Federal Aviation Administration

1. Physiological and Medical Risk Factors for Space Flight Participants: Scientific Justification for Prospective Biomedical Monitoring Federal Aviation Administration Presented at: COMSTAC RLV Working Group By: Melchor J. Antuñano, M.D., M.S. Director, FAA Civil Aerospace Medical Institute Date: October 2007

2. Keep an Open Mind!

3. Commercial Space Launch Amendments Act of 2004 The CSLAA was signed into law on December 23, 2004 to promote the development of the commercial human space flight industry • The public interest is served by creating a clear legal and regulatory regime for commercial human space flight • Establishes “Experimental Permit” • AST has sole authority over licensing of commercial launch and re-entry operations with humans onboard • Allows “informed consent” of the customer to accept the risks of spaceflight Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

4. Requires passengers to be fully informed about all of the potential risks of participating in space flights, allowing them to fly at their own risk. Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

5. What potential risks should be disclosed? • What is an appropriate full-disclosure of potential risks that would: • Minimize liability for the operator? • Not produce excessive fear among prospective space flight participants?

6. 14 CFR Part 460, Subpart B Launch and Reentrywith a Space Flight Participant § 460.45 Operator informing space flight participant of risk. • Before receiving compensation or making an agreement to fly a space flight participant, an operator must satisfy the requirements of this section. An operator must inform each space flight participant in writing about the risks of the launch and reentry, including the safety record of the launch or reentry vehicle type.

7. An operator must present this information in a manner that can be readily understood by a space flight participant with no specialized education or training, and must disclose in writing: (1) For each mission, each known hazard and risk that could result in a serious injury, death, disability, or total or partial loss of physical and mental function. (2) That there are hazards that are not known. (3) That participation in space flight may result in death, serious injury, or total or partial loss of physical or mental function. Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

8. An operator must inform each space flight participant that the U.S. Government has not certified the launch vehicle and any reentry vehicle as safe for carrying crew or space flight participants. • An operator must inform each space flight participant of the safety record of all launch or reentry vehicles that have carried one or more persons on board, including both U.S. government and private sector vehicles. • An operator must describe the safety record of its vehicle to each space flight participant, including launch and reentry accidents and human space flight incidents that occurred during and after vehicle verification. Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

9. An operator must inform a space flight participant that he or she may request additional information regarding any accidents and human space flight incidents reported. (f) Before flight, an operator must provide each space flight participant an opportunity to ask questions orally to acquire a better understanding of the hazards and risks of the mission, and each space flight participant must then provide consent in writing to participate in a launch or reentry. Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

10. Do we know ALL physiological and medical risk factors for prospective space flight participants in suborbital space flights? Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

11. NO! Therefore, we must be prepared to deal with potential physiological and medical risks in disguise. Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

12. This is very important considering that the FAA “Guidance for Medical Screening of Commercial Space Participants” was developed with a built-in flexibility to allow individuals with a variety of medical conditions to participate in commercial suborbital and orbital space flights. Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

13. Relevant Lessons-Learned An example of unexpected medical problems among airline passengers Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

14. During a total of 4,003,809 flights (571,972 flights per year) flown by a carrier from 1995 to 2000, there were 2,042 separate in-flight incidents requiring medical consultations and 312 requiring diversions. Safety and Survivability Issues in Civil Aviation Federal Aviation Administration

16. Examples of Potential Physiological and Medical Risk Factors for Space Flight Participants • Unidentified or undisclosed pre-existing medical conditions • Undisclosed use of medications • Undisclosed use or abuse of alcohol and drugs • Unexpected inflight medical emergencies (acute illnesses or trauma) • Unknown or undisclosed pregnancy • Unexpected psychological responses to confinement • Air sickness and/or space motion sickness Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

17. NASA and Russian Space Programs have reported a variety of physiological and/or medical problems among their astronauts and cosmonauts during short and long-duration space flights. This is particularly important considering that professional astronauts and cosmonauts are subject to a more comprehensive medical screening and/or selection process than commercial space flight participants and flight crews. Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

18. Even NASA and Russian Space Programs do not have considerable space flight experience dealing with physiological and medical risks among individuals who have significant pre-existing medical problems. The fact is that there are still many unanswered questions about the types of medical problems that could be considered acceptable risks during space flight. Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

19. Passenger Safety & Liability Issues Teddy bear or grizzly bear? The problem is that we live in a litigious society where the safety of space participants is a critical issue that the manned commercial space transportation industry must address proactively, prospectively and comprehensively. Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

20. Therefore, one way to increase our understanding of physiological and medical risk factors during RLV flights is to implement a voluntary prospective biomedical monitoring program for space flight participants. This is particularly relevant to ensure the safety of future space flight participants who have pre-existing medical conditions. Physiological and Medical Risks and the Need for Biomedical Monitoring Federal Aviation Administration

21. Proposed Memorandum of Agreement between the FAA Office of Commercial Space Transportation and NASA, concerning Commercial Space Flight Biomedical Data Acquisition and Management