Exemption 10721

January 24, 2014

U.S. Department of Transportation

Docket Operations

West Building Ground Floor

1200 New Jersey Ave S.E.

Room W12-140

Washington, D.C. 20590

Sent to web site: http://www.regulations.gov/

SUBJECT: Petition for Extension of Exemption No. 10721, Emergency Medical Equipment; 14 

CFR121.803, Revised (note revision bars in left margin)

Docket No. FAA-2013-0201

Ladies/Gentlemen:

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

§11.81, Airlines for America, the National Air Carrier Association, and the Regional Airline 

Association, on behalf of their passenger airline members (See Attachment 1) and similarlysituated air carriers petitions for the renewal of Exemption No. 10721, Docket No. FAA-2013-

0201. Exemption No. 10721 expires on March 30, 2014.

In addition, the petitioners request certain additional terms in the extension, if granted, to 

remedy complications arising from limitations of the original granted exemption.

The appropriate technical contact for the purposes of this application is Robert Ireland, 

Managing Director, Engineering and Maintenance, A4A, telephone: (202) 626-4228.

Extension of Exemption 10721

Exemption No. 10721 provides temporary relief, under certain conditions and limitations, from 

specific provisions of 14 CFR §121.803(c)(3) and Part 121 Appendix A, to the extent necessary 

to allow Part 119 carriers conducting Part 121 passenger carrying operations, from the 

requirement to carry one single dose ampule of Dextrose, 50% 50 cc injectable in required 

onboard Emergency Medical Kits (EMK) when, due to a nationwide shortage as presented in 

the original petition, they are unable to procure these items for the kits.

Justification for an extension of Exemption No. 10721 is the same as for the original

Exemption Petition, dated February 26, 2013. The conditions and circumstances with regard to 

public interest and safety, which warranted the original exemption, continue to exist. Although 
Petition for Extension of Exemption 10721

some recovery of supply is anticipated, as evidenced in the attached letters from EMK 

refurbishers/suppliers MedAire and Banyan (Attachments 2 and 3), there is some confidence of 

reliable, steady, adequate supply in the foreseeable future, however the outlook remains 

uncertain. Suppliers will include Dextrose in kits as it becomes available.

Supplemental Request

Exemption 10721 includes the provision that a copy of the Exemption must be carried aboard 

any aircraft operating with a medical kit that does not contain Dextrose in accordance with Part 

121 Appendix A. Carriers have complied in multiple ways, including packing a copy of the 

Exemption inside the EMK with outside labeling, affixing a copy of the exemption to the outside 

of the kit, or carrying a copy elsewhere on the aircraft. As a result, regardless of extension of 

Exemption 10721, kits in service will appear to be non-compliant after March 30, 2014.

The petitioners request consideration, regardless of extension of the Exemption, allowing 

carriers to operate under the terms of the original Exemption or its extension, if granted, until inservice EMKs are returned for normally scheduled refurbishment, or earlier due to use or 

damage. We request this procedure because if no relief is given every EMK will unnecessarily 

need to be repapered with the new exemption. Processing thousands of EMKs before March 

30, 2014 will place a heavy burden on airlines with no safety impact. This may be accomplished 

by outside relabeling of kits with the exemption packed inside or removal of the copies of the 

Exemption being carried external to the kits.

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. 

Given that the need for this Exemption will continue for an unknown period, and in order to 

avoid further potential confusion of maintenance personnel, flight crews, or perceptive 

passengers, it is requested that the portion of the Exemption stipulating physical carriage of a 

copy aboard affected aircraft be withdrawn. If on board physical indication of the missing 

substance remains a requirement, the date of expiration of the Exemption should not be 

displayed.

Emergency Medical Kits have an approximate shelf life of one year, the nominal duration of this 

Exemption. The petitioners suggest FAA should agree that kits in service aboard aircraft may

remain in service for their normal period due to the aforementioned logistical issue of all kits 

needing revision simultaneously when the Exemption eventually expires. We believe both FAA 

and the petitioners are well served, and processes are simplified, with the following substitution 

within the current verbiage of Exemption 10721:

“...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 packaged/produced during the 

effectivity of this Exemption when they, due to the nationwide shortage discussed herein, are 

unable to procure Dextrose for the EMKs.”

Summary of Petition for Extension
Petition for Extension of Exemption 10721

The petitioners request the following: 

1) Extension of Exemption 10721 pertaining to Dextrose, that expires on March 30, 2014.

2) The extension should allow kits to remain in the field that are short of the substance until 

normally returned for refurbishment (“grandfathering”), regardless of recovery of market 

supplies. The intent is to continue extensions for some period after supplies are restored 

to avoid a sudden need to refurbish kits off-schedule, unreasonably straining supply 

capabilities.

We have suggested substitute wording to accomplish this end in the simplest manner.

3) Carriers may use their own effective means to communicate that kits already in the field 

are covered by the proposed extension and remain serviceable for their otherwise full 

currency, despite the expiration date of March 30, 2014 that may be apparent.

4) The extension should stipulate that it must be readily apparent that kits not containing 

Dextrose are in compliance with Exemption 10721 “as revised or extended”, without 

displaying the expiration date.

5) Deletion of the requirement to carry a copy of the Exemption on board the affected 

aircraft.

The renewal of this Exemption is not a controversial issue. As the renewal of this Exemption is 

not precedent setting, A4A requests that publication in the Federal Register be waived.

Your consideration and approval of this request is appreciated.

Respectfully resubmitted January 24, 2014 by: 

Robert L Ireland

Managing Director, Engineering and Maintenance

Airlines for America

202-626-4228
Petition for Extension of Exemption 10721

Stacey Bechdolt, Esq.

Director, Safety & Technical Affairs

Regional Airline Association

2025 M Street, NW

Suite 800

Washington, DC 20036

 

Enclosures/
Petition for Extension of Exemption 10690 – Attachment 1

Attachment 1

Airlines for America National Air Carrier 

Association

Regional Airline Association

(Part 121 passenger carrying) (Part 121 passenger carrying) (Part 121 passenger carrying)

Alaska Airlines Air Transport International Air Wisconsin Airlines Corp.

American Airlines Allegiant Air American Eagle Airlines 

Atlas Air, Inc. Atlas Air, Inc. Cape Air 

Delta Air Lines, Inc. Everts Air Cargo Chautauqua Airlines 

Hawaiian Airlines, Inc. Miami Air International CommutAir

JetBlue Airways Corp. National Airlines Compass Airlines

Southwest Airlines Co. National Air Cargo Empire Airlines

United Airlines, Inc. Northern Air Cargo Endeavor Air

US Airways, Inc. Omni Air International Era Aviation 

Air Canada (Associate Member) Ryan International Airlines ExpressJet 

Sun Country Airlines GoJet Airlines

USA Jet Airlines Great Lakes Aviation 

World Airways Horizon Air

Island Air

Mesa Airlines

Piedmont Airlines 

PSA Airlines 

Republic Airlines 

Seaborne Airlines

Shuttle America 

Silver Airways

SkyWest Airlines, Inc. 

Trans States Airlines
Petition for Extension of Exemption 10690 – Attachment 2

October 31, 2013

Robert L. Ireland

Director, Technical Operations

Airlines for America®

1301 Pennsylvania Avenue NW, Suite 1100

Washington, D.C. 20004-1707

Dear Mr. Ireland,

MedAire produces FAR-compliant medical kits for airlines subject to Part 121 requirements. As such, we 

have provided the following communication to our clients regarding the availabilitiy of Dextrose, a 

required component for Emergency Medical Kits (EMKs) and Enhanced Emergency Medical Kits 

(EEMKs).

DEXTROSE. FAA-required component: Dextrose 50%, inj. 50 mL

Reference: U.S. Title14 CFR 121.803 Emergency Medical Equipment. Exemption No. 10721

UPDATE: As of October 18, Hospira reports they will meet demand for dextrose by the 4th quarter of 

2013.

Amphastar Pharmaceuticals reports they are still experiencing a production shortage.

Beginning November 2013, MedAire expects to have stock available to include the required Dextrose

component in new and refurbished Emergency Medical Kits and Enhanced Emergency Medical Kits.

We are working with clients on an individual basis to schedule the reintroduction of Dextrose in their 

medical kits.

The duration of the Dextrose Grant of Exemption terminates on March 14, 2014, unless sooner 

superseded, rescinded, or extended.

For more information on the Dextrose production shortage, please refer to the following link:

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#dextrose

Thank you for your assistance. Please let us know if we can provide any additional information.

Sincerely,

Heidi MacFarlane Paulo Alves, MD, MSc, FAsMA

Vice President, Strategic Development Vice President, Aviation and Maritime Health

MedAire, an International SOS company MedAire, an International SOS company
Petition for Extension of Exemption 10690 – Attachment 3

Robert L. Ireland

Director, Technical Operations

Airlines for America

1301 Pennsylvania Ave. NW Suite 1100

Washington, D.C. 20004-1707

Re: Dextrose shortage

Dear Mr. Ireland,

I am writing to you on behalf of Banyan International Corporation to request that you petition for an

extension of Exemption No. 10721.

While Banyan is currently able to obtain Dextrose from the manufacturer, it has only recently become

available in limited quantities. Due to the limited release of this product and the lack of full recovery to

date, the supply of future product is still uncertain at best. In order to avoid unnecessary disruption to

the commercial aviation industry, it would be prudent to request an extension of the existing exemption

and for medical kits that have been issued into the field without dextrose under this exemption, be

allowed to remain in the field until such a time as they are returned for refurbishment due to use or

normal expiration. This would allow for a smooth transition, avoid the logistical nightmare of rotating all

medical kits in the system prior to the March 31, 2014 cutoff date and avoid an AOG situation. An

extension would also allow the airlines to obtain the full value/life expectation of each kit that has been

serviced in the last nine to ten months.

We request that the exemption be granted for another year in order to be able to replace this item in an

orderly fashion without disrupting the normal rotation of these kits.

We thank you in advance for your assistance. Please feel free to contact me with any questions you may

have.

Sincerely,

Don Cohen, DMD

Chief Compliance Officer

Banyan International Corporation

2118 E. Interstate 20 • P.O. Box 1779 • Abilene, Texas USA 79604-1779

Within USA: 325.677.1874 • International (001): 325.677.1874 • Facsimile: 325.677.1372

www.StatKit.com