Document ID: FMCSA-2005-23151-1391
Agency: fmcsa
Document Type: Proposed Rule
Title: Insulin Treated Diabetes Mellitus and Commercial Motor Vehicle Drivers
Posted Date: 2016-09-09T04:00Z

[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Proposed Rules]
[Pages 62448-62450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21724]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Part 391

[Docket No. FMCSA-2005-23151]
RIN 2126-AA95

Medical Review Board Task Report on Insulin Treated Diabetes 
Mellitus and Commercial Motor Vehicle Drivers

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of availability; request for comments.

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SUMMARY: In May 2015, FMCSA published a notice of proposed rulemaking 
(NPRM) in the Federal Register to allow drivers with stable, well-
controlled insulin-treated diabetes mellitus (ITDM) to be qualified to 
operate commercial motor vehicles (CMVs) in interstate commerce. The 
comment period closed on July 6, 2015 and the Agency received over 
1,250 comments. In that same month, FMCSA requested the Medical Review 
Board (MRB) to provide the Agency with advice by reviewing and 
analyzing the comments and providing recommendations to FMCSA for its 
consideration. The Agency announces the availability of the MRB's 
report and requests comments on the MRB recommendations. The Final MRB 
Task 15-01 Report is posted in the docket at FMCSA-2005-23151.

DATES: Comments must be received on or before November 8, 2016.

ADDRESSES: You may submit comments bearing the Federal Docket 
Management System (FDMS) Docket No. FMCSA-2005-23151 using any of the 
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of 
Transportation, Room W12-140, 1200 New Jersey Avenue SE., Washington, 
DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room 
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 
5 p.m., ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include FMCSA and docket number FMCSA-2005-
23151. Note that DOT posts all comments received without change to 
www.regulations.gov, including any personal information included in a 
comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or 
comments, go to www.regulations.gov at any time or visit Room W12-140 
on the ground level of the West Building, 1200 New Jersey Avenue SE., 
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, 
except Federal holidays. The on-line FDMS is available 24 hours each 
day, 365 days each year. If you want acknowledgment that we received 
your comments, please include a self-addressed, stamped envelope or 
postcard or print the acknowledgement page that appears after 
submitting comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), 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.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, 1200 New 
Jersey Ave. SE., Washington, DC 20590, or by phone 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:

I. Public Participation and Request for Comments

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

Submitting Comments

    If you submit a comment, please include the docket number for this 
notice (FMCSA-2005-23151), indicate the specific section of this 
document to which each comment applies, and provide a reason for each 
suggestion or recommendation. You may submit your comments and material 
online or by fax, mail, or hand delivery, but please use only one of 
these means. FMCSA recommends that you include your name and a mailing 
address, an email address, or a phone number in the body of your 
document so that FMCSA can contact you if there are questions regarding 
your submission.
    To submit your comment online, go to http://www.regulations.gov, 
put the

[[Page 62449]]

docket number, FMCSA-2005-23151, in the keyword box, and click 
``Search.'' When the new screen appears, click on the ``Comment Now!'' 
button and type your comment into the text box on the following screen. 
Choose whether you are submitting your comment as an individual or on 
behalf of a third party and then submit. If you submit your comments by 
mail or hand delivery, submit them in an unbound format, no larger than 
8\1/2\ by 11 inches, suitable for copying and electronic filing. If you 
submit comments by mail and would like to know that they reached the 
facility, please enclose a stamped, self-addressed postcard or 
envelope.
    FMCSA will consider these comments, in addition to the comments 
submitted in response to the NPRM, in determining how to proceed with 
this rulemaking.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this notice 
as being available in the docket, go to http://www.regulations.gov. 
Insert the docket number, FMCSA-2005-23151, in the keyword box, and 
click ``Search.'' Next, click the ``Open Docket Folder'' button and 
choose the document to review. If you do not have access to the 
Internet, you may view the docket online by visiting the Docket 
Management Facility in Room W12-140 on the ground floor of the DOT West 
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 
a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays.

II. Background

    Diabetes mellitus is a disease manifested by the body's inability 
to maintain normal function of insulin, a substance that controls 
glycemic levels in the blood. Diabetes presents a major health 
challenge, particularly those who drive CMVs in interstate commerce. 
Under 49 CFR 391.41(b)(3), a person is physically qualified to drive a 
commercial motor vehicle if that person has no established medical 
history or clinical diagnosis of diabetes mellitus currently requiring 
insulin for control. Since 2003, FMCSA has maintained an exemption 
program for individuals that use insulin to treat their diabetes 
mellitus, that allows them to drive in interstate commerce if their 
diabetes is stable and they meet criteria of the program. 68 FR 52441 
(Sept. 3, 2003), as revised, 70 FR 67777 (Nov. 8, 2005).
    In May 2015, FMCSA issued an NPRM in the Federal Register to allow 
drivers with stable, well-controlled ITDM to be qualified to operate 
CMVs in interstate commerce. The NPRM would enable individuals with 
ITDM to obtain a Medical Examiner's Certificate (MEC) from a Certified 
Medical Examiner (CME) at least annually in order to operate in 
interstate commerce as long as evidence is presented by the treating 
clinician who prescribes insulin documenting that the driver's 
condition is stable and well-controlled. The comment period on the NPRM 
closed on July 6, 2015, and the Agency received more than 1,250 
comments.

MRB Tasking

    The MRB was established to provide FMCSA with medical advice and 
recommendations on medical standards and guidelines for the physical 
qualifications of operators of CMVs, medical examiner education, and 
medical research. 49 U.S.C. 31149(a)(1). The MRB, in view of its 
statutory creation and advisory function, is chartered by the 
Department of Transportation as an advisory committee under the 
provisions of the Federal Advisory Committee Act. 5 U.S.C. App. See 
http://www.facadatabase.gov/committee/committee.aspx?cid=2084&aid=47. 
See also Announcement of Establishment of the Federal Motor Carrier 
Safety Administration Medical Review Board, 70 FR 57642 (Oct. 3, 2005). 
The members of the MRB are appointed by the Secretary to reflect 
expertise in a variety of medical specialties relevant to the driver 
fitness requirements of FMCSA. 49 U.S.C. 31149(a)(2).
    In an effort to assist in the development of the final rule, on 
July 15, 2015, FMCSA requested advice from the MRB for the Agency to 
consider. Specifically, FMCSA asked the members to review and analyze 
all comments from medical professionals and associations, and identify 
factors the Agency should consider when making a decision about the 
next steps in the diabetes rulemaking. A public meeting to discuss this 
matter was held by the MRB on July 21 and 22, 2015. The Agency received 
the MRB's final report on September 1, 2015. Details of the meeting, 
including the original task, final report and supporting materials used 
by the MRB are posted on the Agency's public Web site: https://www.fmcsa.dot.gov/medical-review-board-mrb-meeting-topics.

MRB Final Report

    The MRB's final report is available in the docket for this 
rulemaking (in addition to being available on the Agency's public Web 
site). The final report contains a number of detailed recommendations 
for FMCSA to consider as it develops a final rule. The Agency believes 
that public comment on the recommendations will assist it in evaluating 
the advice it has received from the MRB. Comments must be limited to 
addressing the recommendations in the MRB final report. A summary of 
the report's major recommendations is set out below:
    The MRB recommended that ITDM drivers be medically disqualified 
unless they meet the following requirements demonstrating their stable, 
well-controlled ITDM:
    1. The driver must provide an FMCSA Drivers With Insulin Treated 
Diabetes Mellitus Assessment Form (set out in the recommendations) to a 
medical examiner that has been completed and signed by the treating 
clinician. The treating clinician must be a Doctor of Medicine, a 
Doctor of Osteopathy, a Nurse Practitioner or a Physician's Assistant 
who prescribed insulin to the driver and is knowledgeable regarding the 
treatment of diabetes.
    2. The driver must receive a complete ophthalmology or optometry 
exam, including dilated retinal exam, at least every 2 years 
documenting the presence or absence of retinopathy/macular edema and 
the degree of retinopathy and/or macular edema if present (using the 
International Classification of Diabetic Retinopathy and Diabetic 
Macular Edema).
    The MRB recommended that medical examiners be allowed to certify an 
ITDM driver as medically qualified for a time period of no longer than 
1 year only if the driver has not experienced any of the 8 
disqualifying factors below (which the MRB believes should be listed in 
49 CFR 391.46):
    1. Any episode of severe hypoglycemia within the previous 6 months.
    2. Blood sugar less than 60 milligrams per deciliter (mg/dL) 
demonstrated in current glucose logs.
    3. Hypoglycemia appearing in the absence of warning symptoms (i.e., 
hypoglycemic unawareness).
    4. An episode of severe hypoglycemia, blood sugar less than 60 mg/
dl, or hypoglycemic unawareness within the previous 6 months; the 
driver should be medically disqualified and must remain disqualified 
for at least 6 months.
    5. Uncontrolled diabetes, as evidenced by Hemoglobin A1c (HbA1c) 
level greater than 10 percent. A driver could be reinstated when HbA1c 
level is less than or equal to 10 percent.
    6. Stage 3 or 4 diabetic retinopathy; a driver should be 
permanently disqualified.
    7. Signs of target organ damage; a driver should be disqualified 
until the

[[Page 62450]]

matter is resolved by treatment, if possible.
    8. Inadequate record of self-monitoring of blood glucose; a driver 
should be disqualified for inadequate records until the driver can 
demonstrate adequate evidence of glucose records (minimum 1 month).
    In addition, the MRB stated that, if a driver is medically 
disqualified due to not meeting the ITDM criteria listed above, the 
driver should remain disqualified for at least 6 months.

Comments Requested

    Comments are requested on any and all of the recommendations 
provided in the advisory final report from the Medical Review Board but 
only on those recommendations. To the extent possible, comments should 
include supporting materials, such as, for example, data analyses, 
studies, reports, or journal articles. FMCSA will consider these 
comments, in addition to the comments submitted in response to the 
NPRM, in determining how to proceed with this rulemaking.

    Issued on: August 30, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-21724 Filed 9-8-16; 8:45 am]
BILLING CODE 4910-EX-P