### Exemption No
. I0690 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 REGIONA L AIRL INE ASSOCIATION


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

### and Part 121, Appendix A, paragraph (2) ofTitle 14, Code of Federal Regulations Regulatory Docket No . FAA -2013 -0034

PAR T IAL GRANT OF EXEMPTION 

### By letter received on January 14,2013. Airlines for America, the National Air Carr ier 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 ofAtropine 0.5 , Sec injectable or equivalent.
AFS-13-159

-E2 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 postpo ne Atropine production
. The petitioners state that this lack ofproduction 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 O rganization (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 ofa 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 ofa summary ofthis petition for exemption because delaying action would adversely affect the petitioners due to the imminent effect on operations caused by the Atropine sh011age
.3 

### The FAA's analysis is as follo w s: The FAA has con s idered fully the petitioners' request and supp011ing information and finds that a prutial grant of exemption would be in th e public interest. All airplanes for which a fli ght attendant is r equired, must car ry an EMK with items listed in part 121 , Appendix A
. T he EMK is considered a ··no-go'· item and is included on the Master M inimum Equipment List (MMEL)
. Current MMEL Policy Letter relief requires an air carrier to repair or replace an EMK within one t li ght when it is incomplete, missing, or inoperativ e. There is no minimum equipment list relief permitting an a ir carrier to depart with an EM K m is sing Atro pine , beyond the one lli ght reli ef described in MMEL policy Letter 73 , titled "MMEL Rclieffor Emergency Medical Eq uipment." The documented Atropine s hot tage create s the poss ibi li t y that a significant number of aircraft would not be able to meet the requirements of Append ix A of part 12 1 and would have to be taken out of ser vice
. As discussed in the petition. EMK suppliers report that Atropine is used for m edical purposes less than one time per thousand EMK units serviced , and Atropine i s predominantly replaced in EMKs due to expiration. Accor dingly, the FAA has determined that the impact on large numb ers of passengers that would be caused by grounding these ai rcraft for lack of Atropine outweighs the bene

### tit of having the medication, which reported ly is infrequently u sed in re sponse 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- b ased medical service providers. The FAA also fmds that, because this medication is reported to rarely be used in flight, it is not in the p ublic interest for EMK suppliers to airlines to be c ompeting with the greater need and demand of ground

-based medical providers tor these medications. 

### The 

### FAA's Decision 

### In considera tio n of the foregoing, I tind that a partial grant of exemptio n i s in the public interest. Thcref()re. pursuant to the authority contained in 49 U .S. C. 

### §§ 40113 and 44701 , delegated to me by the Admini strator, the certificate holders listed in Condition and Limitation No
. I to thi s P artial Grant. are granted an exem ption from 14 CFR 

### § 121.803(c)(3) and Part 12L Appendix A only to the extent necessary to relie ve them from the requirement to carry two single dose ampules of Atropine Sec injectable, in required on-board EMKs when, due to the nati onwide shortage discussed herein
. they are unable to procure the se items for the kits. The FAA i s granting this exemption o nl y to the part 119 cettific ate holders named in the petition that condu ct par t 121 passenger canying operations.4 

### Conditions and Limitations 1
. This exemption applies to the part 119 certiiicate holders authorized to conduct part 121 passenger carrying operations listed below. Air Tran sport International Expre ssJct Republic Airlines Air Wiscons in Airlines GoJet Ryan Interna tional Airlines Corp
. Alaska Airlines Great Lakes Aviation Seaborne Airlines Allegiant Air Haw aiian 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 Airl ines, Inc. Cape Air Miam i 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 A irline s



### - USA Jet Airlines Era Aviation Pinnacle A irlines, Inc. World Airways Everts Air Cargo PSA Airlines 2. A copy of this exemption must be c arried on board each aircraft operating with emergency medical kits that d o 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
. Th is exemption may be used for flights conducted outside ofthe United States. This exemption terminates on January 31. 20 14. unle s s sooner supers eded or rescinded. Issued 

### in Washington , DC , on 

### JAN 25 2013 

# )7-J
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# Mhn M. Allen D1rector, Flight Standards Service