[Federal Register Volume 59, Number 200 (Tuesday, October 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24498]
[[Page Unknown]]
[Federal Register: October 18, 1994]
_______________________________________________________________________
Part VI
Department of Transportation
_______________________________________________________________________
Federal Aviation Administration
_______________________________________________________________________
14 CFR Parts 121, 125, and 135
Protective Glove Requirement; Final Rule
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Parts 121, 125, and 135
[Docket No. 27926 Amendment No. 121-242; 125-22; 135-53]
RIN 2120-AF37
Protective Glove Requirement
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule; request for comment.
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SUMMARY: This amendment requires that disposable latex gloves, or
equivalent nonpermeable gloves, be located onboard aircraft operated in
air carrier, air taxi, and commercial operations. This amendment
responds to the concerns of the FAA and some members of the aviation
industry that a potential health risk exists to crewmembers and
passengers from the possibility of incidental exposure to blood borne
pathogens. This amendment would lessen the possibility of that exposure
and therefore increase the level of safety for both passengers and
crewmembers.
DATES: Effective date December 2, 1994.
Comments must be received on or before December 2, 1994.
ADDRESSES: Send or deliver comments on the rule in duplicate to:
Federal Aviation Administration, Office of the Chief Counsel, Attn:
Rules Docket (AGC-204), Room 916, 800 Independence Avenue SW.,
Washington, DC 20591. Comments may be examined in the Rules Docket
weekdays, except Federal holidays, between 8:30 a.m. and 5:00 p.m.
FOR FURTHER INFORMATION CONTACT:
Daniel V. Meier Jr., Regulatory Branch (AFS-240), Air Transportation
Division, Flight Standards Service, Federal Aviation Administration,
800 Independence Avenue SW., Washington, DC 20591, telephone: (202)
267-3749.
SUPPLEMENTARY INFORMATION:
Background
The Association of Flight Attendants (AFA) stated in a 1990
petition for rulemaking that flight attendants face many hazards in
their work environment. Among these hazards it listed medical
emergencies that involve bleeding, such as nose-bleeds, cuts, and
childbirth, that could expose flight attendants to blood borne diseases
such as Hepatitis B. AFA noted that some carriers currently provide
barrier devices.
The FAA recognizes that crewmembers (usually flight attendants),
passengers, and health care professionals are sometimes called upon to
provide assistance to ill or injured people on aircraft. Providing such
assistance may cause such persons to come into contact with the body
fluids of persons infected with a blood borne pathogen such as the
human immunodeficiency virus (HIV) or the hepatitis B virus (HBV).
Blood is the single most important source of HIV, HBV, and other blood
borne pathogens in the occupational setting. Infection control efforts
for these blood borne pathogens must focus on preventing persons from
being exposed to blood. Medical research indicates that the risk of
transmission of HIV and HBV from other body fluids and materials such
as nasal secretions, sputum, sweat, tears, urine, vomitus and feces is
extremely low or nonexistent. Where blood is visible in these
substances, however, there is a risk of exposure to blood borne
pathogens. The use of protective gloves is the most effective manner in
which to prevent passengers and crewmembers from being exposed to
contaminated blood and other fluids.
The possibility of crewmembers contracting HIV or HBV in their
working environment is remote; nevertheless, the FAA is concerned about
the possibility of unnecessary exposure to blood borne pathogens. The
risk of exposure is greatest among flight attendants because they come
into contact with and assist passengers more frequently than other
crewmembers. However, passengers who are health care professionals, and
flight crewmembers, may also be exposed, when they assist an injured or
ill person on an aircraft. The FAA intends to lessen exposure to blood
borne pathogens and provide a higher level of protection for
crewmembers and any medical volunteer who may need to use the required
aircraft first aid or medical kits. Therefore, the FAA has determined
that it is necessary to require operators to aircraft used in
operations under parts 121, 125, and 135 to install protective gloves
on board those aircraft. This requirement applies to cargo-only as well
as passenger-carrying aircraft. However, it does not apply to operators
that are not required to have a first aid kit on board the aircraft.
Specifically, the rule contains the following requirements: (1)
part 121 operators would be required to install one pair of protective
gloves in the emergency medical kits of all of their aircraft; (2) part
121 operators are also required to distribute pairs of protective
gloves, equal to the number first aid kits on the airplane, as evenly
as practicable throughout the cabin of their aircraft; and (3) part 125
and 135 operators would be required to provide one pair of protective
gloves on their aircraft either in the first aid kit or in a location
that is readily accessible to crewmembers.
Because a crewmember in part 121 operations may need to provide
assistance when the other items of the first aid kit are not needed,
the FAA does not require that the protective gloves be placed in the
first aid kits; rather the rule requires that the gloves be located in
places that are readily accessible for use by crewmembers in the cabin
of the aircraft. This will encourage the use of gloves whenever a
crewmember is required to assist a person and when there is the
possibility of exposure to a body fluid. In reviewing the number of in-
flight emergencies, the FAA has found that the number of first aid kits
is appropriate to the treatment of injuries likely to occur in flight.
The FAA also finds that requiring pairs of protective gloves in a
number equal to the number of first aid kits on board is sufficient.
Readers are reminded that this is a minimum requirement and operators
may provide more gloves if they so elect.
Part 125 and 135 operators are only required to have first aid kits
on board the aircraft. Part 125 and 135 operators may elect to put the
gloves in the first aid kits, or as an alternative, may locate the
gloves in a place that is readily accessible to crewmembers. Because
operations conducted under part 135 are usually of a much shorter
flight duration, multiple pairs of gloves are not required by this
amendment. As with the part 121 operators, multiple pairs of gloves may
be provided if the operator so elects.
The protective gloves required by this amendment must be the
equivalent of latex gloves commonly found in hospitals and other
medical facilities. Operators are expected to maintain and dispose of
the gloves in accordance with acceptable procedures.
This rule does not include new language specifically requiring
additional training for the use of latex gloves or their equivalent.
However, under 14 CFR 121.415(a)(3) and 121.417(b)(3)(iv), part 121
operators are required to include in a training program ``Illness,
injury, or other abnormal situations involving passengers or
crewmembers to include familiarization with the emergency medical kit *
* *.'' Since protective gloves will be required in the medical kit,
part 121 operators will be required to provide training as to their
use. Likewise, 14 CFR 135.331(b)(2)(ii) and 135.331(b)(3)(iv) require
that part 135 operators provide training in ``First aid equipment and
its proper use.'' As the gloves will be required equipment in the first
aid kit on board part 135 operations, part 135 operators will be
required to provide training in the use of the gloves. The FAA does not
intend that this training be accomplished in a special training session
but rather as part of the normal training cycle. Part 125 does not have
training requirements, but rather has testing requirements. The FAA
does not find it necessary to test crewmembers serving in part 125
operations on the use of the gloves or on blood-borne pathogens.
Information on blood-borne pathogens and use of the gloves will be made
available to these operators in a revised AC 120-44, and the agency
finds this source sufficient.
Each part 121 and 135 operator must include as a part of such
training information about blood borne pathogens and the proper use and
disposal of the protective gloves. This training may be accomplished in
a number of ways to include video tapes, computer based instruction, or
pamphlets. Advisory Circular 120-44 is being revised to include
discussion of the various options available to operators to ensure that
an infectious disease awareness program is included in each approved
training program.
Trade Impact Statement
The FAA finds that this amendment will have no impact on
international trade.
Economic Summary
Changes to Federal regulations are required to undergo several
economic analyses. First, Executive Order 12866 directs each Federal
agency to propose or adopt a regulation only upon a reasoned
determination that the benefits of the intended regulation justify its
costs. Second, the Regulatory Flexibility Act of 1980 requires agencies
to analyze the economic effect 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. With respect
to this final rule, the FAA has determined that it: (1) Will generate
benefits that justify its costs and is not ``a significant regulatory
action'' as defined in the Executive Order; (2) is not significant as
defined in the Department of Transportation's Regulatory Policies and
Procedures; (3) will not have a significant impact on a substantial
number of small entities; and (4) will not constitute a barrier to
international trade. Therefore, a full regulatory analysis, which
includes the identification and evaluation of cost reducing
alternatives to this rule, has not been prepared. Instead, the agency
has prepared a more concise analysis of this final rule which is
presented in the following paragraphs.
Costs
The FAA estimates the total cost of the final rule amending parts
121.309(d), 125.207(a) and 135.177(a) to include protective gloves will
be approximately $1.1 million in 1993 dollars ($750,000, discounted)
over the 10-year period 1995-2004. This final rule requires, at a
minimum, (1) part 121 operators to install one pair of protective
gloves in the emergency medical kits of their aircraft; (2) part 121
operators to provide pairs of protective gloves equal in number to the
first aid kits on each of their aircraft; and (3) parts 125 and 135
operators to provide, either in the first aid kit or in a readily
accessible location, one pair of protective gloves for each aircraft.
In addition to the cost of the gloves, the FAA has estimated the
incremental labor cost required for the breaking down of the part 121
emergency medical kits to install protective gloves, the supplying of
gloves throughout part 121 aircraft cabins, the supplying of protective
gloves aboard aircraft operated under parts 125 and 135, and the
required record keeping associated with these activities. The FAA has
also imputed an incremental cost for the containment and disposal of
the gloves after use in keeping with current air carrier, air taxi and
commercial aircraft policies on waste material. Finally, as one option
available to operators to provide infectious disease awareness, the FAA
has also estimated the cost for awareness materials (pamphlets) in
accordance with the anticipated revisions to Advisory Circular 120-44.
The total $1.1 million estimated cost of this final rule for the
1995-2004 time period is comprised of the following components
expressed in 1993 dollars: (1) $242,000 ($160,000, discounted) for part
121 operators to install protective gloves in each aircraft's medical
kit (cost of gloves plus labor) including a cost imputation to reflect
the incremental cost to provide for the in-flight disposal of used
gloves and to provide for their replacement as needed; (2) $174,000
($122,000, discounted) for part 121 operators to provide protective
gloves equal to the number of first aid kits on each aircraft (cost of
gloves plus labor) including a cost imputation to reflect the
incremental cost to provide for the in-flight disposal of used gloves
and to provide for their replacement as needed; (3) $25,000 ($17,000,
discounted) for parts 125 and 135 operators to install one pair of
protective gloves in each aircraft's first aid kit (cost of gloves plus
labor) including a cost imputation to reflect the incremental cost to
provide for the in-flight disposal of used gloves and to provide for
their replacement as needed; and (4) $620,000 ($428,000, discounted)
estimated materials cost to provide to all affected crew members with
infectious disease awareness training and training in the proper use of
the gloves in accordance with Secs. 121.415(a)(3), 121.417(b)(3)(iv),
135.311(b)(2)(ii), and 135.331(b)(3)(iv).
Benefits
The FAA has no recorded incidents in which a crewmember or
passenger sustained serious illness or death as a result of attending
to a passenger with resulting exposure to bloodborne pathogens.
However, based on information obtained from various sources, the FAA
can reasonably approximate the risk involved in attending to a carrier
of the bloodborne pathogens HIV or HBV.
According to information provided by OSHA and the Centers for
Disease Control, the estimated numbers of HIV and HBV carriers in the
general population (255 million) in 1992, were respectively, 1.0
million and 1.2 million. The probability of contact of any kind with a
carrier of either HIV or HBV is approximately 0.004 and 0.005,
respectively; the probability of contact with a person who is a carrier
of either HIV or HBV is 0.00898 adjusted for the probability that the
person is a carrier of both pathogens. Data contained in an FAA study
reports that 1,150 in-flight medical emergencies, e.g., those requiring
the use of the ``doctors only'' medical kit, occur annually (``A Study
of In-Flight Medical Occurrences''; FAA AFS-200, July 1994). In a 1-
year exhaustive study at a major airport, twenty percent of the in-
flight medical emergencies were for lacerative, vomitous or obstetric
conditions, conditions which could potentially result in exposure of
persons to bloodborne pathogens (Richard O. Cummins and Jessica
Schubach, Frequency and Types of Medical Emergencies Among Commercial
Air Travelers; Journal of American Medicine, Vol. 261, No. 9 (1989).
Statistically, this data suggests that at a minimum the frequency of
in-flight medical emergencies each year which could potentially result
in exposure to bloodborne pathogens is two (1,150*0.2*0.00898). Thus,
over a 10-year period, the FAA estimates that care-givers attending to
a person in an in-flight medical emergency will be at risk of being
exposed to bloodborne pathogens on twenty occasions.
International Trade Impact Analysis
This rule will have no effect on the sale of foreign aviation
products or services in the U.S. or on the sale of U.S. products or
services in foreign countries.
Regulatory Flexibility Determination
The Regulatory Flexibility Act of 1980 (RFA) ensures that
government regulations do not needlessly and disproportionately burden
small businesses. The RFA requires the FAA to review each rule that may
have ``a significant economic impact on substantial number of small
entities.'' FAA criteria define ``a substantial number'' as not less
than 11 nor more than one-third of the small entities subject to the
rule. Among air carriers, a small entity is defined as one which owns,
but does not necessarily operate, nine or fewer aircraft. The criteria
define ``a significant impact'' as $102,000 for scheduled air carriers
with 60 or more seats and $57,000 for scheduled air carriers with fewer
than 60 seats. The final rule's amendments will impose a negligible
annual cost burden (about $16 per aircraft) on all air carrier, air
taxi and commercial aircraft operators. This cost burden is not
expected to exceed threshold levels.
Federalism Implications
The regulation adopted herein would not have substantial direct
effects on the states, on the relationship between the states, or on
the distribution of power and responsibilities among the various levels
of government. Therefore, in accordance with Executive Order 12612, it
is determined that this regulation would not have sufficient federalism
implications to warrant the preparation of the Federalism Assessment.
International Civil Aviation Organization 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 (SARP) to the maximum extent
practicable. For this final rule, the FAA was unable to discover an
ICAO requirement for protective gloves.
Likewise, the Joint Aviation Regulations do not specifically list
items required for the first aid or medical kits but do specify that
all items must be serviceable for their intended purpose.
Paperwork Reduction
The current paperwork requirements for part 121 have been approved
under OMB Control No. 2120-008, for part 135 under Control No. 2120-
0039, and for part 125 under Control No. 2120-0085. This proposal adds
no new paperwork requirements.
Good Cause for Immediate Adoption
The FAA finds that notice and public comment for this rulemaking is
impracticable and contrary to the public interest. Because this rule
will lessen a potential health risk to passengers and crewmembers,
those persons should not be further subjected to that potential risk by
a delay in issuing a final rule.
In light of the current wide-spread use of protective gloves by
operators, the agency expects little or no adverse comment on the final
rule. Comments on the amendment are invited, however, and the
Administrator may amend or rescind the rule in view of public comment.
Comments should identify the Docket No. 27926 and be submitted in
triplicate to the address provided above. All comments will be
available for public review, both before and after the closing date for
comments.
Conclusion
For the reasons discussed in the preamble and based on the findings
in the Regulatory Flexibility Determination and the International Trade
Impact Analysis, the FAA has determined that this regulation is not a
significant regulatory action under Executive Order 12866. In addition,
the FAA has determined that this regulation 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
regulation is not considered significant under DOT Regulatory Policies
and Procedures (44 FR 11034; February 26, 1979).
List of Subjects in 14 CFR Parts 121, 125, 135
Air safety, Air transportation, Aviation safety, Safety,
Transportation, Cabin safety, Medical kits, First-aid kits.
The Amendment
Accordingly, 14 CFR parts 121, 125, and 135 are amended as follows:
PART 121--CERTIFICATION AND OPERATIONS: DOMESTIC, FLAG, AND
SUPPLEMENTAL AIR CARRIERS AND COMMERCIAL OPERATORS OF LARGE
AIRCRAFT
1. The authority citation for part 121 continues to read as
follows:
Authority: 49 U.S.C. App. 1354(a), 1355, 1356, 1357, 1401, 1421-
1430, 1472, 1485, and 1502; 49 U.S.C. 106(g) (revised, Pub.L. 97-
449, January 12, 1983).
2. Section 121.309(d) is revised to read:
Sec. 121.309 Emergency equipment.
* * * * *
(d) First aid and emergency medical equipment and protective
gloves.(1) Approved first aid kits and, on passenger flights, an
emergency medical kit for treatment of injuries or medical emergencies
that might occur during flight time or in minor accidents must be
provided and must meet the specifications and requirements of appendix
A of this part
(2) Pairs of protective latex gloves, or equivalent nonpermeable
gloves, equal in number to the number of first aid kits on board the
aircraft. These gloves must be distributed as evenly as practicable
throughout the cabin of the aircraft.
* * * * *
3. Appendix A of part 121 is amended by revising item 3 under
``Emergency Medical Kits'' to read as follows:
Appendix A to Part 121--First Aid Kits and Emergency Medical Kits
* * * * *
Emergency Medical Kits
* * * * *
(3) The approved emergency medical kit must contain, as a minimum,
the following appropriately maintained contents in the specified
quantities:
------------------------------------------------------------------------
Contents Quantity
------------------------------------------------------------------------
Sphygmomanometer............................................. 1
Stethoscope.................................................. 1
Airways, oropharyngeal (3 sizes)............................. 3
Syringes (sizes necessary to administer required drugs)...... 4
Needles (sizes necessary to administer required drugs)....... 6
50% Dextrose injection, 50cc................................. 1
Epinephrine 1:100, single dose ampule or equivalent.......... 2
Diphenhydramine HCI injection, single dose ampule or
equivalent.................................................. 2
Nitroglycerin tablets........................................ 10
Basic instructions for use of the drugs in the kit........... 1
Protective latex gloves or equivalent nonpermeable gloves.... \1\1
------------------------------------------------------------------------
\1\Pair.
* * * * *
PART 125--CERTIFICATION AND OPERATIONS: AIRPLANES HAVING A SEATING
CAPACITY OF 20 OR MORE PASSENGERS OR A MAXIMUM PAYLOAD CAPACITY OF
6,000 POUNDS OR MORE
4. The authority citation for part 125 continues to read as
follows:
Authority: 49 U.S.C. App. 1354, 1421 through 1430, and 1502; 49
U.S.C. 106(g) (Revised Pub. L. 97-449, January 12, 1983.)
5. Section 125.207 is amended by revising paragraph (a)(1)(iii) and
adding paragraph (a)(1)(iv) to read as follows:
Sec. 125.207 Emergency equipment requirements.
* * * * *
(a)(1)(iii) Except as provided in paragraph (a)(1)(iv) of this
section, at time of takeoff, each first aid kit must contain at least
the following or other contents approved by the Administrator:
------------------------------------------------------------------------
Contents Quantity
------------------------------------------------------------------------
Adhesive bandage compressors, 1 in........................... 16
Antiseptic swabs............................................. 20
Ammonia inhalants............................................ 10
Bandage compressors, 4 in.................................... 8
Triangular bandage compressors, 40 in........................ 5
Burn compound, \1/8\ oz or an equivalent of other burn remedy 6
Arm splint, noninflatable.................................... 1
Leg splint, noninflatable.................................... 1
Roller bandage, 4 in......................................... 4
Adhesive tape, 1-in standard roll............................ 2
Bandage scissors............................................. 1
Protective latex gloves or equivalent nonpermeable gloves.... \1\1
------------------------------------------------------------------------
\1\Pair.
(iv) Protective latex gloves or equivalent nonpermeable gloves may
be placed in the first aid kit or in a location that is readily
accessible to crewmembers.
* * * * *
PART 135--AIR TAXI OPERATORS AND COMMERCIAL OPERATORS
6. The authority citation for part 135 continues to read as
follows:
Authority: 49 U.S.C. App. 1354(a), 1355(a), 1421 through 1431,
and 49 U.S.C. 106(g) (Revised Pub. L. 97-449, January 12, 1993).
7. Section 135.177 is amended by revising paragraph (a)(1)(iii) and
adding paragraph (a)(1)(iv) to read as follows:
Sec. 135.177 Emergency equipment requirements for aircraft having a
passenger seating configuration of more than 19 passengers.
* * * * *
(a)(1)(iii) Except as provided in paragraph (a)(1)(iv) of this
section, at time of takeoff, each first aid kit must contain at least
the following or other contents approved by the Administrator:
------------------------------------------------------------------------
Contents Quantity
------------------------------------------------------------------------
Adhesive bandage compressors, 1 in........................... 16
Antiseptic swabs............................................. 20
Ammonia inhalants............................................ 10
Bandage compressors, 4 in.................................... 8
Triangular bandage compressors, 40 in........................ 5
Burn compound, \1/8\ oz or an equivalent of other burn remedy 6
Arm splint, noninflatable.................................... 1
Leg splint, noninflatable.................................... 1
Roller bandage, 4 in......................................... 4
Adhesive tape, 1-in standard roll............................ 2
Bandage scissors............................................. 1
Protective latex gloves or equivalent nonpermeable gloves.... \1\1
------------------------------------------------------------------------
\1\Pair.
(iv) Protective latex gloves or equivalent nonpermeable gloves may
be placed in the first aid kit or in a location that is readily
accessible to crewmembers.
* * * * *
Issued in Washington, DC, on September 26, 1994.
David R. Hinson,
Administrator.
[FR Doc. 94-24498 Filed 10-17-94; 8:45 am]
BILLING CODE 4910-13-M
