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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 401, 415, 431, 435, 440 and 460

[Docket No. FAA-2005-23449]

RIN 2120-AI57

Human Space Flight Requirements for Crew and Space Flight Participants

AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
SUMMARY: The FAA is establishing requirements for human space flight as required by the Commercial Space Launch Amendments Act of 2004, including rules on crew qualifications and training, and informed consent for crew and space flight participants. The requirements should provide an acceptable level of safety to the general public and ensure individuals on board are aware of the risks associated with a launch or reentry. The rule also applies existing financial responsibility and waiver of liability requirements to human space flight and experimental permits. Experimental permits are the subject of a separate rulemaking.
DATES: These amendments become effective February 13, 2007.

Compliance Date: Affected parties, however, do not have to comply with the information collection requirements in SSSS 460.5, 460.7, 460.9, 460.19, 460.45, and 460.49 until the FAA publishes in theFederal Registerthe control number assigned by the Office of Management and Budget (OMB) for these information collection requirements. Publication of the control number notifies the public that OMB has approved these information collection requirements under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: For technical information, contact Kenneth Wong, Deputy Manager, Licensing and Safety Division, Commercial Space Transportation, AST-200, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone (202) 267-8465; facsimile (202) 267-3686; e-mailken.wong@faa.gov. For legal information, contact Laura Montgomery, Senior Attorney, Office of the Chief Counsel, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-3150; facsimile (202) 267-7971, e-maillaura.montgomery@faa.gov.
SUPPLEMENTARY INFORMATION: Availability of Rulemaking Documents

You can get an electronic copy using the Internet by:

(1) Searching the Department of Transportation's electronic Docket Management System (DMS) Web page (http://dms.dot.gov/search);

(2) Visiting the FAA's Regulations and Policies Web page athttp://www.faa.gov/regulations_policies/; or

(3) Accessing the Government Printing Office's Web page athttp://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 amendment number or docket number of this rulemaking.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act statement in theFederal Registerpublished on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visithttp://dms.dot.gov.

Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires the FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. If you are a small entity and you have a question regarding this document, you may contact your local FAA official, or the person listed underFOR FURTHER INFORMATION CONTACT. You can find out more about SBREFA on the Internet athttp://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

Authority for This Rulemaking

The FAA's authority to issue rules on commercial space transportation safety is found in Title 49 of the United States Codes, section 322(a), which authorizes the Secretary of Transportation to carry out Subtitle IX, Chapter 701, 49 U.S.C. 70101-70121 (Chapter 701). The Commercial Space Launch Amendments Act of 2004 (the CSLAA) provides additional authority. Under 49 U.S.C. 70105(b)(4), no holder of a license or permit may launch or reenter crew unless the crew has received training and satisfied medical or other conditions specified in a license or permit, all in accordance with FAA regulations. This rulemaking imposes crew qualification and training requirements and implements the statutory requirement that an operator advise the flight crew and any space flight participant that the U.S. Government has not certified the launch vehicle as safe. Section 70105(b)(5) directs the FAA to promulgate regulations requiring that the holder of a license or permit inform each space flight participant in writing about the risks of launch or reentry.

Table of Contents I. Background II. Description of Final Rule and Discussion of Comments A. Equivalent Level of Safety B. Launch and Reentry With Crew 1. Definitions a. Cabin Crew Suggestion b. Recommendations Regarding Personnel on the Ground c. Carrier Aircraft Personnel d. Payment for Pilot or Remote Operator Training 2. Authority 3. Pilot Qualifications 4. Remote Operator Qualifications 5. Medical Standards for Crew a. Objections to Requiring Medical Certification of Crew Who Do Not Have a Safety-Critical Role b. Recommendations for More Stringent Medical Standards 6. Crew Training 7. Crew Notification 8. Environmental Control and Life Support System a. Requiring Both Monitoring and Control of Atmospheric Conditions or Requiring Only Control b. Open-Loop System Versus Closed-Loop System c. Other Environmental Control and Life Support System Related Comments d. Guidance Plans

9. Smoke Detection and Fire Suppression

10. Human Factors 11. Verification Program 12. Crew Waiver of Claims Against U.S. Government 13. Professional Engineer C. Launch and Reentry With a Space Flight Participant 1. Risk to Space Flight Participants 2. Informed Consent a. Space Flight Participant's Ability To Be Informed 3. Physical Examination 4. Space Flight Participant Waiver of Claims Against U.S. Government 5. Space Flight Participant Training 6. Security Requirements D. Financial Responsibility and Waiver of Liability 1. Changes From What the FAA Proposed in the NPRM 2. Waivers of Claims 3. Federal Preemption 4. Insurance 5. Maximum Probable Loss III. Rulemaking Analyses IV. The Amendment
I. Background

On December 23, 2005, the FAA published a notice of proposed rulemaking (NPRM), “Human Space Flight Requirements for Crew and Space Flight Participants” 70 FR 77261 (Dec. 29, 2005), which discusses the background of the CSLAA and the nascent human space flight industry. The NPRM also discusses the safety considerations underlying the FAA's proposed requirements and each alternative that the agency considered.

In the CSLAA, Congress also directed the FAA to issue guidelines or advisory materials to guide the implementation of the law as soon as practical, and to promulgate requirements governing experimental permits. On February 11, 2005, the FAA issued “Draft Guidelines for Commercial Suborbital Reusable Launch Vehicle Operations with Flight Crew” and “Draft Guidelines for Commercial Suborbital Reusable Launch Vehicle Operations with Space Flight Participants.” On March 31, 2006, the FAA published an NPRM, “Experimental Permits for Reusable Suborbital Rockets.” 71 FR 16251.

II. Description of Final Rule and Discussion of Comments

In this final rule, the FAA changes parts 401, 415, 431, 435 and 440 of Title 14 of the Code of Federal Regulations and establishes a new part 460 in response to the CSLAA's requirement to issue regulations governing crew and space flight participant, by June 23, 2006. Revisions in part 440 codify the financial responsibility and risk allocation regime for activities authorized by a permit and for crew and space flight participants. These requirements supplement other launch and reentry regulations, including those in parts 415, 431, and 435. For example, part 431 governs reusable launch vehicle operations, and contains system safety and risk requirements and operational constraints. An operator of a reusable launch vehicle with a person on board must comply with this rule and part 431.

Part 460 applies to anyone applying for or having a license or permit under Title 14 Code of Federal Regulation (CFR) Chapter III, who conducts a flight with crew or space flight participants on board a vehicle, or employs a remote operator of a vehicle with a human on board.1 This part also applies to a space flight participant or crew member participating in an activity authorized under 14 CFR Chapter III. Part 460 defines crew and flight crew and imposes notification, medical, qualification, and training requirements. It also promulgates informed consent and training requirements for space flight participants.

1

For a vehicle with no one on board that is controlled by a remote operator part 460 does not apply. Instead, an operator will be governed by other parts, such as parts 431 and 435.

The FAA received comments from forty-two entities, including aerospace companies, associations, service providers, individuals and other agencies of the U.S. Government. Operators of launch and reentry vehicles who provided comments include Blue Origin, LLC (Blue Origin), the Personal Spaceflight Federation2 (Federation), Rocketplane Limited, Inc. (Rocketplane), TGV Rockets, Inc., and XCOR Aerospace (XCOR). The following associations, individuals and service providers also commented: Airline Pilots Association International (ALPA); Association of Space Explorers-USA (ASE), International Association of Space Entrepreneurs and Institute for Space Law and Policy (IASE and ISLAP); Knutson & Associates, Attorneys at Law (Knutson); Nickolaus Leggett (Leggett); Planehook Aviation Services, LLC (Planehook); Predesa, LLC (Predesa) and James Snead.

2The Federation is a non-profit trade association consisting of companies whose business involves or will involve commercial human space flight. They provided consensus comments on the NPRM and consist of the following: Air Launch, Armadillo Aerospace, Bigelow Aerospace, Mojave Spaceport, RocketPlane Limited, Inc., Scaled Composites, Space Adventures, SpaceDev, Space Explorations Technologies Corporation (SpaceX), The SpaceShip Company, XCOR Aerospace, X PRIZE Foundation, and Virgin Galactic.

In general, the commenters supported the proposed requirements, but with several suggested changes.

A. Equivalent Level of Safety

The Federation recommended that the FAA consider allowing means of compliance other than those identified in the regulations. In part 460, the FAA will allow an operator to demonstrate that an alternative method of compliance for certain requirements provides an equivalent level of safety and satisfies the rule. The FAA notes that many of the requirements of this part are performance standards that already offer operators a great deal of flexibility. Where a requirement is prescriptive, such as when the FAA requires a pilot certificate, the FAA does not contemplate approving alternatives through the license or permit process unless the requirement explicitly allows alternatives. As the Federation noted, the FAA also has the ability to grant waivers under 14 CFR 404.3. If an operator wishes to pursue a course that is not consistent with the requirements of part 460, the operator must apply for a waiver.

B. Launch and Reentry With Crew

Subpart A of part 460 applies to the flight crew and any remote operator. The only ground crew covered is a remote operator.

1. Definitions

The FAA is retaining the definition of crew required by the CSLAA, that is, any employee of a licensee, transferee, or permittee, or of a contractor or subcontractor of a licensee, transferee, or permittee, who performs activities in the course of that employment directly relating to the launch, reentry, or other operation of or in a launch vehicle or reentry vehicle that carries human beings. As proposed in the NPRM, a crew consists of flight crew, crew on board a vehicle during a launch or reentry, and any remote operator. Also, crew members may be independent contractors as well as employees. As it explained in the NPRM, the FAA defines crew to include all personnel on board, namely the flight crew, as part of the crew, and thus give a broader meaning to crew than one consisting only of a pilot or remote operator. Because Congress contemplated operation oforin a vehicle (emphasis added), Congress appears to have intended some persons on the ground to be included as part of the crew. A remote operator of a vehicle satisfies the Congressional direction to include some ground crew as part of the crew. Also, a remote operator is someone whose employment would directly relate to a launch or reentry, thus satisfying the other statutory prong. Limiting ground crew to remote operators avoids providing notice to personnel on the ground about the dangers of a vehicle they are not going to board. Were the FAA to include more ground personnel as crew, the CSLAA would require an operator to inform those persons that the U.S. Government has not certified the vehicle as safe for carrying crew or space flight participants, 49 U.S.C. 70105(b)(4)(B), which seems an exercise of no benefit.

Commenters raised a number of questions regarding the definition of crew. With the exception of those related to the requirement for a second-class airman medical certificate, they are addressed here.

a. Cabin Crew. The IASE and ISLAP suggested that distinguishing between “cabin crew” and “flight crew” would ensure that the fundamental difference between them—direct involvement invehicle operation as opposed to passenger safety and comfort—would be recognized in future regulations while facilitating clearer discussion of the regulatory responsibilities of each crew member. This suggestion is premature. The FAA will address the recommendation when those circumstances arise.

b. Personnel on the Ground. The FAA, as it proposed in the NPRM, defines a remote operator as a crew member who has the ability to control, in real time, a launch or reentry vehicle's flight path, and is not on board the vehicle. This means that a remote operator is the only member of the ground crew.3

3ASE commented that it believes the portion of the definition of crew “A crew consists of flight crew and any remote operator” to mean if a person is not a flight crew member or a remote operator, then that person is not crew. ASE recommended that the definition read “A crew consistsonlyof flight crew and any remote operator” to avoid any misinterpretation. The FAA does not incorporate the suggested change because it is unnecessary but confirms in this document that if a person is not a flight crew member or a remote operator, then that person is not crew.

Blue Origin requested that the FAA clarify the definition of remote operator to ensure the exclusion of persons on the ground from the definition of crew. Blue Origin recommended that the FAA clarify that “control” means navigation and control of the vehicle, rather than merely being in the chain of command. Blue Origin's clarification would preclude someone who initiated a launch or an abort from being considered part of the crew. Blue Origin reasoned that launch decisions will often be made by a launch director after receiving input from all groups, including air traffic control.

As explained in the NPRM, a remote operator is someone who actively controls the vehicle, and does more than initiate or abort a launch in progress. Active control encompasses navigation as well as control. A mission flight control officer in charge of terminating the flight of an errant expendable launch vehicle would not be treated as a remote operator because he or she does not have the ability to control, in real time, the vehicle's flight path. Accordingly, the FAA does not need to adopt Blue Origin's suggestion.

Predesa suggested expanding ground crew to include “specialists who monitor and maintain vehicle systems via telemetry” as they may assist a remote operator or pilot, and provide information or modify the operations of vehicle systems during flight. Predesa recommended that these personnel possess FAA flight engineer certification or FAA pilot certification. Predesa does not believe that persons who are not on board should be subjected to lesser standards merely because of their location.

The FAA has decided against expanding the definition because the personnel, even though not covered under part 460 if not on board the launch or reentry vehicle, will be subjected, during the license or permit process, to the standards appropriate to their roles. For example, an applicant proposing a reusable launch vehicle mission would have to meet part 431, which requires that a licensed operator implement a system safety process and operational restrictions and satisfy risk requirements. As part of the system safety process, personnel on the ground will receive training to carry out their roles safely, and it is through this training that the personnel on the ground will be held to standards appropriate to their roles. As part of the proposed requirements for obtaining an experimental permit, the FAA intends to require an applicant conduct a hazard analysis. Human error issues and training of ground personnel would be addressed through this analysis. Also, part 431 requirements address the readiness of vehicle safety operations personnel to support flight under nominal and non-nominal conditions.

c. Carrier Aircraft Personnel. Dassault Aviation and Spaceport Associates asked whether the crew of a carrier aircraft4 would be included as crew under part 460. Spaceport Associates pointed out that, in one sense, crew of a carrier aircraft are effectively providing the first stage of the launch although not themselves subject to extraordinary biomedical stresses. Planehook commented that adopting the term “spacecraft pilot” would reduce confusion when distinguishing between the pilot of an aircraft and the pilot of a launch vehicle. According to Planehook, the training of crew on a carrier aircraft should be addressed in 14 CFR part 61 because the vehicle is most likely to remain an air-breathing aircraft. This rulemaking does not treat crew on board a carrier aircraft as crew under part 460.

4Some licensees have used aircraft to assist in space launch. Orbital Sciences Corporation's Pegasus launch vehicle is air-launched from an L-1011 carrier aircraft. Scaled Composites' SpaceShipOne was air-launched from a White Knight carrier aircraft. The L-1011 was issued a supplemental type certificate and operates under two FAA airworthiness certificates: A standard airworthiness certificate for operation without Pegasus and a restricted airworthiness certificate for operations with the Pegasus launch vehicle. White Knight operated under a special airworthiness certificate in the experimental category when it was operating alone or carrying SpaceShipOne. The FAA did not impose requirements on the crew of the carrier aircraft other than those required by the FAA's aviation requirements.

The FAA defines flight crew to mean crew that is on board a vehicle during a launch or reentry. The crew aboard the aircraft are already covered by existing FAA regulations. Thus, new terms such as spacecraft pilot are not necessary to distinguish between aviation and space flight crew.

d. Payment for Pilot or Remote Operator Training. Under this final rule, the FAA will not allow a space flight participant to act as a pilot or remote operator of a launch or reentry vehicle. ASE noted that it is possible that a qualified, medically-certified person may wish to pay an operator to pilot the operator's vehicle. The FAA notes that someone paying to fly, whether as a passenger or at the controls, is a space flight participant rather than an employee.

For public safety reasons, the FAA will not allow space flight participants to pilot launch or reentry vehicles at this time. A space flight participant who wants to pilot a launch or reentry vehicle would have to become an employee or independent contractor of the operator to acquire vehicle and mission-specific training. The operator will be in a better position to evaluate the skills of an employee or independent contractor than of a space flight participant, particularly as those skills relate to the requirements of the operator's particular vehicle. The FAA acknowledges that this restriction may create a dilemma for someone who wishes to acquire training in order to become employed, but, while the technology is so new, it is important for public safety that pilots be highly skilled at the outset.

2. Authority

The FAA has the authority to protect crew. Spaceport Associates questioned the FAA's authority to protect crew when it commented that the FAA should not implement design requirements to protect crew, particularly in light of the requirement to notify crew members that a vehicle has not been certified as safe. The commenter observed, in effect, that the FAA was limited to protecting the general public. Under the CSLAA, the FAA has the authority to protect the crew because they are part of the flight safety system that protects the general public.5

5Even before the passage of the CSLAA, this has been the case. In April 2004 the FAA issued two RLV mission specific licenses: one to Scaled Composites and one to XCOR. These licenses apply to suborbital RLV missions with a pilot on board, where the FAA addressed the safety of the crew inorder to protect the public.See also,Notice of Policy, 68 FR 56039, 56040 (Sept. 29, 2003).

3. Pilot Qualifications

As proposed in the NPRM, § 460.5 requires a pilot of a launch or reentry vehicle to possess and carry an FAA pilot certificate with an instrument rating. The FAA invited public comment on the proposed requirement and received differing views.

Some commenters considered the requirement too lenient. TGV suggested that a pilot certificate might only partially address the knowledge, skills, and abilities necessary for safety. TGV recommended that, in addition to a pilot certificate, the FAA require test pilot credentials or military supersonic experience for single piloted suborbital and orbital vehicles. Because having a pilot certificate may not be sufficient, § 460.5(c)(2) requires aeronautical experience and skills necessary to pilot and control the vehicle.

The Federation and Planehook agreed with the requirement for a pilot to have an instrument rating because, as Planehook commented, the trajectory of a vehicle will pass through Class A airspace at least twice. ALPA also agreed that the pilots or flight crew, including any remote operators acting under part 460, should be certificated.

Focusing on a possible exception to the utility of requiring a pilot certificate, Mr. Nickolaus Leggett recommended against requiring pilots and remote operators of launch vehicles that do not have aircraft characteristics to possess an FAA pilot certificate with an instrument rating. He pointed out that a strictly ballistic suborbital vehicle consisting of a capsule and parachute does not require conventional piloting skills at all. Similarly, Starchaser recommended not requiring a pilot certificate at all and relying only on the performance requirement that a pilot possess the necessary skills and experience for the vehicle. An Air Force member of the Common Standards Working Group (CSWG)6 recommended that the FAA not require that a pilot be certified when a vehicle is unique and lacks any similarity to an airplane.7 The commenter suggested that a properly trained engineer may be a better choice as a pilot for the vehicles that do not resemble aircraft. If the key criterion is to protect the public, an individual intimately familiar with the unique vehicle design, capabilities, and properly trained in the operation and recovery of such vehicles could be a better choice to operate the vehicle than a pilot.

6The CSWG consists of Air Force, FAA, and other government agencies. The CSWG develops, documents, and maintains common safety standards for public safety of the launch and reentry of launch and reentry vehicles.

7The commenter agreed with requiring pilot certification where a vehicle has many characteristics in common with an airplane.

The FAA requires a pilot certificate so that a pilot of a reusable launch vehicle has a basic level of aeronautical experience, an understanding of the National Airspace System (NAS), and an understanding of the regulatory requirements under which aircraft in the NAS operate, including cloud clearance requirements and airspace restrictions. This awareness will enhance overall safety of the NAS, regardless of whether a vehicle has wings. An instrument rating should ensure that pilots of launch and reentry vehicles have acquired the skills of scanning cockpit displays, correctly interpreting the instruments, and responding with correct control inputs. The FAA expects that regardless of the kind of vehicle used, there will be times when a pilot will be relying on instrument skills and competency. Having a pilot certificate and aeronautical experience provides evidence of a basic level of knowledge of and experience with the NAS, such as communications, navigation, airspace limitations, and other aircraft traffic avoidance, that will help promote public safety.

Planehook commented that a pilot or remote operator of a vehicle should have a commercial pilot certificate appropriate to the type of vehicle flown. The FAA's guidelines contain such a recommendation. The FAA did not, however, propose in the NPRM to implement this guideline as a requirement. The FAA did not specify the particular kind of pilot certificate required nor what category, class, type or instrument ratings are needed because different operators are proposing vehicles of varied and unique designs. The pilot certification is not directly transferable from aircraft to launch or reentry vehicles. Rocket-powered vehicles do not operate as aircraft. As Mr. Leggett noted, even for a more manually controlled ballistic vehicle, the skills required differ from those of an aircraft pilot.

The FAA recognizes the validity of these comments. Accordingly, the agency is adopting a performance requirement, § 460.5(c)(2), that requires a pilot and remote operator to possess aeronautical experience and skills necessary to pilot and control the vehicle for any launch or reentry vehicle that will operate in the NAS. To avoid overly burdening the industry, and in recognition of the diverse range of vehicles proposed, the FAA does not require an RLV pilot to hold a pilot certificate for a specific category of aircraft or to have a specific instrument rating on that certificate.

4. Remote Operator Qualifications

Section 460.5 requires a remote operator to possess and carry a pilot certificate with an instrument rating. Section 460.5(c)(1)(iii), however, allows an operator to demonstrate through the license or permit process that an alternative approach provides an equivalent level of safety. In the NPRM, the FAA invited public comment on the proposed requirement that a remote operator of a launch or reentry vehicle with a human on board possess an FAA pilot certificate with an instrument rating and that he or she demonstrate the knowledge of the NAS necessary to operate the vehicle.

Predesa questioned whether it was safe to allow remote operators at all. Predesa pointed out that remote operation of a vehicle could lead to concerns over the security and integrity of telemetry from the vehicle and of the commands sent to control the vehicle. Predesa recommended redundancy in the communications channel or on-board back up in the form of a trajectory controller or, preferably, a pilot on board. James Snead also recommended that a pilot be on board because there is no precedent for flight without one.

The FAA notes that there is precedence for permitting remote operators to control a vehicle. Unmanned aerial vehicles (UAVs) are already operated by the National Aeronautics and Space Administration (NASA) and the military services, and authorized by the FAA. The FAA will address whether the operators can sufficiently control a vehicle through the license or permit process on a case-by-case basis. The safety issues, such as those raised by Predesa, will also be addressed in that process.

The Federation and Starchaser recommended against requiring remote operators to possess pilot certificates at all, let alone with an instrument rating. The Federation recommended that remote operators still demonstrate knowledge, albeit with wide latitude, of the NAS and the deconfliction of airspace necessary to safely operate the vehicle. The Federation claimed the variety of possible vehicles and control schemes renders unnecessary a requirement that remote operators possess a pilot's certificate. According to the Federation, operators can and should be allowed to demonstrate their knowledge of the NAS in other ways, such as by written test. The Federation noted that John Carmack of ArmadilloAerospace successfully operated a vertical takeoff, vertical landing vehicle remotely at the 2005 X PRIZE Cup, without the use of a pilot's license or instrumentation resembling that of an aircraft cockpit.8

8It should be noted that Armadillo's vertical-take off vehicle, which hovered about 25 feet above the ground for a few seconds and had no human on board, was not an FAA licensed launch. Nor did the vehicle have an impact on the NAS.

One commenter, t/Space, suggested that in some instances, remote operation of a launch or reentry vehicle with a human on board may provide backup command and control of the vehicle if the pilot or flight crew is incapacitated or otherwise unable to function. When not intended for nominal flight operations, remote operation from the ground is likely to be limited to execution of pre-planned flight, reentry, or abort scenarios. According to t/Space, the remote operator in these situations would not require the same level of knowledge and experience as a pilot with an instrument rating.

The FAA acknowledges that there may be a variety of vehicle types and control schemes, such as back up remote operators that may be used. Accordingly, for a remote operator, the FAA will allow an operator to demonstrate that something other than a pilot certificate provides an equivalent level of safety.

5. Medical Standards for Crew

Section 460.5(e) requires that each crew member with a safety-critical role possess and carry an FAA second-class airman medical certificate issued in accordance with 14 CFR part 679 and issued no more than 12 calendar months prior to the month of launch and reentry. For example, this means that if a launch were to take place on May 1, 2007, or May 31, 2007, a medical certificate issued anytime in May 2006 would satisfy the requirement. Because the requirement applies to both launch and reentry, operators who plan on a reentry in a different month than the launch should ensure that their crews' medical certificates are still timely for the reentry.

9In the NPRM, the FAA proposed to require that the medical certificate be issued within 12 months of launch or reentry as opposed to 12 months prior to the month of launch or reentry. The proposed time limit might have created confusion because a second-class medical certificate expires at the end of the last day of the twelfth month after the month of the date of examination. 14 CFR 61.23(d)(2). The requirement now provides the same expiration date as part 61.

Requiring a medical certificate only for crew with a safety-critical role marks a change from the NPRM, where the FAA proposed that all crew members, regardless of whether they were safety-critical, possess and carry such a certificate.

a. Objections to Requiring Medical Certification of Crew Who Do Not Have a Safety-Critical Role. Rather than creating a separate class of crew who are not safety critical or modifying the definition of crew as some commenters suggested, the FAA can better address medical risk to the mission by more precisely identifying what triggers the need for a medical certification. In section 460.5(e), the FAA distinguishes between crew members with a safety-critical and non-safety-critical role to determine whether they must satisfy the medical requirements.

Several commenters, including ALPA, generally concurred with the FAA that requiring medical certification is appropriate, particularly for those crew members whose duties are associated with operation of the launch or reentry vehicles. Several suggested that it may not be necessary for all crew members. Planehook and David J. Sullivan-Nightengale commented that a second-class medical certificate was appropriate for the pilot but unnecessary for other crew members. The Federation, t/Space, and XCOR asked the FAA to reconsider requiring a second-class medical certificate for non-safety-critical crew on the grounds that it would be impractical and unnecessary. The Federation claimed that where a regulatory requirement does not respond to a real need, it can negatively impact a flight test. XCOR commented that members of a rocket engine development team will likely serve as flight test engineers on some test flights to permit them to observe engine operation in real time and possibly to adjust parameters of the propulsion system in flight. According to XCOR, these operations are not safety-critical because the flight is aborted if the flight test engineer is incapacitated, and the worst case effect is the loss of some data from that flight.

Blue Origin commented that a person should not be required to have a second-class medical certificate if he or she is only involved in pushing an ignition button or initiating an abort of a vehicle experiencing non-nominal telemetry. TGV Rockets recommended against medical certification for remote operators.

Under today's rule, crew members must complete training on how to perform their duties on board or on the ground so that the vehicle will not harm the public. They also must complete training to be able to perform duties in emergency operations or abort scenarios. Crew members who are not medically stable likely would not be able to meet training or performance requirements.

The FAA agrees that requiring second-class medical certification for crew members who do not perform safety-critical functions is unnecessary. There may be missions when a flight attendant or flight test engineer has duties that would not affect public safety. The FAA, however, anticipates that there may be missions when a flight attendant or flight test engineer does have a safety critical role. Rather than specifying which crew members must have a medical certificate, the FAA requires that only crew members who have a safety-critical role must possess and carry a second-class airman medical certificate.

Jonathan Goff suggested that alternatives to the second-class medical be accepted if they demonstrate an equivalent level of safety. The FAA has decided against this approach because a demonstration of equivalence would likely require the same level of examination and information as a medical certificate. The most straightforward approach is to obtain a second-class medical certificate.

b. Recommendations for More Stringent Medical Standards.Several commenters recommended the FAA adopt more stringent medical standards. The Aerospace Medical Association commented that a second-class medical certificate is acceptable for suborbital flight but more stringent physical standards should be applied to orbital missions. It further posited that the examination should be conducted by a physician with aerospace medicine training and include screening tests consistent with prudent aeromedical practice and recommendations of the U.S. Preventive Services Task Force. Dii Aerospace Laboratories commented that different standards should apply to space flight because the effects of weightlessness and reentry are vastly different for space flight than for standard commercial air travel. If a candidate for a medical certificate had significant medical issues, he or she would not receive certification. The physician would refer that person to a specialist for further evaluation. TGV Rockets commented that a first-class medical certificate should be required for pilots carrying space flight participants.

The FAA proposed requiring a second-class medical certificate so that crew members would demonstrate a basic level of health within 12 months of launch or reentry. Recognizing that second-class medical certification is insufficient for spaceflight, the FAA is also establishing a performancestandard that requires the flight crew to demonstrate an ability to withstand the stresses of space flight sufficiently so that the vehicle will not harm the public. This requirement may be more stringent than the suggested first-class medical certificate for pilots. The stresses experienced in space flight may include high acceleration or deceleration, microgravity, and vibration. The performance standard provides an additional level of safety beyond basic medical certification because flight crew members will have to demonstrate an ability to perform duties in the spaceflight environment in which they plan to operate. As discussed in the NPRM, the FAA recognizes that different standards may be required for orbital and suborbital flights. The FAA will gather data for the development of those standards over time and they may be implemented on a case-by-case basis or through future rulemaking.

6. Crew Training

As proposed in the NPRM, § 460.5(a)(1) requires each member of a crew to complete training on how to carry out his or her role on board or on the ground so that the vehicle will not harm the public. Section 460.7 requires an operator to train each member of its crew and define standards for successful completion in accordance with § 460.5. The FAA received comments on hours of training, simulator training, and the training standard itself.

Starchaser recommended a minimum number of hours of training, but did not provide its reasons for this suggestion. Depending on the role the crew members will have, different amounts of training will be necessary for a crew member to learn his or her role. The FAA will evaluate this need on a case-by-case basis during the license and permit process.

Section 460.5(c)(3) requires a pilot and a remote operator to receive vehicle and mission-specific training for each phase of flight by using a simulator, a similar aircraft, flight testing, or an equivalent method. Mr. Leggett commented that because development of a vehicle would likely include a significant amount of simulation, the FAA should require simulator training. The benefit would be that training could take place in a safe environment. Dii commented that simulator training should be mandatory because realism is critical. Dii noted that a pilot needs to be able to deal with simulator sickness and spatial disorientation.

The FAA does not require the use of simulators in all circumstances because simulators may not exist for all the proposed vehicles. While the use of simulators is recommended, the FAA intends to maximize the training approaches that are acceptable by allowing methods of training other than simulators.

The FAA notes that some simulators intended for aircraft may be used for different launch or reentry vehicles. Section 460.7(b) requires that an operator ensure that either the crew-training device used to meet the training requirements realistically represents the vehicle's configuration and mission or the operator has informed the crew member being trained of the differences. Predesa took issue with this proposed requirement, noting that just because an operator knows of differences between the systems, does not mean that the operator can describe those differences and train crew accordingly. Such training may be possible with data available from vehicle flight tests, but, without such data, Predesa recommended that operators remind the crew of the experimental nature of flight. This is sound guidance that is already encompassed within the requirement.

Alteon Training, L.L.C. (Alteon) observed that requiring that “an operator must train each member of its crew and define standards for successful completion” could be interpreted to mean that only the operator could conduct the required training. According to Alteon, an operator should have the ability to arrange with an approved training provider for the development of training programs. Alteon further commented that the operator would have the responsibility for oversight of the training provider to ensure that the training satisfied the FAA's regulatory requirements. The FAA agrees that an operator can have a contractor provide training, a concept that is already encompassed by § 460.7(a). Ultimately, however, it will be the responsibility of the operator to ensure that crew members are trained properly.

Section 460.7(d) also requires that an operator ensure that all required crew qualifications and training are current before launch and reentry. The NPRM proposed that an operator ensure currency prior to launch or reentry, but, as Predesa pointed out, this language incorrectly implied that an operator could postpone its currency check on a suborbital mission to just prior to reentry. Accordingly, the regulatory text has been changed to specify that currency checks be complete prior to a suborbital launch.

At various points in the crew training requirements, the FAA requires operators to meet certain requirements. For example, as discussed above, an operator must ensure training currency. Ms. Knutson commented that requiring an operator to “ensure” something may create a warranty at odds with the risky nature of space travel at this stage in its evolution. The FAA notes that requiring an operator to ensure to the FAA that an event does or does not take place identifies the purpose of a requirement in order to impose a flexible yet enforceable performance standard. When the regulations require an operator to satisfy a performance standard, the FAA requires that an operator demonstrate the means by which it would satisfy that standard in its application for a license or permit. Grant of authorization constitutes approval of that approach as one that the FAA thinks will ensure satisfaction of the intent of the performance requirement. It is then up to the operator to carry out its method of compliance as described in its application. Because a license requires that an operator amend its application when it would no longer be accurate, the method an operator describes in its application has the same legal effect as a prescriptive requirement.

7. Crew Notification

As proposed in the NPRM, § 460.9 requires an operator to inform, in writing, any individual serving as crew that the United States Government has not certified the launch or reentry vehicle as safe for carrying flight crew or space flight participants.10 An operator must provide this notification prior to employing someone as crew or, if the individual is already employed by the operator, as soon as possible and prior to any launch in which that person will serve as crew.

10The Federation requested that the FAA create a form by which operators could provide this notice. The FAA will not adopt this suggestion in order to preserve flexibility. The required notifications are described in § 460.9.

Blue Origin commented on the logistical difficulties associated with the timing requirements. Blue Origin is concerned that the rule makes no provision for lawful notification when an existing employee is promoted or reassigned to a flight crew position. Section 460.9 requires that an operator provide the notification before entering into any contract or other arrangement to employ an individual. A promotion or reassignment would constitute such “other arrangement,” and the FAA expects an operator to inform the prospective crew member of the required notice prior to the person accepting the new assignment.

Predesa also commented that the FAA does not require the experience and background necessary for crew to identify design or operational flaws that would stop them from participating in a mission. Predesa appears to base this comment on a belief that the CLSAA asks the crew to accept the risk of space flight with full information. The FAA does not interpret the statute in this manner. Rather, the CSLAA and the FAA's attendant regulations impose a duty on a launch operator to inform crew of the absence of U.S. Government certification. Just as with a space flight participant, a crew member may not have the schooling and experience required to discern operational or design flaws. Part of the risk associated with the flights anticipated by this rule is the presence of unknown hazards. The notification requirement requires only that an operator inform the crew that risks exist, not that it identify all potential operational and design hazards.

8. Environmental Control and Life Support System (ECLSS)

Section 460.11 requires that an operator provide atmospheric conditions adequate to sustain life and consciousness for all inhabited areas within a vehicle. The operator or flight crew must monitor and control specific atmospheric conditions in inhabited areas or demonstrate through the license or permit process that an alternative means of compliance provides an equivalent level of safety. This requirement reflects a change from what the FAA proposed in the NPRM in that the FAA will now allow an alternative means of compliance.

Blue Origin suggested that the ECLSS requirements not be applied to short suborbital flights, such as those that are ten to twenty minutes. The FAA notes that the vehicle's atmospheric conditions have to last from the time the cabin is sealed from the external environment until it is opened. When humans are in a closed environment and dependent upon manmade life support systems, a failure to monitor or control the environment even for a short duration could lead to a loss of life or injury. The FAA also understands, however, that some of the atmospheric constituents and conditions may not change significantly in a short duration flight, and the ECLSS for a suborbital mission typically will not be as complex as one for an orbital mission. Therefore, the FAA will continue to require the operator or flight crew to monitor and control atmospheric conditions in inhabited areas but will allow the operator to show an alternate means of compliance that demonstrates an equivalent level of safety.

a. Requiring Both Monitoring and Control of Atmospheric Conditions or Requiring Only Control.The Federation commented that not every life support system must be both monitored and controlled. For example, it is asserted that a dehumidification system may not require monitoring because a proper verification test, which may be performed on the ground, may show that the system has ample capacity to keep humidity below acceptable limits.11 Additionally, the Federation noted some atmospheric conditions need only be monitored without constant, active controls. Similarly, Blue Origin suggested that the FAA clarify that “control” can include passive measures rather than active instrumentation. According to the Federation, if followed literally, the requirement to monitor and control every life support system would drive up the cost and complexity of space vehicles and, as a consequence, possibly drive down reliability with adverse public safety implications. Paragon commented that the requirement to monitor and control contaminants that include particulates and any harmful or hazardous concentrations of gases or vapors should be restricted to those that reasonably can be expected to build up during the course of the spaceflight due to metabolicorother processes occurring in the cabin, or to those potential contaminants for which a source is present in the cabin.

11The FAA notes that in a condensing heat exchanger, the separation of liquid condensate from air, and the collection of liquid condensate, are difficult processes in the expected microgravity environment, and so ground testing may not necessarily provide adequate verification.

The FAA agrees with the Federation and Paragon that only control may be needed in some cases. Control of particulate contaminants in the atmosphere of inhabited areas is an example where the FAA would consider control without requiring monitoring. The passive control method commonly employed is to provide filters, especially high efficiency particulate air filters, for the cabin air return duct inlets. When used with a recirculation fan, filters effectively maintain low concentrations of particulate contaminants in the atmosphere for extended times, with neither rapid nor large changes during spaceflight operation. Consequently, monitoring of the atmospheric concentration of particulate contaminants may not be necessary, especially for a suborbital mission. In order to address these types of systems, the FAA will require the operator or flight crew to monitor and control atmospheric conditions in the inhabited areas as proposed in the NPRM, but will allow the operator to show an alternate means of compliance that will demonstrate an equivalent level of safety. This alternate means of compliance must be approved by the FAA through the license or permit process.

b. Open-Loop System Versus Closed-Loop System. According to the Federation and Blue Origin, any undesirable atmospheric condition can be controlled with an open-loop, rather than closed-loop system.12 The FAA agrees that in some cases an atmospheric condition can be controlled with an open-loop system rather than a closed-loop system with automatic feedback from the monitoring device.

12A closed loop system is a control system with an active feedback loop. A typical example of a closed loop system is one that uses a thermostat to control temperature. The thermostat compares the actual temperature with the desired temperature; if the actual temperature is less than the desired temperature an actuating signal causes the control elements to supply more heat. An open loop system does not have active feedback that compares the controlled variable with the desired input.

For example, carbon dioxide concentrations in the atmosphere in inhabited areas should be monitored and controlled. A carbon dioxide (CO2) control device, however, may operate without automatic feedback from the monitoring device. Without controls, CO2from human respiration would accumulate in the cabin atmosphere. The resulting increase in the concentration of CO2would depend upon the habitable volume of the vehicle, the number of persons on board, and the overall mission duration. To avoid elevated CO2concentrations, an operator must provide controls to remove CO2from the atmosphere at a rate comparable to the respiration rate of the crew members and space flight participants. CO2may be removed by using lithium hydroxide (LiOH) canisters. The LiOH canisters could be replaced on a schedule based on the number of persons on board. Under this scenario, an operator would monitor the carbon dioxide concentration in the cabin atmosphere, to verify in flight that the CO2control devices are operating and are effective in avoiding elevated CO2concentrations. Because any increase in CO2concentration would occur slowly, and because there is a considerable margin between the expected concentration with controls and the threshold concentration where chronic physiological changes begin to appear, a closed-loop control would not be required. Should the crew observe increasing CO2concentrations, thereshould be sufficient time to diagnose and remedy any abnormal operation of the control device, or if that fails, to safely terminate the mission.

Oxygen concentration in the atmosphere is another example of what must be monitored and controlled. Very low oxygen partial pressure constitutes a severe hazard, results in impaired judgment and ability to concentrate, shortness of breath, nausea, and fatigue, affecting the proper functioning of the crew, and so potentially results in catastrophic consequences. Control of oxygen concentration must be closed loop, with the automatic addition of oxygen depending upon the oxygen-measuring device indication.

c. Other ECLSS-related Comments.ASE noted that the FAA did not propose to require protecting safety-critical equipment, such as heat-generating avionics. ASE commented that vehicle designers must recognize the need to cool avionics, which may be in the space-unique environment of low, or no pressure. The FAA agrees on the need to design for adequate thermal control of safety-critical equipment, but the suggested requirement would not be appropriate in the context of a performance based rule. Design requirements for spacecraft avionics equipment are outside the scope of this rule. However, the FAA will evaluate the design, including thermal control, of safety-critical equipment when it reviews a license application.

Predesa requested that the ECLSS requirements be specifically applied to all normal, non-normal and emergency operations, to emphasize the need for secondary or backup environment systems or other means to preserve the atmospheric conditions for the crew. The FAA may find that redundancy is necessary on a case-by-case basis, depending on a particular design, to ensure the crew's ability to protect public safety. At this point, the only redundancies the FAA anticipates requiring for all designs are specified in the regulations, including the requirement for an adequate redundant or secondary oxygen supply for the flight crew.

ASE commented that the space environment offers unique environmental challenges, such as micro-meteorites and orbital debris. It noted dual seals will not address a hull breach by orbital debris. Although a low probability during suborbital flight, a hull breach is not impossible, and the risk dramatically increases during orbital flight due to the increased exposure time. ASE recommended that this and other space-unique hazards be addressed, at least during the licensing or permitting phase. The FAA acknowledges the potential for micro-meteorites and orbital debris, and notes that these details will surface through an applicant's hazard analysis and be resolved during the license or permit process.

d. Guidance Plans.The FAA recognizes and anticipates that there will be many ECLSS designs. The ECLSS requirements are performance based rather than design based with prescriptive requirements. The following factors should be considered in determining if both monitoring and control of an atmospheric condition is needed and whether an open-loop system or closed-loop system with automatic feedback from the monitoring device is necessary:

• Severity of the hazards presented to humans;

• Likelihood for catastrophic or critical consequences of exposure;

• Potential for rapid changes in conditions;

• Potential for changes in conditions of large magnitude;

• Availability of practicable in-flight measurement techniques and devices;

• Access to emergency breathing equipment; and

• Mission duration.

The FAA plans to develop an ECLSS advisory circular or guidance document. This document will address some of the concerns and suggestions of the IASE and ISLAP. The IASE and ISLAP believe that it is premature for the FAA to issue regulations pertaining to ECLSS at this time. Instead, they believe it would make more sense for the FAA to issue guidelines and to refine such guidelines with industry input over time as operators gain experience. According to the IASE and ISLAP, at this time there is simply too much untested diversity of design and proposed operation for “one size fits all” regulation in environmental control and life support areas.

9. Smoke Detection and Fire Suppression

Section 460.13 requires an operator or crew to have the ability to detect smoke and suppress a cabin fire to prevent incapacitation of the flight crew. This requirement is adopted as proposed in the NPRM. Predesa inquired whether the FAA meant to imply that an operator could employ remote systems for fire detection and suppression. Predesa raised operational safety concerns regarding the security and integrity of telemetry to and from the vehicle. The FAA will address these issues during the license and permit process.

10. Human Factors

Section 460.15 requires an operator to take necessary precautions to account for human factors that can affect a crew's ability to perform safety-critical roles. The FAA received no comments on this requirement, and it is adopted as proposed in the NPRM.

11. Verification Program

Section 460.17 requires an operator to successfully verify the integrated performance of a vehicle's hardware and any software in an operational flight environment before allowing any space flight participant on board during a flight. Verification must include flight testing. Predesa requested clarification of this requirement, observing that the NPRM appeared to allow a space flight participant to be carried during first time flight testing in a different operational environment than what was tested. For example, an operator might flight test a reentry from a high altitude. Predesa inquired whether a space flight participant could board for the first flight test into a suborbital micro-gravity environment. The FAA expects that more than a single flight test will be required to verify the integrated performance of a vehicle. Because the FAA did not identify how much flight testing would be required, Starchaser commented that the requirement was open to subjective judgment and potential manipulation. The FAA believes that it would be premature at this time to specify the number of hours of flight testing needed given the variety of launch and reentry vehicle designs and concepts. The appropriate level of testing depends on many factors, including the vehicle's mission profile, operational restrictions, test and flight history, component and subsystem heritage, and design and operating margins. The FAA will initially determine the amount of verification and, specifically, flight testing of launch or reentry vehicles on a case-by-case basis through the license or permit process.

A space flight participant would not be allowed on an envelope expansion flight, that is, a space flight participant would not be allowed to be carried during first time flight testing in a different operational environment than what was tested.

12. Crew Waiver of Claims Against U.S. Government

Section 460.19 requires each member of a flight crew and any remote operator to execute a reciprocal waiver of claims with the Federal Aviation Administration of the Department ofTransportation in accordance with the requirements of part 440. The FAA received no comments on this requirement, and it is adopted as proposed.

13. Professional Engineer

James Snead commented that the FAA should require a professional engineer to prepare and approve an application for an FAA license to launch or reenter. Mr. Snead recommended this requirement as an alternate means to protect public safety where there is no government certification.13 Opposing the recommendation, XCOR commented that FAA's oversight function should not be transferred to a private party because of the potential for conflicts of interest. A professional engineer would be paid by the applicant and thus be under subtle pressure to make decisions in favor of the vehicle developer. The FAA notes that applicants may choose to engage professional engineers, but will not require them.

13Although the licensing process differs from certification, the licensing process also protects public safety.

C. Launch and Reentry With a Space Flight Participant

Subpart B establishes requirements for space flight participants on board a vehicle whose operator is licensed or permitted under this chapter. The subpart applies to a license or permit applicant, licensed or permitted operators and space flight participants.

1. Risk to Space Flight Participants

Several commenters urged that the FAA establish requirements to protect space flight participants. Nicholas Leggett recommended that a pilot have at least one solo flight before transporting passengers. Starchaser advocated pressure suits for space flight participants. As the FAA noted in the NPRM, the CSLAA does not provide the authority to protect space flight participants except in certain circumstances. 49 U.S.C. 70105(c)); 70 FR at 77270. The CSLAA only allows the FAA to issue regulations restricting or prohibiting design features or operating practices that result in a human space flight incident or a fatality or serious injury to space flight participants during an FAA authorized flight until December 23, 2012. For the next six years, the FAA has to wait for harm to occur or almost occur before it can impose restrictions. Instead, Congress requires that space flight participants be informed o