Genome-editing Technology Advisory Panel Background Materials
Legislative History of Advisory Panel Legislation:
LD 1771, Resolve, To Establish the Advisory Panel To Better Understand and Make Recommendations Regarding the Implications of Genome-editing Technology for the Citizens of the State
- Bill tracking and testimony: available here
- Finally passed as: Resolve 2021, Ch. 177
Similar legislation proposed in the prior session:
LD 1601, Resolve, To Establish an Advisory Panel To Study the Implications of Genome-editing Technology for the Citizens of the State
- Bill tracking and testimony: available here
Selected Background Materials:
Date
Item (or author, title, publication info., date)
Notes
2000
Mark S. Frankel & Audrey R. Chapman, Human Inheritable Genetic Modifications: Assessing Scientific, Ethical, Religious and Policy Issues (2000)
Report prepared for the American Association for the Advancement of Science (AAAS) and made available online by AAAS.
February 2017
National Academies of Sciences, Engineering & Medicine, Human Genome Editing: Science, Ethics and Governance, The National Academies Press (2017).
Consensus study report of the: Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations
February 2017
WNYC Studios, Radiolab Podcast: Update: CRISPR (2019)
A closed-captioned version of the podcast is available here.
2018
Nuffield Council on Bioethics, Genome editing and human reproduction: social and ethical issues (2018)
Also available on the website are:
- a shorter guide to the report; and
- a separate document listing the key report recommendations
2019
Joanna Buchthal, et al., Mice Against Ticks: an experimental community-guided effort to prevent tick-borne disease by altering the shared environment, Phil. Trans. R. Soc. B, 374: 20180105 (2019)
January 2019
George Q. Daley, et al., After the Storm ̶ A Responsible Path for Genome Editing, NEJM.org (2019)
Full-text access requires either registration or a subscription.
March 2019
Wonder Collaborative, Human Nature (2019)
The trailer for this documentary is available here.
March 2019
Eric Lander, et al., Comment: Adopt a moratorium on heritable genome editing, 567 Nature 165 (2019)
December 2019
Further Consolidated Appropriations Act, 2020, Pub. L. No. 116-94
See Division B, Title VII, Section 745, which appears on page 120 of the PDF file.
National Academy of Medicine, National Academy of Sciences & The Royal Society, Heritable Human Genome Editing, The National Academies Press (2020)
Consensus study report of the: International Commission on the Clinical Use of Human Germline Genome Editing
October 2020
The Royal Swedish Academy of Sciences, Press Release: The Nobel Prize in Chemistry 2020
Also available on this website are:
- Genetic scissors: a tool for rewriting the code of life (popular science background)
- A Tool for Genome Editing (scientific background)
October 2020
Francois Baylis, et al., Human Germline and Heritable Genome Editing: The Global Policy Landscape, 3 CRISPR J. 365 (2020)
A Supplementary Appendix listing policies in countries around the world, with links to original policy documents, is posted online and frequently updated.
John M. Conley, et al., A New Governance Approach to Regulating Human Genome Editing, 22 N.C. J.L. & Tech. 107 (2020)
Masafumi Omori, et al., Targeted mutagenesis of CENTRORADIALIS using CRISPR/Cas9 system through the improvement of genetic transformation efficiency of tetraploid highbush blueberry, 96 J. of Horticultural Science & Biotech., 153 (2021)
Article abstract (full text access requires a subscription).
March 2021
Walter Isaacson, The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race, Simon & Schuster (2021)
Nonfiction book available for purchase and at several public libraries in the State.
May 2021
International Society for Stem Cell Research, ISSCR Guidelines for Stem Cell Research and Clinical Translation: Version 1.0, (2021)
See Section 1: Fundamental Ethical Principles.
World Health Organization Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, Human Genome Editing: A Framework for Governance (2021)
Also available on the website are:
- A separate document outlining the Committee’s recommendations; and
- A shorter position paper summarizing the framework for governance and recommendations
U.S. Food & Drug Administration, Human Gene Therapy Products Incorporation Human Genome Editing: Draft Guidance for Industry (2022)
See Introduction and Background on pp. 3-4.
June 2022
Casey Crownhart, This CRISPR pioneer wants to capture more carbon with crops, MIT Technology Review (2022)
U.S. Food & Drug Administration, Feed Your Mind: Agricultural Biotechnology
Originally created in March 2020, this website is an FDA education initiative “to help consumers better understand genetically engineered foods, commonly called GMOs or genetically modified organisms.”
Background Materials Proposed After First Meeting of Advisory Panel:
- Her Discovery Changed the World. How Does She Think We Should Use It?, The New York Times (Aug. 15, 2022), available at: https://www.nytimes.com/interactive/2022/08/15/magazine/jennifer-doudna-crispr-interview.html. (A subscription is required to access this article, which profiles Dr. Jennifer Doudna, who won the Nobel Prize in Chemistry for helping develop CRISPR gene-editing technology.)
- New Zealand Geographic documentary about Duchenne Muscular Dystrophy entitled The Death Gene: https://www.nzgeo.com/video/the-death-gene/
- Documentary directed by Renee Tajima-Peña about the sterilization of Mexican immigrant mothers in Los Angeles in the 1960s and 1970s entitled No Más Bebés: a preview of the documentary is available at https://www.pbs.org/independentlens/documentaries/no-mas-bebes/ and the film’s website is available at: http://www.nomasbebesmovie.com/film.
- Siddhartha Mukherjee, The Song of the Cell: An Exploration of Medicine and the New Human (Simon & Schuster 2002) – this book will be published on October 25, 2022 and is described by the publisher as “an exploration of medicine and our radical new ability to manipulate cells.” Information about the book is available here, on the publisher’s website: https://www.simonandschuster.com/books/The-Song-of-the-Cell/Siddhartha-Mukherjee/9781982117351.
Background Materials Proposed During or After Second Meeting of Advisory Panel:
- Article: Zhang, Y., Pribil, M., Palmgren, M. et al., A CRISPR way for accelerating improvement of food crops, 1 Nature Food 200–05 (March 3, 2020), available at https://doi.org/10.1038/s43016-020-0051-8 (A subscription or institutional access is required to access this article, which provides an overview of CRISPR technology, its application to food crops, and implications of regulatory policy for deploying the technology in the developing world.)
- Book: Kent H. Redford & William M. Adams, Strange Natures: Conservation in the Era of Synthetic Biology (Yale University Press 2021). The publisher’s website is available here: https://books.google.com/books?id=rnkwEAAAQBAJ&printsec=frontcover&source=gbs_ViewAPI&hl=en#v=onepage&q&f=false.
- Article: Kent H. Redford & William M. Adams, COP26: Synthetic Biology and Nature-Based Solutions (Yale University Press; Nov. 4, 2021), available at https://yalebooks.yale.edu/2021/11/04/cop26-synthetic-biology-and-nature-based-solutions/.
- Note: this article was published before May 28, 2020, when the USDA’s Animal and Plant Health Inspection Service published its final rule revising the Sustainable, Ecological, Consistent, Uniform, Responsible, and Efficient (SECURE) rule. The SECURE rule regulates the movement (including environmental release) of genetically engineered organisms that are likely to pose plant pest risks.
- Opinion / Insight Piece: Matthew J. Kan & Jennifer A. Doudna, Treatment of Genetic Diseases With CRISPR Genome Editing, 328 JAMA 980 (Sept. 13, 2022), available at https://jamanetwork.com/journals/jama/fullarticle/2796264.
- Advertisement: Representative Hymanson has asked us to share the following advertisement from Boston Children’s Hospital about novel new genetics-based diagnostic and treatment tools: https://www.nytimes.com/paidpost/boston-childrens/flipping-the-diagnostic-playbook.html.
Background Materials Proposed During or After Third Meeting of Advisory Panel:
- Articles on Florida laws:
- Jeff Schmerker, New Florida Law Protects Genetic Testing Info. from Life, Disability, and Long-Term Care Insurance Policy Decisions, Integrated DNA Technologies’ Community Blog Post (Oct. 26, 2020), available at https://www.idtdna.com/pages/community/blog/post/new-florida-law-protects-genetic-testing-info-from-life-disability-and-long-term-care-insurance-policy-decisions
- Aldo M. Leiva, Baker Donelson, New Florida Genetic Privacy Law Imposes Criminal Penalties (Oct. 14, 2021), available at https://www.bakerdonelson.com/new-florida-genetic-privacy-law-imposes-criminal-penalties.
- Mark Rothsetin and Kyle Brothers, Banning Genetic Discrimination in Life Insurance – Time to Follow Florida’s Lead, 383 N. England J. Med. 2099 (Nov. 26, 2020), available at https://www.nejm.org/doi/pdf/10.1056/NEJMp2024123 (Full-text access to this article requires either registration or a subscription.)
- Community Engagement Research Model: Organizing Committee for Assessing Meaningful Community Engagement in Health & Health Care Programs & Policies, Assessing Meaningful Community Engagement: A Conceptual Model to Advance Health Equity through Transformed Systems for Healthi, NAM Perspectives, Commentary, National Academy of Medicine (Feb. 14, 2022), available at https://doi.org/10.31478/202202c.
- Maine Bioscience Day information: https://biomaine.org/event/me-bioscience-day-2022/
- Bioscience Association of Maine (BioME)’s Industry Report. The report, entitled Life Sciences in Maine: State of the Industry 2022 is available as a free download on the following webpage: https://biomaine.org/industry-impact/. The following article also describes the results of this report: Vivien Leigh, Life Sciences are Maine’s Fastest-Growing Industry, News Center Maine (Oct. 14, 2022), available at https://www.newscentermaine.com/article/money/business/life-sciences-are-maines-fastest-growing-industry-business-money-maine-health-technology-local/97-745728a5-2f32-44fc-bce6-531d588f840d.)
- Article: Jennifer Couzin-Frankel, As gene testing surges, lawsuits aren’t far behind, Science (May 7, 2019), available at https://www.science.org/content/article/gene-testing-surges-lawsuits-arent-far-behind#:~:text=doi%3A%2010.1126/science.aax9577
- Article: Scott P. McGrath, et al., Legal Challenges in Precision Medicine: What Duties Arising From Genetic and Genomic Testing Does a Physician Owe to Patients?, Frontiers in Medicine, Vol. 8, Article 663014 (July 26, 2021), available at https://www.frontiersin.org/articles/10.3389/fmed.2021.663014/full.
- Legal research resource: University of Minnesota & Vanderbilt University Medical Center, LawSeq: Mapping & Shaping the Law of Genomics (website with searchable databases of federal laws, state laws and secondary legal materials relevant to genomics), available at https://lawseq.umn.edu/ (last visited Oct. 18, 2022).
Legislative History of Advisory Panel Legislation:
LD 1771, Resolve, To Establish the Advisory Panel To Better Understand and Make Recommendations Regarding the Implications of Genome-editing Technology for the Citizens of the State
- Bill tracking and testimony: available here
- Finally passed as: Resolve 2021, Ch. 177
Similar legislation proposed in the prior session:
LD 1601, Resolve, To Establish an Advisory Panel To Study the Implications of Genome-editing Technology for the Citizens of the State
- Bill tracking and testimony: available here
Selected Background Materials:
|
Date |
Item (or author, title, publication info., date) |
Notes |
|
2000 |
Mark S. Frankel & Audrey R. Chapman, Human Inheritable Genetic Modifications: Assessing Scientific, Ethical, Religious and Policy Issues (2000) |
Report prepared for the American Association for the Advancement of Science (AAAS) and made available online by AAAS. |
|
February 2017
|
National Academies of Sciences, Engineering & Medicine, Human Genome Editing: Science, Ethics and Governance, The National Academies Press (2017). |
Consensus study report of the: Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations |
|
February 2017 |
WNYC Studios, Radiolab Podcast: Update: CRISPR (2019) |
A closed-captioned version of the podcast is available here.
|
|
2018 |
Nuffield Council on Bioethics, Genome editing and human reproduction: social and ethical issues (2018) |
Also available on the website are:
|
|
2019 |
Joanna Buchthal, et al., Mice Against Ticks: an experimental community-guided effort to prevent tick-borne disease by altering the shared environment, Phil. Trans. R. Soc. B, 374: 20180105 (2019) |
|
|
January 2019 |
George Q. Daley, et al., After the Storm ̶ A Responsible Path for Genome Editing, NEJM.org (2019) |
Full-text access requires either registration or a subscription. |
|
March 2019 |
Wonder Collaborative, Human Nature (2019) |
The trailer for this documentary is available here. |
|
March 2019 |
Eric Lander, et al., Comment: Adopt a moratorium on heritable genome editing, 567 Nature 165 (2019) |
|
|
December 2019 |
Further Consolidated Appropriations Act, 2020, Pub. L. No. 116-94 |
See Division B, Title VII, Section 745, which appears on page 120 of the PDF file. |
| September 2020 |
National Academy of Medicine, National Academy of Sciences & The Royal Society, Heritable Human Genome Editing, The National Academies Press (2020) |
Consensus study report of the: International Commission on the Clinical Use of Human Germline Genome Editing |
|
October 2020 |
The Royal Swedish Academy of Sciences, Press Release: The Nobel Prize in Chemistry 2020 |
Also available on this website are:
|
|
October 2020 |
Francois Baylis, et al., Human Germline and Heritable Genome Editing: The Global Policy Landscape, 3 CRISPR J. 365 (2020)
|
A Supplementary Appendix listing policies in countries around the world, with links to original policy documents, is posted online and frequently updated. |
| December 2020 |
John M. Conley, et al., A New Governance Approach to Regulating Human Genome Editing, 22 N.C. J.L. & Tech. 107 (2020) |
|
| 2021 |
Masafumi Omori, et al., Targeted mutagenesis of CENTRORADIALIS using CRISPR/Cas9 system through the improvement of genetic transformation efficiency of tetraploid highbush blueberry, 96 J. of Horticultural Science & Biotech., 153 (2021) |
Article abstract (full text access requires a subscription). |
|
March 2021 |
Walter Isaacson, The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race, Simon & Schuster (2021) |
Nonfiction book available for purchase and at several public libraries in the State. |
|
May 2021 |
International Society for Stem Cell Research, ISSCR Guidelines for Stem Cell Research and Clinical Translation: Version 1.0, (2021) |
See Section 1: Fundamental Ethical Principles. |
| July 2021 |
World Health Organization Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, Human Genome Editing: A Framework for Governance (2021) |
Also available on the website are:
|
| March 2022 |
U.S. Food & Drug Administration, Human Gene Therapy Products Incorporation Human Genome Editing: Draft Guidance for Industry (2022) |
See Introduction and Background on pp. 3-4. |
|
June 2022 |
Casey Crownhart, This CRISPR pioneer wants to capture more carbon with crops, MIT Technology Review (2022) |
|
| Ongoing |
U.S. Food & Drug Administration, Feed Your Mind: Agricultural Biotechnology |
Originally created in March 2020, this website is an FDA education initiative “to help consumers better understand genetically engineered foods, commonly called GMOs or genetically modified organisms.” |
Background Materials Proposed After First Meeting of Advisory Panel:
- Her Discovery Changed the World. How Does She Think We Should Use It?, The New York Times (Aug. 15, 2022), available at: https://www.nytimes.com/interactive/2022/08/15/magazine/jennifer-doudna-crispr-interview.html. (A subscription is required to access this article, which profiles Dr. Jennifer Doudna, who won the Nobel Prize in Chemistry for helping develop CRISPR gene-editing technology.)
- New Zealand Geographic documentary about Duchenne Muscular Dystrophy entitled The Death Gene: https://www.nzgeo.com/video/the-death-gene/
- Documentary directed by Renee Tajima-Peña about the sterilization of Mexican immigrant mothers in Los Angeles in the 1960s and 1970s entitled No Más Bebés: a preview of the documentary is available at https://www.pbs.org/independentlens/documentaries/no-mas-bebes/ and the film’s website is available at: http://www.nomasbebesmovie.com/film.
- Siddhartha Mukherjee, The Song of the Cell: An Exploration of Medicine and the New Human (Simon & Schuster 2002) – this book will be published on October 25, 2022 and is described by the publisher as “an exploration of medicine and our radical new ability to manipulate cells.” Information about the book is available here, on the publisher’s website: https://www.simonandschuster.com/books/The-Song-of-the-Cell/Siddhartha-Mukherjee/9781982117351.
Background Materials Proposed During or After Second Meeting of Advisory Panel:
- Article: Zhang, Y., Pribil, M., Palmgren, M. et al., A CRISPR way for accelerating improvement of food crops, 1 Nature Food 200–05 (March 3, 2020), available at https://doi.org/10.1038/s43016-020-0051-8 (A subscription or institutional access is required to access this article, which provides an overview of CRISPR technology, its application to food crops, and implications of regulatory policy for deploying the technology in the developing world.)
- Book: Kent H. Redford & William M. Adams, Strange Natures: Conservation in the Era of Synthetic Biology (Yale University Press 2021). The publisher’s website is available here: https://books.google.com/books?id=rnkwEAAAQBAJ&printsec=frontcover&source=gbs_ViewAPI&hl=en#v=onepage&q&f=false.
- Article: Kent H. Redford & William M. Adams, COP26: Synthetic Biology and Nature-Based Solutions (Yale University Press; Nov. 4, 2021), available at https://yalebooks.yale.edu/2021/11/04/cop26-synthetic-biology-and-nature-based-solutions/.
- Note: this article was published before May 28, 2020, when the USDA’s Animal and Plant Health Inspection Service published its final rule revising the Sustainable, Ecological, Consistent, Uniform, Responsible, and Efficient (SECURE) rule. The SECURE rule regulates the movement (including environmental release) of genetically engineered organisms that are likely to pose plant pest risks.
- Opinion / Insight Piece: Matthew J. Kan & Jennifer A. Doudna, Treatment of Genetic Diseases With CRISPR Genome Editing, 328 JAMA 980 (Sept. 13, 2022), available at https://jamanetwork.com/journals/jama/fullarticle/2796264.
- Advertisement: Representative Hymanson has asked us to share the following advertisement from Boston Children’s Hospital about novel new genetics-based diagnostic and treatment tools: https://www.nytimes.com/paidpost/boston-childrens/flipping-the-diagnostic-playbook.html.
Background Materials Proposed During or After Third Meeting of Advisory Panel:
- Articles on Florida laws:
- Jeff Schmerker, New Florida Law Protects Genetic Testing Info. from Life, Disability, and Long-Term Care Insurance Policy Decisions, Integrated DNA Technologies’ Community Blog Post (Oct. 26, 2020), available at https://www.idtdna.com/pages/community/blog/post/new-florida-law-protects-genetic-testing-info-from-life-disability-and-long-term-care-insurance-policy-decisions
- Aldo M. Leiva, Baker Donelson, New Florida Genetic Privacy Law Imposes Criminal Penalties (Oct. 14, 2021), available at https://www.bakerdonelson.com/new-florida-genetic-privacy-law-imposes-criminal-penalties.
- Mark Rothsetin and Kyle Brothers, Banning Genetic Discrimination in Life Insurance – Time to Follow Florida’s Lead, 383 N. England J. Med. 2099 (Nov. 26, 2020), available at https://www.nejm.org/doi/pdf/10.1056/NEJMp2024123 (Full-text access to this article requires either registration or a subscription.)
- Community Engagement Research Model: Organizing Committee for Assessing Meaningful Community Engagement in Health & Health Care Programs & Policies, Assessing Meaningful Community Engagement: A Conceptual Model to Advance Health Equity through Transformed Systems for Healthi, NAM Perspectives, Commentary, National Academy of Medicine (Feb. 14, 2022), available at https://doi.org/10.31478/202202c.
- Maine Bioscience Day information: https://biomaine.org/event/me-bioscience-day-2022/
- Bioscience Association of Maine (BioME)’s Industry Report. The report, entitled Life Sciences in Maine: State of the Industry 2022 is available as a free download on the following webpage: https://biomaine.org/industry-impact/. The following article also describes the results of this report: Vivien Leigh, Life Sciences are Maine’s Fastest-Growing Industry, News Center Maine (Oct. 14, 2022), available at https://www.newscentermaine.com/article/money/business/life-sciences-are-maines-fastest-growing-industry-business-money-maine-health-technology-local/97-745728a5-2f32-44fc-bce6-531d588f840d.)
- Article: Jennifer Couzin-Frankel, As gene testing surges, lawsuits aren’t far behind, Science (May 7, 2019), available at https://www.science.org/content/article/gene-testing-surges-lawsuits-arent-far-behind#:~:text=doi%3A%2010.1126/science.aax9577
- Article: Scott P. McGrath, et al., Legal Challenges in Precision Medicine: What Duties Arising From Genetic and Genomic Testing Does a Physician Owe to Patients?, Frontiers in Medicine, Vol. 8, Article 663014 (July 26, 2021), available at https://www.frontiersin.org/articles/10.3389/fmed.2021.663014/full.
- Legal research resource: University of Minnesota & Vanderbilt University Medical Center, LawSeq: Mapping & Shaping the Law of Genomics (website with searchable databases of federal laws, state laws and secondary legal materials relevant to genomics), available at https://lawseq.umn.edu/ (last visited Oct. 18, 2022).