[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Rules and Regulations]
[Pages 35648-35652]
[FR Doc No: 2016-13158]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 10

[Docket No. USCG-2016-0029]

Change-2 to Navigation and Vessel Inspection Circular 04-08:
Medical Certification Standards, Medications, and Medical Review
Process

AGENCY: Coast Guard, DHS.

ACTION: Notice of policy; availability.

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SUMMARY: The Coast Guard announces the availability of Change-2 to
Navigation and Vessel Inspection Circular (NVIC) 04-08, ``Medical and
Physical Evaluation Guidelines for Merchant Mariner Credentials'' (NVIC
04-08). Change-2 to NVIC 04-08 contains revisions to Enclosure (1)
Medical Certification Standards, Enclosure (4) Medications, and
Enclosure (6) Medical Review Process. The revisions to Enclosures (1)
and (6) reflect process and procedural changes related to
centralization of the evaluation of credential applications at the
National Maritime Center and implementation of the final rule that
aligned Coast Guard regulations with amendments to the International
Convention on Standards of Training, Certification and Watchkeeping for
Seafarers and made changes to national endorsements. The revisions to
Enclosure (4) provide more detailed guidance on medications that are
subject to further review, and address comments received in response to
a notice published in the Federal Register on January 28, 2015 seeking
input from the public on this issue.

DATES: Change-2 to NVIC 04-08 is in effect on June 3, 2016.

ADDRESSES: Submit comments online at http://www.regulations.gov in
accordance with Web site instructions.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email LCDR Ian Bird, Office of Commercial Vessel
Compliance (CG-CVC),<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Viewing Documents

    Navigation and Vessel Inspection Circular (NVIC) 04-08 is available
on the Internet at: http://www.uscg.mil/hq/cg5/nvic/pdf/2008/NVIC%2004-08%20CH%201%20with%20Enclosures%2020130607.pdf. It can also be viewed
on the Coast Guard's Web site at: www.uscg.mil/nmc.

Background

    Coast Guard regulations contained in 46 CFR part 10, subpart C,
contain the medical and physical standards that merchant mariner
applicants must meet prior to being issued a merchant mariner medical
certificate. NVIC 04-08 provides guidance to the regulated community on
how to comply with the regulations pertaining to medical and physical
qualifications for merchant mariners.
    On December 24, 2013, the Coast Guard published a final rule in the
Federal Register (78 FR 77796) entitled ``Implementation of the
Amendments to the International Convention on Standards of Training,
Certification and Watchkeeping for Seafarers, 1978, and Changes to
National Endorsements.'' It amended 46 CFR parts 1, 10, 11, 12, 13, and
15 to implement the International Convention on Standards of Training,
Certification and Watchkeeping for Seafarers, 1978 (STCW Convention),
including the 2010 amendments to the STCW Convention, and the
Seafarers' Training, Certification and Watchkeeping Code, as well as
updating requirements for national endorsements. The final rule also
established the merchant mariner medical certificate as a document
issued independently of the merchant mariner credential. Merchant
mariner credentials issued after January 24, 2014, and that require a
general medical examination are not valid for service unless
accompanied by a valid medical certificate. Enclosures (1) and (6) of
NVIC 04-08 required revision to reflect changes implemented with the
final rule and a reorganization of the mariner credentialing function.
    Guidance on medication use contained in Enclosure (4) to NVIC 04-08
prior to Change-2 noted that use of certain medications was considered
disqualifying for issuance of credentials. The guidance did not provide
details on the types of medications that might lead to denial of a
medical certificate, nor did it provide discussion of the information
and criteria that the Coast Guard considers in determining whether to
issue a waiver for certain medications.
    In developing this policy, the Coast Guard sought recommendations
from the Merchant Mariner Medical Advisory Committee (MEDMAC) on waiver
considerations for mariner applicants whose conditions require the use
of potentially impairing medications while operating under the
authority of the credential. In response to Coast Guard Task Statement
14-09, Medical Evaluation of Merchant Mariners Treated with Potentially
Impairing Medications, MEDMAC recommended that medications with central
nervous depressant effects, such as opioid, benzodiazepine, or non-
benzodiazepine medications, be considered disqualifying and generally
not waiverable. They also recommended that the following medications be
determined disqualifying: medications that impair vision,
anticoagulants, anti-metabolites and cancer treatments, sedating anti-
histamines, antipsychotics, opioid-like analgesics, anti-seizure
medications, and stimulant medications, such as amphetamine and
methylphenidate. MEDMAC's recommendations did not include specific
criteria for waiver consideration for mariners whose conditions require
the use of potentially impairing medication while operating under the
authority of the credential.
    On January 28, 2015, the Coast Guard published a notice in the
Federal Register requesting public comments on a proposed revision to
Enclosure (4) that would provide more in-depth guidance on these issues
(80 FR 4582).
    We summarize the policy contained in Change-2 to NVIC 04-08 and
address the public comments received on the proposed revision to
Enclosure (4) below.

Discussion

    Enclosure (1) and Enclosure (6). The revised Enclosure (1) Medical
Certification Standards summarizes the medical and physical
requirements for mariner endorsements and provides additional guidance
regarding the medical certificate. The revision to Enclosure (6)
provides guidance on the medical review process used to determine if a
mariner meets the medical and physical standards for issuance of a
medical certificate.
    Enclosure (4)--Medications. The revision to Enclosure (4) provides
guidance to the regulated community on medications that may be deemed
disqualifying for issuance of a medical certificate due to risks of
impairment or other safety concerns. The new guidance also clarifies
the extenuating circumstances related to the use of potentially
impairing medications that the Coast Guard weighs in evaluating risks
to public and maritime safety, and

in determining suitability for a medical waiver. The revised enclosure
additionally provides a safety warning to mariners advising them to
refrain from operating under the authority of the credential when they
are under the influence of any medication that can cause drowsiness, or
impair cognitive ability, judgment, or reaction time. The revised
guidance for mariners seeking a waiver to use potentially impairing
medications while operating under the authority of the credential
follows.

I. Medication Waivers Requiring Special Consideration

    Medications that may impair cognitive ability, judgment or reaction
time are considered disqualifying for issuance of credentials. The
underlying condition, as well as the effects of the medications, may
lead to denial of a medical certificate or may result in issuance of a
waiver.
    Due to the documented risks of impaired cognition, judgment, and
reaction time associated with the use of certain legally prescribed
controlled substances; the Coast Guard has determined that use of these
medications while acting under the authority of the credential
generally will not be waived. These medications include, but are not
limited to opioid/opiate medications, benzodiazepine medications, non-
benzodiazepine sedative hypnotic medications, and barbiturate
medications. However, waivers may be considered, on a case-by-case
basis, if the Coast Guard determines that there are exceptional
circumstances that warrant consideration for a waiver.
    Exceptional Circumstances. The criteria for waiver consideration
for applicants seeking to use, or be under the influence of,
medications that may impair their cognitive ability, judgment, or
reaction time, while acting under the authority of the credential, are
listed below. Applicants unable to meet all of the criteria are only
considered for a waiver under extraordinary circumstances, if the Coast
Guard deems the risk of impairment to be sufficiently low. The criteria
follow.
    1. The mariner was previously granted a waiver allowing use of the
same medication while working under the authority of the credential,
where the credential was of the same scope of authority.
    2. The mariner demonstrated compliance with all terms of the prior
waiver.
    3. There were no accidents or other safety concerns related to
medication, judgment, cognitive ability, or reaction time during the
course of the prior waiver period(s).
    4. The mariner has been on a stable medication regimen for a
minimum of 2 years, as documented by the treating physician and
pharmacy records.
    a. Mariners who have required periodic increases in medication
dosing during the preceding 2-year period would not meet this
criterion.
    b. Mariners who have consistently or periodically supplemented
their medication regimen with other disqualifying medications during
the 2-year period are not likely to be considered as meeting this
criterion. For example, an individual who has been on a stable dose of
one opioid pain medication for 2 years, but has also periodically taken
or filled prescriptions for an opioid cough medication during that same
time period, would not be considered as being on a stable dose of
medicine.
    c. Mariners whose medication dose has been decreased or tapered
off, without subsequent dose increase, may be considered as meeting
this criterion.
    5. The mariner is not seeking to use, or be under the influence of,
more than one medication with risk for impairment while working under
the authority of the credential.
    6. The mariner's treating physician provides written assessment
that adequately addresses all information requested in the section on
Recommended Evaluation Data for Medication Waivers Requiring Special
Consideration, and that supports a determination that the mariner is at
low risk for medication impairment based upon objective testing and
standard evaluation tools.
    7. When requested, formal neuropsychological/neurocognitive
testing, performed as outlined in the section providing guidance on
formal neuropsychological/neurocognitive evaluation, documents the
absence of significant medication impairment.
    8. The mariner does not use any other medications or have any other
medical conditions, which may alone, or in combination, adversely
affect the mariner's fitness.
    9. Use of methadone may not be waived under any circumstances.
    The risk presented by the mariner's position may be considered in
determining whether to grant a waiver. Because of the wide-range of
operational conditions, it is impossible to set out in advance which
positions may be suitable for a waiver. The Coast Guard retains final
authority for the issuance of waivers. Waivers may include restrictions
and/or operational limitations on the credential.
    Recommended Evaluation Data for Medication Waivers Requiring
Special Consideration. Applicants seeking consideration for a
medication waiver for the use of medications that may impair cognitive
ability, judgment, or reaction time, while acting under the authority
of the credential, should submit the additional information detailed
below, for each medication.
    1. A letter from the prescribing and/or treating physician that
includes the following:
    a. Whether the physician has familiarized himself/herself with the
detailed guidelines on medical conditions and medications contained in
NVIC 04-08.
    b. Whether the physician understands the safety-sensitive nature of
the credential and the specialized shipboard environment.
    c. A detailed discussion of the condition that requires the use of
the potentially impairing medication.
    d. A description of any known complications experienced by the
mariner from the use of a particular medication, level of current
stability, and prognosis of the underlying condition. The physician
should also provide his or her professional opinion on whether the
condition is suitable for safety-sensitive work.
    e. A description of the dosage and frequency of use of the
medication (this description should be very specific; ``as needed'' is
not sufficient information). The description should also reflect that
the physician has reviewed the mariner's pharmacy records for
documentation of the number of pills dispensed for use each month and
documentation of the length of time that the mariner has been on the
medication.
    f. A detailed statement about whether the mariner is taking the
medication as directed, and if there are any concerns of misuse or
overuse of the medication.
    g. A statement about whether the mariner is compliant with therapy
and follow-up appointments.
    h. A statement about whether the mariner requires use of this
medication while at work, or while aboard the vessel. If the mariner
requires use of the potentially impairing medication while at work or
while aboard the vessel, the physician should provide a detailed
explanation and rationale for the use.
    i. A statement about whether the physician has advised the mariner
of the risks of impairment related to the medication. The physician
should also discuss any risks advised, as well as any instructions
discussed with the mariner for mitigating risk.
    j. A statement about whether the mariner's other medications,
medical

conditions, and work/sleep conditions might compound the impairing
effects of this medication. This discussion should reflect that the
physician has knowledge of the specifics of the mariner's medications,
medical conditions, and work/sleep schedule.
    k. A statement about whether the physician has formally evaluated
the mariner for the presence of any impairing medication effects. This
discussion should include a description of the method of evaluation
utilized, as well as the findings.
    l. A medical opinion of whether the mariner has any medication
effects that would impede safe operation of a vessel or interfere with
work in a safety sensitive position. This discussion should include the
rationale for the physician's opinion.
    m. A statement of whether the physician has advised the mariner
that it is safe to operate a vessel, operate hazardous machinery, and
perform safety sensitive functions while under the influence of this
medication.
    2. When specifically requested by the reviewing authority,
additional amplifying information, to include a formal
neuropsychological/neurocognitive evaluation.
    a. In particular, mariners seeking waivers to use or be under the
influence of potentially impairing opioid/opiate, benzodiazepine,
sedative hypnotic, and/or barbiturate medications, while acting under
the authority of the credential, may be asked to submit the results of
a formal neuropsychological/neurocognitive evaluation.
    b. The Coast Guard will not normally request a neuropsychological/
neurocognitive evaluation unless the applicant meets all other
requirements for waiver consideration. This is to prevent mariners from
undergoing costly testing when issuance of a waiver is unlikely.
    c. Mariners are advised that submission of neuropsychological/
neurocognitive evaluation results does not guarantee issuance of a
waiver.
    d. When a formal neuropsychological/neurocognitive evaluation is
requested, the assessment should include objective assessment of the
following functions, at a minimum:
    (1) Alertness, arousal, and vigilance;
    (2) Attention (focused, shifting, and divided), processing speed,
and working memory;
    (3) Reaction time (choice and complex), psychomotor function, upper
motor speed, and coordination;
    (4) Sensory perceptual function;
    (5) Executive function: mental flexibility, adaptive problem
solving, abstract reasoning, impulse control, risk taking/risk
assessment, organizational ability (including visual spatial
organization), and planning;
    (6) Memory; and
    (7) Communication skills.
    e. When a formal neuropsychological/neurocognitive evaluation is
requested, the evaluation and narrative interpretation must be provided
by a neuropsychologist who is board-certified and licensed in the
United States.
    f. The report of the formal neuropsychological/neurocognitive
evaluation should also include:
    (1) Documentation of witnessed administration of the medication in
question by a licensed medical provider; and
    (2) Documentation of the time interval between ingestion of the
medication and administration of the neuropsychological/neurocognitive
testing battery.

II. Safety Warning for Mariners

    Certain medications, whether prescription or over-the-counter, have
known impairing effects and their labels warn about the risk of
drowsiness and caution against use while driving or operating hazardous
machinery.
    The nature of shipboard life and shipboard operations is such that
mariners may be subject to unexpected or emergency response duties
associated with vessel or crew safety, and prevention of pollution and
maritime security at any time while aboard a vessel.
    In the interest of safety of life and property at sea, the Coast
Guard views shipboard life and the attendant shipboard duties that can
arise without warning, as safety sensitive duties that are analogous to
operating hazardous machinery. As such:
    1. Mariners are advised to discuss all medication use with their
treating providers and to inform them of the safety sensitive nature of
their credential; and
    2. Mariners are cautioned against acting under the authority of
their credential while under the influence of medications that:
    a. Can cause drowsiness; or
    b. Can impair cognitive ability, judgment, or reaction time; or
    c. Can carry warnings that caution against driving or operating
heavy machinery.
    3. Mariners are advised that they are considered to be acting under
the authority of the credential anytime they are aboard a vessel in a
situation to which 46 CFR 5.57(a) applies, even when off-watch or while
asleep.

Public Comments on the Proposed Revision to the Medication Policy,
Enclosure (4) to NVIC 04-08

    The Coast Guard's notice sought general comments on whether the
proposed revision to Enclosure (4) adequately addresses safety concerns
regarding merchant mariners whose medical conditions require use of
potentially impairing medication. The Coast Guard received 13 comment
letters in response.
    The majority of commenters expressed general agreement with the
proposed policy clarification, noting that it provides a case-by-case
or individualized assessment of a mariner applicant's condition,
instead of imposing a blanket denial for all mariner applicants who
require the use of potentially impairing medications, while operating
under the authority of the credential. The Coast Guard notes that even
prior to Change-2, NVIC 04-08 provided for a case-by-case evaluation of
each applicant's condition. The additional specificity of the guidance
and criteria included in Change-2 will help provide a consistent
framework for those evaluations.
    One commenter suggested that the guidance in the proposed policy be
made enforceable by incorporating it into regulation. This same
commenter also recommended that the guidance include a requirement for
mariners to inform vessel owners/operators when they are under the
influence of prescription or over-the-counter medications. The Coast
Guard disagrees with both comments. First, the purpose of this proposed
policy is not to regulate, but instead, to provide guidance to the
regulated community on how the Coast Guard evaluates mariners who
require the use of certain medications. The policy provides the
framework for individualized assessment and allows flexibility for
consideration of factors specific to each affected mariner. On the
issue of requiring mariners to inform vessel owners/operators about
their medications, the Coast Guard does not have any statutory
authority to enact such a requirement.
    Two commenters disagreed with the policy clarification, arguing
that it is overly restrictive in that it presumes that all mariners on
the medications are impaired and does not give sufficient deference to
the opinion of the treating physician. The Coast Guard notes that the
policy is stringent, but holds that it strikes an adequate balance that
includes strong consideration of the treating physician's opinion along
with objective assessment for signs of

impairment. Because of the safety sensitive nature of the medical
certificate, the Coast Guard contends that neither mariner self-
assessment, nor provider limited office-based assessment, is sufficient
to rule out the risk of significant cognitive impairment in cases where
the mariner seeks to use medications with known risk of impairment
while operating under the authority of their credential. The Coast
Guard notes that this opinion was also shared by all of the medical
professionals who provided comment on the policy. They all agreed that
the treating provider's office assessment would not be sufficient to
ensure that a mariner applicant was free of impairing medication
effects when using medications of this type.
    Three commenters opposed the proposed policy clarification, arguing
that the Coast Guard should never issue waivers for mariners who
require the use of potentially impairing medications, while operating
under the authority of the credential, regardless of the circumstances.
The Coast Guard acknowledges that individuals who use potentially
impairing medications may suffer impairment, but finds that there is no
evidence to support a conclusion that all individuals will uniformly
suffer impairment. On this basis, the Coast Guard disagrees with
imposing a new, blanket exclusion against all mariners who require the
use of potentially impairing medication while operating under the
authority of the credential. The merchant mariner medical regulations
contained in 46 CFR part 10, subpart C, do not prohibit the use of
legally prescribed medications, to include opioids, benzodiazepines,
and non-benzodiazepine sedative hypnotics; and NVIC 04-08 has always
provided for an individualized assessment of mariner applicants.
    The Coast Guard additionally emphasizes that the proposed policy
clarification is not a change in policy; rather, it provides the
regulated community with specificity and outlines the factors that the
Coast Guard will consider during the individualized assessment of
mariner applicants who require the use of potentially impairing
medications, while operating under the authority of the credential. The
individualized assessment considers whether the specifics of an
applicant's medical condition, medical history, medication use, and
cognitive functioning indicate a low likelihood of impairment, or
indicate findings that suggest impairment. The Coast Guard contends
that the policy clarification contained in Change-2 to NVIC 04-08
adequately strikes a balance between potential safety concerns and
putting mariners out of work unnecessarily, and that individuals who
meet all of the criteria outlined in this policy are at low enough risk
to warrant consideration for a medical waiver. A blanket exclusion of
mariner applicants who meet all of these criteria would likely put
mariners out of work without sufficient cause.
    One commenter recommended that the Coast Guard provide stronger
guidance for over-the-counter anti-motion sickness agents, noting that
some of these agents are so sedating that they are sometimes used to
induce sleep. The Coast Guard agrees and included a safety warning for
use of anti-motion sickness agents that cause drowsiness or impairment.
    One commenter argued that the proposed policy clarification's
requirement for mariners to report all over-the-counter medications
taken is confusing and unnecessarily broad. The commenter noted that
while the current medication guidance only requires reporting of over-
the-counter medications that were taken for a period of 30 days or
more, the proposed guidance suggests that mariners would be held
accountable if they did not remember to report even a single dose of a
vitamin or fiber tablet taken. The Coast Guard acknowledges that the
proposed language on medication disclosure may cause unnecessary
concern and confusion. The language in the proposed policy was revised,
therefore, to retain the language from the current guidance document
regarding the disclosure of over-the-counter medications. The revised
language reads: mariner applicants need only report over-the-counter
medications that were taken for a period of 30 days or more, within the
90 days prior to the date that the applicant signs the application to
the Coast Guard.
    Regarding the use of neuropsychological/neurocognitive evaluation,
two commenters asserted that the Coast Guard should require
neuropsychological/neurocognitive evaluation for all mariners seeking
to use potentially impairing medication, while operating under the
authority of the credential. Another commenter agreed that such testing
would be useful, but contended that such testing would be time and cost
prohibitive. Two commenters opposed requiring neuropsychological/
neurocognitive evaluations for all applicants in this category because
they deemed it unnecessary and expensive. The Coast Guard agrees that
while it might be ideal to review neuropsychological/neurocognitive
evaluation results for all mariner applicants who seek to use
potentially impairing medications when operating under the authority of
the credential, such testing may not be necessary in all cases.
Therefore, the Coast Guard has retained the wording from the proposed
policy indicating that a neuropsychological/neurocognitive evaluation
need only be provided when requested by the Coast Guard, as part of the
individualized assessment.
    Another commenter argued that the Coast Guard would not be able to
implement a process to request neuropsychological/neurocognitive
evaluation on the basis that testing is time-consuming and expensive,
and that there are no objective neurocognitive evaluation tools that
are readily available to primary care providers. The Coast Guard agrees
that neuropsychological/neurocognitive evaluation may be expensive and
time consuming and that the associated evaluation tools are not readily
available to primary care providers. However, we disagree with the
assertion that their use is not warranted in certain situations. Such a
situation may occur during the course of conducting an individualized
assessment. Without information from a neuropsychological/
neurocognitive evaluation, the evaluator is left to presume the
presence or absence of medication impairment based upon limited
information. To presume that an applicant is impaired by their
medication and deny them medical certification when no impairment truly
exists, may result in extraordinary costs for the mariner applicant,
including loss of employment, with resultant loss of home and
healthcare. Alternatively, to assume that no medication impairment
exists when a mariner applicant is actually experiencing impairment,
may result in unacceptably high costs to public and maritime safety,
should a maritime casualty result. It is important to note that this
section of the proposed policy describes the information that the Coast
Guard will consider when determining whether extenuating circumstances
exist that warrant consideration for a medical waiver for mariners
seeking to use potentially impairing medications, while operating under
the authority of the credential. As is often the case for any medical
condition that is disqualifying and generally not approved for waiver,
the evaluation to determine extenuating circumstances may often require
assessment and testing that is beyond the scope of the primary care
provider. When formal neuropsychological/neurocognitive evaluation is
requested as part of the individualized assessment for use of impairing
medications, while

operating under the authority of the credential, the Coast Guard fully
expects that this evaluation will be performed by a specialist trained
to perform such evaluations. The Coast Guard also notes that while this
testing may be time-consuming and expensive, a formal
neuropsychological/neurocognitive evaluation can provide critical
documentation on the presence or absence of impairing medication
effects for those mariners seeking to use potentially impairing
medication, while operating under the authority of the credential. When
the Coast Guard determines that a formal neuropsychological/
neurocognitive evaluation is needed, the results of the assessment will
be considered in the context of the other extensive medical
documentation provided to determine whether extenuating circumstances
exist that warrant special consideration for a medical waiver. The
decision of whether such testing is too time-consuming or too expensive
will ultimately be left up to the individual mariner who seeks to
demonstrate extenuating circumstances.
    On the question of which neuropsychological/neurocognitive
functions should be measured, and the appropriate standard for test
outcome, one commenter opined that such a determination would require
further substantial research on individual job requirements. Another
commenter recommended that the Coast Guard add memory and communication
skills to the proposed list of neuropsychological/neurocognitive
domains, to make the overall panel similar to that used by the Federal
Aviation Administration. Another commenter recommended that a witness
observe the mariner applicant taking the medication in question prior
to the administration of the neuropsychological/neurocognitive
evaluation. The Coast Guard considered all of these comments and noted
that there are already well-established, validated testing measures for
various domains of neuropsychological/neurocognitive functioning.
Additionally, other modes of transportation have identified specific
neuropsychological/neurocognitive domains that are critical for tasks
such as flying an airplane or for driving a motor vehicle. The
neuropsychological/neurocognitive functions identified for evaluation
in the proposed policy reflect those functions recommended as critical
for safe motor vehicle driving. In consideration of the public
comments, the current policy has been revised to include testing of
memory and communication skills as required elements of the
neuropsychological/neurocognitive evaluation, when such testing is
requested by the Coast Guard. The current policy also specifies that
medication administration should be witnessed and documented by a
provider prior to the conduct of neuropsychological/neurocognitive
evaluation, when such testing is requested by the Coast Guard.

Authority

    This document is issued under the authority of 5 U.S.C. 552(a), 46
U.S.C. 7101 et seq., 46 CFR part 10, subpart C, and Department of
Homeland Security Delegation No. 0710.1.

V.B. Gifford,
Captain, U.S. Coast Guard, Director of Inspections & Compliance.
[FR Doc. 2016-13158 Filed 6-2-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)]
[Proposed Rules]
[Pages 21770-21772]
[FR Doc No: 2016-08351]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-5466; Directorate Identifier 2015-NM-183-AD]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Dassault Aviation Model FALCON 7X airplanes. This proposed AD
was prompted by investigation results that determined that a certain
thickness of the fuel tank panels is insufficient to meet the
certification requirements. This proposed AD would require inspecting
the thickness of the fuel tank panels, and repair if necessary. We are
proposing this AD to detect and correct improper thickness of the fuel
tank panels. Improper thickness increases the risk of damaging and
puncturing a fuel tank wall panel as a result of a high energy
lightning strike, which could lead to loss of electrical power and/or
other essential functions, possibly resulting in reduced control of the
airplane or ignition of a fuel tank.

DATES: We must receive comments on this proposed AD by May 31, 2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Dassault
Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South
Hackensack, NJ 07606; telephone<PHONE_NUMBER>; Internet http://www.dassaultfalcon.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
5466; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-5466;
Directorate Identifier 2015-NM-183-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2015-0216, dated October 28, 2015 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Dassault
Aviation Model FALCON 7X airplanes. The MCAI states:

    Several rear fuselage tanks of the Falcon 7X were assembled on
the production line with a lateral panel, which had been excessively
chemically-milled in some areas. Investigation results determined
that the remaining thickness is insufficient to meet the
certification requirements. Dassault Aviation identified the
individual aeroplanes that are potentially affected by this
production deficiency. Due to this reduced thickness, the risk of
damaging and puncturing a fuel tank wall panel as a result of a high
energy lightning strike is increased.
    This condition, if not detected and corrected, could lead to
loss of electrical power and/or other essential functions, possibly
resulting in reduced control of the aeroplane or ignition of a fuel
tank.
    To address this potential unsafe condition, Dassault Aviation
published Service Bulletin (SB) 7X-245 to provide inspection and
repair instructions.
    For the reasons described above, this [EASA] AD requires a one-
time inspection of

the fuel tank wall panels and, depending on findings, accomplishment
of a repair.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
5466.

Related Service Information Under 1 CFR Part 51

    Dassault Aviation has issued Service Bulletin 7X-245, dated June 8,
2015. The service information describes procedures for measuring fuel
tank panel thickness, and repair if necessary. This service information
is reasonably available because the interested parties have access to
it through their normal course of business or by the means identified
in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 6 airplanes of U.S.
registry.
    We also estimate that it would take about 8 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost about $0 per
product. Based on these figures, we estimate the cost of this proposed
AD on U.S. operators to be $4,080, or $680 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 20 work-hours and require parts costing $2,244, for a cost
of $3,944 per product. We have no way of determining the number of
aircraft that might need this action.
    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Dassault Aviation: Docket No. FAA-2016-5466; Directorate Identifier
2015-NM-183-AD.

(a) Comments Due Date

    We must receive comments by May 31, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Dassault Aviation Model FALCON 7X airplanes,
certificated in any category, serial numbers (S/Ns) 17 through 21
inclusive, S/Ns 86 through 90 inclusive, S/Ns 115 through 119
inclusive, S/Ns 129 through 138 inclusive, and S/N 155.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Reason

    This AD was prompted by investigation results that determined
that a certain thickness of the fuel tank panels is insufficient to
meet the certification requirements. We are issuing this AD to
detect and correct improper thickness of the fuel tank panels.
Improper thickness increases the risk of damaging and puncturing a
fuel tank wall panel as a result of a high energy lightning strike,
which could lead to loss of electrical power and/or other essential
functions, possibly resulting in reduced control of the airplane or
ignition of a fuel tank.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspection and Repair

    Within 99 months or 4,100 flight cycles, whichever occurs first
since the date of first delivery of the airplane, inspect for
improper thickness of the fuel tank panels, in accordance with the
Accomplishment Instructions of Dassault Service Bulletin 7X-245,
dated June 8, 2015. If improper thickness is found during this
inspection, before further flight, repair the fuel tank panels, in
accordance with the Accomplishment Instructions of Dassault Service
Bulletin 7X-245, dated June 8, 2015.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN:

Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Dassault Aviation's EASA
Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.

(i) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2015-0216, dated October 28,
2015, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2016-5466.
    (2) For service information identified in this AD, contact
Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000,
South Hackensack, NJ 07606; telephone<PHONE_NUMBER>; Internet http://www.dassaultfalcon.com. You may view this service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on March 30, 2016.
Victor Wicklund,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-08351 Filed 4-12-16; 8:45 am]
 BILLING CODE 4910-13-P