[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]
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