Exemption No. I 0690 

UNITED STATES OF AMERICA 

DEPARTMENT Of TRANSPORT AriON 

FEDERAL AVIATION ADMINISTRATION 

WASHINGTON, DC 20591 

In the matter of the petition of 

AIRLINES FOR AMEI{ICA 

NATIONAL AIR CARRIER ASSOCIATION 

AND REGIONAL AIRLINE ASSOCIATION 

for an exemption from 121 .803 (c) (3) 

and Part 121, Appendix A, paragraph (2) 

of Title 14, Code of Federal Regulations 

Regulatory Docket No. 

FAA-2013-0034 

PARTIAL GRANT OF EXEMPTION 

By letter received on January 14,2013. Airlines for America, the National Air Carrier 

Association, and the Regional Airline Association 1301 Pennsylvania Avenue NW., 

Washington, DC 20004, petitioned the Federal Aviation Administration (FAA) on behalf of 

the airlines named in their petition for an exemption from § 121 .803( c )(3) and Appendix A of 

part 121, Title 14, Code ofF ederal Regulations. The proposed exemption, if granted, would 

provide relief from the requirement to include Atropine in an Emergency Medical Kit (EMK). 

The petitioners indicate they arc making this request due to a nationwide manufacturing 

supply shortage that leaves affected certificate holders without an alternate means to comply 

with the requirements of Appendix A. 

The petitioners require relief from the following regulations: 

Section 121.803(c)(3) prescribes, in pertinent part, that passenger-carrying airplanes 

operating under part 121 mles for which a flight attendant is required must have 

approved emergency medical kits that meet the specifications and requirements of Part 

121, Appendix A. 

Part 121, Appendix A, '·Emergency Medical Kits" specifies, in pertinent part, that an 

EMK must include two single dose ampules of Atropine 0.5, Sec injectable or 

equivalent. 

AFS-13-159-E 
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The petitioner supports its request with the following information: 

The petitioners state that Atropine, a medication required to be carried in EMKs, is not 

available due to a manufacturing shortfall and an increase in demand. One major EMK 

supplier has informed the petitioners that it will deplete its Atropine supply as of 

January 25, 2013; another indicates that its Atropine supply is already depleted. As such, the 

petitioners indicate that their member air carriers are not able to meet the atropine 

requirement. 

The petitioners enclosed two letters from major EMK airline suppliers and refurbishers, 

Banyan International Corporation and MedAire. as evidence ofthe Atropine shortage. The 

petitioners state that Banyan and MedAire are major EMK airline suppliers. The petitioners 

indicate that of the four pharmaceutical companies that manufacture Atropine one 

manufacturer has decided to stop producing Atropine and another has decided to indefinitely 

postpone Atropine production. The petitioners state that this lack of production has resulted 

in two remaining manufacturers rationing remaining supplies to first-line responders such as 

hospitals and paramedic units. In addition. the letter trom Banyan states that it has verified 

with the Food and Drug Administration (FDA) that there are no FDA-approved foreign 

Atropine manufacturers authorized to impmt Atropine into the United States to relieve the 

shortage. The petitioners assert that, while the FDA has the authority to extend the expiration 

date on drugs such as Atropine, the manufacturer must petition the FDA for an extension of 

the expiration date by providing drug stability data, which no manufacturer has done. 

The petitioners state that MedAire has reported that roughly 1% of the EMKs returned for 

refurbishment (to restock an EMKs contents) are missing Atropine due to use, loss, or 

damage. The petitioners also state that Banyan reports that Atropine is used less than one 

time per 1,000 units serviced. 

Finally, the petitioners request that they be able to exercise the privileges of the exemption 

outside the United States. They state that the International Civil Aviation Organization 

(ICAO) standards require aircraft authorized to carry more than 100 passengers to be equipped 

with "accessible and adequate medical supplies: · but recommends that injectable Atropine be 

available as part of a medical kit tor use by medical doctors or other qualified persons on 

certain aircraft. Accordingly. the petitioners state that the absence of Atropine in an EMK on 

an aircraft operating outside the United States would not violate ICAO requirements. 

The FAA has determined that good cause exists to waive publication of a summary of this 

petition for exemption because delaying action would adversely affect the petitioners due to 

the imminent effect on operations caused by the Atropine sh011age. 
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The FAA's analysis is as follows: 

The FAA has considered fully the petitioners' request and supp011ing information and finds 

that a prutial grant of exemption would be in the public interest. 

All airplanes for which a flight attendant is required, must carry an EMK with items listed in 

part 121 , Appendix A. The EMK is considered a ··no-go'· item and is included on the Master 

Minimum Equipment List (MMEL). Current MMEL Policy Letter relief requires an air 

carrier to repair or replace an EMK within one tlight when it is incomplete, missing, or 

inoperative. There is no minimum equipment list relief permitting an air carrier to depart with 

an EMK missing Atropine, beyond the one llight relief described in MMEL policy Letter 73, 

titled "MMEL Rclieffor Emergency Medical Equipment." 

The documented Atropine shottage 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. As discussed in the petition. EMK suppliers report that Atropine is used 

for medical purposes less than one time per thousand EMK units serviced, and 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 bene tit of having the medication, which reportedly 

is infrequently used in response to on board medical events. 

Further, as discussed in the petition, the nationwide Atropine shortage is affecting not only 

EMK suppliers to airlines, but also ground-based medical service providers. The FAA also 

fmds 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 tor these medications. 

The FAA's Decision 

In consideration of the foregoing, I tind that a partial grant of exemption is in the public 

interest. Thcref()re. pursuant to the authority contained in 49 U.S.C. §§ 40113 and 44701 , 

delegated to me by the Administrator, the certificate holders listed in Condition and 

Limitation No. I to this Partial Grant. are granted an exemption from 14 CFR § 121.803(c)(3) 

and Part 12L Appendix A only to the extent necessary to relieve them from the requirement to 

carry two single dose ampules of Atropine Sec injectable, in required on-board EMKs when, 

due to the nationwide shortage discussed herein. they are unable to procure these items for the 

kits. The FAA is granting this exemption only to the part 119 cettificate holders named in the 

petition that conduct part 121 passenger canying operations. 
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Conditions and Limitations 

1. This exemption applies to the part 119 certiiicate holders authorized to conduct 

part 121 passenger carrying operations listed below. 

Air Transport International ExpressJct Republic Airlines 

Air Wisconsin Airlines GoJet Ryan International Airlines 

Corp. 

Alaska Airlines Great Lakes Aviation Seaborne Airlines 

Allegiant Air Hawaiian Airlines. Inc. Shuttle America -··· -·· 

American Airlines Horizon Air Silver Airlines 

American Ea le Island Air SkyWest Airlines, Inc. 

Atlas Air, Inc. JetBlue Airways Corp. Southwest Airlines, Inc. 

Cape Air Miami Air International Sun Country Airlines 

Chatauqua Airlines National Airlines Trans States Airlines 

ConunutAir National Air Cargo United Airlines, Inc. 

Compass Airlines Omni Air International US Airways, Inc. 

Delta Air Lines, Inc. Piedmont Airlines - USA Jet Airlines 

Era Aviation Pinnacle Airlines, Inc. World Airways 

Everts Air Cargo PSA Airlines 

2. A copy of this exemption must be carried on board each aircraft operating with 

emergency medical kits that do not include Atropine as required by Appendix A of 

part 121. 

3. The pilot in command must inform crewmembers that any emergency medical kits 

on board the aircraft may not contain Atropine as part of the pre-flight briefing. 

4. This exemption may be used for flights conducted outside of the United States. 

This exemption terminates on January 31. 2014. unless sooner superseded or rescinded. 

Issued in Washington, DC, on JAN 2 5 2013 

)7-J .. Mhn M. Allen 

D1rector, Flight Standards Service