Medical Considerations for Manned Commercial Space Flight Melchor Antuñano, M.D., M.S.

1. Medical Considerations for Manned Commercial Space Flight Melchor Antuñano, M.D., M.S. Director, FAA Civil Aerospace Medical Institute

2. National Space Society (NSS) Ad Astra Magazine (Jan/Feb 2001 Issue) “Some regulation of space access is probable, but it is critical to engage in frank discussion that takes into account a variety of viewpoints in order to create logical guidelines that will not completely prevent the public from being able to fly in space”

3. National Space Society (NSS) Ad Astra Magazine (Jan/Feb 2001 Issue) “Other short-term effects of spaceflight, such as skeletal and heart muscle weakening, bone loss, and radiation exposure are generally limited and are likely to pose minimal risk to an otherwise healthy space traveler. However, those with known heart disease, osteoporosis, or even cancer may be disqualified from space travel as the potential for worsening their medical conditions exists”

4. AsMA In 1999 the Aerospace Medical Association (AsMA) approved the following resolution: “The Aerospace Medical Association urges that appropriate agencies develop relevant U.S. Federal policies, procedures, guidelines, and regulations to ensure the health and safety of human crewmembers and passengers who will be involved in manned commercial space flights in the near future”

5. AsMA On November 20, 2000, the Aerospace Medical Association convened a task force to develop a position paper on “Medical Guidelines for Space Passengers” Guidelines were published in the “Aviation, Space and Environmental Medicine” journal in October 2001 and November 2002

6. Manned commercial space operations will include various types of RLVs with different flight envelopes • It is reasonable to expect that here will be some form of regulatory oversight (national and international) of these activities • It is very important to avoid excessiveregulatory oversight that could interfere with the development of this emerging industry

7. February 2004 The U.S. House of Representatives sent to the Senate the Commercial Space Launch Amendments Act of 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 suborbital vehicles • Allows “informed consent” of the customer to accept the risks of spaceflight

8. October 2004 The U.S. Senate has put on hold approval of this Act due to disagreements over how much protection to offer potential space travelers

9. “The greatest danger for most of us is not that our aim is too high and we miss it, but that it is too low and we reach it” Michelangelo

10. The problem is that we live in a litigious society where the safety of RLV occupants is likely to become an issue that the manned commercial space transportation industry will have to face sooner or later

11. Reusable Launch Vehicles (RLV) represent the most feasible approach for the development and implementation of successful manned commercial space flights

12. FAA SUPPORT OF MANNED COMMERCIAL SPACE OPERATIONS IN THE U.S.

13. Letter from the FAA Associate Administrator for AST (October 8, 1998) Public Safety Issues for Launch and Reentry Reusable Launch Vehicles (RLVs) and Reentry Vehicles (RVs) Human rating safety requirements for RLVs (life support requirements, training and personnel qualifications, and functional responsibility for public safety-related operations)

14. FAA Associate Administrator for AST (October 2003) AST releases “Draft Guidelines for Licensed Suborbital RLV Operations with Flight Crew”

15. FAA Office of Aerospace Medicine (August 2003 to present) CAMI is producing a report on “Minimum Environmental Control & Life Support Guidelines for Manned Commercial RLVs”

17. FAA Office of Aerospace Medicine • March 1998: The Federal Air Surgeon approved establishment of the Space Medicine Program Committee (SMPC) at the Civil Aerospace Medical Institute (CAMI) • June 1998: The SMPC met at CAMI and established the Space Medical Certification Subcommittee (SMCS) • April 1999: The SMCS produced a final draft on “Medical Standards for Orbital Commercial Space Flight Crews” that was submitted to the Federal Air Surgeon for review

18. FAA Office of Aerospace Medicine • June 1999: The SMPC produced a prioritized list of medical and human factors research needs in support of manned commercial space operations that was submitted to AST • February 2000: The SMCS produced a final draft on “Recommended Guidelines for Medical Screening of Commercial Space Passengers” that was submitted to the Federal Air Surgeon and AST for review • March 2003: The “Guidelines” were approved by the Federal Air Surgeon and were submitted to AST for final consideration and subsequent discussion with COMSTAC on October 26, 2004

19. What did we do to medically certify SpaceShipOne test pilots?

20. We authorized a routine Class 2 Airman Medical Certificate issued by an Aviation Medical Examiner (AME) and reviewed by the Aerospace Medical Certification Division at CAMI

21. “Recommended Guidelines for Medical Screening of Commercial Space Passengers”

22. What is the minimum “Right Stuff” for passengers in commercial space flights?

23. How conservative should medical screening guidelines be for space passengers in order to: Promote the preservation of life and the safety of the flight? and at the same time Avoid imposing an obstacle to the successful establishment and growth of the manned space tourism industry?

24. “The problem is never how to get new, innovative thoughts into your mind, but how to get the old ones out” Dee Hock

25. MEDICAL SCREENING GUIDELINES FOR SPACE PASSENGERS Such guidelines should enable the identification of prospective space passengers who have certain medical conditions that are likely to: • result in in-flight death • result in a sudden in-flight medical emergency • compromise in any other way the health and safety of all occupants onboard a commercial space vehicle

26. Main Risk Factors Relevant to the Development of Guidelines for Medical Screening of Commercial Space Passengers • Exposure to acceleration/deceleration • Exposure to decreased barometric pressure • Exposure to microgravity • Exposure to radiation (solar and cosmic)

27. In view of the wide variety of possible approaches to design, produce and operate manned commercial RLVs the guidance for medical screening applies differently to two categories of space passengers: Passengers on suborbital space flights or exposed to a G-load of up to +3Gz during any phase of the flight. Passengers on orbital space flights or exposed to a G-load exceeding +3Gz during any phase of the flight.

28. Guidance for Medical Screening of Passengers on Suborbital Flights or Exposed to a G-Load of up to +3Gz During any Phase of the Flight.

29. This medical screening guidance is based on the following assumptions: • An in-flight cabin environment with a barometric pressure not exceeding 8,000 ft (10.91 psi), where passengers will not be required to use a pressurized suit • Passengers will be able to perform an emergency evacuation without assistance

30. A Common Sense Approach • Passengers complete a medical history questionnaire prior to every flight (single or multiple) • A company physician who is experienced or trained in the concepts of aerospace medicine reviews the completed questionnaire • Passengers do not need to undergo a physical examination nor to complete medical laboratory testing unless deemed necessary by the company physician upon review of the completed questionnaire

31. Recommended Medical History Questionnaire for Suborbital Space Passengers • Otitis, sinusitis, bronchitis, asthma, or other respiratory disorders • Dizziness or vertigo • Fainting spells, or any other loss of consciousness • Seizures • Tuberculosis • Surgery and other hospital admissions • Visits to physicians in the last 3 years • Recent significant trauma • History of decompression syndrome (DCS) • Anemia or other blood disorders

32. Heart or circulatory disorders, including implanted pacemaker or defibrillator • Mental disorders • Claustrophobia • Attempted suicide • Use of medications • Alcohol or drug dependence or abuse • Date of last menstrual period, current pregnancy, recent post-partum (less than 6 weeks), or recent spontaneous or voluntary termination of pregnancy • Diabetes • Cancer • Rejection for life or health insurance

33. Medical Conditions that may Contraindicate Passenger Participation in Suborbital Flights Any deformities (congenital or acquired), diseases, illnesses, injuries, infections, tumors, treatments (pharmacological, surgical, prosthetic, or other), or other physiological or pathological conditions that may: • Result in an in-flight death • Result in an in-flight medical emergency • Interfere with the proper use (don and doff) and operation of personal protective equipment • Interfere with in-flight emergency procedures or emergency evacuation • Compromise the health and safety of the passenger or other space vehicle occupants, and/or the safety of the flight

34. An established clinical diagnosis or finding of any of the following conditions may contraindicate participation in space flight and should be evaluated on a case-by-case basis: • Acute or chronic use of any medication (prescription and/or non-prescription), drug, or substance • Severe trauma or invasive medical procedures (diagnostic or therapeutic) associated with significant functional deficit • Severe acute or chronic infections or communicable/contagious diseases (including blood borne infectious diseases) • Cancer

35. Any psychiatric, psychological, mental, or behavioral disorder that would cause an individual to become a potential hazard to him/herself or to others. • Current pregnancy, recent post-partum (less than 6 weeks), or recent spontaneous or voluntary termination of pregnancy • History of individual exposure to ionizing radiation (single dose or cumulative) that exceeds the maximum exposure limit of 5 mSv in 5 years recommended by the International Commission on Radiological Protection. • Any other medical conditions that may result in significant functional impairment or that may be aggravated by exposure to the environmental or operational stress factors of space flight.

36. Suggested handling of prospective space passengers who have medical conditions that may contraindicate participation in space flight: • These individuals could be given medical clearance on a case-by-case basis by the company physician • Based on the specific nature of the medical condition, an individual could be temporarily prohibited from participation in space flight until such a condition resolves or until it can be effectively brought under medical control

37. Other Considerations • Prospective passengers should be informed on the potential hazards to health of space flight, including the hazards of exposure to solar and cosmic radiation, acceleration, and microgravity • It must also be recognized that no conclusive data exist concerning the potential adverse physiologic and pathologic effects of space flight on infants or young children. For this reason, operators may wish to establish a minimum age for passengers participating in space flights.

38. RISK FACTORS FOR THE OCCUPANTS OF SPACE VEHICLES 1) EXTERNAL ENVIRONMENTAL FACTORS 2) OPERATIONAL FACTORS (Vehicle and Flight Operations) 3) INDIVIDUAL FACTORS

39. RISK FACTORS FOR THE OCCUPANTS OF SPACE VEHICLES 1) EXTERNAL ENVIRONMENTAL FACTORS: - Weather (during the atmospheric phase of flight) - Barometric pressure - Ambient temperature - Solar and cosmic radiation - Microgravity/weightlessness - Space debris (natural and human-made) - Post-emergency landing or post-crash survival issues

41. Short exposures in suborbital flights Largest solar super flare on record occurred at 21:51 pm on Monday, April 2, 2001

42. Longer exposures in suborbital flights But then several even larger solar superflares occurred on November 2003

43. Success

45. Space debris will be a risk factor for the occupants of orbital space vehicles A speck of paint from a satellite dug a pit in a space shuttle window nearly ¼ inch wide NASA has replaced more than 80 shuttle windows due to debris impacts

46. Space debris is a concern for the safety of people on the ground January 1997 – A 580 pound tank from the 2nd stage of a Delta 2 survived reentry and crashed in Georgetown, Texas January 2001 – A 140 pound payload assist module of a Delta 2 crashed in Saudi Arabia

48. RISK FACTORS FOR THE OCCUPANTS OF SPACE VEHICLES 2) OPERATIONAL FACTORS (Vehicle and Flight Operations): - Type of acceleration profile (take off/launch, cruise, landing) and relative position of the occupants during acceleration exposure - Type of flight profile (ascent rate, maximum altitude, descent rate, duration of the flight) - Cabin/suit pressurization profile - Noise/vibration exposure during flight

49. SpaceShipOne test pilots did not use pressure suits

50. RISK FACTORS FOR THE OCCUPANTS OF SPACE VEHICLES 2) OPERATIONAL FACTORS (Vehicle and Flight Operations): - Breathing air (composition, contaminants, CO2 removal, volume per occupant) - Cabin/suit temperature and humidity - Impact/crash exposure (structural integrity or crashworthiness, occupant restraint systems, personal protective equipment, emergency evacuation systems, etc.)