Policy Concerning the Special Issuance of Medical Certificates to Diabetic Airman Applicants

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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