By Philip Brasher, Executive Editor, Agri-Pulse

Copyright © 2019, Agri-Pulse Communications, Inc., Excerpted with Permission

 

Crop developers say USDA’s effort to streamline its regulation of biotech crops will still slow the commercialization of many gene-edited products, but groups representing grain traders, food processors and restaurant chains are slamming the department’s proposal, claiming it could lead to trade disruptions and undermine consumer confidence.

 

Under the proposed rule issued in June, bioengineered plants would be exempted from regulation by USDA if the modifications could be produced through traditional breeding techniques, making them unlikely to pose a greater plant pest risk than conventionally bred crops.

 

Crop developers would have three options under the proposed rule: They would be allowed to decide on their own whether their modifications are exempt from regulation; Companies could seek confirmation letters from USDA of the exempt status; Or they could ask USDA to determine whether the trait is regulated or not.

 

The National Grain and Feed Association, Corn Refiners Association, National Oilseed Processors Association, North American Export Grain Association and North American Millers Association said in a joint statement to USDA that the proposal is “fundamentally flawed and is inconsistent with the agency’s obligation to protect the economic value of U.S. agricultural and food exports.”

 

Other food industry groups, including the Grocery Manufacturers Association, National Restaurant Association and American Bakers Association, joined the grain industry on a shorter statement that said the proposal also risked undermining consumer confidence.

 

“If USDA is unable to inform consumers on what is available in the market, it is likely that consumer confidence in USDA will wane. Additionally, we believe the proposed regulatory framework opens the door for significant criticism of APHIS and genetic engineering technologies,” the statement said.

 

The groups called on USDA to slow implementation of the changes to its regulatory system until the Food and Drug Administration and Environmental Protection Agency issue rules or guidance on how they plan to oversee gene-edited crops.

 

Tuesday was the deadline for industry organizations, advocacy groups and the public to file comments on a proposed rule issued in June to rewrite USDA’s Part 340 regulatory process for genetically engineered plants.

 

The Biotechnology Innovation Organization (BIO) and American Seed Trade Association urged USDA’s Animal and Plant Health Inspection Service to expand the proposed regulatory exemptions, which are based on the concept that modifications that could be achieved through “traditional breeding techniques” should not require USDA approval. The four exemptions include modifications achieved solely through the deletion of genetic material or through single base pair substitutions.

 

The American Seed Trade Association says “significant applications of genome editing” could fail to qualify for the proposed exemptions. The group said the exemptions should cover a range of genetic changes that have been traditionally made through mutations, sometimes with chemicals or radiation.

 

More than 3,200 crop varieties, from heat-tolerant cotton to Ruby Red grapefruit, have been bred since the 1950s through induced mutations, the group said.

 

Plants modified through mutations induced by chemical means or radiation can be used in organic production.

 

BIO said, “Techniques commonly used by plant breeders today are capable of creating a much broader array genetic modifications than the limited exemptions proposed.”

 

Nina Fedoroff, a molecular biologist who served as the State Department’s science and technology adviser during the George W. Bush administration, agreed that the exemptions were too limited.

 

“The kinds of modification that can be made through traditional breeding, which now defined to include chemical and radiation mutagenesis, cover a much larger array of genetic changes than is included in the detailed list of exemptions listed in the proposed rule,” wrote Fedoroff, who is a science adviser in the Olsson Frank Weeda Terman Matz law firm.

 

But the groups representing grain traders and processors argued that USDA hasn’t provided scientific justification for the exemptions in the proposed rule and that the self-determination approach “risks undermining consumer acceptance and international regulatory recognition of APHIS’s regulatory oversight.”

 

The biotech industry acknowledged that USDA should require some form of mandatory notification. BIO, which represents a wide range of biotech companies, said breeders should be required to file a notification, which would include details of why it is exempt from regulation, at least 90 days before putting the product on the market. The information would later be posted on an agency website. The notification requirement would apply to a product that a developer self-determines to be exempt, not just to those products for which the developer seeks formal confirmation from USDA that it is exempt.

 

“BIO looks forward to working with the Agency on implementing guidance that achieves transparency without limiting innovation in either commodity or specialty crops,” the group said in its 43-page filing with APHIS.

 

ASTA also supports mandatory notification, although the industry is still debating what the requirements should be, said ASTA President Andy LaVigne.

 

The National Corn Growers Association cautioned the agency to consider how a mandatory notification system “might be perceived in international markets” and whether and how the notification process would “hinder global acceptance” of biotech products.

 

The National Association of Wheat Growers, which also is concerned about protecting its export markets, called on the federal government to “actively engage with our trading partners as soon as possible to work toward consistent, science-based policies across countries to avoid trade disruptions.

 

“All foreign customers expect the continued oversight by USDA to ensure consistent food safety, which is fundamental to their confidence in purchases of U.S. wheat,” the group said in its comments, noting that half the wheat American farmers grow is sold for export.

 

The vast majority of the more than 5,400 comments that have been posted online so far have been critical of the administration for seeking to streamline biotech regulations.

 

The Center for Science in the Public Interest, a consumer advocacy group that is generally supportive of agricultural biotechnology, also thinks USDA is going too far in deregulating the products.

 

CSPI specifically opposes allowing companies to self-determine whether their products are subject to regulation and says the proposed exemptions are too expansive, not too narrow, as BIO, ASTA and Fedoroff argue.

 

The proposed rule would eliminate USDA oversight of many ‘traditional’ plants that are genetically engineered, “which could result in harm to human health, the environment, and/or U.S. agricultural interests. We are also concerned that many of the proposed exemptions from oversight are not supported by the necessary scientific data and analysis that would ensure they will not result in adverse impacts,” CSPI said in its comments.

 

The group goes on, “U.S. consumers and trading partners will not accept unregulated GE products unless the basis for exempting oversight is based on scientific evidence.”

 

An advocacy group that has long fought USDA in court over biotech regulation, the Center for Food Safety, claims in its comments that the exemptions would “drastically shrink the scope of regulation to a small subset” of genetically engineered organisms.

 

“This exemption scheme is arbitrary and capricious, and contrary to sound science, because as APHIS itself concedes, it is impossible to determine whether a specific GE modification on a specific plant could in fact have been effected by means of traditional breeding techniques,” CFS says.

The organization contends the exemption criteria are so explicit that crop breeders won’t bother to consult with APHIS on whether their products are regulated.

A USDA official said recently that the department should be on track to finalize the regulatory changes in mid-2020.

By Elizabeth Westendorf, USW Assistant Director of Policy

This week, Wageningan University —one of the top agricultural universities in the world, located in the Netherlands —issued a press release about their research on using gene editing to produce “gluten safe” wheat so that individuals with Celiac disease can enjoy wheat products. It is possible to remove all gluten genes from wheat; however, this process has a negative impact on baking quality and the wheat-food product. Instead, Wageningan PhD candidate Aurélie Jouanin is researching the use of CRISPR/Cas9 technology to modify specific wheat genes to produce wheat with safe gluten that does not cause an allergic reaction.

This is only one of many exciting research projects around the world using plant breeding innovation. These new technologies allow for precise changes to plant DNA to help address thorny challenges—consumer health, environmental stressors and disease pressures, among others. And as scientists find innovative ways to address complex issues, outdated and overly burdensome regulations struggle to catch up.

U.S. Wheat Associates (USW) recognizes that advanced technology is imperative to helping farmers adapt to changing and challenging growing environments. Traditional breeding often takes too long and produces results that are too random to consistently keep up with evolving diseases and pests, and it has very little hope of doing something at the same scale as the potential of Jouanin’s research.

However, new technology also needs to be paired with consumer engagement and smart trade decisions. Recognizing this, the USW and the National Association of Wheat Growers (NAWG) adopted a joint statement on plant breeding innovation policy.

This statement distinguishes the importance of new technology in breeding for everyone along the supply chain, from farmers to international customers to consumers. It reaffirms our support of continued research; of fair, science-based regulation where necessary; and of the U.S. and foreign governments taking steps to ensure open trade flows. The statement also argues that plant breeding innovations should be clearly differentiated from traditional biotechnology in regulatory discussions, with internationally harmonized definitions and scientific standards.

Government regulations often move slowly. However, in this case, that slow movement can have serious repercussions on the agricultural industry and on consumers who could benefit from new technology. With this new policy statement, USW sends a clear message of support for science-based decision making and the opportunities that plant breeding innovation present for wheat.

By Haley Ahlers, Innovation Lab for Applied Wheat Genomics Project Manager. Reprinted with permission from Kansas Wheat. See the original article here.

Kansas State University scientists, in collaboration with the International Wheat Genome Sequencing Consortium (IWGSC), published in the international journal Science on August 16, 2018, a detailed description of the complete genome of bread wheat, the world’s most widely-cultivated crop. This work will pave the way for the production of wheat varieties better adapted to climate challenges, with higher yields, enhanced nutritional quality and improved sustainability.

The research article-authored by more than 200 scientists from 73 research institutions in 20 countries- presents the reference genome of the bread wheat variety Chinese Spring. The DNA sequence ordered along the 21 wheat chromosomes is the highest quality genome sequence produced to date for wheat. It is the result of 13 years of collaborative international research and the generous support of the National Science Foundation, Kansas farmers and many others.

“It is a dream come true for Kansas wheat farmers, who were the first to invest in the wheat genome sequencing project and pivotal in rallying U.S. wheat farmers in support of the wheat genome sequencing project,” said Dr. Bikram Gill, distinguished professor at Kansas State University who organized the first National Science Foundation and U.S. Department of Agriculture-sponsored workshop planning meeting on wheat genome sequencing in Washington, D.C., in 2003.

A key crop for food security, wheat is the staple food of more than a third of the global human population and accounts for almost 20 percent of the total calories consumed by humans worldwide, more than any other single food source. It also serves as an important source of vitamins and minerals.

Kansas farmers grow an average of 340 million bushels of wheat each year, but acres planted to wheat have dropped dramatically over the past decade, from 10 million acres to fewer than 8 million. To meet future demands of a projected world population of 9.6 billion by 2050, wheat productivity needs to increase by 1.6 percent each year. In order to preserve biodiversity, water and nutrient resources, the majority of this increase has to be achieved via crop and trait improvement on land currently cultivated, rather than committing new land to cultivation. In order for farmers to dedicate these precious resources to wheat production rather than production of other crops, wheat farming must become profitable.

With the reference genome sequence now completed, breeders have at their fingertips new tools to address global challenges. They will be able to more rapidly identify genes and regulatory elements underlying complex agronomic traits such as yield, grain quality, resistance to fungal diseases and tolerance to physical stress-and produce hardier wheat varieties.

“Completion of the sequence is a landmark event that will serve as a critical foundation for future wheat improvement,” said Dr. Allan Fritz, Kansas State University professor and wheat breeder. “It is the key to allowing efficient, real-time integration of relevant genetics, making the selection process more efficient-it’s a turbocharger for wheat breeding!”

It is expected that the availability of a high-quality reference genome sequence will boost wheat improvement over the next decades, with benefits similar to those observed with maize and rice after their reference sequences were produced.

“Kansas wheat farmers have been supporting the wheat genome sequencing efforts through the Kansas Wheat Commission’s wheat assessment since the establishment of the IWGSC in 2005, with a cumulative amount of nearly a quarter of a million dollars,” said Justin Gilpin, chief executive officer for Kansas Wheat. “The sequence of the bread wheat genome has already had a positive effect on wheat improvement, which not only affects the science behind wheat breeding, but has a long-lasting positive outcome in regard to wheat producer productivity, profitability and, ultimately, livelihoods.”

Sequencing the bread wheat genome was long considered an impossible task, due to its enormous size – five times larger than the human genome-and complexity-bread wheat has three sub-genomes and more than 85% of the genome is composed of repeated elements.

“It is exciting to be a part of this landmark achievement,” said Dr. Jesse Poland, associate professor at Kansas State University and director of the Wheat Genetics Resource Center and the USAID Innovation Lab for Applied Wheat Genomics. “This international effort, toward something that was once deemed impossible, will have tremendous impact on wheat in Kansas, and the world.”

The impact of the wheat reference sequence has already been significant in the scientific community, as exemplified by the publication on the same date of six additional publications describing and using the reference sequence resource, one appearing in the same issue of Science, one in Science Advances and four in Genome Biology. In addition, more than 100 publications crediting the reference sequence have been published since the resource was made available to the scientific community in January 2017.  “We are extensively using the new reference sequence for more informed molecular breeding” commented Poland.  “It is really having a big impact.”

In addition to the sequence of the 21 chromosomes, the Science article also presents the precise location of 107,891 genes and of more than 4 million molecular markers, as well as sequence information between the genes and markers containing the regulatory elements influencing the expression of genes.

The IWGSC achieved this result by combining the resources it generated over the last 13 years using classic physical mapping methods and the most recent DNA sequencing technologies; the sequence data were assembled and ordered along the 21 chromosomes using highly efficient algorithms, and genes were identified with dedicated software programs.

All IWGSC reference sequence resources are publicly available at the IWGSC data repository at URGI-INRA Versailles and at other international scientific databases such as GrainGenes and Ensembl Plants.

The Science article is entitled “Shifting the limits in wheat research and breeding using a fully annotated reference genome” and can be read here.

About the IWGSC

The IWGSC, with 2,400 members in 68 countries, is an international, collaborative consortium, established in 2005 by a group of wheat growers, plant scientists, and public and private breeders. The goal of the IWGSC is to make a high-quality genome sequence of bread wheat publicly available, in order to lay a foundation for basic research that will enable breeders to develop improved varieties. The IWGSC is a U.S. 501(c)(3) non-profit organization. www.wheatgenome.org