Space & Health News – August 2019 – Law and Order

WELCOME TO SPACE & HEALTH NEWS, our monthly briefing of opportunities and advances in deep space medicine and space healthcare. In this issue, we take a closer look at the landscape of laws and regulations governing space healthcare in the U.S., and at the gaps and opportunities in the policy space.


SPACE LAW IN BRIEF

The history of space law started over 100 years ago, with an article published in 1910 in Paris, by a Belgian lawyer, Emile Laude, who believed a new body of law should govern relations in space. Out of those early beginnings, space law took shape gradually, with important commentaries and dissertations being published in the 1930s, 1940s and 1950s.

By the time Sputnik-1 was launched on October 4, 1957, theoretical constructs had turned into practical concerns, and the need for a new body of law to regulate the activities of humankind in space became stringent. Several countries – USSR, United States, Japan, France, Canada and Argentina, to name a few – enacted national space laws devoted to the oversight of national activities in space. The United Nations’ Committee on the Peaceful Uses of Outer Space (COPUOS) issued several treaties and declarations of principles during this time, the most important one being the Outer Space Treaty (OST), signed by the United States, the United Kingdom and the Soviet Union in 1967.

The OST stipulated that exploration and use of the outer space should be carried out for the benefit of all humanity, and that outer space could not be subject to any appropriation or claim of sovereignty. It was a huge step forward in the history of space law and it served to govern space activities and relations for over 50 years. Yet, it lacked in many regards. The OST omitted to set clear rules for the ownership of metals, minerals and other resources that may be found on celestial bodies, and similarly failed to impose policy constraints on human behavior in outer space.  

The gaps in the OST led the international community to renew its efforts, during the 1970s, to create a multilateral agreement for the use of the Moon and other celestial bodies similar to the one established for the sea floor (per the United Nations Convention on the Law of the Sea). The resulting agreement, the Agreement Governing the Activities of States on the Moon and Other Celestial Bodies, also known as the Moon Treaty or the Moon Agreement – failed to garner ratification from any of the states engaged in crewed space exploration. The United States, many of the European Space Agency member countries, as well as Russia, China and Japan refused to sign it, which essentially rendered the agreement moot.

In 2015, under pressure from increasingly impatient investors and space mining companies, the U.S. Congress passed a new law – the Commercial Space Launch Competitiveness Act (referred to as the Space Act) – to grant U.S. space firms the rights to own and sell natural resources they mine in space. At the same time, other players, such as the Grand Duchy of Luxembourg and Belgium, also found opportunity in the loose and sometimes contradictory nuances of past space legislation, and used it to forth their own legal frameworks for the ownership of space resources and for the authorization and supervision of space missions.

In 2017, the American Space Commerce Free Enterprise Act was introduced in the House and approved by the Committee on Science, Space, and Technology. The draft bill is seen as both innovative as well as controversial, as it seeks to promote the growth of the U.S. private space sector with minimal regulatory burdens. The Act sets out a new authorization and control procedure for nontraditional private space activities (such as space mining) under the authority of the Department of Commerce, Office of Space Commerce (OSC), and it also streamlines the existing procedure to obtain a permit to operate private remote sensing systems. The draft bill is now with the Senate for review. Given that no movement has been made on it for over a year, its future looks doubtful.

Of particular interest to those focused on the field of space medicine and space healthcare is the fact that none of the treaties and pieces of legislation mentioned so far include any stipulations concerning the health and well-being of space crew and space travelers in general, or, even more broadly, regarding the preservation of human rights and well-being in space.

AGENCY-SPECIFIC SPACE LEGISLATION

To find evidence of legislative concern for the health of individuals whose profession takes them on high-risk missions into space, one has to follow the breadcrumb trail to the specific agencies governing the various facets of crewed space exploration and crew health, and examine the laws authorizing the mandates and activities of each one of these agencies.

Navigating the landscape of laws and policies applicable to the health and health care aspects of human space exploration is a difficult task, both at the national and – even more so – at the international level.

Now, this is easier said than done, since, at least in the United States, an authoritative list of such agencies does not exist.

Information triangulated from sources such as GlobalEdge, Wikipedia, Congressional Research Service, Space Foundation, Dept. of State website, and from a recent study done by the National Academies of Sciences, Engineering, Medicine – shows that the landscape of federal agencies involved in governing and overseeing aspects of United States’ space exploration program is quite crowded, and it includes:

Agency-specific legislation includes:

[1] The National Aeronautics and Space Administration Transition Authorization Act of 2017 is the latest bill authorizing funding for NASA’s core mission objectives (exploration, space operations, space technology, safety and mission services among them). The bill also authorizes the extension of International Space Station operations until at least 2024 and support for the development of a commercial capability to transport astronauts to low-Earth orbit, and affirms congressional support for several major NASA science missions currently in development.

[2] Sections 441-443 of the NASA Transition Authorization Act of 2017 provide for the implementation of new provisions including the “To Research, Evaluate, Assess, and Treat Astronauts Act,” also referred to as the “TREAT Astronauts Act” or the “TREAT Act.” The TREAT Astronauts Act authorizes NASA to monitor, diagnose, and treat medical and psychological conditions associated with spaceflight. These services are extended both to active service astronauts as well as to retired astronauts, provided they have been on at least one space mission.

[3] The Commercial Space Launch Act of 1984, as amended and re-codified at 51 U.S.C. 50901 – 50923 (the Act), authorizes the Department of Transportation (DOT) and, through delegations, the Federal Aviation Administration’s (FAA) Office of Commercial Space Transportation (AST), to oversee, authorize, and regulate both launches and reentries of launch and reentry vehicles, and the operation of launch and reentry sites when carried out by U.S. citizens or within the United States. The Act directs the FAA to exercise this responsibility consistent with public health and safety, safety of property, and the national security and foreign policy interests of the United States. The Act was subsequently updated with the passage of the U.S. Commercial Space Launch Competitiveness Act 2015 (H.R. 2262), sometimes referred to as the Spurring Private Aerospace Competitiveness and Entrepreneurship Act of 2015.

[4] The Military Health System is DoD’s military health care delivery operation, which provides health services and medical benefits to active duty personnel, military retirees and their families. Should DoD pursue a course of sending its military personnel on space missions, the National Defense Authorization Act (NDAA) and Military Health Law legislation and regulations governing the Military Health System would extend to military space crew.


The U.S Department of Health and Human Services (HHS), not included on this list, has put in place several agreements and Memorandums of Understanding with NASA to participate in biomedical research and research into radiation-induced human health risks and medical countermeasures. Although HHS’ stated mission is to ” enhance the health and well-being of all Americans”, the department does not currently drive any policy-setting efforts with regards to the health and health care afforded to space crew personnel.

SPACE POLICY-MAKING

In his influential essay “The Formulation of Health Policy by the Three Branches of Government”, Hon. Lawrence Gostin, J.D., Professor of Medicine at Georgetown  University and Professor of Public Health at the Johns Hopkins University, points to the agencies in the government’s executive branch as being best-positioned to define health policies. He caveats his conclusion with the following stark observation. “America’s  expansive range of policymaking bodies and groups seeking to influence  policy”, he states, “render it impossible to offer a systematic and comprehensive  analysis of health policy formulation.”

As valid today as it was in 1995, when his essay was published, Prof. Gostin’s comment rings true not just in areas traditionally linked to health policy – health care, public health, and biotechnology – but also in the emerging fields of space medicine and space healthcare.

First off, within each of the federal agencies listed in the table above as bearing responsibility for space activities and regulations, several offices have been created to advise on certain aspects of space policy-making and/or policy execution.  The Commercial Space Transportation Advisory Committee (COMSTAC) for instance, established in 1984, provides information, advice, and recommendations to the Federal Aviation Administration (FAA) on critical matters concerning the U.S. commercial space transportation industry. Similarly, the Defense Space Council (DSC), created in 2010, serves as the principal advisory forum to inform, coordinate and resolve space issues for DoD. At NASA, given the breadth of its space-related activities, multiple offices – including the Office of Safety & Mission Assurance (OSMA), the Chief Health and Medical Officer (OCHMO), and the Office of Planetary Protection – play policy-setting roles.  

In addition, various White House offices are involved in setting out and implementing space policy – including the Office of Science and Technology Policy (OSTP), the National Security Council (NSC) and the Office of Management and Budget (OMB). These federal offices are charged with shaping the space-related policies and activities of the U.S. government. The National Space Council, reestablished in 2017 and chaired by the Vice President of the United State, also plays a large role in the formulation and execution of U.S. space policy.

Last but not least, a number of U.S.-based think tanks and research forums have been established over time, which promote international coordination on space research topics and provide advisory support to the federal government. The Space Studies Board (SSB) is a prominent example. The SSB provides an independent, authoritative forum for information and advice on all aspects of space science and applications, and it serves as the focal point within the National Academies of Sciences, Engineering, and Medicine for activities on space research. The SSB also serves as the U.S. National Committee for the International Council for Science Committee on Space Research (COSPAR).

CURRENT SPACE HEALTH POLICIES AND STANDARDS

NASA and, to a lesser extend, the Federal Aviation Administration (FAA), are the primary (and possibly the only) U.S. federal agencies currently engaged in setting policies and standards concerning the health care aspects of space exploration. A representative selection of the policies formulated by these two agencies is provided in the table below.

Agency Sample Policy/ Standard/
Rule
Brief Description
FAA Human Space Flight Requirements for Crew and Space Flight Participants

December 15, 2006
Provides rules on crew qualifications and training, and informed consent for crew and space flight participants, to ensure 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.
FAA Guidance on Informing Crew and Space Flight Participants of Risk

April 4, 2017
Requires launch or reentry operators to inform each crew member in writing of the following: “The United States Government has not certified the launch vehicle and any reentry vehicle as safe for carrying flight crew or space flight participants.” A launch or reentry operator must provide this statement to the crewmember before entering into any contract or other arrangement to employ that individual.
FAA Federal Aviation Regulations : TITLE 14—Aeronautics and Space, CHAPTER III, SUBCHAPTER C—LICENSING, PART 460—HUMAN SPACE FLIGHT REQUIREMENTS

Current as of August 26, 2019  
Lays out FAA’s policies governing human spaceflight requirements in Subpart A (Launch and Reentry with Crew) and Subpart B (Launch and Reentry with a Spaceflight Participant). They include requirements for informing crew of risk, informing space flight participant of risk, collecting spaceflight participants’ waiver of claims against U.S. Government, and training the crew and the spaceflight participants on how to handle emergency situations.  
FAA Federal Aviation Regulations : TITLE 14—Aeronautics and Space, CHAPTER I, SUBCHAPTER D—AIRMEN, PART 67—MEDICAL STANDARDS AND CERTIFICATION

Current as of August 26, 2019
Prescribes the medical standards and certification procedures for issuing medical certificates for airmen (and airwomen – sic!) – including space crew – and for remaining eligible for a medical certificate.
NASA NASA Occupational Health Program – NPD 1800.2D

August 12, 2016 – August 12, 2021
Documents NASA’s policy to promote and maintain the physical and mental well-being of its employees, both in the workplace and on international travel and assignment.
NASA NASA Medical System Quality Assurance – NPD 1850.1

February 23, 2010 – February 23, 2020
Stipulates NASA’s adherence to high norms of quality assurance by conducting a comprehensive program to systematically review and improve the quality of medical and behavioral health services and the efficiency and effectiveness of the utilization of staff and resources in the delivery of such services.
NASA NASA Health and Medical Technical Authority (HMTA) Implementation – NPR 7120.11

November 1, 2011 – March 1, 2020
Provides the procedural requirements and processes for implementing Health and Medical Technical Authority (HMTA) throughout the Agency
NASA Human-Rating Requirements for Space Systems – NPR 8705.2C

July 10, 2017 – July 10, 2022
Defines and implements the additional processes, procedures, and requirements necessary to produce human-rated space systems that protect the safety of the crew and passengers on NASA space missions
NASA NASA Health and Medical Requirements for Human Space Exploration – NPR 8900.1B

December 16, 2016 – December 16, 2021
Provides the procedural requirements and processes for the NASA Health and Medical System for Human Space Exploration.
NASA Medical Operations Responsibilities in Support of Human Spaceflight Programs – NPD 8900.1G

May 31, 2002 – May 31, 2022
Lays out the medical operations responsibilities assigned to the Chief Health and Medical Officer (CHMO), the Office of the Chief Health and Medical Officer (OCHMO), the Human Exploration and Operations (HEO) Mission Directorate, and to each NASA Center Director.
NASA Astronaut Medical and Dental Observation Study and Care Program – NPD 8900.3H

August 16, 2011 – August 16, 2022
Affirms NASA’s policy to provide medical and dental care and occupational monitoring to astronauts, payload specialists, and other space flight participants while they are on active duty with NASA.
NASA NASA Health and Medical Policy for Human Space Exploration – NPD 8900.5B

December 22, 2011 – December 22, 2022
Affirms NASA’s policy to provide a safe environment for crewmembers, provide health and medical care systems for crewmembers, maintain crewmember health and medical services up-to-date, provide health and medical training to crewmembers, establish space flight health and medical standards, and Sponsor health and medical clinical research to enable human space exploration.

STILL MISSING …

The existing milieu of space-oriented U.S. laws, guidelines, policies and regulations outlined in this article serves as the foundation for the health care system afforded to NASA astronauts today. By its very intent and purpose, this health care system is limited in scope – since it ONLY caters to NASA astronauts and no one else. NASA astronauts, thanks to the stringent selection process employed when assessing applicants, are by no means representative of the general workforce in the U.S. The individuals accepted in the NASA astronaut program are in their prime years, in exceptional physical and mental shape, and the great majority of them come from other branches of the U.S. government – meaning they are already government employees covered by government health care and retirement benefits. Once accepted into the program, NASA astronauts receive more than two years of mission training, including comprehensive medical training, and have to pass additional fit-for-flight testing before receiving a mission assignment.

While the existing FAA policies set medical standards requirements for all crew and spaceflight participants regardless of who their employer is, the current regulatory framework does not stipulate any standards of health care for employers other than NASA. In the same vein, there are no stipulations with regards to the type of health insurance coverage crew members should have, the employer’s vs. the individual’s responsibility for procuring the said health insurance, and for paying premium costs and out-of-pocket expenses. As a result, commercial companies sending their staff on space missions operate in a somewhat gray area, where the allocation of health risks and corresponding costs between the company and its space-faring employees is governed by invisible rules which may not be entirely fair to the employee, or to the company, or even to society at large if externalities are not considered.

Crew members and participants on long-duration space missions are exposed to significant health hazards. Life in micro-gravity (or zero gravity), in isolation and confinement, and subject to the dangers of ionizing radiation – leads to both physical and cognitive deconditioning and a host of health conditions, some treatable and some irreversible. [Image reproduced from the ISDC2019 presentation “The Man on the Moon Needs Healthcare”]

With the International Space Station opening its gates to commercial business – and travelers – starting next year, actuarials somewhere must already be busy estimating risks and forecasting health insurance premiums. Whether the “space health insurance” market is going to be regulated or, on the contrary, will be left to its own devices, will act either as a booster or as a dampener on the availability and affordability of commercial crew, and, implicitly, on the future expansion of our space exploration efforts.

Moreover, as soon as a (slightly) more diverse human population starts visiting the International Space Station and, soon thereafter, other space stations, the Moon, and at some point in the future, Mars, that population will bring along the same types of questions, problems and issues besetting health care down here on Earth, such as:

  • What does “equal access to health care” mean, in an outer space setting?
  • How does one get health insurance coverage for travel/work in space? Can one travel to space without individual health insurance? <gasp!>
  • How can health care in space be made more affordable?
  • How is the quality of health care measured? How are quality targets enforced?
  • How is emergency care provided? Who pays for it?
  • Considering the effects of space travel on the human body, is space travel going to be considered a “health pre-condition” once a crew member returns from space?

All considered, the gaps in the existing U.S. legislation and policies with regards to providing for the health and health care of ALL space travelers are significant – but not intractable. A concerted effort spearheaded by the federal agencies responsible for the health of our citizens and backed by congressional support will be essential to democratizing the access to space. Technology-wise, commercial space exploration is on its way to becoming a reality. The question is – will the U.S. be ready for it?

Featured image contains vector elements by Istvan Brecz-Gruber (Pixabay) and by Freepik. 

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