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Policy: Makers, Shakers, and Breakers

Policy: Makers, Shakers, and Breakers

Cumbers:  Welcome to everybody. Antony, let’s start with you. Is what you’re doing regulated?  And has the policy around biotechnology helped or hindered you in your startup?
Evans: There’s a relatively broad range of things that we’re doing. Everything in biotechnology is regulated to some degree. I think you need to be very careful separating the product regulation and the process regulation. And by that I mean the regulation of which the end product which you sell to people is covered, versus the process by which you make that product, which is a very separate process. And actually that’s sort of where more of the FBI issues pop up. So we have a broad set of regulations that fit over what we’re doing. There’s all kinds of regulations around ordering DNA, making sure that those sequences are appropriate, who can do it. You know if you want to order reagents, you have to go through certain processes. There’s a set of regulations around that, the lab, all of that. But the most important for us is the product regulations. We have a couple of areas that we touch into. The first is our genetically-modified plant and the plant’s seeds that we are sending out. We have recently received determination from APHIS (Animal Plant Health Inspection Service) that that product will not be regulated by them.
You: So what is APHIS?
Evans: APHIS is the USDA’s biotechnology regulatory arm. So they’re responsible for regulating all genetically modified things that fall under USDA’s regulatory permits, which predominantly means the Plant Pest Protection Act but also means invasive species and some other related things. We also sell a few other things that are more heavily regulated. We sell a transform-a-plant-at-home kit, which uses Agrobacterium, which is a plant pest and which is regulated under a permit process, which means that before someone can receive our kit, they have to apply to USDA for a permit to receive that kit. That kit as well is regulated by the EPA because it’s a genetically-modified bacteria. So any commercial genetically-modified microorganism is regulated by the EPA, and so we have that Agrobacterium is regulated by the EPA and as well we are currently we are currently in the process of going through the MCAN process, which is microbial commercial activity process, for what will be the first genetically-modified consumer microbe.
Cumbers: So in summary that sounds like not much regulation at all.
Evans: It’s taken me two years to really unpack how this works. So I would say we’re reasonably regulated, despite what people think.
Cumbers: I mean this is amazing and you really are becoming a world authority in this area.
Simon: It’s like a “Scrabble” game.
Cumbers: Well I don’t think you can use acronyms in “Scrabble,” but...Eri, when you were setting up BioCurious, I seem to remember there was some—Mountain View didn’t really want this there.
Gentry: Oh you remember that.
Cumbers: This biohacker space in their neighborhood and that’s why it’s in Sunnyvale. Is that true?  And did you have to deal with any hoops in order to get it set up?
Gentry: So anyone who lives in the Bay Area knows that it’s cheaper to do things in Sunnyvale, so that’s one reason—
And we didn’t have a lot of money. As one of the first Kickstarter projects, we were only working with $35,000 to set up a lab and it was extremely naïve but we managed to do it. And we looked up regulations for starting a community lab for starting a biohacker space. And can you imagine decades ago, people in government, in federal government—and Greg, maybe you can respond to this later—but how would a conversation go where you’re trying to set up proactive regulation around synthetic biology? Or around any sort of microbiological work? Like, “Well, let’s set into place some regulations for biohackers when they start doing things out of the reach of academia and industry.” And really it’s something that people didn’t anticipate and if you think about us trying to do that with $35,000, there are different levels of thinking, and that naiveté that I mentioned, that helped us to actually go forth and do that. And so really painstakingly, we talked to the city of Mountain View. They readily took a meeting with us. Their responses were pretty frank that, “We haven’t heard of something like this before. We have labs and we educational groups; we haven’t seen them mix together. And we don’t know how to treat this. It will be novel and it will be expensive, but you can do it. It will just be money.” And that phrase was said again and again, “It will just be money.” And it’s like, “Okay, maybe we’ll try to work with a group that has more vision.”
Cumbers: So that’s great insight, novel and expensive, but you can do it. And if ever you thought of more daunting words to a scrappy startup getting by then it’s those.
Ed, so when did you become interested in reaching out to the biohacker community? And where does that fall on the timescale of Eri starting BioCurious—in what year?
Gentry: We started in our garage lab around late 2009 and opened the space in mid-2011.
Cumbers: Okay. And now you have how many?
Gentry: And I knew of Ed before we even started the garage lab.
Cumbers: Okay. And now you have how many members?
Gentry: We have about 70 people who use the space on a month-to-month basis and we have over 1,800 people who are in our extended community. So that would be people who would come to the space for an event, for a class, for a workshop, etc...
Cumbers: Right. So Ed, how does that fall on the timeline of the FBI’s interest?
You: So just a little bit of background. I’m part of the FBI’s Weapons of Mass Destruction Directorate, it’s the youngest division within the FBI. It was born out of the events of 9/11 and the anthrax mailings. Our primary mission is to proactively engage with the different stakeholders, so it was not just the biohacker community, but we were also heavily engaged in reaching out to the synthetic biology community abroad. So I should preface what I’m saying, which is that we’re not a regulatory agency.  So it really is, whether you’re working in a garage laboratory or a community lab or a university setting or a private sector company startup or all the way up to the Pfizers of the world, it really is about this is a very important beneficial area with important innovations that are coming out. And the bottom line is how do we engage in protecting and safeguarding these important developments that is going to be beneficial to society not only in the US but globally.
I’m going to go out on a limb here to talk about some of the policy standpoints and the challenges, because it’s a shame that we’re not having this meeting in the other rooms, together because I can tell you right now that even from a DC standpoint, a Washington DC policy standpoint on biosecurity, it always goes towards pathogens, so dangerous viruses, bacteria, toxins. There are many—I mean the media was really brutal to the biohacker community at first when they became aware of this. Like, “Oh, so the Frankenstein modifications of viruses”—
Gentry: Yeah, zombie viruses in your neighborhood.
You: Yeah. And is a world-ending pandemic going to be coming out a garage? Which is really hilarious, if you think about it. But again, important innovation’s coming out of it, but from my standpoint and from the FBI’s standpoint, it’s we have to broaden the scope of security. So for example, synthetic biology, a lot of it—and we had mentions of it this morning—heavily reliant on data, whether it be different omics to your social media, all of that. And I can honestly say I don’t think anybody’s looking at the security implications of that. So for example, back in September of last year, Community Health Systems outside Tennessee, that system was hacked into, 4.5 million patient records were accessed. Anthem/Blue Cross two months ago, 80 million patient records were accessed. And literally just five days, Premera Blue Cross up in the Pacific Northwest, they got hacked. What really worries me about this latest hack is that they actually got not only the patient information but the medical records too. So if you think about it, even within our own organization, the focus is on the financial impact. You know if someone’s going to take the personal information, open up false credit card accounts, whatever. Fine, that’s one element. But think about it, I mean—and we had a taste of it this morning—if you access millions of patient medical information now you have demographics, medical condition, treatment, drug regimes, therapies, really valuable information from a drug study, clinical trail aspect. So bottom line, we may have screwed the pooch and jumpstarted somebody’s own pharmaceutical endeavor. Nobody’s thinking about it from that way. And when it comes to discussions on policy and security, it always trends to the pathogens. And it ranges from potentially an economic loss and our ability to stay globally competitive all the way to if you’re wearing wearable technology that, you know, again, measures your daily caloric intake, your physical activity, what are the security standards there? So for example, I can foresee that in the near future it’s going to be a stalker’s paradise, because now you’re going to be able to determine when is somebody home? When are they going to be leaving? What is their daily intimate activities? Andrew Hessel really had an amusing story where some of the wearable technologies measure your physical metabolic rate, so you can basically tell when someone’s having sex. Which is great, okay, but what happens if you’re noticing someone’s metabolic activity and it looks like they’re having a nooner, but wait a minute, he’s supposed to be—or he or she’s supposed to be at work and their spouse is at home. So that opens the door to extortion or coercion and these different aspects are not talked about. And one final example, your genetic information, so if you tossed your gum out in the street, there’s nothing stopping someone from taking that and submitting that for sequencing. And now I have the most intimate information about who you are and there are very little protections from having someone do that to you. HIPAA was mentioned this morning, too, the Health Information Portability and Protections Act. Yes it has some element of protections as far as privacy, but what we failed to mention is that that’s only tied to insurance claims. So if you go to a third party commercial vendor and you’re submitting your samples for sequencing, HIPAA does not apply. So what happens if that third party commercial vendor goes bankrupt or gets acquired by a foreign company? What happens to your personal information then? So there are these broader issues on security that’s not even registered in the policy regime. There’s a lot of talk, robust talk, on privacy. But from a security vulnerability standpoint, particularly from a law enforcement standpoint, there’s very little discussion happening.
Cumbers: So you think everyone fixates on the policy and the regulation because of a pathogen or a bioweapon, but you think that the actual broader implications for society and the economy, are much larger from other forms—
You: So there’s a spectrum of risks and threats, right? So there is that one element, and I’ll get on my soapbox for a little bit, but I challenge you, when we go back into the plenary session, if you ask how many people are familiar with the Biological Weapons Convention, there’s only going to be a handful of people who say yes, whereas everything that they’re doing, if it has any impact on the life sciences, the BWC impacts them. But we’re not educating individuals about that very nature and it is because of the fact that biology had been exploited and abused in the past. But in a sense of being better citizens of science, we should be educated on that.
Cumbers: So Greg, to bring you in, you know we have a lot of regulations, particularly around the pharmaceutical industry. A lot of them are put in place to protect us. It’s broadly agreed that they hinder innovation, but you know which of those are good regulations that should remain, and which do you think should be changed to allow more innovation in the pharma space?
Simon: Well first, I realize I need to hack my wife’s Jawbone immediately.
That’s number one. Number two I’ve been in many meetings with the FBI over my career and they’ve never once said boner, nooner, or screwed the pooch.
So it’s a new FBI. That’s good to know.
Cumbers: Don’t worry, it’s not being recorded.
Simon: Yeah, I’m sure. Not by anybody we know.
Government regulation is a necessary but insufficient piece of any new technology going out into the public. How many people here avoid buying GMO foods? And if my wife were here you could add her hand to yours. I can’t even convince my own wife that GMO foods are safe and I was involved with that in ’85.
So one anecdote to show you why regulations are often not the problem. In ’85 when I was a staff director of a health science committee sub-committee, we started basically all the hearings that were done on the future of genetically-modified organisms in the environment and food and gene therapy and bioethics. And we gathered a lot of data and our position was regulatory actions should be based on data not philosophy, and we need to regulate things to gather data about spread in the environment, human health, animal health, before we start going down the road of either banning everything or allowing everything. Now 23 years later, we have all this data that no GMO food has every caused any harm to anybody. More people have a problem with peanuts on airplanes that will ever have a problem with GMO foods. I was on the Obama transition for the FDA and a woman from the Union of Concerned Scientists, who testified at my hearing in 1985, gave testimony about FDA and said the exact same thing 23 years later about why we shouldn’t allow GMO foods.
How does the government deal with that? That’s not the government’s problem. The government had said, “It’s safe, it’s regulated, it’s factual.” But the consumer groups take the position that this is a moral issue. It’s a moral issue. The government can’t really regulate moral issues very well. And the regulations—I was laughing about synthetic meat being a generally recognized as safe food. Go to Iowa and tell any of the mega-farms that you want to create synthetic meat and have it be regulated as “generally recognized as safe.” Assume you’re at war. Do not assume for a moment it won’t be regulated. They’re at war, immediately, with the farm-industrial complex. That will be not easy. It’s desirable, it’s just not easy.
So if you look at the drug regulations, I started an organization in ’03 called FasterCures about how to speed up medical research, including the regulatory process. And every time we try to speed things up, there’s a glitch. The thalidomide glitch lasted 50 years, right? So now we’re much better, and anybody in biopharma will tell you that more has been approved in the last several years under Peggy Hamburg, and more has been accelerated than at any time in the past 20, 25 years. The problem has been medical devices and diagnostics. Why? Because they had a few glitches. Hip implants that would break, 23andMe didn’t answer their mail. And so that’s two steps back instead of one step forward. So the government is regulated—and Juan Enriques has a great skit on this—the government is regulated by people afraid of doing harm. The problem is, harm to whom? If you are a terminally ill patient, what harm can they do to you? But if you’re a pharma company whose drug you’re trying to donate for compassionate use and it helps somebody, you don’t get to use that data. But if it killed somebody earlier than the disease would, or if it had severe side effects, you have to report that and lose another year of development time. It’s very, very complicated.
At the end of the day, the question is what regulation are we willing to accept? There’s a huge segment of society that is not science-based, not fact-based. That’s also Congress and it’s certainly the consumer groups. And then there’s a huge segment of society that suffers from things that we need to do stuff for, and they’re willing to overcome the scientific objections to early use and trial use.
With regard to pathogens, nothing is as dangerous as the pathogen itself, if you look at the Ebola virus or any number of different things that can kill us, the HIV, etcetera. The ability to hack those and spread them around is another form of suicide bomb, basically. It’s very different to spread those around without being either noticed because you’re in a Hazmat suit, or getting sick and dying yourself. So you know I understand the desire about people hacking and people being able to recreate awful things. The good news is the human race somehow has managed to adapt and survive all these awful things for a long, long time. So even if you attack us with something on purpose, the odds of you doing damage beyond an immediate circle is not nearly as great as it was in 1900 if you were exposed to tuberculosis. So there’s progress, there’s hope.
Cumbers: I want to open up to some questions from the audience, but before I do, Eri what can be done about this, in terms of over-regulation, over burden for innovation? What would you like to see change for the future?
Gentry: I like how Greg positions it—well how everybody positions it, really—is that there’s often a misunderstanding of risk versus potential reward and fear tends to trump people’s decision-making. So it’s kind of like how I studied economics and the idea that behavior didn’t get included into our models of supply and demand, it was ridiculous. And then came, you know, Dan Ariely and his thoughts about irrational decision-making, which should seem so obvious, yet in policy making and in regulation thinking we do use that fear and emotion all the time. So how can we come at it from a place of information? And that means not just on the side of regulators or decision makers but also the people who influence those decisions, constituents. And that’s a side that I’m on, it’s really how do you advocate for a greater understanding of science and a greater excitement of science? Because it is all around us, yet we’re not exposed until we get very sick or until we sort of need something or until there is huge controversy and that’s the wrong time. I’ve gone so far as to say we need more media, television, entertainment, that positions science in the right way, that goes even beyond the Sci-Fi channel, because we all know that lots of us, nerds and geeks like to watch this stuff, but we need to broaden it even more. So that can be done with community labs, that can be done by talking to artists, talking to people who work in food, in music, in beer production. Like one thing we’re working on at BioCurious is putting on a bio and beer event to get people at that place where they’re really interested, it’s beer. They turn to it all the time for many different emotional reasons, but we’re going to uncover some of the science behind it and I think we need to meet people more in the middle, get them to understand through ways that they’re actually going to enjoy. And that knowledge does tend to help people understand more important scientific decisions a little better.
Cumbers: And already we’re seeing a burgeoning industry for these community labs. There are three in the Bay Area, there’s one in New York...
Gentry: We’re getting requests all the time from people worldwide who want to do this. It’s not just biohackers, it’s students and it’s even professors. And people are approaching in the ways that they know how. So some are trying to get VC funding and are. Thomas Landrain in Paris actually got funding from the Mayor of Paris to open up a lab, a huge lab and now he’s opening up several more around the world.
Cumbers: So for that hands-on experience and understanding of biology and genetic engineering, it’s going to take time for it to spread and then a couple of generations at least for people to grow up around it like they have with computers.
Gentry: We’ll see. So we know the growth of bio has been fast and unanticipated, so that’s why we’re not prepared, necessarily, for the shocks. So I’m on the pro side, let’s have an environment where these creative things that we didn’t anticipate can happen for the good.
Cumbers: Ed, did you want to come in?
You: I really wanted to build on that, what Eri just mentioned, it is incredibly on the pro side for us as well, too. And I want to highlight one of the key aspects of—so if I do my job right I kind of widen the aperture of what some of the security concerns could be beyond what I would consider the classical biosecurity conversations. One of the key elements of why we do our outreach is a cornerstone of our program, is that once you have the buy-in of the scientific community, along with the sharing of information, we need to leave them with a resource from the security component, because the field is moving so rapidly, policy’s going to have a really hard time keeping up with the different advances. So one of the important parts of our program are positions within the FBI called local WMD coordinators. So these are special agents that are trained in chemical, biological, radiological and nuclear matters. They are a local subject matter expert and basically a local ambassador. And they reach out to institutions, academia, the commercial sector, the biohacker community, to establish those relationships where we can have that information exchange about we share what the security vulnerabilities, concerns, are going to be. And then in turn ideally what will happen is that we’ll get feedback from the community as to self-identifying what potential vulnerabilities might be, where they could be exploited and that that information exchange is incredibly valuable.
So for example, the aspect of utilizing microbes, yeast, to brew important elements, including pharmaceuticals, it came to our attention from a member of the synthetic biology community, well guess what? You now have the capability to synthetically reprogram baker’s yeast to produce heroin. So it may not be pandemic-causing, like Ebola, but if you think about it, if you’re now able to have a microbe that you just provide a glucose sugar source and now you can brew a potent narcotic for your own home use. There’s tremendous incentive for that to happen. So that could potentially have a huge impact on society. But that again is an aspect from a law enforcement perspective that we’re not really taking into consideration if that technology becomes broadly disseminated. But you have to have, in light of the rapid advances, this important information exchange going on, and partnerships is basically what it is, between the security and the science communities moving forward.
Simon: That’s really interesting.
Evans: Not just the FBI, all the US agencies are really good at outreach. So the EPA has a program by where they meet early-stage startups right at the beginning. And basically if you reach out to them, they will have a meeting with very senior people there, where you can discuss your product and like how it’s going to fit into their regulations. And so I think you mentioned, you know, as to what extent regulations inhibit. I think actually the US regulatory environment, I mean very specifically the US, because the rest of the world’s a disaster, but the US regulatory environment is actually relatively innovative and supporting of innovation. And I actually think that is a surprise to me. And one of the ways that they do that, and the most important thing they do is they are available. And like I think the people who think that it’s hard, probably haven’t reached out to them. You know USDA’s available on the phone, the FDA has people that will talk to you about your new food and how genetic engineering and how it’s going to fit into their—you can get these guys on the phone, it doesn’t cost anything. You know it’s best to go to Washington and meet them in person if you can. I think one thing they could do is have regional agents like the FBI’s talking about doing and having them in Boston and San Francisco and places like that so that you don’t have to go there. But generally these agencies reach out to you, tell you what you need to do, sometimes you are pretty amazed. We had to go through a low volume exemption under TSCA in order to be able to ship DNA to people, which was a, you know, 90-day process, I mean for something gene synthesis companies make and ship all the time.
Cumbers: And tell everyone what TSCA is.
Evans: TSCA’s the Toxic Substance Control Act, which is the chemical regulatory environment. So we had to do some stuff like that, but you know we have a regulatory burden, but it’s not insurmountable for a startup and so I think that’s something that’s important to recognize a little bit.
Simon: In contrast to the EU. Try to get a phone call to the EU sometime and their regulatory scheme.
Evans: Our products, for approval in the EU, need a Parliament vote.
Simon: Wow.
Evans: A Parliament vote, right? So the EU has taken the view that they need to separate the regulatory group that is responsible for providing the data on which the decision is being taken, and they’ve taken the governance perspective that the group that prepares that data has to be separate to the group that takes the decision on that data. And so the equivalent of that would be, in the US, would be that the EPA would be responsible for collecting the data, and they would then give it to Congress to vote on. And that’s what happens in the EU. And that’s basically why there’s—you know, Monsanto’s given up trying to get stuff approved, because Germany and France are blocking GMOs for political reasons, related to their own democratic vote, and the whole thing’s [INDISCERNIBLE 29:48]. So I think we need to be careful saying the regulatory burden in the US is bad, because compared to the rest of the world—there’s nowhere else that you could start a synthetic biology startup and really expert to get products to market.
You: There’s another challenge too. Over the years we’ve engaged with the biohacker community, not only domestically but internationally. And we’ve shared this vision of, there’s a shared responsibility to safeguard this enterprise. And one of my favorite stories, it’s kind of sad though, is that there was one international community lab member and he was so taken with this message that as soon as he went back to his home country, he made a beeline to their national police and wanted to introduce himself, like, “This is who I am. We have a community lab space.” And the response was, “You’re who? And you do what?” So from a policy standpoint, there needs to be the same kind of law enforcement support of these type of—and thanks for the shout out. I mean there really does need to be a security community that’s sensitive to how important some of these endeavors are and then how are they best positioned to protect it. Because if something happens in the scientific community that’s a real security issue, you better be darned sure that they can report that to the corresponding law enforcement entity and that they understand what the implications are and adequately respond to it. We have that pretty covered here in the US, but I can’t speak for what happens internationally.
Cumbers: Diego, you had a question? Just introduce yourself.
Rey: Diego Rey with GeneWeave. We’re a startup company developing in vitro diagnostics. And it’s more to echo to Antony was saying. You know I get that question asked all the time, you know, “Tell me about the FDA. How much of a pain in the butt is that?” And really it all depends. To Antony’s point, if there’s something that there’s precedence for, you know, you’re building a better mousetrap, it’s really an enabler. It tells you, “Here’s what you’ve got to do to clear your tests through the FDA. You show me these things, talk to us, we’ll work it out.” And it’s all about the communication you have with that agency. You know if you go in there, throw something over the fence, who knows what’s going to happen. But you start a dialogue early on, they’re accessible. And it’s really an enabler, I would say.
It maybe gets a little hairier when you’re building something brand new, no one’s ever done before and that’s going to take a lot more communication. But the important point is that, yeah, there’s definitely communication. So at least in the in vitro diagnostic space, with the FDA, it’s been a positive experience.
Cumbers: David.
Kirkpatrick: I have a few. But I mean I would ask Antony, the thing you said about no other country, is that really true of China? Couldn’t you basically do it in China?
Evans: China’s an interesting, weird case. There’s the laws in China and then there’s can you do it?
Evans: And I think they’re not perfectly aligned.
Kirkpatrick: Okay.
Evans: So you know we’re looking at China as one of our follow-on markets. You know China signed the CBD, so—the Convention on Biological Diversity it’s one of the principle anti-synthetic biology GMO international regulations. It has very painful steps that you have to prove in order to be able to release a product in a country that’s signed that international treaty and has ratified it into law. The US has not signed that treaty, which is why the US is free to do things like the Coordinated Framework on Biotechnology, which was a brilliant of piece of legislation actually, I think, in principle, because it enabled all the innovation that we’re seeing. Whereas other countries have these like precautionary principles and you’ve got to do 52,000 tests. So China signed this, but on the ground, if you’re politically connected, it’s immaterial. And so I think China’s a bit of a black hole when it comes to that.
Cumbers: Antony, before we go back, could you just outline the Coordinated Framework and why that’s such a good piece of legislation?
Evans: Yeah, so they had three central tenants in the Coordinated Framework. Tenant one regulate the product, not the process, which basically means that you don’t care how it’s made, it just cares what the end phenotype is. Nobody else does that. The tenant two was that only scientifically rational arguments are permitted in the risk discussion. I mean, this is the core principle. Sounds pretty sensible but like, you know, you look at Europe. At their core they’ve violated that and they’ve made it a political decision-making process. So you know you can see the variation.
Kirkpatrick: When was that law? I’m sorry.
Evans: 1986? ’85 or ’86.
Kirkpatrick: Where you involved in it?
Simon: I was very involved in that. That’s the nicest thing anybody’s ever said to me.
Kirkpatrick: Sorry, I didn’t mean to cut you off. Fantastic. I saw him beaming over there. Keep going.
Evans: And I’ll get through into how it impacts our ability to do what we do in a second. But the third tenant of it is that the genetically modified products exist on a continuum and therefore existing regulatory statures are appropriate to review existing risks, which is the third sort of tenant. What this means for us, for instance, is that the reason that our plants do not have to go through a regulatory review process, follows exactly from those three tenants. Those three tenants are so scientifically robust now, that you cannot scientifically argue with them.
But what that means, you know, people call us, they say, “Why are your plants not regulated? Isn’t that a loophole?” Well it’s absolutely not a loophole, because start with this idea, with principle one: regulate the product. Okay, so we just look at the product. It doesn’t matter that it’s made with genetically modified stuff. And principle three, that it’s on a continuum, so what do you look at? You look at the existing regulation. Well we decided that we only regulate plant pests, we only regulate invasive species, and a few other things like pesticides and some other things around that.
So as long as you’re not one of those things, you don’t have to be regulated. That allows room for us to innovate. So as long as we avoid things that are plant pests, yeah hello, we don’t want to create—you know, maybe a terrorist wants to do that, but we don’t want to do that. Then we have an avenue where we’re not regulated. That allows us to do all of the things that we’re doing, default. It just flows logically from those rules. And so I think that is why the US is going to be very, very successful in this industry going forward, is back to those sort of principles. China, different, you know, they’re just going to do it, right? Regulation be damned, I think.
Kirkpatrick: Well I have a few follow-ups, which are dangerous. I should be careful because I’m not—but you sounded so positive at the same time that you listed, at the very beginning, these incredible barriers that you have to overcome to send one product to some customer. Are you really comfortable with the fact that you have to get those two different layers of approval to ship that kit to those people? I mean that sounds contradictory.
Evans: Could it be lighter? Yes. Politically is that going to happen? No. The big test for me will come in May. You know we’re going through the MCAN process with the EPA. If we’re able to get through that successfully then I’ll say it’s great. If they try and ban us then I’ll probably be less enthusiastic. But the principle is it took me a long time to learn these regulations but now I’m—you know, there’s startups here, I share what we’ve learned, I think the knowledge will get out. I don’t know if it will be a hindrance. The big risk is that people try and change the rules and they try and impose more strict rules. Because if you are regulated as a plant, it’s estimated to cost $100 million dollars. So there’s this enormous binary system where just because we use a gene gun, not an Agrobacterium to do the transformation, which is a process issue, it’s goes from $100 million dollar regulatory process, to me writing a letter to them and them writing a letter back saying, “If what you say is true, then we’re not going to regulate you.”
Simon: Let’s put this in context for a minute. If he were a private company raising money and he shipped a prospectus to a client, or a potential buyer, to invest in his company that he didn’t know. He would’ve gone to jail before the JOBS Act passed in 2012. If you want to talk about to talk about regulation, it’s easier for him to ship his product to an individual he doesn’t know than it used to be to ship his prospectus about his company to somebody he didn’t know. And that’s still the case in terms of accredited and non-accredited investors. If you want to get into really hairy regulations where you go to jail, that’s in the securities field, which does not pose any threat to health, just to contextualize the situation.
Evans: But I would like to be able to ship GMO organisms without even needing to go through these approval processes. And like the EPA is going to hit a massive problem at some stage, I believe this year, their resources are going to get constrained. Because we submitted our MCAN on February 1st, we were the seventh. They’ve done something like 70 over the last 15 years. And they number them sequentially. And this is well known that the EPA does not currently have the capacity for what’s coming.
Simon: No, they never well.
Evans: —there’s going to be some problems coming. And then you know they have a 90-day legal mandate, which means that they have to give you a decision within 90 days. And if they fail, then you get free carte blanche, basically. And so there are lots of stresses and strains within this system. I don’t want to give the impression that it’s a well-oiled, well-working system. There are tons of these stresses. And you know the USDA having their own rule-making—I mean, there’s lots going on in this space.
Palmer: Hi I’m Megan Palmer, I’m at Stanford University and a few other places. Actually I just wanted to pick up exactly on that. First of all it’s really exciting to see Antony describe the Coordinated Biotechnology framework, coming from like two years of asking around these questions. So that’s really cool.
But I wanted to ask how do we actually think about these, both the resource constraints and as related to that, how to have this sort of relationship building between the different communities that need to figure out what needs to change? So Ed has been really great in terms of bringing together communities around talking about sort of policy constraints and how we work between here and DC. But how do we scale that type of interaction so that you can still get these answers to questions? And along these lines, like how do you make the EPA a compelling place to work? How can you make it attractive to want to work in these sort of functions facilitating productive constraints or design parameters around our products? Instead of just, you know, barriers? So and maybe just fourth, like what are the types of relationships and how do we build them?
Cumbers: Ed, any thoughts on that? You’re inside a government agency.
You: Well fundamentally, I think it goes back to—and I don’t mean it to sound like a cop-out because we had this discussion before—but it really boils down to education. And what I mean by that is that we heard this morning that even eighth graders are doing genetic engineering now. That is the time where we need to not only provide the support in science education and the technical expertise development, but that’s also where we need to start ingraining some of what it means to be a citizen-scientist. So not only the protecting the fidelity of science but also safeguarding it. Educating them about the fact that there’s something like the Biological Weapons Convention, UN Security Counsel Resolution 1540, all of which exist for a reason. And the fact is is that it’s a call to protect science from ever being abused or exploited. And that’s not a hard message to sell. I think everybody would agree to that. But that needs to be a starting point and if you have that common understanding, it will help build, facilitate some of those important relationships that will happen. Because quite honestly, I’m a little—and this is just my personal perspective, it’s not an official FBI standpoint—but seeing where things are going in the field of synthetic biology, we need to have that education and those talking points now. Because I cited those significant cyber-intrusions, and you know that’s on top of the Home Depot and the Target, but seeing where things are going now and to leverage these important synthetic biology applications that are coming out, open data sets are going to be a huge driving factor, which means like social media, your Twitter feed, everything that’s out in the open. What happens though is that in the interest of utilizing these different diagnostics or whatever, you’re pulling in, you’re aggregating all these different data points that are existing in the open. They’re not secure, they’re not financial related, which is, you know, traditional security. But you’re just bringing in disparate pieces of flotsam that will help you make a better decision. But once you’ve gathered that, you’ve now imbued it with value, it has now become a commodity. And once you’ve done that it becomes a security vulnerability, and I don’t think anybody’s thinking about what does security look like in this framework? And in order to get at that we need to start to educating, if you’re a bioengineer, if you’re bioinformatics, if you’re a software developer, we need to just start discussing these security vulnerabilities from the get-go.
Cumbers: So Greg, when the Coordinated Framework came out, what education and outreach did you do to communicate it to people?
Simons: Well, we were right in the middle between the consumer groups who wanted us to ban everything and the right-wingers, this was the Reagan administration, who wanted to allow everything without getting any data. And the agencies wouldn’t give up their own jurisdictions, which is why he has to go through TSCA, APHIS, all these things. We were initially proposing that there be one regime and that it wouldn’t be in the Agriculture Department, which is notoriously bad at regulating anything. And it wouldn’t be treated like a toxic substance, which is just a bad way to start talking about GMOs in general. But agencies being agencies and committees having jurisdiction by agency, that wasn’t going to happen. So the whole point was forcing the agencies to coordinate, which is why it’s called what it’s called. And we had literally hearings in the dozens to get USDA and EPA and FDA all on the same panel, and NIH. This wasn’t long after the Asilomar agreements, to talk about how they’re going to not drive someone crazy.
But, to your question, if you think about what the EPA and the FDA are being asked to do, the FDA has a handful of people to check all imported drugs from China. The EPA’s chasing people dumping toxic waste and all kinds of air pollution, Clean Air Act, Clean Water Act. And as Antony said, there’s 70 applications in what he’s doing. If you’re the head of EPA, how much money are you really going to spend on that? Now theoretically, it shouldn’t matter whether you call them or send it over the transom, the regulatory response should be the same. But that’s not how it works. And I dare to say that’s not how it works in any of your companies either. You know you read all the interviews now with the Silicon Valley VC guys and they all say, “We really don’t look at anything unless somebody we know brings it in the door.” Well the EPA feels the same way. Unless you really take an effort to communicate with them—you just throw it over the transom, that’s not a priority for them. You have to put a face on it, because—and I love Dan Ariely—we are irrational beings. That’s my Tweet from this morning, is will the Internet of bio-things really change the behavior of bio-things given that they’re not rational? And any amount of data doesn’t move people. It really doesn’t. We still have eight people here who won’t buy GMO foods for whatever reason. So the regulatory scaling, which is going to have to happen, needs to be as simple as—remember how had it used to be to get a passport? And now you can do the whole thing online. There are so many things that way, but it’s really hard when you’re dealing with stuff that he’s worried about and you’re dealing with stuff that people might eat or might let out in their neighborhood. Now there a lot of things people let out in the neighborhood now—even rainwater that they should be capturing—that’s ruining the environment that we’re not dealing with. So, you know, 1,000 biohack labs and 70 glowing plants don’t scale to the problem that makes people do stuff. But even the stuff that does scale to the problem isn’t being dealt with. And that’s really scary. That’s really scary.
Evans: I have one other suggestion that I think could make a difference to outreach, which is the CBI rules. So when you submit one of these documents, you are allowed as a company to mark stuff as confidential business information. So what 90% of companies do—we do the opposite, we basically mark nothing unless it’s really core IP that we want to patent, because we sort of want to promote transparency. I think a quite easy win would be to not allow companies to do that and to make it—so at the moment, the agencies have to fight the company on that not being declared, which means basically that if you do a Freedom of Information Act request on one of these documents, you get something that’s just like black lines all the way through. And I think if we flip that around, so that most of that information was available, then if you want to do something, you can look up and you can say, “Oh, that microbe, I want to do something similar to that.” And you can then get the information. And all of the safety and stuff, why is safety data CBI?
Simons: Even in the pharmaceutical area it’s CBI.
Evans: It doesn’t make any sense to me. So a super-easy win would be to just make that stuff much easier to access and then anyone can like download it online and hack it. And I think that would make things much easier.
Cumbers: So let’s take the last question here.
Carr: Hi, I’m Gary Carr, I work for a PR company, WCG here in San Francisco, but for 15 years I worked as a PR guy in Washington, including a couple of years at CMS/HHS, when Tommy Thompson resigned or left the HHS, he said, “The most surprising thing that happened to me while I was here was that no one poisoned our food supply.” I mean I was very taken aback. I didn’t think it was a really great PR move for him to say.
It was clearly showing the sensitivity and you know the years that I spent in government and politics, usually what drives people is the fear, “We’re going to get criticized for X.” and it happens in agencies and companies, whoever’s dealing—“We’re going to get criticized, they’ll bash the crap out of us, if we don’t do X.” So I think to a large degree people operate from that, and the stat you mentioned about Peggy Hamburg under the FDA approving more drugs than the previous 20 years, she didn’t get rewarded for that. No one pays attention to that. So it seems to me, and I’d be interested in your reaction, is what can innovators do to call attention to the fact that they want a partner it a positive way to reward the regulators and the policy makers for doing things that they ought to be doing anyway? The FCC is driven by punishing regulators, the FDA even doesn’t have good social media guidance, because their way to regulate that is draft regulation and punish people for doing something wrong, rather than saying, “Here’s how to do it and we want to encourage you and we want to work with you.” They don’t get rewarded for that. So I think the question is how can we reward people who are in these roles?
Gentry: One way is they come to Silicon Valley and get jobs, such as yourself.
Carr: Right.
Simons: Well, Tommy Thompson’s chairman of my board, and he’s still surprised they haven’t poisoned the food supply.
You make an interesting juxtaposition. In the financial world, the innovation occurs first and then the FCC chases you. And in the case of people like Bernie Madoff, even though it was clear that there was something going on, it took them years to chase him and figure it out. Whereas in the FDA, the innovation has to wait for the FDA to say, “Now you can do it.” So the FDA has to act first and then you can innovate. It’s a very frustrating thing. The media has to take responsibility for a lot of irresponsible stuff they put out there. There was an article in the “New York Times” Style Section last week about how cellphones cause cancer and that your wearable device is going to cause cancer. And they were hit with a barrage of letters from the people who’ve done the studies that show that that’s total bullshit. And why in the world would you let a style reporter do a pseudoscience article in the “New York Times” of all places? And now they have to walk that back from years. So the fact of the matter is that—what’s his name? George Chesterton said, you know, “A beautiful sunrise is noticed once and then we forget about the next one.” Every innovation that happens is immediately no longer newsworthy. Remember Ebola was going to eat the country? Now it’s nothing about Ebola. HIV was going to eat the country, now there’s nothing about all the progress we’ve made in HIV. It’s just assumed that we’re going to do it. So there has to be a culture change inside the media and interestingly enough, of all people, Arianna Huffington is doing this with something called What Works, which is a whole new series in her press world of articles about things that are working, not just things that are on fire.
Audience: [INDISCERNIBLE 52:33]
Simons: [LAUGHS] So I personally am very despondent, and the more I read the “Behavioral Economist” the worse it gets, that education can ever happen. Education is the hardest thing.
Cumbers: Great. We just have enough time to thank Ed You from the FBI, Greg Simons from Poliwogg. Eri Gentry, Institute for the Future, and Antony Evans from Glowing Plants. So thanks again, this has been a great session.


Edward You

Supervisory Special Agent, Weapons of Mass Destruction Directorate, Biological Countermeasures Unit, FBI

Eri Gentry

Technology Horizons Research Manager, Institute for the Future

Gregory C. Simon

Chief Executive Officer, Poliwogg

John Cumbers

CEO and Founder, SynBioBeta

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