Researchers in England have developed genetically modified wheat with higher levels of iron. Support GM wheat trials by sending your comments by 4 March 2019 to Defra (the Department for Environment, Food and Rural Affairs). Email your comments to gm-regulation@defra.gsi.gov.uk with the subject line 19/R52/02.
Defra isn’t holding a vote or a popularity contest. They ask specifically for “representations on any risks of damage being caused to the environment by the release applied for in this application.” If you choose to provide a comment, remember that helpful comments are evidence-based. Discuss the specific risks and benefits posed by the GM wheat in this application, not just GMOs in general. The information below and in the project FAQ may be useful as you write your email.
Iron deficiency is still a major problem – biofortification is one solution
Many groups of people across the world suffer from iron deficiency anemia. It is a serious problem that causes stunting in children and doubles the risk of death for pregnant women. Iron deficiency anemia has been reduced with supplementation and fortification of foods. Even with those efforts, iron deficiency remains a major global health problem.
Unfortunately, staple grains lack genetic diversity for iron, so breeding for higher levels of iron isn’t really possible for crops like wheat and corn. Plant breeding has been successful in developing wheat with higher levels of zinc, another mineral important for human health. But despite decades of trying, international plant breeders have not been able to increase iron levels in wheat.
One concern with biofortification as a solution to micronutrient deficiency is whether costly seed will be made available to all. In the case of this GM high-iron wheat, private seed-company interests are not currently a concern: “the development of this particular wheat line was initially funded by the not-for profit organisation HarvestPlus (2013 – 2014), and subsequently it was publicly funded by the UK Biotechnology and Biological Sciences Research Council.” Licencing and breeding the trait into locally-relevant varieties is still a consideration, but the first step is making sure the trait performs in a field environment.
Drs. James Connorton, Janneke Balk, and Cristobal Uauy “used the recently published wheat genome to locate two genes that were responsible for transport of iron. They then used one of these genes to direct more iron into the endosperm, the part of the grain from which white flour is milled.” The primary genes involved are from wheat, meaning that the trait is cisgenic (same species) rather than transgenic (different species), though many would still call the wheat a “GMO.” (See Intro to GMOs by the SciMoms for more details.)
As described in their FAQ, there is usually 5 to 8 mg iron per kg of white wheat flour, which is not high enough for human nutritional needs. Therefore, many countries require iron to be artificially added to wheat-based foods to prevent iron deficiency. The United Kingdom requires 16.5 mg iron per kg of milled white flour. Using biotechnology, the researchers developed a wheat variety with 20 mg iron per kg of milled white flour – when plants are grown in greenhouse conditions.
The next step is for the researchers to grow the plants outdoors in a field trial. According to the John Innes Centre, “two small-scale field trials are planned to take place at the John Innes Centre on the Norwich Research Park, within our existing, confined, GM trial facilities, between April and September in each year from 2019 to 2022.”
Support GM wheat trials today
If you follow the guidelines we outline above, your comment could have a significant impact on these trials, and someday could help people with iron deficiency around the world.
Field trials are just one important step in the process – if the trials show the wheat variety has higher iron levels in a typical field environment, the researchers still have much work to do. The wheat would also face many, many more regulatory processes in each country where it might be grown.
If this sounds like beneficial research to you, there’s still time to comment. Support GM wheat trials by sending your comments by 4 March 2019 to Defra. Specifically, email your comments to gm-regulation@defra.gsi.gov.uk with the subject line 19/R52/02.
The American Association for the Advancement of Science (AAAS) has presented an award for Scientific Freedom and Responsibility annually since 1980. “It honors scientists, engineers or organizations whose exemplary actions have demonstrated scientific freedom and responsibility in challenging circumstances. “
These awards have gone on these past 38 years without much notice, recognizing worthy scientists and organizations for their service. For example, the 2018 award went to Marc Edwards, “a civil and environmental engineer whose team documented lead contamination in the water supply of Flint,” Michigan. This year is a little different…
The 2019 AAAS award winners are…
The award announcement is no longer accessible, but you can view a PDF here.
This year’s award was so controversial that many scientists took to Twitter to express their displeasure. AAAS has revoked public view from the announcement page (though Biofortified saved a PDF) and AAAS announced on Twitter that they will not give the award as planned.
We are taking steps to reassess the 2019 Award for Scientific Freedom and Responsibility, after concerns were voiced by scientists and members. This award will not be presented next week as originally planned while we further evaluate the award selection.
Like many others, I am curious about the circumstances of the nomination and award process, and what happened behind closed doors that resulted in this surprising retraction. In this post, I humbly suggest that AAAS has an opportunity here to improve not just one award or one committee but to reconsider how the organization can encourage different types of scientists to work together.
Sarath Gunatilake, University of California, Long Beach – Mental health, international health, hospital management and quality assurance, training health care workers, disaster management, and occupational and environmental health research in international settings.
Channa Jayasumana, Rajarata University of Sri Lanka – Causes and treatments for chronic kidney disease, nephrotoxins, epistemology, and traditional medicine systems.
Priyantha Senanayake, Hela Suwaya Organization (lead researcher on the 2014 paper) – Additional research unknown, a full bio for this author was not found.
Sisira Siribaddana, Rajarata University of Sri Lanka (lead researcher on the 2015 paper) – Tropical medicine, chronic kidney disease, snake bites, diabetes, complementary and alternative medicine, and bioethics.
Dr. Gunatilake has strong opinions about glyphosate. He “describes the deadly chemical as an octopus with poisonous tentacles reaching far and wide” as breathily reported in a Daily Mirror article, Glyphosate without adjuvants not very useful. Dr. Jayasumana also has some strong opinions, even testifying at the so-called “Monsanto Tribunal” that use of glyphosate has caused “ecocide”.
Dr. Senanayake is the founder of “Hela Healing“, which sells purportedly medicinal rice at many pharmacies and stores in Sri Lanka. In 2014, Dr. Senanayake was recognized by the first lady of Sri Lanka for her work on chronic kidney disease, as reported in Priyantha Senanayake awarded as a [heroine]. According to May God Natha help agriculture ministry!, she conducted “black magic” for the agriculture minister, was personally “issuing orders to ministry officials”, and was providing rice to the education services ministry when the article was published in 2015. According to Programme held at the Ministry to promote herbal drink, she was also to provide “porridge drink” to the ministry of defense, including their military and national guard. As she is clearly a person of great influence in Sri Lanka, it is unclear why Dr. Senanayake was not included on the award. Note that some meaning or context may have been added or lost when source articles were translated to English; any change in meaning from the original was not intentional on Biofortified’s part.
According to the AAAS press release about the award, the two researchers “faced death threats and claims of research misconduct while working to determine the cause of a kidney disease epidemic that has claimed tens of thousands of lives in their home country of Sri Lanka and around the world.” I was not able to find independent verification of such death threats, though I am searching only in English.
Clearly, these two public health researchers want to protect public health and according to the announcement they did face “challenging circumstances”. So in that sense, they are deserving of this award. Unfortunately, they did not exemplify scientific responsibility in the conclusions that they drew.
Before continuing, I want to be clear – I’m not necessarily saying that researchers with unusual results should not be honored for perseverance in the face of adversity. No one should face death threats, no matter their research claims. Researchers should be free to seek funding and to attempt to publish results, even when they go against the overall consensus on a subject.
Glyphosate is an easy target
Glyphosate is a surprisingly controversial herbicide. The controversy is surprising because of how benign it is. As the SciMoms explain, like GMOs, glyphosate has become a scapegoat or proxy for many socio-economic issues in food, agriculture, and beyond.
Iida Ruishalme has published an extensive series about glyphosate if you would like to get into specifics. Briefly, animals, including humans, do not have the metabolic pathway affected by glyphosate. Dietary exposure of glyphosate is low. Even among the most exposed populations, glyphosate does not cause cancer. There has been limited evidence that glyphosate could be an endocrine disrupter, but it was not identified by an endocrine disrupting chemical by the US Environmental Protection Agency in their Tier 1 Screening Results and Tier 1 Assays: “there was no convincing evidence of potential interaction with the estrogen, androgen or thyroid pathways.”
Use of glyphosate has increased over time. In Long-term trends in the intensity and relative toxicity of herbicide use, Andrew Kniss showed that in the United States, “glyphosate accounted for 26% of maize, 43% of soybean and 45% of cotton herbicide applications” in 2014/2015. But, because of glyphosate’s low toxicity relative to other herbicides, it only contributed a small percentage of the chronic toxicity hazard in these crops.
Because of its prevalent use globally, glyphosate is an easy target. But in some ways, further replacement of other herbicides with glyphosate would further reduce overall risk.
If only chronic kidney disease of unknown etiology (CKDu) could be stopped by just removing glyphosate. But this hypothesis didn’t pan out in 2014, or today. Three recent reviews and meta-analyses tell us the full story.
CKDu currently occurs among agricultural workers in 5 areas of the world: North Central Province in Sri Lanka, Andhra Pradesh in India, Tunisia, El Minya in Egypt, and parts of El Salvador and Nicaragua. CKDu presents differently in each area and seems to be associated with different factors in each area as well, according to a 2017 review Endemic Nephropathy Around the World.
The reviewers also describe 2 previous unexplained chronic kidney disease epidemics with similar symptoms but that pre-date glyphosate. Itai-Itai disease in Japan, first identified in the 1910s, was found to be due to cadmium-contaminated crops. Balkan endemic nephropathy, first identified in the 1950s, was found to be due to accidentally consuming seeds from a toxic herb. Subsequent cases have been identified when people intentionally take certain toxic herbs as herbal remedies.
Pesticide exposures and chronic kidney disease of unknown etiology: an epidemiologic review, also from 2017, “performed a systematic review of epidemiologic studies that addressed associations between any indicator of pesticide exposure and any outcome measure of CKD.” They confirm that “existing studies provide scarce evidence for an association between pesticides and regional CKDu epidemics.” They suggest that more studies should be done.
Despite the lack of evidence for the hypothesis that glyphosate causes CKDu, Sri Lanka banned glyphosate in 2014, apparently in large part due to the work of the awardees. In 2015, the National Academy of Sciences of Sri Lanka issued a Statement on the Banning of Glyphosate, suggesting that the evidence points to the need for clean water and medical care for people in the affected area, education about safe use of pesticides, and controls on the importation of sub-standard pesticides – all evidence-based measures. When we blame the wrong things for public health problems, people continue to get hurt.
The glyphosate ban decreased yields, increased erosion, and may have increased illegal use of pesticides, according to Ban on Glyphosate: Planters’ plea for an alternative. These problems are described again in Glyphosate ban must be lifted and many other articles. The ban was finally lifted in 2018. With this award emboldening anti-glyphosate activists, are we more or less likely to see evidence-based solutions now?
AAAS Award for Scientific Freedom and Responsibility
At this time, we have little information about exactly what happened with this award. But we do know how the selection process works, according to AAAS:
Nominations should be sent via postal mail or email… All nominations are reviewed by a selection committee, which consists of five members chosen for diversity of background and sensitivity to the activities honored by this award. The committee’s selection must be endorsed by the AAAS Board of Directors at their fall meeting.
The first step is nomination, which begs the question of who submitted the nomination packet. It is entirely reasonable to imagine that some well-written letters extolling the virtue of supposedly ground-breaking research would sound very compelling to award committee members who are entirely unfamiliar with the field. Add information about persecution and death threats for their science and the story is still more compelling.
Selection
Given that this is the Award for Scientific Freedom and Responsibility, you’d think the awardees are likely chosen by members of the Committee on Scientific Freedom and Responsibility (CSFR) or a committee they selected. This 15-person committee currently has 2 members with expertise in the biological sciences; they are both medical doctors. None have a background related to agriculture or pesticides. That said, they have an incredible diversity of research and expertise.
However, as CSFR member Matthew Brown describes, the Committee on Scientific Freedom and Responsibility does not have this task. Instead, the AAAS Scientific Responsibility, Human Rights & Law Program (SRHRL) convenes the selection committee. SRHRL is run by a program staff of 5, including an assistant. None have a background related to agriculture or pesticides, or even biology or chemistry. Would they have chosen anyone with a background in these for the selection committee?
Due to their backgrounds, the program staff may have been unaware of or unable to see the controversy around glyphosate as it might have been presented in a nomination letter. But at least some of them should have been able to do a quick literature search for causes of CKDu (as I did for this post) and find that the researchers’ hypothesis was weak at best. If not able to do this themselves, they could have found some scientists who could evaluate the claims and research the background a bit before deciding upon an awardee.
Endorsement
Per the terms of the award, the AAAS Board of Directors endorsed the selection. The Board of 5 includes 2 biological scientists, both in medicine. These eminent leaders of science presumably reviewed the selection and decided it was an appropriate award. Like the program staff, the AAAS Board may have been unaware of the controversy around glyphosate. But again, they should be able to search the literature for confirmation of the nominees’ claims.
Promotion
As weed scientist Andrew Kniss pointed out on Twitter, there were many concerning phrases in AAAS’s announcement.
This wording is much stronger than warranted, when we consider both the paper being recognized and all of the other available research on glyphosate. I suspect this language came directly from the nomination packet.
The announcement for the award was written by a science writer from the AAAS Newsroom. Like the Committee and the AAAS Board, the writer may have been unaware of the controversy around glyphosate, but he could have searched for more information.
Disheartening disinformation
Altogether, this seems to have been a systemic lack of information-seeking and some confirmation bias, combined with as-yet unknown motivated nomination letter writers. While some on Twitter cried foul, I don’t see evidence that this was anything nefarious by AAAS. This award situation is new, but it’s part of an all too familiar narrative.
Writing about the glyphosate ban in Sri Lanka, Buddhi Marambe, weed scientist of the University of Peradeniya in Sri Lanka summarizes:
We have failed to look at issues taking the totality into consideration. The complex problems in agriculture have no single and simple answers, especially with regard to national level food security. Forces with political and spiritual ideologies have always succeeded in the recent past in over-ruling even the most basic scientific principles. This is a pathetic story.
The best way to ensure that everything from small awards to large grants to policy decisions and more are based on both social and scientific merit is to have different views represented at the table. In short, biologists, chemists, and more need to volunteer and be present where all of these things are discussed and decisions are made. When we do, we need to be open to listening to everyone, and work toward understanding the ethicists and sociologists. Working towards mutual understanding helps everyone.
This isn’t just about the 2019 AAAS Scientific Freedom and Responsibility Award. The award is just another indicator for old, deep problems. The silos of “hard science” and “soft science” hurt all of science and all of society. Those working on technological applications often aren’t considering the societal implications of their work while those who are considering the societal implications might not have enough in-depth experience with the tech itself.
Unfortunately, researchers in the “hard sciences” often don’t volunteer for work in the “soft sciences”. Why would they? While we give lipservice to other things, the currency of academia is publications – not mentoring, not outreach, certainly not serving on award committees. Yet if there had been just one agronomist on this committee, the nomination could have been flagged.
There does seem to be a growing number of cross-trained scientists, which is encouraging – but anecdotally, we’re also finding trouble fitting into traditional careers that don’t reward “extracurricular” activities when we’re in research roles, yet we’re too experienced and too educated for many other roles.
This is where AAAS comes in. Instead of sweeping this award situation under the rug, how amazing would it be if they found ways to encourage silo breaking? If anyone has the power to advocate for new incentives for interdisciplinary work, it’s the world’s largest interdisciplinary scientific society. Ideas have already been developed, such as those presented in the 2018 paper Overcoming early career barriers to interdisciplinary climate change research.
It would be easy enough to determine which Sections are under-represented. For example, according to the Bureau of Labor Statistics Occupational Outlook Handbook, in 2016 there were 19,900 physicist and astronomer jobs, growing at a rate of 14%, while there were 43,000 agricultural and food scientist jobs, growing at a rate of 7%. AAAS could look at the current membership and provide incentives such as discounted membership and discounted meeting attendance to under-represented fields. Membership of $125 per year might not seem like much but it adds up when you consider various domain-specific societies that we must also belong to. AAAS could also encourage institutions to permit researchers to use grant funds to pay for membership, something that is not universally allowed.
On a related note, science communication is another area where AAAS could demonstrate leadership on the policy side. AAAS provides top-notch science communication training and events, and and they even have a Communication Toolkit on their website. The organization clearly sees value in scientists communicating with the public. But getting scientists excited about outreach doesn’t help much when there’s little to no reward for doing it. Changing performance evaluations to include outreach would show that this activity has value – and AAAS is one organization that could provide leadership and encourage institutional change.
AAAS has shown incredible leadership on many topics over the years, including taking major steps against harassment, advocating for human rights, training scientist diplomats, and much more. In that context, developing and implementing incentives for interdisciplinary involvement both inside and outside AAAS itself and helping those who are cross-trained to find roles that use their skills seems almost easy. Then next time there’s a questionable award nomination, it will be dealt with easily.
Editor’s note: Thanks to our commenters for providing needed information! Updated February 11, 2019 to add information about Priyantha Senanayake, and to elaborate on what AAAS could do differently to reduce such missteps in the future. Updated February, 14 2019 to correct how the selection committee is chosen, and to add a note about what AAAS could do to encourage scientists in science communication.
Sometimes fiction can teach us more about a topic than complicated diagrams. Science communicator Rebecca Nesbit has published a short story titled The Golden Ticket that uses sibling rivalry to discuss biofortified golden rice.
The story begins:
Two hours before my sister says her wedding vows, I have already made the final touches to my makeup. I take a step back from the mirror and assess whether she will notice any change in me. Thankfully, the last few years have treated me kindly.
Read the full story at LabLit, and let us know what you think in the comments!
Adam Smith (1723-1790) was a Scottish economist and philosopher.
Adam Smith may be known as the father of capitalism but he was also a man profoundly interested in social justice. In “The Wealth of Nations” Smith’s most famous work showcased how commerce operates between individuals seeking to maximize their own returns.
In his less noted work “The Theory of Moral Sentiments”, he analyzed social interactions and how individuals aspire to help and support one another. Smith’s interest in social relationships trumped his interest in trade as he was constantly fine-tuning “The Theory of Moral Sentiments”, his first book, right up until his death – long after he had put “The Wealth of Nations” to bed. Here I argue that if Adam Smith was living today, he would endorse genetically modified foods to both improve commerce and provide social justice.
As described by historian Thomas J. Ward:
One could argue that Smith’s ultimate quest was social justice. He advocated an open market with economic and social protocols between countries that would result in an overall improvement in the living conditions of the common citizen. … Smith’s “invisible spectator’s” concern for the other, including the downtrodden of his society, are prerequisites to facilitate economic opportunities, greater social justice, and peace.
Within the ivory towers, today’s plant biologists are improving crop productivity for academic wealth: papers and research grants, the paucity of which is a subject for another time! Given current regulatory hurdles, the dream of bringing these crop improvements to the world’s poor is a fantasy. There is no mysterious “invisible hand” operating in the global market place to thwart the use of GMOs. It is a systematic campaign of misinformation by ill-informed, malicious groups. (GMO stands for Genetically Modified Organism. For more information, see Intro to GMOs by the SciMoms.)
When Smith referred to the “invisible hand” it was a metaphor for the motives that intentionally caused actions, which once taken, had unintended consequences. The ‘unmistakable hand” of the anti-GMO campaign has been to suppress the wealth of impoverished nations.
Agricultural development is a powerful tool to end poverty. Growth in the agriculture sector is two to four times more effective in raising incomes among the poor. If GMO crops are not utilized to save water, diminish fertilizer costs, and improve yield we have effectively limited the tools available to the world’s poor. Anti-GMO groups are handcuffing the world’s poorest people to their current plight.
GMOs and Moral Sentiment
Smith argues in “The Theory of Moral Sentiments” that our moral ideas and actions are the fabric of our social selves. He argues that our social behavior is a better guide to moral action than reason. Though scientists (and agbiotech) are self-interested, we have to work out how to live alongside others without doing each other harm.
The scientific consensus (and it is a consensus!) finds that GMO plants are safe and don’t seem to harm the environment. Hundreds of studies have been done (and millions of dollars spent) to show unequivocally that GMO plants are safe. Scientists are not creating GMO foods to harm consumers or the environment. Can the same be said for vocal groups that are anti-GMO?
The Bottom Line
Economic considerations of profitability, efficiency, and productivity are paramount for agriculture. If we forgo monetary gain to maintain specific environmental standards this would point to a moral agriculture viewpoint. Adam Smith would want us to take this moral perspective.
However, GMO foods do not require this choice to be made, as they are productive, efficient, and environmentally sound. By Smith’s standards, the anti-GMO rhetoric is difficult to defend because it does not support profit, efficiency, or most importantly, social justice.
Written by Guest Expert
Kendal Hirschi works at the Children’s Nutrition Research Center at Baylor College of Medicine and is Associate Director of Research at the Vegetable and Fruit Improvement Center at Texas A&M. His research program centers on many biomedical issues and has published papers using bacteria, yeast, crops, zebrafish, mice, and human subjects. His research goal is to increase the nutritional content of crops, in collaboration with clinical faculty at Baylor College of Medicine. His long-term goal is to bridge the chasm between plant biology and nutritional sciences.
Editors note: Thomas J. Ward quote added 3 February 2019 to provide a definition for social justice in the context of Adam Smith, which is different from the definition that might commonly be assumed in 2019.
On December 20th, 2018, the USDA Agricultural Marketing Service (AMS) released the final rule for the National Bioengineered Food Disclosure Standard. It’s 239 pages of dense text that everyone in the food system is trying to quickly figure out. What does it all mean? How will the standard impact farmers, processors, and food manufacturers? How will it impact international trade? Consumers will want to know how new labels will impact their choices at the grocery store.
In this post, I’ll open the box and look at what’s excluded, discuss prohibition of “may be” labels, and talk about how much this will cost. Mary Mangan has shared her initial reactions to the final rule in First Look at the Bioengineered Label Final Rule on the Biofortified Blog, and you can find more information on our Bioengineered Label News page.
First, I wanted to point out that AMS had a lot of prior food labeling laws and regulations to work within. As is typical for most regulations, AMS could only act within the restrictions of the National Bioengineered Food Disclosure Standard, the law that was passed by Congress in July 2016.
Further, many of the weird parts of these bioengineered labeling regulations are weird because they had to snake around and within the thicket of existing food labeling regulations. Changing other laws and regulations was outside the scope of these regulations, even if it it would have made things easier for AMS, for food manufacturers, and for consumers.
This regulation, called the National Bioengineered Food Disclosure Standard (NBFDS), must be implemented by January 1, 2020. Small companies have until January 1, 2021. It is possible, though unlikely, that Congress would pass another food labeling law before that date that would change how this labeling regulation and other regulations overlap.
Defining bioengineered
Defining GMO has always been tricky. Biotechnology is an ever advancing technology, and different US and international agencies have defined it differently for different purposes. Under the National Bioengineered Food Disclosure Standard, bioengineered food is:
food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature; provided that such a food does not contain modified genetic material if the genetic material is not detectable…
Or, more simply, “The Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature.”
Bioengineered food is not: “An incidental additive present in food at an insignificant level and that does not have any technical or functional effect in the food”.
That dance between what bioengineered is not (exclusion) and what it is (inclusion) is central to this regulation. We start with a “List of Bioengineered Foods” or foods that are presumed to be bioengineered and then look at exclusions from there:
Implementing this label could cost $569 million to $3.9 billion for the first year alone. How will this impact our grocery bills?
The National Bioengineered Food Disclosure Standard has numerous exclusions to what is required to be labeled. Some of the bioengineered label exclusions are due to other labeling laws and regulations and how they overlap with this regulation. Some of the exclusions are unique to this regulation.
Here are the lists of what’s excluded (not required to be labeled) and included (required to be labeled) as I found in my initial read of the final rule. Am I missing any? Let me know in the comments.
Excludes
foods with undetectable modified genetic material
Certified Organic foods
food served in a restaurant or similar retail food establishment
ready-to-eat items prepared by grocery stores
food made by “very small food manufacturers” with annual receipts of less than $2.5 million (which means 74% of food manufacturers and 45% of dietary supplement manufacturers do not have to comply with bioengineered labels)
distilled spirits, wines, or malt beverages
pet food and feed for animals
food derived from an animal (meat, eggs, milk, honey, rennet and other enzymes derived from animals) that has eaten bioengineered feed
multi-ingredient food products that contains meat, poultry, or egg product (including beef broth, if identified as a composite ingredient) as the first ingredient
multi-ingredient food products that contains broth, stock, water, or similar solution as the first ingredient, and a meat, poultry, or egg product as the second ingredient
processing aids and enzymes if they are not listed as ingredients
up to 5% inadvertent presence of bioengineered ingredients
Includes
foods with detectable modified genetic material, if they meet one or more of the following inclusions:
raw and processed foods (raw produce, seafood, dietary supplements, and most prepared foods, such as breads, cereals, non-meat canned and frozen foods, snacks, desserts, and drinks
wines with less than seven percent alcohol by volume and beers brewed without malted barley and hops
chewing gum
dietary supplements
processing aids and enzymes if they are listed as ingredients
food derived from a microorganism that has eaten bioengineered “feed”
Exclusions in practice
Collage by Anastasia Bodnar.
Just for the sake of an example, let’s look at two types of Hormel Chili. I’m only using Hormel here because they have they have conveniently similar products to compare with the ingredients online. The standard used pork stew as an example.
Both the Vegetarian with beans and NO Beans chili types of Hormel Chili contain soy flour, which likely would need to be labeled as bioengineered, unless Hormel was to source non-bioengineered soy flour. Note: nucleic acids can be found in soy flour so it is not an exempt product on that basis.
However, let’s look at the first few ingredients of each chili type. Vegetarian with beans has “Water, Beans, Tomatoes”. Even though soy is 9th in the ingredient list for the vegetarian chili, and listed as being less than 2% or less of the product, it would require a bioengineered label. NO Beans has “Water, Beef and Pork, Textured Soy Flour”. Even though soy is 3rd in the ingredient list, it would not require a bioengineered label.
Why is this so weird? Again, AMS had to work within existing food labeling laws and within the National Bioengineered Food Disclosure Standard. As such, products like NO Beans chili that are subject to the Federal Meat Inspection Act, Poultry Products Inspection Act, or the Egg Products Inspection Act don’t get bioengineered labels but products like Vegetarian with beans chili would likely get such a label – even if they both contain the exact same soy flour.
Wait, there’s more! A product can escape bioengineered labeling and contain up to 5% bioengineered ingredients, as long as those ingredients are there inadvertently. So you could have unlabeled chili that actually contains more bioengineered ingredients than Hormel Vegetarian with beans, while the Hormel with 2% or less soy flour requires a bioengineered label.
“May be” is not allowed
Collage by Anastasia Bodnar.
Hormel is somewhat ahead of the game when it comes to following the bioengineered label exclusions. They already have a “may be produced with genetic engineering” label on their Vegetarian with beans chili, but do not have such a label on the NO Beans chili.
Except… Hormel and many other companies will have to change their current labels that state “may be produced with genetic engineering” or “may be partially produced with genetic engineering” because the NBFDS explicitly prohibits “may be” statements for the purposes of meeting bioengineered labeling requirements.
In some cases, this will force companies to label products as bioengineered when there isn’t any bioengineered content. As I wrote nearly 10 years ago in What’s in a label?, some ingredients can have multiple sources, including various plants, animals, and even petroleum. Companies might choose different versions of an ingredient based on cost or other factors. If one potential source of an ingredient would require a bioengineered label, and the product contains detectable genetic material, then the company would need to either label all of the product just in case they use that ingredient, or continually be ready to swap out labels.
Bioengineered labeling is mandatory and costly
Note that bioengineered labels, like all GMO or non-GMO labels, don’t provide much in the way of useful information. As AMS states in this final rule:
Nothing in the disclosure requirements set out in this final rule conveys information about the health, safety, or environmental attributes of BE food as compared to non-BE counterparts. In fact, the regulatory oversight by USDA and other Federal Government agencies ensures that food produced through bioengineering meets all relevant Federal health, safety, and environmental standards.
And yet, despite the lack of a health, safety, or environmental risk that can be attributed to bioengineered foods in aggregate, this sunny logo will start showing up on products soon. Companies have until January 1, 2020 (January 1, 2021 for small companies) to comply. They must label their products or reformulate to avoid bioengineered ingredients. This process is expected to be costly:
USDA estimates that the costs of the NBFDS would range from $569 million to $3.9 billion for the first year, with ongoing annual costs of between $51 million and $117 million.
If we are going to mandate that food companies spend money, why not ask that they spend money on real issues like food safety and nutrition? As I described in an article for SciMoms, we already have higher food prices for organic and non-gmo labeled foods. Now we can expect to see conventional food prices to go up as companies pass these costs on to the consumer. Even worse, with this high cost comes no clear benefit:
The NBFDS is not expected to have any benefits to human health or the environment. Any benefits to consumers from the provision of reliable information about BE food products are difficult to measure.
The lack of health, safety, or environmental benefits along with the huge cost of this regulation leaves me wondering why that “may be” option wasn’t left in place. It would have provided some transparency while greatly reducing cost, as I mentioned in my public comment to AMS on behalf of Biology Fortified. I’m also left wondering why the industry’s very functional voluntary labeling wasn’t left in place. Tempting as it may be, discussion of what could or should be is over, and now we talk about what is.
What’s next?
Even though no one will be totally satisfied with these regulations, overall AMS did a thorough job of justifying their decisions in the final rule. It is a good example of regulatory compromise across diverse stakeholder groups. While others have identified some gaps, such as lack of a definition for non-GMO, we now have a national path forward rather than a state-by-state patchwork. That’s good for industry, but more importantly, good for consumers. Find news and information about the Bioengineered Label on our dedicated page.
Editor’s note: The USDA Agricultural Marketing Service (AMS) released their bioengineered label final rule today. Learn about the bioengineered label’s definitions in Anastasia Bodnar’s post Bioengineered Label – Consumer Impacts and find news and updates on our Bioengineered page. Mary Mangan tweeted her observations, with many helpful screenshots of the interesting bits from the final rule, and we have shared her full tweetstorm here with her permission, with minor editing for formatting and consistency. See Mary’s full thread on Twitter (@mem_somerville) or on the Thread Reader App.
Well, there goes my day. 239 pages of federal document… Let’s discuss with #bioengineered hashtag.
Pg 8: Pet food not included in label rule: “Therefore, although pet food and animal feed are “food” under the FDCA, such foods for animals are not covered by this regulation, pursuant to the amended Act. “
Pg 8: “Other examples of “food” under the FDCA include dietary supplements, processing aids, and enzymes.” Oh, processing aids… does that mean enzymes like in cheese making…?
Pg 9: Multi-ingredient stuff has special rules. I will never understand this.
Pg 11: must have DNA, I think? “foods with undetectable modified genetic material are not bioengineered foods”
Pg 12: “For refined foods that are derived from bioengineered crops, no disclosure is required if the food does not contain detectable modified genetic material.” So cheese prolly wouldn’t… still digesting…
We have a list. We’re checkin’ it twice. We’re gonna find out who is… wait, what section?
Pg 21: “The following foods comprise the List of #Bioengineered Foods: alfalfa, apple (ArcticTM varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-resistant varieties), pineapple (pink flesh)…” Where can I get #GMO pineapple??
Pg 49: I think this says QR codes and phone numbers are OK. And you can get texts about #bioengineered food. You cannot use “may be…” language.
Pg 62: #bioengineered label can be done voluntarily, if desired.
Pg 67: Enforcement. “records audits and examinations, hearings, and public disclosure of the summary of the results of audits, examinations, and similar activities”. I think this means it’s not via lawsuits and recalls, just paper pushing. But I am not a lawyer.
Pg 70: Mandatory compliance begins January 1 2022.
Pg 77: Can’t tell if something is BE if there’s no DNA. Aligned with other countries, sugar and refined oils exempted from labels. And I heard heads asplode.
Pg 79: We’re telling you again this has nothing to do with health claims, all the “food, including that produced through bioengineering, meets all relevant Federal health, safety, and environmental standards”
Pg 81: I think this says it’s not adding #CRISPR and editing to the definitions.
Pg 87: No, we’re not calling them #GMO. Buh-bye. [editorial comment]
Pg 92: Nah, we aren’t touching “found in nature” either.
Pg 103: #CRISPR / TALENS again. No, we still don’t distinguish on the tech used, but on the ultimate product.
Pg 111: No, we aren’t going after undetectable DNA. [this whole section is a series of comment/responses that are kind of tedious and repetitive in many ways. Zzzzzzzzzz 💤]
Pg 113: Animals fed with #bioengineered foods are not subject to BE labels.
Pg 115: No, if an animal was treated with a #GMO pharmaceutical [say, a vaccine like Organic Consumers hates] it’s still not #bioengineered.
Pg 117: Grafting non-BE stuff to BE-modified rootstocks does not trigger #bioengineered labeling, “because they do not contain modified genetic material”.
Pg 118: Hipster food trucks are now listed in with “restaurants” and are all exempt from #bioengineered labeling. [Ok, it might not have said hipster…]
Pg 126: Nope, @nonGMOProject and the other schemers not getting a free pass, and they better not mislead anybody. We can only give National Organic Program stuff a pass.
Pg 127: Mutagenesis is conventional breeding.
Pg 128: Let’s say it loud for those in the back: “NBFDS is a marketing standard and not related to health or safety,”(NBFDS = National Bioengineered Food Disclosure Standard, btw)
Pg 135: Oh, did we mention this is a marketing thing? No, we aren’t going for the 0.9% threshold because it doesn’t matter, and would be onerous and costly.
Pg 141: “Water and salt do not contain DNA and would therefore, as individual ingredients under Alternative 1-A, never trigger disclosure.” Things you have to say.
Pg 142: Nah, we aren’t doing PCR. It’s all paperwork.
Pg 143: Nope, we aren’t calling ’em #GMO, and we’ll teach you to like it.
Pg 146. Did we mention we still aren’t using #GMO, and we’ll teach you to like it?
Pg 148: We heard you didn’t like any of the labels. We changed the wording so it says #Bioengineered. Enjoy! [ps you can get the labels here]
Pg 151: We heard you hate the QR codes too. Too bad, we have to. But there are other routes. Phone numbers and texts.
Pg 156: There are several pages of discussion of text messages. 💤📱
Pg 160: Another section relating to small biz and the burdens of this. There have been several section, but biz sizes aren’t my area of focus so I haven’t mentioned that so far. But they are in there, several sections.
Pg 163: Another section on bulk foods. Like small biz, this is just not something I’m focused on, so it’s there–just haven’t commented on it… 💤
Pg 170+: Record keeping. 💤But that leads to enforcement issues (pg 175)–what happens if there’s a challenge? 5 days to get paperwork together. No fines. No recalls. But we’ll put your name up on the wall for people to point at and laugh. Or something.
Pg 181: Date and rationale explained. Jan 2022 for mandatory labeling.
Pg 187+: Starts the RIA, Regulatory Impact Analysis. Lots of back-and-forth about how (or how not) to calculate costs along the chain from farmers to consumers. I am now too bored to care.
Pg 196: Starts the federal paperwork reduction notice stuff… for many pages. Lots more on record keeping. This may be of interest to farmers and grocers, but 💤
Pg 206: Has a Civil Rights Review section. I’m mildly impressed this administration still does that… Mostly about phones and data plans. They think the phone number solves this.
Pg 208: Cost estimate for the label program. This is an expensive escapade, for this: “The NBFDS is not expected to have any benefits to human health or the environment.” Your tax dollars at work.
Pg 215-end: Seems to start the official text of the regs. I’ll assume the legal eagles will check on this. And I’m out. /fin
In Dicamba drift – Part 1, I described what the dicamba herbicide is, showed how it works, and provided resources about human health effects of dicamba. I also described how dicamba drift happened in 2016, 2017, and 2018. If you haven’t read Part 1 yet, go there first, then come back to Part 2. In this post, I have the timeline of how dicamba drift became a problem, and what may happen in 2019. In Part 3, I’ll discuss some of the specific issues associated with applying dicamba and what might be causing the drift. Part 4 wraps up the series by considering the response of the dicamba manufacturers and potential social impacts this whole debacle might have moving forward.
Dicamba drift picks up
It seems like dicamba drift was a sudden problem. In actuality, dicamba has always been a particular risk for drift. Dan Charles, agriculture correspondent at NPR, summed up dicamba’s problem potential this way: “Dicamba… is notorious for a couple of things: It vaporizes quickly and blows with the wind. And it’s especially toxic to soybeans, even at ridiculously low concentrations.” Dicamba’s volatility was described in 1979, and various formulations over the years have attempted to reduce the likelihood of the herbicide to evaporate at certain temperatures. Dicamba’s impacts on soybeans have also been known for decades, with extension agents recommending dicamba not be used near soybeans as early as 1971.
Many plant species show visible damage from small amounts of dicamba, particularly at early growth stages. Dicamba injury is particularly easy to see in soybean; it causes characteristic cupping of leaves, as shown in the image below. Despite its drawbacks, farmers used dicamba for many years without too much trouble. They didn’t use it very widely, mostly to treat weeds in corn. Farmers knew to avoid using dicamba near broadleaf crops during the growing season because of their high susceptibility to damage.
Something changed in January 2015: the USDA approved dicamba tolerant soybean and cotton. Monsanto had their elite genetics tied up with the dicamba tolerance trait, so they began selling seed right away. That meant farmers were already planting about 20 million acres of dicamba tolerant soybeans in the spring of 2016. Because the Coordinated Framework for the Regulation of Biotechnology keeps regulatory authorities separate, the USDA was able to approve the GE crops without considering what might happen with the associated herbicides.
EPA didn’t approve a lower volatility formulation of dicamba for use on these dicamba tolerant crops until November 2016. Specifically, the approved formulations are XtendiMax by Monsanto, FeXapan by DuPont, and Engenia by BASF. In the meantime, farmers who planted dicamba tolerant soybeans had some difficult choices. Many had glyphosate resistant weeds that could decrease yields. Not treating weeds before they produce seed could result in worse weed problems the following year. Farmers could use older dicamba formulations that were not labeled for use with the GE crops. That would solve their weed problems and protect the yields of their soybeans – but it would also be in violation of the law.
Some farmers did choose to break the law and applied dicamba off-label to their GE dicamba tolerant soybeans. Reports from extension agents in the early summer of 2016 showed that dicamba drift was a major problem, and that illegal application was the culprit. Farmers could be fined by states for illegal use, but the fines were too small to be a deterrent. Farmers can face prison time for such violations; one farmer may serve 20 years for illegal application of dicamba and lying about it to investigators. Healthy soybean plants (left) have broad, flat leaves. Dicamba-injured soybeans (right) have cupped leaves. Healthy soybean image by United Soybean Board, injured soybean image by the University of Arkansas, both via Flickr.
The drift continues
In January 2017, four farm and environmental groups filed a lawsuit against the EPA. They argued that the dicamba registrations are illegal because EPA didn’t follow parts of the Endangered Species Act and the Federal Insecticide, Fungicide and Rodenticide Act. That case is still pending (in November 2018, Monsanto filed a motion to dismiss the case). If the judges rule the registrations are in fact illegal, then we might go back to dicamba tolerant seeds with no dicamba formulations that can be used with them.
With the new dicamba formulations available, you might think that lawsuit was a bit premature. The drift should decrease, and things should quiet down for dicamba, right? Unfortunately, that’s not what happened. In 2017, US farmers continued to plant GE dicamba tolerant soybeans in large numbers: 40 million acres, about half of the US soybean crop. Even though the correct formulation of dicamba was available, drift continued.
Kevin Bradley at the University of Missouri tallied all the reports for 2017. He found “2,708 dicamba-related injury cases currently under investigation by various state departments of agriculture around the US, and that there were approximately 3.6 million acres of soybean that were injured by off-site movement of dicamba at some point during 2017.” This may represent only a small fraction of the actual dicamba drift damage.
In October 2017, EPA implemented some changes to the pesticide labels in an effort to reduce the drift problems for 2018. A July 2018 estimate by Kevin Bradley found around 600 cases of injured soybeans making up about 1.1 million acres. This may be a decrease from 2017, but data stopped coming in after July. We don’t know the true extent of the 2018 damage.
What’s next for dicamba
With all the problems of 2016, 2017, and 2018 – what’s next for dicamba, and more importantly, what’s next for farmers and their neighbors? On Halloween 2018, the EPA announced changes to the dicamba pesticide registration, giving farmers a few short months to plan. States are scrambling to implement training for pesticide applicators on the updated pesticide labels. The EPA summarizes the changes:
EPA reached an agreement with manufacturers on measures to further minimize the potential for damage to neighboring crops from the use of over-the-top dicamba formulations used to control weeds in dicamba-tolerant cotton and soybeans. The [manufacturers] agreed to registration and labeling changes including making these products restricted-use, record keeping requirements, and certain additional spray drift mitigation measures for the 2018 growing season.
The EPA emphasizes that farmers may use only the new dicamba formulations on dicamba tolerant crops. Using other dicamba products for that purpose is a violation of the label, and the label is the law. As Dan Charles reports, “the [EPA’s] decision is likely to boost sales of dicamba-tolerant seeds next year. Some farmers, in fact, say that they’ll be forced to plant them. Otherwise, their crops could be damaged by dicamba fumes drifting in from neighboring fields.”
Planting dicamba tolerant seed might help some soybean and cotton farmers, but changes to the dicamba registration may not reduce damage to other crops, or to native vegetation. It also doesn’t help farmers who hoped to grow organic or non-GMO soybeans or cotton, or any crop besides dicamba tolerant soybean and cotton, or naturally tolerant grasses like corn. Bob Hartzler at Iowa State University lists EPA’s changes in a post titled Moving Forward with Dicamba. Also see his initial thoughts on the new approach to dicamba management.
People under the supervision of a certified applicator are no longer allowed to make applications.
Applications are allowed only from 1 hour after sunrise to 2 hours before sunset (previously the restriction was between sunrise and sunset).
Applications are restricted to 45 days after planting or prior to R1 stage of soybean, whichever comes first (previously the restriction was up to and including the R1 stage).
Applications cannot be made if rain within 24 hours may result in soil runoff (previously the label stated not to apply if rain is expected to occur within 24 hours).
The label clarifies what constitutes sensitive areas and where downwind buffers are required. The applicator must survey the area for sensitive crops and residential areas, and then not apply the product when wind is blowing towards these areas. It is up to the applicator to determine the appropriate distance between the target site and sensitive area. One of the more important changes is that the label states that managed or mowed areas adjacent to fields are now considered a non-sensitive area. Thus, the road right-of-way can be considered part of the 110 ft downwind buffer.
There is a new restriction regarding buffers around the entire field in counties with endangered species.
Dicamba specific training will again be required for all applicators using the registered products on dicamba-resistant soybean.
Herbicide tolerant crops have undoubtedly made weed control easier for farmers, and have resulted in a small but notable reduction in herbicide toxicity in US agriculture. Adoption rates in the US have been astoundingly high, with farmers in the US planting genetically engineered (GE) varieties for over 90% of corn, cotton, and soybean acres, as shown in this chart from the US Department of Agriculture (USDA).
Herbicide tolerance traits are often created with genetic engineering, such as the infamous Roundup Ready crops that are tolerant to glyphosate, but can also be developed with traditional breeding or mutagenesis, such as Clearfield wheat that is tolerant to imazamox. Herbicide tolerant crops have been in the news in part due to the newest version on the market – dicamba tolerant crops. Specifically, there have been problems with dicamba drift, meaning the herbicide hasn’t consistently stayed in the fields where it was sprayed.
Dicamba “is a widely used herbicide on agricultural crops, fallow land, pastures, turfgrass, and rangeland. It was first registered in the US in 1967. Historically, most dicamba applications occurred in late winter or early spring for removal of broadleaf weeds prior to planting crops. It is registered for use in agriculture on corn, wheat, cotton, soybeans, and other crops.”
Dicamba is a growth regulator that acts like natural plant hormones called auxins. The herbicide 2,4-D is also a growth regulator. Plants need natural auxins to grow in a normal shape in response to external stimuli like light and gravity, as in the sped-up Arabidopsis plant below.
Dicamba is sold as Banvel, Clarity, DiFlexx, Engenia, XtendiMax, and other name brands. Dicamba selectively controls broadleaf weeds (such as dandelion and ragweed), but grasses (including crops like corn and rice) are naturally resistant.
When a plant has too much growth regulator, it grows in unexpected ways and eventually dies. This could happen if it has a mutation in auxin-related genes or if it is sprayed with dicamba, for example. The cells divide too fast in the wrong directions, and they don’t respond to external stimuli as they should. Since plant growth regulators act specifically on plants, the effects on animals (and humans) are limited.
Human health and dicamba
Dicamba is a relatively safe pesticide, when used as intended. For example, a large study of pesticide applicators by the National Institutes of Health found “did not find clear evidence for an association between dicamba exposure and cancer risk”, and a later examination of the same data set by Health Canada similarly found that dicamba was not “associated with a significant increase in overall cancer incidence.”
People and animals would need to consume large amounts of dicamba for there to be health effects, and dicamba is excreted quickly. “Dicamba is moderately toxic by ingestion and slightly toxic by inhalation or dermal exposure.” However, fish may be more susceptible to harm. A summary of human health impacts of dicamba can be found on the National Library of Medicine’s TOXNET, but keep in mind that 1) studies on isolated cells or in animals are not necessarily predictive of human health impacts and 2) some of the information provided is for other pesticides.
As is typical for pesticides, there may be impacts to human health and the environment due to inactive ingredients, such as surfactants. Pesticides should always be applied according to the label – such as with proper protective gear and away from waterways.
Dicamba is drifting
First, what is drift? Pesticides are formulated and labels instruct application in ways that keep the pesticide where it was applied. Still, drift is always a possibility when using any pesticide, on the farm or at home. As described by the National Pesticide Information Center:
Pesticide drift is the airborne movement of pesticides from an area of application to any unintended site. Drift can happen during pesticide application, when droplets or dust travel away from the target site. It can also happen after the application, when some chemicals become vapors that can move off-site. Pesticide drift can cause accidental exposure to people, animals, plants and property.
Drift often happens when there is an unexpected weather change during or shortly after pesticide application. Farmers generally follow pesticide labels (the Label is the Law) and use pesticides in a way that minimizes drift (drift = wasted pesticide = wasted money), so drift happens at a fairly constant, low level.
Dicamba has been in use since its registration in 1967. Farmers used dicamba with minimal incidents all the way up to 2016. Then, in 2016, 2017, and 2018, there were many, manyincidents of reported dicamba drift onto non-tolerant crops, and the problem is likely much larger than reported. In Nebraska for example, a survey of farmers found that 51% of respondents had dicamba injury on non-dicamba tolerant soybean, but only 7% of those filed an official complaint with the Nebraska Department of Agriculture.
The damage isn’t just to soybean. Drift from dicamba is impacting wild plants, too. Beekeepers in some areas have reported that dicamba reduced pollen and nectar sources for their bees. Dicamba has also caused damage to small farmers growing speciality crops and to homeowner’s landscaping. People may not report damage because they want to stay friendly with neighbors. But drift keeps happening, harming relationships in addition to the plants, including one dicamba-motivated murder.
The financial damage to soybean at least may be limited. A recent meta-analysis looked at soybean response to dicamba drift and found that while visible damage could be caused by very low amounts of dicamba, visible damage isn’t necessarily an indicator of yield loss. Dicamba injury is easy to see in soybean; it causes characteristic cupping of leaves, as shown in the image below.
When there is financial damage, farmers have a few options. Initially, crop insurance did not cover dicamba drift, but rules have changed: farmers should check with their insurance agent immediately upon discovering damage. Farmers might use liability insurance to help recover losses, but insurance companies will not cover off-label (illegal) applications. Neighbors also have the option of negotiating with each other out of court, or can pursue a civil lawsuit, all typical options for chemical trespass. Of course, the first step is to document the damage. Healthy soybean plants (left) have broad, flat leaves. Soybeans injured by dicamba drift (right) have characteristic cupped leaves. Healthy soybean image by United Soybean Board, injured soybean image by the University of Arkansas, both via Flickr.
Why is dicamba drifting more since 2016 compared to previous years? Coincidentally, the USDA approved dicamba tolerant soybean and cotton in 2015, and farmers began planting in 2016. The story is far more complicated than that, though.
For a timeline of how dicamba drift became a problem starting in 2015 through 2018, and for a preview of what might happen in 2019, see Dicamba Drift – Part 2. In Part 3, I’ll discuss some of the specific issues associated with applying dicamba and what might be contributing to drift. Part 4 wraps up the series by considering the response of the dicamba manufacturers and potential social impacts this whole debacle might have moving forward.
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.
We need to talk about conflicts of interest (COIs) in scientific research. Specifically, we need to talk about the difference between COIs and research misconduct. There seems to be a misunderstanding in the media and public conversations that a COI is research misconduct. While a COI may lead a researcher to commit research misconduct, a COI is not, on its own, research misconduct. What are conflicts of interest? A COI is a situation in which a person has multiple competing interests, financial or other, that have the potential to compromise or bias their judgment or objectivity. COIs exist whether or not decisions are affected. COIs merely recognize the potential for wrongdoing based on conflicting motivations.
COIs are generally divided into two categories: intangible and tangible. Intangible COIs involve academic activities and scholarship, while tangible COIs involve financial relationships. Tangible COIs can include intellectual property rights, consulting fees, honoraria, gifts, ownership or royalties. Examples of intangible COIs are: delaying publication of a manuscript to benefit the next grant application, or a researcher’s bias in interpreting data towards his or her own hypothesis.
Different types of COIs have different potentials that can lead to bias. A free pen or a free sandwich provided at a seminar is not the same as funding a study, which is also not the same as covering a portion, or all, of a scientist’s salary. What is scientific misconduct?
In the United States, the US Office of Science and Technology Policy has defined research misconduct as follows: Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
Fabrication is making up data or results and recording or reporting them.
Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
Research misconduct does not include honest error or differences of opinion.
In science, everything comes down to credibility. Research misconduct erodes trust between colleagues, between scientists and funding agencies, and between the institution of science and the public. Thus, research misconduct is taken very seriously within the scientific community. Consequences of research misconduct can range from retraction of papers to being banned from receiving funding, depending on the severity and scope of the misconduct. Being found guilty of research misconduct often marks the end of a scientist’s career, as seen by a severe decline in number of publications and funding after the misconduct. What’s the difference between a conflict of interest and research misconduct? Image credit: Thinkstock
While conflicts of interest may lead to research misconduct, they are not evidence of misconduct nor are conflicts of interest necessarily misconduct on their own. The presence of a COI may demand closer scrutiny of the research to determine if misconduct or bias affected the interpretation of the results. However, a COI itself is not research misconduct, nor does the existence of a COI automatically mean that research misconduct occurred. This is not to minimize the importance of the disclosure of COIs. It is this very transparency that allows us to identify problems, limit COIs and scrutinize research that may be biased. In science, credibility is our currency. Transparency and disclosure about conflicts of interest are critical to maintain our credibility.
Disclosing COIs makes us all better able to identify our own and others’ biases. This is why all US scientists at federally funded institutions disclose COIs and external activities. Each institution has an office that is devoted to reviewing COIs and implementing measures to help minimize these conflicts and their effect on research outcomes. Disclosure of COIs is taken very seriously. In fact, failure to disclose COIs is itself misconduct.
Disclosure is also important beyond the official institutional disclosure system. Typically, when scientists give presentations in our own university, at other institutions or at conferences, speakers include relevant COIs at the beginning and acknowledge funding sources at the end. Journals also have requirements about COI disclosure that must be met before publication. Failure to do so can result in retraction of a paper.
It’s also important to note that the presence of COIs, and even misconduct, does not necessarily negate the data. Determining if misconduct or bias occurred and if it invalidates the data is complicated and requires close scrutiny of the data and the specific situation.
A few examples from the archives of Retraction Watch help to illustrate how complex it is to sort out issues of COI, misconduct and data validity.
In this example, authors forged the paperwork to add an author who did not contribute. This is a clear case of misconduct that resulted in a retraction, but the data is still valid.
Research misconduct involving methodological flaws, fabricating data or other invalid manipulations of data would invalidate the data collected. In this case, a collaborator falsified data resulting in two retractions. This clearly invalidates the published data.
Failure to disclose a COI is misconduct, but whether a paper is retracted or corrected depends on whether there are findings of additional misconduct. The examples listed on this link show the variety of ways that the failure to disclose COIs are handled.
It’s also possible for there to be methodological flaws resulting from honest mistakes and errors that lead to retraction of a paper, but these are not considered misconduct.
There is often criticism that scientists do not take conflicts of interest seriously enough to appease the concerns of the lay public. However, this argument conflates COIs with research misconduct. The scientific community requires disclosure of COIs to help identify and monitor possible cases of misconduct. Awareness and disclosure of COIs allow the public and the scientific community to assess whether misconduct or bias occurred. Scientists are not generally penalized for the mere presence of COIs; they are penalized for research misconduct. We need to stop automatically punishing scientists for having COIs. It’s not having a COI that’s a problem, it’s how COIs influence research that can become problematic. Let’s make sure we are judging the behavior of scientists, not based on just the existence of COIs, but based on how they act in the face of those conflicts. This article originally appeared on The Sound of Science blog, and was published on the Biofortified Blog on 10 March 2016. At that time, we believed it was important to revisit a discussion of research ethics and to clarify what constitutes research misconduct and what does not due to the allegations of research fraud and misconduct raised against Dr. Federico Infascelli. We are republishing it in 2018 because these are still important concepts that both scientists and the public need to understand.
One example of a gene edited animal is 
Biofortified 