Drug and Alcohol Testing of Certain Maintenance Provider Employees Located Outside of the United States, 14621-14630 [2014-05653]
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Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Proposed Rules
Dated: March 6, 2014.
Marianne O. Markowitz,
Acting Administrator.
[FR Doc. 2014–05549 Filed 3–14–14; 8:45 am]
BILLING CODE 8025–01–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 120
[Docket No.: FAA–2012–1058; Notice No.
14–02]
RIN 2120–AK09
Drug and Alcohol Testing of Certain
Maintenance Provider Employees
Located Outside of the United States
Federal Aviation
Administration (FAA), DOT.
ACTION: Advance notice of proposed
rulemaking (ANPRM).
AGENCY:
The FAA is considering
amending its drug and alcohol testing
regulations to require drug and alcohol
testing of certain maintenance personnel
outside the United States. Specifically,
the FAA is considering requiring certain
air carriers to ensure that all employees
of certificated repair stations, and
certain other maintenance organizations
that are located outside the United
States, who perform safety-sensitive
maintenance functions on aircraft
operated by that air carrier are subject
to a drug and alcohol testing program
that has been determined acceptable by
the FAA Administrator and is consistent
with the applicable laws of the country
in which the repair station is located.
Safety-sensitive maintenance functions
include aircraft maintenance and
preventive maintenance duties. This
action is necessary to address a statutory
mandate. The FAA has determined that
it needs additional information to
develop a proposed rule and assess its
likely economic impact. This notice
invites comments on a variety of issues
related to proposing drug and alcohol
testing requirements for the relevant
employees of covered maintenance
providers.
SUMMARY:
Send comments on or before
May 16, 2014.
ADDRESSES: Send comments identified
by docket number FAA–2012–1058
using any of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov and follow
the online instructions for sending your
comments electronically.
• Mail: Send comments to Docket
Operations, M–30; U.S. Department of
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DATES:
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Transportation (DOT), 1200 New Jersey
Avenue SE., Room W12–140, West
Building Ground Floor, Washington, DC
20590–0001.
• Hand Delivery or Courier: Take
comments to Docket Operations in
Room W12–140 of the West Building
Ground Floor at 1200 New Jersey
Avenue SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
• Fax: Fax comments to Docket
Operations at (202) 493–2251.
Privacy: In accordance with 5 USC
553(c), DOT solicits comments from the
public to better inform its rulemaking
process. DOT posts these comments,
without edit, including any personal
information the commenter provides, to
www.regulations.gov, as described in
the system of records notice (DOT/ALL–
14 FDMS), which can be reviewed at
www.dot.gov/privacy. https://
DocketsInfo.dot.gov.
Docket: Background documents or
comments received may be read at
https://www.regulations.gov at any time.
Follow the online instructions for
accessing the docket or go to the Docket
Operations in Room W12–140 of the
West Building Ground Floor at 1200
New Jersey Avenue SE., Washington,
DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: For
technical questions concerning this
action, contact Rafael Ramos, Office of
Aerospace Medicine, Drug Abatement
Division, AAM–800, Federal Aviation
Administration, 800 Independence
Avenue SW., Washington, DC 20591;
telephone (202) 267–8442; facsimile
(202) 267–5200; email: drugabatement@
faa.gov.
For legal questions concerning this
action, contact Neal O’Hara, Attorney,
Regulations Division, AGC–240, Federal
Aviation Administration, 800
Independence Avenue SW.,
Washington, DC 20591; telephone (202)
267–5348.
For cost and benefit questions
concerning this action, contact Nicole
Nance, Office of Aviation Policy and
Plans, APO–300, Federal Aviation
Administration, 800 Independence
Avenue SW., Washington, DC 20591;
telephone (202) 267–3311.
SUPPLEMENTARY INFORMATION:
Comments Invited
See the ‘‘Additional Information’’
section for information on how to
comment on this ANPRM and how the
FAA will handle comments received.
The ‘‘Additional Information’’ section
also contains related information about
the docket, privacy, and the handling of
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14621
proprietary or confidential business
information. In addition, there is
information on obtaining copies of
related rulemaking documents.
Authority for This Rulemaking
The FAA’s authority to issue rules on
aviation safety is found in title 49 of the
United States Code (U.S.C.). 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. In carrying out part A (Air
Commerce and Safety) of subtitle VII,
the Administrator is directed to act
consistently with obligations of the
United States Government under an
international agreement and to consider
applicable laws and requirements of a
foreign country. See 49 U.S.C.
40105(b)(1)-(2). Additionally, section
308(d)(2) of the FAA Modernization and
Reform Act of 2012 (the Act), 49 U.S.C.
44733 requires that:
Not later than 1 year after the date of
enactment of this section, the [FAA]
Administrator shall promulgate a proposed
rule requiring that all part 145 repair station
employees responsible for safety-sensitive
maintenance functions on part 121 air carrier
aircraft are subject to an alcohol and
controlled substances testing program
determined acceptable by the Administrator
and consistent with the applicable laws of
the country in which the repair station is
located.1
In 49 U.S.C. 44733(d)(2) Congress did
not address employees of maintenance
providers located outside the United
States that are not certificated by the
FAA. However, authorized persons
performing safety-sensitive maintenance
functions on aircraft operated by part
121 air carriers in accordance with 14
CFR 43.17 are substantially similar to
those employees of part 145 repair
stations located outside the United
States for whom the FAA has been
directed to propose drug and alcohol
testing. Because of their substantial
similarity, under the authority of 49
U.S.C. 44701(a)(5), which requires the
Administrator to promote the safe flight
of civil aircraft in air commerce by
prescribing regulations and minimum
standards for practices, methods, and
procedures that the Administrator finds
necessary for safety in air commerce and
national security, we request comment
on the application of these requirements
to this group/category of authorized
persons.
1 Except when quoting the text of section 308 of
the Act, the FAA uses the term ‘‘drug’’ rather than
‘‘controlled substance’’ in this ANPRM, because an
illegal substance in the United States may be legal
to use in the country in which a covered
maintenance provider is located.
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I. Overview of Advance Notice of
Proposed Rulemaking (ANPRM)
The Act requires the FAA to propose
alcohol and drug testing requirements
for employees of part 145 repair stations
located outside the United States who
perform safety-sensitive maintenance
functions on aircraft operated by part
121 air carriers, as the FAA currently
does not require drug or alcohol testing
for such personnel. Currently, as
required under 14 CFR part 120,
employees performing aircraft
maintenance and preventive
maintenance duties on part 121, 135 or
91.147 certificated air craft within the
U.S. are required to be subject to drug
and alcohol testing. The FAA believes
Congress intended that preventive
maintenance is a safety-sensitive
maintenance function as currently
described under 14 CFR part 120,
therefore safety-sensitive maintenance
functions include both aircraft
maintenance and preventive
maintenance duties.2
While Congress did not address
maintenance providers that are not
certificated by the FAA in 49 U.S.C.
44733(d)(2), authorized persons
performing safety-sensitive maintenance
functions on aircraft operated by part
121 air carriers in accordance with 14
CFR 43.17, are substantially similar to
the employees of part 145 repair stations
in other countries for whom the FAA
must propose drug and alcohol testing.
Therefore, the FAA is also considering
whether to require each part 121 air
carrier to ensure that authorized persons
performing safety-sensitive maintenance
functions on aircraft operated by that
part 121 air carrier in accordance with
14 CFR 43.17, and is not also a
certificated part 145 repair station, are
subject to drug and alcohol testing
programs that meet the same or similar
requirements as programs for their
counterparts at part 145 repair stations
located outside the United States.
Currently, there are approximately
120 part 145 repair stations located
outside the United States whose
employees perform safety-sensitive
maintenance functions on aircraft
operated by part 121 air carriers. There
are also organizations in one other
country outside the United States that
are not part 145 repair stations, but
whose employees perform safety2 Alcohol and drug testing of employees of part
145 repair stations located in the United States who
perform safety-sensitive maintenance functions on
aircraft operated by part 121 air carriers is already
required under 14 CFR part 120. The FAA does not
anticipate making any changes as part of this
rulemaking to its drug and alcohol testing
requirements that apply to safety-sensitive
personnel within the United States.
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sensitive maintenance functions on
aircraft operated by part 121 air carriers
in accordance with 14 CFR 43.17.
II. Background
A. Statement of the Issue
The FAA’s drug and alcohol testing
regulations, contained in 14 CFR part
120, do not extend to companies or
individuals who perform safetysensitive functions, including, but not
limited to, aircraft maintenance and
preventive maintenance, outside of the
United States. They currently apply to
all air carriers and operators authorized
to conduct operations under part 121 or
part 135; all air traffic control facilities
not operated by the FAA or by or under
contract to the U.S. military; all air tour
operators as defined in 14 CFR 91.147;
and all part 145 certificate holders and
contractors who employ individuals
who perform, either directly or by
contract, including subcontract at any
tier, any of the following safety-sensitive
functions: Flight crewmember duties,
flight attendant duties, flight instruction
duties, aircraft dispatcher duties,
aircraft maintenance and preventive
maintenance duties, ground security
coordinator duties, aviation screening
duties, air traffic control duties.
Additionally, the regulations do not
permit any part of the testing process,
including specimen collection, to be
conducted outside the United States. As
described above, the Act requires that
the FAA propose extending drug and
alcohol testing to employees of part 145
repair stations located outside the
United States who perform safetysensitive maintenance functions on part
121 air carrier aircraft in a manner
consistent with local laws.
B. International Civil Aviation
Organization (ICAO) Standards and
Recommended Practices
International Civil Aviation
Organization (ICAO) standards do not
presently require ICAO Member States
to establish (or direct industry to
establish) testing programs to deter or
detect inappropriate drug and alcohol
use by aviation personnel with safetysensitive responsibilities. However, a
number of ICAO standards and
recommended practices address misuse
of drugs and alcohol by aviation
personnel and recognize the potential
hazard that such misuse may pose to
aviation safety. For example, the
recommended practice in paragraph
1.2.7.3 of Annex 1 (Personnel Licensing)
to the Convention on International Civil
Aviation (the ‘‘Chicago Convention’’),
states that ICAO Member States ‘‘. . .
should ensure, as far as practicable, that
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all licen[s]e holders who engage in any
kind of problematic use of substances
are identified and removed from their
safety-critical functions.’’ ICAO further
recommends that ‘‘[r]eturn to the safetycritical functions may be considered
after successful treatment or, in cases
where no treatment is necessary, after
cessation of the problematic use of
substances and upon determination that
the person’s continued performance of
the function is unlikely to jeopardize
safety.’’ In addition, the standard in
paragraph 2.5 of Annex 2 (Rules of the
Air) to the Chicago Convention states
that ‘‘[n]o person whose function is
critical to the safety of aviation (safetysensitive personnel) shall undertake that
function while under the influence of
any psychoactive substance, by reason
of which human performance is
impaired. No such person shall engage
in any kind of problematic use of
substances.’’ See also paragraphs 1.2.6,
1.2.7, 6.3.2.2, 6.4.2.2, and 6.5.2.2 of
Annex 1 to the Chicago Convention.
C. History
The FAA’s original drug testing rule,
published in 1988 (53 FR 47024),
required drug testing of certain aviation
personnel, including some that
performed safety-sensitive functions
outside the United States. However, the
effective date of the rule with respect to
testing outside the territory of the
United States was deferred on a number
of occasions to permit related
negotiations with governments and
international organizations to continue
in an orderly and effective fashion. In
1994, the FAA published two final rules
related to drug and alcohol testing.
Alcohol Misuse Prevention Program for
Personnel Engaged in Specified
Aviation Activities (59 FR 7380)
established the FAA’s alcohol testing
requirements. The alcohol testing rule
was not extended to employees located
outside the territory of the United States
due to significant logistical issues and
possible conflicts with local laws. AntiDrug Program for Personnel Engaged in
Specified Aviation Activities (59 FR
42922) amended certain provisions of
the existing FAA drug testing rules to
comply with the requirements of the
Omnibus Transportation Employee
Testing Act of 1991. The drug testing
requirements were not extended to
employees located outside of United
States territory due to significant
practical and legal concerns. Rather, the
rule specifically stated that no employee
located outside of the United States
would be tested for drugs. Additionally,
in 1994, the FAA published a Notice of
Proposed Rulemaking (NPRM),
Antidrug Program and Alcohol Misuse
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Prevention Program for Employees of
Foreign Air Carriers Engaged in
Specified Aviation Activities, to address
requirements in the Omnibus
Transportation Employee Testing Act of
1991. This NPRM required foreign air
carriers operating into the U.S. to
implement testing programs like those
required of U.S. air carriers unless
‘‘multilateral action was taken to
support an international aviation
environment free of substance abuse’’.
However, in 2000, the FAA withdrew
the NPRM stating, ‘‘For the foregoing
reasons, the FAA is withdrawing the
rulemaking proposed on February 15,
1994, and is leaving within the purview
of each government the method chosen
to respond to the ICAO initiatives. We
will continue to view a multilateral
response as the best approach to
evolving issues in the substance abuse
arena. Should the FAA subsequently
determine, however, that the scope of
the threat of substance abuse is not
being adequately addressed by the
international community, the FAA will
take appropriate action, including the
possible re-initiation of this
rulemaking.’’
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D. Related Actions
Under 49 U.S.C. 44733(d)(1), Congress
mandated that the Secretary of State and
the Secretary of Transportation, acting
jointly, request the governments of
countries that are members of ICAO to
establish international standards for
alcohol and drug testing of persons that
perform safety-sensitive maintenance
functions on commercial air carrier
aircraft. The FAA strongly supports the
development of such international
standards and believes that they would
help deter and detect drug and alcohol
use that could compromise aviation
safety.
III. Discussion of Proposals Under
Consideration
Although ICAO standards and many
countries’ aviation regulations prohibit
the use of drugs and alcohol by certain
aviation personnel in circumstances in
which such use may threaten aviation
safety, many countries either do not
require testing of such personnel to
verify compliance or do not extend such
testing to maintenance personnel.
Congress, however, has now enacted
legislation that requires the FAA to
propose a rule requiring that all Part 145
repair station employees responsible for
safety-sensitive maintenance functions
on part 121 air carrier aircraft, not just
those in the United States, be subject to
a drug and alcohol testing program that
is acceptable to the Administrator and
consistent with the applicable laws of
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the country in which the repair station
is located.
The FAA is aware, however, that
establishing drug and alcohol testing
requirements for such personnel
presents complex practical and legal
issues and could impose potentially
significant costs on industry. Therefore,
the FAA is issuing this ANPRM, rather
than an NPRM, to seek comments from
the public, as well as interested
governments, to help inform the
development of a proposed rule and the
analysis of its economic impact.
The FAA expects to propose to allow
the testing process to take place outside
the United States.3 Any part of the
testing process conducted outside the
United States would need to be both
acceptable to the Administrator and
permitted under the applicable laws and
regulations of the relevant foreign
country or countries. The FAA believes
that it would be less expensive and
logistically simpler to conduct testing
for the relevant employees of covered
maintenance providers in the country
where the covered maintenance
provider is located or possibly in a
nearby country.
The FAA understands that other
countries may have a wide variety of
laws and regulations concerning the use
of and testing for alcohol and drugs. The
FAA further understands that other
countries’ laws and regulations
concerning other matters, such as
personal privacy and employment, may
affect whether and under what
circumstances drug and alcohol testing
may be conducted in those countries.
Some countries might need to pass
authorizing legislation before they could
permit testing within their borders. The
FAA also recognizes the diversity of
policy, moral, and religious views that
exist internationally regarding drug and
alcohol use and testing.
The FAA seeks input from the public
and interested governments to help
inform the development of a proposed
rule and the analysis of its economic
impact. In responding to the requests for
comment below, the FAA asks that
commenters distinguish between
responses relating to alcohol testing and
those relating to drug testing, if the same
comment does not apply to both.
A. Foreign Countries Laws and
Regulations
To help the FAA expand its
understanding of the laws and
regulations of other countries that bear
on drug and alcohol testing, the FAA
requests the information described
3 For example, suitable laboratory facilities for
analyzing specimens would need to be available.
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14623
below regarding countries in which
covered maintenance providers are
located. It would be particularly helpful
to receive the requested information
regarding the countries’ laws and
regulations from the responsible
government authorities of the relevant
country, although private parties are
also encouraged to provide information.
A 1. Is drug and alcohol testing of any
aviation personnel required in that
country, and, if so, for what categories
of aviation personnel (e.g., pilots, flight
attendants, maintenance personnel,
flight dispatchers, others (please
specify))?
A 2. Please provide an explanation of
laws and regulations on other subjects,
such as personal privacy or
employment, which may affect the
permissibility of drug and alcohol
testing in the country, the circumstances
under which such testing may be
conducted, or the manner in which it
may be conducted. Please include
information on which categories of
aviation personnel are subject to these
requirements (e.g., pilots, flight
attendants, maintenance personnel,
flight dispatchers, others (please
specify)). English language copies of the
applicable laws and regulations would
be greatly appreciated.
A 3. What types of testing are (a)
permitted and (b) required under the
laws and regulations of the country?
Please address the following testing by
type:
a. Pre-employment testing;
b. Random testing during
employment;
c. Periodic testing during
employment;
d. Testing based on a reasonable
cause/suspicion that an employee is
under the influence of alcohol or drugs
while performing a safety-sensitive
function or within a certain period of
time before or after performing such a
function;
e. Post-accident testing;
f. Return-to-duty and follow-up
testing of individuals who have
previously tested positive for alcohol or
drugs;
g. Any other drug or alcohol testing
(please specify)?
A 4. Should an FAA regulation
include a provision to allow regulated
parties to apply for a waiver 4 if any
provision conflicts with a foreign law or
regulation? Please state the rationale for
4 Based on the waiver provision in the Office of
the Secretary of Transportation’s nondiscrimination on the basis of disability in air travel
regulations described in 14 CFR § 382.9.
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why such a waiver provision should or
should not be included.
B. Program Elements of Acceptable Drug
and Alcohol Testing
The FAA is considering addressing
the program elements listed below in
establishing the criteria for determining
whether a drug and alcohol testing
program is acceptable to the
Administrator. Questions associated
with each program element are listed
below.
1. A defined set of circumstances
under which testing is conducted for
alcohol and the most pervasive drugs of
abuse in the relevant country. Under the
FAA’s current domestic drug and
alcohol testing regulations for persons
performing flight crewmember duties,
flight attendant duties, flight instruction
duties, aircraft dispatcher duties,
aircraft maintenance and preventive
maintenance duties, ground security
coordinator duties, aviation screening
duties, air traffic control duties testing
is required in the following
circumstances:
• Pre-employment (for drugs only);
• Randomly during employment;
• After an accident;
• If there is reasonable cause/
suspicion to believe that an individual
is under the influence of alcohol or
drugs while performing safety-sensitive
functions or within a certain period of
time before or after performing such
functions;
• Return-to-duty testing and followup testing before and after returning an
employee to duty who previously tested
positive for alcohol or drugs or refused
to submit to testing.
B1. For a program to be found
acceptable to the Administrator, should
the FAA require that testing be
conducted under all of the above
circumstances for which it is required in
the U.S.? If not, under what
circumstances should testing be
required?
2. Types of substances tested. 49
U.S.C. 44733(d)(2) requires that the
proposed rule include ‘‘alcohol and
controlled substances testing’’. The
substances that are tested in the United
States include alcohol, marijuana,
cocaine, opiates, phencyclidine (PCP),
and amphetamines. The FAA recognizes
that the drugs of concern in other
countries may vary depending upon
conditions in those countries. Therefore,
the FAA poses the following questions:
B2a. Should an acceptable program
require testing for, at a minimum, the
drugs for which the FAA requires
testing in the United States? If not,
please provide information on which
drugs should be tested for, at a
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minimum, to constitute an acceptable
program.
B2b. At what concentrations should a
test for alcohol, drugs, or their
metabolites be considered positive?
Should an acceptable program identify
set ceiling concentrations above which
tests must be considered positive? If so,
what should those levels be?
3. A mechanism that is an effective
deterrent to drug and alcohol misuse.
The FAA views random testing as an
effective deterrent because there is an
element of surprise. Employees subject
to random testing receive little notice
before they must report for testing.
Other countries or industry may have
developed other effective methods of
deterrence and some countries may
prohibit or significantly restrict the use
of random testing. The FAA poses the
following questions with respect to this
potential program element:
B3a. Does the country allow or require
random drug and/or alcohol testing? If
so, please describe the process.
B3b. If the country does not allow or
require random drug and/or alcohol
testing, are there laws to prohibit
random testing?
B3c. If random testing is not allowed
in a given country, what other methods
could be used to successfully deter
employees from misusing drugs or
alcohol while performing safetysensitive duties or within a certain
period of time before performing such
duties? How would such misuse be
detected?
4. Procedures that ensure the
integrity, identity, and proper analysis
of the collected specimen to ensure
accuracy of the test result. In the United
States, the U.S. Department of
Transportation has adopted a chain-ofcustody process developed by the U.S.
Department of Health and Human
Services (HHS) to document the
handling and storage of a specimen from
the time it is collected until the time it
is released to the testing facility. This
process, coupled with the FAA’s
requirement that testing programs in the
United States use a laboratory certified
by HHS, helps ensure the accuracy of
testing results. The FAA poses the
following questions with respect to this
potential program element:
B4a. What testing methods, if any, in
addition to those currently permitted
under part 120, should be permitted in
programs outside the United States?
B4b. What standards should
personnel and laboratories or other
facilities in foreign countries be
required to meet? Please address the
following matters:
• Personnel qualifications;
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• Measures to prevent adulteration,
substitution, or mistaken identification
of specimens;
• Measures to ensure drug and
alcohol testing information is only
released to authorized persons;
• Measures to determine whether
there is a legitimate medical explanation
for a positive test result;
• Other relevant considerations
(please specify).
B4c. HHS-certified laboratories are
not available outside the United States;
therefore, should a program be
acceptable if it allows the use of other
laboratories that have been certified by
DOT, another regulatory authority, or
international organization as meeting
equivalent or more stringent
international standards?
5. A means of ensuring that an
employee who returns to work [after
violating the law] is no longer misusing
alcohol or drugs. If an employee who
violated the drug or alcohol regulations
is permitted to return to work, it is
important to have a means for ensuring
that the employee is no longer misusing
alcohol or drugs and a means of
detecting such misuse if it recurs after
the employee returns to safety-sensitive
duties. The return-to-duty process in the
United States is described in the
Department of Transportation’s
regulations at 49 CFR part 40, subpart O.
The FAA poses the following questions
with respect to this potential program
element:
B5a. What are the minimum standards
that employees who have violated drug
and alcohol regulations should meet
before they return to performing safetysensitive maintenance functions?
B5b. If follow-up testing is not
permitted, what other methods would
ensure that an employee who has
previously tested positive for alcohol or
drugs does not misuse them again after
returning to safety-sensitive duties?
C. Existing Drug and Alcohol Testing
Programs in Other Countries
The FAA recognizes that existing drug
and alcohol testing programs in other
countries may take various forms and
must comply with the applicable laws
and regulations of those countries. In
some countries, drug and alcohol testing
programs may be established by
industry in accordance with regulations
promulgated by a government agency, as
is the case in the United States. In
others, a government agency may
administer a national drug and alcohol
testing program. In yet others, industry
participants may have voluntarily
established drug and alcohol testing
programs as a good business practice or
for competitive advantage in the
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marketplace without being required to
do so. In addition to the information
provided in part B above, the FAA
requests the information described
below about existing drug and alcohol
testing programs in other countries,
whether legally mandated or voluntarily
established. The FAA is interested in
both nationwide information for other
countries and information pertaining to
the testing programs of specific
companies or the members of an
association:
C 1. Which drugs are most pervasively
misused in the country? Please provide
data to support this answer.
C 2. Are testing programs in the
country:
a. Administered by a national
regulatory authority;
b. Required to be established by
industry participants under that
country’s laws and regulations;
c. Voluntarily established by industry
participants;
d. Other (please specify)?
C 3. Please describe the process that
is followed after an employee’s drug test
is confirmed positive or alcohol
concentration is confirmed to be above
the permitted limit, including at what
point an individual would be removed
from safety-sensitive duty.
C 4. If the country allows drug or
alcohol testing, what protections does
the country’s legal system provide for
the employee?
C 5. What are the potential
consequences in that country,
including, but not limited to,
enforcement action by the relevant
government authority, when an
individual who performs safetysensitive aviation duties tests positive
for alcohol or drugs?
D. Miscellaneous
D 1. Should the FAA include within
the scope of a proposed rule all
authorized persons performing safetysensitive maintenance functions on
aircraft operated by part 121 air carriers
in accordance with 14 CFR 43.17 ?
Please include the rationale for why
such personnel should or should not be
subject to testing in any comment.
IV. Regulatory Notices and Analyses
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A. Regulatory Evaluation
Changes to Federal regulations must
undergo several economic analyses.
First, Executive Order 12866 and
Executive Order 13563 direct that each
Federal agency shall 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
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of 1980 (Pub. L. 96–354) requires
agencies to analyze the economic
impact of regulatory changes on small
entities. Third, the Trade Agreements
Act (Pub. L. 96–39) 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 requires agencies to consider
international standards and, where
appropriate, that they be the basis of
U.S. standards. Fourth, the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4) 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 with base year of 1995).
This portion of the preamble
summarizes the FAA’s questions about
the economic impacts of a future
proposed rule.
Congress mandated that the FAA
propose a rule requiring that all
employees of part 145 repair stations
who perform safety-sensitive
maintenance functions on part 121 air
carriers’ aircraft be subject to an alcohol
and drug testing program that has been
determined acceptable by the
Administrator and is consistent with the
applicable laws of the country in which
the repair station is located. This
mandate requires the FAA to propose
drug and alcohol testing for employees
of part 145 repair stations located
outside the United States who perform
safety-sensitive maintenance functions
on aircraft operated by part 121 air
carriers. The FAA understands that the
implementation of such a regulation
would impose costs on industry, the
FAA, and perhaps other parties.
The FAA might also extend this
testing requirement to include all
authorized persons performing safetysensitive maintenance functions on
aircraft operated by part 121 air carriers
in accordance with 14 CFR § 43.17. It is
very difficult, however, for the FAA to
reliably estimate such costs at this time,
given the limited information about
other countries’ relevant laws and
regulations, existing drug and alcohol
testing programs in other countries, the
actual and potential costs associated
with conducting drug and alcohol
testing in other countries (which is
expected to vary), the cost of
establishing testing programs in
countries where they do not currently
exist, and other relevant information. To
help gauge the economic impact of a
proposed rule, the FAA is requesting
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14625
information from industry, as well as
from the government of countries as
described below. For all cost questions
in this ‘‘Regulatory Notices and
Analyses’’ section, please note who
bears or would bear the costs (e.g., the
employee; the air carrier for whom work
is performed; the covered maintenance
provider, a regulatory authority, other
(please specify)) in any response
provided.
In January 2006, the FAA issued a
final rule entitled Antidrug and Alcohol
Misuse Prevention Programs for
Personnel Engaged in Specified
Aviation Activities (71 FR 1666). That
rule amended the FAA’s regulations
governing drug and alcohol testing in
the United States to clarify that each
person who performs a safety-sensitive
function for a regulated employer by
contract, including by subcontract at
any tier, is subject to testing.
Consequently, the regulatory evaluation
for that final rule (hereinafter referred to
as the ‘‘2005 Regulatory Evaluation’’),
which was published in Docket No.:
FAA–2002–11301, addresses costs
associated with drug and alcohol testing
in the United States.
The FAA is providing information
from the 2005 Regulatory Evaluation to
provide the public with an
understanding of the types and level of
detail of information needed to
accurately estimate the economic
impact of a rule for drug and alcohol
testing of employees of covered
maintenance providers who perform
safety-sensitive maintenance functions
on aircraft operated by part 121 air
carriers. The FAA understands that the
costs associated with drug and alcohol
testing are likely to be different outside
the United States and may vary from
country to country. The FAA also
understands that the specific details of
drug and alcohol testing programs likely
vary from country to country; however,
the FAA expects that, for any drug and
alcohol testing program, there will be
costs associated with the testing
process, training and education,
developing and maintaining a testing
program, and keeping (and possibly
submitting) any documentation that
may be required by national regulatory
authorities or as part of a voluntary
program’s policies. The FAA requests
that commenters also provide
information about any other costs that
may be relevant. The FAA is interested
in data at the national level, from the
members of associations, and from
specific companies’ programs. There
were a number of basic assumptions
that the FAA made in the 2005
Regulatory Evaluation. The FAA
assumed the following:
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All employees who are subject to drug
and alcohol testing under FAA
regulations in the United States are
subject to the following types of tests:
pre-employment (for drugs only),
random, post-accident, reasonable
cause/suspicion, return-to-duty, and
follow-up. The 2005 Regulatory
Evaluation considered the cost of testing
to include the actual cost of the test, as
well as the cost of the employee’s time.
Please answer the following questions.
RE 1. For each year of the last 10
years, please provide the number of (a)
drug and (b) alcohol tests conducted on
aviation personnel who perform safetysensitive functions and the number of
positive tests, regardless of whether
maintenance personnel are currently
tested under the particular program
described. If maintenance personnel are
currently tested, please provide the
number of (a) drug and (b) alcohol tests
conducted on maintenance personnel
that perform safety-sensitive functions
and the number of positive tests for
such personnel separately. For an
example of the type of data that the FAA
seeks, see the table below from the 2005
Regulatory Evaluation.
specify))? If traveling to another
country, what is the distance from the
relevant country? How much time will
be spent traveling?
RE 5. What is the cost of (a) the drug
test and (b) the alcohol test per person?
Do or would the costs differ for different
categories of tests (i.e., pre-employment,
post-accident, reasonable cause/
suspicion, random, periodic, return-toduty, follow-up, or other (please
specify))? How long does it take for an
employee to complete each of these
tests? If screening tests for (a) drugs or
(b) alcohol are or would be conducted,
followed by confirmatory testing when
the screening test is positive, what are
or would be the costs associated with
conducting (a) the screening test and (b)
the confirmatory test?
RE 6. How many maintenance
personnel in the relevant country or in
a particular company or group of
companies perform safety-sensitive
maintenance functions? How many of
them perform safety-sensitive
maintenance functions on aircraft
operated by part 121 air carriers (and are
not directly employed by such air
carriers)? How many are subject to drug
and alcohol testing?
RE 7. How many new employees are
hired to perform safety-sensitive
maintenance functions per year? How
many maintenance employees who
perform safety-sensitive functions leave
per year? The FAA will need to be able
to estimate testing costs in future years.
See the table below for an example from
the 2005 Regulatory Evaluation.
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Testing Costs
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• Time for a drug test (hours)—0.75;
• Time for an alcohol test (hours)—
0.75;
• One instructor for every 20
supervisors and/or employees to be
trained
• Maintenance employee salary—
$33.07/hour;
• Maintenance supervisor salary—
$39.68/hour;
• Instructor—$36.37/hour;
• Clerical—$18.62/hour;
The FAA requests comments on these
assumptions.
RE 2. What types of testing are
required for (a) drugs and (b) alcohol
(e.g., pre-employment, post-accident,
reasonable cause/suspicion, random,
return-to-duty, follow-up, other (please
specify))?
RE 3. What types of personnel are
subject to (a) drug and (b) alcohol
testing in the relevant country,
company, or among the members of the
association (e.g., pilots, flight
attendants, air traffic controllers, flight
dispatchers, maintenance personnel,
other (please specify))?
RE 4. Is drug and alcohol testing
currently conducted in the relevant
country? If not, how would a
requirement to drug and alcohol test be
met (i.e. travel to a different country,
implement a testing program within the
relevant country, or other (please
tkelley on DSK3SPTVN1PROD with PROPOSALS
• Maintenance providers affected by
that rule would develop and implement
their own programs, instead of being
covered under another company’s
program or using a service agent with
already-established procedures.
• An additional 2.5% of maintenance
workers would be subject to the
antidrug and alcohol misuse prevention
programs under that rule.
• The number of employees in the
maintenance sector grows at 1.5% per
year.
• There would be two supervisors per
contractor and that the attrition rate for
mechanics was approximately 10% per
year.
The FAA requests comments on these
assumptions.
The FAA also assumed the following
values:
• Price of a drug test—$45;
• Price of an alcohol test—$34;
RE 7. What is or would be the annual
cost per person of each category of staff
required to conduct testing (collection
personnel, laboratory personnel, other
(please specify))?
tkelley on DSK3SPTVN1PROD with PROPOSALS
Training and Education Costs
In the United States, for each drug
and alcohol testing program, the
employer must train employees and
supervisors on the effects and
consequences of drug use on personal
health, safety, and work environment, as
well as the manifestations and
behavioral cues that may indicate drug
use and abuse. The regulations do not
specify the amount of time associated
with this training; in the 2005
Regulatory Evaluation, the FAA
assumed 30 minutes.
Under current regulations,
supervisors who will make reasonable
cause/suspicion determinations must
receive at least 60 minutes for each
program (for a total of 120 minutes).
Supervisors must also receive recurrent
training under the FAA’s drug testing
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rules. The rules do not say when the
recurrent training must occur or how
long it must be; however, the FAA
recommends recurrent training every 12
to 18 months and that it include an
element on alcohol testing. For the 2005
Regulatory Evaluation, the FAA
assumed that the recurrent training
occurs every 12 months and takes 60
minutes.
Please answer the following questions.
RE 8. What are or would be the initial
and recurrent training and education
costs, on a per person basis? For:
a. Employees subject to testing,
b. Supervisors,
c. Persons authorized to determine
whether there is reasonable cause/
suspicion to believe that an employee
may be under the influence of alcohol
or drugs while performing, or within a
certain amount of time before or after
performing, a safety-sensitive function
and that the employee should be tested
on that basis,
d. Specimen collectors,
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e. Persons responsible for analyzing
specimens for alcohol, drugs, or their
metabolites,
f. Persons involved in determining or
recommending the appropriate course of
treatment and/or education for an
employee who has tested positive for
drugs or alcohol,
g. Other personnel involved in the
drug or alcohol testing program (please
specify)?
RE 9. How many personnel in
category (g) of question RE8 receive or
would receive (1) initial and (2)
recurrent training and/or education
annually?
RE 10. What was or would be the cost
of developing any necessary training
program initially, including materials,
and what is or would be the annual cost,
including materials, of maintaining it?
What types of training materials are or
would be required?
RE 11. What are or would be the
annual costs of the staff required to
conduct training? How many staff
would be required to conduct training?
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RE 12. How often is/must/would
recurrent training be conducted?
Program Development and Maintenance
Costs
Under the rule for which the 2005
Regulatory Evaluation was conducted, it
was assumed that each affected
maintenance provider would have to
devote resources to developing drug and
alcohol testing programs. In addition,
each affected maintenance provider
would have to spend time to produce
information required to either obtain an
operations specification for its part 145
certificate or register its drug and
alcohol program with the FAA. At the
FAA, the submitted information would
have to be processed and entered into
the appropriate database.
In calculating program development
costs in the 2005 Regulatory Evaluation,
the FAA assumed 16 hours for start-up
program development. The FAA
estimated that, for affected maintenance
providers that chose to register with the
FAA, it would take each one 20 minutes
at $21 per hour to gather the required
information and submit it to the FAA.
At the FAA, the submitted information
has to be processed. In the 2005
Regulatory Evaluation, the FAA
estimated that an administrative
assistant, an FG–7 being paid at about
$25.00 per hour, would enter this
information into a database. The FAA
assumed that administrative assistants
would need 10 minutes to input the
information.
Please answer the following questions.
RE 13. How much would it cost
(besides training costs already
addressed above or cost to do the actual
testing) to develop a drug and alcohol
testing program? What would be the
annual program maintenance costs
(besides training costs already
addressed above)? What items are
included in both of these types of costs?
RE 14. Is the drug and alcohol testing
program regulated by an agency of a
government? If so, how much time per
year is required to prepare and maintain
required documentation and submit
information to the responsible
regulatory authority? What information
items must be submitted? How long
does it take for the company to gather
this information? How long does it take
for the responsible regulatory authority
to process the submission? Who at the
responsible regulatory authority
processes these submissions?
RE 15. How many submissions must
be made per year?
RE 16. What are or would be the costs
of staff required to evaluate employees
who have tested positive for drugs or
alcohol and to provide any needed
education and/or treatment? What
would the cost of treatment be, in terms
of employees time and opportunity
cost? How many such staff would be
needed? What are or would be the other
costs associated with any program of
treatment and/or education?
RE 17. What are or would be the costs
for a laboratory in the relevant country
to obtain HHS, its equivalent, or more
stringent certification, including both
fees and the costs of any actions that
would need to be taken to meet the
applicable certification standards?
Please specify the certification
standards being used as a point of
reference in any comments.
RE 18. Is shipping specimens to an
existing HHS-certified or DOT approved
laboratory a reasonable alternative?
What would be the costs associated with
packaging and shipping specimens to
one of the existing HHS-certified
laboratories for testing?
• Refusal to submit to a required drug
or alcohol test (the company must also
notify the FAA); and
• Medical Review Officer (MRO)
reports of verified positive drug test
results for employees holding airman
medical certificates issued by the FAA
under 14 CFR part 67. (Both the MRO
and the company must also notify the
FAA.)
Please answer the following questions.
RE 19. What are or would be the
annual recordkeeping or other
documentation costs associated with the
drug and/or alcohol testing program?
RE 20. Who maintains or would
maintain any required documentation
(e.g., employer, government agency,
other (please specify))?
RE 21. What documentation is or
would be required to be maintained by
and/or submitted to the responsible
regulatory agency? How much time
would be needed to prepare and/or
submit the documentation?
RE 22. What is the format for
recordkeeping?
Annual Documentation Costs
The FAA indicated in the 2005
Regulatory Evaluation that it believed it
was possible that illegal drug use or
alcohol misuse by members of the
aviation community may have
contributed to additional accidents or
incidents. The FAA acknowledged the
fact that there had not been any aviation
accidents directly attributed to a
maintenance worker misusing or
abusing drugs or alcohol.5 However, as
the table below shows, maintenance
employees had among the highest
positive rates on alcohol and drug tests
among aviation-related employees, so
the connection between illegal drug use
and alcohol misuse and maintenancerelated accidents certainly could exist.
The FAA stated that it was important to
note that not only are maintenance
workers rarely tested after an accident
(only 0.05% and 0.09% of maintenance
workers are administered post-accident
alcohol and drug tests, respectively), but
it would be difficult to directly tie poor
maintenance work, due to inappropriate
drug use or alcohol misuse, to an
accident that may occur weeks or
months later, particularly with the
widespread use of contract workers at
many different tiers.
The FAA’s drug testing regulations
require each company to document both
the initial and recurrent training for
supervisory personnel who make
reasonable cause determinations. In the
2005 Regulatory Evaluation, the FAA
assumed that the cost of this
documentation is about $1.30 per
record, which included record creation,
filing, and storage. The same sort of
documentation is needed for the
supervisors who determine whether
reasonable suspicion exists concerning
probable alcohol misuse. The FAA
assumed the cost of this documentation
is also about $1.30 per record. The
FAA’s existing regulations require
documentation of such things as:
• Training of employees in the
requirements of the antidrug program;
• All reasonable cause/suspicion
cases;
• If a post-accident alcohol test is not
administered within 2 hours following
the accident, the reasons the test was
not promptly administered;
• If a post-accident alcohol test is not
administered within 8 hours following
the accident, the reasons the test was
not promptly administered;
Accident Prevention Benefits
5 That analysis was limited to maintenance
workers because that was the population affected by
that rulemaking.
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The 2005 Regulatory Evaluation
indicated that, while there had been no
documented aviation accidents in the
United States in the time period
analyzed that were directly attributed to
misuse or abuse of drugs or alcohol by
maintenance personnel, the FAA
believed it was possible that such
misuse or abuse may have contributed
to aviation-related accidents. The FAA
believed it was prudent to base the
estimated benefits of the final rule on
avoiding one part 135 accidents over the
next 10 years, thus avoiding a total of
5 fatalities and a destroyed or damaged
airplane. The FAA estimated the
benefits of avoided fatalities at $15
million. This number of accidents,
fatalities, and destroyed airplanes was
less than 1% of all maintenance-related
accidents that had occurred; the FAA
considered these benefits to be
reasonable. The total benefits in the
2005 regulatory evaluation were
calculated by assuming an equally likely
chance of avoiding these accidents in
each of the next 10 years. Total benefits
summed to $15.07 million ($10.59
million, discounted).
Please answer the following questions.
RE 22. What benefits has the relevant
country/company seen from drug and
alcohol testing?
RE 23. Are you aware of any accidents
in which drug or alcohol misuse by
safety-sensitive aviation personnel (e.g.
pilots, flight attendants, maintenance
personnel, air traffic controllers, flight
dispatchers, other (please specify)) may
have caused or contributed to the
accident? Please describe the
circumstances and identify the type of
safety-sensitive personnel whose drug
or alcohol misuse may have caused or
contributed to the accident. Were there
any fatalities, injuries, or damage to
aircraft? If so, please describe. How
many confirmed positive drug and
alcohol tests occur annually in the
country/company?
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RE 24. Have industry participants
experienced a savings in insurance
premiums as a result of drug and
alcohol testing?
B. International Compatibility
In keeping with the United States’
obligations under the Chicago
Convention, it is FAA policy to conform
to ICAO Standards and Recommended
Practices to the maximum extent
practicable. The FAA has determined
that there are no ICAO Standards and
Recommended Practices that exactly
correspond to the regulations being
considered for proposal, as ICAO
neither requires nor recommends that
Member States implement testing of
aviation personnel with safety-sensitive
responsibilities for alcohol or drugs. As
discussed in the Background section of
this preamble, however, there are a
number of ICAO standards and
recommended practices that address the
misuse of drugs and alcohol by such
personnel and recognize the potential
hazard that such substance misuse may
pose to aviation safety.
C. 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 ANPRM
qualifies for the categorical exclusion
identified in paragraph 312d and
involves no extraordinary
circumstances.
V. Executive Order Determinations
A. Executive Order 12866, Regulatory
Planning and Review, Executive Order
13563, Improving Regulation and
Regulatory Review and DOT Regulatory
Policies and Procedures
The FAA is soliciting comments on
the potential costs and benefits of the
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14629
initiatives in the ANPRM. This ANPRM
has been drafted and reviewed in
accordance with Executive Order 12866
and Executive Order 13563. This
ANPRM has been reviewed by the
Office of Management and Budget and
is considered ‘‘significant’’ under the
Department of Transportation’s
Regulatory Policies and Procedures.
B. Executive Order 13132, Federalism
The FAA has analyzed this ANPRM
under the principles and criteria of
Executive Order 13132, Federalism. The
agency has determined that this action
would not have a substantial direct
effect on the States, or the relationship
between the Federal Government and
the States, or on the distribution of
power and responsibilities among the
various levels of government, and,
therefore, would not have Federalism
implications.
C. Executive Order 13211, Regulations
That Significantly Affect Energy Supply,
Distribution, or Use
The FAA analyzed this ANPRM under
Executive Order 13211, Actions
Concerning Regulations that
Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). The
agency has determined that it would not
be a ‘‘significant energy action’’ under
the executive order and likely would
not have a significant adverse effect on
the supply, distribution, or use of
energy.
VI. Additional Information
A. Comments Invited
The FAA invites interested persons to
participate in this rulemaking by
submitting written comments, data, or
views. The Agency also invites
comments relating to the economic,
environmental, energy, or federalism
impacts that might result from adopting
the proposals in this document. The
most helpful comments reference a
specific portion of the proposal, or a
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specific question posed by the FAA, and
fully explain the rationale for any
comment, include supporting data, if
applicable. To ensure the docket does
not contain duplicate comments,
commenters should send only one copy
of written comments, or if comments are
filed electronically, commenters should
submit only one time. The FAA requests
that all comments be submitted in
English.
The FAA will file in the docket all
comments it receives, as well as a report
summarizing each substantive public
contact with FAA personnel concerning
this ANPRM. Before acting on this
ANPRM, the FAA will consider all
comments it receives on or before the
closing date for comments. The FAA
will consider comments filed after the
comment period has closed if it is
possible to do so without incurring
expense or delay. The Agency may
change its potential proposals in light of
the comments it receives.
Proprietary or Confidential Business
Information: Do not file proprietary or
confidential business information in the
docket. Such information must be sent
or delivered directly to any of the
persons identified in the FOR FURTHER
INFORMATION CONTACT section of this
document, and marked as proprietary or
confidential. If submitting information
on a disk or CD ROM, mark the outside
of the disk or CD ROM, and identify
electronically within the disk or CD
ROM the specific information that is
proprietary or confidential.
Under 14 CFR 11.35(b), if the FAA is
aware of proprietary information filed
with a comment, the Agency does not
place it in the docket. It is held in a
separate file to which the public does
not have access, and the FAA places a
note in the docket that it has received
it. If the FAA receives a request to
examine or copy this information, it
treats it as any other request under the
Freedom of Information Act (5 U.S.C.
552). The FAA processes such a request
under Department of Transportation
procedures found in 49 CFR part 7.
B. Availability of Rulemaking
Documents
Electronic copies of rulemaking
documents may be obtained from the
Internet by—
1. Searching the Federal eRulemaking
Portal (https://www.regulations.gov);
2. Visiting the FAA’s Regulations and
Policies Web page at https://
www.faa.gov/regulations_policies or
3. Accessing the Government Printing
Office’s Federal Digital System at
https://www.gpo.gov/fdsys/.
Copies may also be obtained by
sending a request to the Federal
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Aviation Administration, Office of
Rulemaking, ARM–1, 800 Independence
Avenue SW., Washington, DC 20591, or
by calling (202) 267–9680. Commenters
must identify the docket or notice
number of this rulemaking.
All documents the FAA considered in
developing this ANPRM, including
economic analyses and technical
reports, may be accessed from the
Internet through the Federal
eRulemaking Portal referenced in item
(1) above.
Issued in Washington, DC, under the
authority set forth in 49 U.S.C. 44733 on:
March 5, 2014.
James R. Fraser,
Federal Air Surgeon.
[FR Doc. 2014–05653 Filed 3–14–14; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 514
[Docket No. FDA–2014–N–0108]
New Animal Drug Applications;
Confidentiality of Data and Information
in a New Animal Drug Application File
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA or Agency) is
proposing to amend its regulation
regarding the confidentiality of data and
information in and about new animal
drug application files to change when
certain approval-related information
would be disclosed by the Agency. This
change would ensure that the Agency is
able to update its list of approved new
animal drug products within the
statutory timeframe. It would also
permit more timely public disclosure of
approval-related information, increasing
the transparency of FDA decision
making in the approval of new animal
drugs.
DATES: Submit either electronic or
written comments by June 2, 2014. If
FDA receives any significant adverse
comments, the Agency will publish a
document in the Federal Register
withdrawing the direct final rule within
30 days after the comment period ends.
FDA will then proceed to respond to
comments under this proposed rule
using the usual notice and comment
procedures.
SUMMARY:
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You may submit comments,
identified by Docket No. FDA–2014–N–
0108, by any of the following methods:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Mail/Hand Delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2014–N–0108 for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number(s), found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Scott Fontana, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0656.
SUPPLEMENTARY INFORMATION:
I. Background
Section 512(i) (21 U.S.C. 360b(i)) was
added to the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) by the
Animal Drug Amendments of 1968
(Pub. L. 90–399). Section 512(i) requires
the conditions and indications of use of
a new animal drug to be published in
the Federal Register upon approval of a
new animal drug application (NADA)
filed under section 512(b) of the FD&C
Act.
In 1974, FDA revised its regulations
regarding the confidentiality of
information in applications in § 135.33a
(21 CFR 135.33a) to include provisions
of the Freedom of Information Act (Pub.
L. 89–487). That revision established
that public disclosure by the Agency of
certain data and information in an
NADA file could not occur before the
Federal Register notice of approval
E:\FR\FM\17MRP1.SGM
17MRP1
Agencies
[Federal Register Volume 79, Number 51 (Monday, March 17, 2014)]
[Proposed Rules]
[Pages 14621-14630]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05653]
=======================================================================
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 120
[Docket No.: FAA-2012-1058; Notice No. 14-02]
RIN 2120-AK09
Drug and Alcohol Testing of Certain Maintenance Provider
Employees Located Outside of the United States
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Advance notice of proposed rulemaking (ANPRM).
-----------------------------------------------------------------------
SUMMARY: The FAA is considering amending its drug and alcohol testing
regulations to require drug and alcohol testing of certain maintenance
personnel outside the United States. Specifically, the FAA is
considering requiring certain air carriers to ensure that all employees
of certificated repair stations, and certain other maintenance
organizations that are located outside the United States, who perform
safety-sensitive maintenance functions on aircraft operated by that air
carrier are subject to a drug and alcohol testing program that has been
determined acceptable by the FAA Administrator and is consistent with
the applicable laws of the country in which the repair station is
located. Safety-sensitive maintenance functions include aircraft
maintenance and preventive maintenance duties. This action is necessary
to address a statutory mandate. The FAA has determined that it needs
additional information to develop a proposed rule and assess its likely
economic impact. This notice invites comments on a variety of issues
related to proposing drug and alcohol testing requirements for the
relevant employees of covered maintenance providers.
DATES: Send comments on or before May 16, 2014.
ADDRESSES: Send comments identified by docket number FAA-2012-1058
using any of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov and follow the online instructions for sending your
comments electronically.
Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
Fax: Fax comments to Docket Operations at (202) 493-2251.
Privacy: In accordance with 5 USC 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy. https://DocketsInfo.dot.gov.
Docket: Background documents or comments received may be read at
https://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Rafael Ramos, Office of Aerospace Medicine, Drug
Abatement Division, AAM-800, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone (202) 267-
8442; facsimile (202) 267-5200; email: drugabatement@faa.gov.
For legal questions concerning this action, contact Neal O'Hara,
Attorney, Regulations Division, AGC-240, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone (202) 267-5348.
For cost and benefit questions concerning this action, contact
Nicole Nance, Office of Aviation Policy and Plans, APO-300, Federal
Aviation Administration, 800 Independence Avenue SW., Washington, DC
20591; telephone (202) 267-3311.
SUPPLEMENTARY INFORMATION:
Comments Invited
See the ``Additional Information'' section for information on how
to comment on this ANPRM and how the FAA will handle comments received.
The ``Additional Information'' section also contains related
information about the docket, privacy, and the handling of proprietary
or confidential business information. In addition, there is information
on obtaining copies of related rulemaking documents.
Authority for This Rulemaking
The FAA's authority to issue rules on aviation safety is found in
title 49 of the United States Code (U.S.C.). 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. In carrying out part A (Air Commerce and Safety) of subtitle
VII, the Administrator is directed to act consistently with obligations
of the United States Government under an international agreement and to
consider applicable laws and requirements of a foreign country. See 49
U.S.C. 40105(b)(1)-(2). Additionally, section 308(d)(2) of the FAA
Modernization and Reform Act of 2012 (the Act), 49 U.S.C. 44733
requires that:
Not later than 1 year after the date of enactment of this
section, the [FAA] Administrator shall promulgate a proposed rule
requiring that all part 145 repair station employees responsible for
safety-sensitive maintenance functions on part 121 air carrier
aircraft are subject to an alcohol and controlled substances testing
program determined acceptable by the Administrator and consistent
with the applicable laws of the country in which the repair station
is located.\1\
---------------------------------------------------------------------------
\1\ Except when quoting the text of section 308 of the Act, the
FAA uses the term ``drug'' rather than ``controlled substance'' in
this ANPRM, because an illegal substance in the United States may be
legal to use in the country in which a covered maintenance provider
is located.
In 49 U.S.C. 44733(d)(2) Congress did not address employees of
maintenance providers located outside the United States that are not
certificated by the FAA. However, authorized persons performing safety-
sensitive maintenance functions on aircraft operated by part 121 air
carriers in accordance with 14 CFR 43.17 are substantially similar to
those employees of part 145 repair stations located outside the United
States for whom the FAA has been directed to propose drug and alcohol
testing. Because of their substantial similarity, under the authority
of 49 U.S.C. 44701(a)(5), which requires the Administrator to promote
the safe flight of civil aircraft in air commerce by prescribing
regulations and minimum standards for practices, methods, and
procedures that the Administrator finds necessary for safety in air
commerce and national security, we request comment on the application
of these requirements to this group/category of authorized persons.
[[Page 14622]]
I. Overview of Advance Notice of Proposed Rulemaking (ANPRM)
The Act requires the FAA to propose alcohol and drug testing
requirements for employees of part 145 repair stations located outside
the United States who perform safety-sensitive maintenance functions on
aircraft operated by part 121 air carriers, as the FAA currently does
not require drug or alcohol testing for such personnel. Currently, as
required under 14 CFR part 120, employees performing aircraft
maintenance and preventive maintenance duties on part 121, 135 or
91.147 certificated air craft within the U.S. are required to be
subject to drug and alcohol testing. The FAA believes Congress intended
that preventive maintenance is a safety-sensitive maintenance function
as currently described under 14 CFR part 120, therefore safety-
sensitive maintenance functions include both aircraft maintenance and
preventive maintenance duties.\2\
---------------------------------------------------------------------------
\2\ Alcohol and drug testing of employees of part 145 repair
stations located in the United States who perform safety-sensitive
maintenance functions on aircraft operated by part 121 air carriers
is already required under 14 CFR part 120. The FAA does not
anticipate making any changes as part of this rulemaking to its drug
and alcohol testing requirements that apply to safety-sensitive
personnel within the United States.
---------------------------------------------------------------------------
While Congress did not address maintenance providers that are not
certificated by the FAA in 49 U.S.C. 44733(d)(2), authorized persons
performing safety-sensitive maintenance functions on aircraft operated
by part 121 air carriers in accordance with 14 CFR 43.17, are
substantially similar to the employees of part 145 repair stations in
other countries for whom the FAA must propose drug and alcohol testing.
Therefore, the FAA is also considering whether to require each part 121
air carrier to ensure that authorized persons performing safety-
sensitive maintenance functions on aircraft operated by that part 121
air carrier in accordance with 14 CFR 43.17, and is not also a
certificated part 145 repair station, are subject to drug and alcohol
testing programs that meet the same or similar requirements as programs
for their counterparts at part 145 repair stations located outside the
United States.
Currently, there are approximately 120 part 145 repair stations
located outside the United States whose employees perform safety-
sensitive maintenance functions on aircraft operated by part 121 air
carriers. There are also organizations in one other country outside the
United States that are not part 145 repair stations, but whose
employees perform safety-sensitive maintenance functions on aircraft
operated by part 121 air carriers in accordance with 14 CFR 43.17.
II. Background
A. Statement of the Issue
The FAA's drug and alcohol testing regulations, contained in 14 CFR
part 120, do not extend to companies or individuals who perform safety-
sensitive functions, including, but not limited to, aircraft
maintenance and preventive maintenance, outside of the United States.
They currently apply to all air carriers and operators authorized to
conduct operations under part 121 or part 135; all air traffic control
facilities not operated by the FAA or by or under contract to the U.S.
military; all air tour operators as defined in 14 CFR 91.147; and all
part 145 certificate holders and contractors who employ individuals who
perform, either directly or by contract, including subcontract at any
tier, any of the following safety-sensitive functions: Flight
crewmember duties, flight attendant duties, flight instruction duties,
aircraft dispatcher duties, aircraft maintenance and preventive
maintenance duties, ground security coordinator duties, aviation
screening duties, air traffic control duties. Additionally, the
regulations do not permit any part of the testing process, including
specimen collection, to be conducted outside the United States. As
described above, the Act requires that the FAA propose extending drug
and alcohol testing to employees of part 145 repair stations located
outside the United States who perform safety-sensitive maintenance
functions on part 121 air carrier aircraft in a manner consistent with
local laws.
B. International Civil Aviation Organization (ICAO) Standards and
Recommended Practices
International Civil Aviation Organization (ICAO) standards do not
presently require ICAO Member States to establish (or direct industry
to establish) testing programs to deter or detect inappropriate drug
and alcohol use by aviation personnel with safety-sensitive
responsibilities. However, a number of ICAO standards and recommended
practices address misuse of drugs and alcohol by aviation personnel and
recognize the potential hazard that such misuse may pose to aviation
safety. For example, the recommended practice in paragraph 1.2.7.3 of
Annex 1 (Personnel Licensing) to the Convention on International Civil
Aviation (the ``Chicago Convention''), states that ICAO Member States
``. . . should ensure, as far as practicable, that all licen[s]e
holders who engage in any kind of problematic use of substances are
identified and removed from their safety-critical functions.'' ICAO
further recommends that ``[r]eturn to the safety-critical functions may
be considered after successful treatment or, in cases where no
treatment is necessary, after cessation of the problematic use of
substances and upon determination that the person's continued
performance of the function is unlikely to jeopardize safety.'' In
addition, the standard in paragraph 2.5 of Annex 2 (Rules of the Air)
to the Chicago Convention states that ``[n]o person whose function is
critical to the safety of aviation (safety-sensitive personnel) shall
undertake that function while under the influence of any psychoactive
substance, by reason of which human performance is impaired. No such
person shall engage in any kind of problematic use of substances.'' See
also paragraphs 1.2.6, 1.2.7, 6.3.2.2, 6.4.2.2, and 6.5.2.2 of Annex 1
to the Chicago Convention.
C. History
The FAA's original drug testing rule, published in 1988 (53 FR
47024), required drug testing of certain aviation personnel, including
some that performed safety-sensitive functions outside the United
States. However, the effective date of the rule with respect to testing
outside the territory of the United States was deferred on a number of
occasions to permit related negotiations with governments and
international organizations to continue in an orderly and effective
fashion. In 1994, the FAA published two final rules related to drug and
alcohol testing. Alcohol Misuse Prevention Program for Personnel
Engaged in Specified Aviation Activities (59 FR 7380) established the
FAA's alcohol testing requirements. The alcohol testing rule was not
extended to employees located outside the territory of the United
States due to significant logistical issues and possible conflicts with
local laws. Anti-Drug Program for Personnel Engaged in Specified
Aviation Activities (59 FR 42922) amended certain provisions of the
existing FAA drug testing rules to comply with the requirements of the
Omnibus Transportation Employee Testing Act of 1991. The drug testing
requirements were not extended to employees located outside of United
States territory due to significant practical and legal concerns.
Rather, the rule specifically stated that no employee located outside
of the United States would be tested for drugs. Additionally, in 1994,
the FAA published a Notice of Proposed Rulemaking (NPRM), Antidrug
Program and Alcohol Misuse
[[Page 14623]]
Prevention Program for Employees of Foreign Air Carriers Engaged in
Specified Aviation Activities, to address requirements in the Omnibus
Transportation Employee Testing Act of 1991. This NPRM required foreign
air carriers operating into the U.S. to implement testing programs like
those required of U.S. air carriers unless ``multilateral action was
taken to support an international aviation environment free of
substance abuse''. However, in 2000, the FAA withdrew the NPRM stating,
``For the foregoing reasons, the FAA is withdrawing the rulemaking
proposed on February 15, 1994, and is leaving within the purview of
each government the method chosen to respond to the ICAO initiatives.
We will continue to view a multilateral response as the best approach
to evolving issues in the substance abuse arena. Should the FAA
subsequently determine, however, that the scope of the threat of
substance abuse is not being adequately addressed by the international
community, the FAA will take appropriate action, including the possible
re-initiation of this rulemaking.''
D. Related Actions
Under 49 U.S.C. 44733(d)(1), Congress mandated that the Secretary
of State and the Secretary of Transportation, acting jointly, request
the governments of countries that are members of ICAO to establish
international standards for alcohol and drug testing of persons that
perform safety-sensitive maintenance functions on commercial air
carrier aircraft. The FAA strongly supports the development of such
international standards and believes that they would help deter and
detect drug and alcohol use that could compromise aviation safety.
III. Discussion of Proposals Under Consideration
Although ICAO standards and many countries' aviation regulations
prohibit the use of drugs and alcohol by certain aviation personnel in
circumstances in which such use may threaten aviation safety, many
countries either do not require testing of such personnel to verify
compliance or do not extend such testing to maintenance personnel.
Congress, however, has now enacted legislation that requires the FAA to
propose a rule requiring that all Part 145 repair station employees
responsible for safety-sensitive maintenance functions on part 121 air
carrier aircraft, not just those in the United States, be subject to a
drug and alcohol testing program that is acceptable to the
Administrator and consistent with the applicable laws of the country in
which the repair station is located.
The FAA is aware, however, that establishing drug and alcohol
testing requirements for such personnel presents complex practical and
legal issues and could impose potentially significant costs on
industry. Therefore, the FAA is issuing this ANPRM, rather than an
NPRM, to seek comments from the public, as well as interested
governments, to help inform the development of a proposed rule and the
analysis of its economic impact.
The FAA expects to propose to allow the testing process to take
place outside the United States.\3\ Any part of the testing process
conducted outside the United States would need to be both acceptable to
the Administrator and permitted under the applicable laws and
regulations of the relevant foreign country or countries. The FAA
believes that it would be less expensive and logistically simpler to
conduct testing for the relevant employees of covered maintenance
providers in the country where the covered maintenance provider is
located or possibly in a nearby country.
---------------------------------------------------------------------------
\3\ For example, suitable laboratory facilities for analyzing
specimens would need to be available.
---------------------------------------------------------------------------
The FAA understands that other countries may have a wide variety of
laws and regulations concerning the use of and testing for alcohol and
drugs. The FAA further understands that other countries' laws and
regulations concerning other matters, such as personal privacy and
employment, may affect whether and under what circumstances drug and
alcohol testing may be conducted in those countries. Some countries
might need to pass authorizing legislation before they could permit
testing within their borders. The FAA also recognizes the diversity of
policy, moral, and religious views that exist internationally regarding
drug and alcohol use and testing.
The FAA seeks input from the public and interested governments to
help inform the development of a proposed rule and the analysis of its
economic impact. In responding to the requests for comment below, the
FAA asks that commenters distinguish between responses relating to
alcohol testing and those relating to drug testing, if the same comment
does not apply to both.
A. Foreign Countries Laws and Regulations
To help the FAA expand its understanding of the laws and
regulations of other countries that bear on drug and alcohol testing,
the FAA requests the information described below regarding countries in
which covered maintenance providers are located. It would be
particularly helpful to receive the requested information regarding the
countries' laws and regulations from the responsible government
authorities of the relevant country, although private parties are also
encouraged to provide information.
A 1. Is drug and alcohol testing of any aviation personnel required
in that country, and, if so, for what categories of aviation personnel
(e.g., pilots, flight attendants, maintenance personnel, flight
dispatchers, others (please specify))?
A 2. Please provide an explanation of laws and regulations on other
subjects, such as personal privacy or employment, which may affect the
permissibility of drug and alcohol testing in the country, the
circumstances under which such testing may be conducted, or the manner
in which it may be conducted. Please include information on which
categories of aviation personnel are subject to these requirements
(e.g., pilots, flight attendants, maintenance personnel, flight
dispatchers, others (please specify)). English language copies of the
applicable laws and regulations would be greatly appreciated.
A 3. What types of testing are (a) permitted and (b) required under
the laws and regulations of the country? Please address the following
testing by type:
a. Pre-employment testing;
b. Random testing during employment;
c. Periodic testing during employment;
d. Testing based on a reasonable cause/suspicion that an employee
is under the influence of alcohol or drugs while performing a safety-
sensitive function or within a certain period of time before or after
performing such a function;
e. Post-accident testing;
f. Return-to-duty and follow-up testing of individuals who have
previously tested positive for alcohol or drugs;
g. Any other drug or alcohol testing (please specify)?
A 4. Should an FAA regulation include a provision to allow
regulated parties to apply for a waiver \4\ if any provision conflicts
with a foreign law or regulation? Please state the rationale for
[[Page 14624]]
why such a waiver provision should or should not be included.
---------------------------------------------------------------------------
\4\ Based on the waiver provision in the Office of the Secretary
of Transportation's non-discrimination on the basis of disability in
air travel regulations described in 14 CFR Sec. 382.9.
---------------------------------------------------------------------------
B. Program Elements of Acceptable Drug and Alcohol Testing
The FAA is considering addressing the program elements listed below
in establishing the criteria for determining whether a drug and alcohol
testing program is acceptable to the Administrator. Questions
associated with each program element are listed below.
1. A defined set of circumstances under which testing is conducted
for alcohol and the most pervasive drugs of abuse in the relevant
country. Under the FAA's current domestic drug and alcohol testing
regulations for persons performing flight crewmember duties, flight
attendant duties, flight instruction duties, aircraft dispatcher
duties, aircraft maintenance and preventive maintenance duties, ground
security coordinator duties, aviation screening duties, air traffic
control duties testing is required in the following circumstances:
Pre-employment (for drugs only);
Randomly during employment;
After an accident;
If there is reasonable cause/suspicion to believe that an
individual is under the influence of alcohol or drugs while performing
safety-sensitive functions or within a certain period of time before or
after performing such functions;
Return-to-duty testing and follow-up testing before and
after returning an employee to duty who previously tested positive for
alcohol or drugs or refused to submit to testing.
B1. For a program to be found acceptable to the Administrator,
should the FAA require that testing be conducted under all of the above
circumstances for which it is required in the U.S.? If not, under what
circumstances should testing be required?
2. Types of substances tested. 49 U.S.C. 44733(d)(2) requires that
the proposed rule include ``alcohol and controlled substances
testing''. The substances that are tested in the United States include
alcohol, marijuana, cocaine, opiates, phencyclidine (PCP), and
amphetamines. The FAA recognizes that the drugs of concern in other
countries may vary depending upon conditions in those countries.
Therefore, the FAA poses the following questions:
B2a. Should an acceptable program require testing for, at a
minimum, the drugs for which the FAA requires testing in the United
States? If not, please provide information on which drugs should be
tested for, at a minimum, to constitute an acceptable program.
B2b. At what concentrations should a test for alcohol, drugs, or
their metabolites be considered positive? Should an acceptable program
identify set ceiling concentrations above which tests must be
considered positive? If so, what should those levels be?
3. A mechanism that is an effective deterrent to drug and alcohol
misuse. The FAA views random testing as an effective deterrent because
there is an element of surprise. Employees subject to random testing
receive little notice before they must report for testing. Other
countries or industry may have developed other effective methods of
deterrence and some countries may prohibit or significantly restrict
the use of random testing. The FAA poses the following questions with
respect to this potential program element:
B3a. Does the country allow or require random drug and/or alcohol
testing? If so, please describe the process.
B3b. If the country does not allow or require random drug and/or
alcohol testing, are there laws to prohibit random testing?
B3c. If random testing is not allowed in a given country, what
other methods could be used to successfully deter employees from
misusing drugs or alcohol while performing safety-sensitive duties or
within a certain period of time before performing such duties? How
would such misuse be detected?
4. Procedures that ensure the integrity, identity, and proper
analysis of the collected specimen to ensure accuracy of the test
result. In the United States, the U.S. Department of Transportation has
adopted a chain-of-custody process developed by the U.S. Department of
Health and Human Services (HHS) to document the handling and storage of
a specimen from the time it is collected until the time it is released
to the testing facility. This process, coupled with the FAA's
requirement that testing programs in the United States use a laboratory
certified by HHS, helps ensure the accuracy of testing results. The FAA
poses the following questions with respect to this potential program
element:
B4a. What testing methods, if any, in addition to those currently
permitted under part 120, should be permitted in programs outside the
United States?
B4b. What standards should personnel and laboratories or other
facilities in foreign countries be required to meet? Please address the
following matters:
Personnel qualifications;
Measures to prevent adulteration, substitution, or
mistaken identification of specimens;
Measures to ensure drug and alcohol testing information is
only released to authorized persons;
Measures to determine whether there is a legitimate
medical explanation for a positive test result;
Other relevant considerations (please specify).
B4c. HHS-certified laboratories are not available outside the
United States; therefore, should a program be acceptable if it allows
the use of other laboratories that have been certified by DOT, another
regulatory authority, or international organization as meeting
equivalent or more stringent international standards?
5. A means of ensuring that an employee who returns to work [after
violating the law] is no longer misusing alcohol or drugs. If an
employee who violated the drug or alcohol regulations is permitted to
return to work, it is important to have a means for ensuring that the
employee is no longer misusing alcohol or drugs and a means of
detecting such misuse if it recurs after the employee returns to
safety-sensitive duties. The return-to-duty process in the United
States is described in the Department of Transportation's regulations
at 49 CFR part 40, subpart O. The FAA poses the following questions
with respect to this potential program element:
B5a. What are the minimum standards that employees who have
violated drug and alcohol regulations should meet before they return to
performing safety-sensitive maintenance functions?
B5b. If follow-up testing is not permitted, what other methods
would ensure that an employee who has previously tested positive for
alcohol or drugs does not misuse them again after returning to safety-
sensitive duties?
C. Existing Drug and Alcohol Testing Programs in Other Countries
The FAA recognizes that existing drug and alcohol testing programs
in other countries may take various forms and must comply with the
applicable laws and regulations of those countries. In some countries,
drug and alcohol testing programs may be established by industry in
accordance with regulations promulgated by a government agency, as is
the case in the United States. In others, a government agency may
administer a national drug and alcohol testing program. In yet others,
industry participants may have voluntarily established drug and alcohol
testing programs as a good business practice or for competitive
advantage in the
[[Page 14625]]
marketplace without being required to do so. In addition to the
information provided in part B above, the FAA requests the information
described below about existing drug and alcohol testing programs in
other countries, whether legally mandated or voluntarily established.
The FAA is interested in both nationwide information for other
countries and information pertaining to the testing programs of
specific companies or the members of an association:
C 1. Which drugs are most pervasively misused in the country?
Please provide data to support this answer.
C 2. Are testing programs in the country:
a. Administered by a national regulatory authority;
b. Required to be established by industry participants under that
country's laws and regulations;
c. Voluntarily established by industry participants;
d. Other (please specify)?
C 3. Please describe the process that is followed after an
employee's drug test is confirmed positive or alcohol concentration is
confirmed to be above the permitted limit, including at what point an
individual would be removed from safety-sensitive duty.
C 4. If the country allows drug or alcohol testing, what
protections does the country's legal system provide for the employee?
C 5. What are the potential consequences in that country,
including, but not limited to, enforcement action by the relevant
government authority, when an individual who performs safety-sensitive
aviation duties tests positive for alcohol or drugs?
D. Miscellaneous
D 1. Should the FAA include within the scope of a proposed rule all
authorized persons performing safety-sensitive maintenance functions on
aircraft operated by part 121 air carriers in accordance with 14 CFR
43.17 ? Please include the rationale for why such personnel should or
should not be subject to testing in any comment.
IV. Regulatory Notices and Analyses
A. Regulatory Evaluation
Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 and Executive Order 13563 direct
that each Federal agency shall 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 (Pub.
L. 96-354) requires agencies to analyze the economic impact of
regulatory changes on small entities. Third, the Trade Agreements Act
(Pub. L. 96-39) 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 requires agencies to consider
international standards and, where appropriate, that they be the basis
of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4) 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 with
base year of 1995). This portion of the preamble summarizes the FAA's
questions about the economic impacts of a future proposed rule.
Congress mandated that the FAA propose a rule requiring that all
employees of part 145 repair stations who perform safety-sensitive
maintenance functions on part 121 air carriers' aircraft be subject to
an alcohol and drug testing program that has been determined acceptable
by the Administrator and is consistent with the applicable laws of the
country in which the repair station is located. This mandate requires
the FAA to propose drug and alcohol testing for employees of part 145
repair stations located outside the United States who perform safety-
sensitive maintenance functions on aircraft operated by part 121 air
carriers. The FAA understands that the implementation of such a
regulation would impose costs on industry, the FAA, and perhaps other
parties.
The FAA might also extend this testing requirement to include all
authorized persons performing safety-sensitive maintenance functions on
aircraft operated by part 121 air carriers in accordance with 14 CFR
Sec. 43.17. It is very difficult, however, for the FAA to reliably
estimate such costs at this time, given the limited information about
other countries' relevant laws and regulations, existing drug and
alcohol testing programs in other countries, the actual and potential
costs associated with conducting drug and alcohol testing in other
countries (which is expected to vary), the cost of establishing testing
programs in countries where they do not currently exist, and other
relevant information. To help gauge the economic impact of a proposed
rule, the FAA is requesting information from industry, as well as from
the government of countries as described below. For all cost questions
in this ``Regulatory Notices and Analyses'' section, please note who
bears or would bear the costs (e.g., the employee; the air carrier for
whom work is performed; the covered maintenance provider, a regulatory
authority, other (please specify)) in any response provided.
In January 2006, the FAA issued a final rule entitled Antidrug and
Alcohol Misuse Prevention Programs for Personnel Engaged in Specified
Aviation Activities (71 FR 1666). That rule amended the FAA's
regulations governing drug and alcohol testing in the United States to
clarify that each person who performs a safety-sensitive function for a
regulated employer by contract, including by subcontract at any tier,
is subject to testing. Consequently, the regulatory evaluation for that
final rule (hereinafter referred to as the ``2005 Regulatory
Evaluation''), which was published in Docket No.: FAA-2002-11301,
addresses costs associated with drug and alcohol testing in the United
States.
The FAA is providing information from the 2005 Regulatory
Evaluation to provide the public with an understanding of the types and
level of detail of information needed to accurately estimate the
economic impact of a rule for drug and alcohol testing of employees of
covered maintenance providers who perform safety-sensitive maintenance
functions on aircraft operated by part 121 air carriers. The FAA
understands that the costs associated with drug and alcohol testing are
likely to be different outside the United States and may vary from
country to country. The FAA also understands that the specific details
of drug and alcohol testing programs likely vary from country to
country; however, the FAA expects that, for any drug and alcohol
testing program, there will be costs associated with the testing
process, training and education, developing and maintaining a testing
program, and keeping (and possibly submitting) any documentation that
may be required by national regulatory authorities or as part of a
voluntary program's policies. The FAA requests that commenters also
provide information about any other costs that may be relevant. The FAA
is interested in data at the national level, from the members of
associations, and from specific companies' programs. There were a
number of basic assumptions that the FAA made in the 2005 Regulatory
Evaluation. The FAA assumed the following:
[[Page 14626]]
Maintenance providers affected by that rule would develop
and implement their own programs, instead of being covered under
another company's program or using a service agent with already-
established procedures.
An additional 2.5% of maintenance workers would be subject
to the antidrug and alcohol misuse prevention programs under that rule.
The number of employees in the maintenance sector grows at
1.5% per year.
There would be two supervisors per contractor and that the
attrition rate for mechanics was approximately 10% per year.
The FAA requests comments on these assumptions.
The FAA also assumed the following values:
Price of a drug test--$45;
Price of an alcohol test--$34;
Time for a drug test (hours)--0.75;
Time for an alcohol test (hours)--0.75;
One instructor for every 20 supervisors and/or employees
to be trained
Maintenance employee salary--$33.07/hour;
Maintenance supervisor salary--$39.68/hour;
Instructor--$36.37/hour;
Clerical--$18.62/hour;
The FAA requests comments on these assumptions.
Testing Costs
All employees who are subject to drug and alcohol testing under FAA
regulations in the United States are subject to the following types of
tests: pre-employment (for drugs only), random, post-accident,
reasonable cause/suspicion, return-to-duty, and follow-up. The 2005
Regulatory Evaluation considered the cost of testing to include the
actual cost of the test, as well as the cost of the employee's time.
Please answer the following questions.
RE 1. For each year of the last 10 years, please provide the number
of (a) drug and (b) alcohol tests conducted on aviation personnel who
perform safety-sensitive functions and the number of positive tests,
regardless of whether maintenance personnel are currently tested under
the particular program described. If maintenance personnel are
currently tested, please provide the number of (a) drug and (b) alcohol
tests conducted on maintenance personnel that perform safety-sensitive
functions and the number of positive tests for such personnel
separately. For an example of the type of data that the FAA seeks, see
the table below from the 2005 Regulatory Evaluation.
[GRAPHIC] [TIFF OMITTED] TP17MR14.004
RE 2. What types of testing are required for (a) drugs and (b)
alcohol (e.g., pre-employment, post-accident, reasonable cause/
suspicion, random, return-to-duty, follow-up, other (please specify))?
RE 3. What types of personnel are subject to (a) drug and (b)
alcohol testing in the relevant country, company, or among the members
of the association (e.g., pilots, flight attendants, air traffic
controllers, flight dispatchers, maintenance personnel, other (please
specify))?
RE 4. Is drug and alcohol testing currently conducted in the
relevant country? If not, how would a requirement to drug and alcohol
test be met (i.e. travel to a different country, implement a testing
program within the relevant country, or other (please specify))? If
traveling to another country, what is the distance from the relevant
country? How much time will be spent traveling?
RE 5. What is the cost of (a) the drug test and (b) the alcohol
test per person? Do or would the costs differ for different categories
of tests (i.e., pre-employment, post-accident, reasonable cause/
suspicion, random, periodic, return-to-duty, follow-up, or other
(please specify))? How long does it take for an employee to complete
each of these tests? If screening tests for (a) drugs or (b) alcohol
are or would be conducted, followed by confirmatory testing when the
screening test is positive, what are or would be the costs associated
with conducting (a) the screening test and (b) the confirmatory test?
RE 6. How many maintenance personnel in the relevant country or in
a particular company or group of companies perform safety-sensitive
maintenance functions? How many of them perform safety-sensitive
maintenance functions on aircraft operated by part 121 air carriers
(and are not directly employed by such air carriers)? How many are
subject to drug and alcohol testing?
RE 7. How many new employees are hired to perform safety-sensitive
maintenance functions per year? How many maintenance employees who
perform safety-sensitive functions leave per year? The FAA will need to
be able to estimate testing costs in future years. See the table below
for an example from the 2005 Regulatory Evaluation.
[[Page 14627]]
[GRAPHIC] [TIFF OMITTED] TP17MR14.005
RE 7. What is or would be the annual cost per person of each
category of staff required to conduct testing (collection personnel,
laboratory personnel, other (please specify))?
Training and Education Costs
In the United States, for each drug and alcohol testing program,
the employer must train employees and supervisors on the effects and
consequences of drug use on personal health, safety, and work
environment, as well as the manifestations and behavioral cues that may
indicate drug use and abuse. The regulations do not specify the amount
of time associated with this training; in the 2005 Regulatory
Evaluation, the FAA assumed 30 minutes.
Under current regulations, supervisors who will make reasonable
cause/suspicion determinations must receive at least 60 minutes for
each program (for a total of 120 minutes). Supervisors must also
receive recurrent training under the FAA's drug testing rules. The
rules do not say when the recurrent training must occur or how long it
must be; however, the FAA recommends recurrent training every 12 to 18
months and that it include an element on alcohol testing. For the 2005
Regulatory Evaluation, the FAA assumed that the recurrent training
occurs every 12 months and takes 60 minutes.
Please answer the following questions.
RE 8. What are or would be the initial and recurrent training and
education costs, on a per person basis? For:
a. Employees subject to testing,
b. Supervisors,
c. Persons authorized to determine whether there is reasonable
cause/suspicion to believe that an employee may be under the influence
of alcohol or drugs while performing, or within a certain amount of
time before or after performing, a safety-sensitive function and that
the employee should be tested on that basis,
d. Specimen collectors,
e. Persons responsible for analyzing specimens for alcohol, drugs,
or their metabolites,
f. Persons involved in determining or recommending the appropriate
course of treatment and/or education for an employee who has tested
positive for drugs or alcohol,
g. Other personnel involved in the drug or alcohol testing program
(please specify)?
RE 9. How many personnel in category (g) of question RE8 receive or
would receive (1) initial and (2) recurrent training and/or education
annually?
RE 10. What was or would be the cost of developing any necessary
training program initially, including materials, and what is or would
be the annual cost, including materials, of maintaining it? What types
of training materials are or would be required?
RE 11. What are or would be the annual costs of the staff required
to conduct training? How many staff would be required to conduct
training?
[[Page 14628]]
RE 12. How often is/must/would recurrent training be conducted?
Program Development and Maintenance Costs
Under the rule for which the 2005 Regulatory Evaluation was
conducted, it was assumed that each affected maintenance provider would
have to devote resources to developing drug and alcohol testing
programs. In addition, each affected maintenance provider would have to
spend time to produce information required to either obtain an
operations specification for its part 145 certificate or register its
drug and alcohol program with the FAA. At the FAA, the submitted
information would have to be processed and entered into the appropriate
database.
In calculating program development costs in the 2005 Regulatory
Evaluation, the FAA assumed 16 hours for start-up program development.
The FAA estimated that, for affected maintenance providers that chose
to register with the FAA, it would take each one 20 minutes at $21 per
hour to gather the required information and submit it to the FAA. At
the FAA, the submitted information has to be processed. In the 2005
Regulatory Evaluation, the FAA estimated that an administrative
assistant, an FG-7 being paid at about $25.00 per hour, would enter
this information into a database. The FAA assumed that administrative
assistants would need 10 minutes to input the information.
Please answer the following questions.
RE 13. How much would it cost (besides training costs already
addressed above or cost to do the actual testing) to develop a drug and
alcohol testing program? What would be the annual program maintenance
costs (besides training costs already addressed above)? What items are
included in both of these types of costs?
RE 14. Is the drug and alcohol testing program regulated by an
agency of a government? If so, how much time per year is required to
prepare and maintain required documentation and submit information to
the responsible regulatory authority? What information items must be
submitted? How long does it take for the company to gather this
information? How long does it take for the responsible regulatory
authority to process the submission? Who at the responsible regulatory
authority processes these submissions?
RE 15. How many submissions must be made per year?
RE 16. What are or would be the costs of staff required to evaluate
employees who have tested positive for drugs or alcohol and to provide
any needed education and/or treatment? What would the cost of treatment
be, in terms of employees time and opportunity cost? How many such
staff would be needed? What are or would be the other costs associated
with any program of treatment and/or education?
RE 17. What are or would be the costs for a laboratory in the
relevant country to obtain HHS, its equivalent, or more stringent
certification, including both fees and the costs of any actions that
would need to be taken to meet the applicable certification standards?
Please specify the certification standards being used as a point of
reference in any comments.
RE 18. Is shipping specimens to an existing HHS-certified or DOT
approved laboratory a reasonable alternative? What would be the costs
associated with packaging and shipping specimens to one of the existing
HHS-certified laboratories for testing?
Annual Documentation Costs
The FAA's drug testing regulations require each company to document
both the initial and recurrent training for supervisory personnel who
make reasonable cause determinations. In the 2005 Regulatory
Evaluation, the FAA assumed that the cost of this documentation is
about $1.30 per record, which included record creation, filing, and
storage. The same sort of documentation is needed for the supervisors
who determine whether reasonable suspicion exists concerning probable
alcohol misuse. The FAA assumed the cost of this documentation is also
about $1.30 per record. The FAA's existing regulations require
documentation of such things as:
Training of employees in the requirements of the antidrug
program;
All reasonable cause/suspicion cases;
If a post-accident alcohol test is not administered within
2 hours following the accident, the reasons the test was not promptly
administered;
If a post-accident alcohol test is not administered within
8 hours following the accident, the reasons the test was not promptly
administered;
Refusal to submit to a required drug or alcohol test (the
company must also notify the FAA); and
Medical Review Officer (MRO) reports of verified positive
drug test results for employees holding airman medical certificates
issued by the FAA under 14 CFR part 67. (Both the MRO and the company
must also notify the FAA.)
Please answer the following questions.
RE 19. What are or would be the annual recordkeeping or other
documentation costs associated with the drug and/or alcohol testing
program?
RE 20. Who maintains or would maintain any required documentation
(e.g., employer, government agency, other (please specify))?
RE 21. What documentation is or would be required to be maintained
by and/or submitted to the responsible regulatory agency? How much time
would be needed to prepare and/or submit the documentation?
RE 22. What is the format for recordkeeping?
Accident Prevention Benefits
The FAA indicated in the 2005 Regulatory Evaluation that it
believed it was possible that illegal drug use or alcohol misuse by
members of the aviation community may have contributed to additional
accidents or incidents. The FAA acknowledged the fact that there had
not been any aviation accidents directly attributed to a maintenance
worker misusing or abusing drugs or alcohol.\5\ However, as the table
below shows, maintenance employees had among the highest positive rates
on alcohol and drug tests among aviation-related employees, so the
connection between illegal drug use and alcohol misuse and maintenance-
related accidents certainly could exist. The FAA stated that it was
important to note that not only are maintenance workers rarely tested
after an accident (only 0.05% and 0.09% of maintenance workers are
administered post-accident alcohol and drug tests, respectively), but
it would be difficult to directly tie poor maintenance work, due to
inappropriate drug use or alcohol misuse, to an accident that may occur
weeks or months later, particularly with the widespread use of contract
workers at many different tiers.
---------------------------------------------------------------------------
\5\ That analysis was limited to maintenance workers because
that was the population affected by that rulemaking.
---------------------------------------------------------------------------
[[Page 14629]]
[GRAPHIC] [TIFF OMITTED] TP17MR14.006
The 2005 Regulatory Evaluation indicated that, while there had been
no documented aviation accidents in the United States in the time
period analyzed that were directly attributed to misuse or abuse of
drugs or alcohol by maintenance personnel, the FAA believed it was
possible that such misuse or abuse may have contributed to aviation-
related accidents. The FAA believed it was prudent to base the
estimated benefits of the final rule on avoiding one part 135 accidents
over the next 10 years, thus avoiding a total of 5 fatalities and a
destroyed or damaged airplane. The FAA estimated the benefits of
avoided fatalities at $15 million. This number of accidents,
fatalities, and destroyed airplanes was less than 1% of all
maintenance-related accidents that had occurred; the FAA considered
these benefits to be reasonable. The total benefits in the 2005
regulatory evaluation were calculated by assuming an equally likely
chance of avoiding these accidents in each of the next 10 years. Total
benefits summed to $15.07 million ($10.59 million, discounted).
Please answer the following questions.
RE 22. What benefits has the relevant country/company seen from
drug and alcohol testing?
RE 23. Are you aware of any accidents in which drug or alcohol
misuse by safety-sensitive aviation personnel (e.g. pilots, flight
attendants, maintenance personnel, air traffic controllers, flight
dispatchers, other (please specify)) may have caused or contributed to
the accident? Please describe the circumstances and identify the type
of safety-sensitive personnel whose drug or alcohol misuse may have
caused or contributed to the accident. Were there any fatalities,
injuries, or damage to aircraft? If so, please describe. How many
confirmed positive drug and alcohol tests occur annually in the
country/company?
RE 24. Have industry participants experienced a savings in
insurance premiums as a result of drug and alcohol testing?
B. International Compatibility
In keeping with the United States' obligations under the Chicago
Convention, it is FAA policy to conform to ICAO Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that exactly correspond to the regulations being considered for
proposal, as ICAO neither requires nor recommends that Member States
implement testing of aviation personnel with safety-sensitive
responsibilities for alcohol or drugs. As discussed in the Background
section of this preamble, however, there are a number of ICAO standards
and recommended practices that address the misuse of drugs and alcohol
by such personnel and recognize the potential hazard that such
substance misuse may pose to aviation safety.
C. 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 ANPRM qualifies for the categorical exclusion
identified in paragraph 312d and involves no extraordinary
circumstances.
V. Executive Order Determinations
A. Executive Order 12866, Regulatory Planning and Review, Executive
Order 13563, Improving Regulation and Regulatory Review and DOT
Regulatory Policies and Procedures
The FAA is soliciting comments on the potential costs and benefits
of the initiatives in the ANPRM. This ANPRM has been drafted and
reviewed in accordance with Executive Order 12866 and Executive Order
13563. This ANPRM has been reviewed by the Office of Management and
Budget and is considered ``significant'' under the Department of
Transportation's Regulatory Policies and Procedures.
B. Executive Order 13132, Federalism
The FAA has analyzed this ANPRM under the principles and criteria
of Executive Order 13132, Federalism. The agency has determined that
this action would not have a substantial direct effect on the States,
or the relationship between the Federal Government and the States, or
on the distribution of power and responsibilities among the various
levels of government, and, therefore, would not have Federalism
implications.
C. Executive Order 13211, Regulations That Significantly Affect Energy
Supply, Distribution, or Use
The FAA analyzed this ANPRM under Executive Order 13211, Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). The agency has determined that it
would not be a ``significant energy action'' under the executive order
and likely would not have a significant adverse effect on the supply,
distribution, or use of energy.
VI. Additional Information
A. Comments Invited
The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. The Agency
also invites comments relating to the economic, environmental, energy,
or federalism impacts that might result from adopting the proposals in
this document. The most helpful comments reference a specific portion
of the proposal, or a
[[Page 14630]]
specific question posed by the FAA, and fully explain the rationale for
any comment, include supporting data, if applicable. To ensure the
docket does not contain duplicate comments, commenters should send only
one copy of written comments, or if comments are filed electronically,
commenters should submit only one time. The FAA requests that all
comments be submitted in English.
The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this ANPRM. Before acting on this ANPRM, the FAA
will consider all comments it receives on or before the closing date
for comments. The FAA will consider comments filed after the comment
period has closed if it is possible to do so without incurring expense
or delay. The Agency may change its potential proposals in light of the
comments it receives.
Proprietary or Confidential Business Information: Do not file
proprietary or confidential business information in the docket. Such
information must be sent or delivered directly to any of the persons
identified in the FOR FURTHER INFORMATION CONTACT section of this
document, and marked as proprietary or confidential. If submitting
information on a disk or CD ROM, mark the outside of the disk or CD
ROM, and identify electronically within the disk or CD ROM the specific
information that is proprietary or confidential.
Under 14 CFR 11.35(b), if the FAA is aware of proprietary
information filed with a comment, the Agency does not place it in the
docket. It is held in a separate file to which the public does not have
access, and the FAA places a note in the docket that it has received
it. If the FAA receives a request to examine or copy this information,
it treats it as any other request under the Freedom of Information Act
(5 U.S.C. 552). The FAA processes such a request under Department of
Transportation procedures found in 49 CFR part 7.
B. Availability of Rulemaking Documents
Electronic copies of rulemaking documents may be obtained from the
Internet by--
1. Searching the Federal eRulemaking Portal (https://www.regulations.gov);
2. Visiting the FAA's Regulations and Policies Web page at https://www.faa.gov/regulations_policies or
3. Accessing the Government Printing Office's Federal Digital
System at https://www.gpo.gov/fdsys/.
Copies may also be obtained 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.
Commenters must identify the docket or notice number of this
rulemaking.
All documents the FAA considered in developing this ANPRM,
including economic analyses and technical reports, may be accessed from
the Internet through the Federal eRulemaking Portal referenced in item
(1) above.
Issued in Washington, DC, under the authority set forth in 49
U.S.C. 44733 on: March 5, 2014.
James R. Fraser,
Federal Air Surgeon.
[FR Doc. 2014-05653 Filed 3-14-14; 8:45 am]
BILLING CODE 4910-13-P