AFS-16-14145-E Exemption No. 10690H

UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

FEDERAL AVIATION ADMINISTRATION WASHINGTON, DC 20591

In the matter of the petition of

AIRLINES FOR AMERICA, Regulatory Docket No. FAA-2013-0034

NATIONAL AIR CARRIER AS SOCIATION,

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

GRANT OF EXEMPTION

By letter dated December 29, 2015, Airlines for America (A4A), the National Air Carrier Association (NACA), and the Regional Airline Associati on (RAA), on behalf of their passenger airline members and sim ilarly situated air carriers, petitioned the Federal Aviation Administration (FAA) for a limited exemption from Title 14 of the Code of Federal Regulations (14 CFR) section 121.803(c)(3) which requires airpla nes with seating capacity of more than nine passengers to carry an Emer gency Medical Kit (EMK) with contents as specified in Appendix A to part 121. Specifically, they requeste d that FAA issue a long-term exemption for use during periods of temporar y supply shortages, beyond operator control, affecting availability of injectable drugs Atr opine, Dextrose, Epinephrin e and/or Lidocaine, as required in Appendix A to part 121. The FAA is reissuing the January 29, 2016 grant of Exemption No. 10690. Corrections were made to update information concerning how

certificate holders that are not members of the as sociations to which this exemption is granted may petition for similar relief.

The pertinent requirements from 14 CFR from which A4A, NACA , and RAA seek relief are:

Section 121.803 Emergency medical equipment.

Section 121.803(c) generally requires, for treatm ent of injuries, medical events, or minor accidents that might occur during flight time, each airplane must have equipment that meets the specifications a nd requirements of Appendix A of this part. Section 121.803(c)(3)2

specifically requires, in airplanes for which a flight attendant is required, an approved emergency medical kit as modified effective April 12, 2004.

Appendix A to Part 121—First Aid Kits and Emergency Medical Kits

E MERGENCY M EDICAL K ITS

Appendix A to part 121 specifica lly requires, as of April 12, 2004, at least one approved emergency medical kit that must contain certai n appropriately maintained medical equipment and drugs in specified quantities, which includes:

 Atropine, 0.5 mg, 5 cc (single dose ampule or equivalent) Quantity-2

 Dextrose, 50%/50 cc injectable, (single dose ampule or equivalent) Quantity-1

 Epinephrine 1:1000, 1 cc, injectable, (singl e dose ampule or equivalent) Quantity-2

 Epinephrine 1:10,000, 2 cc, injectable, (single dose ampule or equivalent) Quantity-2

 Lidocaine, 5 cc, 20 mg/ml, injectable (single dose ampule or equivalent) Quantity-2

The petitioners require relief from the following requirements:

Section 121.803(c)(3) prescr ibes, in pertinent part, that ai rplanes with seating capacity of more than nine passengers carry an Emergency Medical Kit (EMK) with contents as specified in Appendix A to part 121, which includes At ropine, Dextrose, Epinephrine and Lidocaine.

The petitioners support their request with the following information:

The petitioners noted that, since 1986, large passe nger-carrying aircraft ha ve been required to carry an EMK to assist crewmembers or other vo lunteers in responding to an in-flight medical emergency. The scope of that requiremen t was expanded in 1995 to cover 20-30 seat commuter aircraft (60 FR 65831). In 2001, the F AA 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, De xtrose, Epinephrine and Lidocaine (66 FR 19028).

The petitioners additionally noted that the re gulatory provisions e nhancing the required contents of the EMK took effect April 12, 2004, a nd apply to all airplanes for which a flight attendant is required, which currently includes all passenger-carrying airc raft having a seating capacity of more than nine passengers. The peti tioners added that the EMK is considered a “no-go” item that must be on board for the ai rplane 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. They further noted that there is no MEL relief permitting a carrier to depart with an EMK missing any specified contents beyond the one flight relief previously described.

The petitioners added that shortages occur due to multiple factors, including overall nonaviation demand and manufacturing s hortfalls and relate not simply to shortages of substance but also to shortages of prescribed aviati on packaging (e.g. ampules/p re-filled syringes or3

proper dosages). The petitioners additionally noted that suppliers and refurbishers report that they are often unaware of an impending drug s hortage until they expe rience a back-order notification. The petitioners commented that the Atropine and Dext rose shortages in 2012- 2014 were good examples of drug shortages that surfaced with little notice. They further commented that the U.S. Food and Drug Admi nistration (FDA) does not require timely manufacturer drug shortage notices and th erefore, FDA is not a source for advance

information.

The petitioners commented that suppliers and refurbishers, led by MedAire, Inc. (MedAire) and Banyan International Corporation (Banyan) also regularly compete with hospitals and other ground-based users to obtain these drugs . The petitioners further commented that hospitals and first responders ac tually use the substances rath er than discarding them through expiration (as usually occurs in aviation). Petitioners noted, fo r example, that Banyan reported that during one shortage, drug ma nufacturers adopted an Atropi ne distribution system that placed acute care providers (such as hospitals) ah ead of airlines and ev en with this system, acute care providers were not receiving e nough supply, making it even less likely that EMK providers would receive Atr opine for use in aviation.

The petitioners additionally noted that thus far, airlines and their EMK suppliers have been able to address temporary shortages th rough a variety of accommodations and FAA exemptions. They commented that ordinarily, ai rlines maintain a certain number of extra EMKs to replace those that are opened during a medical event and the opened EMKs are then sent back to the EMK 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. Petitioners added, however, that during a shortage, EMKs in which Atropine, Dextrose, Epinephrine or Lidocaine have b een used or have expired cannot be refurbished and returned to use, leaving the airline poten tially without the m eans to comply with the requirements of Appendix A to part 121.

The petitioners also noted that while 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. Petiti oners finally noted that Appendix A to part 121 permits carriers and suppliers to provide eq uivalent substances. However, according to MedAire (and confirmed by certain in house air car rier medical staff), th ere is no equivalent substitute for Atropine, for example.

Previous Petitions for Exemption and Subsequent Operator Action

The petitioners noted that they requested, a nd were granted, separate exemptions that addressed Atropine and Dextrose shortages with short notice to the FAA in early 2013. Petitioners also noted that, with subsequent extensions, these exemptions expire on January 31, 2016, and March 31, 2016, respectively. The petiti oners added that a petition was also submitted in 2010 regarding Epinephrine bu t was withdrawn as supply recovered.4

Petitioners commented that the pattern establis hed by the short-fused Atropine and Dextrose petitions, and the withdrawn Epinephrine petitio n, reflect the uncertainties of information flowing from the drug manuf acturers. They further commented that, 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). They also commented that it is important to note that suppliers of EMKs and the air carriers have unwaveringly demonstrated thei r responsibility to the public by placing the drugs in EMKs whenever the products have been availabl e, even during periods of exemption.

Petitioners added that the lack of timely predictability of shortages, taken with the highly responsible behavior of kit s uppliers, refurbishers, and opera tors, together underscore the appropriateness of a long-term exemption that will be used only when supplies are impaired beyond the control of the operators.

Current Shortages

Petitioners noted that, currently, only the manufac turer Hospira, Inc. (Hospira) is reporting a potential disruption of the four injectables in the first quarter of 2016. Sp ecifically, there is a possible recall of pre-filled syringes impending. This was disclosed to Airlines for America by Banyan on or about December 9, 2015.

Atropine

Petitioners noted that Atropine, a required component of EMKs since 2004, is a “medicine used mainly to increase heart rate that may be needed to assist a passenger with an unstable cardiac rhythm.” They added that Appendix A to part 121 specifies that an EMK must include two Atropine 0.5 mg, 5 cc injectable singl e doses or an Atropine equivalent.

Petitioners additionally noted that major EMK airline suppliers and refurbishers MedAire and Banyan obtain Atropine from f our producers in the United States: Amphastar Pharmaceuticals Inc. (Amphastar), Hospira, American Regent/Luitpold (AR/L), and West-Ward Pharmaceuticals (West-Ward). Petitioners also no ted that, in its letter that accompanied the first petition addressing Atropi ne, Banyan pointed out that th ere are no FDA-approved foreign Atropine manufacturers authorized to import Atr opine into the United States to relieve the shortage.

Dextrose

Petitioners also noted that Dextrose, a required compone nt of EMKs since 1986, is a

“medicine used to treat acute or severe hypoglycemia which may appear in diabetic passengers.” They added that Appendix A to part 121 specifies that an EMK must include one Dextrose 50%/50 cc injectable singl e dose or a Dextrose equivalent.

Petitioners additionally noted that major EMK airline suppliers and refurbishers MedAire and Banyan obtain Dextrose from two producers in the United States: Amphastar and Hospira.5

They added that Appendix A to part 121 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 therapeu tic effects) would be equally effective alternatives, but the future availability of th ese alternative drugs is also unpredictable.

Epinephrine

Petitioners also noted that Epinephrine, a required component of EMKs since 2004, is a “medication used mainly for cardiac resuscita tion.” They added that Appendix A to part 121 specifies that an EMK must include two 1: 1000, 1cc single dose ampules and two 1:10,000, 2cc single dose ampules of Epine phrine or respective equivalents.

Petitioners additionally noted that major EMK airline suppliers and refurbishers MedAire and Banyan obtain Epinephrine from four producers in the United States: Amphastar, Hospira, AR/L, and Par Pharmaceuticals (Par).

Lidocaine

Lastly, petitioners noted that Lidocaine, a required compone nt of EMKs since 2004, is a “medication used mainly in cases of unres ponsiveness to defibrillation and possibly for maintenance of normal heart rhythm after su ccessful defibrillation.” They added that Appendix A to part 121 specifies that an EMK must include two 5 cc, 20 mg/ml, injectable (single dose ampule or equi valent) of Lidocaine.

Petitioners additionally noted that major EMK airline suppliers and refurbishers MedAire and Banyan obtain Lidocaine from four producers in the United States: Amphastar, Hospira, Aurobinda Pharma (Aurobinda), and Freseniu s Kabi USA, LLC (Fresenius Kabi).

The Applicable Regulations and Relief Sought

The petitioners indicated that they seek a long-term exemption from § 121.803(c)(3), which requires passenger-carrying airplanes to be equipped with an EM K containing Atropine, Dextrose, Epinephrine and Lidocaine as specif ied in Appendix A to part 121, First Aid Kits and Emergency Medical Kits, during periods of supply disruptions beyond the control of the EMK suppliers and the air carriers, which may be on a EMK-by-EMK basis, with appropriate labeling of the EMK indicat ing the missing contents.

Reasons for seeking the relief include:

The petitioners noted that: 1) Suppliers cannot provide EMKs stocked with the drugs when pharmaceutical manufacturers do not deliver pr oduct and have not supplied re vised fulfillment dates. 2) Replacement supplies of these substances can not be imported from foreign manufacturers. 3) There is no accepted substitute for Atropi ne, and where substitutes for other drugs may exist, their supplies are no more dependable.6

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 r ecommended during approximately .02% inflight consultations provided by MedAire in 2012. Banyan estimates that Dextrose has been used in fewer than 0.4% of inflight emergencies reported to Banyan in 15 years.

 Epinephrine is also rarely used, having been administered in 0.3% of inflight medical emergencies, per a 2013 study by the New E ngland Journal of Medicine (NEJM). (“Outcomes of Medical Emergencies on Comm ercial Airline Flights”, Peterson, Drew C. M.D., et. al., The New England Journal of Medicine, May 30, 2013)

 Lidocaine is even more rarely used, a ggregated within “other” by the same NEJM study. 5) When member air carriers contact the peti tioners indicating their supply of EMKs with unexpired Atropine, Dextrose, Epinephrine or Lido caine will be depleted soon, the problem is often merely weeks away with poten tial service disruption looming.

The petitioners stated that, without the requested relief, air carriers will periodically and, with little notice, face the decision to ground aircraft. The petitione rs requested long-term relief from the requirement to carry Atropine, Dextro se, Epinephrine or Lidocaine in an EMK due to shortages of those drugs resulting from uncontrollable supply deficit.

Granting the Exemption Would be in the Public Interest

The petitioners noted that, absent this relief, there are no means for airlines to comply with § 121.803, Appendix A to part 121, and MEL requi rements when shortages exist and the drugs need to be restocked in the EMK. They furt her noted that this crea tes the possibility that

aircraft would have to be taken out of serv ice until additional supplies can be obtained, and that, while this would be a last resort, it is not implausible. The petitioners added that grounding otherwise airworthy airc raft for this reason alone w ould disrupt air service and would not be in the interest of the traveling public. They added that granting this exemption would help to ensure that air service continues uninterrupted a nd, in this respect, would serve the public interest.

Granting the Exemption Would No t Adversely Affect Safety

The petitioners commented that shortages of thes e drugs to date have additionally brought to light their limited usage. They added that, for ex ample, MedAire has repo rted that roughly 1% of EMKs returned for refurbishment are missing Atropine due to use, loss, or damage. The petitioners further added th at a returned EMK, unless opened for use, represents approximately one year of service and is ge nerally returned for replacement of expiring contents. The petitioners added that MedA ire and Banyan have both reported to the petitioners qualitatively that the majority of drug usage for airline purposes has been due to expiration, not administration to passengers. Peti tioners also noted that, for example, Banyan7

reports that Atropine is used less than one time per one thousand units serviced, and as previously referenced, usage of the other injectables is also rare.

The petitioners reiterated that suppliers and re furbishers of EMKs and the air carriers have unwaveringly demonstrated their responsibility to the public by placing the required drugs in EMKs, even during periods of exemption, whenev er the products have been available.

The petitioners generally noted that EMKs ar e 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 in-flight medical emergencies. They added that the case-by-case removal of the EM K requirement for these drugs during acute shortages would not adversely affect the safety of the traveling public because th ey are used so infrequently.

Reasons for Exercising the Privileges of th e Requested Exemption Outside the United

States

The petitioners also noted that, due to the unpred ictable nature of situ ations in which this exemption might be used, and in order to avoi d disruptions in intern ational operations, U.S.

carriers would need to be able to exercise th e privileges of this exemption outside the United States. They added that the International Civil Aviation Organizat ion (ICAO) standard requires aircraft to be equipped with “acces sible and adequate medical supplies” and recommends that these supplies include, for ai rcraft 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 emerge ncies.” The petitioners further added that additional guidance provided by ICAO recommends, but does not require, Atropine, Dextrose, and Epinephrine. The petitio ners noted, therefore, that the absence of Atropine, Dextrose, and Epinephrine in an EM K 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 in the Federal Register for public comment. Delaying action on this petition would adversely affect air carriers due to the immine nt effect on operations that would be caused by the possible shortages of At ropine, Dextrose, Epinephrine or Lidocaine.

The FAA’s analysis is as follows:

The FAA has considered fully the petitioners’ request and supporting information and finds that a grant of exemption would be in the public interest.

First, the FAA notes that there are two curre nt exemptions related to this petition for exemption. Exemption No. 10690 (FAA-2013-0034) granted passenger member airlines of the Regional Airline Association, Airlines for America, and National Ai r Carrier Association, and all similarly situated air carriers, an exemption from § 121.803(c)(3) and Appendix A to part 121, to the extent necessary to relieve them from the requirement to carry two single dose ampules of Atropine 5cc inject able, in required on-board EM Ks when, due to the nationwide8

shortage, they are unable to procure these it ems for the kits. The current extension of Exemption No. 10690 (10690D) terminates on January 31, 2016.

Exemption No. 10721 (FAA-2013-0201) granted pa ssenger member airlines of Regional Airline Association, Airlines for America, and National Air Carrier Association, and all similarly situated air carriers, an exempti on from § 121.803(c)(3) and Appendix A to part 121 to the extent necessary to relieve them from the requirement to carry one single dose ampule of Dextrose 50cc injectable, in required on-board EMKs when, due to the nationwide shortage, they are unable to procure these it ems for the kits. The current extension of Exemption No. 10721 (10721A) terminates on March 16, 2016.

Second, the FAA notes that the conditions and reas ons relative to public interest and safety that were the basis for granting Exemption N o. 10690, regarding the shortage of Atropine, and Exemption No. 10721, regarding the shortage of Dextrose, are also valid with respect to possible future shortages of Epinephrine and Lidocaine for suppliers and refurbishers of EMKs used in air carrier operations under part 121.

All airplanes for which a flight attendant is re quired must carry an EMK with items listed in Appendix A to part 121. The EMK is consider ed a “no-go” item and is included on the MMEL. Current MMEL Policy Letter 73, title d “MMEL Relief for Emergency Medical Equipment,” requires an air carrier to repair or replace an EMK within one flight when it is incomplete, missing, or inoperative. There is no MMEL relief permitting an air carrier to depart with an EMK that is missing require d EMK contents beyond the one flight relief described in MMEL Policy Letter 73.

The inability of EMK suppliers and refurbishe rs to obtain and supply Atropine, Dextrose, Epinephrine and/or Lidocaine du ring shortages of one or more of these drugs creates the possibility that a significant number of aircraft would not be able to meet the requirements of Appendix A to part 121 and would have to be taken out of service. As discussed in the petition for exemption, safety would not be adversely affected because data from EMK suppliers and refurbishers demonstrate that At ropine, Dextrose, Epinephrine and/or Lidocaine are rarely used and predominan tly replaced in EMKs due to expiration. Therefore, the caseby-case removal of the EMK requirement for th ese drugs during acute shortages would not adversely affect the safety of the traveling public because they are used so infrequently.

Additionally, the FAA has determined that the impact on large numbers of passengers that would be caused by grounding these aircraft fo r lack of Atropine, Dextrose, Epinephrine and/or Lidocaine outweighs the benefit of having them, since they are used infrequently in response to in-flight medical events.

As the petitioners indicate, shortages occur due to multiple factors, including overall nonaviation demand and manufacturing shortfalls, and relates not simply to shortages of substance but also to shortage s of prescribed aviation packag ing (ampules/pre-filled syringes or proper dosages). The FAA also agrees with th e petitioners that the Atropine and Dextrose9

shortages that occurred during 2012-2014 were appropriate exampl es of drug shortages that

surfaced with little notice.

Further, the FAA agrees with the petitioners th at it is important to note that suppliers of

EMKs and air carriers have c onsistently demonstrated their responsibility to the public by placing the drugs in EMKs whenev er the products have been avai lable, even during periods of exemption.

In considering this petition for exemption, the FAA recognizes that air carriers must cope with periodic nationwide manufacturi ng shortages for certain drugs th at leave affected certificate holders without an alternate means to comply. Further, the nationwide shortages affect not only EMK suppliers for aviation use, but also gr ound-based medical servi ce providers such as hospitals and first responders that provide acute medical care on a frequent basis.

The FAA notes that the great majority of pa ssenger-carrying air carr iers operating under part 121 use EMKs that are suppl ied and/or refurbished by only three companies: MedAire, Inc., Banyan International Corporation and Aero space Accessory Service, Inc. Additionally, all EMK suppliers and/or refurbishers must obtain these drugs from four or fewer drug manufacturers. Therefore, regardless of air car rier size, fleet type(s ), operating environment or business model, all air carri ers operating under part 121 are si milarly situated regarding the ability to obtain Atropine, Dextrose, Lidocaine and/or Epinephrine for EMKs used on their

aircraft.

Previously, when A4A, RAA and NACA petitioned the FAA for relief from certain requirements regarding EMK contents, the FAA gr anted relief to member airlines of these petitioners, as well as to all other “similarly situated air carriers”, which included any air carrier operating under the pr ovisions of part 121 (Exemption Nos. 10690D and 10721A). However, in an effort to manage the exempti ons granted by the FAA and to facilitate operator compliance with the conditions and limitations of a grant of exemption, the FAA is no longer including “similarly situat ed air carriers” in the grants of exemption.

In order for any air carrier that is not a memb er or associate member of A4A, RAA or NACA to exercise the relief provided by this gran t of exemption, they mu st submit a petition for similar relief to the docket. After analysis of the petition, if appropr iate, the FAA will amend Exemption No. 10690 to include the additional air carrier. An air carrier may only exercise the relief provided by this grant of exemption when it is listed in Attachment 1 to Exemption No. 10690, as amended.

The FAA’s Decision :

In consideration of the foregoing, I find that a gr ant of exemption is in the public interest. Therefore, pursuant to the authority c ontained in 49 U.S.C. §§ 106(f), 40113, and 44701, delegated to me by the Administrator, I grant the current members and associate members of Airlines for America, the National Air Carr ier Association, and th e Regional Airline Association, an exemption from 14 CFR § 121. 803(c)(3) to the extent necessary to allow10

aircraft to be operated without meeting the re quirements of Appendix A to part 121 regarding emergency medical kit (EMK) required contents Atropine, Dextrose, Epinephrine and/or Lidocaine, when EMK suppliers an d/or refurbishers are unable to obtain and supply Atropine, Dextrose, Epinephrine and/or Lidocaine.

As previously noted, this grant is limited to the members and associate members, as of the date of this Grant of Exemption, of Air lines for America, th e National Air Carrier Association, and the Regional Airline Association, as listed in Attachment 1 of this Grant of Exemption. Any new or additional members of these associations or other air carriers operating under the provisions of part 121 must petition the FAA separate ly to be able to exercise similar relief as that provided by th is grant of exemption. Air carriers may only exercise the relief provided by this grant of exem ption when they are liste d in Attachment 1 to Exemption No. 10690, as amended. This exemption is subject to the following conditions and

limitations.

Conditions and Limitations

1. A copy of this exemption must be carried on board each aircraft operating with an emergency medical kit (EMK) that does not include Atropine, Dextrose, Epinephrine and/or Lidocaine as required by Appendix A to part 121.

2. As part of the requirement under §119.43(c) to keep each of its employees and other persons used in its operation informed of th e provisions of its ope rations specifications that apply to that employee’s or person’s duties and responsibilit ies, the certificate holders must inform crewmembers that an emergency medical kit on board that aircraft may not contain Atropine, Dextrose, Epine phrine and/or Lidocaine.

3. Should the supply of Atropine, Dextrose, Epinephrine and/or Lidocaine become available to EMK suppliers a nd/or refurbishers, exemption holders must refurbish the EMK with the missing drug(s) at the next scheduled refurbishment date.

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

This exemption terminates on January 31, 2020, unless sooner supers eded or rescinded.

Issued in Washington, DC, on December 12, 2016.

/s/

John Barbagallo Deputy Director, Flight Standards Service