[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Notices]
[Pages 60137-60140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24150]


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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2019-0899]


Special-Issuance Medical Certification: Diabetes Protocol for 
Applicants Seeking To Exercise Airline Transport, Commercial, or 
Private Pilot Privileges

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice; request for comment.

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SUMMARY: With this notice, the Federal Aviation Administration (FAA) 
informs applicants for airman medical certification with insulin-
treated diabetes mellitus (ITDM) of a new protocol available to 
evaluate pilots seeking to exercise pilot privileges as airline 
transport, commercial, or private pilots. The FAA may only certificate 
pilots with ITDM through the special-issuance process with case-by-case 
assessment of overall risk and available risk mitigation. Previously 
available medical science, treatment, and monitoring have allowed the 
FAA to safely provide special issue third-class medical certificates 
for private pilot privileges since 1996, but was not sufficient to meet 
the higher levels of safety demanded for applicants considered for 
airline transport or commercial pilot duties. The new FAA risk 
assessment protocol, based on established advances in medical science 
since 1996, makes it possible to mitigate flight safety risk so that 
applicants seeking first- or second-class special-issuance medical 
certification may be considered for the exercise of either airline 
transport or commercial pilot privileges. Applicants for third-class 
special issuance may apply under the existing third-class-only protocol 
or the new protocol.

DATES: The protocol is effective November 7, 2019.
    Send comments on or before January 6, 2020.

ADDRESSES: You may send comments identified by docket number FAA-2019-
0899 using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your 
comments electronically.
     Mail: Docket Operations, M-30; U.S. Department of 
Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West 
Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket 
Operations in Room W12-140 on the ground floor of the West Building, 
1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at 202-493-2251.
    Privacy: 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 http://www.regulations.gov.
    Docket: Background documents or comments received may be read at 
http://www.regulations.gov at any time. Follow the online instructions 
for accessing the docket or go to the Docket Operations in Room W12-140 
of the West Building Ground Floor at 1200 New Jersey Avenue SE, 
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, 
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Judi Citrenbaum, Office of Aerospace 
Medicine, Federal Aviation Administration, 800 Independence Avenue SW, 
Washington, DC 20591; telephone (202) 267-9689, email. 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

FAA Experience Applying Special-Issuance Procedures for Diabetes

    Under Title 14 of the Code of Federal Regulations (14 CFR), 
Sec. Sec.  67.113(a), 67.213(a), and 67.313(a), insulin-treated 
diabetes mellitus (ITDM) is considered medically disqualifying for 
pilots. The Federal Air Surgeon has discretion under 14 CFR 67.401 to 
authorize special issuance of airman medical certificates to applicants 
who are otherwise disqualified. Historically, the FAA has used this 
discretion to special issue only third-class medical certificates to 
applicants with ITDM

[[Page 60138]]

seeking to exercise private pilot privileges.
    In determining whether an authorization for special issuance may be 
granted to an applicant, the Federal Air Surgeon considers whether the 
privileges permitted by the class of medical certificate requested can 
be performed without endangering public safety for the duration of the 
medical certificate. The FAA must always consider risk when 
implementing its licensing and credentialing programs, and the medical 
certification process is no exception. As specified in 14 CFR 67.401, 
the Federal Air Surgeon ``considers the freedom of an airman, 
exercising the privileges of a private pilot certificate, to accept 
reasonable risks to his or her person and property that are not 
acceptable in the exercise of commercial or airline transport pilot 
privileges, and, at the same time, considers the need to protect the 
safety of persons and property in other aircraft and on the ground.'' 
Much less risk is acceptable in the exercise of commercial or airline 
transport pilot privileges in order to protect public safety.
    Long-term medical risks associated with diabetes include 
cardiovascular, neurological, ophthalmological, and renal 
complications. These factors pose additional hazards to aviation and 
require special scrutiny. Of particular concern with insulin-treated 
diabetes, more so than for oral hypoglycemic treated diabetes, is the 
short-term or immediate risks posed by hypoglycemia or low blood 
glucose. Hypoglycemia can produce impaired cognitive function, 
seizures, unconsciousness, and even death. The functional 
incapacitation associated with hypoglycemia may occur subtly and be 
undetected by the individual or others. Inadequately controlled 
diabetes (with resulting high blood sugar [hyperglycemia]) also can 
lead to impaired function and, effectively, incapacitation. Thus, the 
symptoms that result from both diabetes and its treatment can affect 
flight safety.
    The FAA has incrementally updated the special-issuance medical 
certification protocol for applicants with diabetes. The FAA initially 
did so, in the early 1980's, for individuals who control their diabetes 
with diet and non-insulin hypoglycemic drugs. In 1996, the FAA began 
allowing insulin use for third-class medical certification, which 
limits the applicant to exercising private pilot privileges. This 
incremental approach has been very successful, and the FAA has now 
authorized approximately 500 ITDM pilots for third-class medical 
certification. The third-class special issuance protocol, in part, 
requires a process of finger-stick glucose testing before and during 
flight. The agency has a separate, internal program under FAA Order 
3930.3B (Air Traffic Control Specialist Health Program) to permit FAA 
Air Traffic Control Specialists (ATCSs) with ITDM to continue their 
safety-related duties.
    Applicants with diabetes considered for third-class, special-
issuance medical certification are carefully evaluated and must submit 
to monitoring under a specific medical protocol, just as they would for 
any other specifically disqualifying medical condition under Part 67. 
Special-issuance conditions include careful evaluation of the 
individual's medical history, risk stratification, and the efficacy of 
the individual in controlling the disease. To develop diabetes 
protocols, the FAA considered the input of expert endocrinologists and 
diabetes specialists. The FAA continually reviews its protocols (for 
diabetes and other diseases) to ensure they remain viable and 
appropriate given ever-evolving medical advances. In this regard, the 
agency validates its experience and ensures that safety of flight is 
maintained.

Discussion

Recommendations To Expand the Protocol

    Authorization for ITDM pilots to exercise pilot privileges beyond 
private pilot has been a topic of much discussion for several years 
within the aviation sector. While the FAA has discretion under Sec.  
67.401 to consider allowing ITDM special issuance for higher-rated 
pilots, it has chosen to proceed cautiously. The American Diabetes 
Association and several affected pilots have urged the FAA to update 
its special-issuance process for ITDM beyond third-class medical 
certification by developing an ITDM special-issuance protocol to allow 
the exercise of commercial and airline transport pilot privileges.
    In 2013, the FAA suggested the American Diabetes Association 
consider convening a panel of experts to recommend how to risk stratify 
ITDM pilots for consideration beyond the private pilot certification 
level, to include recommending a protocol for identifying a subset of 
individuals at very low risk for hypoglycemia. The American Diabetes 
Association panel concluded that updating the protocol to airline 
transport and commercial pilots was justified. In their findings 
submitted to the FAA, the ADA panel indicated the following:

    The treatment of insulin treated diabetes has improved 
dramatically over the past thirty-five years with the advent of 
accurate determinations of blood glucose levels using meters with 
sophisticated memory chips and built in analytical programs. These 
developments also include continuous glucose monitors, continuous 
subcutaneous insulin infusion pumps, and improvements in short and 
long acting insulin analogues. These improvements permit real-time 
measurement of blood glucose levels, and have made it far easier for 
people with insulin treated diabetes to maintain near-normal blood 
glucose levels. This, in turn, dramatically reduces the risk of both 
short and long term complications of diabetes with significant 
reduction in the rate of both hyper- and hypoglycemic glucose 
levels. Careful monitoring and management of insulin treated 
diabetes is now routine and the processes involved have become 
streamlined such that school children often self-manage their 
glucose levels with minimal or no adult intervention.

    In addition, the ADA panel concluded the following:

    After considering all the evidence and clinical experience, the 
expert panel concluded that there are pilots with insulin treated 
diabetes whose risk of incapacitation in flight is equivalent to, or 
lower than pilots who do not have insulin treated diabetes. Their 
risk, like the risk presented by pilots who do not have insulin 
treated diabetes, is nonzero, but extremely improbable. It is the 
recommendation of the Expert Panel that FAA policy should be updated 
to reflect current diabetes medicine and permit such pilots medical 
certification at the first, second, and third class level.

    The FAA reviewed the ADA 2013 recommendations and determined they 
provided impetus for a way forward. At the time, however, FAA medical 
experts and consultants were not satisfied that the level of medical 
treatment and technology was sufficiently advanced to consider moving 
forward with higher-level ITDM certification. As such, the FAA 
continued to pursue identifying a protocol that could be used for 
identifying a subset of individuals at very low risk for hypoglycemia. 
Unable to identify such a subset, the FAA turned to its own data on 
third-class ITDM pilots.

FAA Study of Third-Class ITDM Protocol

    In 2015, the FAA Civil Aerospace Medical Institute (CAMI) evaluated 
the experience of U.S. private pilots flying with ITDM in a study 
entitled: ``Risk Assessment in the U.S. Pilot Population from 1983 to 
2005: Diabetes Prevalence and Flight Safety.'' \1\ CAMI conducted this 
study to evaluate trends for obesity and diabetes as reflected in the 
U.S. pilot population and explore the effects on flight safety and 
longevity of pilots

[[Page 60139]]

with these conditions. The study noted that the prevalence of diabetes 
and obesity has increased worldwide, almost doubling between 1980 and 
2014. This study found that the number of pilots with diabetes in the 
U.S. active pilot population rose from 2,768 in 1983 to 10,806 in 2005, 
an almost four-fold increase, reflecting both the increased prevalence 
in the population and the 1996 change in FAA policy. Limited prior 
evidence had suggested that aviators with reported diabetes controlled 
by hypoglycemic medication and diabetes controlled by diet alone were 
at greater accident risk than aviators without these conditions. The 
study reviewed NTSB accident reports from 1997-2005, reporting only 18 
general aviation events involving insulin-dependent pilots.\2\ Two 
accidents resulted in fatalities; one resulted in non-fatal injuries, 
and only one was conducted under instrument flight rules. All but one 
incident (mechanical, not pilot-related) were human factors-related and 
attributed to pilot error. The study concluded that, overall, the NTSB 
data did not indicate that diabetes directly contributed to the 
accidents.
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    \1\ See DOT/FAA/AM-15/5; March 2015.
    \2\ Id. at 11.
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Monitoring Innovations

    Subsequent to the 2015 CAMI study, the FAA continued to follow the 
advances in diabetes medical science, including innovative progress 
with diabetes treatment (e.g., medications), but most particularly with 
an individual's ability to efficiently self-monitor using continuous 
glucose monitoring (CGM) devices. CGM is wearable technology that 
provides a reliable and accepted means for accurately monitoring blood 
sugar levels, and predicting when a change is occurring. CGM 
monitoring, along with standard clinical follow up, reduces the risk of 
hypoglycemia, both inflight and outside the flight environment. CGM 
technology allows affected pilots to address their particular situation 
with good reassurance regarding short- and long-term stability. CGM 
usage allows the FAA to identify a low-risk subset and consider 
applicants whose glycemic stability is sufficiently controlled for 
safety of flight, even for commercial operations. Whereas the existing 
third-class protocol of finger-stick glucose testing before and during 
flight has proven sufficient at the private pilot level, the FAA has 
determined that CGM monitoring sufficiently increases the level of 
safety necessary to effectively validate higher-level piloting. With 
CGM, the FAA has been able to develop evidence-based protocols that 
ensure that each applicant vetted and granted a special issuance to 
their medical certificate is capable of maintaining diabetic control 
appropriate for safety of flight.

Experience of Other Countries Allowing ITDM Pilots To Exercise Pilot 
Privileges Commercially

    The FAA is aware of two civil aviation authorities (CAAs) with 
experience in allowing individuals with ITDM to exercise their 
equivalent of commercial and airline transport pilot privileges. The 
Canadian CAA has approximately two decades of experience implementing a 
more flexible ITDM policy for commercial operations. Pilots (both 
commercial and airline transport pilots) with ITDM also are considered 
for medical certification in the United Kingdom. These CAAs link 
operational limitations and protocols to the medical certificate that 
must be strictly followed. These protocols may include limiting flights 
to multi-crew operations; informing the other pilot of the diabetes 
diagnosis; and training the other pilot on the recognition and 
treatment of hypoglycemia. Commercial pilots with ITDM from other CAAs 
have been flying internationally, including in U.S. airspace, for many 
years with no reported adverse impact on safety.
    While the ITDM protocols from other CAAs have resulted in safe 
operations, the FAA has decided to take a different approach that it 
believes will enhance safety. Rather than imposing operational 
limitations and protocols via the medical certificate,\3\ the FAA has 
developed an approach that is focused on the applicant's health. The 
FAA's ITDM protocol employs updated and proven medical technologies and 
best practices that allow for continuous monitoring and oversight of 
the ITDM individual, thereby reducing the potential for incapacitation. 
Under the FAA's ITDM protocol, the FAA will issue a first- or second-
class special issuance medical certificate to an ITDM applicant only if 
the FAA has determined that safety of flight can be maintained with the 
use of CGM technology.\4\
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    \3\ The FAA notes that it may not condition the continued effect 
of any first-class medical certificate based on compliance with 
functional limitations. See 14 CFR 67.401(d)(4); see also Delta Air 
Lines, Inc., 490 F. Supp. at 918-919 (finding the FAA cannot 
regulate, restrict, or place functional limitations on the cockpit 
duties an airline transport pilot may perform because it usurps the 
authority of the airline).
    \4\ As with all cases the FAA reviews, an authorization for 
special issuance will be based on a favorable determination that 
safety of flight can be maintained. See 14 CFR 67.401(a).
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Exercising Pilot Privileges Internationally With an FAA Special-
Issuance Medical Certificate

    Under International Civil Aviation Organization (ICAO) standards, 
diabetes controlled by insulin is considered specifically disqualifying 
just as it is in the United States. However, ICAO Annex 1 standard 
1.2.4.9 (like U.S. regulation 14 CFR 67.401) applies a flexibility 
clause allowing signatory states (like the United States) to use 
discretion in issuing medical certificates. U.S. regulation refers to 
this discretion as special issuance, whereas ICAO standard refers to it 
as ``accredited medical conclusion'' as follows:

    1.2.4.9 If the medical Standards prescribed in [ICAO Annex 1] 
Chapter 6 for a particular license are not met, the appropriate 
Medical Assessment shall not be issued or renewed unless the 
following conditions are fulfilled:
    (a) accredited medical conclusion indicates that in special 
circumstances the applicant's failure to meet any requirement, 
whether numerical or otherwise, is such that exercise of the 
privileges of the license applied for is not likely to jeopardize 
flight safety;
    (b) relevant ability, skill and experience of the applicant and 
operational conditions have been given due consideration; and
    (c) the license is endorsed with any special limitation or 
limitations when the safe performance of the license holder's duties 
is dependent on compliance with such limitation or limitations.

    The ICAO Manual of Civil Aviation Medicine (Doc 8984) states:

    The methods used to treat diabetic patients have improved over 
recent decades and individuals that require insulin to maintain 
satisfactory blood glucose levels may apply, or re-apply, for a 
license to fly or to undertake air traffic control work. Although 
Annex 1, 6.3.2.16 (and 6.4.2.16, 6.5.2.16 for Class 2 and 3, 
respectively) normally precludes certification of insulin-treated 
diabetic applicants for any class of Medical Assessment, several 
Contracting States permit such applicants to exercise license 
privileges, utilizing the flexibility Standard 1.2.4.9, and others 
may wish to consider doing so.

    U.S. pilots flying under special issuance on U.S.-registered 
aircraft have always been recognized as ICAO-compliant. They have been 
accepted flying in airspace outside of the United States, just as the 
United States accepts foreign air carrier pilots with special issuance 
(including for ITDM) exercising pilot privileges within U.S. airspace.

[[Page 60140]]

New FAA Protocol

Rationale for Considering ITDM Applicants Seeking To Exercise Higher-
Rated Pilot Privileges

    After extensive deliberation and careful consideration, the FAA has 
developed a new FAA ITDM protocol to allow special issuance, based on 
CGM technology, for any class of medical certificate for ITDM 
individuals who meet specific criteria. As discussed, several factors 
contributed to the FAA's decision to develop a new ITDM protocol: Input 
from the expert medical community; years of experience with private 
pilots being special-issued for ITDM; the 2015 CAMI study validating 
safety; the experience of other CAAs with no adverse impact on flight 
safety; medical advances in the treatment of diabetes; and maturation 
of CGM technology.
    Individuals with ITDM seeking to exercise airline transport or 
commercial pilot privileges may submit an application via MedXpress for 
medical review and consideration. CGM use will be implemented for 
first- or second-class special issuance medical certification for ITDM 
applicants. As with all cases the FAA reviews, an authorization for 
special issuance will be based on a favorable determination that safety 
of flight can be maintained. Also, applicants for third-class special 
issuance may apply under the existing protocol or the new CGM-based 
protocol.
    Interested applicants should work with their Aviation Medical 
Examiner, appropriate medical specialists (endocrinologist, 
cardiologist, ophthalmologist, etc.), and the FAA to coordinate 
submission of the appropriate documentation needed for consideration. 
For consideration, potential applicants will need to demonstrate 
stability and adequate control of ITDM using CGM technology for a 
minimum of at least 6 months. In keeping with 14 CFR 67.413 
requirements to provide the FAA with medical history to ensure 
appropriate fitness for flight, applicants applying for the new 
protocol must be able to provide the following:

(1) Initial comprehensive report from the treating, board-certified 
endocrinologist
(2) Initial comprehensive laboratory panel
(3) Finger-Stick Blood Sugar (FSBS) glucose monitoring data
(4) Continuous Glucose Monitoring (CGM) data for at least the preceding 
6-month period (using a device legally marketed in the United States in 
accordance with Food and Drug Administration requirements and 
containing protocol-specific features needed for appropriate in-flight 
monitoring.).
(5) Excel spreadsheet or similar that identifies CGM data for all 
flights for the past 6 months and any actions taken to address low or 
high glucose levels.
(6) Eye evaluation (from a board certified ophthalmologist)
(7) Cardiac risk evaluation (from a board certified cardiologist)

    For more information, applicants interested in applying for an ITDM 
special issuance should consult the specific ITDM protocols, including 
CGM features needed for proper in-flight monitoring, by searching 
``ITDM'' in the Guide for Aviation Medical Examiners at: www.faa.gov/go/ITDM.
    Individuals who may have submitted an application to the FAA in 
advance of this announcement will be contacted if further information 
is needed to process their submission.
    This notice is not legally binding in its own right and will not be 
relied on by FAA as a separate basis for affirmative enforcement action 
or other administrative penalty. Unless otherwise required by statute 
or regulation, conformity with the new protocol described here is 
voluntary only. Nonconformity will not affect rights or obligations 
under existing statutes and regulations.

Inviting Comments

    The FAA is requesting comments on the new ITDM protocol described 
herein. The agency will consider comments received on or before January 
6, 2020. The new ITDM protocol may be revised based on comments 
received.

    Issued in Washington, DC, on October 30, 2019.
Michael A. Berry,
Federal Air Surgeon.
[FR Doc. 2019-24150 Filed 11-6-19; 8:45 am]
 BILLING CODE 4910-13-P