Government shutdown’s lasting impacts

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.

More impacts of the government shutdown

NPR: Shutdown Puts Work On Hold For Researchers Collaborating With Government Scientists
Science Magazine: U.S. government shutdown starts to take a bite out of science
The Scientist: Government Shutdown Hits Funding, Resources, and Morale in Science
Politico: Farmers cut off from their federal lifelines as shutdown persists
Ohio Valley Resource: Farmers Still Dealing With Effects Of Government Shutdown

Biotechnology regulation update

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.

Comment TODAY on edible cottonseed deregulation

The fate of cottonseed rests in your hands.

More than eight years ago, we wrote about a project at Texas A&M University led by Dr. Keerti Rathore to create edible cottonseed. If determined to be safe for food and the environment, this has the potential to make large amounts of protein and calories available that would normally be locked up in the seed. This trait is undergoing deregulation with USDA-APHIS right now, and we encourage our readers to submit comments before the deadline at the end of the day today.

Background

Cotton plants produce a potent defense compound called gossypol, which is toxic to many animals, including humans. Gossypol is produced by special glands throughout the plant, from leaves to seeds, and protects the plants from insect pests and diseases. Some varieties of cotton are glandless and do not produce toxic levels of gossypol, making the seeds and leaves edible. However, because these glandless cotton varieties have lost the protective benefits in their leaves, they are more susceptible to insect damage and are not commonly grown.

Using RNAi, Dr. Rathore’s team at TAMU created a variety they call TAM66274 that “silences” the production of gossypol just in the seeds, producing a plant that defends itself against pests in the leaves, but produces seeds that have ultra-low levels of gossypol in the seeds, making them safe to eat. If applied on a large scale, it could allow humans and many other animals access to the protein contained in cottonseed. According to the data they collected for their application, the composition of the cottonseed was otherwise unchanged, the plants performed the same in the field, and there were very minor changes in the length of the fibers, which they suggest will not be an issue when the trait is bred into “elite” cotton varieties.

The impacts of this trait could be far-reaching. Some estimates suggest that the amount of protein produced in cottonseed worldwide could satisfy the needs of 500 million people. Ruminant animals are able to tolerate some gossypol in their diets, so this trait could create greater flexibility in the animal feed supply. This would turn cottonseed into a valuable co-product of cotton production that could benefit cotton farmers at every scale, producing more food without using more land. Read more about how this trait works and its potential impacts on agriculture in Cotton like Candy.

What APHIS wants to hear from you

Open comment periods for federal regulations are often misunderstood. Some organizations use them to gather signatures (and email addresses) of supporters for their political causes, or set up form letters to mass-send the same talking points over and over to regulators. These actually do nothing more than single letters from one person that say the same thing – because the regulators are looking for public input to identify issues that they should look into during the process – not to count the number of people who think one action or another is a good idea. Back when the FDA was looking for input on biotechnology outreach, there were many opponents and supporters of biotechnology saying “don’t do it” and “do it”, when that was not even a question. It was mandated by Congress, so the question was how should it be done?

Similarly, when the USDA-APHIS is reviewing a genetically engineered crop, they are not going to count how many people say “yes” or “no” to the question of whether to de-regulate (approve) a crop, they want to know what issues related to the economic and environmental impacts they should be aware of when they do the review. Will the crop become a pest on farms? Will it help control pests? Will it benefit the bottom lines of farmers, or reduce the ability of other farmers to farm the way they want to? This is your chance as members of the public, as knowledgeable scientists and science enthusiasts, and as people who think deeply about far-reaching impacts of biotechnological applications, to inform the USDA about data, ideas, and concerns that you have that they can look into when evaluating the crop.
Here it is in their words:

We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Texas A&M AgriLife Research seeking a determination of nonregulated status of cotton designated as event TAM66274, which has been genetically engineered for ultra-low gossypol levels in the cottonseed. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Texas A&M AgriLife Research petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that the Animal and Plant Health Inspection Service may determine should be considered in our evaluation of the petition.

Comments are due today at midnight Eastern Time. Since there is not much time left to comment, you can keep your comments brief, but if you have input to give our regulators, please do! There are only 39 comments showing at the time of writing, so you could have an impact. Take a look at the documents prepared by the TAMU research team, and tell the USDA-APHIS what you think. Join me in submitting a public comment on low-gossypol cotton!

We will be following this trait as it moves along, while thinking about how we can improve our own alerts to help mobilize scientists, farmers, and the rest of you to prepare impactful submissions that can help strengthen the regulatory process.

Advisory committees for biotech

The White House, by Matt Wade via Wikimedia Commons.

What creative ideas do you have for the US biotechnology regulatory agencies? With the White House call for comments closing on November 13th, now is the opportunity to share. In this post, I’ll talk about one idea that will be in Biology Fortified’s comment – feel free to take it and run with it!
We’ve made it easy for everyone to provide comments to the White House, and you can learn more at our post: You can improve US biotechnology regulation.
There are tons of advisory committees across the US government. Why isn’t there one (or more) for biotechnology regulation? Let’s take a look at just a few advisory committees and see what they do. Continue reading →

Menu Overhaulin’

I just graduated this spring from UW-Madison’s Dietetics program. For three years while I was in school, I worked for the Kids Center at the Madison Veterans Affairs Hospital. Back in February 2013, I was given the authority to completely revamp the menu at the VA Kids Center. You must understand that this decision was momentous! For the past seven years, the Kids Center had been operating with a menu inspired by the Great Depression era and pre-World War II rations. Mmmm, there’s nothing like a warm bowl of white rice for breakfast.

There was an incredible amount of eggs in these meals. Egg salad, fried eggs, boiled eggs, and scrambled eggs were the pièce de résistance! Let me tell you, these kids did not enjoy all these eggs with their meals, particularly menu items like egg salad.
The overwhelming majority of menu items lacked any creativity or zest. They were bland meals that you quickly threw together with little feeling – like buttered toast and sugar, eggs galore, and plain rice. The only meals I knew the children actually ate and enjoyed were the garlic toast, bagels and cream cheese, and mini muffins. Other parts of the menu were basic items of childhood snackdom that were re-incorporated into the new menu like cheese and crackers, graham crackers, as well as cereal with milk. So, the ability to revitalize this outdated menu was a welcome breeze of fresh air! It was also excellent experience for me as an aspiring dietitian. Continue reading →

How To Do GMO Food Labeling Right

Written by Steve Savage

A Modest Proposal

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” →

Get the scoop on GMO wheat in Oregon

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:

FDA covers aspects that involve human or animal safety. FDA’s Role in Regulating Safety of GE Foods.
EPA covers plant incorporated protectants (PIPs for short, which refers to any compound produced in plants that may act as a pesticide, such as Bt). EPA’s Regulation of Biotechnology for Use in Pest Management.
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 work of these three agencies is outlined in the Coordinated Framework for Regulation of Biotechnology. Summary of the Coordinated Framework.

Continue reading “Get the scoop on GMO wheat in Oregon” →

How Wrong Is The Latest “Dirty Dozen List?”

Written by Steve Savage

peppers — Peppers produce a variety of natural pesticides, including capsaicin. Peppers by James Walsh via Flickr.

The Environmental Working Group (EWG) says that it “helps protect your family from pesticides.” The purpose of this post is to “help protect your family from dangerously misleading information from the EWG.”
Each year since 1991, the USDA has been publishing the results from a large-scale pesticide residue monitoring program called the Pesticide Data Program (PDP). Each year, a different set of crops is chosen and samples are purchased from regular stores and tested. Year after year, the results of those studies confirm the safety of the food supply. Year after year the EWG misrepresents the data to say otherwise. To understand what that is like for the people who farm those crops, consider this analogy:
Imagine that you are taking a college course that is critical for your graduation, but your entire grade is based on the performance of thousands of other students you don’t even know and with whom you can not communicate. Some of those students’ test results will be chosen at random and the grade for everyone in the class will depend on how they did. When the grading is done, you find out that the class score was over 99%: A+! Then, someone who doesn’t really understand the topic of the class, or chooses not to, re-grades the test and tells your potential future employers that you got a D, and many of them believe the incorrect grade. Continue reading →

Misuse Of A Vietnam Era Tragedy

Written by Steve Savage

Mark Twain once said, “A lie can travel half way around the world while the truth is putting on its shoes.” There was a perfect example of that last month. The Center for Food Safety (CFS) spread the term, “Agent Orange Corn” for Dow AgroSciences’ new biotech corn hybrids that are working their way through the regulatory process. These hybrids have been modified to be more resistant to 2,4-D, an herbicide that was introduced in 1948. This is being cast as a return to the use of Agent Orange and that is completely untrue. There is a lot of interesting detail behind this, but the CFS moniker for the corn is a classic case of information twisting – twisting in a way that is intentionally misleading. The reason that the term “Agent Orange Corn” is inaccurate can be discovered in a 1-minute Wikipedia search, but this did not prevent a host of of bloggers, environmental and Organic organizations, and even “news outlets” from uncritically passing along the disinformation. Continue reading “Misuse Of A Vietnam Era Tragedy” →

Want to study relative risks of GE?

Last Thursday, the United States Department of Agriculture (USDA) and the National Institute of Food and Agriculture (NIFA) posted a new grant – one that readers of Biofortified might be interested to read about. Called the Biotechnology Risk Assessment Grants Program, (PDF) this grant for up to $1 million for each project is for scientists who want to study the environmental risks of genetic engineering in agriculture.
What kinds of environmental risks? Things like basic genetics research, comparing breeding to biotechnology, and downstream effects of environmental release. There is even a section for it you want to submit a research proposal to study co-existence between GE and non-GE crops. You could even study pyramided, or “stacked” GE crops and compare them to single-transgene varieties. So many possibilities. Continue reading “Want to study relative risks of GE?” →