Medical Review Board Task Report on Insulin Treated Diabetes Mellitus and Commercial Motor Vehicle Drivers |
|---|
|
Larry W. Minor
Federal Motor Carrier Safety Administration
9 September 2016
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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