This document summarizes a presentation given at the 2019 Petrie-Flom Center Annual Conference on "Programming Our Genomes, Programming Ourselves: The Moral and Regulatory Limits of Self-Harm in DIY Genomics". The presentation discusses the various US laws and regulations that potentially apply to biotechnology and DIY biology. It notes the challenges of regulating novel technologies that do not fit existing regulatory frameworks. It also discusses different narratives around citizen science and DIY biology, and considers how 20th century regulations distinguished personal/small-scale activities from commercial/large-scale activities.

1. 2019 Petrie-Flom Center Annual Conference
Consuming Genetics
May 17, 2019
Programming Our Genomes, Programming Ourselves
The Moral and Regulatory Limits of Self-Harm in DIY Genomics
Barbara J. Evans, Ph.D., J.D., LL.M.
Mary Ann and Lawrence E. Faust Professor of Law
Professor, Electrical and Computer Engineering
Director, Center for Biotechnology & Law
University of Houston
bjevans@central.uh.edu 713-446-7576

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3. US Coordinated Framework for Regulation of Biotechnology
the anything-but-coordinated framework
EPA Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Toxic Substances Control Act
FDA Federal Food, Drug, and Cosmetic Act
Public Health Service Act
USDA Animal Health Protection Act
Plant Protection Act
Federal Meat Inspection Act
Poultry Products Inspection Act
Egg Products Inspection Act
Virus-Serum-Toxin Act
OSHA Occupational Safety and Health Act
CPSC Consumer Product Safety Act
NIH Guidelines & biosafety requirements for funded research
All Procedural statutes, e.g., NEPA, ESA, APA

4. Source: NAS, Preparing for Future Products of Biotechnology, 2017 4

5. NAS, Preparing for Future Products of Biotechnology, 2017 5

6. The Obvious Regulatory Challenges
• Novel biotech products not fitting into the jurisdictional
“buckets” that trigger regulation
• Changes in technology
• Changes in industry structure
• Regulatory powers not well tailored for managing the risks
• The scope, scale, pace, novelty, and complexity of innovation
threatening to overwhelm available regulatory capacity
• The obvious regulatory challenges are not the real challenges

7. Citizen Science and DIY Bio
Competing Narratives
Political narratives: the “outlaw” and “hacker” portrayals*
The nostalgia narrative*
The “new frontier for institutional science” narrative*
The “democratization of science and medicine” narrative
*Ikemoto: DIY Bio: Hacking Life in Biotech’s Backyard, 51 U.C. Davis L. Rev. 539
(2017)
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8. The commercial/large-scale vs. personal/small-scale
distinction in 20th century regulatory frameworks*
• The de minimis nature of personal/small-scale activities
• High fixed cost of regulatory interventions
• Feasibility of regulating large numbers of small actors
• Privacy rights and concerns about regulatory invasions of
constitutionally protected zones like people’s homes
• Disjunction between the entity that needs to be regulated and
the entity that holds the information regulators need
• Skepticism that compulsory regulation is the best tool to elicit
compliance with norms
Zale, When Everything is Small: The Regulatory Challenge of Scale in the Sharing
Economy, 53 San Diego L. Rev. 949 (2016)

9. How paternalistic was 20th-century regulation really?
The Harm Principle — It is appropriate to regulate an actor to
prevent harms to persons other than the actor
Legal Paternalism — It is appropriate to regulate people to
keep them from harming themselves
• benevolent vs. non-benevolent paternalism
• soft paternalism/soft anti-paternalism—law allows people to
consent to self harm but oversees consent to make sure it is
competent, voluntary, and informed
• But if people are competent and well-informed, should
regulators prevent them from pursuing risky activities?
Legal Moralism—nobody is harmed, but it’s just wrong or yukky
Joel Feinberg, Moral Limits of the Criminal Law, Vol. 3: Harm to Self (1989)

10. How does FDA define Software as a Medical Device?
The term Software as a Medical Device is defined by the
International Medical Device Regulators Forum (IMDRF) as
"software intended to be used for one or more medical
purposes that perform these purposes without being part
of a hardware medical device." …
It can be used across a broad range of technology platforms,
including medical device platforms, commercial "off-the-
shelf" platforms, and virtual networks, to name a few. Such
software was previously referred to by industry, international
regulators, and health care providers as "standalone software,"
"medical device software," and/or "health software," and can
sometimes be confused with other types of software.
FDA, Software as a Medical Device (SaMD), https://www.fda.gov/medical-
devices/digital-health/software-medical-device-samd