### 800 West Idaho • Suite 304 • Boise, Idaho 83702 • 208.333.XTRA (9872)

Date: 11 February 2013

Subject: Petition for Exemption

Reference: Emergency Medical Equipment; 14 CFR121.803.

Dear Sir or Madam :

In accordance with the provisions of Title 14, Code of Federal Regulations (14 CFR) §11.63 and §11.81,

TEM Enterprises d/b/a Xtra Airways (AOC # BJNA472B) petition the Federal Aviation Administration

(FAA) for a limited exemption from 14 CFR §121.803(c)(3) which requires airplan es 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 temporarily suspend for one year a requirement

for air carriers to include Atropine in the EMKs of their aircraft during flight operations because of a

manufacturing supply shortage leaving airlines without the means to comply with the requirements of

Appendix A.

Current Shortage of Atropine

Atropine, a required component of E MKs since 2004, is a “medicine used mainly to increase heart rate that

may be needed to assist a passenger with an unstable cardiac rhythm.” Part 121, Appendix A specifies that

an EMK must include two Atropine 0.5 mg, 5 cc injectable single doses or an Atr opine equivalent.

Historically, our EMK vendor / repair station Majesti c Aerote ch Inc. obtained Atropine from some of the

four producers in the United States, Amphastar Pharmaceuticals Inc., Hospira, Inc., American

Regent/Luitpold, and West

- Ward Pharmaceu ticals. Majesti c Aerote ch Inc. provided us a letter (see

enclosures 1) stating there is currently a critical shortage of Atropine in the U.S. and that it will be

impossible to supply EMKs with Atropine to our members after January 25, 2013. This shortage i s due to

multiple factors, including American Regent’s decision to stop producing Atropine and Hospira’ s decision

to indefinitely postpone Atropine production. This production shortage has resulted in the two remaining

suppliers, West

- Ward and Amphastar rationing remaining supplies to first

- line responders such as hospitals

and paramedic units. In addition, according to Banyan, there are no FDA

- approved foreign Atropine

manufacturers authorized to import Atropine into the U.S. to relieve the shortage. Al so, while FDA has the

authority to extend the expiration date on drugs such as Atropine, 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 an Atropine equivalent, however, according to Majesti c

Aerote ch Inc. there is no equivalent substitute for Atropine.

To date, we have been able to address temporary shortages through a variety of accommodations. We have

depleted our spare 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. During this shortage, EMKs

in which Atropine has been used or has expired cannot be refurbished and returned to use, leaving TEM

Enterprises without the means to comply with the requirements of Appendix A.

The Applicable Regulations and Relief Sought

We seek exemption from 14 CFR 121.803(c)(3), which requires passenger

- carrying airplanes to be

equipped with an EMK containing two single Atropine doses as specified in part 121 Appendix A, EMK

requirements, paragraph 2.

Reasons for se eking the relief include:

### 800 West Idaho • Suite 304 • Boise, Idaho 83702 • 208.333.XTRA (9872)

1) Suppliers cannot provide EMKs stocked with Atropine because recent pharmaceutical

manufacturing changes have reduced the availability of Atropine (also referred to as Atropine

Sulfate) and manufacturers have not supplied revised fulfillment dates;

2) Replacement supplies of Atropine cannot be imported from foreign manufacturers

3) There is no accepted substitute for Atropine

4) Primary kit vendor / repair station Majesti c Aerote ch Inc. reports it has already depleted its

Atropine supply

W ithout the requested relief we will face the decision to ground aircraft. Therefore, we request relief from

the requirement to carry Atropine in an EMK for a period of one year from the date of granting this

petition.

Request for Interim Relief

The exemp tion process is likely to take more than two weeks to complete and therefore we also request that

FAA expedite this petition and in the interim use its discretion to not enforce the requirement to carry

Atropine in Emergency Medical Kits or use any other m eans to provide interim relief, until the agency is

able to answer this petition.

Granting the Exemption Would be in the Public Interest

Absent this relief, there is no means for us to comply with section 121.803, part 121 Appendix A, and

MEL requirement s when Atropine needs 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 airw orthy 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.

A Summary of this Petition that FAA Could Publish in the Federal Register

Petitioners: TEM Enterprises

Affected Regulations: 14 CFR 121.803(c)(3) and 14 CFR part 121, Appendix A

- First Aid

Kit s and Emergency Medical Kits.

Summary of Relief Sought: T he relief would temporarily exempt passenger

- carrying airlines from

having to carry Atropine in EMKs due to a chronic shortage of the drug

Granting this exemption is in the public interest as it avoids potential, unpredictable disruptions in

air transport s ervice.

Reasons for Exercising the Privil eges of the Requested Exemption Outside the United States.

Due to the unpredictable nature of situations in which this exemption might be triggered, in order to avoid

disruptions in intern ational operations TEM En terprises would need to be able to exercise the privileges of

this exemption outside the United States. The International Civil Aviation Organization (ICAO) standard

calls for aircraft to be equipped with “accessible and adequate medical supplies,” and rec ommends that

these supplies include, for aircraft authorized to carry more than 100 passengers on a flight of more than

two hours, “a medical kit, for the use of medical doctors or other qualified persons in treating in

- flight

medical emergencies.” Additio nal guidance provided by ICAO recommends but does not require “Atropine

– injectable”.19 Absence of Atropine in an EMK on an aircraft operating outside the U.S. therefore would

not violate ICAO requirements.

### 800 West Idaho • Suite 304 • Boise, Idaho 83702 • 208.333.XTRA (9872)

Conclusion

For the foregoing reasons, we res pectfully request an expedited exemption from the requirements of 14

C.F.R. § 121.803(c)(3) and Appendix A to Part 121 pertaining to the provision of Atropine in the EMK for

one year or until Atropine is once again commercially available.

Respectful ly,

Ryan Montgomery Marvin Morrill

Chief Inspector Director of Maintenance

TEM Enterprises TEM Enterprises

805 West Idaho Street 805 West Idaho Street

Suite 400 Suite 400

Boise, ID 8370 Boise, ID 8370



### Enclosures/