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Letting science do its job

Part 1: Biotech industry in a quandary over research rights
Part 2: Letting science do its job

NOTE: These two interesting pieces on the corporate limitations the biotech industry places on researchers, are from Ag Professional magazine, a trade publication for agricultural retailers. There should be a third piece in this series. If anyone comes across it, please let us know.

EXTRACTS: [N]ot 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.

"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."

FURTHER READING: Scientific American: Do Seed Companies Control GM Crop Research?
http://www.scientificamerican.com/article.cfm?id=do-seed-companies-control-gm-crop-research
Financial Times: A seedy restriction on research
http://www.gmwatch.org/latest-listing/1-news-items/11406-seedy-research-restriction--global-food-security
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Part 1: Biotech industry in a quandary over research rights
Jim Ruen
Ag Professional, May 2009
http://www.agprofessional.com/show_story.php?id=58449

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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2.Part 2: Letting science do its job
Jim Ruen
Ag Professional, June 2009
http://www.agprofessional.com/show_story.php?id=59162

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.