[Federal Register: March 24, 2005 (Volume 70, Number 56)]
[Rules and Regulations]               
[Page 15193-15196]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr05-12]                         


[[Page 15193]]

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Part III





Department of Transportation





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Federal Aviation Administration



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14 CFR Part 121



Emergency Medical Equipment; Final Rule


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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No. FAA-2000-7119; Amendment No. 121-309]
RIN 2120-AI55

 
Emergency Medical Equipment

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule.

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SUMMARY: We are amending the regulations for emergency medical 
equipment to allow approved power sources that do not have TSO markings 
to be used in automated external defibrillators carried on board 
aircraft. We have found that in at least one instance, power sources 
manufactured before the manufacturer received TSO marking approval are 
identical to those manufactured with a TSO marking. Allowing already-
purchased power sources to be used through their effective life will 
save operators money and will not result in decreased safety when the 
agency has made a finding of equivalency.

DATES: This rule is effective March 24, 2005.

FOR FURTHER INFORMATION CONTACT: David H. Rich, AIR-120, Aircraft 
Certification Service, Federal Aviation Administration, 800 
Independence Avenue, SW., Washington, DC 20591; telephone (202) 267-
7141.

Availability of Final Rule

    You can get an electronic copy using the Internet by:
    (1) Searching the Department of Transportation's electronic Docket 
Management System (DMS) Web page (http://dms.dot.gov/search);    (2) Visiting the Office of Rulemaking's Web page at http://www.faa.gov/avr/arm/index.cfm
; or

    (3) Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html
.

    You can also get a copy by sending a request to the Federal 
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence 
Avenue SW., Washington, DC 20591, or by calling (202) 267-9680. Make 
sure to identify the docket number, notice number, or amendment number 
of this rulemaking.

Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 
1996 requires FAA to comply with small entity requests for information 
or advice about compliance with statutes and regulations within its 
jurisdiction. Therefore, any small entity that has a question regarding 
this document may contact their local FAA official, or the person 
listed under FOR FURTHER INFORMATION CONTACT. You can find out more 
about SBRFA on the Internet at our site, http://www.faa.gov/avr/arm/sbrefa.cfm
.


SUPPLEMENTARY INFORMATION:

Background

    On April 12, 2001 (66 FR 19028), the FAA amended the aircraft 
operating rules of 14 CFR part 121 to require air carriers to carry 
automated external defibrillators (AEDs) on their aircraft as of April 
12, 2004. When used on board aircraft, all required electronic 
equipment that uses lithium batteries as a separate power source must 
meet the power source requirements of Technical Standard Order (TSO) 
C97 or C142.
    Despite several years notice, a primary supplier of AEDs to the 
airline industry applied for TSO approval of its batteries only shortly 
before the effective date of the rule. Since the batteries for these 
AEDs were neither interchangeable nor commercially available, the FAA 
granted relief from the regulation by extending the date for compliance 
with the power source TSO until April 30, 2005 (69 FR 19761, April 14, 
2004).
    In November 2004, the Air Transportation Association (ATA), on 
behalf of 12 of its member carriers, petitioned the FAA for further 
relief from the rule in the form of a long-term exemption (docket 
number FAA-2004-17481). The ATA stated that the batteries used in two 
AEDs manufactured by Philips Medical Systems (Philips) before it 
received TSO marking approval were identical in every respect to the 
ones that were manufactured later with the TSO marking. The ATA noted 
that its carriers had in use or in inventory more than 6,700 of the 
non-TSO-marked batteries.
    Philips was granted TSO marking approval for its two batteries in 
July 2004. As part of our consideration of the exemption petition, the 
FAA recently made an engineering determination that the two Philips 
batteries manufactured before TSO marking approval was granted were the 
equivalent in fit, form and function as those carrying the TSO marking.
    We decided, however, that while relief from the TSO marking 
requirement may be appropriate for the previously manufactured Philips 
batteries, relief in the form of an exemption to a limited number of 
operators is not. The FAA anticipates that there are other carriers 
that use the same Philips AEDs and batteries and are not members of the 
ATA so as to be included in their petition for relief. In fact, we 
received a comment to the ATA petition from Comair indicating that the 
relief requested should be expanded to all air carriers using the 
subject Philips AED and battery combinations.
    We also determined that exemption relief was inappropriate because 
a large portion of the affected air carrier fleet could potentially be 
included. When that happens, it is the responsibility of the agency to 
re-examine the rule and determine whether it needs to be changed. In 
this case, the FAA finds that the public interest is better served by a 
rule that allows for power sources that are found to be equivalent to 
continue to be used, regardless of the carrier or the AED manufacturer.
    Accordingly, the FAA is changing the rule to state that AED power 
sources manufactured before July 30, 2004, and not TSO marked, may 
continue to be used until their expiration date provided that the power 
source manufacturer has requested and received from the FAA a finding 
of TSO equivalency for its product. The FAA is not withdrawing the rule 
that requires the power sources for AEDs to comply with the appropriate 
TSO requirements. TSOs play an important role in maintaining the fit, 
form and function of items used aboard aircraft, and ensure their 
continued quality of manufacture. Only because one manufacturer was 
able to show the FAA that its previously manufactured batteries were 
equivalent did we consider modifying this requirement for the life of 
the already manufactured batteries. Maintaining the TSO requirement for 
all power sources manufactured after July 30, 2004, ensures that no 
other replacement power sources, or ones not approved by the FAA, will 
be allowed on board aircraft.
    By changing the rule, rather than granting an exemption, we are 
allowing for another manufacturer to request and receive the same 
findings of equivalency and approval, if appropriate. A manufacturer 
that seeks the same determination should contact the Aircraft 
Certification Office (ACO) that issued the TSO approval of its AED 
power source for an equivalency finding.
    The April 30, 2005, compliance date for the power source TSO 
remains in effect for carriers using an AED power source that has not 
been specifically

[[Page 15195]]

found by the FAA to be equivalent to the TSO-marked item.
    The FAA is issuing this rule without prior notice or opportunity 
for public comment. When the ATA filed its petition, eight commenters 
responded, all of which supported a grant of relief. Five of the 
comments were from ATA-member air carriers that would have been 
included in the exemption relief. A comment was received from the Air 
Carriers Association of America, requesting that three of its member 
airlines be included in the relief requested by the ATA. One comment 
was from Comair, requesting that all carriers using the subject Philips 
AEDs be included for relief, not just ATA members. The eighth 
commenter, the Allied Pilots Association, supported the requested 
relief.
    In reviewing the comments to the ATA petition, we found that the 
compliance requirement is well-recognized in the air carrier industry. 
The exemption petition from the ATA and the comments received have 
already served to provide the same information that we would expect 
from a notice of proposed rulemaking, and have given us confidence that 
this rule change is appropriate. Further, this rule change is relieving 
in nature and affects compliance that would be required in the near 
future. Accordingly, we are adopting this final rule without prior 
notice and opportunity for prior public comment since later relief 
would negate the benefit of not having to purchase TSO-marked batteries 
and replace them before the compliance date.
    Part 121, Appendix A is being amended to allow the use of AED power 
sources that were manufactured before July 30, 2004, and do not have 
the TSO marking required, provided that the manufacturer of the power 
source has received a finding of equivalency from the appropriate ACO. 
The FAA chose the July 30, 2004, date based on the information 
presented by the ATA in its petition for exemption. The ATA stated that 
Philips received its TSO marking authorization for one battery on June 
9, 2004, and the other on June 17, 2004, and that the batteries became 
available for shipment approximately July 17, 2004. The manufacturing 
date of July 30, 2004 we have chosen allows time for orders in process 
at the time of approval to have been fulfilled. Once the TSO batteries 
became available, non-TSO'd batteries should no longer have been 
purchased, since the requirements of the rule and the shelf life of the 
batteries were well known.

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is 
found in title 49 of the United States Code. Subtitle I, section 106 
describes the authority of the FAA Administrator. Subtitle VII, 
Aviation Programs, describes in more detail the scope of the agency's 
authority.
    This rulemaking is promulgated under the authority described in 
subtitle VII, part A, section 44701 regarding safety regulations. Under 
that section, the FAA is charged with prescribing regulations for 
equipment and procedures that the Administrator finds necessary for 
safety in air commerce. The regulations requiring AEDs were promulgated 
in 2001 in response to the Aviation Medical Assistance Act of April 24, 
1998 [Pub. L. 105-170]. This regulation is within the scope of that 
authority since it affects the use of emergency medical equipment, 
which has been found as necessary for safety in air commerce.

Paperwork Reduction Act

    There are no new requirements for information collection associated 
with this amendment. It is voluntary for a manufacturer to seek an 
equivalency finding for its products manufactured prior to receiving 
approval to mark its product as compliant with the applicable TSO.

International Compatibility

    In keeping with U.S. obligations under the Convention on 
International Civil Aviation, it is FAA policy to comply with 
International Civil Aviation Organization (ICAO) Standards and 
Recommended Practices to the maximum extent practicable. The FAA 
determined that there are no ICAO Standards and Recommended Practices 
that correspond to these proposed regulations.

Good Cause for Immediate Adoption

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 
U.S.C. Sections 553(b)(3)(B)) authorizes agencies to dispense with 
certain notice procedures for rules when they find ``good cause'' to do 
so. Under section 553(b)(3)(B), the requirements of notice and 
opportunity for comment do not apply when the agency for good cause 
finds that those procedures are ``impracticable, unnecessary, or 
contrary to the public interest.''
    As noted, the rule being amended takes effect April 30, 2005. Prior 
notice and public comment is not feasible before that date. Allowing 
the rule to take effect while the change is under consideration would 
result in significant expenditures to purchase TSO-marked batteries and 
replace those in service that have already been found to be equivalent, 
making the delay contrary to the public interest. Also as noted, the 
petition from the ATA and the comments filed in response serve the same 
purpose and have most likely resulted in the same comments that would 
have been generated by an NPRM. Accordingly, the FAA finds that notice 
and public comment to this final rule are unnecessary, and contrary to 
the public interest.

Executive Order 12866 and DOT Regulatory Policies and Procedures

    Executive Order 12866, Regulatory Planning and Review, directs the 
FAA to assess both the costs and benefits of a regulatory change. We 
are not allowed to propose or adopt a regulation unless we make a 
reasoned determination that the benefits of the intended regulation 
justify its costs. Our assessment of this proposed rule indicates that 
it will have a positive economic impact by saving numerous carriers the 
cost of replacing serviceable batteries.
    In its petition requesting an exemption, the ATA estimated that an 
exemption would save its 12 member operators $829,661 over the next ten 
years. This figure represents the value of batteries already purchased, 
plus the additional cost of TSO-marked batteries that would have to be 
purchased and installed by April 30, 2005. Comments submitted in 
response to the ATA petition indicate that several other air carriers 
not represented by the ATA that use Philips AEDs are in the same 
situation of currently using non-TSO marked batteries and having others 
in replacement inventory. The FAA considers the cost savings of this 
rule to be at least the amount stated by the ATA.
    Since the costs and benefits of this change do not make it a 
``significant regulatory action'' as defined in the Order, we have not 
prepared a ``regulatory impact analysis.'' Similarly, we have not 
prepared a ``regulatory evaluation,'' which is the written cost/benefit 
analysis ordinarily required for all rulemaking proposals under the DOT 
Regulatory and Policies and Procedures. We do not need to do the latter 
analysis where the economic impact of a proposal is minimal. This rule 
does not impose any new costs. The costs of compliance with this rule 
were already accounted for when the AED requirement was adopted in 
2001.
    Proposed changes to Federal regulations must undergo several 
economic analyses. First, Executive Order 12866 directs each Federal 
agency

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to propose or adopt a regulation only upon a reasoned determination 
that the benefits of the intended regulation justify its costs. Second, 
the Regulatory Flexibility Act of 1980 requires agencies to analyze the 
economic impact of regulatory changes on small entities. Third, the 
Trade Agreements Act (19 U.S.C. section 2531-2533) prohibits agencies 
from setting standards that create unnecessary obstacles to the foreign 
commerce of the United States. In developing U.S. standards, this Trade 
Act also requires agencies to consider international standards and, 
where appropriate, use them as the basis of U.S. standards. Fourth, the 
Unfunded Mandates Reform Act of 1995 requires agencies to prepare a 
written assessment of the costs, benefits and other effects of proposed 
or final rules that include a Federal mandate likely to result in the 
expenditure by State, local or tribal governments, in the aggregate, or 
by the private sector, of $100 million or more annually (adjusted for 
inflation).
    In conducting these analyses, FAA has determined this rule (1) has 
benefits which do justify its costs, is not a ``significant regulatory 
action'' as defined in the Executive Order nor ``significant'' as 
defined in DOT's Regulatory Policies and Procedures; (2) will not have 
a significant impact on a substantial number of small entities; (3) 
presents no barriers to international trade; and (4) does not impose an 
unfunded mandate on state, local, or tribal governments, or on the 
private sector.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) of 1980, 5 U.S.C. 601-612, 
directs the FAA to fit regulatory requirements to the scale of the 
business, organizations, and governmental jurisdictions subject to the 
regulation. We are required to determine whether a proposed or final 
action will have a ``significant economic impact on a substantial 
number of small entities'' as defined in the Act. If we find that the 
action will have a significant impact, we must prepare a ``regulatory 
flexibility analysis.''
    This final rule has no associated costs but provides benefits to 
all air carriers using AEDs for which a power source equivalent to the 
TSO-marked source exists. Any economic impact is minimal. Therefore, we 
certify that this action will not have a significant economic impact on 
a substantial number of small entities.

Trade Impact Assessment

    The Trade Agreement Act of 1979 prohibits Federal agencies from 
engaging in any standards or related activities that create unnecessary 
obstacles to the foreign commerce of the United States. Legitimate 
domestic objectives, such as safety, are not considered unnecessary 
obstacles. The statute also requires consideration of international 
standards and where appropriate, that they be the basis for U.S. 
standards. The FAA has assessed the potential effect of this rulemaking 
and has determined that it will impose the same costs on domestic and 
international entities and thus has a neutral trade impact.

Unfunded Mandates Assessment

    The Unfunded Mandates Reform Act of 1995 (the Act), enacted as Pub. 
L. 104-4 on March 22, 1995, is intended, among other things, to curb 
the practice of imposing unfunded Federal mandates on State, local, and 
tribal governments. Title II of the Act requires each Federal agency to 
prepare a written statement assessing the effects of any Federal 
mandate in a proposed or final agency rule that may result in a $100 
million or more expenditure (adjusted periodically for inflation) in 
any one year by State, local, and tribal governments, in the aggregate, 
or by the private sector; such a mandate is deemed to be a 
``significant regulatory action.''
    This final rule does not contain such a mandate. Therefore, the 
requirements of Title II of the Unfunded Mandates Reform Act of 1995 do 
not apply.

Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and 
criteria of Executive Order 13132, Federalism. We determined that this 
action will not have a substantial direct effect on the States, or the 
relationship between the national Government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government. Therefore, we determined that this final rule does not have 
federalism implications.

Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically 
excluded from preparation of an environmental assessment or 
environmental impact statement under the National Environmental Policy 
Act in the absence of extraordinary circumstances. The FAA has 
determined this final rule qualifies for the categorical exclusion 
identified in paragraph 312f of the Order and involves no extraordinary 
circumstances.

Energy Impact

    The energy impact of the final rule has been assessed in accordance 
with the Energy Policy and Conservation Act (EPCA Pub. L. 94-163), as 
amended (42 U.S.C. 6362) and FAA Order 1053.1. It has been determined 
that the final rule is not a major regulatory action under the 
provisions of the EPCA.

List of Subjects in 14 CFR Part 121

    Air carriers, Aircraft, Airmen, Alcohol abuse, Aviation safety, 
Charter flights, Drug abuse, Drug testing, Reporting and recordkeeping 
requirements, Safety, Transportation.

The Amendment

    In consideration of the foregoing the Federal Aviation 
Administration amends Chapter I of Title 14 Code of Federal Regulations 
as follows:

PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL 
OPERATIONS

0
1. The authority citation for part 121 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 40119, 44101, 44701-44702, 
44705, 44709-44711, 44713, 44716-44717, 44722, 44901, 44903-44904, 
44912, 46105.

0
2. In Appendix A to part 121, revise paragraph 2 of ``Automated 
External Defibrillators,'' to read as follows:

Appendix A to Part 121--First Aid Kits and Emergency Medical Kits

* * * * *

Automated External Defibrillators

* * * * *
2. After April 30, 2005:
    (a) Have a power source that meets FAA Technical Standard Order 
requirements for power sources for electronic devices used in aviation 
as approved by the Administrator; or
    (b) Have a power source that was manufactured before July 30, 2004, 
and been found by the FAA to be equivalent to a power source that meets 
the Technical Standard Order requirements of paragraph (a) of this 
section.
* * * * *

    Issued in Washington, DC, on March 17, 2005.
Marion C. Blakey,
Administrator.
[FR Doc. 05-5764 Filed 3-18-05; 2:16 pm]

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