Safety Management System, 36414-36417 [E9-17553]
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Federal Register / Vol. 74, No. 140 / Thursday, July 23, 2009 / Proposed Rules
fulfilled in order to make this
determination:
(1) The plant pest in question must be
determined to be a quarantine pest; and
(2) The taxon of plants for planting
must be determined to be a potential
host of that quarantine pest.
(e) Removing a taxon from the list of
taxa not authorized pending pest risk
analysis. Any person may request that
APHIS remove a taxon from the list of
taxa whose importation is not
authorized pending pest risk analysis.
Persons who submit such a request are
encouraged to provide as much
information as possible regarding the
taxon and any quarantine pests that may
be associated with it. APHIS will
conduct a pest risk analysis in response
to such a request. The pest risk analysis
will examine the risk associated with
the importation of that taxon.
(1) If the pest risk analysis supports a
determination that importation of the
taxon be prohibited or allowed subject
to special restrictions, such as a systems
approach, treatment, or postentry
quarantine, APHIS will publish a
proposed rule making the pest risk
analysis available to the public and
proposing to take the action
recommended by the pest risk analysis.
(2) If the pest risk analysis supports a
determination that importation of the
taxon be allowed subject to the general
restrictions of this subpart, APHIS will
publish a notice announcing our intent
to remove the taxon from the NAPPRA
list and making the pest risk analysis
supporting the taxon’s removal available
for public review.
(i) APHIS will issue a notice after the
close of the public comment period
indicating that the importation of the
taxon will be subject only to the general
restrictions of this subpart if:
(A) No comments were received on
the pest risk analysis;
(B) The comments on the pest risk
analysis revealed that no changes to the
pest risk analysis were necessary; or
(C) Changes to the pest risk analysis
were made in response to public
comments, but the changes did not
affect the overall conclusions of the
analysis and the Administrator’s
determination that the taxon poses a
potential risk of introducing a
quarantine pest into the United States.
(ii) If information presented by
commenters indicates that the pest risk
analysis needs to be revised, APHIS will
issue a notice after the close of the
public comment period indicating that
the importation of the taxon will
continue to be listed as not authorized
pending pest risk analysis while the
information presented by commenters is
analyzed and incorporated into the pest
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risk analysis. APHIS will subsequently
publish a new notice announcing the
availability of the revised pest risk
analysis.
§ 319.37–5
[Amended]
7. In § 319.37–5, paragraph (i)
introductory text is amended by
removing the words ‘‘plant diseases’’
and adding the words ‘‘quarantine
pests’’ in their place.
§ 319.37–7
[Amended]
8. Section 319.37–7 is amended as
follows:
a. In paragraph (c)(2)(iii), by removing
the words ‘‘exotic pests’’ and adding the
words ‘‘quarantine pests’’ in their place.
b. In paragraph (c)(2)(iv), by removing
the words ‘‘plant pests that are not
known to exist in the United States’’
and adding the words ‘‘quarantine
pests’’ in their place.
c. In paragraph (d)(5), by removing the
words ‘‘injurious plant disease,
injurious insect pest, or other plant
pest’’ and adding the words ‘‘quarantine
pest’’ in their place.
d. In paragraphs (f)(1) and (f)(2), by
removing the words ‘‘plant pests’’ each
time they occur and adding the words
‘‘quarantine pests’’ in their place.
e. In paragraphs (f)(1) and (f)(2), by
removing the words ‘‘plant pest(s)’’ each
time they occur and adding the words
‘‘quarantine pest(s)’’ in their place.
§ 319.37–8
[Amended]
9. Section 319.37–8 is amended as
follows:
a. In paragraph (e)(2) introductory
text, by removing the words ‘‘disease
and pests’’ and adding the words
‘‘quarantine pests’’ in their place.
b. In paragraph (e)(2)(ii), by removing
the words ‘‘plant pests and diseases’’
and adding the words ‘‘quarantine
pests’’ in their place; and by removing
the words ‘‘injurious plant diseases,
injurious insect pests, and other plant
pests’’ and adding the words
‘‘quarantine pests’’ in their place.
c. In paragraph (e)(2)(iv)(B), by adding
the word ‘‘quarantine’’ before the word
‘‘pests.’’
d. In paragraph (e)(2)(vii), by
removing the words ‘‘plant pests’’ and
adding the words ‘‘quarantine pests’’ in
their place.
e. In paragraph (e)(2)(viii), by
removing the words ‘‘plant pests and
diseases’’ and adding the words
‘‘quarantine pests’’ in their place.
f. In paragraph (e)(2)(xi)(B)
introductory text, by removing the
words ‘‘plant pests’’ and adding the
words ‘‘quarantine pests’’ in their place.
g. In paragraphs (f)(3)(i), (f)(3)(vii),
(f)(3)(viii), and (f)(4), by removing the
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words ‘‘injurious plant diseases,
injurious insect pests, and other plant
pests’’ and adding the words
‘‘quarantine pests’’ in their place.
10. Section 319.37–12 is revised to
read as follows:
§ 319.37–12 Prohibited articles and
articles whose importation is not
authorized pending pest risk analysis
accompanying restricted articles.
A restricted article for importation
into the United States may not be
packed in the same container as an
article whose importation into the
United States is prohibited by this
subpart or in the same container as an
article whose importation is not
authorized pending pest risk analysis
under § 319.37–2a of this subpart.
§ 319.37–13
[Amended]
11. Section 319.37–13 is amended as
follows:
a. In paragraph (b), by removing the
words ‘‘injurious plant disease,
injurious insect pest, or other plant pest,
new to or not theretofore known to be
widely prevalent or distributed within
and throughout the United States’’ and
adding the words ‘‘quarantine pests’’ in
their place; and by removing the words
‘‘injurious plant diseases, injurious
insect pests, or other plant pests’’ and
adding the words ‘‘quarantine pests’’ in
their place.
b. In paragraph (c), by removing the
words ‘‘pests and Federal noxious
weeds’’ and adding the words
‘‘quarantine pests’’ in their place.
Done in Washington, DC, this 17th day of
July 2009.
Cindy Smith,
Acting Deputy Under Secretary for Marketing
and Regulatory Programs.
[FR Doc. E9–17535 Filed 7–22–09; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Parts 21, 119, 121, 125, 135,
141, 142, and 145
[Docket No. FAA–2009–0671; Notice No. 09–
06]
RIN 2120–AJ15
Safety Management System
AGENCY: Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Advance notice of proposed
rulemaking (ANPRM), request for
comments.
SUMMARY: This ANPRM solicits public
comments on a potential rulemaking
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Federal Register / Vol. 74, No. 140 / Thursday, July 23, 2009 / Proposed Rules
requiring certain 14 CFR part 21, 119,
121, 125, 135, 141, 142, and 145
certificate holders, product
manufacturers, applicants, and
employers (hereafter ‘‘product/service
providers’’) to develop a Safety
Management System (SMS). SMS is a
comprehensive, process-oriented
approach to managing safety throughout
an organization. An SMS includes an
organization-wide safety policy, formal
methods of identifying hazards,
mitigating and continually assessing
risk, and promotion of a safety culture.
SMS stresses not only compliance with
technical standards but increased
emphasis on the organizational aspects
and processes that ensure risk
management and safety assurance.
DATES: Send your comments on or
before October 21, 2009.
ADDRESSES: You may send comments
identified by Docket Number FAA–
2009–0671 using any of the following
methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov and follow
the instructions for sending your
comments electronically.
• Mail: Send comments to Docket
Operations, M–30, U.S Department of
Transportation, 1200 New Jersey
Avenue, SE., West Building Ground
Floor, Room W12–140, Washington, DC
20590.
• Fax: Fax comments to Docket
Operations at (202) 493–2251.
• Hand Delivery: Bring 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.
For more information on the rulemaking
process, see the SUPPLEMENTARY
INFORMATION section of this document.
Privacy: We will post all comments
we receive, without change, to https://
www.regulations.gov, including any
personal information you provide.
Using the search function of our docket
Web site, anyone can find and read the
comments received into any of our
dockets, including the name of the
individual sending the comment (or
signing the comment for an association,
business, labor union, etc.). You may
review DOT’s complete Privacy Act
Statement in the Federal Register
published on April 11, 2000 (65 FR
19477–78), or you may visit https://
DocketsInfo.dot.gov.
Docket: To read background
documents or comments received, go to
https://www.regulations.gov at any time
or to Docket Operations in Room W12–
140 of the West Building Ground Floor
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14:47 Jul 22, 2009
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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:
Scott Van Buren, SMS Chief System
Engineer, Office of Aviation Safety
Analytical Services (ASA), Federal
Aviation Administration, 800
Independence Avenue, SW.,
Washington, DC 20591; telephone: (202)
494–8417; facsimile: (202) 267–3992;
e-mail: scott.vanburen@faa.gov. For
legal questions, contact Anne Bechdolt,
Regulations Division, Office of the Chief
Counsel, Federal Aviation
Administration, 800 Independence
Avenue, SW., Washington, DC 20591;
telephone: (202) 267–7230; facsimile:
(202) 267–7971; e-mail:
anne.bechdolt@faa.gov.
SUPPLEMENTARY INFORMATION:
Comments Invited
The FAA invites interested persons to
participate in this request for comments
by submitting written comments, data,
or views. We also invite comments
relating to the economic, environmental,
energy, or federalism impacts that might
result if an SMS rule is established. The
most helpful comments will reference a
specific question in the notice, and
provide detailed explanations of any
recommendations, including supporting
data when applicable. We ask that you
send us only one copy of written
comments, or if you are filing comments
electronically, please submit your
comments only one time.
We will file in the docket all
comments we receive, as well as a
report summarizing each substantive
public contact with FAA personnel
concerning this notice.
Proprietary or Confidential Business
Information
Do not submit information that you
consider to be proprietary or
confidential business information. Send
or deliver this information directly to
the person identified in the FOR FURTHER
INFORMATION CONTACT section of this
document. You must mark the
information that you consider
proprietary or confidential. If you send
the information on a disk or CD–ROM,
mark the outside of the disk or CD–ROM
and also identify electronically within
the disk or CD–ROM the specific
information that is proprietary or
confidential.
When we are aware of proprietary
information submitted with a comment,
we will not place it in the docket. See
14 CFR 11.35(b). We will keep
proprietary information in a separate
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36415
file to which the public does not have
access, and place a note in the docket
that we have received it. If we receive
a request to examine or copy this
information, we treat it as any other
request under the Freedom of
Information Act. See 5 U.S.C. 552. We
process such a request under the DOT
procedures found in 49 CFR part 7.
Availability of Rulemaking Documents
You can get an electronic copy of the
rulemaking documents using the
Internet by:
(1) Searching the Federal
eRulemaking Portal at 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 Web page at https://
www.gpoaccess.gov/fr/.
You can also get a copy by sending a
request to the Federal Aviation
Administration, Office of Rulemaking,
ARM–1, 800 Independence Avenue,
SW., Washington, DC 20591, or by
calling (202) 267–9680. Make sure to
identify the docket number, notice
number, or amendment number of this
rulemaking.
Purpose
This ANPRM requests written
comments in response to the questions
presented. We also welcome any
additional information that may be
helpful in considering an SMS
regulatory framework for providers of
aviation products/services under 14
CFR parts 21, 119, 121, 125, 135, 141,
142, and 145. The FAA is not proposing
any specific regulatory changes in this
ANPRM. The FAA intends to establish
an Aviation Rulemaking Committee
(ARC) to assess comments resulting
from this ANPRM and to provide
recommendations for any SMS
rulemaking effort. After review of all of
the comments submitted in response to
this ANPRM, and review of the ARC
recommendations, the FAA may issue a
notice of proposed rulemaking (NPRM)
proposing specific regulations or
regulatory amendments to create an
SMS rule. Interested persons will have
the opportunity to comment on
proposed changes prior to the adoption
of any final rule regarding SMS.
What Is a Safety Management System?
A Safety Management System (SMS)
is a structured, risk-based approach to
managing safety. The International Civil
Aviation Organization (ICAO) has
defined SMS as a ‘‘systematic approach
to managing safety, including the
necessary organizational structures,
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accountabilities, policies, and
procedures.’’ See ICAO, Safety
Management Manual, at 1.4.2, ICAO
Doc. 9859–AN/460 (1st ed. 2006). An
SMS provides a set of decision-making
processes and procedures that a
product/service provider would use to
plan, organize, direct, and control its
business activities in a manner that
enhances safety and ensures compliance
with regulatory standards. An SMS
incorporates these procedures into
normal, day-to-day business processes.
SMS requires a proactive approach to
discovering and correcting problems
before there are safety consequences. An
SMS also includes processes that seek to
identify potential organizational
breakdowns and necessary process
improvements allowing management to
address a safety issue before a
noncompliant or unsafe condition
results. However, using an SMS is not
a substitute for compliance with FAA
regulations or FAA oversight activities.
Rather, an SMS would ensure
compliance with safety-related statutory
and regulatory requirements.
The FAA, in continuing to develop a
comprehensive and integrated
framework for safety management, is
considering an SMS rule to provide
product/service providers with a
standardized set of requirements for an
SMS. The FAA Aviation Safety
Organization (AVS) describes an SMS as
containing four key components: Safety
Policy, Safety Risk Management (SRM),
Safety Assurance (SA), and Safety
Promotion.
Safety Policy. Safety policy outlines
the methods and processes the
organization’s SMS will use to achieve
the desired safety outcomes. The policy
establishes senior management’s
commitment on behalf of the
organization to incorporate and
continually improve safety in all aspects
of its business. Senior management
would develop measurable and
attainable company-wide safety
objectives, procedures, and processes.
The safety policy establishes and
promotes safety culture throughout all
levels of an organization.
Safety Risk Management (SRM). SRM
processes are used to assess system
design and verify that the system
adequately controls risk. A formal SRM
process describes a system, identifies
hazards, analyzes those hazards to
identify risk, and establishes controls to
manage those risks.
Safety Assurance (SA). SA processes
are used to ensure risk controls
developed under SRM achieve their
intended objectives throughout the life
cycle of a system. The SA process may
reveal hazards not previously identified
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during the SRM process. The SA
process may also allow the product/
service provider to identify or assess the
need for new risk controls, as well as
the need to eliminate or modify existing
controls. These SA monitoring activities
apply to an SMS whether the operations
are accomplished internally or
outsourced. The SA processes include:
information acquisition, analysis,
system assessment, and development of
preventive/corrective action for
nonconformance.
Safety Promotion. Safety promotion
requires creating an environment where
safety objectives can be achieved. Safety
promotion encourages a positive safety
culture. A positive safety culture is
characterized by an adequate knowledge
base, competency, implementation
tools, effective communications,
ongoing training, and information
sharing. Senior management must
provide the leadership to promote and
ensure a positive safety culture
throughout an organization. A positive
safety culture is the product of
individual and group values, attitudes,
and behavior, all committed to the
organization’s safety programs.
In addition to the four components
described above, another important
element of a product/service provider’s
SMS is the ability of the SMS to
interface with other product/service
providers, as well as the regulator. Such
interfacing allows product/service
providers to address issues of mutual
concern and allows the regulator to
evaluate the performance of the
product/service provider’s SMS.
International Civil Aviation
Organization (ICAO) and Safety
Management Systems
In March 2006, ICAO amended Annex
6—which addresses requirements for
the operation of aircraft, commercial air
transport operators, and helicopter
operators—requiring member states to
mandate that their Annex 6 operators
establish an SMS. The March 2006
amendments require member states to
initiate compliance by January 1, 2009.
On December 7, 2007, ICAO proposed
incorporating Annex 6 SMS
requirements into Annex 1 (medical
licensing) and Annex 8, (airworthiness
of aircraft), specifically aircraft and
aircraft component manufacturers, as
well as maintenance facilities. These
proposals, if adopted, would extend the
compliance date for Annex 6
amendments that were adopted in
March 2006 to November 19, 2009, and
require all member states to initiate
compliance with the Annex 1 and
Annex 8 amendments by November 18,
2010. Additional information regarding
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these amendments, as well as ICAO’s
guidance on establishing an SMS
framework, may be found at https://
www.icao.int/anb/safetymanagement/.
The United States has endorsed the
December 7, 2007, ICAO proposal to
require product/service providers under
Annex 1, 6, and 8 to develop an SMS.
Such a requirement would be consistent
with recent National Transportation
Safety Board (NTSB) recommendations
that the FAA requires all part 121
operators to establish SMS programs.
See NTSB Recommendation A–07–10
(January 23, 2007).
FAA Policy and Guidance Materials
In an effort to develop SMS policy
and guidance material, the FAA
reviewed ICAO requirements and
surveyed SMS programs and
development efforts around the world.
The FAA followed SMS developments
in Canada, New Zealand, Australia, and
Britain for program details, best
practices, and lessons learned. We also
examined third-party systems
developed by user organizations
including the International Air
Transport Association (IATA), the
Medallion Foundation, and the
International Business Aviation Council
(IBAC).
As a result, the FAA has developed
policy and guidance material for
establishing an SMS framework within
the FAA, as well as recommendations
for industry product/service providers
in developing their own SMSs.
Advisory Circular (AC) 120–92,
Introduction to Safety Management
Systems for Air Operators, issued June
22, 2006, provides a voluntary
framework by which air operators may
establish an SMS. Some 14 CFR part 91,
121, and 135 operators and some part
145 maintenance organizations have
used this AC for voluntary SMS
development.
The AC provides background and
introductory material on SMS processes
and interfaces with the certificate
holder’s SMS and the FAA oversight
system. Compliance with the AC is
voluntary because there are not, at
present, any SMS regulatory
requirements in the United States. In
addition, in May 2008, the FAA’s
Aviation Safety organization issued
Order VS 8000.367, Aviation Safety
(AVS) Safety Management System
Requirements, prescribing what criteria
AVS services and offices must follow in
implementing an SMS within AVS.
Appendix B of this order provides
specific guidance for product/service
provider SMS development. The FAA
encourages the public to read these
documents to help build an
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Federal Register / Vol. 74, No. 140 / Thursday, July 23, 2009 / Proposed Rules
understanding of SMS principles before
responding to the questions below.
Copies of these documents have been
placed in the docket for this notice.
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Request for Information
The FAA seeks input from the public
on the following questions. In your
comments please refer to the number of
the specific question(s) you are
responding to. Please do not hesitate to
provide additional information
regarding SMS not addressed by these
questions if you believe it would be
helpful in understanding the
implications of imposing an SMS
regulatory requirement. We do not
expect that every commenter will be
able to answer every question. Please
respond to those questions you feel able
to answer, or that address your
particular issue.
1. Please tell us about your
organization, including what products/
services are provided, what FAA
certificates you hold, approximate
number of employees, and your
approximate annual gross revenue.
2. Has your organization implemented
an SMS or components of an SMS based
on any of the guidance materials below?
Please describe your implementation
experience.
a. FAA Order VS8000.367, AVSSMS
Requirements, Appendix B.
b. AC–120–92, Introduction to Safety
Management Systems for Air Operators.
c. FAA-sponsored regulatory or
voluntary programs (e.g., Continuing
Analysis and Surveillance Systems
(CASS), Internal Evaluation Programs
(IEP), Aviation Safety Action Programs
(ASAP), etc.).
d. Foreign civil aviation authorities’
SMS development material (e.g.,
Transport Canada, Civil Aviation
Authority of Singapore (CAAS),
Australia Civil Aviation Safety
Authority (CASA), U.K. Civil Aviation
Authority (CAA)—please specify).
3. Please comment on the sufficiency
of the following SMS guidance material,
and what, if any, additional information
you would need to implement an SMS.
a. FAA Order 8000.367, AVSSMS
Requirements, Appendix B.
b. AC–120–92, Introduction to Safety
Management Systems for Air Operators.
c. Foreign civil aviation authorities’
SMS development material.
d. Third party material (e.g., IATA
Operational Safety Audit (IOSA),
International Standard for Business
Aircraft Operations (IS–BAO), Regional
Air Cargo Carriers Association
(RACCA), Air Cargo Safety Foundation
(ACSF)).
e. Other (please specify).
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4. Do you currently have a quality
management system (QMS) that meets
some accepted standard (e.g., ISO–9000,
Six-Sigma, Baldridge)? How would you
envision your existing system operating
in an SMS framework?
5. If you have voluntarily developed,
or are in the process of developing an
SMS, what impact has SMS had on your
organization in terms of enhanced safety
and compliance with existing CFRs?
6. Which types of product/service
providers should be required to have an
SMS and which, if any, should not?
Please explain the reasoning for your
opinion.
7. If you have implemented an SMS
and conducted cost and benefits
analyses, please describe your findings.
8. What are your main concerns and
recommendations in making the
transition to an SMS regarding the
following?
a. Documentation requirements (e.g.,
developing or updating manuals,
policies, procedures, standard operating
procedures).
b. Recordkeeping requirements (e.g.,
hazard identification data, risk
assessment data, corrective actions).
c. Collection, sharing, and
management of safety information (e.g.,
protection of and access to personally
identifiable information, proprietary
information).
9. What are the initial and recurrent
costs of establishing and maintaining
SMS processes (e.g., internal auditing
and evaluation, data collection,
employee training, computer software,
personnel hiring and training)?
10. What impact has SMS had on your
organization in terms of the resources
necessary to implement and maintain
the system?
11. What new knowledge, skills, and
abilities would your organization need,
if any, to operate successfully within an
SMS?
12. Please give us your thoughts about
the current processes for procuring and
using voluntarily submitted safety data
through FAA programs such as Aviation
Safety Action Program (ASAP) and how
these programs would fit within an SMS
framework.
13. What areas of the current
regulations do you believe already
incorporate SMS principles (e.g.,
continuing analysis and surveillance
system (CASS) under 14 CFR 121.373;
quality or inspection system
requirements under 14 CFR 21.143 and
21.303)? How would you suggest the
FAA avoid any duplicative
requirements in any SMS rulemaking
effort?
14. What concerns and
recommendations do you have about
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36417
setting objective standards for the
evaluation of SMS processes (e.g.,
evaluating SMS effectiveness, defining
scope of hazards, establishing
acceptable levels of risk)?
15. What are practical ways a small
business could apply the elements of an
SMS?
16. What are your concerns and
recommendations regarding the FAA
making the transition to requiring SMS
of product/service providers (e.g.,
schedule for implementation, FAA
acceptance and approval procedures,
oversight)?
17. Please provide any additional
information you think is pertinent.
Issued in Washington, DC, on July 20,
2009.
John Hickey,
Deputy Associate Administrator for Aviation
Safety.
[FR Doc. E9–17553 Filed 7–22–09; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2009–0655; Directorate
Identifier 2008–NM–192–AD]
RIN 2120–AA64
Airworthiness Directives; Boeing
Model 747–200F, 747–200C, 747–400,
747–400D, and 747–400F Series
Airplanes
AGENCY: Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Notice of proposed rulemaking
(NPRM).
SUMMARY: The FAA proposes to
supersede an existing airworthiness
directive (AD) that applies to all Boeing
Model 747–200F, 747–200C, 747–400,
747–400D, and 747–400F series
airplanes. The existing AD currently
requires repetitive inspections for
cracking of certain fuselage internal
structure (i.e., Sections 42 and 46
fuselage frames, upper deck floor beams,
electronic bay access door cutout, nose
wheel well, and main entry doors and
door cutouts), and repair if necessary.
This proposed AD would require
additional repetitive inspections for
cracking of certain fuselage structure
(i.e., Section 41 fuselage frames where
they connect to upper deck floor beams,
and section 41 fuselage frames between
stringer (S–8 and S–12), and related
investigative/corrective actions if
necessary. This proposed AD would
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Agencies
[Federal Register Volume 74, Number 140 (Thursday, July 23, 2009)]
[Proposed Rules]
[Pages 36414-36417]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17553]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Parts 21, 119, 121, 125, 135, 141, 142, and 145
[Docket No. FAA-2009-0671; Notice No. 09-06]
RIN 2120-AJ15
Safety Management System
AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).
ACTION: Advance notice of proposed rulemaking (ANPRM), request for
comments.
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SUMMARY: This ANPRM solicits public comments on a potential rulemaking
[[Page 36415]]
requiring certain 14 CFR part 21, 119, 121, 125, 135, 141, 142, and 145
certificate holders, product manufacturers, applicants, and employers
(hereafter ``product/service providers'') to develop a Safety
Management System (SMS). SMS is a comprehensive, process-oriented
approach to managing safety throughout an organization. An SMS includes
an organization-wide safety policy, formal methods of identifying
hazards, mitigating and continually assessing risk, and promotion of a
safety culture. SMS stresses not only compliance with technical
standards but increased emphasis on the organizational aspects and
processes that ensure risk management and safety assurance.
DATES: Send your comments on or before October 21, 2009.
ADDRESSES: You may send comments identified by Docket Number FAA-2009-
0671 using any of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov and follow the instructions for sending your
comments electronically.
Mail: Send comments to Docket Operations, M-30, U.S
Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
Fax: Fax comments to Docket Operations at (202) 493-2251.
Hand Delivery: Bring 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.
For more information on the rulemaking process, see the SUPPLEMENTARY
INFORMATION section of this document.
Privacy: We will post all comments we receive, without change, to
https://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78), or you may visit https://DocketsInfo.dot.gov.
Docket: To read background documents or comments received, go to
https://www.regulations.gov at any time or 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.
FOR FURTHER INFORMATION CONTACT: Scott Van Buren, SMS Chief System
Engineer, Office of Aviation Safety Analytical Services (ASA), Federal
Aviation Administration, 800 Independence Avenue, SW., Washington, DC
20591; telephone: (202) 494-8417; facsimile: (202) 267-3992; e-mail:
scott.vanburen@faa.gov. For legal questions, contact Anne Bechdolt,
Regulations Division, Office of the Chief Counsel, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone: (202) 267-7230; facsimile: (202) 267-7971; e-mail:
anne.bechdolt@faa.gov.
SUPPLEMENTARY INFORMATION:
Comments Invited
The FAA invites interested persons to participate in this request
for comments by submitting written comments, data, or views. We also
invite comments relating to the economic, environmental, energy, or
federalism impacts that might result if an SMS rule is established. The
most helpful comments will reference a specific question in the notice,
and provide detailed explanations of any recommendations, including
supporting data when applicable. We ask that you send us only one copy
of written comments, or if you are filing comments electronically,
please submit your comments only one time.
We will file in the docket all comments we receive, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this notice.
Proprietary or Confidential Business Information
Do not submit information that you consider to be proprietary or
confidential business information. Send or deliver this information
directly to the person identified in the FOR FURTHER INFORMATION
CONTACT section of this document. You must mark the information that
you consider proprietary or confidential. If you send the information
on a disk or CD-ROM, mark the outside of the disk or CD-ROM and also
identify electronically within the disk or CD-ROM the specific
information that is proprietary or confidential.
When we are aware of proprietary information submitted with a
comment, we will not place it in the docket. See 14 CFR 11.35(b). We
will keep proprietary information in a separate file to which the
public does not have access, and place a note in the docket that we
have received it. If we receive a request to examine or copy this
information, we treat it as any other request under the Freedom of
Information Act. See 5 U.S.C. 552. We process such a request under the
DOT procedures found in 49 CFR part 7.
Availability of Rulemaking Documents
You can get an electronic copy of the rulemaking documents using
the Internet by:
(1) Searching the Federal eRulemaking Portal at 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 Web page at https://www.gpoaccess.gov/fr/.
You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling (202) 267-9680. Make
sure to identify the docket number, notice number, or amendment number
of this rulemaking.
Purpose
This ANPRM requests written comments in response to the questions
presented. We also welcome any additional information that may be
helpful in considering an SMS regulatory framework for providers of
aviation products/services under 14 CFR parts 21, 119, 121, 125, 135,
141, 142, and 145. The FAA is not proposing any specific regulatory
changes in this ANPRM. The FAA intends to establish an Aviation
Rulemaking Committee (ARC) to assess comments resulting from this ANPRM
and to provide recommendations for any SMS rulemaking effort. After
review of all of the comments submitted in response to this ANPRM, and
review of the ARC recommendations, the FAA may issue a notice of
proposed rulemaking (NPRM) proposing specific regulations or regulatory
amendments to create an SMS rule. Interested persons will have the
opportunity to comment on proposed changes prior to the adoption of any
final rule regarding SMS.
What Is a Safety Management System?
A Safety Management System (SMS) is a structured, risk-based
approach to managing safety. The International Civil Aviation
Organization (ICAO) has defined SMS as a ``systematic approach to
managing safety, including the necessary organizational structures,
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accountabilities, policies, and procedures.'' See ICAO, Safety
Management Manual, at 1.4.2, ICAO Doc. 9859-AN/460 (1st ed. 2006). An
SMS provides a set of decision-making processes and procedures that a
product/service provider would use to plan, organize, direct, and
control its business activities in a manner that enhances safety and
ensures compliance with regulatory standards. An SMS incorporates these
procedures into normal, day-to-day business processes. SMS requires a
proactive approach to discovering and correcting problems before there
are safety consequences. An SMS also includes processes that seek to
identify potential organizational breakdowns and necessary process
improvements allowing management to address a safety issue before a
noncompliant or unsafe condition results. However, using an SMS is not
a substitute for compliance with FAA regulations or FAA oversight
activities. Rather, an SMS would ensure compliance with safety-related
statutory and regulatory requirements.
The FAA, in continuing to develop a comprehensive and integrated
framework for safety management, is considering an SMS rule to provide
product/service providers with a standardized set of requirements for
an SMS. The FAA Aviation Safety Organization (AVS) describes an SMS as
containing four key components: Safety Policy, Safety Risk Management
(SRM), Safety Assurance (SA), and Safety Promotion.
Safety Policy. Safety policy outlines the methods and processes the
organization's SMS will use to achieve the desired safety outcomes. The
policy establishes senior management's commitment on behalf of the
organization to incorporate and continually improve safety in all
aspects of its business. Senior management would develop measurable and
attainable company-wide safety objectives, procedures, and processes.
The safety policy establishes and promotes safety culture throughout
all levels of an organization.
Safety Risk Management (SRM). SRM processes are used to assess
system design and verify that the system adequately controls risk. A
formal SRM process describes a system, identifies hazards, analyzes
those hazards to identify risk, and establishes controls to manage
those risks.
Safety Assurance (SA). SA processes are used to ensure risk
controls developed under SRM achieve their intended objectives
throughout the life cycle of a system. The SA process may reveal
hazards not previously identified during the SRM process. The SA
process may also allow the product/service provider to identify or
assess the need for new risk controls, as well as the need to eliminate
or modify existing controls. These SA monitoring activities apply to an
SMS whether the operations are accomplished internally or outsourced.
The SA processes include: information acquisition, analysis, system
assessment, and development of preventive/corrective action for
nonconformance.
Safety Promotion. Safety promotion requires creating an environment
where safety objectives can be achieved. Safety promotion encourages a
positive safety culture. A positive safety culture is characterized by
an adequate knowledge base, competency, implementation tools, effective
communications, ongoing training, and information sharing. Senior
management must provide the leadership to promote and ensure a positive
safety culture throughout an organization. A positive safety culture is
the product of individual and group values, attitudes, and behavior,
all committed to the organization's safety programs.
In addition to the four components described above, another
important element of a product/service provider's SMS is the ability of
the SMS to interface with other product/service providers, as well as
the regulator. Such interfacing allows product/service providers to
address issues of mutual concern and allows the regulator to evaluate
the performance of the product/service provider's SMS.
International Civil Aviation Organization (ICAO) and Safety Management
Systems
In March 2006, ICAO amended Annex 6--which addresses requirements
for the operation of aircraft, commercial air transport operators, and
helicopter operators--requiring member states to mandate that their
Annex 6 operators establish an SMS. The March 2006 amendments require
member states to initiate compliance by January 1, 2009.
On December 7, 2007, ICAO proposed incorporating Annex 6 SMS
requirements into Annex 1 (medical licensing) and Annex 8,
(airworthiness of aircraft), specifically aircraft and aircraft
component manufacturers, as well as maintenance facilities. These
proposals, if adopted, would extend the compliance date for Annex 6
amendments that were adopted in March 2006 to November 19, 2009, and
require all member states to initiate compliance with the Annex 1 and
Annex 8 amendments by November 18, 2010. Additional information
regarding these amendments, as well as ICAO's guidance on establishing
an SMS framework, may be found at https://www.icao.int/anb/safetymanagement/.
The United States has endorsed the December 7, 2007, ICAO proposal
to require product/service providers under Annex 1, 6, and 8 to develop
an SMS. Such a requirement would be consistent with recent National
Transportation Safety Board (NTSB) recommendations that the FAA
requires all part 121 operators to establish SMS programs. See NTSB
Recommendation A-07-10 (January 23, 2007).
FAA Policy and Guidance Materials
In an effort to develop SMS policy and guidance material, the FAA
reviewed ICAO requirements and surveyed SMS programs and development
efforts around the world. The FAA followed SMS developments in Canada,
New Zealand, Australia, and Britain for program details, best
practices, and lessons learned. We also examined third-party systems
developed by user organizations including the International Air
Transport Association (IATA), the Medallion Foundation, and the
International Business Aviation Council (IBAC).
As a result, the FAA has developed policy and guidance material for
establishing an SMS framework within the FAA, as well as
recommendations for industry product/service providers in developing
their own SMSs. Advisory Circular (AC) 120-92, Introduction to Safety
Management Systems for Air Operators, issued June 22, 2006, provides a
voluntary framework by which air operators may establish an SMS. Some
14 CFR part 91, 121, and 135 operators and some part 145 maintenance
organizations have used this AC for voluntary SMS development.
The AC provides background and introductory material on SMS
processes and interfaces with the certificate holder's SMS and the FAA
oversight system. Compliance with the AC is voluntary because there are
not, at present, any SMS regulatory requirements in the United States.
In addition, in May 2008, the FAA's Aviation Safety organization issued
Order VS 8000.367, Aviation Safety (AVS) Safety Management System
Requirements, prescribing what criteria AVS services and offices must
follow in implementing an SMS within AVS. Appendix B of this order
provides specific guidance for product/service provider SMS
development. The FAA encourages the public to read these documents to
help build an
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understanding of SMS principles before responding to the questions
below. Copies of these documents have been placed in the docket for
this notice.
Request for Information
The FAA seeks input from the public on the following questions. In
your comments please refer to the number of the specific question(s)
you are responding to. Please do not hesitate to provide additional
information regarding SMS not addressed by these questions if you
believe it would be helpful in understanding the implications of
imposing an SMS regulatory requirement. We do not expect that every
commenter will be able to answer every question. Please respond to
those questions you feel able to answer, or that address your
particular issue.
1. Please tell us about your organization, including what products/
services are provided, what FAA certificates you hold, approximate
number of employees, and your approximate annual gross revenue.
2. Has your organization implemented an SMS or components of an SMS
based on any of the guidance materials below? Please describe your
implementation experience.
a. FAA Order VS8000.367, AVSSMS Requirements, Appendix B.
b. AC-120-92, Introduction to Safety Management Systems for Air
Operators.
c. FAA-sponsored regulatory or voluntary programs (e.g., Continuing
Analysis and Surveillance Systems (CASS), Internal Evaluation Programs
(IEP), Aviation Safety Action Programs (ASAP), etc.).
d. Foreign civil aviation authorities' SMS development material
(e.g., Transport Canada, Civil Aviation Authority of Singapore (CAAS),
Australia Civil Aviation Safety Authority (CASA), U.K. Civil Aviation
Authority (CAA)--please specify).
3. Please comment on the sufficiency of the following SMS guidance
material, and what, if any, additional information you would need to
implement an SMS.
a. FAA Order 8000.367, AVSSMS Requirements, Appendix B.
b. AC-120-92, Introduction to Safety Management Systems for Air
Operators.
c. Foreign civil aviation authorities' SMS development material.
d. Third party material (e.g., IATA Operational Safety Audit
(IOSA), International Standard for Business Aircraft Operations (IS-
BAO), Regional Air Cargo Carriers Association (RACCA), Air Cargo Safety
Foundation (ACSF)).
e. Other (please specify).
4. Do you currently have a quality management system (QMS) that
meets some accepted standard (e.g., ISO-9000, Six-Sigma, Baldridge)?
How would you envision your existing system operating in an SMS
framework?
5. If you have voluntarily developed, or are in the process of
developing an SMS, what impact has SMS had on your organization in
terms of enhanced safety and compliance with existing CFRs?
6. Which types of product/service providers should be required to
have an SMS and which, if any, should not? Please explain the reasoning
for your opinion.
7. If you have implemented an SMS and conducted cost and benefits
analyses, please describe your findings.
8. What are your main concerns and recommendations in making the
transition to an SMS regarding the following?
a. Documentation requirements (e.g., developing or updating
manuals, policies, procedures, standard operating procedures).
b. Recordkeeping requirements (e.g., hazard identification data,
risk assessment data, corrective actions).
c. Collection, sharing, and management of safety information (e.g.,
protection of and access to personally identifiable information,
proprietary information).
9. What are the initial and recurrent costs of establishing and
maintaining SMS processes (e.g., internal auditing and evaluation, data
collection, employee training, computer software, personnel hiring and
training)?
10. What impact has SMS had on your organization in terms of the
resources necessary to implement and maintain the system?
11. What new knowledge, skills, and abilities would your
organization need, if any, to operate successfully within an SMS?
12. Please give us your thoughts about the current processes for
procuring and using voluntarily submitted safety data through FAA
programs such as Aviation Safety Action Program (ASAP) and how these
programs would fit within an SMS framework.
13. What areas of the current regulations do you believe already
incorporate SMS principles (e.g., continuing analysis and surveillance
system (CASS) under 14 CFR 121.373; quality or inspection system
requirements under 14 CFR 21.143 and 21.303)? How would you suggest the
FAA avoid any duplicative requirements in any SMS rulemaking effort?
14. What concerns and recommendations do you have about setting
objective standards for the evaluation of SMS processes (e.g.,
evaluating SMS effectiveness, defining scope of hazards, establishing
acceptable levels of risk)?
15. What are practical ways a small business could apply the
elements of an SMS?
16. What are your concerns and recommendations regarding the FAA
making the transition to requiring SMS of product/service providers
(e.g., schedule for implementation, FAA acceptance and approval
procedures, oversight)?
17. Please provide any additional information you think is
pertinent.
Issued in Washington, DC, on July 20, 2009.
John Hickey,
Deputy Associate Administrator for Aviation Safety.
[FR Doc. E9-17553 Filed 7-22-09; 8:45 am]
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