[Federal Register Volume 61, Number 41 (Thursday, February 29, 1996)]
[Rules and Regulations]
[Pages 7695-7697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4686]



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DEPARTMENT OF TRANSPORTATION
14 CFR Part 67
[Docket No. 27890]
RIN 2120-AF42

Medical Standards and Certification

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; disposition of comments.

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SUMMARY: On September 9, 1994, the Federal Aviation Administration 
(FAA) issued an emergency final rule amending the general medical 
standard for first-, second-, and third-class airman medical 
certificates. The FAA, in the same document, sought public comment on 
the final rule. This document disposes of the comments received in 
response to that rule.


[[Page 7696]]

ADDRESSES: Comments submitted in response to this rulemaking may be 
examined at the Federal Aviation Administration, Office of the Chief 
Counsel, Rules Docket, room 915-G, 800 Independence Avenue SW., 
Washington, DC, weekdays (except Federal holidays) between 830 a.m. and 
5 p.m.

FOR FURTHER INFORMATION CONTACT:
Tina Lombard, Aeromedical Standards Branch, (AAM-210), Office of 
Aviation Medicine, Federal Aviation Administration, 800 Independence 
Avenue SW., Washington, DC 20591; telephone (202) 267-9655.

SUPPLEMENTARY INFORMATION:

Background

    The general medical standard for the three classes of airman 
medical certificates is detailed in part 67 of Title 14 of the Code of 
Federal Regulations (14 CFR part 67). 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 applicant who is found to meet the 
appropriate medical standards is entitled to a medical certificate 
without restrictions other than the limit of its duration as prescribed 
in 14 CFR part 67.
    An applicant may be ineligible for certification under 
Secs. 67.13(f)(2), 67.15(f)(2), or 67.17(f)(2) if that person has an 
organic, functional, or structural disease, defect, or limitation that 
the Federal Air Surgeon finds: (1) makes the applicant unable to safely 
perform the duties or exercise the privileges of the airman certificate 
the applicant holds or for which the applicant is applying, or (2) may 
reasonably be expected within 2 years of Federal Air Surgeon's finding 
to make the applicant unable to safely perform those duties or exercise 
those privileges.
    Paragraph (f)(2) of Secs. 67.13, 67.15, and 67.17 provides the 
historical basis for denying medical certification in cases where the 
Federal Air Surgeon has determined that an applicant's medication or 
other treatment (including prescription, over-the-counter, and 
nontraditional medication or other treatment remedies) interferes with 
the applicant's ability to safely perform the duties, or exercise the 
privileges, of the airman certificate for which the airman is applying 
or holds.
    Notwithstanding the FAA's long-standing medical certification 
policy and practice regarding medication and other treatment, the U.S. 
Court of Appeals for the Seventh Circuit determined that paragraph 
(f)(2) did not provide a basis for denial of medical certification 
based on medication alone. Bullwinkel v. Federal Aviation 
Administration, 23 F.3d 167, (7th Cir., reh'g. denied). The Seventh 
Circuit's decision that medication alone was not covered by paragraph 
(f)(2) raised serious safety concerns within the FAA. As a result of 
those concerns, the FAA on September 9, 1994, promulgated an emergency 
final rule that was immediately effective to clarify and codify the 
FAA's policy regarding an individual who holds, or is applying for, an 
airman medical certificate in a case where medication or other 
treatment was found to interfere, or may reasonably be expected to 
interfere, with that individual's ability to safely perform airman 
duties (57 FR 46706).
    The September 9, 1994, emergency final rule amended paragraph (f) 
of Secs. 67.13, 67.15, and 67.17 by adding to each a new paragraph (3), 
which sets out the standard for certification where medication or other 
treatment is involved. Each paragraph (f)(3) made ineligible for 
unrestricted medical certification any applicant whose medication or 
other treatment is found by the Federal Air Surgeon to make, or may 
reasonably be expected to make with 2 years after the finding, that 
applicant unable to safely perform the duties or exercise the 
privileges of his or her airman certificate. The final rule did not 
change the FAA's current and long-standing application of the medical 
certification standards. Rather, its sole purpose was to expressly 
codify the agency's practice in light of the Bullwinkel decision.
    Also, for continuity with the current administration of other 
medical certification procedures, reference to this emergency final 
rule was added by revising Sec. 67.25, Delegation of authority, and 
Sec. 67.27, Denial of medical certificate.
    The FAA invited public comment on the final rule and established a 
60-day comment period, which closed on November 8, 1994.

Discussion of Comments

    The FAA received six comments in response to the emergency final 
rule; four comments opposed and two comments supported the rule. The 
commenters included five individuals and one association, the Aerospace 
Medical Association (ASMA).
    One commenter states that the FAA was wrong to amend the rules 
because of a single case. The commenter suggests that a better standard 
would be to list those drugs in the regulations that would be 
considered automatically disqualifying or potentially disqualifying.
    One commenter characterizes the rule as a major change and objects 
to it being issued as a final rule without prior public comment. He 
suggests that the FAA rescind the final rule and schedule the subject 
for a notice of proposed rulemaking.
    One commenter states that his third-class medical certificate was 
revoked because he was taking a medication to control symptoms of 
bipolar disorder. He contends that the matter of disqualification 
should be based solely on the underlying medical condition. He further 
contends that medication can control symptoms for approximately 80 
percent of people with the disorder. The commenter concludes that 
patients taking certain medications for bipolar disorder are 
``effectively cured'' of the underlying condition and should be 
eligible for medical certification.
    One commenter states that there was no cause for issuing an 
emergency rule and that the FAA's policy was shown in court to be 
contrary to law. He contends that the FAA's choice of rulemaking 
procedure was improper. Further, he objects that the September 9, 1994, 
final rule does not specify the names of all disqualifying medication 
or treatment which the rule encompasses. He states that the rule 
enables the FAA to make judgments which may be arbitrary or 
unreasonable. The commenter suggests that this rulemaking action should 
have been contained in an overall revision of parts 61 and 67.
    The ASMA states that it strongly supports the final rule. Further, 
the ASMA concurs with the dissenting opinion in the Bullwinkel case in 
that the general medical standard of the airman medical standards 
should be viewed as including all elements of medicine, i.e., 
medication and other treatments.
    One commenter agrees with the FAA's action but expresses concern 
about the change in the rules without benefit of prior public comment.

FAA Response

    The FAA's rationale for issuing this emergency final rule is fully 
set out in the preamble to the rule published at 59 FR 46706 on 
September 9, 1994.
    As stated in the preamble to the final rule, the FAA determined an 
emergency existed that required immediate action; that determination is 
unchanged by the comments. A delay could have had an adverse effect on 
aviation safety. Neither a notice of proposed rulemaking nor 
incorporation of the amendment into a possible part 67 revision, as 
proposed 

[[Page 7697]]
by commenters, was determined to be in the public interest.
    As to the commenters' call for a ``list'' of disqualifying 
medications, the Federal Air Surgeon has determined that an exhaustive 
``listing'' of specific medications or specific treatments to determine 
an airman's eligibility is not possible. All the positive and negative 
effects of any medication or treatment are rarely appreciated when 
first introduced. In some cases, substantial amounts of time may pass 
before a particular drug or treatment can be judged with confidence, 
particularly with its application to individuals in the aviation 
environment. Because of the continuous changes in the field of medicine 
and pharmacology, the FAA has determined that publishing a static list 
of disqualifying medication is not appropriate or practical.
    In case where an individual has been determined to have a 
disqualifying condition and/or use a disqualifying medication or other 
treatment and requests special issuance of a medical certificate, the 
Federal Air Surgeon considers not only all relevant scientific data on 
the particular condition and/or medication or other treatment but also 
the individual's particular situation and the role that he/she will 
perform in aviation. The case-by-case review can and does result in 
instances where the particular condition and/or medication or other 
treatment precludes the affected individual from receiving even an 
individually tailored special issuance medical certificate. Conversely, 
with the availability of new data and experience, some similarly 
affected individuals may, by adjustments in their medication dosage or 
other treatment, or restrictions in their privileges, for example, 
receive special issuance of medical certificates.
    Because this careful analysis of each special issuance case is 
frequently not fully appreciated, the perception exists that many 
conditions and/or medications or other treatment are always 
disqualifying. In fact, with the availability of new data and 
experience, the Federal Air Surgeon has found it safe to issue special 
medical certificates to the majority of those individuals who 
historically were always denied. But, as there are literally hundreds 
of diagnoses, medications, and other treatments, as well as thousands 
of combinations that frequently change over time, the FAA cannot, as a 
practical matter, produce a ``list'' of medications and/or treatments 
that would be considered disqualifying or, conversely, acceptable for 
airman medical certification.
    While at any point in time there may be treatment and medications 
that preclude the special issuance of a medical certificate, the FAA 
will continue to seek public comment, when appropriate, as it has done 
recently concerning insulin-using diabetics (see 59 FR 67426, September 
29, 1994), to assist the Federal Air Surgeon in formulating policy on 
the special issuance of medical certificates.
    Finally, the Bullwinkel decision highlighted a deficit in FAA 
procedures that the emergency final rule has now corrected; the agency 
does not view the decision as finding the policy and practice of the 
FAA to be ``contrary to law'' as characterized by one commenter. The 
rule change clarifies and resolves any previous ambiguity in FAA's 
medical standards regarding medication and/or other treatment.

Conclusion

    Accordingly, after careful consideration of all the comments 
submitted, the FAA has determined that no further rulemaking action is 
warranted.

    Issued in Washington, DC, on February 23, 1996.
Jon L. Jordan,
Federal Air Surgeon.
[FR Doc. 96-4686 Filed 2-28-96; 8:45 am]
BILLING CODE 4910-13-M