[Federal Register Volume 59, Number 249 (Thursday, December 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31983]
[[Page Unknown]]
[Federal Register: December 29, 1994]
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DEPARTMENT OF TRANSPORTATION
14 CFR Part 67
[Docket No. 26493]
Policy Concerning the Special Issuance of Medical Certificates to
Diabetic Airman Applicants
AGENCY: Federal Aviation Administration, DOT.
ACTION: Request for comments.
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SUMMARY: The FAA is considering a policy change concerning individuals
with diabetes mellitus who apply for airman medical certificates. Under
the current FAA regulations, an established diagnosis of diabetes
mellitus that requires insulin or any other hypoglycemic drug for
control disqualifies an individual from medical certification. The FAA
is considering under what circumstances special issuance of a medical
certificate (a ``waiver'') to an individual who requires insulin might
be appropriate. Before making this determination, the FAA invites
comment on a medical evaluation and monitoring protocol, developed by a
panel of distinguished endocrinologists at the request of the Federal
Air Surgeon, that is recommended by that panel as the basis of a
possible change of policy. The change would permit certain insulin-
using diabetic individuals to receive special issuance of airman
medical certificates.
DATES: Comments must be received by March 29, 1995.
ADDRESSES: Comments on this notice should be mailed or delivered, in
triplicate, to: Federal Aviation Administration, Office of the Chief
Counsel, Attention: Rules Docket (AGC-200), Docket No. 26493, 800
Independence Avenue SW., Washington, DC 20591. Comments mailed or
delivered must be marked Docket No. 26493. Comments may be examined in
Room 915G weekdays, except on Federal holidays, between 8:30 a.m. and 5
p.m.
FOR FURTHER INFORMATION CONTACT:
Dennis P. McEachen, Manager, Aeromedical Standards and Substance Abuse
Branch (AAM-210), Office of Aviation Medicine, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone (202) 493-4075; telefax (202) 267-5399.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested persons are invited to comment on this notice by
submitting such written data, views, or arguments as they may desire.
Comments relating to the environmental, energy, federalism, or economic
impact that might result from adopting this policy are also invited.
Substantive comments should be accompanied by cost estimates. Comments
must identify the regulatory docket number and should be submitted in
triplicate to the Rules Docket address specified above. All comments
received on or before the specified closing date for comments will be
considered by the Federal Air Surgeon.
Background
Part 67 of Title 14 of the Code of Federal Regulations (14 CFR part
67) details the standards for the three classes of airman medical
certificates. A first-class medical certificate is required to exercise
the privileges of an airline transport pilot certificate, while second-
and third-class medical certificates are required to exercise the
privileges of commercial and private pilot certificates, 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 (f)(1) of sections 67.13,
67.15, and 67.17 is the standard for determining an individual's
eligibility for first-, second-, and third-class medical certification
based on medical history or clinical diagnosis of diabetes mellitus. An
individual with diabetes using hypoglycemic drugs for control is not
eligible for medical certification under the standards. That same
individual, however, may be eligible for restricted medical
certification; i.e., a grant of special issuance of a medical
certificate. Under long-standing FAA policy and practice, however, a
diabetic using insulin for control is not eligible for unrestricted or
restricted medical certification.
Under Sec. 67.19, 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
sections 67.13, .15, and .17 of the Title 14 Code of Federal
Regulations. The Federal Air Surgeon considers relevant factors on a
case-by-case basis to determine whether the individual's medical
condition, medication, or other treatment is consistent with aviation
safety and will permit special issuance of a medical certificate.
In the late 1980's, the FAA began to grant special issuance of
medical certificates to individuals who controlled their diabetes with
diet and hypoglycemic drugs. It has been, however, the long-standing
policy and practice of the Federal Air Surgeon not to consider special
issuance of a medical certificate where the individual has a clinical
diagnosis of insulin-treated diabetes mellitus (ITDM).
This policy and practice is 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, is the immediate risk
posed by hypoglycemia or low blood sugar. 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.
Despite the considereable morbidity associated with diabetes, 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, air traffic control
specialists (ATCS) with ITDM 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 and the efficacy of his or her efforts to control the disease.
Those determined safe by the FAA to perform air traffic control duties
are monitored by frequent blood sugar measurements while on duty. In
addition, the blood sugar is maintained at a somewhat higher than usual
level to prevent or reduce the likelihood of incapacitating
hypoglycemia. The protocol also requires close supervision and
prohibits solo duty.
In 1991, the American Diabetes Association (ADA) petitioned the FAA
to amend its policies to permit ITDM individuals to be issued medical
certificates on a case-by-case basis. The petition was published in the
Federal Register (56 FR 10383, March 12, 1991). The ADA further
requested the creation of an FAA-appointed medical task force to
develop a medical protocol capable of permitting meaningful case-by-
case review.
At the request of the Federal Air Surgeon, the protocol used for
ATCS's was considered for possible use for ITDM airman applicants. A
new, modified protocol is proposed by the same group of
endocrinologists and is published below. This protocol, in whole or
part or as subsequently modified, may form a basis for change in the
current special issuance policy regarding ITDM.
This notice is intended to facilitate discussion of the issues
relating to current policy regarding the certification of ITDM airman
applicants and the protocol as outlined above. The FAA is not
obligating itself to any course of action at this time.
Request for Comment
The FAA requests comments from interested persons on whether it
should permit special issuance of airman medical certificates to ITDM
airman applicants on a case-by-case basis, based on the protocol that
follows. Commenters are invited to address all aspects of the protocol
and to comment on any additional issues that might be appropriate.
Information concerning any potential effects on aviation safety by
permitting ITDM individuals to be medically certified that the
commenter believes should be considered is also solicited. The protocol
(with some minor editorial clarifications) is reprinted in its entirety
below.
I. Guidelines for Initial Evaluation of Pilots With Insulin-Treated
Diabetes Mellitus (ITDM)
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
medical certificates if they:
1. Have had no recurrent (two or more), severe hypoglycemic
reactions requiring intervention by another party during the past 3
years and
2. Have no current history of hypoglycemia resulting in impaired
cognitive function without warning symptoms (hypoglycemia unawareness).
B. In order to provide an adequate basis for an individual medical
determination, the person with ITDM seeking special issuance of a
medical certificate shall submit the following information to the FAA:
1. A copy of the hospitalization records if admitted for any
diabetes-related cause, including accidents and injuries;
2. Complete reports of any aircraft, automobile, or other incidents
or accidents, whether or not resulting in injury or vehicular/equipment
damage, if due in part, or totally, to diabetes;
3. Results of a complete medical evaluation by a board-certified/
board-eligible endocrinologist or other diabetes specialist approved by
the Federal Air Surgeon concerning the individual's medical history and
current status. The report must include a general physical examination
and, at a minimum, the following:
(a) Two readings of glycated hemoglobin (total A1 or A1C
concentration and the laboratory reference normal range) during the
last 3 months (prior and current);
(b) Confirmation by an ophthalmologist of the absence of clinically
significant eye disease. The eye examination should assess visual
acuity, ocular tension, and presence of lenticular opacities, 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 visual acuity is
affected and prevents the subject from meeting current visual
standards. However, individuals with active proliferative retinopathy
or vitreous hemorrhages should not be medically cleared until the
condition has stabilized, and this has been confirmed by an
ophthalmologist;
(c) If symptomatic, examinations and tests to detect any peripheral
neuropathy or circulatory deficiencies of the extremities;
(d) A detailed report of insulin dosages (including types) and diet
utilized for control; 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,
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 absence of recurrent severe
hypoglycemia and hypoglycemia unawareness should be noted (See IA 1 and
2).
C. The individual petitioning for special issuance of a medical
certificate should have been on insulin treatment for at least 6 months
prior to consideration for special issuance of a medical certificate.
II. Guidelines for Individuals With ITDM Who Have Been Granted Special
Issuance of Airman Medical Certificates
A. Submit to a medical evaluation by a specialist every 3 months.
Such evaluation must include readings of glycated hemoglobin (total A1
or A1C) concentrations. This evaluation shall also contain the
specialist's evaluation as to whether the individual has the ability
and willingness to monitor and manage properly his or her diabetes and
whether diabetes will adversely affect his or her ability to safely
control an aircraft.
B. Carry and use a digital whole blood glucose monitor device with
a computerized memory. Records of all blood glucose measurements must
be provided to the specialist for review during each 3-month
evaluation.
C. Provide, on an annual basis, confirmation by a specialist that
the individual can demonstrate accuracy of measurements of blood
glucose concentration.
D. Provide to the FAA, on an annual basis, ophthalmological
confirmation of the absence of clinically significant retinal disease
that would affect visual acuity and prevent the individual from meeting
current visual standards.
E. Provide a report of any episdoes of hypoglycemia associated with
cognitive impairment whether or not it resulted in an accident or
adverse event.
III. Guidelines of Glucose Management Prior To and During Flight
Individuals with ITDM shall maintain appropriate medical supplies
at all times while acting as a pilot-in-command or in any other
capacity as a flightcrew member. Such supplies shall include, at a
minimum, a whole blood glucose monitor with memory, test strips, blood
sampling lancets, a source of rapidly absorbable glucose, insulin, and
syringes or a portable insulin pump as appropriate. All disposable
materials must be within their expiration dates. Blood glucose
concentrate must be tested within \1/2\ hour prior to takeoff and
landing and hourly during flight. While flying, should circumstances
preclude a particular blood glucose test, intake of an appropriate
snack or other source of glucose (minimum 10 grams (gm)) is an
acceptable alternative. However, no two consecutive tests are to be
replaced by the ingestion of glucose. Listed below are blood glucose
concentration ranges for pilots or other individuals acting in any
other capacity as a flightcrew member and the appropriate actions to be
taken when they occur.
A. Blood glucose less than 100 milligrams/deciliter (mg/dl):
1. Prior to flight. The individual shall ingest an appropriate
snack containing glucose (minimum 10 gm) and recheck blood glucose in
\1/2\ hour. If the blood glucose at recheck is less than 100 mg/dl, the
individual shall eat an additional snack containing glucose and recheck
blood glucose in \1/2\ hour. This process should be repeated until the
blood glucose is 100 mg/dl or greater. These guide points shall be
achieved not more than \1/2\ hour prior to takeoff and
2. If blood glucose during flight is less than 100 mg/dl, a glucose
containing snack (not less than 20gm) shall be ingested and blood
glucose shall be rechecked in \1/2\ hour. The process shall be repeated
until the blood glucose is 100 mg/dl or greater.
B. Blood glucose 100-300 mg/dl: no action needed. Recheck blood
glucose in 1 hour or eat a snack containing a minimum of 10 gm of
carbohydrate in 1 hour and recheck blood glucose in 2 hours.
C. Blood glucose greater than 300 mg/dl: recheck in \1/2\ hour; if
blood glucose has risen further, take an appropriate amount of insulin
and recheck in \1/2\ hour; if glucose has declined, recheck in 1 hour.
The above protocol, as recommended by the endocrinologists panel,
is but one option the FAA is considering concerning ITDM airman
applicants. Comment also is requested concerning a policy of not
granting special issuance of airman medical certificates to any ITDM
individuals, with or without an approved monitoring protocol. In
addition, comment is requested whether such ITDM individuals if
medically certified, should be restricted by class of medical
certificate (e.g., only third-class medical certificate, etc.), by
class of airman certificate (e.g., private pilots, etc.), or by
operational limitation (e.g., no multiengine aircraft or dual pilots
operations only, etc.). Please address comments on the issues above and
any other issues related to the requested comment areas, to the Rules
Docket address specified at the front of this document.
Issued in Washington, DC, on December 22, 1994.
Jon L. Jordan,
Federal Air Surgeon.
[FR Doc. 94-31983 Filed 12-23-94; 9:01 am]
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