February 26, 2013

U.S. Department of Transportation Docket Operations West Building Ground Floor, Room W12

- 140 1200 New Jersey Avenue, SE Washington, DC 20590

Subject: Petition for Exemption

Reference: Emergency Medical Equipment; 14 CFR121.803.

Dear Sir or Madam:

In accordance with the provisions of Title 14, Code of Federal Regulations (14 CFR) §11.63 and §11.81, Airlines for America, the National Air Carrier Association, and the Regional Airline Association, on behalf of their passenger airline members (See enclosure 1) and similarly

- situated air carriers, petition for a limited exemption from 14 CFR §121.803(c)(3) which requires airplanes with seating capacity of more

than nine passengers to carry an Emergency Medical Kit (EMK) with contents as specified in Appendix A

to Part 121. Specifically, we request that FAA suspend for one year a requirement for air carriers to include Dextrose in the emergency medical kits (EMKs) of thei r aircraft during flight operations because of a manufacturing supply shortage leaving airlines without the means to comply with the requirements of Appendix A.

B ackground

Since 1986, large passenger

- carrying aircraft have been required to carry an EMK t o assist crewmembers or other volunteers in responding to an in

- flight medical emergency. 1 FAA has required a single Dextrose dose ampule or equivalent since the 1986 EMK final rule. The requirement to carry an EMK was

extended in 1996 to cover 20

- 30 seat commuter aircraft. 2 In 2001, the Federal Aviation Administration (FAA) issued new regulations implementing the Aviation Medical Assistance Act of 1998, which among other provisions called for airlines to augment their EMKs. 3 The regulatory provision expand ing the required contents of the EMK took effect April 12, 2004, and applies to all airplanes for which a flight attendant is required, 4 which currently would include all passenger

- carrying aircraft having a seating capacity of more than nine passengers. 5 The EMK is considered a “no

- go” item that must be on board for the airplane to be operated, 6 and current Master Minimum Equipment List (MMEL) relief requires a carrier to refurbish or replace the EMK within one flight after it has been used or otherwise be comes incomplete; there is no MEL relief permitting a carrier to depart with an EMK missing Dextrose, beyond the one flight

relief described above. 7

1 Emergency Medical Equipment Requirements Rule, 51 Fed. Reg. 1218 (Jan. 9, 1986).

2 60 Fed. Reg. 65831 (Dec. 20, 1995).

3 66 Fed. Reg. 19028 (April 12, 2001).

4 14 C.F.R. §121.801(c)(3).

5 14 C.F.R. §121.391(a)(1).

6 See 66 Fed. Reg 19033.

7 See FAA MMEL Policy Letter 73, “MMEL Relief for Emergency Medical Equipment.”

### EMK Petition for Exemption

– Dextrose

February 26, 2013

Current Shortage of Dextrose

Dextrose, a required component of EMKs since 1986 8 , is a “medicine used to treat acute or severe hypoglycemia which may appear in diabetic passengers. Part 121, Appendix A specifies that an EMK must include one Dextrose 50%/50 cc injectable single dose or a Dextrose equivalent.

Historically, major EMK airline suppliers and r efurbishers MedAire, Inc. and Banyan International Corporation, obtained Dextrose from two producers in the United States, Amphastar Pharmaceuticals Inc. and Hospira, Inc. MedAire and Banyan have notified operators and provided letters to A4A (see

enclosur es) 9 stating there is currently a critical shortage of Dextrose in the U.S. and that it will be impossible to supply EMKs with fresh Dextrose to our members after February 20, 2013. This shortage is due to multiple factors including overall demand and a manufacturing shortfall. The manufacturers have indicated that backlogged demand should be fulfilled by late second quarter 2013, with a ramp up of supply in the meantime. MedAire predicts the shortage will affect their specific supply until late second

qu arter 2013 or after. Finally, Appendix A permits carriers and suppliers to provide a Dextrose equivalent and MedAire states two Dextrose 25% doses (equivalent to one 50% dose) or one 1mg Glucagon dose (providing similar therapeutic effects) would be equall y effective alternatives 10 but the future availability of these alternative drugs is uncertain.

Refurbishers report that they are often unaware of an impending drug shortage until they experience a

back

- order notification. The Atropine and Dextrose shortage s are good examples of drug shortages that surfaced with little notice. The FDA does not require timely manufacturer drug shortage notices and
therefore, FDA is not a source for advance information.

Thus far, airlines and their kit suppliers have been ab le to address temporary shortages through a variety of accommodations. Ordinarily, airlines maintain a certain number of extra EMKs to replace those that are opened during a medical event; the opened EMKs are then sent back to the kit supplier for refurbis hment. In addition, all EMKs are restocked periodically since some of the medications they contain have a shelf

life of as little as one year. During the early portion of this shortage, EMK providers refurbished kits using

Dextrose from EMKs that were retu rned before their normal shelf

- life expiration date. However, when that supply was consumed, , kits could no longer be refurbished and returned to use, leaving the airline without the means to comply with the requirements of Appendix A. 11 Both MedAire and B anyan report they have exhausted all supplies at this time. MedAire has already begun notification to airlines that they have no means to supply Dextrose, and absent an exemption, can no longer supply FAA

- complaint

EMKs. 12

The Applicable Regulations and Rel ief Sought

We seek exemption from 14 CFR 121.803(c)(3), which requires passenger

- carrying airplanes to be equipped with an EM K containing Dextrose as specified in part 121 Appendix A, EMK requirements, paragraph 2. We also request that FAA approve the Dex trose substitutes listed, below so that carriers could voluntarily use them as a substitute for Dextrose if the drugs become available during the requested exemption period.

 Dextrose 25% which may be given at twice the 50 cc dosage, or

 Glucagon 1mg kit (dr y powder and water reconstitution kit)

8 51 Fed. Reg. 1223.

9 MedAire letter to Robert Ireland, A4A, dated February 21, 2013, attached ; Banyan letter to Robert Ireland, A4A, dated February
22, 2013, attached

10 See also, Comparison of intravenous glucagon and dextrose in treatment of severe hypoglycemia in an accide nt and emergency department , Diabetes Care, Volume 10, No. 6, November

- December 1987.

11 See MedAire letter page 1.

12 MedAire notification to Alaska Airlines, copied by email to Robert Ireland, A4A, February 22, 2013

### EMK Petition for Exemption

– Dextrose

February 26, 2013

* Note: According to MedAire Dextrose 25% currently is unavailable; the availability of Glucagon as an approved substitute is uncertain.

Reasons for seeking the relief include:

1) Suppliers cannot provide EMKs stocke d with Dextrose because recent pharmaceutical manufacturing conditions have reduced the availability of Dextrose and manufacturers have only speculated on further availability. 2) Replacement supplies of Dextrose cannot be imported from foreign manufacturers. 3) The only suggested substitutes are Glucagon and Dextrose 25%. 4) Primary kit provider/refurbishers Banyan and MedAire have exhausted their supply of

Dextrose. 5) Dextrose is rarely used; having been recommended during approximately .02% in

- flight

consultations provided by MedAire in 2012 13 . Banyan estimates that Dextrose has used in fewer than 0.4% of inflight emergencies reported to them in 15 years. 6) Airlines contacting A4A have indicated their supply of EMKs with unexpired Dextrose will be depleted soon, and FA A

- complaint EMKs cannot be supplied.

Without the requested relief carriers will face the decision to ground aircraft

.

Therefore, we request relief from the requirement to carry Dextrose in an EMK for a period of one year from the date of granting this p etition, or until supplies have stabilized with availability to airline sources. Further, we also respectfully request that the Exemption, if granted, not require a PIC pre

- flight briefing on Dextrose but instead require that the “certificate holder” info rm the crew. Flight attendants will know if the EMK includes Dextrose because of mandatory pre

- flight safety inspections and EMK labeling from the refurbishers. Alternatively, FAA could require that carriers provide a bulletin to flight attendants.

Reque st for Interim Relief

The exemption process is likely to take more than two weeks to complete and therefore we also request that FAA expedite this petition and in the interim use its discretion to not enforce the requirement to carry Dextrose in Emergency Medical Kits or use any other means to provide interim relief, until the agency is able to answer this petition.

Granting the Exemption Would be in the Public Interest

Absent this relief, there is no means for airlines to comply with section 121.803, part 121 Appendix A, and MEL requirements when Dextrose needs to be restocked in the EMK. This creates the possibility that aircraft would have to be taken out of service until additional supplies can be obtained. While this would
be a last resort, it is not i mplausible. Grounding otherwise airworthy aircraft for this reason alone would disrupt air service and is not in the interest of the traveling public. Granting this exemption would help to ensure that air service continues uninterrupted and in this respect would serve the public interest.

Granting the Exemption Would Not Adversely Affect Safety

The shortage of Dextrose has additionally brought to light its limited usage. While Dextrose is important for certain types of emergency medical treatment, it is infrequently used. MedAire, which provides emergency medical consultation to airlines as well as supplying EMKs, estimates that in 2012, Dextrose was recommended during app roximately 0.02% in inflight consultations, or five out of 25,000 , while Banyan similarly states a usage rate of 0.4% of all inflight emergencies known to them over a 15 year period. According to Banyan, EMK refurbishers also regularly compete with hospit als and other ground

based users of Dextrose who use the substance more often than discard it through expiration. Banyan reports that during this shortage, producers have adopted a distribution system that places acute care

13 MedAire letter, page 2

### EMK Petition for Exemption

– Dextrose

February 26, 2013

providers (such as hospitals) ah ead of airlines; even with this system acute care providers are not receiving enough supply, making it even less likely that EMK providers will receive Atropine in the near

future. 14

EMKs are not intended to be comprehensive, or to include treatment for eve ry possible medical condition, but instead provide options for addressing the most frequent types of medical emergencies. 15 The removal of the EMK requirement for Dextrose would not adversely affect the safety of the traveling public

because it is used inf requently. 16 Safety will also not be adversely impacted if the FAA approves equivalent drug substitutions.

A Summary of this Petition that FAA Could Publish in the Federal Register

Petitioners: Airlines for America, the National Air Carrier Association, and the Regional Airline Association

Affected Regulations: 14 CFR 121.803(c)(3) and 14 CFR part 121, Appendix A

- First Aid Kits and Emergency Medical Kits.

Summary of Relief Sought: The relief would temporarily exempt passenger

- carrying airlines from having to carry Dextrose 50%/50cc injectable ampules in EMKs due to a chronic shortage of the drug.

Granting this exemption is in the public interest as it avoids potential, unpredictable disruptions in scheduled and unscheduled air transport service.

Reasons for Exercising the Privileges of the Requested Exemption Outside the United States.

Due to the unpredictable nature of situations in which this exemption might be triggered, in order to avoid disruptions in international operations U.S. carriers wo uld need to be able to exercise the privileges of this exemption outside the United States. The International Civil Aviation Organization (ICAO) standard calls for aircraft to be equipped with “accessible and adequate medical supplies,” and recommends that these supplies include, for aircraft authorized to carry more than 100 passengers on a flight of more than two hours, “a medical kit, for the use of medical doctors or other qualified persons in treating in

- flight medical emergencies.” Additional guidance provided by ICAO recommends but does not require “Dextrose

– injectable”. 17 Absence of Dextrose in an EMK on an aircraft operating outside the U.S. therefore would not violate ICAO requirements.

14 Banyan letter page 2.

15 FAA Advisory Circular AC

- 121

- 33B, 1/12/2006

16 A4A further notes that a recent FAA decision to reduce MEL relief allowing only one flight before restocking an opened EMK instead of three flights results in many carriers purchasing and maint ain ing a second EMK for each airplane , which requires acquiring additional atropine.

17 ICAO, International Standards and Recommended Practices, Annex 6 to the Convention on International Civil Aviation (Ninth Edition, July 2010), Part I, para. 6.2.2

### EMK Petition for Exemption

– Dextrose

February 26, 2013

Conclusion

For the foregoing reasons, we respectfully requ est an expedited exemption from the requirements of 14 C.F.R. § 121.803(c)(3) and Appendix A to Part 121 pertaining to the provision of Dextrose in the EMK for one year or until Dextrose is once again commercially available.

Respectfully submitted Februar y 26, 2013 by:

Douglas Mullen Stacey Bechdolt, Esq.

Assistant General Counsel Director, Safety & Technical Affairs

Airlines for America Regional Airline Association 2025 M Street, NW

Suite 800 Washington, DC 20036

George Paul

Director of Technical Services

National Air Carrier Association

1000 Wilson Boulevard

Suite 1700 Arlington, Virginia 22209

- 3928

Enclosures/

cc:
Mr. John Allen Mr. Steve Douglas

Federal Aviation Administration Federal Aviation Administration Director, Flight Standards Service, AFS

- 1 Flight Standards Service 800 Independence Ave., SW Aircraft Maintenance Division, AFS

- 300 Washington, DC 20591 470 L’Enfant Plaza, SW Washington, DC 2002 4

Mr. John Duncan

Federal Aviation Administration Deputy Director for Policy, Flight Standards, AFS

- 2P 800 Independence Ave., SW Washington, DC 20591

Mr. Les Smith

Federal Aviation Administration Flight Standards Service Air Transport Division, AFS

- 200 800 Independence Avenue, S.W., Washington, DC 20591Enclosure 1

Passenger Airline Association Members

Airlines for America National Air Carrier

Association Regional Airline Association

Alaska Airlines Air Transport International Aerolitora

American Airlines Allegiant Air Air Wisconsin Airlines Corp.

Atlas Air, Inc. Atlas Air, Inc. AirNet Systems Inc.

Delta Air Lines, Inc. Everts Air Cargo American Eagle Airlines

Hawaiian Airlines, Inc. Kalitta Air Cape Air

JetBlue Airways Corp. Lynden Air Cargo Chautauqua Airlines

Southwest Airlines Co. Miami Air International CommutAir

United Air Lines, Inc. National Airlines Compass Airlines

US Airways, Inc. National Air Cargo Empire Airlines

Air Canada (Associate Member) Northern Air Cargo Era Aviation

Omni Air International ExpressJet

Ryan International Airlines GoJet

Southern Air Grand Canyon Airlines/Scenic

Sun Country Airlines Great Lakes Aviation

USA Jet Airlines Horizon Air

World Airways Island Air

Jazz Air

Mesaba Aviation

New England Airlines

Piedmont Airlines

Pinnacle Airlines, Inc.

PSA Airlines

Republic Airlines

Seaborne Airlines

Shuttle America Silver Airways SkyWest Airlines, Inc.

Trans States Airlines