BEFORE THE 

FEDERAL AVIATION ADMINISTRATION 

WASHINGTON D.C. 

Petition of: 

DELTA AIR LINES, INC. 

OPERATING CERTIFICATE 0ALA026A 

For exemption of certain requirements of 

14 CFR 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 petitions the Federal 

Aviation Administration (FAA), pursuant to 14 C.F.R. Part 11 for relief from 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 

drugs Atropine, Dextrose, Lidocaine, or Epinephrine, named in Part 121, Appendix A. 

Section of the Federal Aviation Regulations Affected 

§ 121.803 Emergency medical equipment 

(a) No person may operate a passenger~carrying airplane under this 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 

passenger compartment, 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, or the item itself, 

must be marked as to date of last inspection. 

(c) For treatment of injuries, medical events, or minor accidents that might occur during 

flight time each airplane must have the following equipment that meets the specifications 

and requirements of appendix A of this part: 

(1) Approved first-aid kits. 

(2) In airplanes for which a flight attendant is required, an approved emergency 

medical kit. 

(3) In airplanes for which 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 product and have not supplied revised fulfillment 

dates. 

2. Replacement supplies of these substances cannot be imported from foreign 

manufacturers. 

3. There is no accepted substitute for Atropine, and where substitutes for other drugs 

may exist, their supplies are no more dependable. 

4. These drugs are rarely used; 

• Banyan estimates that Atropine is used less than one time per one thousand 

units serviced 

• Dextrose is rarely used; having been recommended during approximately 

.02% in-flight consultations provided by MedAire in 2012. Banyan 

estimates that Dextrose has used in less than 0.4% of inflight emergencies 
Petition for Exemption- 14 CFR 121.803 

Delta Air Lines, Inc. 

January 25, 2016 

Page 3 

reported to them in 15 years. 

• Epinephrine is also rarely used, having been administered in 0.3o/o of 

inflight medical emergencies per a 2013 study by the 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 relief from 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 Assistance Act of 1998, which among other provisions called for airlines to augment 

their EMKs and include Atropine, Dextrose, Lidocaine, and Epinephrine. The regulatory 

provision expanding the required contents of the EMK took effect April 12, 2004, and 

applies to all airplanes for which a flight attendant is required, which currently includes all 

passenger-carrying aircraft having a seating capacity of more than 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 relief described above. 

Shortages occur due to multiple factors including overall non-aviation demand and 

manufacturing shortfalls, 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 2012-2014 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. 

Suppliers/refurbishers, led by MedAire and Banyan also regularly compete with hospitals and 

other ground- based users to obtain these drugs. Hospitals and first responders use the 
Petition for Exemption - 14 CFR 121.803 

Delta Air Lines, Inc. 

January 25, 2016 

Page 4 

substances more often than they discard it through expiration {as usually occurs 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 it even 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 of accommodations and FAA exemptions. 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 refurbishment. In addition, all 

EMKs are restocked periodically since some of the medications they contain have a shelflife of as little as 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 potentially without the means to comply with the 

requirements of Appendix A. 

Also, white FDA has the authority to extend the expiration date on the drugs, the drug 

manufacturer must petition the FDA with drug stability data asking for an extension, which 

no manufacturer has done. Finally, Appendix A permits carriers and suppliers to provide 

equivalent substances, however, according to MedAire (and confirmed by in house air 

carrier medical staff) there is no equivalent substitute for Atropine, for example. 

Previous Petitions tor Exemption and Subsequent Operator Action 

The industry requested and was granted separate exemptions for Atropine and Dextrose on 

very short notice in early 2013. With subsequent extensions, these Exemptions currently 

expire on January 31, 2016 and March 31, 2016 respectively. 

The pattern established by the short-fused Atropine and Dextrose petitions, reflect the 

uncertainties of information flowing from the manufacturers. For apparently commercial 

reasons, shortage durations vary widely and are not communicated in a timely manner to 

suppliers and refurbishers of EMKs (principally MedAire and Banyan). 

It is important to note that suppliers of EMKs and the operators have unwaveringly 

demonstrated their responsibility to the public by placing the drugs in EMKs whenever the 

products have been available, even during periods of exemption. 

The tack of timely predictability of shortages, taken with the highly responsible behavior of 

kit suppliers and operators, together underscore the appropriateness of a long-term 

Exemption that will be used only when supplies are impaired beyond their control. 
Petition for Exemption - 14 CFR 121.803 

Delta Air Lines, Inc. 

January 25, 2016 

Page 5 

Current Shortages 

Currently only Hospira is reporting a potential disruption of the four injectables in the first 

quarter of 2016. Specifically, there is a possible recall of pre-filled syringes impending. This 

was disclosed by Banyan on or about December 9, 2015. 

•Atropine 

Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International 

Corporation, obtain Atropine from four producers in the United States, Amphastar 

Pharmaceuticals Inc., Hospira, Inc., American Regent/Luitpold, and West-Ward 

Pharmaceuticals. In Banyan's letter that accompanied the first petition addressing 

Atropine, they pointed out that there are no FDA-approved foreign Atropine 

manufacturers authorized to import Atropine into the U.S. to relieve the shortage. 

•Dextrose 

Major EMK 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 similar therapeutic effects) would be equally effective 

alternatives but the future availability of these alternative drugs is also unpredictable. 

•Epinephrine 

Epinephrine, a required component of EMKs since 20041 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 or respective 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, Amphastar 
Petition 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 of production. 

Request for Expedited consideration 

DAL is also requesting that, as part of this Petition for Exemption request, the public 

comment phase be waived as per Title 14 CFR Part 11.87(a), which states: 

"The FAA may not publish a summary of your petition for exemption and request 

comments if you present or we find good cause why we should not delay action on your 

petition. The factors we consider in deciding not to request comment include: 

(a) Whether granting your petition would set a precedent ... 

It is the opinion of DAL that since the mitigating actions are already in place and the relief 

requested has been demonstrated to and approved by the FAA as exemptions 10690 

(Atropine) and 10721 (Dextrose), that this exemption would not set a precedent. 

No Adverse Effect on Public Safety 

The shortages of these drugs to date have additionally brought to light their limited usage. 

For example, MedAire has reported that roughly 1% of EMKs returned for refurbishment are 

missing Atropine due to 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 qualitatively that the 

predominance of drug usage for airline purposes has been due to expiration, not 

administration to passengers. For example, Banyan reports that Atropine is used Jess than 

one time per one thousand units serviced. As previously referenced, usage of the 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, or to include treatment for every possible 

medical condition, but instead provide options for addressing the most frequent types of 

medical emergencies. The case- by-case removal of the EMK requirement for these drugs 

during acute shortages would not adversely affect the safety of the 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 air transport service. 
Petition for Exemption - 14 CFR 121.803 

Delta Air Lines, Inc. 

January 25, 2016 

Page 7 

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, 

and in order to avoid disruptions in international operations, Delta would 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 Atropine, Dextrose, and Epinephrine. Absence of Atropine, Lidocaine, Dextrose, or 

Epinephrine in an EMK on an aircraft operating outside the U.S. therefore would not 

violate ICAO requirements. 

Conclusion 

For the foregoing reasons, we respectfully request a long term exemption from the 

requirements of 14CFR § 121.803(c)(3) and Appendix A to Part 121 pertaining to the 

provision of Atropine, 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) if you have questions or require additional information. 

Stephen M. Dickson 

Senior Vice 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 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 20591 

Ms. Nancy Claussen 

Federal Aviation Administration Flight Standards Service 

Aircraft Transport Division, AFS-200 

800 Independence Avenue, S.W ., 

washington, DC 20591 

Mr. Tim Shaver 

Federal Aviation Administration Flight Standards Service, 

Aircraft Maintenance Division AFS-300 

470 L'Enfant Plaza, SW 

Washington, DC 20024 
Petition for Exemption- 14 CFR 121.803 

Delta Air Lines, Inc. 

January 25, 2016 

Page 9 

Summary for 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, petitions the Administrator for 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.