Qualifications of Drivers; Diabetes Standard

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Part 391

[Docket No. FMCSA-2005-23151]

RIN 2126-AA95

Qualifications of Drivers; Diabetes Standard

AGENCY:

Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION:

Final rule.

SUMMARY:

FMCSA revises its regulations to permit individuals with a stable insulin regimen and properly controlled insulin-treated diabetes mellitus (ITDM) to be qualified to operate commercial motor vehicles (CMVs) in interstate commerce. Previously, ITDM individuals were prohibited from driving CMVs in interstate commerce unless they obtained an exemption from FMCSA. This rule enables a certified medical examiner (ME) to grant an ITDM individual a Medical Examiner's Certificate (MEC), MCSA-5876, for up to a maximum of 12 months. To do so, the treating clinician (TC), the healthcare professional who manages, and prescribes insulin for, the treatment of the individual's diabetes, provides the Insulin-Treated Diabetes Mellitus Assessment Form (ITDM Assessment Form), MCSA-5870, to the certified ME indicating that the individual maintains a stable insulin regimen and proper control of his or her diabetes. The certified ME then determines that the individual meets FMCSA's physical qualification standards and can operate CMVs in interstate commerce.

DATES:

This final rule is effective November 19, 2018, except for amendatory instruction 5.b. which is effective November 19, 2019. Comments sent to the Office of Management and Budget (OMB) on the collection of information must be received by OMB on or before November 19, 2018.

Petitions for Reconsideration of this final rule must be submitted to the FMCSA Administrator no later than October 19, 2018.

FOR FURTHER INFORMATION CONTACT:

Ms. Christine A. Hydock, Chief, Medical Programs Division, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, by telephone at (202) 366-4001, or by email at

fmcsamedical@dot.gov.

If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

SUPPLEMENTARY INFORMATION:

This final rule is organized as follows:

I. Rulemaking Documents

A. Availability of Rulemaking Documents

B. Privacy Act

II. Executive Summary

A. Purpose of the Amendments

B. Summary of Major Provisions

C. Benefits and Costs

III. Abbreviations and Acronyms

IV. Legal Basis for the Rulemaking

V. Background

A. Brief History of Physical Qualification Standards for CMV Drivers With ITDM

B. Exemption Program

C. May 4, 2015, NPRM

D. September 9, 2016, Notice of MRB Task Report; Request for Comments

E. July 27, 2017, Notice of Proposed ITDM Assessment Form and Request for Comments

VI. Discussion of Comments and Responses

A. Comment Overview

B. Qualifications of a Certified ME To Examine an ITDM Individual

C. Definition and Qualifications of a TC

D. Role and Relationship of the TC and Certified ME

E. TC Written Notification (ITDM Assessment Form)

F. Certified ME Certification and TC Evaluation Frequency

G. Annual Certification of Individuals With Diabetes Mellitus Not Treated With Insulin

H. Eye Examinations

I. Disqualification for Visual Impairment

J. HbA1C Levels

K. Specific Blood Glucose Limits

L. Severe Hypoglycemic Episodes

M. Hypoglycemia Unawareness

N. Blood Glucose Self-Monitoring

O. Requirement To Carry Readily-Absorbable Glucose

P. Diabetic Complications and Target Organ Damage

Q. Motor Carrier Responsibility To Enforce the ITDM Standard

R. ITDM Individuals Operating CMVs Transporting Passengers or Hazardous Materials

S. ITDM Individuals With Licenses Issued in Canada or Mexico

T. The Grandfather Provision for Insulin-Treated Diabetes

U. Safety of ITDM Individuals

V. Costs and Benefits of the Proposed Rule

W. Privacy Issues

X. Other Comments

Y. Outside the Scope

VII. Section-by-Section Analysis

VIII. International Impacts

IX. Regulatory Analyses

A. E.O. 12866 (Regulatory Planning and Review), E.O. 13563 (Improving Regulation and Regulatory Review), and DOT Regulatory Policies and Procedures

B. E.O. 13771 (Reducing Regulation and Controlling Regulatory Costs)

C. Regulatory Flexibility Act

D. Assistance for Small Entities

E. Unfunded Mandates Reform Act of 1995

F. Paperwork Reduction Act (Collection of Information)

G. E.O. 13132 (Federalism)

H. E.O. 12988 (Civil Justice Reform)

I. E.O. 13045 (Protection of Children)

J. E.O. 12630 (Taking of Private Property)

K. Privacy Impact Assessment

L. E.O. 12372 (Intergovernmental Review)

M. E.O. 13211 (Energy Supply, Distribution, or Use)

N. E.O. 13783 (Promoting Energy Independence and Economic Growth)

O. E.O. 13175 (Indian Tribal Governments)

P. National Technology Transfer and Advancement Act (Technical Standards)

Q. Environment (National Environmental Policy Act of 1969 (NEPA), Clean Air Act (CAA), Environmental Justice)

I. Rulemaking Documents

A. Availability of Rulemaking Documents

For access to docket FMCSA-2005-23151 to read background documents and comments received, go to

http://www.regulations.gov

at any time, or to Docket Services at U.S. Department of Transportation, Room W12-140, 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

In accordance with 5 U.S.C. 553(c), the Department of Transportation (DOT) solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to

www.regulations.gov,

as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at

www.transportation.gov/privacy.

II. Executive Summary

A. Purpose of the Amendments

This final rule amends the Federal Motor Carrier Safety Regulations (FMCSRs) to allow individuals with stable insulin regimens and properly controlled ITDM to drive CMVs in interstate commerce if they meet the physical qualification standards in §§ 391.41, 391.45, and 391.46. The final rule eliminates the diabetes grandfather provision under § 391.64(a) 1 year after the effective date of this rule and also eliminates the need for the Federal diabetes exemption program.

B. Summary of Major Provisions

This final rule allows individuals with stable insulin regimens and properly controlled ITDM to drive CMVs in interstate commerce if they have an annual or more frequent examination by a certified ME who is listed on the National Registry of Certified Medical Examiners (National Registry), are found physically qualified to operate a CMV, and are issued an

MEC, MCSA-5876, from a certified ME. Prior to the annual or more frequent examination by the certified ME, the individual must have an evaluation by his or her TC. The final rule defines a TC as the healthcare professional who manages, and prescribes insulin for, the treatment of the individual's diabetes as authorized by the healthcare professional's State licensing authority.

The TC provides information to the certified ME via the ITDM Assessment Form, MCSA-5870, on which the TC attests that the individual maintains a stable insulin regimen and proper control of his or her diabetes. The certified ME must receive the ITDM Assessment Form, MCSA-5870, no later than 45 days after the individual's TC has completed and signed it for each medical examination. Upon receipt of a valid form, the certified ME will perform an examination, consider the information provided by the TC, and determine whether the individual meets FMCSA's physical qualification standards to operate a CMV safely. If so, the certified ME may issue an MEC, MCSA-5876, for up to a maximum of 12 months.

The final rule requires that all ITDM individuals must provide to the TC at least the preceding 3 months of blood glucose self-monitoring records while being treated with insulin to be eligible for up to the maximum 12-month MEC, MCSA-5876. If an individual does not provide the 3 months of records, the certified ME has discretion to grant the individual up to but not more than a 3-month MEC, MCSA-5876, to allow time for the individual to collect the necessary records. Once the individual has 3 months of blood glucose self-monitoring records, the individual is treated the same as an ITDM individual with 3 months of records. The individual must first go to the TC for evaluation and then to the certified ME, who must exercise independent medical judgment, to determine if the individual is eligible for up to the maximum 12-month MEC, MCSA-5876.

If an ITDM individual has had a severe hypoglycemic episode, the individual is prohibited from operating a CMV and must report the episode to and be evaluated by a TC as soon as is reasonably practicable. The prohibition from operating a CMV continues until the ITDM individual has been evaluated by a TC and the TC determines that the cause of the severe hypoglycemic episode has been addressed and that the individual again has a stable insulin regimen and properly controlled ITDM. Once a TC completes a new ITDM Assessment Form, MCSA-5870, following the episode, the individual may resume operating a CMV. This rule defines a severe hypoglycemic episode as one requiring the assistance of others, or resulting in loss of consciousness, seizure, or coma.

ITDM individuals who have been diagnosed with severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy are disqualified permanently from operating a CMV in interstate commerce. These advanced stages of diabetic retinopathy present a serious risk to visual function, the safe operation of a CMV, and public safety.

The fewer than 100 ITDM individuals currently certified under the diabetes grandfather provision in § 391.64(a) will have 1 year after the effective date of this final rule to comply with the provisions of this rule. During that year, grandfathered individuals may elect to seek medical certification through the provisions of the final rule or § 391.64. However, 1 year after the effective date of this final rule, all grandfathered MECs, MCSA-5876, will become void. FMCSA anticipates that individuals certified previously under § 391.64(a) will find it advantageous to transition to certification under this rule as soon as possible because costs potentially may be reduced and the requirements of this rule are no more stringent than those of § 391.64(a).

FMCSA has determined that this rule will ensure that ITDM individuals can operate a CMV safely. This final rule also creates a clearer, equally effective, and more consistent framework to certify ITDM individuals than a program based entirely on granting exemptions under 49 U.S.C. 31315(b).

C. Benefits and Costs

This rule revises the FMCSRs to permit individuals with a stable insulin regimen and properly controlled ITDM to be qualified to operate CMVs in interstate commerce. Previously, ITDM individuals were prohibited from driving CMVs in interstate commerce unless they obtained an exemption from FMCSA. Revising the regulations will reduce the regulatory burden and result in a $6.21 million cost savings per year—the aggregate of cost savings to ITDM individuals, motor carriers that hire ITDM individuals, and FMCSA.

The notice of proposed rulemaking (NPRM) stage of this rulemaking action predates the January 30, 2017, Executive Order (E.O.) 13771 titled “Reducing Regulation and Controlling Regulatory Costs” (82 FR 9339, Feb. 3, 2017). As such, the analysis of this final rule introduces several changes necessary to clarify that the final rule will result in total costs less than zero. The Agency presents the following comparison of the NRPM and final rule analyses.

The Preliminary Regulatory Impact Analysis (RIA) published with the NPRM estimated that existing exemption holders would realize $0.76 million in cost savings attributable to the rule.

1

It also estimated there to be 209,664 ITDM individuals operating CMVs in interstate and intrastate commerce—a group that the NPRM estimated would incur costs ranging from $7.96 million to $23.90 million depending on the share of that group that would be medically qualified to receive an MEC, MCSA-5876.

2

That range of costs reflected

gross

compliance costs to those individuals; however, on a

relative

basis, the Agency estimated that compliance costs per individual under the proposed rule would decrease by $441 versus the cost to comply with the exemption program.

1

FMCSA Preliminary Regulatory Evaluation of Qualification of Drivers: Diabetes Standard Notice of Proposed Rulemaking, pp. 11-12, which is available in the docket for this rulemaking.

2

Id.

at 12-13.

By reducing compliance costs per ITDM individual, the rule is a deregulatory action both as proposed in the NPRM and again with this final rule. The Agency concludes that an ITDM individual not currently participating in the exemption program will bear the compliance costs of the final rule only if he or she considers the cost to comply to be equal to or lesser than his or her perceived cost of non-compliance. As a result, ITDM individuals not currently participating in the exemption program will incur no new net costs from this rule, while existing exemption holders will (in aggregate) receive a savings of $5.09 million in compliance costs per year. On a per-individual basis, the compliance cost of the final rule is less than the baseline ($332 versus $5,585) during the first year an ITDM individual comes into compliance and is 75.4 percent less than the baseline ($332 versus $1,350) in each year thereafter.

The Final RIA estimates a greater amount of cost savings than in the Preliminary RIA as a result of several changes and updates. First, the Final RIA accounts for new ITDM individuals' opportunity costs of income forgone, as well as corresponding motor carriers' opportunity costs of labor hours forgone, during the period FMCSA processes an exemption program application. These costs were not considered in the Preliminary RIA; the Agency made these changes during the development of the Final RIA in response to comments received on the NPRM. Second, the final analysis has

been adjusted to correct the number of endocrinologist visits per year required by the exemption program, as these visits were not fully accounted for in the Preliminary RIA. Third, the Final RIA updates inputs used to estimate the costs of the rule. Medical fees for the various healthcare professionals' services, driver wage and benefits values, and the population of drivers were updated using 2016 values.

Table 1 summarizes the key requirements of the exemption program and compares them to the final rule. These requirements are reflected in the cost estimates of the exemption program and the final rule.

Table 1—Requirements of the Exemption Program vs. the Final Rule

Exemption program (baseline)

Final rule

• The average processing time for a new exemption application is 77 days, during which applicants cannot drive CMVs in interstate commerce

3

• No exemption needed, therefore no processing wait time.

• Annual examination by a certified ME

• Annual examination by a certified ME.

• Annual vision examination performed by an optometrist or ophthalmologist for evidence of diabetic retinopathy (if retinopathy is present, an ophthalmologist report on stability of disease)

• No annual vision examination is required.

• No annual examination or quarterly evaluations by an endocrinologist are required.

• Annual examination by an endocrinologist and three quarterly visits

• Annual evaluation by the TC who completes an ITDM Assessment Form, MCSA-5870, that is provided to the certified ME.

As shown in Table 2,

the annualized cost of the baseline (the exemption program) is estimated at $8.02 million, while the annualized cost of the final rule is estimated at $1.67 million. The annualized cost savings of the rule are therefore $6.35 million, a 79 percent decrease. These cost savings are distributed among certain groups of ITDM individuals, motor carriers, and FMCSA.

3

The 77 days represents the average processing time for 3,674 exemption applications accepted between 2012 and 2016 in the exemption program database maintained by the contractor that assists FMCSA with the administration of the diabetes exemption program.

Table 2—Total Costs of the Final Rule

[Annualized in millions of 2016$]

Entities potentially impacted

Baseline cost

Final Rule cost

Total cost

Currently Compliant ITDM Individuals

$6.75

$1.66

($5.09)

Future Compliant ITDM Individuals

0.17

0.01

(0.16)

Non-Participating ITDM Individuals

0.00

0.00

0.00

Motor Carriers

0.07

0.00

(0.07)

FMCSA

1.03

0.00

(1.03)

Total

8.02

1.67

(6.35)

FMCSA estimates that currently compliant ITDM individuals (that is, individuals that currently have exemptions) will realize $5.09 million of annualized costs savings because of the rule. These ITDM individuals' costs to comply with the exemption program are estimated at $6.75 million, versus $1.66 million to comply with the final rule. This group of ITDM individuals consists of 3,945 FMCSA exemption holders and an estimated 930 ITDM individuals with intrastate commercial driver's licenses (CDLs) issued exemptions in accordance with State exemption programs.

The Agency estimates that the number of future compliant ITDM individuals that would obtain exemptions in the absence of the rule would increase annually by 27. Under the rule, the annualized cost savings realized by these 27 individuals are estimated at $0.16 million ($0.17 million to comply with the exemption program versus $0.01 million to comply with the final rule). The difference between the two cost estimates is due primarily to the elimination of the opportunity costs associated with the wait for FMCSA to process exemption program applications. Motor carriers are estimated to realize $0.07 million in cost savings due to the elimination of the application processing wait time.

As discussed earlier, ITDM individuals not currently participating in the exemption program (referred to as “Non-Participating ITDM Individuals” in Table 2) incur no new net costs from this rule.

Lastly, the rule will eliminate contractor costs that FMCSA incurs for the administration of the exemption program. The average cost of the remaining 3 option years of the contract is $1.03 million, which the Agency relies on to estimate FMCSA's annual cost savings resulting from the rule.

III. Abbreviations and Acronyms

AAFP American Academy of Family Physicians

AAPA American Academy of Physician Assistants

AAPA-OM American Academy of Physician Assistants in Occupational Medicine

ABA American Bus Association

ACOEM American College of Occupational and Environmental Medicine

ADA American Diabetes Association

Advocates Advocates for Highway and Auto Safety

ANPRM Advance Notice of Proposed Rulemaking

AOA American Optometric Association

APN Advanced Practice Nurse

ATA American Trucking Associations, Inc.

BLS Bureau of Labor Statistics

CAA Clean Air Act

CDC Centers for Disease Control and Prevention

CDL Commercial Driver's License

CE Categorical Exclusion

CFR Code of Federal Regulations

CMV Commercial Motor Vehicle

DC Doctor of Chiropractic

DO Doctor of Osteopathy

DOT Department of Transportation

E.O. Executive Order

FAA Federal Aviation Administration

FHWA Federal Highway Administration

FMCSA Federal Motor Carrier Safety Administration

FMCSRs Federal Motor Carrier Safety Regulations

FR Federal Register

HIPAA Health Insurance Portability and Accountability Act

H&SW Health and Safety Works, LLC

IBT International Brotherhood of Teamsters

ICR Information Collection Request

ITDM Insulin-Treated Diabetes Mellitus

LFC Licencia Federal de Conductor

MD Doctor of Medicine

ME Medical Examiner

MEC Medical Examiner's Certificate, MCSA-5876

MRB Medical Review Board

National Registry National Registry of Certified Medical Examiners

NEPA National Environmental Policy Act

NP Nurse Practitioner

NPRM Notice of Proposed Rulemaking

NTSB National Transportation Safety Board

OMB Office of Management and Budget

OOIDA Owner-Operator Independent Driver Association

PA Physician Assistant

PIA Privacy Impact Assessment

RIA Regulatory Impact Analysis

RN Registered Nurse

SAFETEA-LU Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users

§ Section symbol

SOCO Southern Company Entities

SORN System of Records Notice

TC Treating Clinician

TEA-21 Transportation Equity Act for the 21st Century

TFAC Truckers for a Cause

TTD Transportation Trades Department, AFL-CIO

U.S.C. United States Code

University of Utah University of Utah School of Medicine

UMA United Motorcoach Association

IV. Legal Basis for the Rulemaking

FMCSA has authority under 49 U.S.C. 31136(a) and 31502(b)—delegated to the Agency by 49 CFR 1.87(f) and (i), respectively—to establish minimum qualifications, including medical and physical qualifications, for individuals operating CMVs in interstate commerce. Section 31136(a)(3) requires specifically that the Agency's safety regulations ensure that the physical conditions of CMV drivers enable them to operate their vehicles safely and that certified MEs trained in physical and medical examination standards perform the physical examinations required of such operators.

Additionally, in 2005, Congress authorized the creation of the Medical Review Board (MRB) composed of experts “in a variety of medical specialties relevant to the driver fitness requirements” to provide medical advice and recommendations on qualification standards (49 U.S.C. 31149(a)). The position of Chief Medical Examiner was authorized at the same time (49 U.S.C. 31149(b)). Under section 31149(c)(1), the Agency, with the advice of the MRB and Chief Medical Examiner, is directed to “establish, review, and revise . . . medical standards for operators of commercial motor vehicles that will ensure that the physical condition of operators of commercial motor vehicles is adequate to enable them to operate the vehicles safely.” As discussed in the NPRM (80 FR 25260, May 4, 2015), the Agency asked the MRB to review and report on the current diabetes standard. More recently, the Agency directed the MRB to review and analyze all comments to the NPRM submitted from medical professionals and associations, and identify factors the Agency should consider in this rulemaking. The MRB's recommendations and the Agency's responses are described elsewhere in this final rule.

In addition to the statutory requirements specific to the physical qualifications of CMV drivers (49 U.S.C. 31136(a)(3)), FMCSA's regulations must also ensure that CMVs are maintained, equipped, loaded, and operated safely (49 U.S.C. 31136(a)(1)); that the responsibilities imposed on CMV drivers do not impair their ability to operate the vehicles safely (49 U.S.C. 31136(a)(2)); that the operation of CMVs does not have a deleterious effect on the physical condition of the drivers (49 U.S.C. 31136(a)(4)); and that drivers are not coerced by motor carriers, shippers, receivers, or transportation intermediaries to operate a vehicle in violation of a regulation promulgated under 49 U.S.C. 31136 (which is the basis for much of the FMCSRs), 49 U.S.C. chapter 51 (which authorizes the hazardous materials regulations), or 49 U.S.C. chapter 313 (which is the authority for the CDL regulations and the related drug and alcohol testing requirements) (49 U.S.C. 31136(a)(5)).

This rule is based primarily on 49 U.S.C. 31136(a)(3) and 31149(c) and does not concern the requirements in 49 U.S.C. 31136(a)(1), (2), or (4). FMCSA believes that coercion of drivers with ITDM to violate the current rule preventing them from operating in interstate commerce, which is prohibited by 49 U.S.C. 31136(a)(5), does not and will not occur. On the contrary, motor carriers have been reluctant generally to employ such drivers at all. The original exemption program developed in the 1990s by the Federal Highway Administration (FHWA) and FMCSA's subsequent program under 49 U.S.C. 31315(b) allowed selected ITDM individuals to drive legally for the first time, while also generating data showing that their safety records were at least as good as those of all other drivers.

Section 4129 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) (Pub. L. 109-59, 119 Stat. 1144, 1742, Aug. 10, 2005), in paragraphs (a) through (c), directed the Agency to relax certain requirements of its exemption program for ITDM individuals. Paragraph (d) of section 4129 provides that ITDM individuals may not be held by the Secretary of Transportation to a higher standard of physical qualification to operate a CMV in interstate commerce than other individuals applying to operate, or operating, a CMV in interstate commerce; except to the extent that limited operating, monitoring, and medical requirements are deemed medically necessary under regulations issued by the Secretary. FMCSA has determined that this final rule satisfies the purposes of section 4129(d) by imposing appropriate requirements on such individuals as contemplated by that provision and maintaining current levels of highway safety.

Finally, prior to prescribing any regulations, FMCSA must consider their “costs and benefits” (49 U.S.C. 31136(c)(2)(A) and 31502(d)). Those factors are discussed in the Regulatory Analyses section of this final rule.

V. Background

A. Brief History of Physical Qualification Standards for CMV Drivers With ITDM

In 1939, one of FMCSA's predecessors recommended that CMV drivers have urine glucose tests as part of medical examinations for determining whether they were physically qualified to drive CMVs in interstate or foreign commerce (4 FR 2296, June 7, 1939). That recommendation remained in effect from January 1, 1940, until a replacement standard established by FHWA went into effect on January 1, 1971. In 1970, FHWA established the current standard for ITDM individuals (35 FR 6463, 6464, April 22, 1970), which also includes testing urine for glucose. That standard states that a “person is physically qualified to drive a commercial motor vehicle if that person . . . [h]as no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control” (49 CFR 391.41(b)(3)). Beginning in 1993, however, CMV drivers with ITDM had the opportunity to apply to FHWA for a waiver (57 FR 40690, July 29, 1993), until a 1994 Federal court decision invalidated the

waiver program.

See Advocates for Highway and Auto Safety

v.

FHWA,

28 F.3d 1288 (D.C. Cir. 1994).

In 1998, section 4018 of the Transportation Equity Act for the 21st Century (TEA-21) (Pub. L. 105-178, 112 Stat. 107, 413, June 9, 1998 (set out as a note to 49 U.S.C. 31305)) directed the Secretary to determine the feasibility of developing “a practicable and cost-effective screening, operating, and monitoring protocol” for allowing ITDM individuals to operate CMVs in interstate commerce. This protocol “would ensure a level of safety equal to or greater than that achieved with the current prohibition on individuals with insulin treated diabetes mellitus driving such vehicles” (section 4018(a)).

As also directed by section 4018, FHWA compiled and evaluated the available research and information. It assembled a panel of medical experts in the treatment of diabetes to investigate and report on issues concerned with the treatment, medical screening, and monitoring of ITDM individuals in the context of operating CMVs. In July 2000, FMCSA submitted a report to Congress titled, “A Report to Congress on the Feasibility of a Program to Qualify Individuals with Insulin Treated Diabetes Mellitus to Operate Commercial Motor Vehicles in Interstate Commerce as Directed by the Transportation Equity Act for the 21st Century” (TEA-21 Report to Congress). This report concluded that it was feasible to establish a safe and practicable protocol containing three components allowing some ITDM individuals to operate CMVs. The three components were as follows: (1) Screening of qualified commercial drivers with ITDM; (2) establishing operational requirements to ensure proper disease management by such drivers; and (3) monitoring safe driving behavior and proper disease management.

On July 31, 2001, as a result of the conclusions found in the TEA-21 Report to Congress, FMCSA published a notice proposing to issue exemptions from the FMCSRs allowing ITDM individuals to operate CMVs in interstate commerce (66 FR 39548). After receiving and considering comments, FMCSA issued a notice of final disposition (“2003 Notice”) establishing the procedures and protocols for implementing the exemptions for ITDM individuals (68 FR 52441, Sept. 3, 2003). In conformity with the conclusions of the TEA-21 Report to Congress, the 2003 Notice implemented the three protocol components recommended in the report, with a few modifications. Beginning in 2003, ITDM individuals could apply to FMCSA for an exemption from the prohibition of operating CMVs in interstate commerce.

B. Exemption Program

FMCSA administers an exemption program for ITDM individuals who wish to become qualified or maintain their physical qualifications as CMV drivers. The Agency administers this exemption program under 49 CFR part 381, subpart C, according to directives in the 2003 Notice and a notice of revised final disposition published in 2005 (70 FR 67777, Nov. 8, 2005).

To apply for an exemption under the program administered by FMCSA, the individual must submit a letter application with medical documentation showing the following:

4

4

The requirements to apply for and maintain an exemption are not exhaustive.

(1) The ITDM individual has been examined by a board-certified or board-eligible endocrinologist who has (i) conducted a comprehensive evaluation including one glycosylated hemoglobin test (HbA1C) with a result within a range of 7 to 10 percent, inclusive,

5

and (ii) signed a statement regarding his or her determinations;

5

FMCSA subsequently removed the requirement to include one HbA1C result on the application itself.

(2) The ITDM individual has obtained a signed statement from an ophthalmologist or optometrist indicating that the individual has been examined, has no unstable proliferative diabetic retinopathy, and meets the vision standard in § 391.41(b)(10); and

(3) The ITDM individual has obtained a signed copy of both a certified ME's Medical Examination Report Form, MCSA-5875, and an MEC, MCSA-5876, showing that the individual meets all physical qualification standards in § 391.41(b) other than the diabetes standard.

FMCSA does not conduct medical examinations of any individuals in the exemption program. Instead, it makes its decision whether to grant the exemption based on individual applications and supporting documentation from healthcare professionals. FMCSA cannot grant an exemption unless it is likely that a level of safety would be achieved that is equivalent to, or greater than, the level that would be achieved without the exemption (49 U.S.C. 31315(b) and 49 CFR 381.305(a)).

Before granting a request for an exemption, FMCSA must publish a notice in the

Federal Register

. The notice explains a request has been filed and provides the public an opportunity to inspect the safety analysis, and any other relevant information known to the Agency, and to comment on the request. The notice must identify: The individual who will receive the exemption; the provision(s) from which the individual will be exempted; the effective period; and all terms and conditions of the exemption. After the conclusion of the comment period, FMCSA must publish a notice of its decision to approve or deny the request.

Once approved, to maintain an exemption, the driver must:

(1) Have annual medical recertification by a certified ME;

(2) Have quarterly evaluations by an endocrinologist;

(3) Have annual comprehensive medical evaluations by an endocrinologist;

(4) Have annual vision evaluations that confirm there is no evidence of unstable proliferative diabetic retinopathy and the driver meets the vision standard for CMV drivers;

(5) Maintain appropriate medical supplies for glucose management, including a monitor, insulin, and an amount of rapidly-absorbable glucose, in the vehicle to be used as necessary;

(6) Follow a protocol to monitor and maintain blood glucose levels; and

(7) Report to the Agency all episodes of severe hypoglycemia, any significant complications relating to diabetes, the inability to manage his or her diabetes, and any involvement in a crash or other adverse event.

A driver must reapply for an exemption every 2 years. FMCSA may revoke an exemption immediately under standards established in § 381.330.

C. May 4, 2015, NPRM: Qualifications of Drivers; Diabetes Standard

In the May 2015 NPRM, FMCSA proposed to amend its physical qualification standards in § 391.41 to allow ITDM individuals to operate CMVs (80 FR 25272). Proposed paragraph (b)(3) provided that an individual was physically qualified to drive a CMV either by having no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control, or by meeting the requirements in new § 391.46.

The NPRM also proposed to reorganize § 391.45, which provides when individuals must be medically examined and certified, and to add a new paragraph (e). That proposed paragraph required any ITDM individual who had been qualified for an MEC, MCSA-5876, under the standards in § 391.46 to be medically examined and certified as qualified to drive at least every 12 months.

Proposed § 391.46 provided that an ITDM individual was physically qualified to operate a CMV if the individual otherwise met the physical qualification standards in § 391.41, or had the exemption or skill performance evaluation certificate, if required, and had the medical evaluations required by § 391.46.

Prior to the annual or more frequent examination by a certified ME, the ITDM individual would have to be evaluated by the TC. The TC was defined in the proposed rule as a physician or health care professional who manages and prescribes insulin for the treatment of individuals with diabetes mellitus. The TC would have to determine that within the previous 12 months the individual: Had no severe hypoglycemic reaction resulting in a loss of consciousness or seizure, or requiring the assistance of another person, or resulting in impaired cognitive function; and had properly managed his or her diabetes. During the period of medical certification, the individual was required to monitor and maintain blood glucose records as determined by the TC and submit those blood glucose records to the TC at the time of the evaluation.

At least annually, the ITDM individual would have to be medically examined and certified by a certified ME as physically qualified in accordance with § 391.43 and as free of complications that might impair the individual's ability to operate a CMV. The certified ME would be required to obtain written notification from the individual's TC that the individual's diabetes was being properly managed. The certified ME also would have to evaluate whether the individual was physically qualified to operate a CMV.

Although not part of the proposed regulation, FMCSA requested comments on whether it should prohibit drivers with ITDM from being medically qualified to operate CMVs carrying passengers and hazardous materials, and whether removing the grandfather provision would affect any driver adversely who is operating currently under § 391.64. Finally, the Agency also requested comment on the need for an ITDM individual to be examined by an optometrist or ophthalmologist as a condition of passing the medical examination.

D. September 9, 2016, Notice of Availability; Request for Comments: Medical Review Board Task Report on Insulin-Treated Diabetes Mellitus and Commercial Motor Vehicle Drivers

The NPRM's comment period closed on July 6, 2015. In that same month, FMCSA directed the MRB to review and analyze all comments to the NPRM from medical professionals and associations, and to identify factors the Agency should consider when making decisions about the next steps in the diabetes rulemaking (MRB Task 15-1). In response, the Agency received MRB Task 15-1 Report (2015 MRB report) dated September 1, 2015. FMCSA published a

Federal Register

notice on September 9, 2016, announcing the availability of the 2015 MRB report and requesting comments on the MRB recommendations (81 FR 62448). The MRB's recommendations are considered in the Discussion of Comments and Responses section below. The full report is available in the docket for this rulemaking, in addition to being available on the Agency's website at

https://www.fmcsa.dot.gov/advisory-committees/mrb/mrb-task-15-01-report.

E. July 27, 2017, Notice and Request for Comments: Agency Information Collection Activities; Information Collection Revision Request—Medical Qualification Requirements, OMB Control Number 2126-0006 (Proposed ITDM Assessment Form)

On July 27, 2017, FMCSA published a 60-day notice announcing that it was considering submitting an Information Collection Request (ICR) to OMB for its review and approval (82 FR 35041). In anticipation of this final rule, the notice invited public comment on a revision to an information collection titled

Medical Qualification Requirements,

covered by OMB Control Number 2126-0006, which is currently due to expire on August 31, 2018. Based on the MRB's 2015 analysis of the comments and its recommendations, as well as public comments to the NPRM, FMCSA announced that it was considering replacing the previously proposed written notification from the TC with the ITDM Assessment Form. The form would be completed by the TC and provided to the certified ME. The 60-day notice, draft supporting statement, and proposed form are available in the docket for this rulemaking. The comment period closed on September 25, 2017. The comments are addressed in the Discussion of Comments and Responses section below.

VI. Discussion of Comments and Responses

A. Comment Overview

In this rule, FMCSA responds to public comments to the following

Federal Register

documents.

NPRM:

In response to the May 2015 NPRM (80 FR 25260), FMCSA received 1,281 submissions between May 4, 2015, and February 16, 2016.

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Based on a review of those submissions, 114 submissions were identified as non-germane and four submissions were duplicates. Almost all commenters expressed general support for the proposed rule, though many asked for more detail about the proposal. These commenters include CMV drivers, individuals diagnosed with diabetes, relatives of individuals diagnosed with diabetes, diabetes educators, health care professionals, and medical associations. General opposition to the proposed rule cited a risk to public safety as the basis for opposition contending that insulin-controlled diabetes is not a condition well-suited to the demands of operating CMVs. These commenters included two individuals diagnosed with diabetes, a physician, and a diabetes educator. Of the generally-supportive submissions, 561 were form letters. The common reasons cited for general support of the proposal include the following: It would treat ITDM individuals fairly by assessing how diabetes affects each individual rather than focusing on the diagnosis of diabetes or use of insulin alone; it would simplify the qualification procedures for ITDM CMV drivers and focus on their operational safety by requiring that they be evaluated by healthcare professionals; it would improve safety by encouraging ITDM CMV drivers to properly manage their condition rather than to hide it in an effort to keep their jobs; and this action would enable CMV drivers newly diagnosed with ITDM to keep their jobs and encourage more individuals to enter the workforce, thereby reducing the driver shortage.

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FMCSA stated in the NPRM, at 80 FR 25261, that it would not respond to comments made in response to the March 17, 2006, advance notice of proposed rulemaking (ANPRM) (71 FR 13801). The Agency requested that commenters reference any previous relevant comments in their comments to the NPRM. Therefore, this final rule does not respond to the comments submitted in response to the ANPRM.

Approximately a dozen commenters expressed general opposition to the proposed diabetes standard. Most of these commenters cited the risk to public safety for their opposition to the proposed rule and contended that insulin-controlled diabetes is not a condition well-suited to the demands of operating CMVs.

2015 MRB Report:

In response to the September 2016 notice of availability and request for comments on the 2015 MRB report (81 FR 62448), FMCSA received 41 comments, one of which was a duplicate. Commenters focused

on specific recommendations within the 2015 MRB report.

ITDM Assessment Form:

In response to the request for comments on the ICR and the ITDM Assessment Form (82 FR 35041), FMCSA received 44 comments. Rather than providing substantive comments on the content or structure of the ITDM Assessment Form, 39 commenters discussed the issue of allowing ITDM individuals to operate CMVs. None of these commenters presented new issues that were not raised in the comments submitted in response to the NPRM or the 2015 MRB report. Five substantive comments related to the ITDM Assessment Form are discussed in the appropriate section below (TC Written Notification (ITDM Assessment Form)).

B. Qualifications of a Certified ME To Examine an ITDM Individual

NPRM:

FMCSA proposed that ITDM individuals be medically examined and certified by a certified ME listed on the National Registry as provided in § 391.43.

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The Agency notes that the categories of healthcare professionals eligible to be listed on the National Registry are advanced practice nurses (APNs), doctors of chiropractic (DCs), doctors of medicine (MDs), doctors of osteopathy (DOs), physician assistants (PAs), and other healthcare professionals authorized by applicable State laws and regulations to perform physical examinations (49 CFR 390.103). APNs, also referred to as advanced practice registered nurses (APRNs), are registered nurses (RNs) educated at the masters or post masters level who have passed a national certification test in a specific role and patient population. The types of APNs are certified nurse practitioners (CNPs or NPs), clinical nurse specialists (CNSs), certified registered nurse anesthetists (CRNAs), and certified nurse-midwifes (CNMs).

See https://www.ncsbn.org/aprn.htm

(Accessed May 25, 2018).

Comments on the Qualifications of a Certified ME to Examine an ITDM Individual:

Both the American Academy of Physician Assistants (AAPA) and the American Academy of Physician Assistants in Occupational Medicine (AAPA-OM) supported FMCSA's proposal and noted that PAs are qualified to examine and certify any individual who operates a CMV. These commenters stated that the certified ME does not need to be a specialist to examine an individual.

The National Transportation Safety Board (NTSB) noted that some certified MEs have no experience prescribing medications or managing the effects of insulin; thus, they would have to accept the TC's assessment without further evaluation. The American College of Occupational and Environmental Medicine (ACOEM) stated the certified ME should be an MD or DO experienced with the treatment and evaluation of diabetes and diabetes treated with insulin to medically qualify individuals using insulin; therefore, there should be designated certified MEs who review and medically qualify individuals using insulin. The ACOEM stated further that some certified MEs are making certification determinations pertaining to individuals with medical conditions that they are unable to independently diagnose or treat.

A number of commenters stated that the certified ME should be a physician (either an MD or DO) or have other professional qualifications. For example, individuals who identified themselves as the first five members appointed to the MRB (herein after “former MRB members”)

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wrote in their comment that there are now thousands of certified MEs who have no significant medical training. These former MRB members also stated that the primary care and tertiary care providers for individuals with diabetes often do not understand the specific demands on CMV drivers. Based on these considerations, the former MRB members wrote that FMCSA cannot meet the statutory requirement under 49 U.S.C. 31136(a)(3) for periodic physical examinations of individuals by having the TC work in conjunction with the certified ME.

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The Agency notes that the comments expressed by the former MRB members in their letter were received in the docket in response to the Agency's request for public comments.

Unless TCs are required to have appropriate additional training, experience, and certification, Truckers for a Cause (TFAC) suggested that FMCSA require that ITDM individuals get their MECs, MCSA-5876, from a certified ME who is an MD, DO, NP, or PA. TFAC was concerned that not all certified MEs,

e.g.,

DCs, will have the medical expertise to evaluate the information from a TC. TFAC wrote that in some States, for example Illinois, it would be a violation of State law for a DC to render an expert medical opinion on an individual meeting a diabetes treatment requirement. An individual commenter wanted to delay a rulemaking until there is assurance that the certified MEs can safely screen ITDM individuals.

2015 MRB Report:

The 2015 MRB report did not change the qualifications of certified MEs for conducting medical certification examinations on ITDM individuals.

Comments on the MRB Report Regarding the Qualifications of a Certified ME:

The University of Utah School of Medicine (University of Utah) stated that, unless the form proposed by the MRB clearly specifies what the outcome of a particular response is, the only alternative is to have diabetes examinations done by those with medical backgrounds, which is “particularly mandatory because of the large number of non-medically trained examiners.” An NP who is a certified ME hoped that NPs and PAs certified in primary care and experienced in managing patients with ITDM would not be excluded from certifying ITDM individuals. The NP stated that numerous studies have demonstrated that APNs in primary care settings perform as well as physicians in terms of clinical outcomes and patient satisfaction. The ACOEM stated that the certified ME must have the training and knowledge to evaluate whether the documentation provided is sufficient. Concentra commented that certified MEs who are not licensed to prescribe insulin should not be allowed to certify an individual with ITDM.

FMCSA Response:

In this final rule, the Agency continues to provide that ITDM individuals may be examined and medically certified by any certified ME on the National Registry. As such, the categories of healthcare professionals eligible to become certified MEs remain unchanged from when the National Registry was established (77 FR 24104; April 20, 2012). All certified MEs are required to be licensed, registered, or certified by their States to perform physical examinations. FMCSA will continue to rely on State determinations regarding which categories of healthcare professionals have sufficient education and training to qualify them to perform physical examinations.

To become a certified ME and be listed on the National Registry, healthcare professionals are required to receive training on the Agency's physical qualification standards and the demands of driving a CMV, complete a certification test, and receive a certificate evidencing that they are qualified to perform medical certification examinations and determine who is qualified to safely operate a CMV. A State has found certified MEs to possess sufficient medical training to perform a physical examination and the Agency has found them to be proficient in the use of the medical protocols necessary to perform the medical certification examination in accordance with the FMCSRs. As such, the Agency's certified MEs have a significant training on performing medical certification examinations. Moreover, the National Registry allows FMCSA to monitor and audit certified MEs and to provide periodic training to its certified MEs.

The current categories of certified MEs have been evaluating individuals with diabetes and have been making qualification determinations based on the existing physical qualification standards in § 391.41(b) for many years. In addition, conditions that may result from complications of diabetes may also result from medical conditions other than diabetes. The Agency has no data that suggests MEs have had difficulty applying the physical qualification standards to individuals with diabetes or to any specific conditions. If a certified ME encounters a condition that is outside his or her scope of practice or requires evaluation by a specialist, FMCSA expects the certified ME to make any appropriate referral and to confer with the specialist as necessary.

FMCSA emphasizes that the role of the certified ME is to conduct a medical certification examination to determine if the individual meets the physical qualification standards and to evaluate the safety impact of any medical conditions; it is not to diagnose or treat individuals. As such, FMCSA has concluded that it is not necessary for a certified ME to be licensed or certified to diagnose and treat every condition that is addressed by the physical qualifications standards. FMCSA has no data that suggests that this longstanding conclusion is flawed.

The Agency has determined that its certified MEs are qualified to examine and medically certify that ITDM individuals are physically qualified to drive a CMV in accordance with § 391.43 and new § 391.46, and are free of complications that may impair an individual's ability to safely operate a CMV. The Agency finds that this medical certification approach through certified MEs is consistent with congressional intent to have certified MEs make an individualized assessment of an individual's health status and ability to safely operate a CMV.

C. Definition and Qualifications of a TC

NPRM:

The NPRM defined a TC as a physician or healthcare professional who manages and prescribes insulin for the treatment of diabetes mellitus.

Comments on the Definition and Qualifications of a TC:

Because of the TC's personal knowledge of the driver's medical history and condition, both the Illinois Office of the Secretary of State and the Owner-Operator Independent Driver Association (OOIDA) stated that the TC would be able to make an accurate determination of a driver's condition. The Illinois Office of the Secretary of State agreed with FMCSA's proposal to use the TC, working with a certified ME to complete the physical examination of drivers.

Some commenters, including AAPA, AAPA-OM, and TFAC, stated that a TC should be a physician, PA, or NP who manages and prescribes insulin for the treatment of individuals with diabetes mellitus. AAPA and AAPA-OM noted these represent the three types of healthcare professionals in the United States who provide primary medical care. In rural and other medically-underserved communities, a PA may be the only healthcare professional.

The AAPA-OM noted further that PAs are trained in primary care and complete board certification every 10 years in primary care. The AAPA-OM commented that PAs have been treating patients with complicated medical conditions for over 40 years and should be allowed to continue the evaluations of commercial drivers with ITDM.

The American Trucking Associations, Inc. (ATA) requested that FMCSA further define the term TC to reduce ambiguity and ensure the person making the recommendation is properly certified and knowledgeable about ITDM. Health & Safety Works, LLC (H&SW) was concerned FMCSA did not address drivers who receive insulin without a prescription and therefore would not have a TC. This commenter recommended FMCSA should state that “anyone without a prescription or a treating clinician may not be qualified to operate a CMV in interstate commerce.”

Some commenters agreed with FMCSA that TCs do not need to be licensed physicians or specialists in diabetes treatment and management, but could be other types of healthcare professionals. Commenters, including the ATA, the American Diabetes Association (ADA), the International Brotherhood of Teamsters (IBT), and TFAC, supported allowing the certified ME to consult with the TC instead of requiring approval from an endocrinologist, noting that driver access to board-certified endocrinologists may be limited. The IBT wrote that the TC, rather than an endocrinologist, would be a more suitable medical provider to monitor any of the progressive conditions associated with diabetes (

e.g.,

nerve damage to the extremities and diabetic retinopathy).

The American Academy of Family Physicians (AAFP) urged FMCSA to allow applicants to be examined by their family physicians, rather than endocrinologists. This commenter noted that not all applicants have access to an endocrinologist, and the family physician is more than capable of managing and treating patients with diabetes, as well as completing the forms needed by CMV drivers.

Some commenters, including the American Bus Association (ABA), two diabetes educators, a physician, an NP, and the Southern Company Entities (SOCO), disagreed with the proposal and wanted ITDM individuals to continue to be evaluated by endocrinologists. While ABA appreciated the interest in simplifying the process or putting fewer restrictions on the medical professionals available to drivers with ITDM, it could not support this proposed provision because in its opinion endocrinologists are the best qualified individuals to be engaged in the process. SOCO would require a note from the treating physician with a specialty in diabetes, such as an endocrinologist, who is also familiar with the essential job functions of a commercial driver. The note would document that the driver is stable and not experiencing hypoglycemic episodes.

The NP objected to removing an endocrinologist from the process of certifying drivers with ITDM because it significantly limits objective, specialized medical assessment of the disease. This commenter indicated that primary care providers are sometimes too lenient.

While they did not indicate that evaluation by an endocrinologist is necessary, some commenters stated that the TC should be a licensed physician or other medical professional with appropriate training. In order to address sufficient training in diabetes, the complications of diabetes, and interactions among diabetic medications, the former MRB members stated that an MD or DO should, at a minimum, oversee a mid-level provider and this physician should countersign the forms approving the ITDM driver as safe to drive. An RN stated that drivers should be followed by a primary care physician. A physician commented that a diabetologist—not an endocrinologist—should evaluate patients for safety because they are better equipped to determine whether a patient with type 1 diabetes might be a low-risk driver. Advocates for Highway and Auto Safety (Advocates) stated that the Agency should require the TC to be a physician and establish penalties for both drivers and TCs who submit falsified reports, specifically concerning diabetes management and severe hypoglycemic reactions.

The ADA agreed that requiring a specialist to perform evaluations of drivers with ITDM is unnecessary. It stated that internists or primary care

physicians—not endocrinologists—treat many individuals with diabetes and that there are parts of the country where no endocrinologists are available. The ADA commented that the important qualification is that the TC must have knowledge of the disease and treatment regimens in order to assess an individual's diabetes management and determine whether CMV operation is safe and practicable in accordance with the revised standard and accompanying diabetes guidelines.

TFAC agreed that requiring an evaluation by a board-certified endocrinologist places an undue burden on a driver, due to the lack of these specialists nationwide. However, TFAC did not think that FMCSA's qualifications for a TC specified enough medical training and certification to evaluate properly a CMV operator with ITDM. TFAC recommended that the TC have completed appropriate additional training and have the experience to hold a certification in Advanced Diabetes Care and Management.

A physician wrote that FMCSA is putting the TC, whose duty is to his or her patient, in the position of losing patients who will doctor shop until they find a TC to sign off on their condition.

2015 MRB Report:

The 2015 MRB report recommended that a TC be defined as the MD, DO, NP, or PA who prescribes insulin to the driver and is knowledgeable regarding the treatment of diabetes.

Comments on the MRB's Report on the Definition and Qualifications of a TC:

The AAPA stated that allowing PAs who have clinical experience with diabetes to act as TCs will ensure that drivers who are under the care of a PA can remain in compliance with FMCSA regulations, while continuing to see their current healthcare provider. It commented that this is particularly important in medically-underserved areas, where there may be less access to specialists. The AAPA described the breadth of PA education, testing, and experience, particularly as it applies to diabetes.

OOIDA agreed that letting an MD, DO, NP, or PA who has prescribed insulin to the driver perform the assessment will provide a better way to determine if the driver's condition is well-controlled. It would reduce the costs and treatment delays caused by the requirement for an evaluation by a board-certified or board-eligible endocrinologist.

A certified ME, who is an NP, commented that there is a shortage of MD and DO primary care providers in her region; therefore, the use of NPs and PAs improves access to needed care. She also stated that access to endocrinologists is limited in her area, so most ITDM individuals are managed by their primary care providers.

The ADA stated that an appropriate TC, including endocrinologists, physicians, PAs, NPs, and diabetes educators, is one who is knowledgeable and experienced in the management of diabetes, not necessarily a specialist.

A driver, a certified ME, and SOCO stated that a TC, as defined by the MRB, is not qualified to properly assess drivers with ITDM. These commenters indicated that only an endocrinologist should assess such drivers. The certified ME stated that the rulemaking will increase the burden on the certified ME and affect the certified ME's willingness to accept a “clinician” statement about a driver's control of diabetes mellitus.

H&SW, the University of Utah, AAFP, Concentra, and an individual were not satisfied with the definition and qualifications of a TC in the 2015 MRB report and indicated that the TC should meet additional requirements. Some commenters stated that many TCs are not familiar with the requirements of commercial driving. For example, H&SW noted that the total reliance on the TC to evaluate a driver's management of his or her diabetes was a flaw in the proposal. H&SW pointed out that FMCSA has no authority over the TC. It did not agree that the Agency should assign responsibility to the TC, who is not certified to perform CMV physical examinations.

The University of Utah wanted the TC to have knowledge of at least 3 years of the driver's treatment—either through direct knowledge or from medical records. The commenter added that there also had to be a mechanism to stop drivers with ITDM from doctor shopping for a favorable opinion. Concentra stated that the TC should have treated the driver for the preceding 12 months, so the TC can attest to the lack of hypoglycemic reactions and to the driver having properly managed the diabetes.

While the AAFP urged FMCSA to allow drivers to be examined by their primary care physicians, rather than to require examination by an endocrinologist, it asked FMCSA to allow only a DO or MD to perform these services. Both Concentra and the individual indicated that the non-physician healthcare professional should qualify as a TC only if under the supervision of an endocrinologist or other physician.

The individual commenter warned that the TC must be held to high standards, and any TC who submitted a falsified or disingenuous report should be penalized. This commenter also wrote that FMCSA should require the TC to notify the Agency if the driver becomes noncompliant or if the driver discharges the TC.

FMCSA Response:

The final rule does not limit the TC to a specific discipline or require the TC to be an endocrinologist. The Agency agrees with commenters who stated that an appropriate TC is one who is knowledgeable and experienced in the management of diabetes and is not necessarily a specialist.

FMCSA defines the TC in the final rule as a healthcare professional who manages, and prescribes insulin for, the treatment of the individual's diabetes mellitus as authorized by the healthcare professional's State licensing authority. The final rule establishes that the ITDM individual must have a prescription from his or her TC for treatment with insulin. FMCSA adds this requirement because prescriptive authority for some healthcare disciplines may be limited by the State's scope of practice. This requirement ensures that the healthcare professional who routinely treats the ITDM individual is the one who prescribes the individual's insulin for treatment.

The Agency declines to specify disciplines that may serve as the TC for purposes of this rulemaking due to the differences in scopes of practice among States. Some areas of the country may be underserved in some disciplines and have greater access to other disciplines. FMCSA finds that identifying specific disciplines disadvantages individuals who may not have access to those healthcare professionals. The Agency's definition allows for maximum flexibility in addressing issues related to shortages in various categories of licensed healthcare professionals in all States.

FMCSA agrees with the commenters who stated that requiring evaluation by an endocrinologist is burdensome to ITDM individuals seeking certification because of the scarcity of endocrinologists in many regions of our country. A June 2014 Endocrine Society white paper states that there were approximately 4,841 adult endocrinologists engaged in clinical practice in 2011, and it projected a shortage of 1,484 adult endocrinologists by 2015.

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The paper also shows that 85 percent of office visits for diabetes were with physicians other than

endocrinologists.

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As stated in the NPRM, a requirement to be evaluated by an endocrinologist seems impracticable for most drivers with ITDM (80 FR 25266). The frequent monitoring by a specialist as required by the exemption program was a financial burden for many individuals, many of whom have primary care providers who are capable of prescribing and managing insulin treatment for their patients. The Agency has concluded that the higher cost of an endocrinologist evaluation is not justified given that a TC can determine that the individual has a stable insulin regimen and properly controlled ITDM.

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“Endocrine Clinical Workforce: Supply and Demand Projections” prepared for the Endocrine Society by the Lewin Group, 2014, pp. 1-2. Available at

https://www.endocrine.org/~/media/endosociety/files/advocacy-and-outreach/important-documents/white-paper-endocrinology-workforce-final-white-paper.pdf

(May 25, 2018).

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Id.

at 40.

The requirement that the TC must be the healthcare professional who manages, and prescribes insulin for, the treatment of the individual who is being evaluated makes it likely that the TC will be the individual's primary care provider. As the commenters indicate, primary care providers are well trained and experienced in managing diabetes and provide most care for diabetes in many areas. As such, FMCSA is not requiring that a qualified TC hold any specific certification or have any specialized training with respect to diabetes. The Agency agrees with commenters that TCs who have personal knowledge of an individual's medical history and treatment regimens will be able to make an accurate determination as to whether an individual maintains a stable insulin regimen and proper control of his or her ITDM. As such TCs managing, and prescribing insulin for, the treatment of ITDM individuals are well-suited to monitor for complications related to diabetes. FMCSA is confident that when necessary, TCs will refer the ITDM individual to appropriate specialists for any additional medical evaluations for diabetes-related co-morbid conditions requiring specialized diagnosis and treatment.

FMCSA anticipates that the TC would have an ongoing relationship with the individual being evaluated, but is not requiring that the TC treat the individual for any specific period. If the TC is newly establishing a relationship with an individual seeking evaluation, the TC may exercise his or her independent medical judgment with respect to the need to obtain and review prior medical records and whether the TC has sufficient information to complete the ITDM Assessment Form, MCSA-5870, and to attest the information provided is true and correct to the best of the TC's knowledge. Similarly, FMCSA declines to require the TC to notify the Agency if a driver becomes noncompliant or discharges the TC. The need to obtain the required information from a TC who is prescribing insulin for the treatment of the individual's ITDM should discourage noncompliance and doctor shopping for a favorable attestation.

FMCSA emphasizes that it is not relying on the TCs to make the medical qualification determination. FMCSA is implementing the ITDM Assessment Form, MCSA-5870, as recommended by the 2015 MRB report, that asks specific questions of the TC and provides information needed for medical certification determinations by the certified ME. Evaluation by the TC in this collaborative manner is consistent with current certified ME practice during the medical certification process. Certified MEs confer routinely with and obtain the treating providers' opinions concerning the stability of individuals' underlying medical conditions and how the medical conditions may impact safety. This process minimizes the concern that TCs who are primary care providers may be lenient because certified MEs make the determination regarding physical qualification.

D. Role and Relationship of the TC and Certified ME

NPRM:

FMCSA proposed that, prior to the annual or more frequent examination by the certified ME, the ITDM individual would have to be evaluated by the TC. The TC would determine that within the previous 12 months the individual had no severe hypoglycemic reaction and had properly managed his or her diabetes. The certified ME had to obtain written notification from the individual's TC that the individual's diabetes was being properly managed and had to evaluate whether the individual was physically qualified to operate a CMV.

Comments on the Role and Relationship of the TC and Certified ME:

The IBT supported the Agency's proposal. It stated that, although the TC may not be thoroughly familiar with FMCSA regulations or tasks performed by a CMV driver, subsequent evaluation by a certified ME would complement the role of the TC in the certification process. The ADA noted that the NPRM had not made completely clear the role of the certified ME in evaluating the applicant's diabetes. However, the ADA supported a two‐step certification process where the TC certifies that the individual with ITDM meets the revised diabetes standard and the certified ME completes the certification process with regard to all other aspects not related to diabetes. If the certified ME had concerns about an individual's diabetes, the ADA recommended that the certified ME should consult the TC or an independent diabetes healthcare professional for verification.

A number of commenters wanted certified MEs and TCs to work directly together. For example, given that certified MEs are ultimately responsible for certifying individuals, the Transportation Trades Department, AFL-CIO (TTD) and the Amalgamated Transit Union wanted FMCSA to encourage certified MEs and TCs to work closely together so that fit individuals may work.

The ACOEM added that allowing the certified ME, who has the training and understanding of the role of the CMV operator, to obtain and review additional medical information would increase the margin of safety in the determination, while lessening the certified ME's liability in relying on a TC who might not fully understand the safety concern. The ACOEM commented that FMCSA should require the TC to sign a statement saying that the ITDM individual can manage his or her health condition.

A physician/certified ME, who is also board-certified in occupational medicine, questioned the value of having certified MEs for ITDM individuals, if the certified MEs simply defer to the TC. This commenter wanted FMCSA to clarify that a certified ME can request whatever medical information is necessary to make a sound determination. He also stated that the increased cost and responsibility for the certified ME would be reflected in higher fees.

The NTSB noted that FMCSA allows healthcare professionals who are not licensed to prescribe medication to medically-certify individuals who operate CMVs. Because these certified MEs have no experience prescribing medications or managing the effects of insulin or other diabetic medications, the NTSB indicated that these certified MEs must accept a TC's assurance of “proper management” without further evaluation. The NTSB commented that a TC's interpretation of proper management, as well as the individual's compliance with recommendations, might vary considerably.

TFAC noted that the certified ME is required to certify the ITDM individual is free of complications, while the written notification from the TC gives the certified ME no information about how the TC made that determination. This commenter proposed that “the statement required from the TC make[s] it clear in the area of diabetes management it is the TC who is rendering the expert medical opinion that the driver is `safe' therefore

relieving the medical examiner from concerns about potential liability.”

H&SW disagreed with FMCSA relying solely on the TC for information about the ITDM individual's management of his or her diabetes. It recommended that FMCSA require the collection of documentation by the TC as only one piece of the data gathered by the certified ME. It further suggested that FMCSA should also require the certified ME to obtain additional test and laboratory results, review glucose logs, and ensure the ITDM individual has received hypoglycemic awareness training. If documentation from a TC is the only tool the certified ME has, H&SW indicated the Agency is permitting the TC to make the medical certification decision even though he or she is not listed on the National Registry. A physician questioned how the certified MEs will protect themselves from discrimination lawsuits when they do not approve every individual recommended by the TCs.

Some commenters were concerned that the NPRM did not provide the certified ME with sufficient specific criteria to determine if the individual's diabetes was properly managed or if he or she was physically qualified to operate a CMV. H&SW indicated that the certified ME needs to see the blood sugar logs and the results of the eye examination; ensure the driver has had hypoglycemic awareness training; and check the blood levels for glucose to make an evidence-based decision regarding whether the driver is physically qualified to operate a CMV.

2015 MRB Report:

The 2015 MRB report recommended that a questionnaire be developed for the TC to complete and send to the certified ME. Based on the responses to the questionnaire, the TC was to indicate whether the individual had stable, well-controlled diabetes and had no severe hypoglycemic episodes over the past year, and to state that neither the individual's diabetes nor diabetes-related medical conditions would impair the ability to operate a CMV safely. The MRB recommended specifically that the final determination as to whether the ITDM individual was physically qualified to drive a CMV was to be made by the certified ME.

Comments on the MRB's Report on the Role and Relationship of the TC and Certified ME:

In response to this recommendation, OOIDA, Concentra, H&SW, and the ACOEM commented on the appropriate relationship between certified MEs and TCs. Concentra commented that certified MEs should be able to review a TC's records of an ITDM individual for at least the preceding year. OOIDA had concerns that the certified ME could override the TC's determinations. It suggested that certified MEs should provide “sound medical evidence” before challenging the TCs findings or requiring individuals to undergo more testing. H&SW added that the certified ME should be given the tools that the TC has and should ask for detailed tests and laboratory reports from the TC, if needed. H&SW also wrote that FMCSA should put the TC in a consultation position, especially because the certified MEs will be held responsible should the ITDM individual have a crash. The ACOEM stated that certified MEs must review at least 3-5 years of medical records so the certified ME can evaluate the individual's condition independently.

FMCSA Response:

This final rule continues the two-step process for medical certification in which the TC evaluates the individual's insulin regimen and control of his or her ITDM, then a certified ME performs an examination and determines whether the individual is physically qualified under all medical standards to operate a CMV. FMCSA agrees with commenters that the medical information provided by the TC to the certified ME should be relevant and useful and allow a certified ME to make an appropriate medical certification determination on an ITDM individual. As such, FMCSA is adding a requirement in this final rule that the TC complete an ITDM Assessment Form, MCSA-5870, rather than simply provide written notification that the individual's diabetes was being properly managed.

As discussed above, the Agency relies on State licensing authorities to make scope of practice determinations and has found that the TCs and certified MEs are qualified to perform their respective roles in this collaborative certification process. The role of the individual's TC, who is experienced in the management of diabetes, is to attest on the ITDM Assessment Form, MCSA-5870, that the individual maintains a stable insulin regimen and proper control of his or her ITDM. The role and responsibility of the certified ME, who is trained in FMCSA's physical qualification standards and the demands of operating a CMV, is to medically certify that the ITDM individual can safely operate a CMV. In making the qualification determination, the certified ME is to consider the attestation and information provided by the TC, but the certified ME does not automatically defer to the TC's attestation or rely solely on it. Consistent with current practice for any medical condition, the certified ME may confer with the TC concerning an individual's medical history and status, make appropriate referrals, or request medical records, all with appropriate consent.

The final rule relies on the TC's knowledge of an individual and understanding of the treatment of ITDM and the certified ME's knowledge of the requirements to operate a CMV and FMCSA regulations. FMCSA agrees with commenters and the MRB, as discussed more fully below, that the certified ME must be provided with more information regarding how the TC made his or her determinations. This rule adopts the ITDM Assessment Form, MCSA-5870, as the way to communicate that information.

The form requests specific information to assist both the TC and the certified ME in evaluating and assessing whether an ITDM individual maintains a stable insulin regimen and proper control of his or her diabetes. The TC will have the relevant and current information on the individual's medical history needed to complete and sign the ITDM Assessment Form, MCSA-5870.

FMCSA notes that, if a certified ME also meets the qualifications to be an individual's TC, the certified ME may perform the TC evaluation and medical certification examination contemporaneously. The certified ME who also acts as the TC must still complete the ITDM Assessment Form, MCSA-5870.

E. TC Written Notification (ITDM Assessment Form)

NPRM:

FMCSA proposed that the certified ME must obtain written notification from the individual's TC that the individual's diabetes is being managed properly.

Comments on TC Written Notification:

Some commenters stated that FMCSA should develop a comprehensive form to organize the certification criteria, thus ensuring that the information was complete and providing the certified ME the information necessary to determine that the individual is physically qualified. The former MRB members suggested a form that includes sections completed by the driver, the TC, and an ophthalmologist or optometrist. Some commenters, like the ADA, OOIDA, the IBT, and the ACOEM, recommended the use of specific forms or checklists that they suggested be adopted. Several commenters had extensive lists of documentation they suggested the TC should provide to the certified ME

including: Properly-maintained glucose logs; proof of proper diabetes management and compliance; records related to any hypoglycemic episodes; HbA1C testing results; and proof of yearly preventive care to screen for the long-term side effects of diabetes, such as retinopathy. Some commenters, like the ACOEM, requested a full packet of documentation be submitted to the certified ME.

Many commenters said the requirements of the proposed rule needed clarity or more specific guidance for the TC or certified ME to use to decide whether an ITDM individual may operate a CMV in interstate commerce. Concentra suggested that the Agency review the criteria with leading endocrinologists who specialize in diabetes.

Other commenters suggested adoption of best practices. The NTSB suggested that FMCSA emulate the Federal Aviation Administration (FAA) and the United States Coast Guard, which require operators with ITDM to be evaluated using published or scientifically-based standards. An individual commenter suggested that FMCSA model the requirements after FAA requirements, adjusted to allow ITDM individuals to take insulin by pump or manual injection. H&SW provided specific recommendations, some based on requirements cited by the ADA and Canada's qualifications for ITDM individuals.

TFAC understood FMCSA's reluctance to make very specific medical requirements, as the science of treatment options changes; yet, it noted there is a need for specificity in medical requirements to ensure there is consistency in how certified MEs handle situations. TFAC stated that without clear criteria, normal practice standards would be established by individual certified MEs and litigators, rather than by FMCSA through rulemaking. A physician who had experience with a discrimination lawsuit stated that, unless FMCSA provides specific certification guidance, the TC and the certified ME will avoid the risk of litigation by allowing individuals who should not be driving to get an MEC, MCSA-5876.

2015 MRB Report:

The 2015 MRB report recommended that FMCSA develop a questionnaire for the TC to provide to the certified ME and provided an outline of specific information to obtain. The TC would complete, sign, and send the form to the certified ME. The form would also be signed by the ITDM individual. The report also recommended specific criteria in several areas including severe hypoglycemic episodes, glucose logs and self-monitoring blood glucose, HbA1C results, eye examinations, and diabetic complications.

Comments on the General MRB Recommendation to Develop a Form:

The AAPA supported using the MRB recommended form as proposed. It stated that the degree of uniformity provided by the form would ensure that all TCs are assessing commercial drivers in the same way and using the same metrics when evaluating a driver's health. Additionally, a certified ME commended inclusion of the TC's signature and stated that the form would facilitate communication between the certified ME and TC. The ADA appreciated the efforts of the MRB to provide instruction to the TC regarding clinical indicators for evaluation but indicated the criteria were medically inappropriate in several places. An endocrinologist provided a sample of an assessment form used by the Pennsylvania DOT in the evaluation of ITDM drivers.

Concentra stated that the MRB-proposed form was lengthy, complex, and lacked specific direction, particularly in identifying serious co-morbid diseases. The University of Utah stated that the form was just an outline and needed exact requirements and consequences. It wanted a place for the ITDM individual to sign to attest to its truthfulness and to include a penalty for that individual not being truthful. It also stated that the final draft form should be made available to the public for comment. The ADA stated that having an ITDM individual sign the form would be inappropriate because FMCSA does not have the legal authority to require the TC to report any information to a certified ME unless the patient provides express permission for such reporting.

Proposed ITDM Assessment Form:

FMCSA agreed with commenters that a form would enhance communication between the TC and certified ME and provide consistent information to certified MEs. Accordingly, FMCSA prepared a proposed ITDM Assessment Form and published a 60-day notice on July 27, 2017, announcing that it was considering replacing the previously proposed written notification from the TC with the ITDM Assessment Form (82 FR 35041). The Agency sought comment on the form, which is available in the docket for this rulemaking.

Comments on the ITDM Assessment Form:

Five commenters provided substantive comments specific to the ITDM Assessment Form in response to the 60-day notice. An endocrinologist wholeheartedly agreed with the proposed approach of the form. A certified ME supported the use of the form and stated that it should be passed along to the treating primary care physician for completion and then should be reviewed by a certified ME who is knowledgeable about the challenges of driving a CMV. Another certified ME was concerned that the form requests information on severe hypoglycemic events for only the past 3 months. This commenter stated that he “would want to know of any severe hypoglycemic events over the past 5 years, as previous guidance from the FMCSA Examiner's Handbook for diabetics not on insulin, was not to certify if there had been a severe hypoglycemic event within the past 12 months, or 2 within the last 5 years.” The commenter also wanted to know the lowest recorded finger-stick blood glucose over the preceding 3 months and all HbA1c results for the preceding year. An MD stated that the form should include questions about co-morbid conditions such as peripheral neuropathy, sleep apnea, uncontrolled hyperlipidemia, or hypertension being treated by the TC.

The ADA was concerned about the requirement that a driver be on a stable insulin regimen for the prior 3 months. The ADA also stated that the Agency requires the driver to have his or her HbA1C measured intermittently over the last 12 months with the most recent measure within the preceding 3 months and noted that newly-diagnosed individuals will not have that data.

FMCSA Response:

The Agency agrees with commenters that more than written notification from the individual's TC that the individual's diabetes is being managed properly should be provided by the TC to the certified ME. The final rule requires that the TC complete the ITDM Assessment Form, MCSA-5870, to provide additional information for the certified ME about the ITDM individual's medical history. The Agency has considered the forms and checklists provided by commenters, and has determined that the ITDM Assessment Form, MCSA-5870, collects the appropriate information to enable the certified ME to make his or her certification determination. Comments on specific criteria are discussed below by substantive area.

With respect to the comment that the form should be completed by the treating primary care physician, FMCSA is not limiting the TC role to physicians. As discussed above, FMCSA expects that the TC will be the individual's primary care provider for diabetes treatment.

A certified ME determines whether an individual meets FMCSA's physical qualification standards as of the time of the medical certification examination. Therefore, FMCSA has determined that providing information to the certified ME regarding whether an ITDM individual has had a severe hypoglycemic episode in the prior 3 months is generally sufficient. As discussed elsewhere in this preamble, that time frame coincides with the Agency's requirement that an ITDM individual provide the TC with 3 months of blood glucose self-monitoring records to be eligible for up to the maximum 12-month MEC, MCSA-5876. The Agency finds that this is a balanced approach for ITDM individuals that allows time to demonstrate a stable insulin regimen and proper control of ITDM, while providing enough information for the certified ME to determine whether the individual can safely operate a CMV. In any event, an ITDM individual is also required to provide the certified ME with a completed ITDM Assessment Form, MCSA-5870, for any severe hypoglycemic episodes that may have occurred since any previous medical certification examination, so the certified ME will be aware of such episodes. With respect to comments suggesting that the form be consistent with guidelines provided in the Medical Examiner Handbook, FMCSA notes that the Handbook, a tool certified MEs could consider during the medical certification process, has now been withdrawn.

The ITDM Assessment Form, MCSA-5870, already includes questions about co-morbid medical conditions as suggested by a commenter. It also provides an area for additional comments by the TC where other relevant conditions may be referenced.

The final rule requires that, to be eligible for up to the maximum 12-month MEC, MCSA-5876, all ITDM individuals must provide to the TC at least the preceding 3 months of blood glucose self-monitoring records while being treated with insulin. If an individual does not provide the 3 months of records, the certified ME has discretion to grant the individual up to but not more than a 3-month MEC, to allow time for the individual to collect the necessary records. Once the individual has 3 months of blood glucose self-monitoring records, the individual is treated the same as an ITDM individual with 3 months of records. The individual must first go to the TC for evaluation and then to the certified ME, who must exercise independent medical judgment, to determine if the individual is eligible for up to the maximum 12-month MEC.

The form asks has the individual had HbA1C measured intermittently over the last 12 months, with the most recent measure within the preceding 3 months, and, if so, to attach the most recent result. The Agency notes that the lack of HbA1C data does not automatically disqualify an individual from being medically certified.

In the final form, FMCSA made changes to be consistent with the terminology, definitions, and requirements in the final rule. The Agency also made minor changes to improve clarity and organization. More specifically, a sentence was added to specify that the certified ME must receive the form and begin the medical examination no later than 45 days after the date on the signed form; however, FMCSA notes that the medical certification determination does not need to be completed within 45 days. The Agency also added a provision that an ITDM individual who is being evaluated after a severe hypoglycemic episode must retain the form and give it to the certified ME at the next medical certification examination. FMCSA removed the question that asked whether the individual experienced any severe hypoglycemic episodes in the absence of warning symptoms in the preceding 3 months. The Agency found the question was redundant of the general request for information about severe hypoglycemic episodes. The Agency added a request for the individual's driver's license number and issuing State, but agrees with the ADA that it is not appropriate for the form to require the individual's signature. The Agency also added a request for the TC's medical credential, as well as professional license number and the issuing State, to be able to identify these individuals. Finally, FMCSA modified the TC's attestation on the form.

The Agency notes that the ITDM Assessment Form, MCSA-5870, is available on FMCSA's Medical Programs and National Registry websites. Additionally, once the TC has signed and dated the form as required, the form is provided to the certified ME by either the ITDM individual or the TC.

F. Certified ME Certification and TC Evaluation Frequency

NPRM:

In the NPRM, FMCSA proposed that at least annually, a certified ME listed on the National Registry must examine and certify that the ITDM individual is physically qualified and free of complications that would impair the individual's ability to operate a CMV. Prior to the annual or more frequent certified ME's examination, the individual would have to be evaluated by the TC.

Comments on Certified ME Certification and TC Evaluation Frequency:

While some commenters wanted an interval of 2 years between medical certification of drivers, others stated the ITDM individual should be examined more frequently. For example, the ADA, SOCO, Advocates, and H&SW agreed with the proposed interval of at least annual examination. The ATA and AAPA-OM suggested a graduated approach whereby certified MEs would issue shorter-term medical certifications initially and longer-term certifications after the initial period during which the ITDM individual demonstrated his or her condition was stable and properly controlled. The ATA recommended that the longest term of certification should not exceed a year. A physician/certified ME wrote that the endocrinologist is responsible for stating that the ITDM individual is well controlled throughout the year; this commenter stated that the NPRM took a step back from the effort to improve medical examinations.

2015 MRB Report:

The 2015 MRB report recommended that a certified ME could certify an ITDM individual as medically qualified for no more than 1 year if the individual had no disqualifying factors. The MRB did not make a specific recommendation regarding the frequency of the TC evaluation. No comments were received concerning the MRB report in this regard.

FMCSA Response:

FMCSA agrees with commenters who stated that ITDM individuals should not be granted medical certification for a period longer than 12 months. Annual or more frequent recertification by the certified ME allows for earlier detection and consideration of any changes or complications that may impact an ITDM individual's ability to safely operate a CMV. If a certified ME determines an individual should not be qualified for the maximum 12 months, the certified ME may certify that individual for a shorter period. FMCSA finds that this approach allows for the application of individualized medical certification determinations based on the certified ME's medical discretion. ITDM individuals must see their TC prior to every medical certification examination to ensure they maintain a stable insulin regimen and proper control of their ITDM as the rule requires.

G. Annual Certification of Individuals With Diabetes Mellitus Not Treated With Insulin

NPRM:

In the NPRM, the Agency did not propose that individuals with diabetes mellitus not treated with insulin (non-ITDM individuals) be recertified at least annually. However, FMCSA cited the 2007 MRB recommendation to require annual or more frequent medical recertification for

all

individuals with diabetes mellitus, and requested comment on the recommendation.

Comments on Annual Certification of Non-ITDM Individuals:

The IBT, Illinois Office of the Secretary of State, and the ADA said the Agency should not require that non-ITDM individuals obtain recertification at least annually because a change to the current procedure for qualifying these individuals is not warranted. The ADA commented that non-ITDM individuals should be able to hold a medical certificate for up to 24 months like other individuals, unless their healthcare provider or the certified ME determines otherwise. In contrast, Advocates recommended that the Agency should establish more frequent medical certification for all individuals with diabetes.

2015 MRB Report:

The 2015 MRB report did not address the requirement that non-ITDM individuals be recertified at least annually; no comments were received concerning the MRB report in this regard.

FMCSA Response:

FMCSA agrees with commenters that a 2-year recertification period for non-ITDM individuals is appropriate and will not adopt the MRB's 2007 recommendation. FMCSA finds that is not necessary to impose a requirement for annual certification of these individuals because certified MEs have a long history with certification of non-ITDM individuals. Certified MEs have been trained that they may issue short duration MECs, MCSA-5876, for medical conditions that require frequent monitoring or where additional medical information is needed. Moreover, the commenters provided no data that suggests annual medical certification of non-ITDM individuals is warranted.

H. Eye Examinations

NPRM:

The NPRM did not propose any changes to the existing vision standards. The Agency requested comments on the need for an ITDM individual to be examined by an optometrist or ophthalmologist as a condition of passing the physical examination.

Comments on Eye Examinations:

The ADA commented that it should be left to the judgment of the TC to refer the individual to an optometrist or ophthalmologist, as needed, based on clinical indicators that a screening by an eye specialist is necessary. The ADA's Standards of Medical Care recommend that individuals with type 1 diabetes be screened for retinopathy within 5 years of diagnosis because retinopathy is estimated to take at least 5 years to develop following hyperglycemia. The Standards of Care recommend that patients with type 2 diabetes be screened shortly after diagnosis. The ADA further commented that after one or more normal eye examinations, individuals with well-controlled type 2 diabetes had essentially no risk of developing significant retinopathy within 3 years of a normal examination. According to the ADA's comments, “[n]ot all individuals with diabetes will develop vision complications, and among those that do, not all will interfere with safe driving ability. As such, only those CMV drivers who pose a high risk—because of the presence of complications that interfere with driving, such as impaired vision—should be further assessed by a specialist to determine if the risk is too high.” OOIDA endorsed the comments submitted by the ADA.

The Illinois Office of the Secretary of State agreed with the proposal, provided that the ITDM individual can meet the vision standards in § 391.41(b)(10). It stated that the process will provide a reasonable certainty that any ITDM individual who cannot meet the standards will be discovered by the certified ME during the annual examination and the process will not present any threat to general traffic safety. The IBT also agreed with the proposal and FMCSA that meeting the vision acuity standard provides “ `reasonable certainty of discovering and mitigating risks associated with any safety-related condition that would interfere with meeting the standard, including diabetic retinopathy.' ”

Some commenters, including H&SW and the ACOEM, stated that FMCSA should require an annual evaluation from an ophthalmologist or optometrist. SOCO suggested that FMCSA should require a note from an ophthalmologist or optometrist stating that the individual is free of diabetic-related retinal disease and vision impairing cataracts and has good field of vision in both eyes. The NTSB stated that diabetic retinopathy can cause loss of areas of vision without affecting acuity; therefore, a dilated retinal eye examination is an annual standard of care for most ITDM individuals. It indicated that eliminating the annual ophthalmological examination will increase the likelihood of ITDM individuals driving CMVs with significant diabetic retinopathy and degraded visual performance, which will pose a hazard to public safety. A physician/certified ME stated that if the exemption program is eliminated he will continue to expect at least annual assessment from an ophthalmologist.

Several commenters that were in favor of requiring annual eye examinations, including the American Optometric Association (AOA) and the former MRB members, noted that the certified ME may not have the experience and training to perform dilated eye examinations or have the specialized equipment necessary to do so. The former MRB members noted that by the time an ITDM individual experiences reduced visual acuity that is captured by the relatively crude examination performed by a certified ME, it is often too late to avoid complications. Thus, the former MRB members stated there is further need for mandatory, annual eye examinations for retinopathy by ophthalmologists or optometrists.

The AOA noted it is important to understand that the entire range of diabetic retinopathy complications are predominantly asymptomatic and can occur without any deterioration in visual acuity. It stated that a visual acuity test is not a substitute for a dilated eye examination, which is the only appropriate method for evaluating the eye health of ITDM individuals and for predicting with high confidence which individuals will retain adequate visual function in the interim between eye examinations. It was concerned that the current proposal could put drivers and the public at serious risk. The AOA suggested, rather than requiring evaluation by an ophthalmologist, FMCSA could reduce the cost and burden to ITDM individuals, while maintaining quality of evaluation, by allowing a doctor of optometry to evaluate those applicants.

TFAC suggested FMCSA require a vision examination by a qualified eye specialist when the individual goes on insulin treatment and every 2 years thereafter. It suggested that the eye specialist complete a form acknowledging familiarity with the requirements of 49 CFR and the physical demands of a CMV operator.

2015 MRB Report:

The 2015 MRB report included the recommendation that ITDM individuals receive a complete eye examination by a qualified ophthalmologist or optometrist, including a dilated retinal examination, at least every 2 years. This examination should document the presence or

absence of retinopathy and macular edema, and, if present, the degree using the International Classification of Diabetic Retinopathy and Diabetic Macular Edema. The MRB advised increasing the frequency of these examinations based on the ophthalmological findings.

Comments on the MRB's Report on Eye Examinations:

HS&W concurred with the MRB's recommendation. The National Rural Electric Cooperative Association commented that it was not opposed to a comprehensive eye examination

11

every 2 years, but having the TC attest that the TC reviewed the results of the report was “duplicative at best and onerous at worst.”

11

The AOA commented that “comprehensive eye examination” is the proper terminology to describe the general evaluation of the complete visual system, including a dilated retinal examination, rather than “an ophthalmology or optometry exam.”

The AOA, the ACOEM, and several individuals suggested a comprehensive eye examination should be conducted on an annual basis. The AOA stated that its evidence-based guidelines explain that the clinical signs of diabetic retinopathy can appear early in the disease process; however, individuals many not experience symptoms until relatively late, at which time treatment may be less effective. The AOA noted that “[t]he success of appropriate intervention and management strategies depends upon accurate and timely detection of diabetic eye disease.” The University of Utah stated that individuals with non-proliferative retinopathy should be required to have annual comprehensive eye examinations.

The ADA repeated its prior comments to the NPRM that an annual comprehensive eye examination is not required by its Standards of Care. It again concluded that it should be left to the judgment of the TC to refer the ITDM individual to an ophthalmologist or optometrist as needed.

FMCSA Response:

This rule does not include a mandatory requirement or specify the frequency for comprehensive eye examinations for ITDM individuals. FMCSA finds the Standards of Care and comments presented by the ADA to be persuasive and reasonable. Given that not all individuals with diabetes will develop vision complications, FMCSA has determined that it would be inconsistent with the rule's emphasis on individualized assessment to impose a required frequency for a separate comprehensive eye examination by an ophthalmologist or optometrist as a condition of passing the medical certification examination for all ITDM individuals. FMCSA also finds that to do so is inconsistent with Congress' instruction that the Agency may not hold ITDM individuals to a higher standard than other individuals unless it is medically necessary. The Agency's determination that annual comprehensive eye examinations should not be required also is supported by the MRB's recommendation that ITDM individuals undergo such examinations every 2 years, unless clinical indicators suggest otherwise.

The Agency finds that the TC is in the best position to determine for each ITDM individual when a comprehensive eye examination is necessary and, when warranted, to make a referral to an ophthalmologist or optometrist. If any eye condition that may impact an ITDM individual's ability to safely operate a CMV is present, it is reasonable for the Agency to expect that the ITDM individual's TC will ensure that proper comprehensive eye examinations are obtained to appropriately monitor any progressive vision impairment. As with all medical certification examinations, with the ITDM individual's consent, the certified ME may confer as needed with the TC or an eye specialist to determine whether additional information or evaluation is necessary prior to the medical certification decision.

The final rule does not change the existing requirement that all individuals must meet the vision standard in § 391.41(b)(10) to operate a CMV. The Agency continues to find that meeting the vision standard provides reasonable certainty of discovering and mitigating risks associated with any safety-related condition that would interfere with meeting the standard. As such, this rule does not include a mandatory requirement or specify the frequency for comprehensive eye examinations for ITDM individuals.

I. Disqualification for Vision Impairment

NPRM:

The NPRM did not propose that any specific visual complications associated with diabetes would disqualify an ITDM individual from being medically qualified.

Comments on Disqualification for Vision Impairment:

Commenters stated that no diabetic retinopathy above stage 1 is acceptable. The risks of progression, which may occur very suddenly, are too high. No laser treatments or intraocular injections for retinopathy should be allowed. Additionally, vision exemptions should not be acceptable in this context.

2015 MRB Report:

If ITDM individuals had stage 3 or 4 of diabetic retinopathy, the MRB recommended that such individuals be disqualified permanently from medical certification.

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The Agency sought clarification from the MRB and was informed that stage 3 diabetic retinopathy could be termed severe non-proliferative diabetic retinopathy and stage 4 diabetic retinopathy could be termed severe proliferative diabetic retinopathy.

Comments on the MRB's Report on Disqualification for Vision Impairment:

Commenters agreed that stage 3 or 4 retinopathy should be a permanent disqualification because of the significant risk of sudden vision compromise from bleeding or retinal detachment. In addition, the ADA noted that the standard treatment for this stage is pan-retinal photocoagulation, which cuts down night vision and peripheral vision that are important to CMV operation.

The University of Utah stated that anything beyond non-proliferative retinopathy should be disqualifying because epidemiological studies suggest sudden onset of vision impairment is too common. This commenter also stated that it should be made clear that any laser treatments or intraocular injections for treatment of retinopathy would preclude driving. Additionally, monocular driving in combination with any degree of retinopathy, not just stage 3 or 4 retinopathy, should be clearly disqualifying due to the inability to have a compensatory eye combined with the potential suddenness of onset of vision impairments.

In contrast, an endocrinologist stated the 2015 MRB recommendation is relatively arbitrary. Proliferative retinopathy, even after laser therapy, affects vision variably. Thus, not all individuals in these categories will have significant vision impairment. The endocrinologist commented that the criterion should be based on function, such as acuity, night vision, and response times to stimuli in the periphery of visual fields. An individual wrote that, if an ITDM individual receives treatment for the diabetic retinopathy and an ophthalmologist states that the individual can operate a CMV safely, the retinopathy should not be a disqualifying factor.

FMCSA Response:

This final rule requires that the certified ME disqualify permanently from medical certification any ITDM individual who is diagnosed with severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy.

The Agency agrees with the 2015 MRB report and commenters that ITDM individuals with advanced stages of diabetic retinopathy pose a safety risk while operating a CMV. ITDM individuals whose diabetic retinopathy has reached the advanced stages of

severe non-proliferative or proliferative diabetic retinopathy are at risk of sudden incapacitation from a detached retina or bleeding. FMCSA agrees, therefore, that ITDM individuals with severe non-proliferative or proliferative diabetic retinopathy should be disqualified permanently from operating a CMV. Given that treatment for advanced diabetic retinopathy impacts night and peripheral vision adversely, which are important for operating a CMV, the Agency has determined that there is a rational basis to find that ITDM individuals with severe non-proliferative or proliferative diabetic retinopathy should be permanently disqualified from being medically certified, despite treatment.

The Agency declines to incorporate any specific definition of severe non-proliferative or proliferative diabetic retinopathy in either the ITDM Assessment Form, MCSA-5870, or the regulation. Instead, the Agency refers to classification categories created by eye specialists, such as the National Eye Institute

13

and the International Clinical Diabetic Retinopathy Disease Severity Scale,

14

with which eye specialists are familiar and well versed for the definitions. Adding a specific definition would not assist the trained eyecare specialist in making a clinical determination.

13

See https://nei.nih.gov/diabetes/content/english/know

(Accessed May 25, 2018).

14

See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874488/

(Accessed May 25, 2018).

With respect to the disqualification determination process, the ITDM Assessment Form, MCSA-5870, asks the TC whether the ITDM individual has been diagnosed with severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy. If it is noted on the form that the ITDM individual has been diagnosed as such, the certified ME may rely on that representation and disqualify the individual permanently from medical certification. Alternatively, the certified ME may exercise his or her independent medical judgment and refer the individual for further evaluation prior to making a certification determination.

J. HbA1C Levels

NPRM:

The NPRM did not propose a standard for HbA1C levels for medical qualification of ITDM individuals.

15

15

The A1C blood test is often referred to as the hemoglobin A1C, HbA1C, or glycohemoglobin test.

See https://www.niddk.nih.gov/health-information/diabetes/overview/tests-diagnosis/a1c-test#1

(Accessed Sept. 13, 2017).

Comments on HbA1C:

The former MRB members wanted FMCSA to state its position on acceptable HbA1C levels, and recommended that driving be allowed when the HbA1C is below 10 percent. A physician indicated that FMCSA needs to establish specific guidance regarding what HbA1C level would enable an individual to operate a CMV safely and asked whether a level of 12 percent is satisfactory. The commenter stated that FMCSA will need to provide a table as it does for blood pressure. An RN stated that ITDM individuals should be required to have an HbA1C test every 3 months. Another commenter stated that an individual should check his or her HbA1C every 6 months.

The ACOEM and TFAC would require the TC to send the certified ME the current HbA1C results. TFAC stated that this should be done within 30 days of certification. TFAC commented further that the HbA1C test provides the best information available on long-term control and cannot be falsified as a daily blood glucose log can. The NTSB suggested that FMCSA could require clinical information, including HbA1C levels, from the TC to demonstrate that the individual meets specified criteria.

The ADA, on the other hand, opposed requiring a specific HbA1C range when licensing ITDM individuals, and recommended that FMCSA not use this “medically unjustified criterion” in any form. The ADA noted that, taken alone, an HbA1C above 7 percent in no way indicates the individual cannot operate a CMV safely. The ADA, along with the ACOEM, maintained that an HbA1C test is a useful indicator of diabetes management when used in conjunction with other assessment tools to assess an individual's ability to drive safely. The ADA wrote that diabetes management decisions should be made by an individual and his or her physician based on how diabetes affects that person.

2015 MRB Report:

The 2015 MRB report recommended that an ITDM individual with uncontrolled diabetes be disqualified from operating CMVs. The evidence for uncontrolled diabetes would be an HbA1C level greater than 10 percent. The ITDM individual could be reinstated when his or her HbA1C level is less than or equal to 10 percent.

Comments on the MRB's Report on HbA1C:

The ACOEM was the sole commenter who supported this recommendation. It added that the ITDM individual could be reinstated only when the recommended HbA1C level is maintained for at least 3 months.

Some commenters objected to a threshold of 10 percent. An MD commented that this level does not take into consideration individual variability in glycation rate and that the criterion could be tighter. An individual wrote that HbA1C is not clearly defined as a range as it is in Canadian and European regulations nor is the level in the healthy or controlled range.

Other commenters, including H&SW, an MD, the ADA, and the ATA, objected to the use of HbA1C altogether to determine whether an individual is safe to drive. H&SW wrote that the HbA1C test measures average blood sugar over 3 months, and does not give information about hypoglycemic episodes. An MD commented that he is not aware of any evidence that a high HbA1C renders an individual unfit to drive. The MD added that, while a high HbA1C may result in neuropathy, retinopathy, and other end organ damage that could lead to unsafe driving, these conditions take many years to develop and an HbA1C greater than 10 percent does not mean that an individual has these conditions. Because individuals on oral medications would be allowed to drive with HbA1C levels higher than 10 percent, the MD indicated that this rule would discriminate against ITDM individuals and create a disincentive for individuals to seek appropriate treatment with insulin. The MD recommended either removing this recommendation or increasing the HbA1C threshold to 12 percent.

The ADA and the ATA wrote that the HbA1C test is a useful indicator of poor diabetes management when used with other assessment tools. The ADA highlighted that the HbA1C measure does not predict hypoglycemia. Additionally, a high HbA1C does not impair driving, and evaluation of end organ damage will identify individuals whose diabetes leads to complications that impact safe driving. The ATA stated that disqualifying an individual for an HbA1C level greater than 10 percent may be somewhat arbitrary. This recommendation could create a disparity between individuals who are managing their diabetes with and without insulin. The ATA suggested that the certified ME should work with the TC to determine whether a high HbA1C presents a danger. It recommended further that FMCSA should consider other factors, in addition to a high HbA1C level, for determining whether an individual's diabetes is well-controlled and maintained.

FMCSA Response:

FMCSA agrees with comments that HbA1C values should not be relied upon as a sole measure of an ITDM individual's ability to safely operate a CMV. The final rule allows the TC to evaluate all relevant clinical factors to determine whether an individual maintains proper control of

his or her ITDM. HbA1C levels are one factor the TC may consider in making that determination.

FMCSA agrees further that making a medical qualification determination based solely on a specific HbA1C level is inconsistent with the rule's emphasis on individualized assessment. In addition, the National Institute of Diabetes and Digestive and Kidney Disease states that HbA1C test results can be up to 0.5 percent higher or lower than the reported actual percentage; can be unreliable for people of African, Mediterranean, or Southeast Asian heritage; and can be altered by diseases that affect blood or hemoglobin.

16

While a high HbA1C level may suggest that complications from diabetes might develop in the future, it does not mean that an individual presently has complications or is unsafe to drive a CMV.

16

See https://www.niddk.nih.gov/health-information/diabetes/overview/tests-diagnosis/a1c-test#1

(Accessed Sept. 13, 2017).

The ITDM Assessment Form, MCSA-5870, asks the TC to report whether the individual has had HbA1C measured intermittently over the past 12 months, with the most recent measure within the preceding 3 months. If so, a copy of the most recent laboratory result is to be attached to the form so that it is available to the certified ME.

K. Specific Blood Glucose Limits

NPRM:

The NPRM did not propose a specific range for blood glucose readings.

Comments on Establishing Specific Glucose Limits:

The NTSB suggested FMCSA require ITDM individuals meet specified criteria to demonstrate that their diabetes is properly managed, including an acceptable range for blood glucose. Some commenters, including a retired FAA safety inspector, the former MRB members, an RN, the ACOEM, and H&SW, recommended specific acceptable blood glucose limits. The retired FAA safety inspector stated that a reading lower than 80 mg/dL should be flagged, which would give the individual time to correct blood glucose. The former MRB members said ITDM individuals should maintain blood glucose levels of at least 100 mg/dL while driving. If a blood glucose value is less than 60 mg/dL, the ACOEM would require the individual to repeat the test at least every 30 minutes until 90 mg/dL is reached. During this time, the individual would have to document that he or she was not driving and provide additional documentation on the low reading. H&SW stated that a blood glucose level within the normal range of 80 to 140 mg/dL would be appropriate.

The ADA wrote that it is appropriate to evaluate blood glucose readings. However, there is no legitimate medical reason to automatically disqualify individuals whose blood glucose logs show some readings below 100 mg/dL or above 400 mg/dL, as stipulated in the current exemption program.

2015 MRB Report:

The MRB recommended that if an ITDM individual had a blood glucose measure of less than 60 mg/dL, as demonstrated in the current glucose logs, the individual would be disqualified for at least 6 months.

Comments on the MRB's Report on Establishing Specific Blood Glucose Limits:

Many commenters objected to the disqualification of an ITDM individual for having a single reading below 60 mg/dL. Several commenters stated that it was not appropriate to set a blood glucose standard for when an individual is not on duty. They, along with the ATA and ADA, discussed that a single reading of a blood glucose level below 60 mg/dL should not be sufficient to disqualify an ITDM individual. They stated that the Agency should consider whether a low blood glucose recording was an isolated incident or part of an overall pattern of poorly-controlled diabetes.

The ADA stated that the recommendation is “an extreme overreaction to the potential risk of hypoglycemia, and does not provide for individualized assessment of a specific driver's diabetes risk.” It continued that a blood glucose level less than 60 mg/dL is dangerous only if it is not treated. The ADA commented that, instead of disqualifying the individual, it is important to determine the cause of the low blood glucose level. The ADA strongly urged the Agency to eliminate all categorical glucose levels from the list of disqualifying factors.

An endocrinologist stated that all ITDM individuals will have some blood glucose readings below 60 mg/dL, perhaps once a week. In the endocrinologist's opinion, disqualifying individuals for a blood glucose level any time it was under 60 mg/dL would be “unreasonable/discriminatory.” A different MD stated that disqualification based on a onetime reading of less than 60 mg/dL “seems arbitrary.” The MD continued that “[t]his rare low blood glucose reading does not imply the driver's diabetes is uncontrolled or that the driver has a problem with hypoglycemic unawareness.”

The ATA noted that there are several factors that can cause blood glucose to drop low, including titration following a new treatment. For this reason, the ATA stated that the TC and certified ME should review blood glucose logs to determine whether the low blood glucose level was an isolated incident.

The ACOEM stated that a blood glucose level of less than 60 mg/dL is probably too low, as once the blood glucose is at 60 mg/dL the individual is likely to already be having symptoms. If the blood glucose is below 70 mg/dL, the ACOEM recommended that the ITDM individual should not be permitted to drive until all blood glucose logs show levels above 70 mg/dL for at least 6 months, with recurrent episodes triggering progressive duration of out of service periods.

FMCSA Response:

The Agency agrees with commenters that an ITDM individual should not be disqualified for a single blood glucose reading that falls below or above a specific limit. The intent of the final rule is for an individualized assessment of the stability of the individual's insulin regimen and control of his or her ITDM, as determined by the TC, and of whether the individual satisfies the physical qualification standards, as determined by the certified ME. Therefore, FMCSA finds it is appropriate for TCs to set individualized, clinically-based parameters for blood glucose limits for ITDM individuals rather than establishing a regulatory requirement. TCs should look for frequent occurrences of low blood glucose levels and determine the cause. For example, frequent low blood glucose levels may indicate potential improper diabetes management or other underlying medical issues. While the certified ME considers the TC's input on whether the ITDM individual maintains a stable insulin regimen and proper control of his or her ITDM, it is the certified ME's responsibility to consider safety and make a physical qualification determination.

L. Severe Hypoglycemic Episodes

NPRM:

FMCSA proposed to allow ITDM individuals to drive CMVs if they were free of severe hypoglycemic reactions in the 12 months prior to the TC evaluation. A severe hypoglycemic reaction was described as one that results in loss of consciousness or seizure, requires the assistance of another person, or results in impaired cognitive function.

Comments on Severe Hypoglycemic Episodes:

The former MRB members, Concentra, the NTSB, and the ACOEM recommended that FMCSA establish specific, measurable standards to define a severe hypoglycemic episode.

Comments included concerns regarding ways of reporting severe hypoglycemic episodes and the length of time between episodes. Advocates supported the proposed rulemaking, but was concerned that the reporting requirement may be too lax and open to potential abuse. SOCO recommended a note from the TC stating that the ITDM individual is stable on current therapy and is not experiencing hypoglycemic episodes. This commenter would require immediate reporting to the certified ME and the TC of new or recurring hypoglycemia. Instead of the proposed 12 months, a diabetes educator stated that ITDM individuals should have to follow-up at least every 6 months with an endocrinologist and diabetes educator to make sure that the individuals are not having multiple episodes of hypoglycemia or hyperglycemia.

The former MRB members, Advocates, the ATA, and AAPA-OM agreed that FMCSA should remove any ITDM individual who has a severe hypoglycemic episode within a year from work for at least 1 year. AAPA-OM stated that there should not be recurrent (two or more) severe hypoglycemic episodes in the last 5 years. The former MRB members recommended periods of longer than 12 months for not allowing ITDM individuals to operate CMVs if they had more than two episodes in the last 5 years. Concentra commented that the safety risks from acute hypoglycemia are too great not to be defined and that FMCSA should review the criteria with leading endocrinologists who specialize in diabetes. The NTSB was concerned that the NPRM required only that the TC determine that an individual has had no severe hypoglycemic episodes and that the diabetes is properly managed, rather than providing clinical information to demonstrate that the individual meets specified criteria.

2015 MRB Report:

The 2015 MRB report defined a severe hypoglycemic episode as loss of consciousness, seizures or coma, requiring the assistance of others, or needing urgent treatment (glucagon injection or intravenous glucose). If an ITDM individual had an episode of severe hypoglycemia within the previous 6 months, the MRB recommended that the individual be disqualified from operating a CMV for at least 6 months.

Comments on the MRB's Report on Severe Hypoglycemic Episodes:

The ADA, the ACOEM, and the University of Utah stated that the recommended definition needs to be clarified. For example, the ADA stated that urgent treatment is too broad a term and could include self-treatment by an individual who recognizes dropping blood glucose. The University of Utah commented that a glucose level below 60 mg/dL is the same as severe hypoglycemia. This commenter also suggested that there should be a requirement for the ITDM individual who experienced an episode to make some adjustment to prevent another episode from occurring. H&SW recommended that moderate hypoglycemia should be addressed in the rulemaking because it can pose a serious concern.

Some commenters supported the recommendation that an ITDM individual who experienced a hypoglycemic episode be disqualified for 6 months, while others who disagreed with it, including an endocrinologist, stated the disqualification was unreasonable and discriminatory to ITDM individuals. Commenters who opposed this recommendation, again including the endocrinologist, stated that episodes that occurred off duty should not count against the ITDM individual, as they have no safety implications. They noted that there are many reasons for low blood glucose, such as acute illness, infections, or medication. Commenters, including OOIDA, stated that disqualifying ITDM individuals for 6 months would be financially burdensome on these individuals and may even lead to job losses. Rather than having FMCSA set a specific timeframe for disqualification, commenters, such as the ADA, stated that the TC should determine the length of the disqualification period, or determine that the disqualification has been lifted as a result of corrective measures or lapse in time since the disqualifying event(s). Concentra noted generally that the 6-month disqualification period may be difficult for the certified ME to track and that it is conceivable the individual could be seen by another certified ME who would be unaware of the disqualification.

Some commenters stated that a single episode of severe hypoglycemia should not be disqualifying and that the issue needs to be recurring. For example, the ADA stated that “any policy that disqualifies a driver on the basis of a single episode of severe hypoglycemia is misguided.” Instead, the ADA maintained, the TC should determine the cause of the low blood glucose, whether it was an isolated incident, and the likelihood of such an episode recurring. In contrast, the University of Utah and the ACOEM stated that the Agency should consider progressively longer periods of disqualification based on the frequency of these episodes. The University of Utah indicated that there must be a limit to the number of severe hypoglycemia episodes.

FMCSA Response:

In the final rule, FMCSA has revised the NPRM and 2015 MRB definitions of a severe hypoglycemic episode to eliminate ambiguity and potential redundancy. FMCSA also has clarified that the scope of the definition is

severe

episodes by eliminating from the definitions that the episode results in impaired cognitive function or requires urgent treatment. The revised definition provides a more objective standard that allows for more consistent determinations regarding what constitutes a severe hypoglycemic episode. A severe hypoglycemic episode is defined as an episode requiring the assistance of others, or resulting in a seizure, coma, or the loss of consciousness.

In view of the potential impact on safety, FMCSA is clarifying in the final rule that an ITDM individual certified as physically qualified to operate a CMV who experiences a severe hypoglycemic episode is prohibited from operating a CMV. The Agency is adding a requirement in the rule that such an individual must report the episode to and be evaluated by a treating clinician as soon as is reasonably practicable.

The driving prohibition continues until the ITDM individual has been evaluated by a TC (who meets the specifications in the rule), and a TC determines that the cause of the severe hypoglycemic episode has been addressed and that the individual again has a stable insulin regimen and properly controlled ITDM. Once a TC completes a new ITDM Assessment Form, MCSA-5870, following the episode, the individual may resume operating a CMV. The rule requires the ITDM individual to retain the form and to provide it to the certified ME at the individual's next medical certification examination so the certified ME will be aware of the prior episode.

The Agency agrees with commenters that after an ITDM individual experiences a severe hypoglycemic episode the individual must demonstrate that the cause of the episode has been addressed and that a future episode is not likely to recur. However, the Agency also agrees with some commenters that prohibiting an individual from driving for 6 to 12 months after a severe hypoglycemic episode is onerous for both ITDM individuals and employers. In addition, a period of 6 to 12 months is not necessary medically to determine stability in most instances because severe hypoglycemic episodes are often the result of short-term causes. For

example, in certain circumstances, the cause of an episode might be able to be addressed while an individual is in an emergency room or other medical facility, and a TC could complete a new ITDM Assessment Form, MCSA-5870, at that time. Moreover, the Agency lacks data that suggest an ITDM individual who has experienced a severe hypoglycemic episode is likely to experience another episode within any specific timeframe, and commenters, as well as the MRB, have not provided any relevant data.

Accordingly, the final rule does not establish a specific timeframe that an ITDM individual is prohibited from operating a CMV following a severe hypoglycemic episode. Rather, the rule defers to a TC to make an individualized assessment as to when the cause of the episode has been addressed and the individual again has a stable insulin regimen and properly controlled ITDM. A TC is in a good position to obtain and take in to account an ITDM individual's medical history. Therefore, a TC is also in a good position to determine and treat the cause of a severe hypoglycemic episode, assess the response to treatment, determine when the cause has been addressed, and, then, complete an ITDM Assessment Form, MCSA-5870.

FMCSA finds that any regulatory requirement that specifies a timeframe that an ITDM individual is prohibited from operating a CMV is not consistent with the intent of this rule to provide for individualized assessment. The individualized approach the Agency has adopted appropriately balances the safety of the motoring public with encouraging ITDM individuals to seek proper treatment and to comply with the rule's requirements.

The Agency emphasizes that a TC is not determining whether the ITDM individual is qualified to operate a CMV following a severe hypoglycemic episode. Rather, a TC's role continues to be limited to determining whether the ITDM individual has a stable insulin regimen and properly controlled ITDM.

FMCSA has considered the comments to the effect that severe hypoglycemic episodes that occur when an ITDM individual is off duty have no effect on safety. The Agency has revised the definition to clarify that the episodes of hypoglycemia that trigger the prohibition from operating a CMV and the reporting requirement are only those that are

severe.

FMCSA has concluded that it is in the interest of safety to require that ITDM individuals seek treatment after having experienced any severe hypoglycemic episode to ensure that the cause of the episode has been addressed.

FMCSA also declines to establish by regulation that any particular number of severe hypoglycemic episodes automatically disqualifies an ITDM individual from operating a CMV. Such a requirement would be contrary to the individualized assessment approach adopted in this rule. Instead, TCs will consider prior episodes of severe hypoglycemic episodes in determining whether an individual has a stable insulin regimen and properly controlled ITDM. Additionally, certified MEs will be aware of prior episodes via the ITDM Assessment Form, MCSA-5870, provided at any subsequent medical qualification examination.

FMCSA notes that the existing requirement that a new medical examination and certification must be obtained when an individual has a physical or mental injury or disease that impairs the individual's ability to perform his or her normal duties

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could, depending on the circumstances, be applicable to the ITDM individual who experiences a severe hypoglycemic episode. Such ITDM individuals would be subject to a new evaluation by the TC, including completion of a new ITDM Assessment Form, MCSA-5870, and subsequent medical examination by the certified ME.

17

Now recodified without change in 49 CFR 391.45(f) by this final rule.

FMCSA declines to define or establish by regulation a moderate hypoglycemic episode as a disqualifying event. FMCSA expects the TC to evaluate a moderate hypoglycemic episode and any other diabetic complications in determining whether the individual maintains a stable insulin regimen and proper control of his or her ITDM.

The Agency developed the ITDM Assessment Form, MCSA-5870, that gathers information about an individual's diabetes and addresses many of the commenters' concerns. The Agency has concluded, through the completion of the form and evaluation of available subjective and objective clinical data, such as interviewing the individual and reviewing blood glucose records for fluctuations over time, that the TC is equipped to provide an appropriate assessment for the certified ME to review.

M. Hypoglycemia Unawareness

NPRM:

The proposed rule did not address hypoglycemic events occurring without prior warning, also known as hypoglycemia unawareness.

Comments on Hypoglycemia Unawareness and Hypoglycemia Unawareness Training:

The former MRB members commented that, to be qualified to drive, the ITDM individual should not experience hypoglycemia unawareness. The ATA added that the certified ME or TC should evaluate whether the individual has experienced any episodes of hypoglycemia unawareness. In terms of hypoglycemia awareness training, several commenters recommended that FMCSA require this training as a part of the diabetes qualification process to prevent an ITDM individual from experiencing a hypoglycemic episode while operating a CMV. Commenters who supported this requirement include Advocates, H&SW, the ACOEM, and TFAC. Comments on this topic included how often ITDM individuals should attend training sessions and how they should provide documentation to prove their attendance.

2015 MRB Report:

The MRB recommended in its report that an ITDM individual who had hypoglycemia unawareness within the previous 6 months be disqualified from operating a CMV for at least 6 months.

Comments on the MRB's Report on Hypoglycemia Unawareness:

Commenters generally agreed that impaired awareness of hypoglycemia is incompatible with driving and asked FMCSA to clarify the definition of hypoglycemia unawareness. For example, an MD suggested defining hypoglycemia unawareness as hypoglycemia under 50 ml/dL appearing in the absence of warning symptoms. The MD noted that symptoms of hypoglycemia in many well-controlled ITDM individuals without hypoglycemia unawareness do not arise until the glucose level is under 50, so clinicians may mistakenly label individuals as having hypoglycemia unawareness. The MD agreed, however, that an episode of hypoglycemia unawareness, as he defined it, should result in disqualification for 6 months.

On the other hand, most commenters indicated that a 6-month disqualification period is too long. An endocrinologist stated that the period of 6 months is arbitrary, and, in her opinion, unreasonable and discriminatory. Comments included the view that a single episode of hypoglycemia unawareness should not be disqualifying, and that such episodes need to be recurring or ongoing. The ADA and an endocrinologist indicated that ITDM individuals should be allowed to return to driving once the appropriate measures to avoid hypoglycemia and create awareness have been established.

While some commenters indicated that an ITDM individual should be reinstated once the hypoglycemic unawareness issue is resolved, the University of Utah stated that there should be a minimum, perhaps 6 months, of blood glucose logs and symptom reviews to ascertain that the individual had regained awareness of hypoglycemia. The ACOEM stated that if an ITDM individual with hypoglycemia unawareness is later able to demonstrate hypoglycemia awareness and is certified, but hypoglycemia unawareness recurs, that individual should be permanently disqualified. The ACOEM commented further that, if an ITDM individual is not experiencing awareness of a blood glucose level below 60 mg/dL, the individual should be permanently barred from operating a CMV.

FMCSA Response:

FMCSA has determined that hypoglycemia unawareness on its own should not be considered for medical qualification. Hypoglycemia unawareness would be considered by the TC in determining whether the individual has a stable insulin regimen and proper control of his or her ITDM. Due to the individualized effect of occurrences of hypoglycemia unawareness, the assessment, evaluation, and treatment for this condition should be a component of the TC's individualized management for a stable insulin regimen and proper control of the ITDM individual's diabetes. To assist the TC in educating ITDM individuals regarding hypoglycemic unawareness, FMCSA is planning to develop education and outreach information to promote recognition of hypoglycemia unawareness.

N. Blood Glucose Self-Monitoring

NPRM:

During the period of medical certification, the NPRM required the ITDM individual to monitor and maintain blood glucose records as determined by the TC. The ITDM individual would submit those records to the TC at the time of evaluation. The NPRM did not propose a minimum insulin use period for new or established ITDM individuals to be eligible for medical certification.

Comments on Blood Glucose Self-Monitoring:

Some commenters, including a retired FAA safety inspector, the former MRB members, an RN, the ACOEM, and H&SW, recommended a specific schedule for blood glucose monitoring. Commenters generally suggested testing prior to driving and then every 4 to 6 hours while driving. The retired FAA safety inspector recommended the most frequent monitoring, with testing 1 hour before driving and at least every 2 hours while driving.

The ACOEM recommended that a log be required consisting of at least 2 weeks of testing four times per day (before meals and at bedtime). It would require the blood glucose log to be downloaded and printed directly from the glucometer—no typed or handwritten logs—and to have a time stamp for each blood glucose value.

Concentra stated that FMCSA should discuss the criteria for self-monitoring blood glucose while driving. A diabetes educator stated that ITDM individuals should follow up at least every 6 months with an endocrinologist who would download their blood glucose readings. SOCO also recommended that a glucose log be maintained for review by the treating doctor.

Advocates was concerned about the lack of definitions for “appropriate ranges” and “management.” To support and document the conclusions of the TC, Advocates recommended that the Agency require ITDM individuals to submit blood glucose records for a specified time prior to the medical evaluation. Advocates indicated that leaving the definition of the appropriate level of reporting to the TC could encourage TC shopping.

The IBT and Concentra asked for clarification on how long insulin must be used before an ITDM individual can be certified to drive. The AAPA-OM commented that an ITDM individual must be on insulin for at least 2 years prior to certification. The ACOEM wrote that FMCSA should require a new insulin user to demonstrate stability, control, and lack of hypoglycemia over a period of time before being medically cleared for driving; this monitoring cycle could be more frequent at the discretion of the TC and the certified ME. The ACOEM commented that the Law Enforcement Officer Medical Guideline requires 3 months of stable insulin regimen for individuals on insulin for treatment of type 2 diabetes mellitus, and 6 months for individuals on insulin for treatment of type 1 diabetes mellitus. If the individual is on an insulin pump, the ACOEM would require the TC to send the certified ME a summary report on the use of the pump.

2015 MRB Report:

The MRB report recommended that the suggested ITDM form request information on how many times per day the individual is testing blood glucose. It also suggested that ITDM individuals test blood glucose before driving and every 4 hours while driving.

The MRB recommended that the form request information about whether an individual on insulin with type 2 diabetes has been on a stable medication regimen for 3 months prior to evaluation by the TC. For individuals who have been newly diagnosed with type 1 diabetes, the minimum period of insulin use to establish medication regimen stability would be not less than 2 months. For individuals who have type 2 diabetes and are converting to insulin use, the minimum period of insulin use to establish medication regimen stability would be not less than 1 month.

The MRB specified that all ITDM individuals must have documentation of ongoing self-monitoring of blood glucose; however, established insulin users must have records covering a minimum of the most recent 3 months. This monitoring must be done using a finger stick glucose meter that stores every reading and records date and time of the readings, which the user can download. Handwritten blood glucose records would not be acceptable. The MRB recommended that an ITDM individual be disqualified for an inadequate record of self-monitoring blood glucose, “

i.e.,

unreliable or absent capillary blood glucose measurements.” This disqualification would last until the individual could demonstrate adequate evidence of glucose records, and a minimum of 1 month.

Comments on the MRB's Report on Blood Glucose Self-Monitoring:

The University of Utah commented that the wording “[i]nadequate record of self-monitoring of blood glucose” was “insufficiently clear.” It recommended that it be specified how many readings can be missing over what period. It suggested considering blood glucose self-monitoring five times per day on days spent driving and four times per day on other days. The ACOEM asked what would be defined as adequate self-monitoring, which may differ based on the treatment. If left to the examiner to determine, the ACOEM commented that the examiner must be someone who can evaluate and treat individuals who use insulin. The ACOEM asked if the monitoring criteria would mirror the exemption program—prior to driving and every 4 hours while driving.

The ADA agreed with the importance of reviewing blood glucose records as part of an individualized assessment of an ITDM individual. It was concerned that the adequacy of records was referenced, but left undefined. The ADA stated that the adequacy of the records should be determined only by the TC. The ADA stated that it is inappropriate for the certified ME or anyone else to determine how often an ITDM

individual should be testing blood glucose.

The ADA was the only commenter that discussed the length of time an ITDM individual should be on insulin before being eligible to be medically certified. It noted the discrepancy between requiring an individual with type 2 diabetes treated with insulin to be on a stable medication regimen for 3 months, and the recommendation that an individual with type 2 diabetes converting to insulin use be using insulin for not less than 1 month. The ADA commented that these two standards should be the same and follow the criteria of the existing exemption program, which requires that an individual with type 2 diabetes use insulin for 1 month prior to eligibility for medical certification.

In terms of disqualification for inadequate records, the ADA stated that an ITDM individual should never be disqualified on the assumption that the individual's records of blood glucose monitoring are inadequate. An individual stated that the rule should allow for extenuating circumstances beyond the ITDM individual's control, such as difficulties with the blood glucose monitor. In such circumstances, the commenter felt it would be unfair to penalize the individual.

Some commenters wanted the rule to do more to increase the likelihood that an ITDM individual would keep blood glucose records. The University of Utah wanted a mechanism in the rule to assure ongoing compliance with blood glucose monitoring requirements. Concentra was concerned that an ITDM individual who was certified and became non-compliant would be able to continue to drive without FMCSA's knowledge. It stated that there should be a mechanism in place to require the TC to notify FMCSA if the individual becomes non-compliant or discharges the TC. H&SW wrote that the ITDM individual has “additional impetus to keep blood glucose logs when a regulation requires it.” A physician recommended that patients who have type 1 diabetes mellitus for over 5 years use continuous glucose sensors to minimize their risk of driving while hypoglycemic to ensure safety for the others on the road.

FMCSA Response:

FMCSA agrees with the 2015 MRB recommendations and other commenters that a requirement for a period of blood glucose self-monitoring records should be included in the final rule. The final rule requires that all ITDM individuals must provide at least the preceding 3 months of blood glucose self-monitoring records while being treated with insulin to the TC to be eligible for up to the maximum 12-month MEC, MCSA-5876. If an individual does not provide the 3 months of records, the certified ME has discretion to grant the individual up to but not more than a 3-month MEC, MCSA-5876, to allow time for the individual to collect the necessary records. Once the individual has 3 months of blood glucose self-monitoring records, the individual is treated the same as an ITDM individual with 3 months of records. The individual must first go to the TC for evaluation and then to the certified ME, who must exercise independent medical judgment, to determine if the individual is eligible for up to the maximum 12-month MEC, MCSA-5876.

FMCSA has included the 3-month requirement for blood glucose self-monitoring records while being treated with insulin for all ITDM individuals. FMCSA has determined that there is no basis to differentiate blood glucose self-monitoring record requirements based on whether individuals have been newly diagnosed with type 1 diabetes or have type 2 diabetes and are converting to insulin use because both categories are beginning the use of insulin.

The Agency is requiring 3 months of records because this timeframe provides current blood glucose self-monitoring records to the TC, and is generally consistent with medical practice standards for follow-up visits for ITDM individuals. The Agency finds that this is a balanced approach for ITDM individuals that allows time to demonstrate a stable insulin regimen and proper control of ITDM, while providing enough information for the certified ME to determine whether the individual can safely operate a CMV.

The final rule does not establish the specific frequency of blood glucose monitoring. FMCSA finds that any regulatory requirement that specifies monitoring frequency does not support the intent of the rule for individualized assessment. Rather, the rule provides that ITDM individuals must self-monitor blood glucose in accordance with the specific treatment plan prescribed by the TC.

The TC is most familiar with the ITDM individual's medical history. As such, the TC is in the best position to determine the specific blood glucose monitoring plan, including monitoring requirements while driving a CMV, and whether the submitted blood glucose self-monitoring records are consistent with the plan. The Agency finds that this rule encourages the maintenance of blood glucose records in a manner that is focused on good monitoring practices, as well as maintaining proper control of the individual's diabetes and the overall health of the individual. Because daily testing and recording of results are routine aspects of managing ITDM, the rule's requirements do not impose any additional burden on ITDM individuals.

ITDM individuals must self-monitor blood glucose in accordance with the specific treatment plan prescribed by the TC. They must maintain blood glucose records measured with an electronic glucometer that stores all readings, that records the date and time of readings, and from which data can be electronically downloaded. A printout of the electronic blood glucose records or the glucometer must be provided to the TC at the time of any evaluation. Handwritten blood glucose records are not acceptable. As long as the ITDM individual can satisfy the foregoing requirements, the self-monitoring may be performed by finger stick or continuous glucose sensor.

O. Requirement To Carry Readily-Absorbable Glucose

NPRM:

In the NPRM, FMCSA did not propose that ITDM individuals must carry readily-absorbable glucose, which is required under the existing exemption program.

Comments on the Requirement to Carry Readily-Absorbable Glucose:

H&SW, Concentra, and a certified ME/physician commented that ITDM individuals should have readily-absorbable glucose within reach while driving to mitigate the risk of severe symptoms developing from a hypoglycemic episode. TFAC, on the other hand, stated that the requirement to carry readily-absorbable glucose is overly burdensome and would not improve safety.

2015 MRB Report:

The 2015 MRB report did not address carrying readily-absorbable glucose. No comments were received concerning the MRB report in this regard.

FMCSA Response:

The final rule does not require that ITDM individuals carry a readily-absorbable form of glucose. FMCSA finds that treatment for potential hypoglycemia is more appropriately a component of diabetes management as instructed by the TC rather than a mandate by a regulatory agency.

P. Diabetic Complications and Target Organ Damage

NPRM:

The NPRM proposed that ITDM individuals must meet the physical qualification standards in § 391.41 and be free of complications that might impair their ability to operate a CMV.

Comments on Diabetic Complications and Target Organ Damage:

Several commenters, including SOCO, the ATA, the NTSB, and the ACOEM, indicated that FMCSA should require evaluation of ITDM individuals to make sure that they do not show signs of diabetic complications or target organ damage. Commenters wanted ITDM individuals to be evaluated for complications such as diabetic neuropathy, paresthesia, and proprioception. Commenters also stated that ITDM individuals' kidney function should be evaluated by measuring creatinine. The ACOEM provided that an ITDM individual with kidney function worse that stage 3 should not be qualified. If the ITDM individual had stage 2 kidney function, the individual should be more closely monitored.

The ACOEM added that ITDM individuals have the same cardiovascular risk as someone with established coronary artery disease; thus, cardiovascular risk factors should be evaluated. The ACOEM recommended that ITDM individuals who meet certain Cardiovascular Advisory Panel Guidelines should be subject to the same medical qualifying criteria as those individuals with known coronary heart disease, including an exercise stress test. If there is evidence of ischemia, or the left ventricular ejection fraction is less than 40 percent, then the individual would be deemed ineligible for certification. SOCO also commented that FMCSA should require evaluation and documentation of the presence of coronary atherosclerosis and peripheral or cerebral vascular disease. Concentra commented that the safety risks from long-term co-morbidities are too great not to be defined and that FMCSA should review the criteria with leading endocrinologists who specialize in diabetes. The NTSB wrote that many ITDM complications cannot be identified by a routine physical examination.

2015 MRB Report:

The MRB report recommended that, if there were signs of target organ damage, as evidenced by peripheral neuropathy, diabetic nephropathy, or cardiovascular disease, with the risk of impairing the ability to operate a CMV safely, an ITDM individual would be disqualified until the problem was resolved by treatment, if possible.

Comments on the MRB's Report for Diabetic Complications and Target Organ Damage:

The ACOEM and the ADA supported the MRB recommendation, but the ACOEM added that there should not be a risk of the target organ damage recurring. An individual commented that the only factor should be whether the complication impairs the individual's ability to safely operate a CMV. An MD commented that the language “signs of target organ damage” is not specific and may not be an appropriate disqualifier. The MD recommended that the query should be whether symptomatic target organ damage is present that could render an ITDM individual unsafe to operate a CMV. If so, the ITDM individual should be disqualified until the matter is resolved by treatment.

The University of Utah stated that the phrase “[d]isqualification until resolved by treatment, if possible” is unclear. It noted that one could not resolve a heart attack by treatment and generally it is impossible to completely resolve neuropathy. This commenter recommended that those with four or more multiple conditions should be precluded from driving. For nephropathy, the prior Renal Medical Expert Panel and MRB recommendations should be applied, including staging of the nephropathy.

Concentra asked for specific direction regarding the diagnostic tests, including their frequency, that should be used to evaluate cardiovascular disease and diabetic nephropathy in ITDM individuals. It also asked that FMCSA clearly define the severity of diabetic nephropathy that would warrant disqualification.

FMCSA Response:

In the final rule, the Agency continues to require that an ITDM individual must meet the physical qualification standards in § 391.41, have an exemption unrelated to diabetes, or have a Skill Performance Evaluation Certificate, if required. With the exception of diabetic retinopathy, the Agency declines to establish specific regulatory requirements pertaining to complications that may arise from diabetes.

The TC for the ITDM individual is best suited to provide information regarding diabetes complications. Moreover, the ITDM Assessment Form, MCSA-5870, adopted in this rule includes specific questions for the TC to identify diabetes complications and possible target organ damage. In making the final medical certification decision, the certified ME will consider the TC's information provided on the form in determining whether the individual meets the physical qualification standards to safely operate a CMV. FMCSA notes that the target organ complications associated with diabetes can result from any number of other medical conditions that certified MEs evaluate. Therefore, certified MEs should be familiar with the medical certification process involving such conditions.

FMCSA agrees with the MRB that an individual who has a complication from diabetes that interferes with safely operating a CMV should not be medically qualified to operate a CMV. The Agency finds, however, that diabetes complications should not automatically preclude medical certification. Such determinations should be based on an individualized assessment and the severity of symptoms. A complication becomes a disqualifying factor only if it impairs the ability to operate a CMV safely. As an alternative to disqualification, a certified ME may determine that an ITDM individual is unqualified until treatment is received and appropriate intervention mitigates or addresses the problem.

Q. Motor Carrier Responsibility To Enforce the ITDM Standard

NPRM:

FMCSA did not propose any new requirements for motor carriers to enforce the ITDM physical qualification standard.

Comments on Motor Carrier Responsibility to Enforce the ITDM Standard:

The ATA stated that no responsibility for monitoring and submitting compliance information should fall on the motor carrier; instead, it wrote this responsibility most appropriately resides with the certified MEs, TCs, and the ITDM individuals. However, the ATA did want motor carriers to retain access to the health information available on the “medical long form” and other sources to monitor compliance with § 392.3. ABA stated that passenger carriers should not be “placed at the risk of assessing the medical condition of a driver or whether the driver is vigilant in maintaining [his or her] condition.”

2015 MRB Report:

The MRB did not address the issue of motor carriers enforcing the ITDM standard. No comments were received concerning the MRB report in this regard.

FMCSA Response:

The final rule revises the physical qualification standard for ITDM individuals, but does not create any new or additional monitoring or compliance requirements for motor carriers beyond those already set out in general terms in the FMCSRs.

See

49 CFR 390.11, 391.11(a), and 391.41(a). The provisions of § 392.3 relate only to determining whether to allow an ill or fatigued individual to operate a CMV. The rule does not require access to any medical records, such as an individual's Medical Examination Report Form, MCSA-5875, to make that determination.

R. ITDM Individuals Operating CMVs Transporting Passengers or Hazardous Materials

NPRM:

FMCSA did not propose to restrict ITDM individuals from being medically qualified to operate CMVs carrying passengers or hazardous materials but indicated that the MRB recommended in 2007 that ITDM individuals be restricted from passenger and hazardous materials transportation. The Agency requested public comment on this issue.

Comments on ITDM Individuals Operating CMVs Transporting Passengers or Hazardous Materials:

The ADA, the IBT, OOIDA, and the Illinois Office of the Secretary of State supported allowing ITDM individuals to continue to operate CMVs carrying passengers or hazardous materials. These commenters agreed with FMCSA that the risk pos

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