[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]
BILLING CODE 4910-13-M