February 27, 2016

Docket Management Facility

U.S Department of Transportation

1200 New Jersey Avenue

SE West Building Ground Floor Room W12-140

Washington, DC 20590

Re: Petition for Exemption No. 10690, Docket No. FAA-2013-0034

Dear Sir or Madam:

In accordance with the provisions of Title 14, Code of Federal Regulations (14 CFR) §11.63 and 

§11.81, Peninsula Airways, Inc, petition 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.

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 nine 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 backorder 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 

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, Peninsula Airways has been able to address temporary shortages through a variety of 

accommodations and FAA exemptions. Ordinarily, Peninsula Airways maintains 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 shelf-life 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, 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. 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 for Exemption and Subsequent Operator Action

Airlines for America requested and was granted separate exemptions for Atropine and Dextrose 

on very short notice in early 2013. Peninsula Airways was included in this exemption as a 

“similarly situated carrier". With subsequent extensions, these Exemptions currently expire on 

January 31, 2016 and March 31, 2016 respectively. This is Peninsula Airways initial petition for

this exemption.

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 lack 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.

The Applicable Regulations and Relief Sought

Peninsula Airways, Inc. seeks long-term exemption from 14 CFR 121.803(c)(3), which requires 

passenger-carrying airplanes to be equipped with an EMK containing Atropine, Dextrose, 

Lidocaine, 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 reported to them 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 England Journal of Medicine.17

• Lidocaine is even more rarely used, aggregated within “other” by the footnoted NEJM

study.
Without the requested relief, carriers 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.

Granting the Exemption Would be in the Public Interest

Absent this relief, there is no means for Peninsula Airways to comply with section 121.803, part 

121 Appendix A, and MEL requirements when shortages exist and the drugs need to be 

restocked in the EMK. This creates the possibility that aircraft would have to be taken out of 

service until additional supplies can be obtained. While this would be a last resort, it is not 

implausible. Grounding otherwise airworthy aircraft for this reason alone would disrupt air 

service and is not in the interest of the traveling public. Granting this exemption would help to 

ensure that air service continues uninterrupted and in this respect would serve the public 

interest.

If you have any questions regarding this topic, please contact me immediately at (907)771-2569

Respectfully,

William Batman

Director of Operations

Peninsula Airways

6100 Boeing Ave

Anchorage, AK 99502

peninsula airways inc. | 6100 boeing avenue | anchorage alaska 99502

907.771.2500 | fax 907.771.2664 | info@penair.com | penair.com