Exemption 10690C

October 30, 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. 10690C, Emergency Medical Equipment; 14 

CFR121.803

Docket No. FAA-2013-0034

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. 10690C, Docket No. FAA-2013-

0034. Exemption No. 10690C expires on January 31, 2015.

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 10690

Exemption No. 10690C extended temporary relief originally granted by Exemption 10690 in 

January 2013, 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 that require operators to carry two single 

dose ampules of Atropine 5cc 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. 10689C is the same as for the original

Exemption Petition, dated January 14, 2013. The conditions and circumstances with regard to 

public interest and safety, which warranted the original exemption, continue to exist. Although 

limited recovery of supply is occurring, as evidenced in the attached letters from EMK 

refurbishers/suppliers MedAire and Banyan (Attachments 2 and 3), there is no confidence of 
Petition for Extension of Exemption 10690

reliable, steady, adequate supply in the foreseeable future. When available, the product is being 

placed in new and refurbished kits.

Summary of Petition for Extension

The petitioners request the following: 

1) Extension of Exemption 10690C pertaining to Atropine, that expires on January 31, 

2015.

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

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.

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

are covered by the proposed extension despite the Exemption expiration date that may 

be visible.

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

Atropine are in compliance with Exemption 10690 “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 submitted October 30, 2014 by: 

Robert L Ireland

Managing Director, Engineering and Maintenance

Airlines for America

202-626-4228
Petition for Extension of Exemption 10690

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. National Airlines Chautauqua Airlines 

Hawaiian Airlines, Inc. Omni Air International CommutAir

JetBlue Airways Corp. Sun Country Airlines Compass Airlines

Southwest Airlines Co. Empire Airlines

United Airlines, Inc. Endeavor Air

US Airways, Inc. Era Aviation 

Air Canada (Associate Member) ExpressJet 

GoJet Airlines

Great Lakes Aviation 

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 22, 2014

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 

can provide the following regarding the current availability of Atropine, a required component for 

Emergency Medical Kits (EMKs) and Enhanced Emergency Medical Kits (EEMKs).

Currently our Atropine supply is not readily available with our minimum one-year dating requirement, 

however the general supply of the drug remains acceptable. We have more product on order that we 

expect to be year or better dated.

While this is an update as of today, it is important to note that drug availability is a dynamic situation and 

is subject to change on very short notice. Availability of Atropine remains a concern for our operations.

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

Sincerely,

Heidi MacFarlane

Vice President, Aviaition Work Health &

Emergency Services Products

MedAire, an International SOS company

Paulo Alves, MD, MSc, FAsMA

Vice President, Aviation and Maritime Health

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

October 21, 2014

Robert L. Ireland

Director, Technical Operations

Airlines for America

1301 Pennsylvania Avenue NW Suite 1100

Washington, D.C. 20004-1707

Re: Atropine shortage

Dear Mr. Ireland,

I am writing this letter as a follow up to our November 11. 2013 request for extension of 

Exemption No. 10690. As the extension date of January 31, 2015 approaches, I regret to inform 

you that the flow of Atropine from the manufacturers is still not dependable. Although we have 

been receiving stock and placing it in all incoming kits for months, the FDA Drug shortages 

website still shows Atropine currently in shortage. Hospira states it is available but they are 

having a shortage per manufacturer and Amphastar states it is still experiencing a product 

shortage due to an increase in product demand caused by market supply issues. This is the same 

language they used in 2013 when the first extension was granted.

As I stated, although the product is currently available, through past performance there is no 

guarantee that product will continue to be available in a dependable fashion for the foreseeable 

future. Rather than let this extension lapse and then in two months’ time find ourselves in the 

same situation as previous to the granting of the exemption, we request that Exemption No. 

10690 be extended for another year. We assure you that as long as product is obtainable, all 

incoming kits will continue to be refurbished with viable product as required by the original 

statute. We simply would like to maintain the option of not including it in the event the 

manufacturers are unable to continue to keep up with demand.

Thank you for your continued assistance in this matter

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