[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]]

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Part II





Department of Transportation





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Federal Aviation Administration



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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.

-----------------------------------------------------------------------

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