More evidence of Scientific Malpractice in GM assessment process
Comment from GM-Free Cymru:
Under wraps
NATURE BIOTECHNOLOGY, VOLUME 27, NUMBER 10, October 2009
http://www.emilywaltz.com/Biotech_crop_research_restrictions_Oct_2009.pdf
This article by Emily Waltz, published (surprisingly!) in "Nature Biotechnology", follows another one written by her and published in "Nature" in September. ("GM crops: Battlefield" by Emily Waltz, Nature 461, 27-32 (2009) doi:10.1038/461027a, 2 September 2009
http://www.nature.com/news/2009/090902/full/461027a.html?s=news_rss
http://www.gmfreecymru.org/pivotal_papers/battlefield.html
We hope that this might be some part of an attempt by "Nature" publications to redress the balance, following the outcry from the scientific community following the Ermakova set-up and the use of the "dummy proof" tactic in which the Editor of "Nature Biotechnology", Andrew Marshall, was heavily implicated.
http://www.gmfreecymru.org/pivotal_papers/rottweiler.htm
Interestingly enough, the new papers by Emily Waltz coincide with two further papers published in the American farming press, which we also reproduce below. AGProfessional is not a little mag promoting organic farming -- it is a mainstream publication which represents the interests of industrial / high input farming -- and it's interesting that it should have devoted space to this issue. The articles, both by Jim Ruen, will not have amused Syngenta, Dow, Monsanto and BASF, all of whom use its pages to promote their products.
We had hoped that there had been progress on sorting this issue out, on the basis of a carefully-worded press item from the American Seed Trade Association: http://www.gmfreecymru.org/news/Press_Notice23Sept2009.htm
A seed is planted: New dialogue makes significant progress in addressing independent seed research Some progress on GM research blocking? American Seed Trade Association, USA. 12 August 2009
http://www.amseed.org/news_enews081209.asp
However, it now appears that there has been no real progress since 26 scientists "broke cover and signed a Letter to the EPA in Spring 2009:
US EPA Docket EPA-HQ-OPP-2008-0836. Available at
http://www.regulations.gov/fdmspublic/ component/main? main=DocumentDetail&o=090000648084de39 http://www.gmfreecymru.org/pivotal_papers/corporate_monopoly.htm
The assessment system for GM crops and foods is as corrupt as ever, with the industry showing no desire to change things for the better, or to consider the interests of the consumer. Their commercial ambitions are still paramount, and they are not going to do anything to allow research, or to publish research results, that might reveal things about their patented GM varieties that might cause the public to be concerned. So research continues to be blocked and manipulated on the flimsiest of pretexts, with more and more evidence coming out of outright scientific fraud. Consider Emily Waltz's description of the manner in which a Pioneer transgenic corn (containing a binary toxin, Cry34Ab1/Cry35Ab1) was tested and approved in 2001. That is truly chilling -- and it is clear that Pioneer placed its commercial ambitions far above any concerns for the environment or public health.
So where does this leave us? Sadly, the lack of progress on the other side of the pond is matched in Europe. We have made frequent representations to the EC, to EFSA, to the UK government, FSA and the so-called "independent committees" like ACRE and ACNFP, and to bodies charged with overseeing scientific ethics -- and none of them actually seems to understand what we are talking about. We just have to persist. For a start, we will bring these papers to their attention and ask them -- yet again -- what they propose to do about the fact that the bulk of the evidence on which they base their assessments of GM varieties is questionable at best and corrupt at worst.
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Under wraps
NATURE BIOTECHNOLOGY, VOLUME 27, NUMBER 10, October 2009
http://www.emilywaltz.com/Biotech_crop_research_restrictions_Oct_2009.pdf
*Are the crop industry's strong-arm tactics and close-fisted attitude to sharing seeds holding back independent research and undermining public acceptance of transgenic crops? Emily Waltz investigates.
The increasingly fractious relationship between public sector researchers and the biotech seed industry has come into the spotlight in recent months. In July, several leading seed companies met with a group of entomologists, who earlier in the year had lodged a public complaint with the US Environmental Protection Agency (EPA) over restricted access to materials. In a letter to the EPA, the 26 public sector scientists complained that crop developers are curbing their rights to study commercial biotech crops. "No truly independent research can be legally conducted on many critical questions involving these crops [because of company-imposed restrictions]," they wrote.
In turn, the seed companies have expressed surprise at the outcry, claiming the issue is being overblown. And even though the July meeting, organized by the American Seed Trade Association in Alexandria, Virginia, did result in the writing of a set of principles for carrying out this research, the seed companies are under no compunction to follow them. "From the researchers’ perspective, the key for this meeting was opening up communication to discuss the problem," says Ken Ostlie, an entomologist at the University of Minnesota in St. Paul, who signed the complaint. "It will be interesting to see how companies implement the principles they agreed upon."
What is clear is that the seed industry is perceived as highly secretive and reluctant to share its products with scientists. This is fueling the view that companies have something to hide.
Who's in control?
It's no secret that the seed industry has the power to shape the information available on biotech crops, referred to variously as genetically engineered or genetically modified (GM) crops. Commercial entities developed nearly all of the crops on the US market, and their ownership of the proprietary technology allows them to decide who studies the crops and how. "Industry is completely driving the bus," says Christian Krupke, an entomologist at Purdue University in West Lafayette, Indiana.
Company control starts with a simple grower's contract. Anyone wishing to buy transgenic seeds has to sign what's called a technology stewardship agreement that says, among many things, that the buyer cannot conduct research on the seed, nor give it to someone else for research. This means scientists can't simply buy seeds for their studies, and farmers can't slip them some on the side. Instead, scientists must get permission from the seed companies or risk a lawsuit. "You need permission from industry and you have to specify what you want to do with the plants," says Bruce Tabashnik, an entomologist at the University of Arizona in Tucson.
Seed companies can refuse a research request for any reason, and they get fairly inventive. In 2002, Paul Gepts, a plant geneticist at the University of California, Davis, wanted to check for the presence of transgenic maize in Mexican households after reports that DNA from GM maize had transferred to local varieties.
He requested seed samples from three companies, explaining that he wanted to compare them to the seeds from the Mexican households to see if they contained the same genetic material. "I thought naively that that would be a courtesy and I could get a small sample. But they didn’t really want to do it," Gepts says. According to emails reviewed by Nature Biotechnology, Monsanto, based in St. Louis, told Gepts to get a powder sample from Europe, which didn't work well for the experiment, Gepts says. Gan-Yuan Zhong, a researcher at the time at Johnston, Iowa–based Pioneer Hi-Bred, told Gepts that the company didn't have the "appropriate material" to share. And Syngenta, in Basel, suggested Gepts collaborate with the Mexican government, which was investigating the issue.
How often these kinds of rejections are happening is unclear. Some may be isolated instances; others result from company policies. For example, Syngenta recently implemented a rule prohibiting any study that compares its commercial crops to other companies' crops, according to Paul Minehart, a spokesperson for Syngenta. One scientist affected by the change, Minnesota's Ostlie, wanted to compare how three companies' insect-resistant corn varieties fared against local species of rootworms. All three products had been commercialized, and Syngenta, Monsanto and Pioneer gave Ostlie permission to do the study for the 2007 growing season. But for the 2008 season, Syngenta backed out. "In late 2007, we changed our policies on research," says Minehart. "We decided not to get involved in any comparison studies," he says. Many Syngenta products contain components licensed from other companies, and Syngenta has agreements with those companies that they won't compare their products, Minehart says.
The idea of having to get permission from companies to do studies is a deterrent in itself. "There are three strategies that people take," says Elson Shields, an entomologist at Cornell University in Ithaca, New York. "Some are just not doing the research. Some are changing their experimental protocols so that they are acceptable to industry - which may or may not be a good thing," he says. "And some are just going out and buying the seeds and doing the research in violation of the technology agreements."
Requesting permission from the companies can be daunting. The requester usually has to describe in detail the design of the experiment— information scientists may not want to divulge. Some researchers object to revealing their hypotheses because it provides companies with a head start in preparing a rebuttal. Once the company and the scientist agree on the design, they must negotiate the terms of the research agreement. Negotiations tend to break down when companies want to limit or control publication of the study. "When you are funded by state and federal dollars, you have an obligation that the research you conduct is public and published," says Beverly Durgan, dean of extension services at the University of Minnesota. "So signing research secrecy agreements is something we really can't do," she says. The US Department of Agriculture’s (USDA) research arm, Agricultural Research Service (ARS), has a similar policy. "We can sometimes agree to some limitations on publishing like having the company review the results X days before publication," says Kalpana Reddy, in the office of tech transfer at ARS. "But we won't agree to any sort of blanket approval, which would limit our right to publish."
Negotiations in 2008 between Monsanto and two universities—North Dakota State University and the University of Minnesota— broke down when Monsanto insisted on approving publication of any data on its newly commercialized transgenic sugar beets, according to Durgan. The university had proposed "the general type of research our faculty would conduct with any new crop variety," she says. "Monsanto wanted the right to approve all publications, and we said that was not possible," she says. As a result, no sugar beet research was conducted by Minnesota or North Dakota State University in the 2008 growing season. A Monsanto spokesperson claims that "it became necessary to manage research agreements more carefully" when separately, Monsanto's sugar beet became an object of litigation. Monsanto and the two universities came to a compromise for the 2009 growing season.
Studying crops hasn't always been this difficult. "Before biotech came around, when new varieties came out, local groups would get together and have a local trial," says Alan McHughen, a plant biotechnologist at the University of California, Riverside. Crop clubs, composed of local farmers and university scientists, would do agronomic studies to see which varieties perform best and how they interact with the local environment. "If it was okay in the past, I don't see why companies would object to it now," says McHughen.
Most major seed companies seem to have made an effort to enable scientists to do such agronomic research. Pioneer, Monsanto, Syngenta and Indianapolis-based Dow AgroSciences say they have negotiated multiyear agreements with major universities that give those scientists the freedom to conduct and publish most agronomic research without having to get permission from the company for every study (Box 1). But the limits of these agreements are often unclear. A group at Penn State generated a list to "put in front of companies to find out what kind of research falls under these agreements," says Dennis Calvin, an entomologist at the university. The new principles drafted by the seed trade association this summer may help clarify, and possibly expand, these limits. The group aims to finalize the draft by the end of the year.
Keeping tabs
Industry spokespeople say they were surprised by the scientists’ complaint to the EPA. "It's clear that academics have an issue that needs some attention," says Eric Sachs, director of global scientific affairs at Monsanto, who attended the July meeting. “But some scientists we’ve talked to think this issue has been blown way out of proportion,” he says. “The language in that letter seemed to suggest that some products on the market may very well be unsafe because they haven’t been adequately tested. That’s going too far in my mind,” he says.
The companies say they have to keep tabs on public sector research because they want to make sure the studies are done with good stewardship practices and in accordance with regulations. If there is an adverse event with a precommercial product, seed makers could be liable, even if the event occurred under the watch of a public sector scientist. Any adverse events with commercial products have to be reported to regulatory authorities as well.
Industry spokespeople also say they want to be mindful of the integrity of US grain exports so that products that haven’t received approval in some countries aren’t sent there. Companies also want to protect their intellectual property (IP) and their investment in the product. They are particularly averse to allowing the public sector to breed crops or to characterize the genetic composition of the plant. After all, a biotech crop can cost up to $100 million to develop, according to industry estimates. "Where would you stand if this were your product?" asks Carol Mallory-Smith, a weed scientist at Oregon State University in Corvallis.
And, companies want the studies done right. "If you do some poorly organized research proposal, a company might not be inclined to give you the seeds because they're afraid it won't cast a favorable light on their product," says Rick Goodman, a food scientist at the University of Nebraska-Lincoln and a former Monsanto researcher. "The consequences can be huge," he says. Biotech crops are intensely scrutinized, and any negative study that comes out tends to be widely disseminated by vocal anti-GM groups. Companies have spent countless hours defending themselves from such groups. "Critics are looking for any little problem with the technology," adds Tabashnik.
Industry spokespeople say they want strong relationships with academics because they depend on their expertise. In fact, seed companies frequently pay academics to study precommercial products, similar to consulting arrangements or discovery work carried out in academia for big pharma. Monsanto, for example, will pay anywhere from a couple thousand dollars to do a single-field study to a couple hundred thousand dollars to do more complex laboratory work or an animal feeding study. "If industry wasn't sponsoring this research there would be much fewer data than there is now," says Blair Siegfried, an entomologist at the University of Nebraska-Lincoln.
Shoddy studies?
A potential check on industry's control over the data is the role that regulatory agencies play on product approval. But some scientists worry that these agencies aren't asking for the right safety tests. "Companies put in mountains of data but there's no devil's advocate - no other side," says Krupke at Purdue.
In the US, under the Federal Food, Drug and Cosmetic Act of 1938, the FDA is responsible for ensuring that food is safe to eat, although by statute, it regulates only food additives. By that definition, most crops are exempt from FDA approval, although companies tasked with ensuring their products are safe often voluntarily submit a considerable amount of information. Certain types of commercialized crops also fall under the jurisdiction of the USDA and the EPA: the USDA is concerned with minimizing gene flow, the EPA regulates crops containing pesticides, such as those with insect-resistance traits. Transgenic and conventional crops with other traits - herbicide tolerance or nutritional enhancement - could enter the marketplace with almost no review of the potential health impacts1. The EPA also regulates unintended effects on nontarget insects, although a review of published studies identified problems that limit their usefulness2,3. The fact that much of the data submitted to regulatory agencies remains confidential business information that is not shared with the research community means that for many crops (transgenic or otherwise), little information on human or environmental toxicity is known. Certainly, there is a paucity of such studies in the literature. Spanish researcher Jose Domingo, at Rovira i Virgili University in Reus, conducted a literature review of toxicity studies conducted on commercialized GM crops. So few research papers turned up in his search that he asked, "Where is the scientific evidence showing that GM plants/food are toxicologically safe?"4.
In some instances, university scientists have raised concerns about data submitted to regulatory agencies, but had no recourse. In 2001, for example, Pioneer was developing a transgenic corn variety that contained a binary toxin, Cry34Ab1/Cry35Ab1, to fend off rootworms. The company asked some university laboratories to test for unintended effects on a lady beetle. The laboratories found that nearly 100% of lady beetles that had been fed the crop died after the eighth day in the life cycle. When the researchers presented their results to Pioneer, the company forbade them from publicizing the data. "The company came back and said ‘you are under no circumstances able to publicize this data in any way’," says a scientist associated with the project, who asked to remain anonymous. Because the product had not yet been commercialized, the research agreement gave Pioneer the right to prevent publication of their results.
Two years later, Pioneer received regulatory approval for an antirootworm corn variety with the same toxin—Cry34Ab1/Cry35Ab1. But the data submitted to the EPA had no sign of potential harm to lady beetles, even though Pioneer had followed common EPA testing protocols. In one study, the company fed purified toxins to the lady beetles only through the seventh day of their life cycle - one day short of what was found to be their most susceptible stage. In a second study, the company followed the lady beetles through the end of their life cycle but used a different mode of feeding, through a homogenized powder consisting of half prey and half pollen, and didn’t see any effect, according to Jim Register, a scientist at Pioneer. Register also says that although Pioneer’s commercialized product contains the same toxin as the one the universities studied, it is a different construct—key genes were integrated into a different place in the genome.
The anonymous researcher maintains that Pioneer's studies are flawed. The EPA was made aware of the independently produced data, but opted not to act, according to the anonymous source. Pioneer would also not give the scientists permission to redo the study after the crop was commercialized.
Scientists can in theory review the data companies file with regulatory agencies. "Independent scientists mostly want to review the data to see if it's good science or regulatory junk science and also to conduct their own research," says Bill Freese, an analyst at the Center for Food Safety in Washington, DC. But roadblocks exist to this as well. Scientists have to submit Freedom of Information Act (FOIA) requests, which can take months, and allows access only to information that is not confidential business information. In this regard, the USDA has been accused by a National Academy of Sciences committee of allowing companies to make excessive claims of confidential business information5.
Companies have been known to take the confidentiality of data on their GM crops to even greater extremes. Tabashnik says a Dow AgroSciences employee once threatened him with legal action if he published information he received from the EPA. The information concerned an insect-resistant variety of maize known as TC1507, made by Dow and Pioneer. The companies suspended sales of TC1507 in Puerto Rico after discovering in 2006 that an armyworm had developed resistance to it. Tabashnik was able to review the report the companies filed with the EPA by submitting a Freedom of Information Act request. "I encouraged an employee of the company [Dow] to publish the data and mentioned that, alternatively, I could cite the data," says Tabashnik. "He told me that if I cited the information...I would be subject to legal action by the company," he says. "These kinds of statements are chilling."
Many think that companies aren't helping their image with these strong- arm tactics and a close-fisted attitude to materials sharing. The industry has taken a lot of hits over the years, particularly from activist groups ready to pounce on any sliver of anti-GM information. "If there's a sense that a problem is being swept under the carpet, then that only fuels the fear," says Tabashnik. "I think it's better to be open about it," he says. "It's not as if one problem with one variety means the whole technology isn’t useful."
Emily Waltz, Nashville
1. Freese, W. & Schubert, D. Biotechnol. Genet. Eng. Rev. 21, 299–324 (2004). 2. Marvier, M. Ecol. Appl. 12, 1119 –1124 (2002). 3. Marvier, M. et al. Science 316, 1475–1477 (2007). 4. Domingo, J. Crit. Rev. Food Sci. Nutr. 47, 721–733 (2007). 5. Committee on Environmental Impact Associated with Commercialization of Transgenic Plants, National Research Council, National Academy of Sciences. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation (The National Academies Press, Washington, DC, 2002).
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SOURCE: AgProfessional.com, USA
AUTHOR: Jim Ruen
URL: http://www.agprofessional.com/show_story.php?id=58449
DATE: 01.05.2009
PART 1. BIOTECH INDUSTRY IN A QUANDARY OVER RESEARCH RIGHTS
Once upon a time there was a stool supporting agriculture with three legs. One leg was the farmers who tilled, planted and harvested. The second leg was the companies who supplied the inputs the farmer used. The third leg was the public researchers-U.S. Department of Agriculture and land grant researchers who studied farming practices and inputs, did basic agronomic research and made recommendations based on comparative studies and laboratory analysis. The stool was stable, and agriculture grew and prospered.
Times change. The research leg is becoming wobbly and the stool less stable, due in part to a little noticed clause in biotech seed purchase agreements. The clause prohibits research with commercialized seed without permission. The legal language is clear. No research is allowed. Syngenta, Monsanto and Pioneer (Dow AgroSciences deferred questions to an industry group) all say they encourage comparative research and support academic research. Yet they have retained language that restrains it.
Steve Sodeman likes the idea of the three- legged stool-farmer, company and public researchers working together. Right of company refusal begs the credibility question for the Minnesota corn producer, crop consultant and member of the National Corn Growers Association Biotechnology Working Group. It’s one he feels should be of concern to the entire industry.
”We are just at the beginning of the trait world,” he said. ”I think it is in the best interest of the farmer to have the public researcher involved in checking some of this stuff.”
The restraints also reflect on the credibility of the partnership that has existed. ”I like to be able to respond to the farmers of Indiana when they have questions,” said Larry Bledsoe, Extension entomologist, Purdue University. ”When I am asked my opinion and I have to say that I can’t answer because of a confidentiality agreement with a company, there is silence and blinks from the farmer audience. They feel uncomfortable and so do I.”
Technically, if you stick to the legal language, the prohibition would also include full-service ag retailers with plots, farmers who do comparative or analytical plots of any kind and certainly crop consultants and farm managers who do comparisons of products and advise their clients of the results.
Does this mean that corporate legal departments are waiting to swoop down on unsuspecting farmers, retailers, consultants and farm managers? No, of course not...well, probably not. However, they could, even though it would likely be a public relations nightmare. Those individual plots are also not the research that is of concern to the companies.
It is the broader university and other public research institutions that are a concern and the focus of the issue. In order to legally work with biotech crops, these researchers must negotiate permission. The permission may or may not mandate protocols, exclusions and data review. It can and often does mandate confidentiality.
The exception to this requirement is Monsanto, which has signed blanket permission for research with its commercialized biotech seeds with more than 150 institutions. Yet the language remains, and permission, even granted, can be withdrawn.
”It puts the seed company in the gatekeeper role in terms of what they will and will not allow,” said Ken Ostlie, Extension entomologist, University of Minnesota. ”We are no longer able to actively research where science leads us in the best interest of growers and the public we serve. My dilemma now is do I do as my heart says and do the comparative research and risk getting sued, or do I knuckle under?”
Entomologists Raise Concerns
When Ostlie and other university Extension entomologists met in January to discuss current cooperative research, they raised the issue with attending company representatives. They were told the limitations would remain due to legal concerns.
When 26 of those entomologists sent a letter (names withheld) to the Environmental Protection Agency’s biotechnology advisory committee regarding the limitations, the New York Times ran an article about the concerns.
Since then the debate has broadened and the questions sharpened as the advisory committee asked for more information and the National Academy of Sciences requested a report on the issue from the entomologists. Members of the National Corn Growers Association are raising the issue within their organization and the possibility of congressional involvement is being raised.
Defenders of the status quo point to the need for preventing misuse or theft of proprietary technology, controlling irresponsible and improper protocols or inadequate stewardship of traits. Critics point to a desire by some companies to control the flow of information to protect market position and a need for open and unbiased research. Some on both sides suggest there is a lot of miscommunication going on, and most on both sides agree the issue must and can be worked out.
”It’s in our interest to enable the research community to do this kind of work,” said Eric Sachs, lead for global scientific affairs, Monsanto. ”It’s in our best interest and the industry’s for researchers to understand the products and help growers get the most from them. We are in dialogue with other companies in the industry, talking about the issue in hopes of coming out with a more consistent approach.”
Understanding the Ramifications
At first glance, the issue is simply one of permission to do research, but for the researchers involved, the National Academy of Sciences and the industry at large, it goes much deeper. For the first time that anyone can point to, research is being limited on commercial products. For public researchers, it is a damned if they do and damned if they don’t situation. If they complain, they fear they will no longer receive permission for even limited research; hence the names withheld in the letter. Some entomologists are speaking out in this article and elsewhere, perhaps putting future research hopes on the line, but they feel it is worth the risk.
”We have to ask permission from each company to do the research, and that gives the company the right to refuse,” explained Elson Shields, Extension entomologist, Cornell University, and a spokesman for the group of 26. ”Refusal has happened, and it comes in one of several ways. Out right written refusal is rare. Verbal is more common, and the third is endless legal wrangling that costs the research institution so much in legal fees that they say no, or negotiations continue past planting date.”
Corn grower Sodeman’s concerns were raised when a University of Minnesota research study funded by the Minnesota Corn Growers was stopped when a company pulled approval. In 2007, Ostlie had sought and received permission to compare the Agrisure, Herculex and YieldGard events. For Sodeman and other Minnesota corn growers funding the study, the information was vital.
”We’ve seen a tremendous increase in problems with the Northern corn rootworm,” explained Ostlie. ”Most research on transgenic seed has been done on Western corn rootworm. Our corn growers asked for comparative research on the three events, how they affect the rootworm and impact on root injury, lodging and yield.”
Syngenta pulled out a year into the study. Reasons given remain unclear, stated Ostlie. It was the first time he had run into such a problem with any company on an approved study. However, each of the four major seed companies was cited by entomologists who signed the complaint letter to the EPA.
”A company may want to minimize the negative consequences of research, but in the long run, it’s the truth about these events that is important,” said Ostlie. ”We have to let science do its job.”
Part 2: Letting Science Do Its Job In our next issue, we will look at the origins of the restraint on research with biotech seeds and its continuing impact, as well as changes in research funding mechanisms that are changing the role of public research in agriculture.
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URL: http://www.agprofessional.com/show_story.php?id=59162
DATE: 01.06.2009
PART 2: LETTING SCIENCE DO ITS JOB
Jim Ruen
Editor’s Note: This is the second of a three-part series on agricultural research looking at restraints imposed on research related to GMO seed and the future of public research funding. In this article, we are looking at the origins of research restraints, why they have continued and their implications on access to market information.
Jerry Caulder has been involved in the biotech industry for more than 30 years. The San Diego-based biotech leader remembers all too well when it was more like a Wild West town than the industry it is today. First at Monsanto and then as a founder of Mycogen Seed, he was intimately involved in the research and patent uncertainties and legal gunfights that marked those early days.
”Twenty years ago, when most of these rules and licenses were first promulgated, we didn’t know how easy or difficult it would be to get around the new plant patents,” said Caulder, currently serving as executive chairman of Finistere Partners, LLC, a venture capital firm, and several biotech companies. ”If one amino acid was changed, would a new patent be issued? We made things as restrictive as we could in part to protect intellectual property.”
Tremendous amounts of money were being invested in products that, once produced, could literally reproduce themselves. A wary public and government regulatory agencies were concerned about accidental release of unapproved, altered genetic material. Like the diseases and pests released from Pandora’s box, altered genes, once released, might never be recaptured. Companies realized that if public researchers or anyone else misused the material, it could put those investments in jeopardy.
”Once academics started doing things with our products, we would have no quality control over them,” said Caulder. ”Industry doesn’t mind being hung out once in a while, but we don’t want to buy the rope.”
Is there still a need for restrictions?
Are those restraints still needed? After all, not even the companies and the industry involved can offer examples of similar research restrictions with any other commercial product. Public researchers suggest they may simply be a way to control what research is carried out. Even staunch supporter Caulder questions the end results of the long-time restraints.
”Preventing basic research wasn’t the intent,” he said. ”There always has to be a balance between intellectual property rights and how you treat public researchers.”
Is there balance? Certainly thousands of research agreements have been signed and carried out, many with the very entomologists who raised their concerns over research restraints with the Environmental Protection Agency, earlier this year. Indeed these same researchers emphasize having had good relationships with the companies on ”approved” research.
Although seed industry sources insist the ”no research” clause in purchaser agreements is not intended to limit agronomic research, agreement on what is agronomic research is harder to find. While Monsanto and Dow stipulate their seed cannot be used for research, Syngenta’s license goes so far as to prohibit even generating cooperative data against corn seed containing non-Syngenta technologies.
”Agronomic research is a pretty broad term, and every company likely has a different definition, but generally it would cover observable activity in the field,” said Andy LaVigne, president and CEO, American Seed Trade Association (ASTA).
Sharyl Sauer, Pioneer Hi-Bred spokesperson, said Pioneer encourages any type of agronomic and comparative yield testing to ensure their products are delivering value. However, she added, ”If you want to do more in-depth research, then we request you contact us to work on the request. Very few requests are turned down. When it comes to yield trials on commercial products, researchers can publish at will.”
Up for Interpretation
Monsanto claims a much broader interpretation of allowable research both for growers and academic researchers. ”What we restrict is people developing new methods to test for the presence or absence of proprietary traits in seeds that potentially might not go through the appropriate validation process and could result in data that could be misleading,” said Eric Sachs, lead for global scientific affairs, Monsanto. ”If researchers say they need to be able to test plant material, we provide tools and methods to do it. We don’t think more research methods are needed.”
Sachs pointed to his company’s academic research agreement and suggested that academic/public researchers don’t realize how broad the agreement is in its interpretation of agronomic research. When asked about issues of resistance management, non-target impact on natural enemies, pollen movement, effect on pollinators and other non-target organisms and breakdown of Bt in crop residues, Sachs insisted researchers were free to pursue any and all such issues.
Although such a broad interpretation might be welcomed by public researchers, some find the term ”agronomic research” too vague. After a discussion with an intellectual property associate about whether non- target studies were agronomic, Chris DiFonzo, an Extension entomologist at Michigan State University, said she would err on the side of caution and get formal permission for such research. Once as a cooperator on a Bt resistance study that was discontinued when its leader was threatened with legal action and on a non-target study that was cut short because it was not permissible to provide Bt pollen to a colleague, DiFonzo is not about to take any chances.
Even if she was confident the agreement with MSU covered research she and her associates might undertake today, she pointed out it only covers one company. In addition, without specifics spelled out, a researcher would never know when they might have overstepped the company’s allowed research.
”Why treat patented, commercialized transgenic seed any different from patented, commercialized insecticides?” asked DiFonso. ”As long as the label language is followed regarding rate, crop, safety rules, environmental regulations, applicator certificate, etc., any insecticide may be purchased by a scientist and used in research. This open access has resulted in a wealth of research on the impact of insecticides not only on agronomic traits, crop yield and the target pest, but on non-target species, secondary pest outbreaks, resistance formation, off-target movement, environmental impacts and breakdown.”
DiFonso pointed out that some of this work was likely unpopular with the manufacturers. However, she added, ”It is a fundamental responsibility of universities to conduct such research.”
Protecting Intellectual Property
Monsanto’s Sauer posits that there are many reasons for companies to limit research, including ensuring compliance with government and corporate biostewardship rules, as well as protecting intellectual property and germplasm and trait licensing. ”If we have agreements with another company, we have to meet the contractual obligation with them,” said Sauer.
However, fulfilling stewardship rules and misappro-priation of the intellectual property are each covered separately from the research restraints in the signed agreements. It is stewardship concerns that were the basis of the EPA requiring signed statements, suggested Sachs.
Christian Krupke, Extension entomologist, Purdue University, stressed that nobody wants to infringe on intellectual property, much less violate stewardship agreements. What they do want is to be able to ask the questions that industry may not ask for whatever reason.
”You can’t expect companies in the business to ask every conceivable question a university researcher might ask,” he said. ”We want to keep these products around and ensure they are durable for the long run. These restrictions make it much more difficult for public researchers to work toward that goal.”
Elson Shields, Extension entomologist, Cornell University, pointed out that unless EPA mandates continued research post registration, it might not happen; yet pre-commercialization research is based only on small plots. ”Only after registration, when it is in large fields, can you address movement of insects, what the impact will be on the landscape and impact on beneficials versus what was seen in the small plots,” explained Shields. ”What confidence can we have in the EPA if they aren’t getting the full picture?”
For Steve Sodeman, a Minnesota corn grower and crop consultant, concerns are closer to home. ”I worry about paying $20 an acre for a particular trait and have resistance develop,” he said. ”What is the value in that? We need the independent public researchers looking at that.”
For researchers like DiFonzo, Shields and Krupke, that concern strikes to the heart of the matter. ”I don’t think these events are being evaluated nearly as rigorously as they could be,” said Krupke. ”We may or may not agree with the findings of company X, but you can bet we will be asking some different questions.”
What Can Be Questioned?
Perhaps the most serious aspect of the entire issue is the fact that even raising it was considered risky on the part of the entomologists. The original letter to the EPA advisory committee was to be anonymous. Nine, fearing it would have little validity, stepped forward, while another two dozen were very nervous about even taking a stand, reported Shields.
The concern is not that the companies involved will quit funding their research. Ken Ostlie, Extension entomologist, University of Minnesota, pointed out that only 5 percent to 7 percent of his research is company funded. His and other researchers’ concerns run much deeper. If no research can be carried out without the express approval of the company, researchers not in favor with the companies could be cut off from doing their jobs with current products on the market, as well as with new products being introduced.
”It is my impression, after 30 years as an Extension ento-mologist, that we serve as quality control and independent testers, even as far as consumer protection,” said Shields. ”We are severely handicapped in that role by not being able to do independent research. If we have to ask the company for permission, that gives them the right to refuse. If refused, you either don’t do it or you put your institution at risk.”
As an example, Shields cited restraint on mode of action research and resistance. Would an insect strain resistant to an event from one company be resistant to another company’s mode of action? Companies will not grant permission for such studies, he said, even though they would have relevance on decisions pending at EPA.
In the presentation to the National Academy of Sciences, Shields stated, ”All data flowing to EPA flows from either industry approved studies, where results are ”approved” by the company, or from the company’s own ”in-house” studies.”
”The companies claim it would threaten their intellectual property rights, but this isn’t patent infringement. Their only reason is to control the data,” claimed Shields. ”We are trying to work with the EPA to require that in order for a product to be licensed for sale, the company would have to allow research on it. We are talking here about commercialized products and the freedom to do whatever is needed to answer questions that will impact agricultural producers and ag business.”
Although ASTA’s LaVigne maintains the need for a controlled approach to research, change may be coming. ”Although we were surprised by the comments made to the EPA, companies in the industry are looking at agreements and seeing if changes need to be made,” said Lavigne. ”The seed industry is very supportive of researchers and the Land Grant system and will continue to be.”
As the issue stands today, there is no ”court of appeals” for a researcher to go to if research permission is denied. For example, while ASTA may have been surprised at the concerns raised, the entomologists had first approached their company counterparts at a regional research meeting about their concerns. They were told restraints would not be eased, thus the appeal to the EPA.
Certainly, there is no reason for a company to agree to research that could harm its marketing position, even if it offers vital agronomic information for growers. Whether Shields and other researchers will be able to freely ask and answer questions in the future remains uncertain. What is clear is that the issue has been raised, the seed companies are responding and the industry as a whole is watching.
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Note: There is one part of this series still to be published.