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F ebruary 20

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F ederal Avia

U .S. Depart m

W est Buildi n

N ew Jersey A

W ashington

,

Re: P

L adies and G

S wift Air LL C

o perations, r

e xemption f

S wift Air fro m

m ore fully d

s uch time a s

s ub j ect of t h

A s the EMK s

e mergency r

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R egional Air

t heir air car r

1 21.803(c)( 3

c arry an EM K

t hat Atropin

D ocket No. F

n support o

a n acute na t

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t his shortfal l

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m edication f

A dditionally

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exemptio VIA WWW.

, 2003

tion Admini

m ent of Tra n

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A venue, SE

, DC 20590

etition for E

G entlemen:

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. (“Swift Air ”

r espectfully

rom 14 C.F. R

m the requi r

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s it acts on t h

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f their requ e

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xemption; 1

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t ion (collect

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ndix A, to t h

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i ations”), pe

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f fective date. t 121 passe n

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h e extent n e

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p edite this p

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f February, w

his request

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Carrier Ass o

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f more than

ndix A, fro m

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r carriers, d e

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a tions’ Petiti

3 (d), requirin n ger carryin g

1

, for an

e cessary to r e

K its (“EMKs” )

etition 1 and

a tions that a

w e request

o ciation, an d

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m 14 C.F.R.

nine passe n

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with the

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t ernative

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air

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n for anFebruary 20, 2013

Page 2

that: (i) remaining Atropine supplies are currently being rationed for distribution to front

‐ line

responders such as hospitals and paramedic units; and (ii) the supplier had verified with the Food

and Drug Administration (“FDA”) that no foreign Atropine manufacturers have been authorized to

import Atropine into the United States in response to this critical nationwide shortage. This supplier

additionally noted that, in its experience refurbishing EMKs, Atropine is used less than one time per

one thousand units serviced. Finally, the Associations’ Petition stated that no manufacturers of

Atropine have applied to the FDA to extend the expiration date for Atropine.

On January 25, 2013, the FAA acted favorably on the Associations’ Petition, granting a partial

exemption, for a duration of one year, from 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, “only

to the extent necessary to relieve them from the requirement to carry two single dose ampules of

Atropine 5cc injectable, in required on

‐ board EMKs when, due to the nationwide shortage discussed

herein, they are unable to procure these items for the kits.” Exemption No. 10690 (the

“Exemption”) at 3. In explaining its decision, the FAA stated:

The documented Atropine shortage creates the possibility that a significant number of

aircraft would not be able to meet the requirements of Appendix A of part 121 and would

have to be taken out of service

. . . EMK suppliers report that Atropine is predominantly

replaced in EMKs due to expiration. Accordingly, the FAA has determined that the impact on

large numbers of passengers that would be caused by grounding these aircraft for lack of

Atropine outweighs the benefit of having the medication, which reportedly is infrequently

used in response to on board medical events.

Further

... the nationwide Atropine shortage is affecting not only EMK suppliers to airlines,

but also ground

‐ based medical service providers. The FAA also finds that, because this

medication is reported to rarely be used in flight, it is not in the public interest for EMK

suppliers to airlines to be competing with the greater need and demand of ground

‐ based

medical providers for these medications.

Exemption at 3. However, and notwithstanding the Carrier Associations’ request that relief be

granted to their air carrier members and similarly

‐ situated air carriers, the FAA granted the

Exemption “only to the part 119 certificate holders named in the petition that conduct part 121

passenger carrying operations.” Id.

Swift Air faces the same acute nationwide shortage for Atropine in on board EMKs as that set forth

in the Associations’ Petition. Given that the Exemption, by its express terms, is limited to only the

members of the Carrier Associations, Swift Air is compelled to separately petition for the same relief

already provided for under the Exemption. In acting on this petition, Swift Air respectfully requests

that the FAA take notice of all information submitted by the Carrier Associations in Regulatory

Docket No. FAA

‐ 2013

‐ 0034.

The Specific Regulation from Which an Exemption is Sought (14 C.F.R. § 11.81(b))

Swift Air petitions the FAA for an exemption from 14 C.F.R. 121.803(c)(3), requiring passenger

‐

carrying airplanes to be equipped with an EMK containing Atropine in the manner prescribed at

part 121, Appendix A, EMK requirements, paragraph 2.February 20, 2013

Page 3

The Extent of and Reasons for the Requested Relief (14 C.F.R. § 11.81(c))

Swift Air requests an exemption from 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, only to the

extent necessary to relieve Swift Air from the requirement to carry two single dose ampules of

Atropine 5cc injectable in required on board EMKs, when, due to the nationwide shortage described

herein and in Regulatory Docket No. FAA

‐ 2013

‐ 0034, Swift Air is unable to procure such Atropine for

its on board EMKs.

Swift Air submits that good cause exists for the FAA to expedite, and waive publication of a

summary of, this petition before acting on the request. Moreover, until such time as the FAA acts on

this petition, Swift Air asks that the FAA exercise its discretion not to enforce the regulations that

are the subject of the relief requested herein.

In support of this requested relief, and as the FAA found in issuing the Exemption, the national

Atropine shortage has significantly increased the likelihood that many passenger carrying aircraft

will be unable to meet the requirements of part 121, Appendix A. This shortage has been widely

documented and is now aggravated by the rationing of Atropine supplies to front

‐ line responders

such as hospitals and paramedic units. Furthermore, replacement Atropine cannot currently be

imported into the United States and there is not an acceptable substitute for Atropine, as explained

in the Associations’ Petition. As also set forth in the Associations’ Petition, EMK suppliers providing

Atropine to air carriers have already depleted, or soon will deplete, their available stock.

Granting of the Exemption Would Be in the Public Interest and Benefit the Public as a Whole

(14 C.F.R. § 11.81(d))

Without the relief requested herein, it is not possible for Swift Air to comply with the requirement

under 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, with respect to Atropine in on board EMKs. 2

As a consequence, unless the relief is granted, Swift Air would have no choice but to remove aircraft

from passenger carrying operations pending procurement of additional Atropine supplies. Grant of

the relief requested herein would allow the continuation of uninterrupted, critical air service, and,

therefore, would be in the public interest.

Furthermore, given that a rationing system has been instituted for Atropine, whereby preference is

assigned to front

‐ line responders such as hospitals and paramedic units, continuing to require Swift

Air and similarly

‐ situated air carriers to comply with the requirement to include Atropine in EMKs

during this critical period of national shortage would, in fact, be contrary to the national interest. In

this regard, and as the FAA found when issuing the Exemption on January 25, 2013, “[T]he

nationwide Atropine shortage is affecting not only EMK suppliers to airlines, but also ground

‐ based

medical service providers. The FAA also finds that, because this medication is reported to rarely be

used in flight, it is not in the public interest for EMK suppliers to airlines to be competing with the

greater need and demand of ground

‐ based medical providers for these medications.” Exemption at

3.

2 Under FAA policy standardizing Master Minimum Equipment List (“MMEL”) requirements for the

deferral of approved emergency medical equipment, including EMKs, the continued operation of an

aircraft with an incomplete EMK is only authorized for a maximum of one flight to a location where

repairs or replacements can be made. See FAA MMEL Policy Letter (PL) 73, Revision 5 (Jun. 15,

2011).February 20, 2013

Page 4

Granting of the Exemption Would Not Adversely Affect Safety (14 C.F.R. § 11.81(e))

As set forth in the EMK supplier letters submitted with the Associations’ Petition, and as the FAA

observed in granting the Exemption, Atropine is reportedly used for medical purposes less than one

time per thousand units serviced. Moreover, when Atropine is replaced in EMKs, the predominant

reason is expiration

‐ not the depletion of Atropine in connection with on board medical events. In

fact, and as the FAA also noted in the Exemption, Atropine “reportedly is infrequently used in

response to on board medical events.” Exemption at 3. Thus, exempting Swift Air would not

adversely impact the safety of the traveling public, as Atropine usage during on board medical

events is extraordinarily rare.

Suitable Summary for Publication in the Federal Register (14 C.F.R. § 11.81(e))

Petitioner Swift Air LLC.

Regulation from which exemption sought: 14 C.F.R. 121.803(c)(3) and part 121, Appendix A

‐ First

Aid Kits and Emergency Medical Kits

Nature of requested exemption: The requested relief would temporarily exempt, for

one year, the petitioner from the requirement to

include Atropine in its on board emergency medical

kits when, due to a nationwide shortage of the drug, it

is unable to procure this item for such kits.

Reasons Why the Privileges Need to be Exercised Outside the U.S. (14 C.F.R. § 11.81(g))

Swift Air will be required to exercise the privileges of the requested exemption outside the United

States, given that its aircraft with on board EMKs are routinely rotated between domestic and

international passenger carrying operations. As set forth in the Associations’ Petition, the

International Civil Aviation Organization’s (“ICAO”) standards, as they relate to EMKs, require

operators to ensure aircraft are equipped with accessible and adequate medical supplies. The ICAO

standards recommend, in the case of aircraft authorized to carry more than 100 passengers on a

flight exceeding two hours, “a medical kit, for the use of medical doctors or other qualified persons

in treating in

‐ flight medical emergencies.” Similarly, the ICAO merely recommends, but does not

require, Atropine, in such medical kits. As a consequence, grant of the relief sought herein would

not be contrary to ICAO requirements.

Conclusion

Based on the foregoing, Swift Air respectfully requests an exemption from 14 C.F.R. 121.803(c)(3)

and part 121, Appendix A, to the extent necessary to relieve Swift Air from the requirement to carry

two single dose ampules of Atropine 5cc injectable in on board EMKs, when, due to the nationwide

shortage described herein and in Regulatory Docket No. FAA

‐ 2013

‐ 0034, Swift Air is unable to

procure such Atropine for its on board EMKs. Swift Air further requests that the FAA expedite this

petition and, until such time as it acts on the petition, exercise its discretion not to enforce the

regulations that are the subject of the relief requested herein.F

P

R

B

C

S

c F ebruary 20

, P age 5

R espectfully

B oris van Lier

C OO

S wift Air, LLC

c c: Mr. J o

Fede r

Direc

800 I n

John.

Mr. J o

Fede r

Depu

800 I n

Was h

John.

Mr. L

Fede r

Fligh t

800 I n

Was h

Lesli e

Mr. S

Fede r

Fligh t

Aircr a

470 L

Was h

stev e , 2013

submitted,

.

o hn Allen

r al Aviation A

tor, Flight S t

n dependen c

allen@faa. g

o hn Duncan

r al Aviation A

ty Director f

n dependen c

h ington, DC 2

s.duncan@ f

es Smith

r al Aviation A

t Standards S

n dependen c

h ington, DC 2

e .smith@fa a

teve Dougl a

r al Aviation A

t Standards S

a ft Mainten a

L ’Enfant Plaz

h ington, DC 2

e n.w.dougla s A dministrat

t andards Se r

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A dministrat

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