Impact of USDA Regulations on the Use of Genetically Modified Plants as Biofuel Feedstocks (Part 1)

As noted in a previous entry in this blog, the use of certain genetically modified plants as feedstocks for biofuel production may be subject to regulations promulgated by the U.S. Department of Agriculture (USDA) that have been used for over two decades to regulate the agricultural biotechnology industry. In this posting I will discuss the growing number of transgenic plant varieties intended for biofuel use that have already been submitted for USDA review and used in field trials under this rule, and in the posting that will follow, I’ll consider the impact these regulations may have on the development of improved fuel feedstocks using advanced biotechnology.   

USDA’s biotechnology regulations, found in 7 CFR Part 340 of the Code of Federal Regulations, have been the major U.S. government rules that have covered uses of transgenic plants in agriculture and more recently the increasing interest in using plants for other industrial purposes, such as production of pharmaceuticals, industrial products, and phytoremediation.  The regulations are administered by the division of USDA known as the Animal and Plant Health Inspection Service (APHIS), through a dedicated office within APHIS called Biotechnology Regulatory Services (BRS). Today, many research field tests involving the most commonly studied species can be conducted merely upon 30 days advance notice to the agency, but certain uses of transgenic plants for less-familiar industrial uses would likely require submission of a permit application 120 days in advance of a proposed field test, with USDA approval of the permit needed before the test could begin. Field tests conducted to date of improved energy crops have made use of both the notification and the permit systems, depending on the crop species to which the genetic modifications have been made. To obtain approval for unlimited commercial sale of a transgenic plant variety, the applicant must submit a petition to have USDA “delist” that variety, to have it removed from the need for regulation, thus allowing anyone to grow the plant without a permit, a process that at least one company has initiated for a new energy crop.   

Examples of Approved Field Uses of Modified Plants as Biofuel Feedstocks   

As of this writing in May/June 2010, there have been a number of transgenic plant varieties engineered for improved biofuel production that have been reviewed by APHIS Biotechnology Regulatory Services. These projects have been at several different stages of commercial development, ranging from early field tests to at least one application for commercial approval via the “delisting” process. The following is a summary of those applications that have been submitted by for-profit companies, grouped in a company-by-company manner (expanded company profiles can be found in earlier entries of this blog). There have also been several applications from academic institutions for field use of plants that appear to have been engineered for improved biofuel production, but those are not listed here. More information about the permits and notifications listed here can be found at the field release database search site administered for APHIS by Virginia Tech University. Please also note that there have also been numerous field trials of transgenic biofuel crops that have taken place in Canada, principally by Agrisoma and Targeted Growth, Inc. These will be described in a future entry in this blog.   

ArborGen has been the industry leader in improving trees through advanced genetics, and in recent years the company has diversified from its roots in the forestry industry to begin developing purpose grown trees to produce cellulosic ethanol. ArborGen is particularly targeting trees such as U.S. plantation hardwoods, and among the potential bioenergy products the company is developing are cold tolerant eucalyptus; short rotation hardwoods; and short rotation pine varieties. ArborGen has conducted numerous field tests of engineered trees – from 2001 through May 2010, the company had submitted about 280 permit applications and notifications to APHIS for field tests of engineered trees of several different species, almost all of which have progressed to field trials. More recently, Arborgen has obtained USDA clearance for field testing of Eucalyptus hybrids and clones genetically modified with traits such as cold tolerance and altered lignin biosynthesis being developed as improved energy crops: for example, just since 2008, the company has made the following 19 submissions all involving Eucalyptus modified with such traits.   

Permits (all for Eucalyptus)  

  • 10-112-101r, for planting in Alabama, submitted 04/22/10,  Pending.
  • 08-039-102rm, for planting in 7 states, submitted 02/03/10,  issued 04/23/08 (note: 172.7 acres)
  • 09-070-101rm, for planting in Florida and South Carolina, submitted  03/11/09, issued 04/29/09
  • 06-325-111r, for planting in Alabama, submitted 06/03/08,  issued 06/27/07
  • 08-151-101r, for planting in Florida, submitted 05/30/08,  issued 06/12/08
  • 08-014-101rm, for planting in Florida and South Carolina, submitted 01/14/08,  issued 05/12/10  (note: 130.5 acres)*
  • 08-011-106rm, for planting in 6 states, submitted 01/11/08,  issued 05/12/10 (note: 197.2 acres)*

Notifications (all for Eucalyptus)  

  • 09-208-103n,  for planting in South Carolina,  submitted 07/27/09
  • 09-182-101n,  for planting in South Carolina,  submitted 07/01/09
  • 09-023-106n,  for planting in South Carolina,  submitted 01/23/09
  • 08-175-101n,  for planting in Florida,  submitted 06/23/08
  • 08-157-102n,  for planting in Alabama, Louisiana, Mississippi and South Carolina,  submitted 06/05/08
  • 08-157-101n,  for planting in South Carolina,  submitted 06/05/08
  • 08-148-101n,  for planting in South Carolina,  submitted 05/27/08
  • 08-144-104n,  for planting in Alabama and South Carolina,  submitted 05/23/08
  • 08-134-103n,  for planting in Alabama, Florida, Louisiana, and South Carolina,  submitted 05/13/08
  • 08-095-104n,  for planting in South Carolina,  submitted 04/04/08
  • 08-092-115n,  for planting in Alabama and South Carolina,  submitted 04/01/08
  • 08-063-115n,  for planting in South Carolina,  submitted 03/03/08

*The two permits listed last above (Numbers 08-014-101rm and 08-011-106rm) were only recently (May 12, 2010) issued by APHIS upon the completion of an Environmental Assessment and a finding of no significant risk. This will be discussed in more detail in the next entry of this blog.  

Ceres, Inc. develops and markets low-carbon, non-food grasses for advanced biofuel and biopower uses. The company is already selling high-yielding switchgrass cultivars and high-biomass sorghum hybrids under the Blade Energy Crops brand, and Ceres plans to use marker-assisted breeding and other technology platforms to introduce a additional enhancements to these crops, including further increases in biomass yield and other agronomic and compositional improvements. Ceres is also carrying out an advanced trait development project to increase biomass yields of energy grasses by as much as 40% in coming years, while simultaneously decreasing the use of inputs such as nitrogen fertilizers, in a project which has received funding from the Advanced Research Projects Agency – Energy. On May 20, 2010, Ceres announced that it had entered into a research collaboration with Novozymes, the world’s largest enzyme provider, to co-develop customized plant varieties and enzyme cocktails for the production of cellulosic biofuel. The companies will initially work to determine the best enzyme cocktails for the biorefining of Ceres’ commercial switchgrass seed products. The partners will also begin similar evaluations of sweet sorghum, and Ceres’ researchers plan to develop customized plant varieties that can be degraded more easily by Novozymes’ enzymes.  

Ceres has obtained three USDA permits since 2008 for field testing of drought tolerant or sterile switchgrass, and currently has three pending permit applications for engineered switchgrass that appear to correspond to to the ARPA-funded project, as follows.  

  • 10-130-103rm, Switchgrass with increased nitrogen utilization, for planting in Georgia, submitted 05/10/10, application pending 
  • 10-116-105rm, Switchgrass with increased nitrogen utilization (also increased drought tolerance and sterility), for planting in California, submitted 04/26/10, application pending 
  • 10-054-102rm, Switchgrass with increased nitrogen utilization, for planting in Tennessee, submitted 02/23/10, application pending   

Edenspace Systems Corporation ia plant biotechnology company that is developing innovative new energy crops. Responding to the market need for lower-cost ways to produce cellulosic biofuels such as ethanol and butanol, Edenspace is developing Energy Corn™ and other enhanced energy crops such as poplar and sorghum. On May 19, 2010, Edenspace announced a collaborative agreement with Syngenta Ventures for the development of new energy crops. Under the terms of the collaboration, Syngenta will be licensing Edenspace access to intellectual property and expertise relating to crop technology, in return for Edenspace equity and certain rights to commercialize Edenspace-developed technology. Edenspace will utilize Syngenta’s technology in its development of new traits in corn, sorghum, switchgrass, and other energy crops.   

Edenspace has made several USDA submissions for field uses of plants engineered for  “improved digestibility”. Details of the genetic modifications were not part of the public record, but likely involve modifications to lignin, or expression of heterologous enzymes that could enhance the digestibility of the cellulosic components of the crop. One other notification was for poplar trees that had been engineered with altered cell walls. The company’s submissions include the following tests conducted under notifications: 

  • 10-098-103n, Corn with digestibility improved, for planting in Kansas, submitted  04/08/10
  • 09-310-102n, Corn with digestibility improved, for planting in Puerto Rico, submitted  11/06/09 
  • 09-308-106n, Corn with digestibility improved, for planting in Puerto Rico, submitted  11/04/09 
  • 09-175-101n, Poplar with cell wall altered, for planting in Kansas, submitted 07/24/09.
  • 09-074-101n, Corn with digestibility improved, for planting in Kansas, submitted  03/15/09

In addition, Edenspace has had one permit application approved for a biofuel crop:    

  • Permit No. 09-054-105r, for field use of Grey Poplar in Kansas, submitted 03/10/09, issued 05/06/09.

Infinite Enzymes is using a plant biotechnology platform to produce commercially available enzymes for converting cellulosic biomass to ethanol. The technology utilizes the transgenic maize production system—producing enzymes in the embryo, or germ, of the corn seed. Infinite Enzymes has applied for and obtained the following permits for field use of its transgenic corn plants expressing cellulase enzymes. The most recent permit would encompass a planting of 15 acres in Arkansas, larger than any of the previous submissions.   

  • 10-056-103rm, Corn expressing a cellulase, for planting in Arkansas, submitted  02/25/10, issued  03/12/10
  • 09-225-105rm, Corn expressing a cellulase, for planting in Puerto Rico, submitted  08/13/09, issued 10/15/09
  • 09-053-101rm, Corn expressing a cellulase, for planting in Illinois, submitted 02/22/09, issued 03/12/09
  • 09-034-101rm, Corn expressing a cellulase, for planting in Arkansas, submitted  02/03/09, issued 03/31/09
  • 08-216-101rm, Corn expressing a cellulase, for planting in Puerto Rico, submitted  08/03/08, issued 09/29/08

 Syngenta is a world-leading, multinational agribusiness company. Its two main commercial areas  are the sale of seeds and crop protection products. Syngenta’s major activity in biofuels is a line of transgenic corn expressing an engineered thermostable amylase for enhanced ethanol production. This corn variety, which the company refers to as its “output trait corn amylase”, is sold under the brand name Enogen. Originally known by the internal product name “Corn [Maize] event 3272”, this line was developed using recombinant DNA technology to introduce into corn the amy797E gene and the pmi marker gene. In 2005, after many years of field trials, Syngenta submitted a petition to USDA to have this corn variety deregulated to permit commercial sale of the seed. Although USDA issued an Environmental Assessment in June 2009 stating their intention to grant the petition, the matter was opened for public comment and USDA has not, to date, made a decision on the deregulation petition. This will be discussed in more detail in the next entry of this blog.  

Syngenta has conducted numerous field trials of engineered corn and other crops over the years. According to a 2007 regulatory filing with USDA, the following are the field trials for Event 3272 corn which had been conducted through the date of the 2005 deregulation petition.  

Year   USDA Notification or Permit No.   Trial Sites by State  
2002   02-022-02r/m   HI  
2003   03-021-01r/m   FL,IA,IL,MN,PR,SD,WI  
    03-021-02r/m   HI  
2004   04-051-08n   IA  
    04-064-04n   FL,HI,IA,ID,IL,IN,KY,MN,NE,PA,PR,SD,WI  
    04-082-03n   IA  
    04-126-03n   NE  
    04-203-03n   PR  
    04-216-02n   HI  
2005   05-042-09n   HI, NE  
    05-049-10n   CO,FL,HI,IA,ID,IL,IN,KY,MN,MO,NE,PR,SD,WI  
    05-102-02n   IL  
    05-104-08n   HI  
    05-255-01n   HI  

 Targeted Growth, Inc. (TGI) is a crop biotechnology company focused on developing products with enhanced yield and improved quality for the agriculture and energy industries. Founded in 1998, TGI has developed a technology portfolio based on the principle that regulating cell cycle processes can directly and significantly enhance plant yields.  The company is using conventional breeding and biotechnology to enhance the suitability of select energy crops for use as fuels, by improving sugar, starch and oil profiles, as well as characteristics of cell wall formation. For ethanol production TGI is focused on corn and sorghum; for biodiesel, soybean, canola, and Camelina. The company has made over 50 submissions to USDA for field test approvals since 2002: the following are the ones among these submissions that appear most relevant to the development of biofuel feedstocks. These include the following tests conducted under notifications:  

  • 10-119-104n, Corn with increased sugar content, for planting in Iowa, submitted 04/29/10
  • 10-081-107n,  Corn with increased sugar content and yield increase, for planting in Iowa, Illinois submitted 03/22/10
  • 10-029-101n,  Corn with increased sugar content, yield increase, increased digestibility, for planting in Iowa, Illinois submitted 01/29/10
  • 09-140-101n, Corn with enhanced digestibility of plant wall, increased sugar content and yield increase, for planting in Indiana
  • 09-075-113n, Corn with increased digestibility, for planting in Indiana, Iowa, submitted 03/16/09  

In addition, TGI has had one permit application approved for a biofuel crop:  

  • 08-154-102r , Camelina engineered for increased yield, for planting in California, Montana and Washington State, submitted 06/16/09, issued 05/05/09

The experience of these companies in going through the USDA regulatory process has mostly been positive, and approval for most research field trials has been fairly easy to obtain. However, the experiences of Arborgen and Syngenta in requesting USDA approval for activities beyond small-scale research may offer a cautionary note to other developers of transgenic energy crops. In the next blog entry, I’ll discuss the issues that have arisen in USDA’s review of those requests and their possible implications for future applicants, and I’ll also make some general comments about the impact of the USDA regulations on development of transgenic biofuel feedstocks.  

D. Glass Associates, Inc. is a consulting company specializing in several fields of biotechnology. David Glass, Ph.D. is a veteran of nearly thirty years in the biotech industry, with expertise in industrial biotechnology regulatory affairs, patents, technology licensing, and market and technology assessments. This blog provides back-up and expanded content to complement a presentation Dr. Glass made at the EUEC 2010 conference on February 2, 2010 entitled “Prospects for the Use of Genetic Engineering in Biofuel Production.” The slides from that presentation, along with more information on D. Glass Associates’ regulatory affairs consulting capabilities, are available at www.slideshare.net/djglass99 or at www.dglassassociates.com.

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