[Federal Register Volume 59, Number 174 (Friday, September 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22207]


[[Page Unknown]]

[Federal Register: September 9, 1994]


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Part II





Department of Transportation





_______________________________________________________________________



Federal Aviation Administration



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14 CFR Part 67




Medical Standards and Certification; Final Rule
DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 67

[Docket No. 27890; Amendment No. 67-15]
RIN 2120-AF42

 
Medical Standards and Certification

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: This final rule restates the general medical condition 
standards for first-, second-, and third-class airman medical 
certificates. In determining an applicant's eligibility for medical 
certification, the FAA's long-standing policy and practice have been to 
consider an applicant's medication and other treatment under the 
general medical conditions standards. In a recent decision by the U.S. 
Court of Appeals for the Seventh Circuit, however, the court found that 
the general medical condition standards cannot be interpreted to 
provide a basis for disqualification due to medication alone. This 
emergency final rule is, therefore, necessary to restate the general 
medical condition standards for an individual whose medication or other 
treatment makes or is expected to make that individual unable to safely 
perform the duties or exercise the privileges of an airman certificate.

DATES: Effective September 9, 1994. Comments must be received by 
November 8, 1994.

ADDRESSES: Comments on this rule should be mailed or delivered, in 
triplicate, to: Federal Aviation Administration, Office of the Chief 
Counsel, Attention: Rules Docket (AGC-200), Docket No. 27890, 800 
Independence Avenue, SW., Washington, DC 20591. Comments mailed or 
delivered must be marked Docket No. 27890. 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 final rule 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 amendment 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 Administrator. This rule may be amended in 
consideration of comments received.

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 applicant who is found to meet the appropriate medical standards, 
based on medical examination and evaluation of the applicant'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)(2) of Secs. 67.13, 67.15, and 67.17 is the standard 
for determining an applicant's eligibility for first-, Psecond-, and 
third-class medical certification based on general medical conditions. 
Specifically, under paragraph (f)(2), an applicant is ineligible for 
unrestricted medical certification if he or she 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 the Federal Air Surgeon's 
finding to make the applicant unable to safely perform those duties or 
exercise those privileges. The Federal Air Surgeon's finding must be 
based on the applicant's case history and appropriate, qualified, 
medical judgment relating to the condition involved.
    Paragraph (f)(2) long has been the 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) interfere 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. The medication or other 
treatment may or may not be associated with an underlying medical 
condition that would be disqualifying for medical certification. For 
example, a hypnotic medication, such as a benzodiazepine, may be 
prescribed to treat a condition such as recurrent insomnia. Recurrent 
insomnia, depending on the circumstances, may not preclude eligibility 
for medical certification. The medication used to treat the condition, 
however, has potential adverse effects, such as dizziness, drowsiness, 
ataxia, and ``hangover.'' Exposure to such a medication could 
unpredictably interfere with the applicant's ability to safely perform 
the duties or exercise the privileges of the airman certificate held or 
applied for, posing a hazard to the applicant and to public safety.
    Other medications have potential adverse effects that can occur 
with unpredictable frequency, duration, or severity. These adverse 
effects can be numerous and can include such conditions as cardiac 
arrhythmia, hypotension, over-sedation, and akathesia. Each of these 
effects may be inconsistent with aviation safety. In addition, some 
forms of treatment (e.g., surgery, radiation therapy, chemotherapy, and 
hemodialysis) have adverse effects that can interfere with an airman's 
ability to safely perform the duties or exercise the privileges of an 
airman certificate. The Federal Air Surgeon considers relevant factors 
on a case-by-case basis, including potential adverse effects, to 
determine whether the medication or other treatment received by an 
airman is inconsistent with medical certification.
    Notwithstanding the FAA's long-standing medical certification 
policy and practice under paragraph (f)(2) regarding medication and 
other treatment, the U.S. Court of Appeals for the Seventh Circuit 
recently determined that paragraph (f)(2) does not provide a basis for 
denial of medical certification based on medication alone. Bullwinkel 
v. Fed. Aviation Admin., No. 93-1803 (7th Cir., Apr. 27, 1994), reh'g. 
denied, 1994 U.S. App. LEXIS 15779 (June 23, 1994) The Bullwinkel case 
involved the use of lithium. The focus of the Seventh Circuit's 
decision was not on the safety concerns that lithium use poses; 
instead, the court centered its attention on interpreting the specific 
language of the regulation. Although the court's decision concerned the 
airman's use of a medication, its rationale could apply to other forms 
of treatment as well.
    The FAA disagrees with the Seventh Circuit's narrow reading of 
paragraph (f)(2) in the Bullwinkel case. However, regardless of the 
merits of the respective positions on how to interpret paragraph 
(f)(2), the Seventh Circuit's decision raises serious safety concerns 
that require the immediate adoption of an amendment that expressly 
states the FAA's authority to disqualify an individual who holds or is 
applying for an airman medical certificate in cases where medication or 
other treatment may interfere with that individual's ability to safely 
perform airman duties.
    This final rule amends paragraph (f) of Secs. 67.13, 67.15, and 
67.17 by adding new paragraph (f)(3). New paragraph (f)(3) sets out the 
standard for certification where medication or other treatment is 
involved. Paragraph (f)(3) makes ineligible for unrestricted medical 
certification any applicant whose medication or other treatment the 
Federal Air Surgeon finds makes, or may reasonably be expected to make 
within 2 years after the finding, that applicant is unable to safely 
perform the duties or exercise the privileges of an airman certificate. 
This final rule does not change the FAA's current and long-standing 
application of the certification standards. Rather its sole purpose is 
to expressly state the agency's practice in light of the Bullwinkel 
decision.
    Also, for continuation of the current administration of medical 
certification procedures, reference to this emergency final rule is 
added by revising section 67.25, Delegation of authority, and section 
67.27, Denial of medical certificate.

Good Cause Justification for Immediate Adoption

    This amendment is being adopted without notice and a prior public 
comment period because delay in adoption could have a significant 
adverse effect on aviation safety, and because the amendment effects no 
change in well established agency application of the medical 
certification standards.
    Therefore, the FAA finds that: (1) An emergency situation exists 
requiring the immediate adoption of this amendment; (2) the publication 
of a notice of proposed rulemaking with its opportunity for public 
comment is impracticable; and, (3) good cause exists for amendment in 
less than 30 days.

Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1980 (Pub. L. 
96.511), there are no requirements for information collection 
associated with this rule.

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 would have a significant 
economic impact, either detrimental or beneficial, on a substantial 
number of small entities. FAA Order 2100.14A, Regulatory Flexibility 
Criteria and Guidance, provides threshold cost and small entity size 
standards for complying with RFA review requirements in FAA rulemaking 
actions. After reviewing the projected effects of the rule in light of 
these standards, the FAA finds that the rule would not have significant 
economic impact on a substantial number of small entities.

International Trade Impact Statement

    The rule would have little or no impact on trade for both U.S. 
firms doing business in foreign countries and foreign firms doing 
business in the United States.

Federalism Implications

    The rule adopted herein will not have substantial direct effects on 
the states, on the relationship between the Federal 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, it is determined that this final rule does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.

International Civil Aviation Organization (ICAO) and Joint Aviation 
Regulations

    In keeping with U.S. obligations under the Convention on 
International Civil Aviation, it is FAA policy to comply with ICAO 
Standards and Recommended Practices to the maximum extent practicable. 
The FAA has determined that this rule does not conflict with any 
international agreement of the United States.

Conclusion

    The FAA has determined that this final rule is an emergency rule 
that must be issued immediately to correct an unsafe condition. Based 
on the findings in the Regulatory Flexibility Determination and the 
International Trade Impact Analysis, the FAA has determined that this 
final rule will 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 final rule is not considered 
significant under DOT Regulatory Policies and Procedures (44 FR 11034; 
February 26, 1979).

List of Subjects in 14 CFR Part 67

    Airman medical certification, Airman medical standards, Air safety, 
Air transportation, Aviation safety.

The Amendment

    In consideration of the foregoing, the FAA amends part 67 of Title 
14 of the Code of Federal Regulations as follows:

PART 67--MEDICAL STANDARDS AND CERTIFICATION

    1. The authority citation for part 67 continues to read as follows:

    Authority: 49 U.S.C. app. 1354, 1355, 1421, 1422, and 1427; 49 
U.S.C. 106(g).

    2. Section 67.13 is amended by adding paragraph (f)(3) to read as 
follows:


Sec. 67.13  First-class medical certificate.

* * * * *
    (f) * * *
    (3) No medication or other treatment that the Federal Air Surgeon 
finds--
    (i) Makes the applicant unable to safely perform the duties or 
exercise the privileges of the airman certificate that the applicant 
holds or for which the applicant is applying; or
    (ii) May reasonably be expected, within 2 years after the finding, 
to make the applicant unable to perform those duties or exercise those 
privileges;

and the findings are based on the case history and appropriate, 
qualified, medical judgment relating to the medication or other 
treatment involved.
* * * * *
    3. Section 67.15 is amended by adding paragraph (f)(3) to read as 
follows:


Sec. 67.15  Second-class medical certificate.

* * * * *
    (f) * * *
    (3) No medication or other treatment that the Federal Air Surgeon 
finds--
    (i) Makes the applicant unable to safely perform the duties or 
exercise the privileges of the airman certificate that the applicant 
holds or for which the applicant is applying; or
    (ii) May reasonably be expected, within 2 years after the finding, 
to make the applicant unable to perform those duties or exercise those 
privileges;

and the findings are based on the case history and appropriate, 
qualified, medical judgment relating to the medication or other 
treatment involved.
* * * * *
    4. Section 67.17 is amended by adding paragraph (f)(3) to read as 
follows:


Sec. 67.17  Third-class medical certificate.

* * * * *
    (f) * * *
    (3) No medication or other treatment that the Federal Air Surgeon 
finds--
    (i) Makes the applicant unable to safely perform the duties or 
exercise the privileges of the airman certificate that the applicant 
holds or for which the applicant is applying; or
    (ii) May reasonably be expected, within 2 years after the finding, 
to make the applicant unable to perform those duties or exercise those 
privileges;

and the findings are based on the case history and appropriate, 
qualified, medical judgment relating to the medication or other 
treatment involved.
    5. The first sentence of paragraph (b) of Sec. 67.25 is revised to 
read as follows:


Sec. 67.25  Delegation of authority.

    (a) * * *
    (b) The authority of the Administrator, under subsection 314(b) of 
the Federal Aviation Act of 1958 (49 U.S.C. 1355(b)), to reconsider the 
action of an aviation medical examiner is delegated to the Federal Air 
Surgeon, the Chief, Aeromedical Certification Division, an each 
Regional Flight Surgeon. Where the applicant does not meet the 
standards of Sec. 67.13(d)(1)(ii), (d)(2)(ii), (f)(2), or (f)(3), 
Sec. 67.15(d)(1)(ii), (d)(2)(ii), (f)(2), or (f)(3), or 
Sec. 67.17(d)(1)(ii), (d)(2)(ii), (f)(2), or (f)(3), any action taken 
under this paragraph other than by the Federal Air Surgeon is subject 
to reconsideration by the Federal Air Surgeon. * * *
* * * * *
    6. Paragraph (b)(3) of Sec. 67.27 is revised to read as follows:


Sec. 67.27  Denial of medial certificate.

    (b) * * *
    (3) By the Manager, Aeromedical Certification Division, AAM-300, or 
a Regional Flight Surgeon is considered to be a denial by the 
Administrator under the Act except where the applicant does not meet 
the standards of Sec. 67.13(d)(1)(ii), (d)(2)(ii), (f)(2), or (f)(3), 
Sec. 67.15(d)(1)(ii), (d)(2)(ii), (f)(2), or (f)(3), 
Sec. 67.17(d)(1)(ii), (d)(2)(ii), (f)(2), or (f)(3).
* * * * *
    Issued in Washington, DC on September 1, 1994.
David R. Hinson,
Administrator.
[FR Doc. 94-22207 Filed 9-2-94; 4:38 pm]
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