Harmonizing Schedule I Drug Requirements

AGENCY:

Federal Motor Carrier Safety Administration, DOT.

ACTION:

Final rule.

SUMMARY:

The Federal Motor Carrier Safety Administration (FMCSA) amends 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 (CMVs) under any circumstances. The rule harmonizes FMCSA's provisions regarding pre-employment and return-to-duty test refusals with corresponding Department of Transportation (DOT)-wide provisions. Finally, the rule corrects inaccurate uses of the term “actual knowledge.”

DATES:

This final rule is effective February 29, 2012.

ADDRESSES:

All background documents, comments, and materials related to this rule may be viewed in docket number FMCSA-2011-0073 using either of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov.
• 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.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Public Participation

A. Viewing Comments and Documents

B. Privacy Act

II. Abbreviations

III. Background

A. History

B. Legal Authority

IV. Comments on the Proposed Rule

V. Section-by-Section Analysis

VI. Changes to the Proposed Rule in This Final Rule

VII. Regulatory Analyses

I. Public Participation

A. 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.

B. Privacy Act

All comments received are posted without change to http://www.regulations.gov. 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

CAA Clean Air Act

CFR Code of Federal Regulations

CMV Commercial Motor Vehicle

DEA Drug Enforcement Administration

FMCSA Federal Motor Carrier Safety Administration

FR Federal Register

NEPA National Environmental Policy Act

OTETA Omnibus Transportation Employee Testing Act of 1991

U.S.C. United States Code

III. Background

A. History

The Federal laws governing drugs of abuse are set forth in 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. Controlled substances are drugs and other substances that have a potential for abuse and psychological and physical dependence. The Drug Enforcement Administration (DEA) is the primary agency responsible for enforcing the Federal controlled substance laws. The DEA regulations, which implement these laws, are found in 21 CFR parts 1300 to 1321. As part of these regulations, DEA publishes an updated list of controlled substances in 21 CFR 1308.11 through 1308.15. The controlled substances are divided into five schedules. The controlled substances listed in the schedule that are relevant to this rulemaking, Schedule I controlled substances, 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 16236, March 31, 2010).

The Omnibus Transportation Employee Testing Act of 1991 (OTETA) 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. FMCSA's related drug and alcohol testing regulations are in 49 CFR part 382, “Controlled Substances and Alcohol Use and Testing.”

Section 382.213 prohibits 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, the Federal Motor Carrier Safety Regulations (FMCSRs) include 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). The regulation 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). Section 391.43(f) incorporates the substance of § 391.41(b)(12) in the instructions to the medical examiner.

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).

On July 8, 2011 (76 FR 40306), FMCSA proposed a rule to resolve a perceived inconsistency among: §§ 382.213, 391.41(b)(12), 391.43(f), and 392.4 of the FMCSRs; DOT-wide drug regulations in part 40; and DEA regulations. The Notice of Proposed Rulemaking (NPRM) proposed to eliminate these perceived inconsistencies by making three changes to FMCSA's regulations. The first was to amend the minimum physical qualifications for CMV drivers to clarify that the use of Schedule I drugs is prohibited under all circumstances. The second was to require that drivers who refuse to submit to pre-employment and return-to-duty tests be subject to the same referral, evaluation, and treatment steps that are required after refusing other types of tests. The third was to replace the term “actual knowledge” with the word “knowledge” in the context of regulations addressing employers' knowledge of positive test results. The comment period ended on September 6, 2011, and the Agency received two comments.

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) gives the Secretary of Transportation (Secretary) 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 by 49 U.S.C. chapter 311, subchapters I and III, relating to CMV programs and safety regulation. This rule implements, in part, the Administrator's delegated authority under Section 206(a)(3) of the 1984 Act to ensure that the physical condition of CMV operators is adequate to enable them to operate vehicles safely by clarifying that drivers may not use Schedule I drugs and be qualified to drive CMVs under any circumstances. The rule also exercises the broad recordkeeping and implementation authority under Section 211. The other subsections of Section 206(a) do not apply because this final rule only addresses the physical condition of CMV drivers.

In addition, and as stated above, OTETA (Pub. L. 102-143, Title V, 105 Stat. 917, at 952, October 28, 1991, partially codified at 49 U.S.C. 31306), mandated the alcohol and controlled substances (drug) testing program for DOT. OTETA required the Secretary 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.”

IV. Comments on the Proposed Rule

FMCSA received two comments in response to the NPRM (76 FR 40306, July 8, 2011). The commenters included a member of the public and the American Trucking Associations (ATA). Both commenters expressed support for the rulemaking. The individual commenter stated the final rule “can help with the safety on the road and the public.” Specifically, ATA “commended FMCSA for its continued efforts to clarify and improve the drug and alcohol testing regulations.”

Pre-employment Tests

ATA commented that it believed that the proposed changes to § 382.211 (pre-employment tests) would likely be ineffective because any driver that fails a pre-employment test would probably seek a position elsewhere and not report the failed test to future employers. ATA stated that this is a loophole that cannot be closed until FMCSA implements a national clearinghouse for drug/alcohol test results.

FMCSA Response. Implementation of a national clearinghouse is outside the scope of the rule FMCSA proposed. FMCSA is considering, however, addressing this issue as a part of a future rulemaking.

V. Section-by-Section Analysis

Sections 382.201 and 382.215

This rule amends §§ 382.201 and 382.215 to correct improper use of the term “actual knowledge.” 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. FMCSA replaces the term “actual knowledge” with “knowledge” in these sections, clarifying that these prohibitions refer to the knowledge of test results, not employer observation of prohibited conduct.

Section 382.211

Prior to this final rule, § 382.211 only prohibited drivers from refusing to submit to a post-accident, random, reasonable suspicion, or follow-up drug or alcohol test. This rule amends this section to include refusals for pre-employment testing and return-to-duty testing as additional prohibitions. This amendment makes the regulation consistent with DOT-wide drug and alcohol testing rules at 49 CFR 40.191(a)(3).

Section 382.213

Prior to this final rule, the text of § 382.213 prohibited 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. In this final rule, the Agency amends 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 changes make it clear that Schedule I drugs may not be used by a CMV driver under any circumstances. FMCSA's regulations 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

Prior to this final rule, § 391.41(b)(12)(i) stated 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) contained 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. Previously, § 391.41(b)(12) did not differentiate between Schedule I and non-Schedule I drugs for the purpose of the prescription exception. However, 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.

The Agency amends § 391.41 to remove any ambiguity and to clarify that the exception that allows a CMV driver to use a substance or drug if it 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, only applies to non-Schedule I prescribed substances, amphetamines, narcotics, or other habit-forming drugs.

Section 391.43(f) incorporates the substance of § 391.41(b)(12) into pages 4 and 8 of the Instructions to the Medical Examiner. FMCSA makes no other changes to this document.

VI. Changes to the Proposed Rule in this Final Rule

This final rule makes the following minor changes to the NPRM to improve the clarity and intent of the rule.

The final rule removes the term “controlled substance” from §§ 382.213 and 391.41(b)(12) and replaces it with “drug or substance.” This new language conforms to terminology the DEA uses in its regulations at 21 CFR part 1308. The final rule also changes the language in §§ 382.213(b) and 391.41(b)(12)(ii) that references non-Schedule I drugs or substances and replaces it with the phrase “that is identified in the other Schedules in 21 CFR part 1308.” The Agency did not intend to expand the scope of these sections to non-scheduled drugs. This change makes the Agency's intent clear by specifically stating that they only apply to the use of drugs or substances that appear on one of the DEA's controlled substances schedules.

The final rule changes the following highlighted language proposed in § 391.41(b)(12)(ii): “Does not use any non-Schedule I controlled substance except when the use is pursuant to the instructions of a licensed medical practitioner * * * ” After further consideration, the Agency concluded that this change of language is inconsistent with language used elsewhere in the Agency's regulations and would be confusing to public. As a result, the final rule does not adopt this change. The final rule removes the language “pursuant to the instructions of” and replaces it with the original language in this section, “prescribed by.”

The final rule also changes § 391.43(f) to reflect these changes on pages 4 and 8 of the Instructions to the Medical Examiner.

Finally, the final rule removes the following language from page 8 of the Instructions to the Medical Examiner: “If a driver uses a Schedule I drug or other substance, an amphetamine, a narcotic, or any other habit-forming drug, it may be cause for the driver to be found medically unqualified,” and replaces it with: “If a driver uses an amphetamine, a narcotic or any other habit-forming drug, it may be cause for the driver to be found medically unqualified. If a driver uses a Schedule I drug or substance, it will be cause for the driver to be found medically unqualified.” This change harmonizes the Instructions with the other changes made in this final rule. Specifically, it makes clear that a driver using a Schedule I drug or substance is not medically qualified to drive under any circumstances.

VII. 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 rule do not exceed the $100 million annual threshold nor does the Agency expect the rule to have substantial Congressional or public interest. Therefore, this rule has not been formally reviewed by the Office of Management and Budget. No expenditures are required of the affected population because the rule only clarifies existing rules, amends inconsistencies in FMCSA's current regulations, and harmonizes them with 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 (Pub. L. 104-121, Title II, 110 Stat. 857), the rule is not expected to have a significant economic impact on a substantial number of small entities because the rule only clarifies existing rules, amends inconsistencies in FMCSA's current regulations, and harmonizes them with the DOT-wide regulations and DEA regulations. Accordingly, I certify that a regulatory flexibility analysis is not necessary.

Assistance for Small Entities

In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 858), FMCSA wants to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking initiative. If the rule affects 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 rule. FMCSA does not intend to take action against small entities that have questions about this 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 $143.1 million (which is the value of $100 million in 2010 after adjusting for inflation) or more in any 1 year. This rule will not result in such expenditure; FMCSA expects the effects of this rule to be minimal because it only clarifies existing rules, amends inconsistencies in FMCSA's current regulations, and harmonizes them with the DOT-wide regulations and DEA regulations.

Paperwork Reduction Act

This rule calls 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 rulemaking and determined that this rule is not a privacy-sensitive rulemaking because it will 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 either preempts State law or imposes a substantial direct cost of compliance on States or localities. Although States and localities are prohibited by 49 U.S.C. 31306(g) from adopting or enforcing a law or regulation inconsistent with OTETA or its implementing regulations, parts 382 and 391 and this rule do not impose substantial direct costs of compliance on States or localities. FMCSA has therefore determined that this rule does not have implications for federalism.

Executive Order 12630 (Taking of Private Property)

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

Executive Order 13211 (Energy Effects)

FMCSA analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency 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 rule does not use technical standards. Therefore, FMCSA did not consider the use of voluntary consensus standards.

National Environmental Policy Act and Clean Air Act

FMCSA analyzed this rule 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 action does not have any effect on the quality of the environment. Therefore, this rule 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).

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 amends 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.

2. Amend § 382.201 by removing the word “actual” between the words “having” and “knowledge.”

3. Revise § 382.211 to read as follows:

4. Revise § 382.213 to read as follows:

5. Amend § 382.215 by removing the word “actual” between the words “having” and “knowledge.”

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. Revise § 391.41 paragraph (b)(12) to read as follows:

8. Amend § 391.43(f) by removing the Medical Examination Report for Commercial Driver Fitness Determination, form 649-F (6045), and adding in its place the following form, to read as follows: