USDA Seeks Public Comment on Deregulating Corn Genetically Modified to Facilitate Ethanol Production
27 November 2008
The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) is seeking public comment on a petition submitted by Syngenta Seeds, Inc. to deregulate corn genetically engineered (GE) to express high levels of a novel alpha-amylase enzyme—a thermal-tolerant digestive enzyme that turns the corn’s starch into sugar for ethanol. (Earlier post.)
Microbially produced alpha-amylases are commonly used commercially in the starch-processing step during corn dry-grind and wet milling processing for ethanol production. Syngenta’s concept for its engineered corn, designated as transformation Event 3272, is that the grain will serve as the source of amylase enzyme in the dry-grind ethanol process, replacing the addition of microbially produced enzyme.
The Event 3272 grain expressing the alpha-amylase enzyme will be mixed with conventional corn at the processing plant. The modified seeds don’t increase the yield, they just make the grain easier to process. In describing the work in 2002, Syngenta estimated that the high-amylase seeds could cut production costs by 10%.
APHIS has regulated the corn through its notification and permitting process since 2002. As part of the decision making process, APHIS also has prepared a draft environmental assessment (EA) for review and comment.
Following the comment period, APHIS makes a determination of nonregulated status if it can conclude that the organism does not pose a plant pest risk. If APHIS grants the petition for deregulation, the GE corn and its progeny would no longer be regulated. The product could then be freely moved and planted without the requirement of permits or other regulatory oversight by APHIS. The scientific evidence indicates that there are unlikely to be any environmental, human health or food safety concerns associated with the GE corn, APHIS said.
Syngenta’s Event 3272 corn contains two transgenes:
The amy797E gene encoding the thermostable alpha-amylase protein; and
The pmi (manA) gene from Escherichia coli, which encodes the enzyme phosphomannose isomerase, used as a plant selectable marker.
The amy797E alpha-amylase enzyme is a chimeric enzyme derived from three wild-type alpha-amylases from the archael order Thermococcales. This enzyme was selected for development due to its increased thermostability and activity during the high temperatures required for starch hydrolysis in dry-grind ethanol production from corn. Expression of the amy797E gene in Event 3272 is driven by the promoter from a maize seed storage (gamma-zein) gene and the pmi gene is driven by the maize polyubiquitin promoter.
Event 3272 plants contain a single copy of both the amy797E and pmi genes; a single copy of both the gamma-zein and ubiquitin promoters; and do not contain any of the backbone sequences from the transformation plasmid pNOV7013.
This genetic insert also contains the terminator sequences from two plant pests, cauliflower mosaic virus and Agrobacterium tumefaciens. Both of these sequences are well-characterized, and are noncoding regulatory regions only. These sequences will not cause Event 3272 corn to promote plant disease.
DNA sequencing of Event 3272 confirmed that the overall integrity of the intended insert and the contiguousness of the functional elements had been maintained. Statistical analyses over multiple generations confirmed that the amy797E gene is stably inherited in the expected Mendelian ratio.
Syngenta field tested Event 3272-derived corn hybrids for two years (2003 and 2004) at more than 25 locations in several states across the US Corn Belt. Data generated demonstrate that the genetic modifications did not have any unintended effects on seed germination, dormancy, plant growth habit and general morphology, life-span, vegetative vigor, flowering and pollination, grain yield, stress adaptations or disease susceptibility. Syngenta said that these data support the conclusion that Event 3272 hybrids are unlikely to form feral persistent populations, or to be more invasive or weedy than conventional maize hybrids, and would not display higher rates of outcrossing than unmodified maize.
Compositional analysis data suggests that Event 3272 hybrids are nutritionally equivalent in composition to other commercial corn hybrids and will not pose an increased plant pest risk or have increased weediness potential over conventional maize hybrids. A mammalian safety assessment for both the amy79E and pmi proteins showed no adverse effects.
APHIS is responsible for protecting US agriculture and the environment from animal and plant pests. APHIS regulates GE products in cooperation with the Environmental Protection Agency (EPA) and the US Department of Health and Human Services’ Food and Drug Administration (FDA). In compliance with agency policy, Syngenta Seeds, Inc. submitted a food and feed safety and nutritional assessment summary to FDA for this GE corn. EPA is not involved in evaluating this GE corn because it has not been engineered to produce a pesticide or to be tolerant to an herbicide.
The comment period is open through 20 January 2009.
Resources
Federal Register notice
Syngenta USDA Petition for Nonregulated Status of Corn Event 3272
Syngenta Seeds, Inc. Alpha-Amylase Maize Event 3272 (SYN-E3272-5) Draft Environmental Assessment
Don't worry, they are just looking for religion but they express that in very complicated scientific ways. Religion is there to give new energy or to bring back the natural energy of the peoples. It's not necessary to modified the genes of corn or microbes. They feel useless so they try to invent new solution to the lazy that don't want to put on the market my futur car that i said will be propel by water electrolisis.
Posted by: a.b | 27 November 2008 at 08:21 AM
The key issue is cross-pollination with non-genetically modified corn. Nearby fields of non-GM corn are going to get this gene whether they want it or not. We should not let this gene become a permanent member of the corn gene pool. Until there is a way to remove this gene from the gene pool it should be banned.
Posted by: James White | 27 November 2008 at 11:36 AM
The key issue is cross-pollination with non-genetically modified corn. Nearby fields of non-GM corn are going to get this gene whether they want it or not. We should not let this gene become a permanent member of the corn gene pool. Until there is a way to remove this gene from the gene pool it should be banned.
Posted by: James White | 27 November 2008 at 11:36 AM
"In describing the work in 2002, Syngenta estimated that the high-amylase seeds could cut production costs by 10%."
Here we have it. It's all about money/profits/riches. Let's put the food supply at risk. Genetics through [natural] directed processes are fine. Genetics through the extraction of a non-plant family gene and inserting it into a plant, animal or human is playing with disaster.
If someone can't see the reason for concern.. think new compounds that form in the modified object or issues with the person or animal that would consume said modified item. We don't even understand how the entire genome works and we think we understand all potential permutations of a changed biology?
The money will win out, and the rest of us will pay the heavy price for greed.
Posted by: itsaboutchoice | 27 November 2008 at 01:11 PM
"(Syngenta) Data generated demonstrate that the genetic modifications did not have any unintended effects on seed germination, dormancy, plant growth habit and general morphology, life-span, vegetative vigor, flowering and pollination, grain yield, stress adaptations or disease susceptibility."
It might be prudent to duplicate this study by a neutral third party before going forward.
Posted by: gr | 27 November 2008 at 03:25 PM
The thing is, corn is a food crop, so modifying it into a non-food crop is risky. (It could lead to contaminating our food supply)
A better idea is to pick some other non-food plant(with an already high oil/starch/sugar content) and modify that into a source of biofuel.
Posted by: John Taylor | 27 November 2008 at 03:42 PM
GM is is up there with population as unpopular and passionate topics for disagreement.
Climate change deniers while vocal tend to be self destructing in their argument, personality and as such are generally recognised as sad.
Religion has in the main adopted the optional and recognises or encourages personal beliefs into it mandate.
Religious fanaticism with its millenia old history of 'ethnic cleansing' not withstanding.
The subject of genetics recognises there are risks and benefits as with most of human activity.
There needs to be ongoing study and monitoring with review and action to make good the negative outcomes. IE the anti GM lobby is a major flag waver re concerns and on the ground knowledge.
Like many such concerned person unfair costly personal damage can be part of the territory.
A responsible GM industry puts up and makes good if it is to be ethically sustainable and in this area it has a long way to go.
However IMO it is entirely feasible and rational to recognise the potential of GM to reduce pollution and ecological footprint.
Many scientifically trained and disciplined persons see that business as usual in a world variously described as one planet less than sustainable or eleven planets short of area if we adopt the lifestyle of the top 20 countries.
This constitutes extraordinary times requiring extraordinary action.
There is also a high level of confidence in the science among ethicist as well as a recognition that the human condition and curiosity has brought the (current) understanding of genetics with a large frontier of study.
There are powerful motivations beyond greed.
Although there is an early history of just that which should be properly addressed.
Given recognition of risk benefit and likely future development of this area, better open discussion and criticism with accountability mandates.
Posted by: arnold | 27 November 2008 at 04:21 PM
For all those saying "Oh GM is bad/ what about cross-pollination"...think through what could be the consequences of cross-pollination in this case: some plants in the neighbouring fields of corn MIGHT gain the amylase gene (though without a positive selection pressure for aquiring this gene it is less likely) - is that really so bad? It doesn't offer the corn plant any advantage when it is growing - it is a neutral change. The gene will only be activated if the grain is pre-treated - if the corn is fed to animals it will do NOTHING. It won't detract from the animals' health, it won't make them resistant to antibiotics. Having said all that it would be interesting to consider what, if any, impact it might have on other corn-based food products - indeed could it make it easier to process?
I absolutely agree that GM crops do have to be tightly regulated and carefully considered on a case by case basis, but I do think that in this instance people are over reacting and damning the technology before they have heard the whole story.
Posted by: KE | 28 November 2008 at 06:14 AM
P.S. I suspect that the initial cost of buying such grain each year may put off corn-growers - particularly the smaller famers as they are unlikely to see the 10% cost benefit that the ethanol producers would get. How much amylase containing corn do you need to hydrolyse the starch in a batch of mixed grain?
Posted by: KE | 28 November 2008 at 06:22 AM
This completely ignores the fact that corn ethanol is a dead end. There is no reason to take any sort of risk on this GM corn.
Posted by: John | 28 November 2008 at 07:32 AM
ADDRESSES: You may submit comments by either of the following methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0016
to submit or view comments and to view supporting and related materials available electronically.
• Postal Mail/Commercial Delivery: Please send two copies of your comment to
Docket No. APHIS–2007–0016, Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700 River Road, Unit 118, Riverdale, MD 20737–1238.
Please state that your comment refers to Docket No. APHIS–2007–0016.
Posted by: richard schumacher | 28 November 2008 at 08:55 AM
You know it's strange I have always supported corn ethanol, but ONLY because what other biofuels do we have at the present time? But now this is absolutely ridiculous to use GE corn!! The real cellulosic and other biofuels are about to TAKE OFF. We should not even be discussing GE corn, I agree.
Posted by: Steve-O | 28 November 2008 at 01:11 PM
I am flabbergasted by the negative responses in this thread. Putting the food supply at risk -- what risk? These changes put a new protein into the plants, a protein you could probably eat by the pound without ill effect (aside from gaining weight). They looked for negative effects and found none. Are the anti's here asking for absolute proof of a negative before they will stop objecting?
As for the objection that this is just for saving money -- money is extremely important. It's so important that most people trade the finite and limited hours of their lives to get more of it, through a process we call "work". Don't diss things that save money.
Posted by: Paul F. Dietz | 29 November 2008 at 08:01 AM
Just DO IT!
Posted by: NIKE | 01 December 2008 at 04:09 PM