BEFORE THE FEDERAL AVIATION ADMINISTRATION WASHINGTON D.C.



### Petition of: DELTA AIR LINES, INC. OPERATING CERTIFICATE 0ALA026A For exemption ofcertain requirements of 14CFR 121.803(c)(3) Docket FAA-2016-

PETITION OF DELTA AIR LINES, INC. FOR AN EXEMPTION

January 

### 25, 2016
Delta Air Lines, Incorporated, operating certificate DALA026A, hereby petitionsthe Federal Aviation Administration (FAA), pursuantto 14 C.F.R. Part 11 for relieffrom Federal Aviation Regulation (FAR) §121.803(c)(3), provided certain conditions and limitations are met. Specifically, Delta petitions 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 issue a long-term exemption for use during periods of temporary supply shortages, beyond operator control, affecting availability of injectable drugsAtropine, Dextrose, Lidocaine, or Epinephrine, named in Part 121,Appendix A.
Section ofthe FederalAviation Regulations Affected 

### § 121.803 Emergency medical equipment (a) No person may operate a

**passenger~carrying** airplane underthis part unless it is equipped with the emergency medical equipment listed in this section. (b) Each equipment item listed in this section- (1) Must be inspected regularly in accordance with inspection periods established in the operations specifications to ensure its condition for continued serviceability and immediate readiness to perform its intended emergency purposes; (2) Must be readily accessible to the crew and, with regard to equipment located in the passengercompartment, to passengers;Petition for

**Exemption~** 14 CFR 121.803 Delta Air Lines, Inc. January 25, 2016 Page 2 (3) Must be clearly identified and clearly marked to indicate its method of operation; and (4) When carried in a compartment or container, must be carried in a compartment or container marked as to contents and the compartment or container, orthe item itself, must be marked as to date of last inspection. (c) Fortreatment ofinjuries, medical events, or minor accidents that might occur during flight time each airplane must have the following equipmentthat meetsthe specifications and requirements ofappendix A ofthis part: (1) Approved first-aid kits. (2) In airplanes for which a flight attendant is required, an approved emergency medical kit. (3) In airplanes forwhich a flight attendant is required, an approved emergency medical kit as modified effective April 12, 2004.
Requested Relief
We seek long-term exemption from 14 CFR 121.803(c)(3), which requires

**passenger~** carrying airplanes to be equipped with an EMK containing Atropine, Dextrose, Udocaine, or Epinephrine as specified in part 121 Appendix A, EMK requirements, paragraph 2 during periods of supply disruptions beyond the control of the EMK suppliers and the operators, which may be on a kit-by-kit basis, with appropriate labeling of the kits indicating the shortage. Reasons for seeking the relief include: 

### 1. Suppliers cannot provide EMKs stocked with the drugs when pharmaceutical manufacturers do not deliver productand have notsupplied revised fulfillment dates. 2. Replacement supplies ofthese substances cannot be imported from foreign manufacturers. 3. There is no accepted substituteforAtropine, and where substitutesfor other drugs may exist, their supplies are no more dependable. 4. These drugs are rarely used; • Banyan estimatesthatAtropine is used lessthan onetime peronethousand unitsserviced • Dextrose is rarely used; having been recommended during approximately .02% in-flightconsultations provided by MedAire in 2012. Banyan estimatesthat Dextrose has used in less than 0.4% of inflight emergenciesPetition for Exemption- 14 CFR 121.803 Delta Air Lines, Inc. January 25, 2016 Page 3 reported to them in 15years. • Epinephrine is also rarely used, having been administered in 0.3o/o of inflight medical emergencies per a 2013 study bythe New England Journal of Medicine. • Lidocaine is even more rarely used, aggregated within "other" by the footnoted NEJM study. 5. When Delta is notified by suppliers that their supply of Atropine, Dextrose, Lidocaine, or Epinephrine will be depleted soon, the problem is often merely weeks away, with potential service disruption looming. Without the requested relief, Delta will periodically and with little notice face the decision to ground aircraft. Therefore, we request long-term relieffrom the requirement to carry Atropine, Dextrose, Lidocaine, or Epinephrine in an EMK that has a shortage resulting from uncontrollable supply deficit. 

### Background Since 1986, large passenger-carrying aircraft have been required to carry an EMK to assist crewmembers or other volunteers in responding to an in-flight medical emergency. That requirement was extended in 1996 to cover 20-30 seat commuter aircraft. In 2001, the Federal Aviation Administration (FAA) issued new regulations implementing the Aviation Medical AssistanceAct of 1998, which among other provisions called forairlines to augment their EMKs and include Atropine, Dextrose, Lidocaine, and Epinephrine. The regulatory provision expanding the required contents ofthe EMK took effectApril 12, 2004, and appliesto all airplanesforwhich aflightattendant is required, which currently includesall passenger-carrying aircraft having a seating capacity of morethan n'me passengers. The EMK is considered a "no-go" item that must be on board for the airplane to be operated, and current Master Minimum Equipment List {MMEL) relief requires a carrier to repair or replace an EMK within one flight of an incomplete, missing or inoperative EMK; there is no MEL relief permitting a carrier to depart with an EMK missing any specified contents beyond the one flight reliefdescribed above. Shortagesoccurdueto multiplefactors including overall non-aviation demandand manufacturingshortfalls, and relates not simply to shortages of substance, but also shortages of prescribed aviation packaging (ampules/pre-filled syringes or proper dosages). Refurbishers report that they are often unaware of an impending drug shortage until they experience a back-order notification. The Atropine and Dextrose shortages in 2012-2014aregood examplesofdrugshortagesthatsurfaced with little notice. The FDA does not require timely manufacturer drug shortage notices and therefore, FDA is not a source for advance information. Suppliers/refurbishers, led by MedAireand Banyan also regularlycompetewith hospitals and otherground- based usersto obtain these drugs. Hospitalsand first responders use thePetition for Exemption

- 14 CFR 121.803 Delta Air Lines, Inc. January 25, 2016 Page 4
substances more often than they discard itthrough expiration {as usuallyoccurs in aviation). For example, Banyan reported that during one shortage, producers adopted an Atropine distribution system that placed acute care providers (such as hospitals) ahead of airlines; and even with this system acute care providers were not receiving enough supply, making iteven less likely that EMK providers would receive Atropine. Thus far, airlines and their kit suppliers have been able to address temporary shortages through a variety ofaccommodations and FAA exemptions. Ordinarily, airlines maintain a certain number ofextra EMKs to replace those that are opened during a medical event; the opened EMKs are then sent back to the kit supplierfor refurbishment. In addition, all EMKs are restocked periodically since some ofthe medications theycontain have a shelflife ofas littleas one year. However, during a shortage, EMKs in which Atropine, Dextrose, lidocaine, or Epinephrine have been used or have expired cannot be refurbished and returned to use, leaving the airline potentiallywithoutthe means to comply with the requirements ofAppendixA. Also, white FDA has the authority to extend the expiration date on the drugs, the drug manufacturer must petitionthe FDA with drug stability data asking for an extension, which no manufacturer has done. Finally, AppendixA permitscarriersand suppliersto provide equivalentsubstances, however,accordingto MedAire (and confirmed by in house air carrier medical staff) there is no equivalent substitute for Atropine, for example.

Previous Petitionstor Exemption and SubsequentOperator Action The industry requested and was granted separate exemptionsforAtropine and Dextrose on very short notice in early 2013. With subsequentextensions, these Exemptions currently expire on January 31, 2016 and March 31, 2016 respectively. The pattern established by the short-fused Atropine and Dextrose petitions, reflectthe uncertainties ofinformationflowing from the manufacturers. For apparentlycommercial reasons, shortage durations vary widely and are not communicated in a timely manner to suppliers and refurbishers ofEMKs (principally MedAire and Banyan). It is important to note that suppliers of EMKs and the operators have unwaveringly demonstrated their responsibilityto the public by placing the drugs in EMKs wheneverthe products have been available, even during periods ofexemption. The tack oftimely predictability ofshortages, taken with the highly responsible behaviorof kitsuppliers and operators, together underscore the appropriateness of a long-term Exemption that will be used only when supplies are impaired beyond their control.Petitionfor Exemption

- 14 CFR 121.803 Delta Air Lines, Inc. January 25, 2016 Page 5



### CurrentShortages Currently only Hospira is reporting a potential disruption ofthe four injectables in the first quarter of2016. Specifically, there is a possible recall ofpre-filledsyringes impending.This was disclosed by Banyan on orabout December 9, 2015. 

### •Atropine Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtain Atropinefrom fourproducers inthe United States,Amphastar Pharmaceuticals Inc., Hospira, Inc.,American Regent/Luitpold, and West-Ward Pharmaceuticals. In Banyan's letterthataccompanied thefirst petition addressing Atropine, they pointed out that there are no FDA-approved foreign Atropine manufacturers authorized to importAtropine intothe U.S. to relieve the shortage.


### •Dextrose MajorEMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtained Dextrose from two producers in the United States, Amphastar Pharmaceuticals Inc. and Hospira, Inc. Appendix A permits carriers and suppliers to provide a Dextrose equivalent and MedAire states two Dextrose 25% doses (equivalent to one SO% dose) or one lmg Glucagon dose {providing similartherapeutic effects) would be equally effective alternatives but the future availability ofthese alternative drugs is also unpredictable. 

### •Epinephrine Epinephrine, a required component of EMKs since 2004 1 is a "medication used mainly for cardiac resuscitation." Part 121, Appendix A specifies that an EMK must include two 1:1000, lee single dose ampules and two 1:10,000, 2cc single dose ampules of Epinephrine orrespective equivalents. Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtain Epinephrine from four producers in the United States, Amphastar Pharmaceuticals Inc., Hospira, Inc., American Regent/Luitpold, and Par Pharmaceuticals. 

### •Lidocaine Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtain Epinephrine from four producers in the United States, AmphastarPetition for Exemption

- 14 CFR 121.803 Delta Air Lines, Inc. January 25, 2016 Page 6
Pharmaceuticals Inc., Hospira, Inc., Aurobinda Pharma, and Fresenius Kabi USA, LLC. American Regent/Luitpold recently announced discontinuance ofproduction.

Requestfor Expedited consideration DAL is also requesting that, as part ofthis Petition for Exemption request, the public comment phase be waived as perTitle 14 CFR Part 11.87(a), which states: "The FAA maynotpublish a summary ofyourpetition forexemption andrequest comments ifyoupresentor we findgoodcause why we shouldnotdelay action on your petition. The factors we considerin deciding not to requestcommentinclude: (a) Whethergranting yourpetition wouldseta precedent

... It is the opinion of DALthat since the mitigating actions are already in place and the relief requested has been demonstrated to and approved bythe FAA as exemptions 10690 (Atropine) and 10721 (Dextrose), that this exemption would notset a precedent.
NoAdverse Effect on Public Safety The shortages ofthese drugs to date have additionally brought to lighttheir limited usage. For example, MedAire has reported that roughly 1% ofEMKs returned for refurbishmentare missing Atropine dueto use, loss, or damage. A returned EMK, unless opened for use, represents approximately one year of service and is generally returned for replacement of expiring contents. MedAire and Banyan have both reported qualitativelythatthe predominance ofdrug usage forairline purposes has been dueto expiration, not administration to passengers. For example, Banyan reports thatAtropine is used Jess than one time perone thousand unitsserviced. As previously referenced, usage ofthe other injectables is also rare. We reiterate, suppliers of EMKs and the operators have unwaveringly demonstrated their responsibility to the public by placing the drugs in EMKs, even during periods of exemption, whenever the products have been available. EMKs are not intended to be comprehensive, orto includetreatment for every possible medical condition, but instead provide options for addressing the mostfrequent types of medical emergencies. The case- by-case removal ofthe EMK requirementforthesedrugs during acuteshortages would notadverselyaffectthe safety ofthe traveling public because they are used so infrequently.

Public Interest Granting this exemption is in the public interest as it avoids potential, unpredictable disruptions in scheduled and unscheduled airtransportservice.Petition for Exemption

- 14 CFR 121.803 Delta Air Lines, Inc. January 25, 2016 Page 7
Reasons for Exercisingthe Privileges ofthe Requested Exemption Outside the UnitedStates Due to the unpredictable nature of situations in which this exemption might be triggered, and in orderto avoid disruptions in international operations, Delta would need to be able to exercise the privileges ofthis 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, forthe useofmedicaldoctors orotherqualified persons in treating in-flight medical emergencies."Additional guidance provided byICAO recommends butdoesnot requireAtropine, Dextrose, and Epinephrine. Absence ofAtropine, Lidocaine, Dextrose, or Epinephrine in an EMK on an aircraft operating outside the U.S. therefore would not violate ICAO requirements.

Conclusion Fortheforegoing reasons, we respectfully requesta long term exemptionfrom the requirements of 14CFR 

### § 121.803(c)(3) and Appendix A to Part 121 pertaining to the provision ofAtropine, Dextrose, Lidocaine, and Epinephrine in the EMK during periods of commercially unavailability.

Please contact Chuck Schramek, Director- Quality Assurance, Compliance, and Business Support at 404-715-1112 (office) ifyou have questions or require additional information.

Stephen M. Dickson SeniorVice President Flight Operations Delta Air Lines, Inc.Petition for Exemption- 14 CFR 121.803 Delta Air Lines, Inc. January 25, 2016 Page 8
Cc: Mr. John Duncan Federal Aviation Administration Director, Flight Standards Service, AFS-1 800 IndependenceAve., SW washington, DC 20591

Mr. Les Smith FederalAviationAdministration FlightStandards Service AirTransport Division, AFS-200 800 IndependenceAvenue, S.W., Washington, DC 20591

Ms. NancyClaussen FederalAviationAdministration Flight Standards Service AircraftTransport Division, AFS-200 800 IndependenceAvenue, S.W., washington, DC 20591
Mr. Tim Shaver FederalAviation Administration FlightStandards Service, Aircraft Maintenance Division AFS-300 470 L'Enfant Plaza, SW Washington, DC 20024Petition for Exemption- 14 CFR 121.803 Delta Air Lines, Inc. January 25, 2016 Page 9 Summaryfor Federal Register Petitioner: Affected Regulations: Summary of Relief Sought: Delta Air Lines, Inc. 14 CFR 121.803(c)(3) and 14 CFR part 121, Appendix A - First Aid Kits and Emergency Medical Kits.

Delta Air Lines, Inc., Operating Certificate DALA026A, petitionsthe Administratorfor relief from 14 CFR 121.803(c)(3) and 14 CFR Part 121, Appendix A
- First Aid Kits and Emergency Medical Kits. The relief would temporarily exempt Delta Air Lines from having to carry certain injectable drugs in EMKs only during acute shortages beyond operator control.