AFS-13-252-E

Exemption No. 10721

UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

FEDERAL AVIATION ADMINISTRATION

WASHINGTON, DC 20591

 

In the matter of the petition of 

 

AIRLINES FOR AMERICA 

NATIONAL AIR CARRIER ASSOCIATION

AND REGIONAL AIRLINE ASSOCIATION Regulatory Docket No. FAA-2013-0201

 

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 February 26, 2013, Airlines for America, the National Air Carrier 

Association, and the Regional Airline Association 1301 Pennsylvania Avenue NW., 

Washington, DC 20004, 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 Appendix A of part 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 petitioners indicate 

they are making this request due to a nationwide manufacturing supply shortage that leaves 

affected 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 petitioners require relief from the following regulations:

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

operating under part 121 rules for which a flight attendant is required must have 

approved EMKs that meet the specifications and requirements of part 121, 

Appendix A. 
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part 121, Appendix A, “Emergency Medical Kits” specifies, in pertinent part, that an 

EMK must include one single dose ampule of Dextrose, 50% 50 cc injectable or 

equivalent.

The petitioners support their request with the following information:

The petitioners state that Dextrose, an item required to be carried in EMKs, is not available 

due to multiple factors, including 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 impossible 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, the petitioners include 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 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 providers/refurbishers, Banyan and MedAire, have exhausted their supply 

of Dextrose.

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

The petitioners 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 condition 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 EMK 
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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 carriers 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 out 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 traveling 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 States. 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 

available 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 petitioners’ request and supporting information and finds 

that a grant of exemption would be in the public interest.

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

part 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 an air carrier to depart with an EMK 
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missing Dextrose, beyond the one flight relief described in MMEL Policy 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, 

the FAA has determined that the impact on large numbers 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 petitioners indicate, Dextrose is rarely used. While plausible, the FAA finds the 

petitioners’ proposed alternative, to substitute glucagon 1 mg (when available) for Dextrose 

50% 50cc injectable, would be overly burdensome and less likely to be effective in treating 

hypoglycemia. Dextrose (a form of glucose) acts directly and immediately. Glucagon must 

be reconstituted 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 procedures for using them, therefore, could lead to human error and reduced 

operational efficiency. What is more, substituting glucagon, a more costly medication the 

FAA has never specifically evaluated for use in the EMKs as a substitute for Dextrose, 

presents added economic burden. 

Substituting Dextrose 25% [2 doses] has always been an acceptable equivalent to a single 

dose ampule of Dextrose 50% 50cc injectable; however, according to MedAire, Dextrose 25% 

is unavailable, just as the availability of Glucagon 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. 

Further, as discussed in the petition, the nationwide 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 pilot in 

command conduct a pre-flight briefing 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 

procedures for air carrier notification to crewmembers regarding this exemption.
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The FAA requests that, to the extent possible, the petitioners 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 Airlines for America, the National Air 

Carrier Association, the Regional Airline Association and similarly situated air carriers, are 

granted an exemption from 14 CFR § 121.803(c)(3) and part 121, Appendix A, paragraph (2),

only to the extent necessary to relieve them from the requirement to carry Dextrose 50%,

50cc, 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 following 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 aircraft 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 its operations 

specifications that apply to that employee’s or person’s duties and responsibilities, 

the certificate holders must inform crewmembers that any emergency medical kits 

on board the aircraft may not contain Dextrose. 

4. This exemption may be used 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