AFS

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- E Exemption No. 10721

UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

FEDERAL AVIATION ADMINISTRATION WASHINGTON, DC 20591

In the matter of the petition of

AI R LINES FOR AMERICA

NATIONAL AIR CARRIER ASSOCIATION

AND REGIONAL AIRLINE ASSOCIATION Regulat ory Docket No. FAA

- 2013

- 0 201

for an exemption from § 121.803 (c) (3)

and p art 121, Appendix A, paragraph (2) of Title 14, Code of Federal Regulations

GRANT OF EXEMPTION

By letter dated February 26 , 2013 , Airlines for America

, the National Air Carrier Association, and the Regional Airline Association 1 301 P ennsylvania Avenue NW.

, Washington, DC 20 0 04, petitioned the Federal Aviation Administration (FAA) on behalf of

the passenger airline members named in their petition, and similarly situated air carriers, for a limited exemption from § 121.803(c)(3) and Appe ndix A of p art 121

, Title 14, Code of Federal Regulations. The proposed exemption, if granted , would provide relief from the requirement to carry Dextrose in an Emergency Medical Kit (EMK)

. The petitioner s indicate they are making this request due to a n ationwide manufacturing supply shortage that leaves

a ffected certificate holders without the means to comply with the requirements of Appendix

A

. The petitioners also request that the FAA approve substitutes for Dextrose 50% 50cc : Dextrose 25% (at twice the 50 cc dosage) or glucagon 1 mg (dry powder and water reconstitution kit).

The petitioner s require relief from the following regulations :

Section 121.803(c) (3) prescribes , in pertinent part, that passenger

- carrying airplanes operating under part 121 ru les for which a flight attendant is required must have approved EMKs that meet the specifications and requirements of p art 121,

A ppendix A.2

p art 121, Appendix A

, “Emergency Medical Kits” specifies, in pertinent part, that an

EMK must include one single d ose ampule of Dextrose , 5 0% 50 cc injectable or equivalent.

The petitioner s support their request with the following information:

The petitioners state that Dextrose

, an item required to be carried in EMK s
, is not available

due to multiple factors, includ ing overall demand and a manufacturing shortfall. According to the petitioners, major EMK suppliers and refurbishers no longer are able to obtain Dextrose

from the two main producers in the United States. As such, as of February 20, 2013, it has

become i mpossible to replace Dextrose in EMKs.

The petitioners enclose two letters from two major EMK airline suppliers and refurbishers, Banyan International Corporation and MedAire, as evidence of the Dextrose shortage. Based on this input, t he petitioners in clude the following, specific reasons for seeking the

relief:

1) Suppliers cannot provide EMKs stocked with Dextrose because recent pharmaceutical manufacturing conditions have reduced the availability of Dextrose and manufacturers have only speculated on fu rther 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 s /refurbishers

, Banyan and MedAire

, have exhausted their supply

of Dextros e.

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

flight consultations provided by MedAire in 2012. Banyan estimates that Dextrose has

been used in fewer than 0.4% of in

- flight emergencies reported to them in 15 years.

6) Ai rlines contacting the petitioners have indicated their supply of EMKs with unexpired Dextrose will be depleted soon, and FAA

- compliant EMKs cannot be supplied.

The petitioners request that the F AA approve Dextrose substitutes. MedAire indicates that the following would be equally effective alternatives ; however, the future availability of these

alternatives also is uncertain:

- Dextrose 25%

, which may be given at twice the 50 cc dosage, or

- Glucagon 1mg kit (dry powder and water reconstitution kit)

T he petitioner s request relief from the requirement to carry Dextrose in an EMK for a period of 1 year or until supplies have stabilized with availability to airline sources. Further, the petitioners request that the exemption, if granted, exclude a conditio n that the Pilot in

Command conduct a pre

- flight briefing on Dextrose but instead require that the “certificate holder” inform the crew. The petitioners contend that flight attendants will know if the EMK3

includes Dextrose because of mandatory pre

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

The petitioners indicate that, without the requested relief, air carri ers will face the decision to ground aircraft. Granting this exemption would help to ensure that air service continues uninterrupted and

, in this respect

, would serve the public interest.

According to the petitioners, the shortage of Dextrose has brought to light its limited usage. While Dextrose is important for certain types of emergency medical treatment, it is infrequently used. MedAire estimates that, in 2012, Dextrose was recommended during approximately 0.02% of in

- flight consultations, or five o ut of 25,000. Similarly, Banyan states a Dextrose usage rate of 0.4% of all in

- flight emergencies know to them over a 15

- year period.

The petitioners indicate that removal of the requirement for Dextrose would not adversely affect the safety of the trav eling public because it is used infrequently. Safety also will not be adversely impacted if the FAA approves equivalent substitutions.

Finally, the petitioners request that they be able to exercise the privileges of the exemption

outside the United State s. They state that International Civil Aviation Organization (ICAO) standards require aircraft authorized to carry more than 100 passengers to be equipped with “accessible and adequate medical supplies,” but recommend that injectable Dextrose be

availabl e as part of “a medical kit for use of medical doctors or other qualified persons in treating in

- flight medical emergencies.” Accordingly, the petitioners state that the absence of Dextrose in an EMK on 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 the airlines due to the imminent effect on operations that would be caused by the Dextrose shortage.

The FAA's analysis is as follows:

The FAA has considered fully the petitioner s ’ request and supporting information and finds

that a grant of exemption would be in th e public interest.

All airplanes for which a flight attendant is required, must carry an EMK with items listed in

p art 121, Appendix A. The EMK is considered a “no

- go” item and is included on the Master Minimum Equipment List (MMEL). Current MMEL Policy Letter relief 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 a n air carrier to depart with an EMK4

missing Dextrose , beyond the one flight relief des cribed in MMEL P olicy Letter 73, titled “MMEL Relief for Emergency Medical Equipment.”

The documented Dextrose shortage creates the possibility that a significant number of aircraft would not be able to meet the requirements of Appendix A of part 121 and would have to be

taken out of service. As discussed in the petition

, EMK suppliers and refurbishers report that

Dextrose is hardly used and predominantly replaced in EMKs due to expiration. Accordingly,

t he FAA has determined that the impact on large num bers of passengers that would be caused by grounding these aircraft for lack of Dextrose outweighs the benefit of having it , which

, reportedly

, is infrequently used in response to in

- flight medical events

.

As the petitioner s indicate, Dextrose is rarely u sed. While plausible , the FAA finds the petitioners’ proposed alternative, to subst itute g lucagon 1 mg (when available) for Dextrose 50% 50cc injectable, would be overly burdensome and less likely to be effective in treating hypoglycemia. Dextrose (a for m of glucose) acts directly and immediately. Glucagon must

be recon stituted as a liquid before use; works indirectly and with delayed response; and will not work in all cases. The extra burden associated with procuring substitutions and implementing proc edures for using them , therefore, could lead to human error and reduced operational efficienc y. What is more, substituting g lucagon, a more costly medication the FAA has never specifically evaluated for use in the EMKs as a substitute for Dextrose,

presen ts added economic burden.

S ubstituting Dextrose 25% [2 doses] has always been an acceptable equivalent to a single dose ampule of Dextrose 50% 50cc injectable ; however, accord ing to MedAire

, Dextrose 25%

is unavailable , just as the availability of Gluca gon is uncertain

.

The FAA has determined, therefore, that the merits of exempting Dextrose 50% 50cc injectable without substitution (for the short term), outweigh the potential benefits of refurbishing the EMKs with glucagon 1 mg, when available.

Fur ther, as discussed in the petition, t he nationwid e Dextrose shortage is affecting not only EMK suppliers

, but also ground

- based medical service providers. The FAA also finds that,

because this item is reported to rarely be used in flight, it is not in the public interest for EMK suppliers to be competing for Dextrose with the greater need and demand of ground

- based medical providers.

The FAA has considered the petitioners’ request to exclude a condition that the p ilot in

c ommand conduct a pre

- flight bri efing on the Dextrose shortage but instead require that the

“certificate holder” inform the crew. The FAA agrees that in accordance with 14 CFR § 119.43 (c) it is the certificate holder’s duty to maintain operations specifications. Each

certificate holder shall keep each of its employees and other persons used in its operation informed of the provisions of its operations specifications that apply to that employee’s or person’s duties and responsibilities. The petitioners will adhere to their established

p rocedures for air carrier notification to crewmembers regarding this exemption.5

The FAA requests that, to the extent possible, the petitioner s file any future exemption requests in keeping with provisions outlined in 14 CFR part 11.

The FAA’s Decision

In consideration of the foregoing, I find that a grant of exemption is in the public interest. Therefore, pursuant to the authority contained in 49 U.S.C. §§ 40113 and 44701, delegated to me by the Administrator, passenger airline members of Airline s for America, the National Air Carrier Association, the Regional Airline Association an d similarly situated air carriers, are granted an exemption from 14 CFR § 121.803(c)(3) and p art 121, Appendix A , paragraph (2), only to the extent necessary to relieve them from the requirement to carry Dextrose 50%,

5 0 cc
, single dose ampule or equivalent, in required on

- board EMKs when they , due to the nationwide shortage discussed herein

, are unable to procure Dextrose for the EMKs

. This exemption is subject to the f ollowing conditions and limitations:

Conditions and Limitations

1. This exemption applies to all part 119 certificate holders authorized to conduct part 121 passenger carrying operations

.

2. A copy of this exemption must be carried on board each aircr aft operating with emergency medical kits that do not include Dextrose as required by Appendix A of part 121.

3. As part of the requirement under § 119.43(c) to keep each of its employees and other persons used in its operation informed of the provisions of i ts operations specifications that apply to that employee’s or person’s duties and responsibilities

, t he certificate holders must inform crewmembers that any emergency medical kits

on board the aircraft may not contain Dextrose

.

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

This exemption terminates on March 30 , 2014 , unless sooner superseded or rescinded.

Issued in Washington, DC, on March 14, 2013

/s/

John S. Duncan Director, Flight Standards Service