A page dedicated to (links to) discussions of the laws and regulations that affect BioCurious, DIYbio, or citizen science in general

Laws governing our space

DIYbio, synthetic biology, genetic engineering

BioSafety

• The simplified version:
• The source of the DNA matters. If the host and the origins of all the components are non-pathogenic, it's BL1. But if anything comes from a pathogenic organism, it may require BL2 (see http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Toc7261568)
• There's a list of exempt Host-Vector Systems and sources of Gram+ plasmids (see http://oba.od.nih.gov/oba/rac/Guidelines/APPENDIX_C.htm), and a list of specific Certified Host-Vector Systems (http://oba.od.nih.gov/oba/rac/Guidelines/APPENDIX_E.htm)
• There's exceptions to everything (and exceptions to the exceptions on the exceptions)
• Plants and animals have their own set of rules.
• The long version:
• The CDC's Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition has this to say:
  http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf
  p.12: "Genetically modified agent hazards. The identification and assessment
  of hazardous characteristics of genetically modified agents involve consideration of the same factors used in risk assessment of the wild-type organism. It is particularly important to address the possibility that the genetic modification could increase an agent’s pathogenicity or affect its susceptibility to antibiotics or other effective treatments.
  [...]
  The NIH Guidelines are the key reference in assessing risk and establishing an appropriate biosafety level for work involving recombinant DNA molecules.
  [...]
  The NIH Guidelines explicitly address experiments that involve introduction of recombinant DNA into Risk Groups 2, 3, and 4 agents, and experiments in which the DNA from Risk Groups 2, 3, and 4 agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems."
• The NIH Guidelines can be found at: http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm. The relevant parts seem to be in SECTION III. EXPERIMENTS COVERED BY THE NIH GUIDELINES. The subsections underneath are ordered from most to least hazardous, starting with III-A, "Major Actions under the NIH Guidelines". We'd want to play in sections III-D, E or F.
• III-F covers some experiments that are completely exempt, and includes an interesting APPENDIX C. EXEMPTIONS UNDER SECTION III-F-6. "Those that do not present a significant risk to health or the environment". This appendix excludes E.coli K12, Saccharomyces, Kluyveromyces, B.subtilis and B.licheniformis Host-Vector Systems, and Extrachromosomal Elements from a list of Gram Positive Organisms. All of those would be fine in BL1 (with the usual exceptions to the exceptions...)
• Section III-E is essentially another blanket exemption: "Experiments not included in Sections III-A, III-B, III-C, III-D, III-F, and their subsections are considered in Section III-E.  All such experiments may be conducted at BL1 containment.  [...] For example, experiments in which all components derived from non-pathogenic prokaryotes and non-pathogenic lower eukaryotes fall under Section III-E and may be conducted at BL1 containment."
• The one where we most risk running into borderline cases is this one: Section III-D-2. Experiments in Which DNA From Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems. Technically, I believe this could include any time we're using a vector, antibiotic resistance gene, or even a promoter that originated from a pathogenic organism. Experiments under Section III-D-2 can typically be performed under BL2. "The IBC may approve the specific lowering of containment for particular experiments to BL1.  Many experiments in this category are exempt from the NIH Guidelines (see Section III-F, Exempt Experiments)."
   

DIYbio Code of Ethics

• http://diybio.org/codes/
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Intellectual "Property"

Copyright

Patents

• Genomics Law Report
• The Experimental Use Exemption to Patents
• Allowed “for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.”
• Safe harbor for research on pharmaceuticals or medical devices (anything that could lead to an FDA submission).
• Any use of patented matter in research outside pharmaceuticals or medical devices that is in any way related to the business objective of the entity constitutes infringement, even for non-profits. E.g. for universities, the business objective would include educating students, supporting faculty research, obtaining research grants, enhancing status of the university.
• Use of patented research tools in research always constitutes infringement.
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Trademarks

Trade secrets