[Federal Register Volume 61, Number 226 (Thursday, November 21, 1996)]
[Rules and Regulations]
[Pages 59282-59289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29739]
[[Page 59281]]
_______________________________________________________________________
Part II
Department of Transportation
_______________________________________________________________________
Federal Aviation Administration
_______________________________________________________________________
14 CFR Part 67
Special Insurance of Third-Class Airman Medical Certificates to
Insulin-Treated Diabetic Airman Applicants; Policy Statement; Final
Rule
Federal Register / Vol. 61, No. 226 / Thursday, November 21, 1996 /
Rules and Regulations
[[Page 59282]]
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 67
[Docket No. 26493]
RIN 2120-AG30
Special Issuance of Third-Class Airman Medical Certificates to
Insulin-Treated Diabetic Airman Applicants
AGENCY: Federal Aviation Administration, DOT.
ACTION: Policy statement.
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SUMMARY: This document announces the new policy of the Federal Aviation
Administration (FAA) regarding individuals with insulin-treated
diabetes mellitus (ITDM) who apply for airman medical certification. It
also addresses comments received concerning this policy as requested in
a December 1994 Federal Register notice. The new policy will permit
special issuance of third-class airman medical certificates to certain
ITDM individuals who meet selection criteria and who successfully
comply with an FAA-approved monitoring protocol.
EFFECTIVE DATE: December 23, 1996.
FOR FURTHER INFORMATION CONTACT:
Tina Lombard, Program Analyst; Aeromedical Standards Branch (AAM-210);
Office of Aviation Medicine; Federal Aviation Administration, 800
Independence Avenue, SW.; Washington, DC 20591; telephone (202) 267-
9655; telefax (202) 267-5399.
SUPPLEMENTARY INFORMATION:
Background
In late 1994, the FAA published a notice in the Federal Register
(59 FR 67246, December 29, 1994) of its intent to consider a policy
change concerning ITDM individuals who apply for airman medical
certificates. The FAA opened docket no. 26493 and invited comment to it
on a medical evaluation and monitoring protocol for possible use as the
basis of a policy change that would permit certain insulin-using
diabetic individuals to receive special issuance of airman medical
certificates. The 90-day comment period on this proposed policy closed
on March 29, 1995. This document responds to the comments received from
the 1994 notice and to the comments from a 1991 petition of the
American Diabetes Association (ADA). This document also states the
policy of the Federal Air Surgeon concerning the special issuance of
medical certificates to diabetic airman applicants.
Part 67 of Title 14 of the Code of Federal Regulations (CFR) (14
CFR part 67) details the standards for the three classes of airman
medical certificate. A first-class medical certificate is required to
exercise the privileges of an airline transport pilot certificate,
while a second- and third-class medical certificate is required to
exercise the privileges of a commercial pilot and private pilot
certificate, respectively. An airman applicant who is found to meet the
appropriate medical standards, based on medical examination and
evaluation of the individual's history and condition, is entitled to a
medical certificate without restrictions other than the limit of its
duration prescribed in the regulations. Paragraph (a) of Secs. 67.113,
67.213, and 67.313 of part 67 sets forth the standards for determining
an individual's eligibility for first-, second-, or third-class medical
certification based on a medical history or clinical diagnosis of
diabetes mellitus. An individual with diabetes using oral hypoglycemic
drugs or insulin for control is not eligible for medical certification
under these standards.
Under Sec. 67.401, Special Issue of Medical Certificates, the
Federal Air Surgeon has the discretion to issue a medical certificate
to an individual who does not meet the applicable provisions of
subparts B, C, or D of part 67. The Federal Air Surgeon considers
relevant factors on a case-by-case basis to determine whether the
individual's medical conditions, medication, or other treatment is
consistent with aviation safety and will permit special issuance of a
medical certificate. The Federal Air Surgeon may authorize a special
medical flight test, practical test, or medical evaluation to ensure
that the duties authorized by the class of medical certificate applied
for can be performed without endangering air commerce during the period
in which the certificate would be in force. In determining whether the
special issuance of a third-class medical certificate should be made to
an applicant, 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
public safety of persons and property in other aircraft and on the
ground. Special issuance of a medical certificate may impose conditions
and limitations on an individual to ensure safety. These conditions may
include limiting the duration of a certificate, operational and/or
functional limitations, and the results of subsequent medical
evaluations.
In the late 1980's, the FAA began to grant special issuance of
medical certificates to individuals who controlled their diabetes with
diet and oral hypoglycemic drugs. It has been, however, the long-
standing policy of the Federal Air Surgeon not to consider an
individual for special issuance of a medical certificate where the
individual has a clinical diagnosis of insulin-treated diabetes
mellitus.
This policy was based on concerns about the long-term medical risks
associated with diabetes, including cardiovascular, neurological,
ophthalmological, and renal pathologies. Of even greater concern,
especially in the aviation environment, was the immediate risk posed by
hypoglycemia or low blood glucose. Every diabetic is at some risk for
hypoglycemia which can produce impaired cognitive function, seizures,
unconsciousness, and death. Moreover, functional incapacitation
associated with hypoglycemia may occur insidiously and may not be
recognized by the diabetic or by other observers. Diabetics using
insulin are at greater risk for hypoglycemia than those treated by diet
or oral hypoglycemic agents.
The FAA has continued to review its policy of not granting special
issuance of medical certificates to ITDM individuals. In 1992, the FAA
instituted a program to permit, in select cases, ITDM air traffic
control specialists (ATCS) to continue their safety-related duties.
These ATCS's are individually evaluated and, if appropriate, returned
to duty with intensive monitoring under a special medical protocol.
The protocol implemented for ATCS's with ITDM was developed by a
panel of distinguished endocrinologists at the request of the Federal
Air Surgeon and includes careful evaluation of the individual's medical
history, risk stratification, and the efficacy of his or her efforts to
control the disease. Those determined acceptable by the FAA to perform
air traffic control duties are monitored by frequent blood glucose
measurements while on duty. In addition, the blood glucose level is
maintained somewhat higher than usual to prevent or reduce the
likelihood of incapacitating hypoglycemia. The protocol also requires
close supervision and prohibits solo duty.
In February 1991, the ADA petitioned the FAA to amend its policy to
permit ITDM individuals to be issued airman medical certificates on a
case-by-case basis. The petition was published in the Federal Register
(56 FR 10383, March
[[Page 59283]]
12, 1991). The ADA further requested the creation of an FAA-appointed
medical task force to develop a medical protocol capable of permitting
case-by-case review.
In view of its ongoing success with ATCS's, the FAA reviewed its
experience and collected data and presented them to the same panel of
distinguished endocrinologists for its consideration and
recommendations. A new, modified protocol was proposed by the panel for
possible use as the basis for a change in the current special issuance
policy regarding ITDM airman applicants.
Policy Statements
After careful consideration of the (1) comments to Docket No.
26493, Policy Concerning the Special Issuance of Medical Certificates
to Diabetic Airman Applicants; Request for comments; (2) comments to
the 1991 petition by the American Diabetes Association (56 FR 10383,
March 12, 1991); (3) monitoring experience of the FAA medical waiver
program for ATCS's with ITDM; (4) medical advances in the treatment of
diabetes; and (5) evaluation of the proposed medical protocol, the
Federal Air Surgeon has determined that selected ITDM individuals can
be considered for special issuance of an airman medical certificate
under the conditions of the evaluation and monitoring protocol with the
following restrictions:
(1) ITDM individuals may be issued only a third-class airman
medical certificate.
(2) ITDM individuals may exercise only the privileges of a student,
recreational, or private pilot certificate.
(3) ITDM individuals are prohibited from operating an aircraft as a
required crewmember on any flight outside the airspace of the United
States of America.
(4) ITDM individuals are required to be in compliance with the
monitoring requirements of the following protocol while exercising the
privileges of a third-class airman medical certificate:
I. Initial Evaluation of Individuals With Insulin-Treated Diabetes
Mellitus
A. Individuals with ITDM who have no otherwise disqualifying
conditions, especially significant diabetes-related complications such
as arteriosclerotic coronary or cerebral disease, retinal disease, or
chronic renal failure, will be evaluated for special issuance of a
third-class medical certificate if they:
1. Have had no recurrent (two or more) hypoglycemic reactions
resulting in a loss of consciousness or seizure within the past 5
years. A period of 1 year of demonstrated stability is required
following the first episode of hypoglycemia; and
2. Have had no recurrent hypoglycemic reactions requiring
intervention by another party within the past 5 years. A period of 1
year of demonstrated stability is required following the first episode
of hypoglycemia; and
3. Have had no recurrent hypoglycemic reactions resulting in
impaired cognitive function which occurred without warning symptoms
within the past 5 years. A period of 1 year of demonstrated stability
is required following the first episode of hypoglycemia.
B. In order to provide an adequate basis for an individual medical
determination, the person with ITDM seeking special issuance of a
medical certificate must submit the following to: Federal Aviation
Administration, Civil Aeromedical Institute, AAM-310, 6500 South
MacArthur, Oklahoma City, OK 73125.
1. Copies of all medical records concerning the individual's
diabetes diagnosis and disease history and copies of all hospital
records, if admitted for any diabetes-related cause, including
accidents and injuries.
2. Copies of complete reports of any incidents or accidents,
particularly involving moving vehicles, whether or not the event
resulted in injury or property damage, if due in part or totally to
diabetes;
3. Results of a complete medical evaluation by an endocrinologist
or other diabetes specialist physician acceptable to the Federal Air
Surgeon (hereafter referred to as ``specialist''). This report should
detail the individual's complete medical history and current medical
condition. The report must include a general physical examination and,
at a minimum, the following information:
(a) Two measurements of glycated hemoglobin (total A1 or A1C
concentration and the laboratory reference normal range), the first at
least 90 days prior to the current measurement;
(b) A detailed report of the individual's insulin dosages
(including types) and diet utilized for glucose control;
(c) Appropriate examinations and tests to detect any peripheral
neuropathy or circulatory insufficiency of the extremities;
(d) Confirmation by an ophthalmologist of the absence of clinically
significant eye disease. The eye examination should assess, at a
minimum, visual acuity, ocular tension, and presence of lenticular
opacities, if any, and include a careful examination of the retina for
evidence of any diabetic retinopathy or macular edema. The presence of
microaneurysms, exudates, or other findings of background retinopathy,
by themselves, are not sufficient grounds for disqualification unless
it prevents the subject from meeting visual standards. However,
individuals with active proliferative retinopathy or vitreous
hemorrhages will not be considered for special issuance of a medical
certificate until the condition has stabilized and this has been
confirmed by an ophthalmologist; and
4. Verification by a specialist that the individual has been
educated in diabetes and its control and has been thoroughly informed
of and understands the monitoring and management procedures for the
condition and the actions that should be followed if complications of
diabetes, including hypoglycemia, should arise. Such verification
should also contain the specialist's evaluation as to whether the
individual has the ability and willingness to properly monitor and
manage his or her diabetes and whether diabetes will adversely affect
his or her ability to safely control an aircraft. The presence or
absence of recurrent severe hypoglycemia and hypoglycemia unawareness
should be noted. (See I.A. 1., 2. and 3 above.)
C. The ITDM individual applying for special issuance of a medical
certificate should have been receiving appropriate insulin treatment
for at least 6 months prior to submitting a request for special
issuance of a medical certificate.
D. Special medical flight test. If the Federal Air Surgeon
determines that there is need for an ITDM applicant to demonstrate his
or her ability to comply with the medical protocol, the Federal Air
Surgeon, under the provisions of Sec. 67.401, may require a special
medical examination and/or medical flight test prior to a determination
of the applicant's eligibility for special issuance of a medical
certificate.
II. Guidelines for Individuals With ITDM Who Have Been Granted Special
Issuance of Airman Medical Certificates
A. Individuals with ITDM who are granted special issuance of third-
class airman medical certificates must:
1. Submit to a medical evaluation by a specialist every 3 months.
This evaluation must include a general physical examination and a
report of glycated hemoglobin (total A1 or A1C) concentration. This
evaluation shall also contain an assessment of the
[[Page 59284]]
individual's continued ability and willingness to monitor and manage
properly his or her diabetes and of whether the individual's diabetes
or its complications could reasonably be expected to adversely affect
his or her ability to safety control an aircraft.
2. Carry and use a digital whole blood glucose measuring device
with memory that is acceptable to the FAA. Provide records of all daily
blood glucose measurements for review by the specialist at each 3-month
evaluation required above and, if required, to the FAA at any time.
3. Provide to the FAA, on an annual basis, written confirmation by
a specialist that the individual's diabetes remains under control and
without significant complications and that he or she has demonstrated
reasonable accuracy and recordation of his or her blood glucose
measurements with the above described device.
4. Provide to the FAA, on an annual basis, confirmation by an
ophthalmologist of the absence of clinically significant disease that
would prevent the individual from meeting current visual standards.
5. Provide to the FAA, immediately, a written report of any episode
of hypoglycemia associated with cognitive impairment, whether or not it
resulted in an accident or adverse event.
6. Provide a written report to the FAA, immediately, of involvement
in any accidents, including those involving aircraft and motor
vehicles, or other significant adverse events, whether or not they are
believed related to an episode of hypoglycemia.
7. Provide to the FAA, immediately upon determination by a
specialist or other physician, any evidence of loss of diabetes
control, significant complications, or inability to manage the
diabetes. In such a case, the individual shall cease exercising the
privileges of his or her airman certificate until again cleared
medically by the FAA.
III. Glucose Management Prior to Flight, During Flight, and Prior
to Landing
A. Individuals with ITDM shall maintain appropriate medical
supplies for glucose management at all times while preparing for flight
and while acting as pilot-in-command (or other flightcrew member). At a
minimum, such supplies shall include:
1. An FAA-acceptable whole blood digital glucose monitor with
memory;
2. Supplies needed to obtain adequate blood samples and to measure
whole blood glucose; and
3. An amount of rapidly absorbable glucose, in 10 gram (gm)
portions, appropriate to the potential duration of the flight.
B. All disposable supplies listed above must be within their
expiration dates.
C. The individual with ITDM, acting as pilot-in-command or other
flightcrew member, shall establish and document a blood glucose
concentration equal to or greater than 100 milligrams/deciliter (mg/dl)
but not greater than 300 mg/dl within \1/2\ hour prior to takeoff.
During flight, the individual with ITDM shall monitor his or her blood
glucose concentration at hourly intervals and within \1/2\ hour prior
to landing. If a blood glucose concentration range of 100-300 mg/dl in
not maintained, the following action shall be taken:
1. Prior to flight. The individual with ITDM shall test and record
his or her blood glucose concentration within \1/2\ hour prior to
takeoff. If blood glucose measures less than 100 mg/dl, the individual
shall ingest an appropriate 10 gm glucose snack (minimum 10 gm) and
recheck and document blood glucose concentration after \1/2\ hour. This
process shall be repeated until blood glucose concentration is in the
100-300 mg/dl range. If blood glucose concentration measures greater
than 300 mg/dl, the individual shall follow his or her regimen of blood
glucose control, as provided to the FAA by his or her attending
physician, until the measurement of blood glucose concentration permits
adherence to this protocol.
2. During flight.
(a) One hour into the flight, at each successive hour of flight,
and within \1/2\ hour prior to landing, the individual shall measure
and document his or her blood glucose concentration. Listed below are
blood glucose concentration ranges and the actions to be taken when
they occur during flight:
(1) Less than 100 mg/dl: The individual shall ingest a 20 gm
glucose snack and recheck and document his or her blood glucose
concentration after 1 hour.
(2) 100-300 mg/dl: The individual may continue his or her flight as
planned.
(3) Greater than 300 mg/dl: The individual shall land as soon as
practicable at the nearest suitable airport.
(b) The individual, as pilot, is responsible for the safety of the
flight and must remain cognizant of those factors that are important in
its successful completion. Accordingly, in recognition of such elements
as adverse weather, turbulence, air traffic control changes, or other
variables, the individual may decide that a scheduled, hourly
measurement of blood glucose concentration during the flight is of
lower priority than the need for full, undivided attention to piloting.
In such cases, the individual shall ingest a 10 gm glucose snack. One
hour after ingesting of this glucose snack, the individual shall
measure and document his or her blood glucose concentration. If the
individual is unable to perform the measurement of his or her blood
glucose concentration for the second consecutive time, the individual
shall ingest a 20 gm glucose snack and shall land as soon as
practicable at the nearest suitable airport. The individual, under
these circumstances, is not required to measure and document his or her
blood glucose concentration within \1/2\ hour prior to landing.
3. Prior to landing. Except as noted above, the individual must
measure and document his or her blood glucose concentration within \1/
2\ hour prior to landing.
Rationale for Policy Statement
The Federal Air Surgeon has found that the medical certification of
selected ITDM individuals who agree to comply with the above protocol
is appropriate. As noted above, this decision was reached after
reexamining the policy concerning ITDM individuals, reviewing the
comments received from the 1991 ADA petition and the 1994 diabetes
notice, and by evaluating the proposed protocol of the expert panel of
endocrinologists. In formulating this new policy, the Federal Air
Surgeon also reviewed the success of FAA's program for ATCS's with ITDM
and considered the medical and technological advances in the treatment
of diabetes.
This protocol requires thorough screening of an ITDM individual's
medical history for evidence of hypoglycemic episodes or impaired
mentation. Findings from medical studies indicate that such screening
should effectively exclude those at significant risk for incapacitation
caused by hypoglycemia. In the report of the ``Conference on Diabetic
Disorders and Commercial Drivers,'' prepared for the Federal Highway
Administration in March 1988, the authors recommended certification for
certain ITDM drivers whose history revealed the absence of recurrent
hypoglycemia resulting in loss of consciousness or seizure, the absence
of development of seizure or coma without antecedent prodromal
symptoms, and the absence of recurrent ketoacidosis. In a more recent
technical review entitled ``Hypoglycemia,''
[[Page 59285]]
published in Diabetes Care, Volume 17, Number 7, July 1994, Philip E.
Cryer, M.D., Joseph N. Fisher, M.D., and Harry Shamoon, M.D., discuss
clinical issues and current knowledge related to hypoglycemia. Cited in
this review is a study which found that a history of prior severe
hypoglycemia is the most powerful predictor of subsequent severe
hypoglycemia. Another study discussed in this review presents data
which show that ITDM individuals with histories of hypoglycemic
unawareness are at about sevenfold increased risk for severe
hypoglycemia as opposed to those ITDM individuals who are able to
recognize developing hypoglycemia and take action to prevent its
progression to severe hypoglycemia. Further data regarding the
significance of histories of severe hypoglycemia are contained in a
study conducted by the Diabetes Control and Complications Trial (DCCT)
Research Group of Bethesda, MD, and reported in The American Journal of
Medicine, Volume 90, April 1991, entitled ``Epidemiology of Severe
Hypoglycemia in the Diabetes Control and Complications Trial.'' This
study describes the epidemiology of severe hypoglycemia and identifies
patient characteristics or behaviors associated with severe
hypoglycemia in patients with insulin-dependent diabetes mellitus. Data
obtained from this study indicate that a history of severe hypoglycemia
and longer duration of diabetes predicts a higher risk for
hypoglycemia. Finally, on May 24, 1990, in testimony before the
Subcommittee on Post Office and Civil Service, House of
Representatives, Robert Ratner, M.D., Director, Diabetes Center, George
Washington University Medical Center, emphasized that ``(h)istory
provides us with the greatest independent indicator of those
individuals at highest risk for this complication (hypoglycemia) of
diabetes care, and it does allow exclusion of this group.''
The Federal Air Surgeon has found that advancements in the
knowledge, treatment, and self-management of diabetes have made
certification of ITDM individuals possible under certain circumstances.
More efficient techniques for self-monitoring blood glucose, a better
understanding of the dietary needs of diabetic individuals, and the
improved education level of diabetic individuals result in better
control of diabetes, enabling an individual to significantly mitigate
the risk of hypoglycemia. The protocol that an ITDM individual must
follow, as outlined under this policy, will allow for adequate blood
glucose control prior to and during flight through a comprehensive
regimen of blood glucose monitoring and management, thus providing an
appropriate level of safety during operation of an aircraft.
In developing this policy, consideration was given to the
performance of FAA ATCS's with ITDM in continuing their safety-related
duties. This program has been closely monitored since it was instituted
in 1991 and has been incident-free since its inception. This record was
maintained despite the 40-hour rotating work week required of an ATCS,
a significantly longer daily work period of concern for safety than
that of a student, recreational, or private pilot who flies for
relatively short periods on a daily, weekly, monthly, or occasional
basis.
Special issuance of an airman medical certificate to an ITDM
individual is restricted by this policy to an applicant for a third-
class medical certificate. In determining whether the special issuance
of a third-class medical certificate should be made to an applicant,
the Federal Air Surgeon, under Sec. 67.401, considers the freedom of an
airman, exercising the privileges of a student, recreational, and
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.
Discussion of Comments
As noted above, in December 1994, the FAA published a notice
requesting comment on a possible policy change concerning ITDM
individuals who apply for airman medical certification. The FAA invited
comment on a medical evaluation and monitoring protocol for possible
use as the basis of a policy change. In addition, it invited comment on
whether ITDM individuals should be restricted by class of medical
certificate (e.g., only third-class medical certificate), restricted by
class of airman certificate (e.g., private pilot, etc.), or restricted
by operational limit (e.g., dual pilot operation only or no multiengine
aircraft operation). This notice drew a large response from the
aviation community, the medical community, members of Congress, and the
general public. Over 800 comments were received and placed in the
docket.
The FAA received comments on this notice from 93 pilots; 26 medical
organizations, including university-affiliated associations and
diabetes treatment centers; 150 physicians, including 13 aviation
medical examiners; 2 aviation trade associations; and 541 private
individuals and members of Congress.
The ADA, an organization with more than 280,000 members and 800
chapters and affiliates, strongly urged the FAA to end its blanket
prohibition of medical certification of ITDM individuals. The ADA urged
the implementation of a policy without restriction to class of medical
certificate, class of airman certificate, or by operational limitation.
The Association endorsed a waiver system with stringent guidelines,
such as the guidelines set out for comment by the FAA.
ADA stressed the need for case-by-case review of ITDM individuals.
The Association stated that, just as not all nondiabetic persons should
be certified, not all individuals with ITDM should be certified. The
ADA stated that individuals who are not impacted by diabetic conditions
affecting judgment and performance in the cockpit should be considered
for medical certification. In their letter of March 2, 1995, they
advocated exclusion of ITDM individuals at highest risk for
incapacitation (e.g., history of hypoglycemic reaction resulting in
unconsciousness, and episode of severe hypoglycemia without warning
symptoms, or recurrent severe hypoglycemia). The ADA contended that
blood glucose monitoring and the availability of carbohydrates can
eliminate the majority of incidents of severe hypoglycemia and
substantially reduce the number of episodes of mild hypoglycemia. The
Association, a strong advocate of fair and equitable legal and societal
standards for persons with diabetes, also contended that FAA's current
policy on ITDM airman applicants is inconsistent with FAA's own policy
of providing individual evaluation of ATCS's with ITDM.
In February 1991, the ADA petitioned the FAA to amend the special
issuance provisions of part 67, or, alternatively, amend the FAA
special issuance policy to permit the special issuance of medical
certificates to individuals with ITDM on a case-by-case basis. The ADA
also requested the creation of an FAA-appointed medical task force to
develop a medical protocol to permit case-by-case review. Comments
received on the petition totaled 160, most of which supported the
special issuance of medical certificates for individuals with ITDM.
These comments are similar to those received in response to FAA's
notice requesting comments on a proposed policy change (59 FR 672463,
December 29, 1994) and are addressed below. That portion of ADA's 1991
petition which requests a rulemaking
[[Page 59286]]
amendment of the special issuance section of part 67 was addressed in
``Revision of Airman Medical Standards and Certification Procedures and
Duration of Medical Certificates; Final Rule,'' (Docket No. 27940),
that was published in the Federal Register on March 19, 1996 (61 FR
11238).
Comments were received from 24 state affiliates of the ADA. They
unanimously supported a change in FAA policy to individually evaluate
ITDM airman applicants. The affiliates emphasized the need for this
policy to include stringent medical standards to ensure aviation
safety. They stressed that ITDM applicants must meet all the conditions
of the proposed medical evaluation and monitoring protocol, with the
provision that, if any single condition is not met, no medical
certificate should be granted.
The Aircraft Owners and Pilots Association (AOPA) supported a
change in FAA policy concerning ITDM individuals, citing the improved
education level of ITDM individual, enhanced self-management
techniques, and state-of-the-art blood glucose monitoring meters. AOPA
pointed to the success of the FAA policy of case-by-case certification
of diabetics using oral hypoglycemic agents. AOPA stated that they
believe this policy does not compromise safety; and, therefore, it is
reasonable to extend this policy to ITDM individuals. AOPA urged that
special issuance of medical certificates to ITDM applicants be
available for any class of certificate. According to the Association,
individuals should be considered based on their medical condition and
not on the type of flying activities in which they engage.
The Experimental Aircraft Association (EAA) supported the special
issuance of medical certificates to ITDM applicants. EAA supported the
protocol which requires tight control of the initial issuance of
medical certification after individual evaluation and a continuing
program to ensure compliance.
Comments from five FAA aviation medical examiners (AME), all who
support a change in policy, urged restriction of medical certification
to private pilots. Three of these AME's stated that if the program with
those restrictions proved successful, the program should be extended
after a period of time to include first- and second-class medical
certification. One AME, who is a also a pilot, stated that an ITDM
individual who is shown to have consistently and methodically
maintained blood glucose control would have the self-discipline to
follow an approved protocol and the self-discipline required of a
safety conscious pilot.
In general, private individuals supported a change in FAA's policy
concerning the special issuance of medical certificates to ITDM airman
applicants. Most commenters contended that medical certification of
diabetic individuals should be conducted on an individual, case-by-case
basis and that only applicants meeting strict eligibility guidelines be
considered for medical certification. Many commenters stated that
advances in medical knowledge and improved technology make control of
blood glucose easier and more effective and, therefore, should allow
certain ITDM individuals to be medically certified without compromising
aviation safety.
Those individuals who commented on the medical evaluation and
monitoring protocol cited it as being appropriately stringent; and they
stated that adherence to this protocol should address any safety
concerns of the aviation community and the public. The requirement of
the protocol to individually assess an ITDM applicant's physical
condition, assess his or her medical background and records, and review
the ability of the applicant to manage his or her disease was
emphasized repeatedly in responses from individual commenters as being
appropriate. In addition, most of the comments received from certified
diabetes educators, registered dietitians, registered nurses, etc. were
in favor of a policy change and echoed the above individual commenters.
There was a divergence of opinion as to the class of airman medical
certificate that should be offered under a special issuance, with the
majority of individual commenters stating that special issuance should
be offered for all classes of airman medical certification. A smaller
but significant number of respondents advocated granting special
issuance of third-class medical certificates only.
In addition, many individual commenters stated that a requirement
for dual pilot operation would be in the interest of safety and would
address the issue of hypoglycemic reaction and incapacitation during
flight. Opinion was split on whether the requirement for dual pilot
operation should apply to all classes of airman medical certificates or
only to third-class medical certificates held by private pilots.
In opposition to the policy was the American Association of
Clinical Endocrinologists (AACE). AACE opposed any policy change which
would permit ITDM individuals to be eligible for medical certification.
It stated that the associated risks of this disease cannot be
eliminated and that granting medical certification would pose
unnecessary risks to both the patient and the general populace. AACE
contended that the physiological effects of flight and the constraints
of operating an aircraft decrease the likelihood of proper monitoring
and management of blood glucose levels while in flight and increases
the risk of impairment of incapacitation of ITDM individuals.
The Endocrine Society also opposed any change of FAA policy
regarding ITDM individuals. The Society stated that, if a special
issuance of a medical certificate is to be granted, an ITDM individual
who has had even one severe hypoglycemic reaction within the last 3
years should not be eligible for issuance of a medical certificate. It
further contended that food ingestion should never be permitted in lieu
of hourly in-flight glucose testing, that an ITDM individual should
have another qualified pilot in the cockpit at all times, and that an
ITDM individual should not be allowed to pilot commercial aircraft. The
Society pointed to the results of a recent study on the treatment of
individuals with ITDM which shows that proper treatment of patients
with ITDM requires tighter control of blood glucose levels and leads to
an unavoidably higher risk of hypoglycemic reaction. According to the
Society, tight control of the blood glucose level of an ITDM individual
produces significantly better long term outcome through the reduction
of the occurrence of nephropathy, retinopathy, and neuropathy.
Therefore, the Society stated, appropriate treatment of ITDM
individuals would unavoidably lead to a higher risk of hypoglycemic
reaction, which should preclude these patients from obtaining special
issuance of a medical certificate.
There was opposition by 17 physicians, one of whom is a pilot, to
the proposed change in policy. They stated that the FAA's primary
mission is public safety, and the agency should not be pressured to
change its policy by special interest groups. In addition to those
physicians, eight AME's opposed the policy change.
Many pilots and individual commenters who opposed the policy change
stated that the proposed monitoring system is unwieldy and will detract
from the pilot's ability to control the aircraft. They considered the
proposed guidelines too complex. Some pilots contended that it would be
extremely difficult to carry out the proposed monitoring protocol in
the best visual flight rules conditions and
[[Page 59287]]
that it would be impossible to comply in adverse flight conditions.
Concern was expressed regarding the danger of the combined effects of
hypoglycemia and hypoxia in flight.
Some of the above commenters also suggested that the implementation
of the proposed guidelines relies too heavily on the applicant's
objectivity and honesty in assessing his or her medical situation.
The majority of commenters who opposed a policy change stated that
controlled diabetics are always in jeopardy of insulin reactions and
that the risk of hypoglycemia is not satisfactorily reduced or
eliminated by the proposed protocol.
Finally, although the FAA has recently changed its policy to allow
medical clearance of ATCS's under some circumstances, many individual
commenters pointed out that pilots and ATCS's cannot be compared since
ATCS's are subjected to close supervision and prohibited from solo
duty.
FAA Response
In its comment, the ADA stressed the need to restrict some ITDM
individuals from consideration for special issuance of a medical
certificate. It advocated excluding ITDM individuals at risk of
hypoglycemia, i.e., ``individuals with a history of severe hypoglycemic
reactions resulting in the loss of consciousness or seizure, recurrent
severe hypoglycemic reactions requiring intervention by another party,
or recurrent hypoglycemia without warning symptons.'' The panel of
endocrinologists who served at the request of the Federal Air Surgeon
and whose recommendations were included in FAA's notice of December 29,
1994 (59 FR 6724) also recognized the need to restrict ITDM individuals
at risk of hypoglycemia from consideration for special issuance of a
medical certificate. The recommendation of the panel proposed
restricting consideration of eligibility for special issuance to ITDM
individuals who ``have had no recurrent (two or more) severe
hypoglycemic reactions requiring intervention by another party during
the past 3 years and have no current history of hypoglycemia resulting
in impaired cognitive function without warning symptoms (hypoglycemia
unawareness).''
In its new policy, the FAA developed eligibility criteria to
consider only those ITDM individuals who have had no recurrent
hypoglycemic reactions resulting in a loss of consciousness or seizure
within the past 5 years; had no recurrent hypoglycemic reactions
requiring intervention by another party within the past 5 years; and
had no recurrent hypoglycemic reactions resulting in impaired cognitive
function which occurred without warning symptoms in the past 5 years.
The agency has determined that this 5-year time frame and the
requirement for a period of 1 year of demonstrated stability following
the first episode of hypoglycemia in each of the above instances
provides an adequate basis for a medical determination of the
applicant's eligibility. By restricting consideration for special
issuance of a medical certificate to those individuals who meet these
eligibility criteria, the FAA will ensure that only those individuals
at low risk of hypoglycemia are considered under this protocol.
Some individual commenters and pilots stated that the proposed
blood glucose monitoring guidelines to be followed during flight are
complex, unwieldy, and detract from a pilot's ability to control the
aircraft. Under this policy, blood glucose monitoring guidelines to be
followed during flight require an individual with ITDM to monitor his
or her blood glucose concentration at hourly intervals. An individual
may, if he or she is unable to perform an hourly measurement of blood
glucose concentration during flight, ingest a 10 gm glucose snack. One
hour after ingestion of this glucose snack, an individual must measure
his or her blood glucose concentration. If, at this time, the
individual is unable to perform the blood glucose measurement, he or
she must ingest a 20 gm glucose snack and land as soon as possible. The
decision as to the appropriateness of performing a blood glucose test
or ingesting a glucose snack at the prescribed test interval will be
made by the pilot, taking into consideration all factors pertaining to
the safety of his or her flight. Compliance with these monitoring
guidelines during flight should not detract from an individual's
ability to concentrate on flight operations given that the pilot can
make a judgment of the appropriate action to be taken as his or her
flight conditions warrant. The FAA also notes that several commenters
point out the ease with which a trained ITDM individual can accomplish
a glucose determination. One commenter provided a video tape
demonstrating his use of a glucometer during actual flight with a
safety pilot.
Many pilots commenting on the protocol stated that the blood
glucose monitoring system would be extremely difficult to carry out in
VFR conditions and would be impossible to comply with in adverse
conditions. The FAA shares the concern of the commenters that aviation
safety be maintained at all times and that adherence to this protocol
not interfere with the safe operation of an aircraft. However,
compliance with these monitoring guidelines during flight allows a
pilot, after taking into consideration the existing flight conditions,
to determine the appropriateness of performing a blood glucose test or,
at the required test interval, ingesting a glucose snack to ensure that
an appropriate blood glucose level is maintained. This procedure allows
a pilot to comply with the monitoring guidelines while ensuring the
safe operation of his or her aircraft.
Some individual commenters stated that special issuance of a
medical certificate should be offered for all classes of airman medical
certificates. The FAA has determined that special issuance to ITDM
individuals will be limited to applicants for third-class airman
medical certificates. By restricting ITDM individuals to a third-class
medical certificate, the FAA policy allows a student, recreational, or
private pilot to accept reasonable risks to his or her person or
property that are not acceptable in the exercise of commercial or
airline transport pilot privileges.
Many individual commenters compared ITDM air traffic control
specialists to ITDM pilots operating under this policy, citing the
success of the ATCS program and the willingness of the FAA to consider
ITDM ATCS's on a case-by-case basis. These commenters urged the FAA to
extend these privileges to ITDM pilots also. Other individual
commenters pointed out the dissimilar aspects of the two programs,
specifically in that ITDM ATCS's are supervised at all times while on
duty. The FAA is aware of the differences between the two programs and
has considered the responsibilities and the medical certification and
operational requirements of both ITDM ATCS's and ITDM pilots. An ATCS
has daily responsibility for public safety through the operation of the
air traffic control system. In addition to meeting the conditions of
the protocol, the FAA requires that ITDM ATCS's, as do all ATCS's, hold
a medical clearance which is equivalent to the second-class airman
medical certificate required for commercial pilot privileges. And, as
an extra measure of safety, the FAA does not permit solo duty by an
ITDM ATCS. In contrast, ITDM pilots would fly infrequently, at their
own convenience, and would be responsible primarily for the safe
operation of one aircraft. Under this new policy, an ITDM individual
may be considered for a third-class
[[Page 59288]]
airman medical certificate but be restricted to exercise only the
privileges of a student, recreational, or private pilot certificate.
The FAA believes that, under this protocol for individuals with ITDM, a
further restriction from solo flight is not necessary.
The FAA has closely monitored the ITDM ATCS program, and it has
been incident-free since its inception in 1991. This incident-free
record has been maintained although an ITDM ATCS works a 40-hour week,
often on a rotating schedule, which is a significantly longer period of
time than ITDM pilots would operate under the conditions of this
protocol. The FAA believes that the success of its ITDM ATCS program is
an indicator of the feasibility of its new policy concerning ITDM
pilots.
Summary
The FAA has reevaluated the proposed medical evaluation and
monitoring protocol for ITDM individuals published in its 1994 Federal
Register notice (docket no. 26493). After consideration of all the
comments received, the FAA has determined that ITDM individuals
following the conditions and requirements of the protocol described
above will be able to safely perform their airman duties, thus
permitting the special issuance of airman medical certificates to
selected ITDM individuals who agree to and are capable of following the
FAA-prescribed protocol.
International Civil Aviation Organization (ICAO) and Joint Aviation
Regulations (JAR)
The FAA has determined that a review of the ICAO Standards and
Recommended Practices and JAR's is not warranted because there are no
existing comparable rules, and any waiver under this policy would be
limited to the territory of the United States.
Regulatory Evaluation
Proposed changes to Federal regulations must undergo several
economic analyses. First, Executive Order 12866 directs Federal
agencies to promulgate new regulations or modify existing regulations
only if the expected benefits to society outweigh the expected costs.
Second, the Regulatory Flexibility Act of 1980 requires agencies to
analyze the economic impact of regulatory changes on small entities.
Third, the Office of Management and Budget directs agencies to assess
the effect of regulatory changes on international trade. In conducting
these analyses, the FAA has determined that this policy: (1) would
generate benefits exceeding costs; (2) is not ``significant'' as
defined in the Executive Order and DOT's Regulatory Policies and
Procedures; (3) would not have a significant impact on a substantial
number of small entities; and (4) would not constitute a barrier to
international trade.
Cost Benefit Analysis
The FAA expects that this policy will impose additional costs on
those insulin-using diabetics who seek special issuance of a third-
class medical certificate. While the medical records and examinations
required for consideration should be readily available to most
applicants, the specific evaluation requirements of the protocol will
impose those additional requirement costs for all such applicants.
Also, additional costs will be incurred if the applicant is required to
undergo a medical flight test prior to final consideration of a waiver
request. The FAA intends to require most initial ITDM applicants for
student pilot privileges to undergo such testing.
Once an individual has been selected for special issuance under
this policy, additional costs will also be incurred in meeting the
general conditions of the protocol, as well as the individual
conditions, if any, imposed for the term of the special issuance. With
the exceptions of the quarterly and annual examinations and reporting
by appropriate medical specialists of the applicant's diabetes status
to the FAA, the medical requirements of the protocol are already met by
many insulin-using diabetics. Frequent daily blood glucose measurements
using a digital measuring device are a routine activity for many
diabetic individuals that may meet the requirements of the protocol and
impose no additional cost. However, the protocol may require some to
purchase an approved measuring device (approximately $150), perform
more tests (especially while flying), and purchase additional glucose
snacks. The FAA believes that there will be little additional cost
beyond that identified above for appropriate blood glucose management
prior to and during flight.
The FAA believes that this protocol will not have an adverse impact
on safety. The protocol will permit those insulin-using diabetics who
voluntarily apply for and who are found eligible for special issuance
of a third-class medical certificate the opportunity to exercise pilot
privileges in a manner that protects the individuals as well as the
public. Additionally, those individuals receiving special issuance
under this protocol may benefit from the required increased disease
surveillance. The FAA has no data available from which to estimate the
number of individuals who may seek special issuance or the number of
special issuances that would be granted and thus cannot estimate the
total overall cost of this policy. However, the FAA has determined that
the benefits to the individual offered by this policy exceed the
additional cost voluntarily undertaken by individual applicants. If an
individual considers the cost too great, the applicant will not seek
the waiver.
Regulatory Flexibility Determination
The Regulatory Flexibility Act of 1980 (RFA) was enacted by
Congress to ensure that small entities are not unnecessarily or
disproportionately burdened by government regulations. The RFA requires
a Regulatory Flexibility Analysis if a rule is expected to have a
significant (positive or negative) economic impact on a substantial
number of small entities. Based on the standards and thresholds
specified in FAA Order 2100.14A, Regulatory Flexibility Criteria and
Guidance, the FAA has determined that this policy would not have a
significant economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act
This policy does not contain any Federal intergovernmental or
private sector mandate. Therefore, the requirements of Title II of the
Unfunded Mandates Reform Act of 1995 does not apply.
International Trade Impact
The Office of Management and Budget directs agencies to assess the
effects of regulatory changes on international trade. The policy would
not have any impact on international trade.
Federalism Implications
The policy herein would not have substantial direct effects on the
states, on the relationship between the national government and the
states, or on the distribution of power and responsibilities among the
various levels of government. Therefore, in accordance with Executive
Order 12866, October 4, 1993, it is determined that this policy would
not have sufficient federalism implications to warrant the preparation
of a Federalism Assessment.
Conclusion
For the reasons discussed above, including the findings in the
Regulatory Flexibility Determination and the International Trade Impact
Analysis, the FAA has determined that this policy is
[[Page 59289]]
not significant under Executive Order 12866, Regulatory Planning and
Review, issued October 4, 1993. In addition, the FAA certifies that
this policy does not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act. This policy is not considered
significant under DOT Regulatory Policies and Procedures (44 FR 11034,
February 26, 1979) and Order DOT 2100.5, Policies and Procedures for
Simplification, Analysis, and Review of Regulations, of May 22, 1980.
The Federal Air Surgeon, for the reasons set out above, has
determined that the FAA will consider selected ITDM individuals for
special issuance of a third-class airman medical certificate on a case-
by-case basis with the conditions and restrictions set forth in this
policy statement. Individuals will be closely monitored to determine
the effectiveness of this policy. The performance and medical condition
of an ITDM individual will be monitored through the review of medical
evaluations, records of daily blood glucose measurements, reports of
hypoglycemic episodes, and reports of involvement in any accidents or
incidents. The Federal Air Surgeon, at his discretion, may modify or
terminate this policy at any time. If substantive change is made to
this policy, it will be published in the Federal Register. Publication
of this policy statement disposes of the petition submitted by ADA in
1991.
Individuals interested in applying for special issuance of an
airman medical certificate should contact: Federal Aviation
Administration, AAM-300, Civil Aeromedical Institute, 6500 South
MacArthur, Oklahoma City, OK 73125.
Issued in Washington, DC, on November 5, 1996.
Jon L. Jordan,
Federal Air Surgeon.
[FR Doc. 96-29739 Filed 11-18-96; 10:58 am]
BILLING CODE 4910-13-M
