a four- month period of time after the event that triggered the requirement for such a test, the motor carrier will be in violation of part 382 and may be subject to penalties under Sec. 382.507. Section 382.305 Random Testing Question 1: Is a driver who is on-duty, but has not been assigned a driving task, considered to be ready to perform a safety-sensitive function as defined in Sec. 382.107 subjecting the driver to random alcohol testing? Guidance: A driver must be about to perform, or immediately available to perform, a safety-sensitive function to be considered subject to random alcohol testing. A supervisor, mechanic, or clerk, etc., who is on call to perform safety-sensitive functions may be tested at any time they are on call, ready to be dispatched while on- duty. Question 2: What are the employer's obligations, in terms of random testing, with regard to an employee who does not drive as part of the employee's usual job functions, but who holds a CDL and may be called upon at any time, on an occasional or emergency basis, to drive? Guidance: Such an employee must be in a random testing pool at all times, like a full-time driver. A drug test must be administered each time the employee's name is selected from the pool. Alcohol testing, however, may only be conducted just before, during, or just after the performance of safety-sensitive functions. A safety-sensitive function as defined in Sec. 382.107 means any of those on-duty functions set forth in Sec. 395.2 On-Duty time, paragraphs (1) through (7), (generally, driving and related activities). If the employee's name is selected, the employer must wait until the next time the employee is performing safety-sensitive functions, just before the employee is to perform a safety-sensitive function, or just after the employee has ceased performing such functions to administer the alcohol test. If a random selection period expires before the employee performs a safety-sensitive function, no alcohol test should be given, the employee's name should be returned to the pool, and the number of employees subsequently selected should be adjusted accordingly to achieve the required rate. [[Page 16387]] Question 3: How should a random testing program be structured to account for the schedules of school bus or other drivers employed on a seasonal basis? Guidance: If no school bus drivers from an employer's random testing pool are used to perform safety sensitive functions during the summer, the employer could choose to make random selections only during the school year. If the employer nevertheless chooses to make selections in the summer, tests may only be administered when the drivers return to duty. If some drivers continue to perform safety-sensitive functions during the summer, such as driving buses for summer school, an employer could not choose to forego all random selections each summer. Such a practice would compromise the random, unannounced nature of the random testing program. The employer would test all selected drivers actually driving in the summer. With regard to testing drivers not driving during the summer, the employe