23 July 2009
[Federal Register: July 23, 2009 (Volume 74, Number 140)]
[Proposed Rules]
[Page 36414-36417]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy09-6]
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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 http://
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
http://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 http://
DocketsInfo.dot.gov.
Docket: To read background documents or comments received, go to
http://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 http://
www.regulations.gov;
(2) Visiting the FAA's Regulations and Policies Web page at http://
www.faa.gov/regulations_policies/; or
(3) Accessing the Government Printing Office's Web page at http://
www.gpoaccess.gov/fr/index.html.
You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling (202) 267-9680. Make
sure to identify the docket number, notice number, or amendment number
of this rulemaking.
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 http://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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