Recently, the United States endured the longest government shutdown in the nation’s history. For 35 days, without a federal budget passed by Congress and signed by the President, non-essential employees were furloughed and entire agencies were closed. The impacts of the shutdown were far-reaching, impacting the lives of many Americans, and still more people abroad. As the shutdown closed the offices of the USDA, FDA, National Science Foundation, and more, it caused great harm to scientific research, especially agricultural research.
One of the largest and most diverse agriculture-related scientific conferences, the Plant and Animal Genome XXVII Conference, was a microcosm of these impacts. Important sessions were canceled, researchers were blocked from attending, and meetings were missing important collaborators.
I sat down to talk about it with Jason Williams, the Assistant Director of External Collaborations and Lead of CyVerse EOT at Cold Spring Harbor Laboratory. Williams found himself at the center of efforts to help the conference cope with the gaps in the program, and saw how much harm the shutdown caused to US science and its position in the international scientific community. The shutdown may be over now, but its impacts will persist.
Impacts on science and people
While my current research is federally-funded, it was not directly impacted by the shutdown. But colleagues at my institution and nearby agricultural research stations had their work interrupted. And I’ve seen the impacts of previous shutdowns at the USDA offices in Madison, WI, and Asheville, NC.
Funding and access to research facilities is not a faucet that you can turn on and off at will. Research works best when funding is a consistent stream that allows scientists to plan, conduct, present, and maintain their research. That especially goes for the live plants, animals, microbes, and more that must be kept alive! I guarantee that some scientists were sneaking into greenhouses, barns, and more to keep the shutdown from destroying their work, even though they were not getting paid.
The people who dedicate their lives to doing scientific research in service of the public were not only let down, demoralized, and directly harmed by the recent shutdown, so were farmers, travelers, voters, and anyone who benefits from investments in science. (Hint: that’s you.) Internationally, it lowers the reliability of US science, and that’s a barrier to progress that is far more real than the debated barrier that led to this event.
How did the shutdown affect your research? Your farm? Tell us about it in the comments.
There are two upcoming opportunities to learn about the US regulatory system for biotechnology. Both have web-based options so you can attend from anywhere in the world. Check out the topics below and be sure to register! One is next week, on November 7th, and one is on December 3rd.
Biotechnology Regulatory Service
The USDA-APHIS-Biotechnology Regulatory Service (BRS) is holding their annual Stakeholder Meeting on Wednesday, November 7th,10:00 am to 3:30 pm Eastern. Register for the Stakeholder Meeting in advance, and select the webcast option. If you are in the Washington DC area, there is also an option to attend in person.
During the morning session, BRS will “discuss implementation of business process improvements; review biotechnology research, education, and outreach”. During the afternoon session, they will present the new APHIS eFile system. The afternoon session will be of particular interest to any researchers whose work (movement or field trials of certain genetically engineered organisms) is regulated by BRS; you will need to use the new eFile system in 2019.
BRS will provide opportunities for questions. It will be interesting to see if they discuss the FDA’s Plan (below). Another potential topic of interest not on their agenda is whether they will propose regulatory changes in 2019 “to respond to advances in genetic engineering” aka gene editing, regulate GE organisms that present a possible noxious weed risk, and respond to Office of the Inspector General audits, among other issues. Note that if you have questions about the USDA’s proposed Bioengineered label, BRS is not the agency to ask. Labeling is handled by the Agricultural Marketing Service (AMS).
Food and Drug Administration
The Food and Drug Administration (FDA) announced on October 30th their new Plant and Animal Biotechnology Innovation Action Plan. They are holding a webinar on Monday, December 3rd, 12:00 pm to 2:00 pm Central. Register for the Genome Editing in Animals meeting in advance. This meeting is webinar only, with no in-person option.
During this meeting, FDA’s Center for Veterinary Medicine (CVM) and Center for Biologics Evaluation and Research (CBER) will discuss risks and benefits of gene editing in animals. FDA will also discuss “CVM’s flexible, risk-based approach to the regulation of intentional genomic alterations in animals and address common misconceptions associated with the regulation of these products”.
When you register, there is an option to “submit any questions that you have regarding genome editing in animals and CVM’s regulation of animal biotechnology.” Definitely use these three boxes to submit your questions in advance, and help show the FDA what types of concerns the regulated community has on their mind. Note that while FDA does regulate genetically engineered plants, they specify the “webinar will not cover genome editing in plants for human and/or animal food”.
As you consider questions to ask FDA, it may help to think about gene editing like a text editing program – it can delete, replace, and insert, among other functions. Many gene edited organisms will have no new proteins, and potentially no new DNA at all. How will FDA treat each of these different results? What will the regulatory trigger be? How will FDA regulate gene edited animals with no transgenic DNA, or animals where gene editing was used only to delete DNA?
Gene edited animals
One example of a gene edited animal is hornless dairy cow. While horns are useful in the wild, you can imagine that horns can be dangerous for cows and for the humans that tend them. There are naturally hornless cattle but they lack other traits that are important for dairy cows.
Researchers used gene editing to replace a gene in horned cattle with one from hornless cattle. The result? Hornless dairy cows that don’t need to go through a potentially painful de-horning process. Depending on how the FDA decides to regulate gene edited animals, that little piece of cow DNA, which is already in the food supply anyway, could be regulated as an animal drug.
In addition to cattle, gene edited animals include pigs, sheep, goat, tilapia, carp, and chicken. Edits have been made for improving agricultural traits, for medical research, and even for making fancier pets. Each of these different animals will need to be evaluated differently before they can be released either into the food supply or otherwise out of the laboratory.
Need some background in gene editing? Check out highlights from a 2018 symposium about gene editing hosted by the Crop Bioengineering Center at Iowa State University, which include what gene editing is, what it can do, how it is regulated, and consumer acceptance of new technology in food.
On Tuesday, I attended the FDA Biotech Education and Outreach public meeting in San Francisco, and here is my experience participating in this public event. I was happy to be able to make a comment on behalf of Biology Fortified, and the feedback I received was very helpful and gave us guidance on what the FDA wants to know more about. There were some new and fresh voices who provided useful information, as well as familiar faces from groups opposed to biotechnology who provided some comments worth paying attention to, as well as clearly false information worth responding to. And of course, there were a few characters who went beyond misunderstanding the purpose of the meeting and instead promoted their products, conspiracy theories, and the concerns people expressed showed the FDA representatives how deeply problematic this topic has become in the last couple decades.
Getting there
First, it is very difficult for anyone to be able to attend and participate in such meetings. Held on weekdays, and downtown in major cities, the room that could have fit a couple hundred people had closer to 30. People have work, there is the long commute through heavy traffic (especially to get to San Francisco), various costs involved, and also takes preparation. I was joined by Chad Niederhuth, who drove all the way from Sacramento that morning to give a comment, and Zen Honeycutt and Yvette d’Entremont had signed up but did not attend. Anyone who manages to make it to these meetings is a rare exception, and it skews the kinds of comments and perspectives that our government can get. Nevertheless, it is an important way for our government to hear from its citizenry, and I was happy to see many diverse voices in attendance, including those with which I may disagree.
Myself, it was quite a squeeze to be a part of this. I spent the weekend with family in Los Angeles, and drove home Monday, only to eat dinner and immediately continue to San Francisco. Parking in the east bay, I took BART into the city and stayed in the cheapest hotel I could find, a couple blocks away from the event location. I was only able to do this because of our sustaining members, because unlike some of the organizations on either side of the biotechnology debate, we do not have the deep pockets of industry and ideological organizations backing us. The more support we can get, the more you will see us being able to take the time to get involved!
Voices new and old
Agenda, speakers, and Karl’s name badge
The people who signed up to give oral comments were an interesting and diverse group, with some new voices who added some fresh perspectives. The first comment was made by Daniel Westcott, a graduate student at UC Berkeley, who talked about their science communication efforts in the CLEAR program, and spoke about false dichotomies between areas of agriculture like with biotech and organic. Lynn McBride, from the California Farmer’s Union recommended reaching out to farmers and talking about impacts on the farm. James Allison is a high school teacher who came all the way from Loveland, Ohio, and he shared his experiences developing curricula for students in high schools and suggested that the FDA consider that as one route for their communication efforts.
Chad Niederhuth spoke about science-based communication strategies. Credit: Mary Mangan
Stephan Herrera, from Evolva, Inc., recommended creating materials to complement food labeling laws so that the public does not perceive that biotech-derived foods have safety issues, create “Perception vs Reality” documents, and hold challenges for students to create their own videos about food facts. He also emphasized the need for the FDA to understand and employ Search Engine Optimization (SEO) so that their pages can be found by the public. Chad Niederhuth also added that the FDA should base their science communication efforts on science-based recommendations so that they know that they will have an impact.
There were some familiar organizations that campaign against biotechnology who were in attendance and delivered comments as well. Dana Perls from Friends of the Earth gave many critical comments about genetically engineered crops, and directly attacked the scientific consensus on the safety of consuming the genetically engineered crops that are on the market, calling it a “false generalization.” Lisa Ermo, representing Moms Across America, claimed that genetically engineered foods are lower in nutrients (they are not), but mainly spoke about glyphosate in the herbicide Roundup.
Peggy Lemaux, credit: Mary Mangan
There was one familiar voice who signed up to speak in-person who was a welcome addition to the public comments. Peggy Lemaux, a professor at UC Berkeley, was the last person to comment. She told the story of the ice-minus bacteria and how lack of public engagement contributed to poor perceptions, along with researchers wearing suits that “looked like a toxic waste cleanup.” She stressed the importance of university extension programs, and surveying the public’s questions and concerns to figure out what to communicate to them about the technology.
Lawyer Lawyer
The comments from the Center for Food Safety representative, Rebecca Spector, deserve much more attention. Read like they were drafted by lawyers, they also hint at the various ways that the anti-GMO law firm may work to attack and undermine any outreach program from the FDA. For instance, Spector suggested that the “FDA should not communicate anything that is contradicted by agency statements.” As an example, she cited an oft-repeated claim that the USDA said that DroughtGard, a Monsanto GE corn variety engineered for drought tolerance was found by the USDA to be “inferior to conventional breeding” and that it wasn’t any more drought tolerant than other varieties of corn. This is based on a USDA regulatory document (Finding of No Significant Impact, page 33) that said that there are other drought-tolerant corn varieties in different genetic backgrounds that have similar tolerance to drought. It is widely misinterpreted to mean that the drought tolerance doesn’t work, or in this case, claim that it is inferior, but the USDA did not conclude that at all. What is important to remember is that this is a single gene that can confer drought tolerance in almost any genetic background, and can be used in breeding to achieve that trait irrespective of the other traits in the variety. It is a useful advancement, and it protects some of the yield during moderate drought. The Center for Food Safety is misrepresenting the USDA’s comments.
To put it another way, let’s say you engineered a granny smith apple to have a red skin. There are other apples with other genetic backgrounds (other flavors, shapes, sizes, etc) that also have red skin. But this apple is now red with a previously non-red genetic background of the granny smith. The USDA deregulates this red-skinned granny smith and mentions “It is prudent to note that red apple skin is also present in other genetic backgrounds and this new variety does not exceed the redness found in these other varieties.” The Center for Food Safety then reports that genetic engineering is inferior to breeding, that the USDA says it doesn’t work, and the FDA should not be allowed to say that the genetically engineered red-skinned apple is in fact… red.
If the Center for Food Safety told the truth for one day, in a film starring Jim Carrey
Other statements by Spector were worse. She misrepresented the National Academy of Sciences report on GE crops that was published last year, saying that they found that GE crops did not increase yields. The report touched on yield in several places, and stated that they could not conclude that GE crops had increased the rate at which yields were going up, but did in fact state that they had contributed to yield gain. Even Doug Gurian-Sherman, who has worked for CFS, estimated that GE insect-resistant traits had increased yield. Furthermore, Spector said that the industry “failed to produce a commercialized GE crop with enhanced nutritional content.” The Center for Food Safety spends its time suing to stop the approval of every genetically engineered crop that it can, is now complaining that none have come to market? Apparently they missed the approval of high-oleic Plenish soybeans by DuPont Pioneer (see our interview with Susan Knowlton here) and omega-3 fatty acid producing soybeans by Monsanto. I’m sure they just forgot about them.
Rebecca Spector said that the public “should not be given information that is false and misleading” and I wholeheartedly agree.
Consumers Union sides with general safety, argues falsehoods
Elisa Odabashian, representing the Consumer’s Union spoke against “misleading” information about genetically engineered foods. She repeated the same claims about the NAS report and yields, and claimed that GE crops “vastly” increased herbicide use while decreasing insecticide use. She said that Roundup use “increased more than 15 times” but neglected to mention reductions of other herbicides that it replaced, a very common and intentionally misleading statement about pesticide use. Odabashian said that the FDA should only communicate “settled science.” The use of this term seemed very odd, as it has a very specific meaning in political contexts, widely used by opponents of climate change science to undermine its acceptance. She claimed that Golden Rice has stunted growth, citing a poorly-researched blog post that looked at the wrong transgenic event – one that was discontinued 3 years ago. The current Golden Rice variety has already begun the approval process in the Philippines.
Odabasian made some good comments that should be carefully understood by everyone. She said that there is no strong evidence that the GE crops on the market pose safety hazards, although the technology carries some risk. She distanced the Consumer’s Union from the many unsubstantiated claims that genetic engineering is responsible for, such as autism, gluten intolerance, etc. “These claims have been poorly documented, if at all.” These are statements that I agree with. However, the Consumer’s Union has become a source for many of these widespread, unsubstantiated claims. Michael Hansen, a chief scientist working for the organization, has claimed that GE apples might require more pesticides (they don’t), Golden Rice could cause birth defects (it wouldn’t), and a whole host of other claims. I applaud Elisa Odobashian for standing against widespread myths, and daresay that it would be advisable for her organization to take a deeper look into its own role in advancing claims that they are now trying to distance themselves from.
Comments and feedback
I’ll now turn to my own comments delivered during the meeting. As I mentioned previously, Biology Fortified is submitting written comments to the FDA docket to contribute to the information that the FDA has at hand when they put this program together. We could have just submitted them electronically, but I had never participated in this kind of process before. I modified our comments to read them orally, signed up, and hardly slept the night before. I was nervous, but quickly I read our comments, addressing the gaps in public understanding, the need for addressing the issue of safety, farming contexts, and to better explain the FDA’s role in regulating the technology in what’s called the Coordinated Framework. I pointed out that the public needs an independent source for information about nutritionally altered foods and that some FAQ about common questions would be helpful, but advised against addressing every specific claim. I may have spurred many of the anti-consensus claims made by others, but even the Consumer’s Union agreed that evidence of any harm is weak if it even exists.
Karl Haro von Mogel, Credit: Mary Mangan
The FDA also wanted to know where people were getting their information, and how they should go about communicating to the public. Unfortunately, the most easily available information is factually inaccurate, but the upside is that the issue is not deeply polarized. I conveyed a lot of our ideas on how to carry out the outreach, following a “train the trainers” model and using existing networks to get out their message efficiently, rather than reinventing the wheel. I also talked about designing it for social media, and it was these comments that they were particularly interested in. I answered a couple questions about how to go about doing this, who to network with, and we shared a light-hearted moment about how unpredictable and yet so full of potential memes can be.
As a result of the feedback I received, and more ideas that came from the meeting, we’re adding more to our comments to submit them in written form before the deadline. I talked to several of the FDA representatives afterward and they were happy to have our contributions, along with everyone else’s. I’m very glad I went and it was a very valuable experience.
On characters and concerns
The meeting had a few outlandish characters, and its share of genuine concerns expressed about genetically engineered crops. One such character was Mark McAfee, the owner of Organic Pastures Dairy, who quite passionately talked about his personal integrity at length, mounted a defense of raw milk, and attacked the FDA for making his business more difficult. Organic Pastures has been linked to multiple food-borne illness outbreaks such as E. coli, Salmonella, and Campylobacter, some of which have been traced to their products. It got so bad that they started printing labels on their milk bottles talking about their customers’ immune systems as reasons why they could get sick. McAfee spent very little time talking about the issue of the day, but did cap his presentation with saying that the people at the FDA who had been “bought out” had to be rounded up and arrested!
Pamm Larry, from GMO Free California, gave a very disorganized rant that covered everything except her anti-vaccine views. “Why would any critical thinker trust the data?” she said. She complained about why it is considered unethical to demand human studies of GMOs (without any valid hypothesis to test). At the end, she argued that they should instead spend their funds on a scientific study and get Pamela Ronald, Kevin Folta, and Gilles-Eric Seralini in the same room to hammer it out. Her proposal sounded great until she said that the doors should be locked, and 24 hour cameras and bodyguards were necessary! (For whom?) Cooperation across the divide has been repeatedly proposed on our end, and rejected every time. Seralini withdrew from followups to his infamous rat tumor study, so maybe they should have locked the door? Our door is still open.
Alan Reynolds of the EPA, Ritu Nalubola of the FDA, and Doug McKalip from the USDA spoke about their own personal motivations and values.
There were many people who expressed general concerns about biotechnology, and the trustworthiness of the companies and the FDA. They didn’t come to speak to the questions the FDA was posing, but to instead show their opposition to the measure, and their desire for a more approachable FDA with a clearer website. Even Mark McAfee got back up and said he wanted a “mommy-friendly FDA.” They wanted to be able to talk to their regulators, and break down the wall of misunderstanding. They wanted the FDA to know they had concerns about their health, and those of their families. The FDA representatives took some time to talk about their own motivations and concerns about their children and their own health. It seemed at times that even those who were deeply suspicious of the FDA were really elated just to be able to meet them face-to-face and understand that everyone in the room is human and wants to be able to connect and understand each other. Perhaps some of the same people who came to the meeting afraid of biotechnology may someday be thankful of future efforts made possible by how they expressed their concerns that day? Alan Reynolds, one of the three FDA representatives on the stage, said “the most important word today was TRUST.”
Chad and Karl got some much-needed lunch afterward. Credit: KJHvM
The Food and Drug Administration is accepting public comments on a new education and outreach initiative about biotechnology, mandated by Congress. Comments close on Friday, November 17th, and Biology Fortified strongly encourages scientists and members of the public to submit comments to help shape and inform this initiative. A public meeting was held this week in Charlotte, NC, and a second meeting will be held on Tuesday November 14th in San Francisco from 8 am to 1 pm, where members of the public can sign up to submit oral comments as well.
Education and outreach are extremely important to address the wide gap between the scientific literature and public perceptions about biotechnology, and these outreach efforts must themselves be informed by what we know about science communication. Biology Fortified will be submitting our own comments to the federal register, but if you take a look at the comments that have already been submitted online, you can see that there are very few informed comments at all, some of which make accusations of the FDA and swearing insults and implied threats against them. These comments, however, will do little to sway the FDA, but what will have an impact are informed, on-point comments that can help them navigate this issue.
Your comments can and do make a difference. Recently, the USDA scrapped new proposed rules regulating biotechnology that did not make much sense, and this was in part due to the detailed comments that they received. What does the FDA want to hear about?
We invite the public to share information, experiences, and suggestions that can help inform the development of the education and outreach initiative. We invite interested persons, including those participating in the public meetings, to respond to the following questions specifically regarding agricultural biotechnology and biotechnology-derived food products and animal feed:
1. What are the specific topics, questions, or other information that consumers would find most useful, and why?
2. Currently, how and from where do consumers most often receive information on this subject?
3. How can FDA (in coordination with USDA) best reach consumers with science-based educational information on this subject?
The comments received will help FDA identify education goals, messaging, and dissemination strategies for FDA’s Agricultural Biotechnology Education and Outreach Initiative.
Should food with ingredients from genetically engineered crops – “GMOs” – be labeled? Many argue that consumers have a “right to know” about this. Ok, if the real reason for labeling is to provide consumers with knowledge, then the label should read: “Contains ingredients from biotech enhanced crops approved by the USDA, FDA and EPA”
That would tell people what is unique about these crops. Humans have been genetically modifying crops for centuries using a variety of methods. The difference for genetically engineered crops is that they must be fully characterized and tested in order to gain approval from three different regulatory agencies – the USDA, the EPA and the FDA (there is a description of this process below if you are interested). Crops modified in other ways including those generated by conventional breeding, mutation breeding or “wide crosses” or hybrids or doubled haploids don’t have to be tested or approved at all. The clear, international scientific consensus is that genetic engineering involves no unusual risk relative to all the other methods of genetic modification, but this testing was instituted out of an abundance of caution. Thus, any label should let consumers know about this extra level of scrutiny conducted for their benefit. Continue reading “How To Do GMO Food Labeling Right”→
Frank wants to learn more about wheat.
Most Biofortified Blog readers will have heard by now that glyphosate tolerant genetically engineered wheat has been found growing in a field in Oregon. There’s a lot of interesting details to consider, but for now we’ll start with a simple list of links to help you find reliable information as this story develops.
First, let’s look at some general information about regulation of agricultural biotechnology in the US. There are three agencies that cover different aspects:
USDA covers aspects that involve agriculture (including consideration of natural resources), specifically plant health. Within USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for regulation of biotechnology, including shipping and field testing in their Permits, Notifications, and Petitions processes. APHIS’ Role in Biotechnology.
The AquAdvantage salmon has captured the attention of the news, politicians, scientists, and activists, and now you have a chance to learn more about it – directly from the people who developed it. AquaBounty Technologies developed the genetically engineered Atlantic salmon by inserting a salmon growth hormone gene with a promoter from ocean pout that causes the salmon to produce growth hormone year-round. This results in a fish that grows to full size in about half the time of wild salmon.
For an excellent backgrounder on the AquAdvantage Salmon, see this article by Anastasia Bodnar.
AquaBounty Technologies is currently seeking FDA approval for producing the salmon to sell in the United States. This has attracted the attention of competing markets, such as the Alaskan salmon fisheries and their representatives in government, as well as various anti-genetic engineering organizations such as Food and Water Watch and the Center for Food Safety. If approved, the AquaAdvantage salmon would be the first genetically engineered animal intended for human consumption. Continue reading “What do you want to know about AquAdvantage Salmon?”→
One example of a gene edited animal is 
Biofortified 