Harmonizing Schedule I Drug Requirements

AGENCY:

Federal Motor Carrier Safety Administration, DOT.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Federal Motor Carrier Safety Administration (FMCSA) proposes to amend the physical qualifications for drivers and the instructions for the medical examination report to clarify that drivers may not use Schedule I drugs and be qualified to drive commercial motor vehicles under any circumstances. The proposal also harmonizes FMCSA's provisions regarding pre-employment and return-to-duty test refusals with corresponding Department of Transportation (DOT)-wide provisions. Finally, the proposal corrects inaccurate uses of the term “actual knowledge.”

DATES:

Comments and related material must be submitted on or before September 6, 2011.

ADDRESSES:

You may submit comments identified by docket number FMCSA-2011-0073 using any one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov.
• Fax: 202-493-2251.
• Mail: Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001.
• Hand delivery: Same as mail address above, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329.

To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section below for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this proposed rule, call or e-mail Angela Ward, Nurse Consultant, Medical Programs Office, Federal Motor Carrier Safety Administration, telephone: 202-366-3109; e-mail: angela.ward@dot.gov. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826.

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Public Participation and Request for Comments

A. Submitting Comments

B. Viewing Comments and Documents

C. Privacy Act

II. Abbreviations

III. Background

A. History

B. Legal Authority

C. Discussion of Proposed Rule

IV. Section-by-Section Analysis

V. Regulatory Analyses

I. Public Participation and Request for Comments

FMCSA encourages you to participate in this rulemaking by submitting comments and related materials.

A. Submitting Comments

If you submit a comment, please include the docket number for this rulemaking (FMCSA-2011-0073), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an e-mail address, or a phone number in the body of your document so that the Agency can contact you if it has questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov,, click on the “Submit a Comment” box, which will then become highlighted in blue. In the “Document Type” drop down menu, select “Rules,” insert “FMCSA-2011-0073” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Submit a Comment” in the “Actions” column. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.

FMCSA will consider all comments and material received during the comment period and may change this proposed rule based on your comments.

B. Viewing Comments and Documents

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov and click on the “Read Comments” box in the upper right hand side of the screen. Then, in the “Keyword” box, insert “FMCSA-2011-0073” and click “Search.” Next, click “Open Docket Folder” in the “Actions” column. Finally, in the “Title” column, click on the document you would like to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays.

C. Privacy Act

All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. Anyone is able to search the electronic form for all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on January 17, 2008 (73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

II. Abbreviations

III. Background

A. History

The Omnibus Transportation Employee Testing Act of 1991 (OTETA), 49 U.S.C. 31306, mandated that DOT establish a controlled substances (drug) and alcohol testing program applicable to regulated entities and individuals performing safety sensitive functions. Entitled “Procedures for Transportation Workplace Drug and Alcohol Testing Programs,” 49 CFR part 40 contains the DOT regulations that detail how testing must be administered and prescribes procedures to protect the integrity of the process. The FMCSA's related drug and alcohol testing regulations are in 49 CFR part 382, “Controlled Substances and Alcohol Use and Testing.”

DEA implemented the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act and the Controlled Substances Import and Export Act (21 U.S.C. 801-971), as amended. DEA published regulations implementing these statutes in 21 CFR Parts 1300 to 1399. These regulations are designed to ensure an adequate supply of controlled substances for legitimate medical, scientific, research, and industrial purposes, and to deter the diversion of controlled substances to illegal purposes. Controlled substances are drugs and other substances that have a potential for abuse and psychological and physical dependence. DEA lists controlled substances in 21 CFR part 1308. The substances are divided into five schedules. The substances listed in the schedule that are relevant to this rulemaking, Schedule I, have a high potential for abuse and have no currently accepted medical use in the United States (DEA Interim Final Rule on Electronic Prescriptions for Controlled Substances, 75 FR 16237, March 31, 2010). These substances may only be used for research, chemical analysis, or manufacture of other drugs.

Section 382.213 prohibits commercial motor vehicle (CMV) drivers from using any controlled substances when on duty or reporting for duty except when prescribed by a licensed medical practitioner who has advised the driver that the prescribed substance will not adversely affect the driver's ability to operate a CMV. Section 382.213 has remained largely unchanged since its adoption in 1994, outside of a technical amendment changing the term “physician” to “licensed medical practitioner” for the purpose of the prescription exception (61 FR 9556, March 8, 1996).

In addition to those in part 382, FMCSA has several other regulations governing drivers' use of drugs. Section 391.41(b)(12) was first promulgated in 1970, and stated that persons who “use an amphetamine, narcotic, or any habit-forming drug, are not medically qualified to operate a commercial motor vehicle” (35 FR 6463, April 22, 1970). Section 391.43(f) incorporates the substance of § 391.41(b)(12) in the instructions to the medical examiner. Section 391.41(b)(12) was revised several times, most notably in 1984, when the DEA's Schedule I drugs were added to the list of drugs prohibited by § 391.41(b)(12) (49 FR 44215, November 5, 1984). Sections 382.213 and 391.41(b)(12) were designed to complement § 392.4, which prohibits the use of drugs by CMV drivers. Section 392.4 contains an exception for use of non-Schedule I drugs “administered to a driver by or under the instructions of a licensed medical practitioner, as defined in § 382.107 of this subchapter, who has advised the driver that the substance will not affect the driver's ability to safely operate a motor vehicle” (49 CFR 392.4).

B. Legal Authority

FMCSA has general authority to promulgate safety standards, including those governing drivers' use of drugs while operating a CMV. The Motor Carrier Safety Act of 1984 (Pub. L. 98-554, Title II, 98 Stat. 2832, October 30, 1984) (the 1984 Act) provides authority to regulate drivers, motor carriers, and vehicle equipment. It requires the Secretary to ensure that—(1) CMVs are maintained, equipped, loaded, and operated safely; (2) the responsibilities imposed on operators of CMVs do not impair their ability to operate the vehicles safely; (3) the physical condition of CMV operators is adequate to enable them to operate the vehicles safely; and (4) the operation of CMVs does not have a deleterious effect on the physical condition of the operators (49 U.S.C. 31136(a)). Section 211 of the 1984 Act also grants the Secretary broad power in carrying out motor carrier safety statutes and regulations to “prescribe recordkeeping and reporting requirements” and to “perform other acts the Secretary considers appropriate” (49 U.S.C. 31133(a)(8) and (10)).

The FMCSA Administrator has been delegated authority under 49 CFR 1.73(g) to carry out the functions vested in the Secretary of Transportation by 49 U.S.C. chapter 311, subchapters I and III, relating to CMV programs and safety regulation.

As stated above, OTETA (Pub. L. 102-143, Title V, 105 Stat. 917, at 952, Oct. 28, 1991, codified at 49 U.S.C. 31306), mandated the alcohol and controlled substances (drug) testing program for DOT. OTETA required the Secretary of Transportation to promulgate regulations for alcohol and controlled substances testing for persons in safety-sensitive positions in four modes of transportation—motor carrier, airline, railroad, and mass transit. Those regulations, including subsequent amendments, are codified at 49 CFR part 40, “Procedures for Transportation Workplace Drug and Alcohol Testing Programs.” Part 40 prescribes drug and alcohol testing requirements for all DOT-regulated parties, including employers of drivers with commercial driver's licenses subject to FMCSA testing requirements. FMCSA's related drug and alcohol testing regulations are in 49 CFR part 382, “Controlled Substances and Alcohol Use and Testing.”

C. Discussion of the Proposed Rule

This rulemaking is necessary to reconcile and resolve a perceived inconsistency among: §§ 382.213, 391.41(b)(12), 391.43(f), and 392.4 of the Federal Motor Carrier Safety Regulations (FMCSRs); DOT-wide drug regulations in part 40; and DEA regulations. Although § 392.4 clearly prohibits drivers from using Schedule I drugs, it has come to FMCSA's attention that some people might interpret §§ 382.213, 391.41(b)(12) and 391.43(f) to permit their use if recommended by a licensed medical practitioner. The FMCSA has always considered §§ 382.213, 391.41(b)(12), 391.43(f), and 392.4 to prohibit any and all use of Schedule I drugs by CMV drivers. In fact, Federal law prohibits Schedule I drugs from being prescribed in the United States (75 FR 16237, March 31, 2010). Schedule I drugs have a high potential for abuse and no medically accepted therapeutic use (id.). Currently, Federal law only allows for their use in research, chemical analysis, or manufacture of other drugs (id.).

In certain circumstances, a medical review officer can verify a drug test negative when he or she has information that a driver is using a drug under a physician's prescription. However, under DOT-wide rules, no medical review officer may verify a drug test negative for a Schedule I drug, even if he or she has information that a driver is using the Schedule I drug in accordance with a physician's recommendation (49 CFR 40.151(e)). Interpreting FMCSA's regulations to permit drivers to use Schedule I drugs would put the FMCSRs in direct conflict with DOT's comprehensive drug testing program under 49 CFR part 40, which does not permit drivers to use Schedule I drugs. The FMCSA does not believe this is a reasonable interpretation of the regulations. Regardless, to avoid any confusion, this rulemaking would harmonize §§ 382.213, 391.41(b)(12), 391.43(f), and 392.4 with DOT-wide regulations and DEA regulations, and make it clear that drivers may not use Schedule I drugs under any circumstances.

In addition, 49 CFR 382.211 prohibits drivers from refusing to submit to certain types of drug or alcohol tests and establishes such refusals as violations of FMCSA's drug and alcohol regulations. Currently, under DOT-wide regulations, drivers who refuse to submit to pre-employment and return-to-duty tests must complete the return-to-duty process prescribed in part 40, subpart O. However, § 382.211 is inconsistent with the DOT-wide drug and alcohol rules in that it does not include refusals to submit to pre-employment and return-to-duty tests as violations. The FMCSA proposes to correct this inconsistency by adding these two types of refusals to the prohibitions at § 382.211.

Finally, FMCSA proposes changes to 49 CFR 382.201 and 382.215 to clarify the Agency's rules prohibiting an employer from using a driver about whom the employer has actual knowledge of drug or alcohol use, as defined at § 382.107. Sections 382.201 and 382.215 currently state that an employer may not allow an employee to perform safety-sensitive functions if the employer has actual knowledge that the employee has tested positive for drugs or has an alcohol concentration of .04 or greater. However, the term “actual knowledge” is defined in § 382.107 to mean the observation of alcohol or controlled substances use, and is not intended to refer to testing results. As a result, the use of the term “actual knowledge” in these sections is not appropriate. FMCSA proposes to replace the term “actual knowledge” with “knowledge” in these sections. This should clarify that these prohibitions refer to the knowledge of test results, not employer observation of prohibited conduct.

IV. Section-by-Section Analysis

Sections 382.201 and 382.215

An employer has “actual knowledge” that an employee has used drugs or alcohol in violation of FMCSA rules when he or she directly observes or otherwise learns that a driver is using controlled substances or consuming alcohol while on duty (49 CFR 382.107). Actual knowledge, as defined at § 382.107, is distinct from an employer knowing that his or her employee-driver tested positive or refused a DOT drug or alcohol test. Because §§ 382.201 and 382.215 set forth prohibitions related to an employer's knowledge related to testing, not observation, the use of the term “actual knowledge” is not appropriate. The FMCSA proposes to replace the term “actual knowledge” with “knowledge” in these sections. This would clarify that these prohibitions refer to the knowledge of test results, not employer observation of prohibited conduct.

Current § 382.211 prohibits drivers from refusing to submit to a post-accident, random, or reasonable suspicion drug or alcohol test. The Agency proposes to amend § 382.211 to also prohibit refusals for pre-employment testing and return-to-duty testing. This would make this regulation consistent with 49 CFR 40.191(a)(3).

Section 382.213

Section 382.213 currently prohibits CMV drivers from using any drugs when on duty or reporting for duty except when prescribed by a licensed medical practitioner who has advised the driver that the prescribed substance will not adversely affect the driver's ability to operate a CMV. The Agency proposes to amend the language regarding the drugs that CMV drivers are prohibited from using in order to differentiate between Schedule I drugs and non-Schedule I drugs. The proposed changes would make it clear that Schedule I drugs may not be used by a CMV driver under any circumstances. The FMCSA's regulations would continue to permit the use of non-Schedule I drugs under limited circumstances, when prescribed by a licensed medical practitioner.

Sections 391.41 and 391.43

Section 391.41(b)(12)(i) currently states that a driver may not use: Controlled substances on the DEA Schedule I, amphetamines, narcotics, or other habit-forming drugs. Section 391.41(b)(12)(ii) contains an exception for a substance or drug prescribed by a licensed medical practitioner who is familiar with the driver's history and work duties and has advised the driver that the prescribed substance or drug will not adversely affect his or her ability to safely operate a CMV. The FMCSA has never considered this exception to permit use of Schedule I drugs by CMV drivers under any circumstance because Federal law prohibits Schedule I drugs from being prescribed in the United States (75 FR 16237, March 31, 2010). Section 391.43(f) incorporates the substance of § 391.41(b)(12) into pages 4 and 8 of the Instructions to the Medical Examiner. The FMCSA makes no others changes to this document.

Section 391.41(b)(12) and the Instructions for Medical Examiners at § 391.43(f) currently do not differentiate between Schedule I and non-Schedule I drugs for the purpose of the prescription exception. The prescription exception currently states that a CMV driver may use a substance or drug that is prescribed by a licensed medical practitioner who is familiar with the driver's medical history and has advised the driver that the prescribed substance or drug will not adversely affect the driver's ability to safely operate a CMV. The Agency proposes to amend these sections to clarify that this exception only applies to non-Schedule I prescribed substances, amphetamines, narcotics, or other habit-forming drugs.

V. Regulatory Analyses

Regulatory Planning and Review

This action does not meet the criteria for a “significant regulatory action,” either as specified in Executive Order 12866 as supplemented by Executive Order 13563 (76 FR 3821, January 18, 2011) or within the meaning of the DOT regulatory policies and procedures (44 FR 1103, February 26, 1979). The estimated economic costs of the proposed rule do not exceed the $100 million annual threshold nor does the Agency expect the proposed rule to have substantial Congressional or public interest. Therefore, this proposed rule has not been formally reviewed by the Office of Management and Budget. No expenditures would be required of the affected population because the proposed rule would only clarify existing rules, amend inconsistencies in FMCSA's current regulations, and harmonize them with the DOT-wide regulations and DEA regulations.

Regulatory Flexibility Act

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. The term “small entities” comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, as well as governmental jurisdictions with populations of less than 50,000. Accordingly, DOT policy requires an analysis of the impact of all regulations on small entities and mandates that agencies strive to lessen any adverse effects on these businesses.

Under the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, the proposed rule is not expected to have a significant economic impact on a substantial number of small entities because the proposed rule would only clarify existing rules, amend inconsistencies in FMCSA's current regulations, and harmonize them with the DOT-wide regulations and DEA regulations. Accordingly, I certify that a regulatory flexibility analysis is not necessary.

Assistance for Small Entities

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), FMCSA wants to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking initiative. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult the FMCSA point of contact, Angela Ward, listed in the FOR FURTHER INFORMATION CONTACT section of this proposed rule. FMCSA will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Agency.

Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of FMCSA, call 1-888-REG-FAIR (1-888-734-3247).

Unfunded Mandates Reform Act of 1995

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $140.8 million (which is the value of $100 million in 2010 after adjusting for inflation) or more in any 1 year. This proposed rule would not result in such expenditure; FMCSA expects the effects of this proposed rule to be minimal because the proposed rule would only clarify existing rules, amend inconsistencies in FMCSA's current regulations, and harmonize them with the DOT-wide regulations and DEA regulations.

Paperwork Reduction Act

This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Privacy Impact Assessment

FMCSA conducted a Privacy Threshold Analysis for the Notice of Proposed Rulemaking (NPRM) and determined that this proposed rule is not a privacy-sensitive rulemaking because if promulgated as a final rule it would not require any collection, maintenance, or dissemination of Personally Identifiable Information from or about members of the public.

Executive Order 13132 (Federalism)

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on States or localities. FMCSA has analyzed this proposed rule under that Order and has determined that it does not have implications for federalism.

Executive Order 12630 (Taking of Private Property)

This proposed rule would not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

Executive Order 12988 (Civil Justice Reform)

This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

Executive Order 13045 (Protection of Children)

FMCSA has analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This proposed rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.

Executive Order 13211 (Energy Effects)

FMCSA has analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency has determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

Technical Standards

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use technical standards. Therefore, FMCSA did not consider the use of voluntary consensus standards.

National Environmental Policy Act

FMCSA analyzed this NPRM for the purpose of the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.) and determined under our environmental procedures Order 5610.1, published February 24, 2004 (69 FR 9680), that this proposed action does not have any effect on the quality of the environment. Therefore, this NPRM is categorically excluded from further analysis and documentation in an environmental assessment or environmental impact statement under FMCSA Order 5610.1, paragraph 6(r) of Appendix 2. The Categorical Exclusion under paragraph 6(y)(6) relates to “regulations implementing employer controlled substances and alcohol use and testing procedures * * *,” which is the focus of this rulemaking. A Categorical Exclusion determination is available for inspection or copying in the regulations.gov Web site listed under ADDRESSES.

In addition to the NEPA requirements to examine impacts on air quality, the Clean Air Act (CAA) as amended (42 U.S.C. 7401 et seq.) also requires FMCSA to analyze the potential impact of its actions on air quality and to ensure that FMCSA actions conform to State and local air quality implementation plans. The additional contributions to air emissions are expected to fall within the CAA de minimis standards and are not expected to be subject to the Environmental Protection Agency's General Conformity Rule (40 CFR parts 51 and 93).

FMCSA seeks comment on these determinations.

List of Subjects

49 CFR Part 382

• Administrative practice and procedure
• Alcohol abuse
• Drug abuse
• Drug testing
• Highway safety
• Motor carriers
• Penalties
• Safety
• Transportation

49 CFR Part 391

• Alcohol abuse
• Drug abuse
• Drug testing
• Highway safety
• Motor carriers
• Reporting and recordkeeping requirements
• Safety
• Transportation

For the reasons stated in the preamble, FMCSA proposes to amend 49 CFR, parts 382 and 391 as follows:

PART 382—CONTROLLED SUBSTANCES AND ALCOHOL USE AND TESTING

1. The authority citation for part 382 continues to read as follows:

Authority: 49 U.S.C. 31133, 31136, 31301 et seq., 31502; and 49 CFR 1.73.

PART 391—QUALIFICATIONS OF DRIVERS AND LONGER COMBINATION VEHICLE (LCV) DRIVER INSTRUCTORS

6. The authority citation for part 391 continues to read as follows:

Authority: 49 U.S.C. 322, 504, 508, 31133, 31136, and 31502; sec. 4007(b) of Pub. L. 102-240, 105 Stat. 2152; sec. 114 of Pub. L. 103-311, 108 Stat. 1673, 1677; sec. 215 of Pub. L. 106-159, 113 Stat. 1767; and 49 CFR 1.73.

7. Amend § 391.41 by revising paragraphs (b)(12)(i) and (ii) to read as follows: