Medical Standards and Certification; Final Rule DEPARTMENT OF TRANSPORTATION

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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