“In re-opening the allowance for GM babies, whose genetic changes will be passed on to future generations, the FDA is taking the next steps toward toeing the line on genetic human enhancement.” (1)
“If the FDA gives the OHSU researchers a green light to move towards human clinical trials, it will be the first instance of regulatory approval for human germline modification ever, anywhere in the world.” (2)
The following letter, “Human Inherited Genetic Modification of Developing Embryos,” is written to the Cellular, Tissue and Gene Therapy Advisory Committee (CTGTAC), Office of Cellular Tissue and Gene Therapies Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) of the Federal Government of the United States of America (GOV.US).
The letter was in response to a call by CTGAC/CBER/FDA/GOV.US for written dockets for a public hearing on “oocyte modification,” often referred to as three-parent baby production. (3) As a member of the Bioart Ethical Advisory Kommission (BEAK), I thought it my duty to add an aesthetic dimension to the public debate.
Oocyte modification involves nuclear transfer of an ovum nucleus into a surrogate egg (of an other-surrogate egg woman client/provider). This is meant to replace defective mitochondria with the healthy egg white of an enucleated donated egg. This is basically human cloning and a limited form of inheritable genetic modification of the human germline (IGM). The resultant genetic modification is a complicated version of mitochondrial genetic crosstalk with the ‘central’ nuclear genome, as well as understudied, obscure and kinky epigenetic effects of the foreign mom1 (transferred ovum nucleus) in the cytoplasmic maternal factors of mom2 (client/provider). There are as signs of heteroplasmic continuums beyond knowledge’s borders, boredoms or boardrooms imbued in any live young produced from this process.
My initial letter was received by CTGAC/CBER/FDA/GOV.US, but the meeting was canceled due to the government shutdown. (4) Shortly thereafter, I received this response:
Dear Dr. Zaretsky,
Thank you for your interest in the October 22-23, 2013 Cellular, Tissue and Gene Therapies Advisory Committee meeting. The meeting has been postponed due to resource constraints arising from the government shutdown. […] I will keep your comments on file. Comments will be provided to the advisory committee at the time the meeting is rescheduled.
Sincerely, xxxx xxxxxxxx
Designated Federal Officer
FDA Cellular, Tissue and Gene Therapies Advisory Committee
Center for Biologics Evaluation and Research, FDA
The formal IGM&CTGAC/CBER/FDA/GOV.US Oocyte Modification Cellular, Tissue and Gene Therapies Advisory Committee Meeting was eventually held on February 25-26, 2014 in Washington, D.C. (5) As far as I can tell, any mention of my letter or Advisory Committee comments on said text were not recorded in the transcript, nor was any public letter docketed on the website. Perhaps protocol has changed since my last letter to the FDA, “Does Cloned Animal Safety take into account the effect of Aesthetics on the long-term Ecological effects of Food Chain Design?” (6) So, the letter, “Human Inherited Genetic Modification of Developing Embryos” is presented here, publicly, for the first time, in its entirety:
Designated Federal Officer
FDA Cellular, Tissue and Gene Therapies Advisory Committee
Division of Scientific Advisors and Consultants
Center for Biologics Evaluation and Research, FDA
Please include this (text below and attached) as a public docket for your October 22-23 Committee discussion of oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility.
Does Oocyte Modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility take into account the effect of Aesthetics on the long-term Ecological effects of Human Design?
We should not be overly worried about somatic cell nuclear transfer (Oocyte Modification) as added value for In Vitro Fertilization (IVF) technique. The abnormalities that can be expected might be novel knowledge for future clinical trials… or just novel. Our worries stem from the fact that a large percentage of human breeder assistance providers may not have had the Art Historical schooling that most Academic students of Aesthetics might have had. Right now, the only type of ‘taste’ we can see publically embedded in cloned Inherited Genetic Modification (IGM) Human Germline intervention babies is based on ramping up health production. If we are spending millions of taxpayer dollars on making copies of human sires/sows whose profitability is based on medical tropes of health as beauty alone, then we are missing much of what contemporary art can lend to contemporary breeding of posthuman novelty.
How do we decide what is worth engineering for?
In particular, Babies can be designed along a wide variety of Aesthetic gene expressions. Considering the range of gene expressions possible in a collage of multiple genomic pallettes, economic efficiency is neither a simple concept nor our only deciding force. Beyond public acceptance of the technology, there is also public trend diversity, novelty markets and niche power to be brokered in this global competition for more unusual kindred. Stockpiling difference, in and of itself, is a form of security. We need to explore the entire range of the programmed body. Human cloning = somatic cell nuclear transfer = oocyte modification all of which are built as a bridge to widen the variety pool to include Gene Therapeutic (GT) knock-ins or cassette inserts of signature transgene infections into human ovum, sperm, zygote or human embryonic stem cells (hESC). If we are found FACS  sorting germline altered human reproductive hESC tissue in culture, then this Cell Therapy (CT) is an ART  of forming an unlimited edition (as opposed to a one-off). Can we not consider the protocols valid to be used for esoteric, abject and non-utilitarian breeding projects? Isn’t that what we are already involved in? Practitioners or Historians of Futurism, Surrealism, Abstraction, Minimalism and other Contemporary art movements may all have their own special Oogonial clone advisory role to play. Beyond health and beauty lies a glut of diverse industrial beings, born with positive anomalous security for the sake of the widest range of feelings that reaction can attain. Consider what a gifted retro-garde cubist could bring to the table.
What are the cultural aesthetics of our ecological future?
The decision to design babies along a plurality of aesthetic lineages may have an impact on the future of ecology and diversity of our planet. As competitively designed meat puppets take up more and more of the terrestrial grazing land, we have come to understand that we live on a planet dominated by humans and their quest for acquiescence. Designed and cloned transgenic humans are limited editions but they can reproduce and stabilize independently. Bred by industry, transgen[ic].people may be foreign species brought forth from technological sites but are they capable of initiating enough gene expression pattern dissonance for us to want to live with them for generations to come. Sometimes real-time congenital health cures are not enough. There is an economy of aesthetics, which will drive the ecological affect of our engineered future.
What can an understanding of the arts bring to human design?
The history of art may finally come to some use for humanity, through fertility brokers and other replicant applications! However, the aesthetic hazards of breeding without a proper understanding of Western culture and our shared artistic heritage must be taken into account. The arts represent a great asset for IGM design and a great way to insure that the future isn’t born looking dull, retrograde, healthy-ish and a bit too sketchy. Without a firm grasp of Art History, our cloned denizens may not represent our national and international goals as U.S. food and drug producers and consumers. The admixture of global interspecies variety through genetic engineering and the cloning of spectacular hereditary cascades should only be approved through an aesthetic advisory commission made up of artists, art historians and off-the-locus aesthetics specialists. The future of style and the avoidance of our populous birthing any aesthetic hazards are dependent on collaboration between new reproductive biotechnology and the Arts.
I hope these issues will be taken into account as we sculpt new life from the media of biotechnology.
Adam Zaretsky, Ph.D.
Oct 15, 2013
EPA/CDC/(ELSI)/ATF/GMO-VD.STD: Mission Creep
This is where the biopolitical debate inserts itself: on the liminal edge of the ‘actual’. How to harness being? Through techno (m)othering the isness of the ofness. Oocyte transplant technique could be thought of as mitochondrial swapping…or hot mess ovum techno juggling. But the skill set happens to streamline an important step in mass production of designer babies, and it is in review. Currently the debate was stimulated by very promising techniques published by Shoukhrat Mitalipov and his research team at Oregon Health and Science University (OHSU), as well as a request for commercialization by the Boston-based company, Ovascience. In other words, it needs formal regulation because it is working efficiently now. It can go mainstream.
The elephant in the room of course is inheritable genetic modification…possibly putting in motion a regime of high tech consumer eugenics.
Think about mission creep.
These manipulations are not meant to treat people who are sick and suffering, we’re not talking about people having mitochondrial mutations preventing them from developing illness, what we’re talking about is radical experiments on future children and future generations. (9)
Actual experiments in human nuclear transfer have been going on since the early 1990s, particularly in private hospitals that are not rewarded any federal funding (i.e. Advocate Illinois Masonic Medical Center (AIMMC)). Further, corporate human trials in Korea, Sweden, etc. have been developing lines of primate properties that grow NextGEN™ CRISPR (10) by the minute. It is like the nuclear membrane is an inward folding space race for competing transgenic futures. The ironing out of inherited mistakes is a gateway drug to the baroque of IGM potentials.
The FDA currently regulates our gene pool, instead of the Environmental Protection Agency (EPA) or the Center for Disease Control and Prevention (CDC). Are we sure that these transgenic human appliques are either foods or drugs? Is it possible that they are potentially global genetically modified organisms (GMO) capable of ecological diaspora as novel venereal disease (VD) or technologically assisted sexually transmitted disease (STD)? And, if we want an affirmative overcoming without the work of the negative that Foucault implies, perhaps the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF or BATF) should have oversight on methods of transgenesis (i.e. microinjection, electroporation, lipofection and biolistics) and the viral vectors they disseminate. These technologies are both firearms and explosives. How is health, consumerism, industry and federal rubber-stamp oversight going to bring us out into the lines of flight that free-range ideation can provide?
Pitting raw research against consumer rights and always (p)referencing industrial interests, we stand by the hea(l)th of the unborn (read as curing infertility). These parents and their soon to be kin may be the key to opening regulatory approval to revamp our genetic commons. In my opinion the Cellular, Tissue and Gene Therapies Advisory Committee Meeting of February 2014 was a test of public reaction to future coordinated FDA rubber stamp oversight of the continued wild-west pFARMing of rare post-humans. So, I would calmly ask, where are the written documents of public response?
One such letter is printed for you above.
Adam Zaretsky, Ph.D. is a Wet-Lab Art Practitioner mixing Ecology, Biotechnology, Non-human Relations, Body Performance and Gastronomy. Zaretsky stages lively, hands-on bioart production labs based on topics such as: foreign species invasion (pure/impure), radical food science (edible/inedible), jazz bioinformatics (code/flesh), tissue culture (undead/semi-alive), transgenic design issues (traits/desires), interactive ethology (person/machine/non-human) and physiology (performance/stress). A former researcher at the MIT department of biology, for the past decade Zaretsky has been teaching an experimental bioart class called VivoArts at: San Francisco State University (SFSU), SymbioticA (UWA), Rensselaer Polytechnic Institute (RPI), University of Leiden’s The Arts and Genomic Centre (TAGC), and with the Waag Society. Last year he taught DIY-IGM (Do It Yourself Inherited Genetic Modification of the Human Genome) at Carnegie Mellon (CMU) and New York University (NYU). He also runs a public life arts school: VASTAL (The Vivoarts School for Transgenic Aesthetics Ltd.) His art practice focuses on an array of legal, ethical, social and libidinal implications of biotechnological materials and methods with a focus on transgenic humans. Adam is currently Professional Lecturer of Media Arts in the School of Communication and the Arts at Marist College as well as PostDoctoral ARA (Advanced Research Associate), I-Node of the Planetary Collegium, Plymouth University.
1. Ananda, Rady, “FDA to hold first public hearing on GM babies,”Activist Post, (September 16, 2013), http://www.activistpost.com/2013/09/fda-to-hold-first-public-hearing-on-gm.html.
2. Cussins, Jessica, “FDA to Hold Public Meeting about a Form of Human Germline Modification,” Biopolitical Times, (September 12th, 2013), http://www.biopoliticaltimes.org/article.php?id=7150.
3. According to the CTGAC/CBER/FDA/GOV.US Advisory Committee Calendar record of October 16, 2013,”Interested persons may present data information or views orally or in writing on issues pending before the committee.”
4. An automatically generated email response received by the author during said instance of the government shutdown:
From: xxxxxxxx, xxxx <email@example.com>
Date: Tue, Oct 15, 2013 at 2:11 AM
Subject: Automatic reply: Oocyte Modification Public Docket: Adam Zaretsky
To: Adam Zaretsky <firstname.lastname@example.org>
Due to the absence of either and FY 2014 appropriation or Continuing Resolution for the Food and Drug Administration, I am out of the office on furlough and I am not able to read or respond to your message. If you require immediate attention, please contact xxxxxx xxxxxx, 301-xxx-xxxx or xxxxx xxxxx, 301-xxx-xxxx
5. The exact location of the formal Cellular, Tissue and Gene Therapies Advisory Committee meeting: Hilton Washington, D.C. North Gaithersburg Hotel, 620 Perry Parkway, Gaithersburg, MD 20877
6. This letter is both on the record as a formal docket on the FDA website and was presented at the “Eye of the Storm” Arts Catalyst event, Tate Museum, London UK, 2009.
7. FACS: fluorescence activated cell sorting
8. ART: assisted reproductive technology
9. Food and Drug Administration Center for Biologics Evaluation and Research, 59th Meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee February 25th, 2014 (Gaithersburg, MD, 2014), 180-190, http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/CellularTissueandGeneTherapiesAdvisoryCommittee/UCM390945.pdf. Quotes selected from transcribed comments by Marcie Donovsky, Executive Director of the Center for Genetics in Society, located under subheading Agenda Item: Open Public Hearing.
10. According to Genetic Engineering and Biotechnology News, CRISPR, the popular gene editing approach, is proving to be a disruptive technology.