ODA Plant Division BioPharming public comments received

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ODA Plant Division

Department

BioPharming public comments received


Thank you	September 1, 2006	September 20, 2006
August 24, 2006	September 6, 2006	September 21, 2006
August 25, 2006	September 7, 2006	September 22, 2006
August 26, 2006	September 12, 2006
August 29, 2006	September 13, 2006
August 31, 2006	September 19, 2006


Thank you

Thank you very much for your comments on the Biopharm Draft Policy Paper. All of the comments have been reviewed by the committee and changes are being made to the Policy Paper in response to the comments. The final product will be significantly improved because of your input and that provided by other responders. The committee will meet again in late October (please watch for further details) to finalize the document and wrap up their work. Again, thank you for your very valuable comments -- we appreciate your input.


August 24, 2006

Newberg, Oregon I am writing to urge you to adopt a complete ban on biopharming in Oregon for the following reasons: 1. Too little is known about the ecological and health impacts of biotechnology generally as it has been promoted too quickly with too little oversight. In the interest of safety, Oregon should at least wait until more is known before letting it in to our beautiful state. 2. We've just heard of the biotech grass proliferating in Oregon and possibly threatening this huge Oregon industry. Biotech products often "escape" their contained areas and mix with ordinary crops. Containment is not safe. 3. We would lose a lot economically, for our agricultural sector, as much of the world wants nothing to do with biotech agricultural products. Europe and Japan, at least, and many other developing nations that sell to them, would likely refuse our potentially biotech-polluted agriculture. 4. Who knows what pharma-plants might affect? People, animals, plants, the ecosphere--our state is known for its healthy quality of life and natural beauty. Allergic reactions of people could be affected. So could our small vineyard. DON'T APPROVE ANY BIOPHARMS IN OREGON! Beaverton, Oregon To Whom It May Concern -- I am not a scientist but have written about the biopharm issue, hence my knowledge may be better than the average person's. I read your group's list of recommendations and think you're headed in the right direction. I understand and applaud the potential for biopharming, and would welcome such an industry in Oregon, but I also am VERY concerned about the potential problems. Recently, for example, it was reported that genetically engineered grass seed "escaped." My main concern in the recommendations is the reliance you seem to place on the federal agencies involved in this matter. I think the capabilities of the federal agencies that deal with biopharming, under the current administration, have been eroded greatly. Frankly, I would not trust any report or recommendation they produce. (In the area of GE foods, for example, It is my understanding that the FDA doesn't do any safety testing, that the only ones testing are the companies doing the research, and they don't have to report all their testing to the government. This is not comforting.) The credibility of initial and continued oversight of biopharming must be so pure that all Oregonians believe it, and the only way this can occur is for the state to have complete control over initial approval of projects and the full ability to shut projects down if there are any violations on what a company agreed to do. This type of oversight, of course, costs money, so a recommendation might be that firms seeking to do biopharming in Oregon must contribute to a fund to help pay for it. Lastly, when profits occur, new and overwhelming pressures can develop, and if this were the case with biopharming, it could cause tremendous pressure on regulators to ease their controls. I would not want this to happen, so the rules in place at the beginning must be very tight. Thank you for your time.


August 25, 2006

Portland, Oregon Dear Biopharm Committee, I fear that Oregon State University's agriculture scientists will underplay the risk of biopharming since there is discussion of outdoor growing and an assumption that financial guarantees can offset unforeseen events. Our local experience very recently with GE grass seed escape has not yet played out, although we were assured that what did happen could not happen. This is no time for a rodeo approach to the safety of people, plants and animals. This is a time to see if the institutions of democracy, common caution, and a rejection of conformity to corporate norms can stand. This is my Oregon, and I want you to protect it. Jacksonville, Oregon Dear Sirs, I am reticent to comment for I do not hold a college degree in Biology nor pharmaceuticals. However as a backyard gardener and a natural food adherent, I am requesting that Oregon steer clear of allowing bio-engineered food production within our state. As I understand this issue, it is difficult to impossible to control crop cross-contamination even in a controlled environments. There is still not enough research to prove that GMO foods are safe, let alone pharmacologically modified plants, and they do not cause health issues within humans. Once introduced into Oregon soils, what will that do for the Certified Organic growers who are flocking to Oregon and supporting a rapidly growing market? To conclude I am respectively requesting that we as a State do not cross into this process, however we do cultivate the organic industry. Newport, Oregon Please permit me to enter the following comments into the public record regarding the Oregon State debate on the "BioPharm" Bill. I am extremely concerned about the potential human health impacts and environmental impacts of allowing UNTESTED BioPharm crops to be grown outdoors. These should all be grown indoors (greenhouses) and tested for safety BEFORE being grown outdoors. We already know that the GE bent grass grown outdoors in Oregon has been found over three miles from the original test site. We know that both GE long grain rice and Starlink corn have inadvertently found there way into the human food supply, although neither of them have ever been approved as human foods. Even more troubling is that BioPharm crops include drugs that haven't been tested and may not even be intended for use on humans. Many people have allergies to drugs and allowing these to escape into the environment where people have no control over exposure to pollen is not prudent in terms of protecting public health. These plants also have the potential to cause great harm to native plant communities as the spread of pollen and seeds by birds, wind, and water (all completely uncontrollable if grown outdoors) could have disastrous unforeseen impacts on native plants, beneficial insects, birds and other wildlife. Agriculture in Oregon is economically important to the state and outdoor growing of these plant drugs has the potential to contaminate food crops. Both Japan and Europe have stopped accepting US rice and corn because of this contamination, which results in lost markets to US and Oregon farmers. I am requesting that all GE crops be grow exclusively indoors until they are tested for safety to humans exposed to pollen, potential for contamination of food crops and adverse impacts on indigenous biological communites. Canby, Oregon People, Here is an area I do not see covered in the discussion, which is critical to growers throughout Oregon, the United States, and the world. There is an economic and property rights question which is critical to the survival of growers of all sizes in all locations. As shown in the Monsanto/Percy Schmeiser case in Canada (applicable to the US because of NAFTA and GATT), WHEN these GE crops escape onto adjacent lands and then spread beyond, it puts the growers on these lands at extreme economic risk. (The decision can be reviewed on line at http://scc.lexum.umontreal.ca/en/2004/2004scc34/2004scc34.html ) The court determined that the mere fact Monsanto's patented GE crops were growing on Percy's land was sufficient, in and of itself, to be an infringement of patent rights. The fact that Percy did not plant the crops, did not want to grow the crops (and in fact was unaware that he was), and was unable (even with Monsanto's help) to eradicate the crops from his land, was of no significance. Percy was found guilty of patent infringement, and subject to the fees and restrictions of the license used by Monsanto with its authorized growers. This decision was appealed all the way to the Supreme Court of Canada and upheld. Nor was Percy able to recover damages for the loss of his own canola seed line, the product of decades of development and a major source of income. Once contaminated with Monsanto's GE line, it was no longer his, nor were growers interested in buying it. In this particular instance, Monsanto's license calls for a "technology fee" for each hectare of land on which seed containing their GE gene is grown. This means that if Percy ever allows seed with Monsanto's patented gene (either from Monsanto or from a wild cross) to sprout on his land (and no one knows how to eliminate that) he must pay Monsanto's fees. As other growers who also did not plant Monsanto's seed, but had crops contaminated with it found out, Monsanto is actively approaching growers throughout Western Canada and demanding signed contracts and payment of technology fees based on the Schmeiser case. Incidentally, this fee is unregulated, and is not likely to be. This means Monsanto can charge whatever they wish, increasing the fee until growers can no longer afford it and are forced into bankruptcy. Additionally, please note that this infringement is not limited to commercial growers, but to anyone growing (intentionally or not) any seed containing patented genes. Nor is it limited to Monsanto, but applies to any holder of patented life. As a sideline I would like to point out that this would extend to any land anywhere, public or private, agricultural or not, How would you like Monsanto to knock on the door to your home and present you with a bill for technology fees for the plants growing from seed blown into your yard? This court decision upholds this scenario. It seems that, at the very least, any patent holder of GE materials should be held responsible for damage caused by the unintentional or illegal spread of their material, and prevented from demanding any compensation for the unintentional use by others of their patented material. THAT should be in these regulations.


August 26, 2006

Portland, Oregon I am a physician practicing in northeast Portland, with a BS in Biology. I'm really encouraged to see that Oregon is taking the initiative to control and regulate biopharm crops, and am pleased with a number of the recommendations. What I will comment on here is where I feel strongly that these recommendations fall short. First, you are recommending encouragement of the use of non-food crops for outdoor growing. This is totally unacceptable. None of these crops has been tested appropriately for it to be known whether this is a wise move or not. There have been virtually no clinical trials nor any safety testing in humans or even animals. In all matters of science of such potential gravity, the obvious requirement has always been to prove safety before exposing the public and our world to potentially irreversible damage. You have no idea what the consequences of such a move would be, and intuition and reason are completely insufficient to predict the potential damage that could be done. One thing is for sure; it is virtually assured that there will be some level of contamination, whether by pollen flow, equipment, animals or human error. What that contamination will cause is entirely unpredictable. I see that you are recommending applicants post a bond or demonstrate financial responsibility to cover potential damages resulting from such a contamination incident. Frankly, I find this to be insane. We have only to look at past "contaminations" to know that companies routinely resist taking responsibility for the messes they make, often throwing their considerable wealth into lawers to get out of meeting their agreed upon obligations. They are often successful, leaving the burden of clean-up to fall on the public. Worse, the impact is often such that it is virtually impossible to totally clean up the mess no matter how much money and effort is thrown at it. Just because these would be "non-food crops" doesn't mean they won't some how affect other crops, plants or animals that consume them even if humans do not. Why are we even considering such an approach? We are dealing with nature here. This is not some benign high school science project. Once genetic material is out it will be impossible to contain and could cause catastrophic damage to our environment the world over. Not all the money in the world nor the most dedicated clean-up crew can guarantee a successful outcome after a contamination occurs. The public should not be put in the position of being guinea pigs in a vast biological experiment! The burden of proof in terms of safety lies with these Biopharm companies, and MUST be established BEFORE any trials are done outdoors. Given past research fraud and cover-up, there must be well funded, reliable, independent research done as well. Independent research conducted in other countries has shown these types of crops to be extremely dangerous and unpredictable. Their findings have been so dire that many respectable countries have banned such crops entirely! Are we to ignore their findings, fail to do our own research and then allow ourselves to be the ones being tested upon? This is madness! Frankly,there's no guarantee even in greenhouse trials that no contamination will occur, but it WILL occur if trials are done outdoors. Next, was the glaring omission of any recommendations for the regulation of industrial crops. Why is that? This isn't acceptable. Industrial crops also must be proven to be safe prior to being allowed to be grown here (or are they already being grown here?). Biopharm crops clearly pose a greater threat to our national and world security than any terrorist attack ever could. The companies involved in these crops have massive financial incentives (and to be generous, dubious ethical standards) to push their agenda forward at the public's expense. The fact that our state is taking on a more stringent regulatory role that the national goverent is a great relief to us all, but your recommendations, while a good start, are not providing an adequate level of protection for public health, the environment or farmers and food processors. Not by a long shot. My assessment: Good first draft, but needs significant work! Thank you for all you are doing to safeguard us and hold biopharm companies to account. Please, don't give an inch where our wellfare is concerned. Tigard, Oregon Thank you for recording my concerns about biopharming in Oregon. There is no financial guarantee which can undo the harm of crop contamination. Biopharm is an accident waiting to happen and will cause irreparible harm to the state's agriculture. It simply should not be allowed. Thank you.


August 29, 2006

Baker City, Oregon I understand that you are asking for public comment on biopharming in Oregon. I would like to say that I oppose any genetically engineered organisms grown or used in the state of Oregon. Thank You


August 31, 2006

Location unknown As a former regulatory affairs professional for an international biotech firm that uses GMOs to produce GMO enzymes, I strongly support biopharmingin Oregon. A case-by-case approach is necessary at least at this stage toprotect Oregon's natural resources. Among all other measures, the firm musthave a satisfactory quality system to prevent contamination and to ensure traceability. They must be able to comply with pertaining federal, state,and local regulations. And they must be inspected. The safety evaluationof the products and the GMO animal/plants, however, is the responsibility ofthe firm and the federal agencies.


September 1, 2006

Portland, Oregon I for one do not want biopharm in Oregon. Why? Because the wind that blows can blow the genetically modified organiss to the next field and beyond. It will contaminate our organic food crops and cause more ills to allergic people or cause people that weren't allergic before to be allergic. I believe in prevention not doing something after the fact - then its hard to stop. No to biopharm!!!


September 6, 2006

Salem, Oregon This letter is in protest of biopharming. We don't need pharmaceuticals in our food. Most of the drugs now have side effects sometimes worse than problem. It just doesn't make sense. Is corporations making big money more important than peoples health?


September 7, 2006

Tempe, Arizona My organization, Water Balance, LLC, is in the business of irrigation consulting in Arizona. We view the vision of Arizona State University guest presenters to this process as worthy, at least at an arm's length. We are not PhD scientists, just well-educated "scientists" and "engineers." Our wish for the Oregon initiative is that they invest wisely. Better, they invest with sagacity. Our full comments will follow. Hints of the content follow: How is the law crafted to make special interests harmless? How are special interests neutralized? What would constitute a perfect, very conservatively estimated, record after 15 years of your policy? What would be examples of best intentions gone array when governmental regulations attempted to frame the objectives of that which has not yet been discovered? Why should producers have / not have 2 of five votes regarding what will / will not be the production protocol...purely in crop science terms?


September 12, 2006

Norman, Oklahoma 12 September 2006 Oregon Biopharming Ad-Hoc Committee Mr. Jim Rue, Chair Biopharm Comments Plant Division, Oregon Department of Agriculture 635 Capitol Street N.E. Salem, Oregon 97301-2532 Dear Mr. Rue and Committee members: I am a law professor who has taught and written about agricultural biotechnology law and policy since 1997. I have written approximately fifteen articles on various aspects of law and policy relating to agricultural biotechnology. I teach a three-hour academic credit course on this topic at the University of Oklahoma College of Law. I have read the Committee’s Draft Policy Statement and Recommendations. I offer the following comments about the draft. I praise the Committee for adopting an “endorsement, moderate scope” policy. The proven benefits of agricultural biotechnology and the significant present potential and future promise of agricultural biotechnology for pharmaceuticals deserves endorsement. By the “endorsement, moderate scope,” the Committee has allowed Oregon to be open to the developments and benefits of biopharming for the betterment of society and agriculture. While it is prudent to be aware of possible risks, it is important to create a policy for Oregon that focuses on the endorsement and that does not undermine this policy of endorsement. In this light I have three specific comments where I suggest that the policy may be improved. The draft contains a recommendation that the Directors of Agriculture and Public Health have the authority to modify, restrict, or veto a permit for field trials. The request for better collaboration between BRS and the State of Oregon to insure that Oregon has adequate opportunities to communicate and participate in the permit process is reasonable and insures that concerns of Oregon are carefully heard, discussed, and considered. However, to allow Oregon to impose modifications, restrictions, or to veto the permit creates an overly burdensome administrative system. The relevant federal agencies provide sufficient protection and should have the sole authority to make decisions. Oregon Biopharmaceutical Committee The draft contains a recommendation that applicants post a bond or demonstrate financial responsibility. The draft makes an excellent recommendation that federal agencies make an initial safety assessment. By making an initial safety assessment, federal agencies should be able to tier the risk into safety categories and set tolerances for adventitious presence. For low-risk pharmaceutical crops with tolerances, there should be minimal or no risks of safety. Consequently, for low-risk crops there should also be no need for a bond or financial responsibility. For higher-risk pharmaceutical crops, federal agencies should increase the conditions in order to minimize adventitious presence and to keep any adventitious presence below tolerance levels. In other words, the conditions of the permit should be such that there is no need for a bond or financial responsibility. The focus should be on compliance with conditions of the permit. The present system of legal liability for permit applicants, pharmaceutical companies, and growers is sufficient to handle and to compensate any potential damage. With a tiered-system for pharmaceutical crops, the claims of damage should be very small in number and small in amount. In light of the adequacy of the present system of legal liability, if Oregon were to impose a bond or demonstration of financial responsibility, Oregon would be imposing costs that are unnecessary and, therefore, excessively burdensome. I should make clear that when I use the word “damage” I mean physical harm to neighboring crops that makes those crops adulterated. The word “damage” does not, and should not, include “pure economic loss” such as market disruptions or market loss. American law recognizes “pure economic loss” in relatively few instances and has not recognized “pure economic loss” in any cases involving agricultural biotechnology. The draft contains a recommendation that the Directors of Agriculture and Public Health have the authority to implement a state permit review system, if necessary. Oregon should not create a parallel state permit review system. There are two reasons for opposing a state permit review system. First, although the precise legal relationship between federal laws and state laws on agricultural biotechnology is unclear, there is a strong argument that any duplicative state permit system is preempted by federal laws. Hence, to create an Oregon state permit review system is likely to involve Oregon in litigation about preemption of the state system by the federal system. Second, with adequate participation of Oregon in the BRS permit process (see point # 1), Oregon has expressed its concerns, discussed its concerns, and had its concerns considered. Hence, an Oregon state permit review system creates a duplicate regulatory system with attendant additional costs and delays. If Oregon were to create a duplicative state permit review system, the basic policy of the draft – “endorsement, moderate scope” – would be significantly undermined. I thank you for the opportunity to submit these comments. Canby, Oregon As a very concerned citizen of Oregon, I am commenting on the possibility that this state will become involved in growing plants spiced with pharmaceuticals. Already this state has a genetically engineered bentgrass taking over the natural grasses in our environment. We were all told this couldn't happen, but it has and now our grass seed farmers could lose their entire livelihood because of it. We were also told that the genetically engineered rice wouldn't cause a problem, but we see that it has also slipped out of trial areas and has been introduced into our wild natural rice. Are we going to let them tell us that these modified pharmaceuticals won't get out? Can you see this getting out into our food supply and having people die because they are allergic to certain drugs. We would all be eating food containing drugs that could possibly be lethal to certain people, especially our elderly and children. Why are we trying to eliminate man from this earth? For Money? How many people have died so far from eating contaminated food? No statistics are out there because the companies involved in this GMO catastrophe aren't willing to acknowledge there is a problem. Our global friends are smarter than we are, they won't accept these low standards of crop contamination. Why do we? Our family is very concerned and won't support the GMO industry as it stands now, even though our present food supply contains over 50% GMO ingredients. Without food labeling, eating food in our supermarkets now is like playing Russian Roulet with our lives. We support local farmers and eat non processed foods, grow our own food when we can and raise our own animals to make sure we stay healthy. We see our neighbors and friends always sick with allergies, heart problems, diabetes, and all over malaise eating these foods that have not been tested, just let out into our environment. I hope that Oregon realizes we must protect our farmers who grow our natural organic food. This is a large clean agricultural state and we hope it remains that way. Big money is not always the answer, clean healthy food is more important. The USDA is not going to help in regulating these new biopharming crops. They haven't been much help with the GMO products that have contaminated our food supply, killing our animals and making people sick. We don't even want to mention that we now have weed strains that are resistant to the "round-up" products that have been spliced with our foods. Monsanto has even sued organic farmers for growing GMO crops, that contaminated their crops from the wind, and our justice system lets that happen. I, as a citizen of this state and these United States hope that Oregon isn't swayed by the Money that will be thrown at them to take this biopharming into the state. Money is not worth the sacrifice this state's farmers and citizens will go through if these products get out into our environment. No one can assure us that we will be safe. Thank you Portland, Oregon I am totally opposed to biopharming or GMO farming in Oregon or anywhere. The USDA is inept at best at regulating this industry, and the state of Oregon will be at the mercy of the immoral, unethical and greedy practices of many of the corporations involved in this type of research and farming. It appears, unfortunately, to be a done deal, and I an others will probably be saying in the future - I told you so. Haven't you already learned from the recent bent grass fiasco, and perhaps you should take a look at other fiascoes and practices in the GMO industry which remain off the radar screen. It would be nice and the right thing to do for someone to come to their senses, and fully realize what you and the state of Oregon are facing.


September 13, 2006

St. Louis, Missouri This is a well balanced and reasonably considered approach which allows an important technology to move forward with appropriate safeguards for public health. I would like to thank the committee for the opportunity to participate, and commend them on the manner in which this was undertaken. The result is, undoubtedly, not entirely to the satisfaction of any specific stakeholder, and thus is likely to be subject to criticism from all sides. This is, however, most likely a sign that you have hit the target square on.


September 19, 2006

Portland, Oregon We have reviewed the draft policy document, and would like to make the following comment: The Board of Pharmacy has reviewed the conclusions of the Biopharmaceutical Ad Hoc Committee and requests that the conclusions be amended to include reference to this Board's statutory authority and obligations under ORS 689.155 to register and inspect any organization that is established in Oregon for the purpose of manufacturing pharmaceuticals. Manufacture is defined in ORS 689.005(20) to include preparation and propagation either directly or indirectly from substances of natural origin. We do not make this comment as a road block to progress, but to ensure that this Board's statutory requirements for registration are not overlooked in any future process. If there are any questions, we would be happy to discuss them with you. Santa Clara, California Dear Mr. Rue and other members of the Biopharming Ad Hoc Committee, I am an associate professor of Biology at Santa Clara University. My research is focused upon the potential environmental risks of genetically modified crops. I have published over a dozen reports on this subject in scientific journals and books, and have been invited to speak on this topic both nationally and internationally. My current research on the environmental risks of genetically modified crops is funded by the US Environmental Protection Agency (although my comments here reflect only my own opinions). I would like to congratulate your committee for producing one of the most reasoned and balanced sets of policy recommendations that I have seen on any aspect of genetically modified plants. I agree with your conclusion that a case-by case review of pharma plants is necessary -- the risks posed by pharmaceutical products will certainly vary depending on both the pharmaceutical compound and the plant used for its production. Many people become so star-struck by the scientific novelty and the potential economic gains promised by these plants that they choose to turn a blind eye to rationale concerns about the associated risks. In contrast, you have produced a document that acknowledges the very real possibility that pharma plants could harm humans and wildlife. Two of your policy recommendations stand out as especially important for the maintenance of public safety -- one is the recommendation that ODA negotiate the power to veto a permit for the growth of a pharma crop that it sees as unsafe and the second is the recommended requirement that applicants demonstrate financial responsibility should there be problems. These are important steps forward. I strongly disagree, however, with the notion that "... low level adventitious presence of biopharmaceutical products ... is not likely to pose significant impacts on humans or environmental health." This is a completely unsubstantiated statement, and the implication is that we should take a roll of the dice, with the health of children and the environment at stake. The fact is that most drug trials examine the effects of exposure to pharmaceutical products either over a short period in healthy subjects or over a longer period in subjects who require treatment. From animal studies, we know that low doses that have no effect on adults can have profound effects on the development of young individuals. Do you really want the children of Oregon to potentially consume a low dose of any unprescribed and unnecessary pharmaceutical during their most critical developmental stages? I do not intend to be alarmist here, but I also feel it is inappropriate to give the false assurance that the current language implies. Thus, I recommend that the unsubstantiated claim regarding "low level adventitious presence of biopharmaceutical products" be removed from this document. A more accurate statement would be, "Empirical studies documenting the safety or danger of exposures to low levels of pharmaceutical products for a complete cross section of the human population are lacking." In addition, each policy recommendation be reconsidered in light of the reality that long-term exposure of children and the environment to even very low doses of seemingly benign pharmaceutical products has not been established as safe. Given the uncertainty regarding the effects of low level exposure, drugs should not be produced out of doors where contamination of food supplies and the environment is highly likely. Lastly, it may be worthwhile to require a cost-benefit analysis as one component of the risk assessment for any pharmaceutical crop. This would require data substantiating the benefits to the public in terms of lower prices for pharmaceutical products or greater availability of pharmaceutical products. If pharma plants cannot be demonstrated to benefit society through cheaper and more widely available drug treatments, then even the smallest risk would not seem to be worth taking. Thank you very much for considering my comments


September 20, 2006

Location unknown Please do not allow biopharming in the State of Oregon, this will only endanger our eco system. As an organic farmer I find this to be a quest only to impove on something that is already perfect. To try and change what nature has perfected is only going to endanger the health of our children and generations to come. Portland, Oregon I write to urge the ODA to re-think their stance on permitting biopharm crops to be grown in Oregon. And I am particularly disturbed to hear that my tax dollars will be used to fund this "experiment" with our precious food supply. This is an outrage! It's also one of the worst investments imaginable - after over 300 tests, not ONE biopharm crop has led to an FDA approved drug. Who has the ODA relied on for their research and analysis? There are few, if any, independent or peer-reviewed studies on the dangers of biopharm and other genetically engineered crops. Industry "analysis" or that of federal agencies with many members or ex-employees from Monsanto, the leading corporate cheerleader for GMO crops, are hardly reputable or reliable sources. Too little is known about the dangers to our public health or our environment & what is known has been kept from public view. The growth of consumer demand for organic foods in our state has dramatically increased over the last few years. That is the trend of our future; not a faux food supply contaminated with Roundup, bacteria, viruses, anti-biotics, chemicals and pesticides. The ODA has an obligation to protect the safety of the food supply in this beautiful state; not experiment with our future and our health. All biopharming should be banned unless and until it has been proven safe to the satisfaction of independent scientists. Florence, Oregon As an Oregon taxpayer, I strongly object to the use of my tax money to invest in biopharmaceuticals. If this taxpayer money is being used to test these crops, this seems to me, to be a conflict of public and private interest. If I, as an individual, not a large multinational corporation, had a product to test to make a profit on, the state certainly wouldn't pay for my testing. Why then, are you spending my tax money to help these corporations to test their products to possibly make a profit? Do we have an excess of tax money in this state? Is that why college tuition has been doubled at some institutions, etc.? Investing our tax money in this gamble is unwise and I request that this ruling be reconsidered! I look forward to hearing from you on this matter. Florence, Oregon I am appalled that the ODA is not taking more measures to insure the safety of our environment. While I am an opponent of biopharm technology, if we must have it in the state of Oregon I would request that all crops be contained. There should be NO cost to the tax payer for anything concerning the production or containment of biopharm crops. The chemical companies that control this technology should be the ones to financially support these projects AND be 100% accountable for any mishaps, God forbid. There should be no genetically altered food crops/ for animal or humans. Countries around the world are saying NO to all kinds of GE crops. Let's not be a guinea pig for the chemical industry. Keep Oregon green and healthy. San Diego, California OREGON BIOPHARMING The following is in response to the Oregon Biopharmaceutical Committee Policy Statement and Recommendations. I am David Schubert. I have a PhD in immunology, but currently work on drug development for neurological diseases and stroke. I am a professor at the Salk Institute for Biological Studies in San Diego, where I have been on the faculty for 36 years. I have written extensively on the regulation and safety testing of genetically engineered (GE) food, including publications in the leading biotechnology journal, Nature Biotechnology. Together with William Freese, I co-authored the most thorough peer-reviewed document on GE food safety testing and regulation in the US. Since my daily academic science deals with both the same technology used in the construction of transgenic GE plants (it was initially developed in animals) and biomedical issues related to human disease, I feel that I am qualified to comment on the problems associated with the production of pharmaceuticals in food crop plants. The overall conclusion of the following is that it would be exceedingly unwise to allow the production of pharmaceuticals in food crops under any conditions. The primary reason for this conclusion is that the plant product or the genes producing the pharmaceutical are going to escape containment and get into the food supply. This fact poses not only a potentially serious health risk, but also the possibility of eliminating export markets for the products as has occurred recently with GE rice and corn. The secondary reasons are that despite the hype from biotech companies, there is going to be little or no economic benefit to the State from this technology due to its limited scope and technical difficulties in getting FDA approval for the drugs, and also because there are now elegant ways to produce the same drugs more economically in both animal cell culture and non-food plants, such as the aquatic plant Lemma, that are not grown outside of the greenhouse. All of the following statements are derived from either published material or public lectures. We have a large plant biology group at Salk, with frequent seminars and lectures on plant biotechnology, so I believe that I am somewhat up to date on the subject. First, I would like to commend the Committee for the time and effort that its members took to examine this very important issue. It would be great if California would do the same! While I agree with many of the statements and recommendations, there are a number if issues that should be reconsidered. These are detailed below. Background: The involvement of the State of Oregon in the federal regulatory process is a wise decision, for as widely publicized in the recent court decision against the EPA in Hawaii and documented by several NGOs, the federal government has repeatedly done a very poor job either monitoring or otherwise controlling biopharming. This is clearly because of the involvement of the big agricultural biotech companies in the government regulatory policies. My concern is that the industry would also exert inappropriate influence over the State regulatory functions, but if set up properly this need not be the case. It should also be pointed out that many if not most academic plant biologists are funded by the biotech industry and that the experimental tools they all require, such as the ‘gene gun’, are controlled by industry patents, so great care should be taken to get independent scientists on review panels. Proceedings: Paragraph one. The statement that " food crops are expected to be the safest and most economically efficient means of production…" is simply not true. To my knowledge not a single pharmaceutical produced in a food crop has ever been approved for drug use by the FDA, and it is very unlikely that any but the most trivial will be for many years, if ever. The simple reason for this is that the proteins made in plants are going to be different from those produced in animal cells, where essentially all of our vaccines, etc are currently made. These differences, which are due to the addition of unique plant sugars to the protein, may make the drug or vaccine extremely dangerous due to possible immunological reactions to the aberrant sugar-protein combination. Until this specific problem is solved by genetically engineering human sugar metabolism into plants, which is extremely difficult if not impossible, there are going to be major problems getting biopharmed drugs approved. For this reason, and the fact that very efficient methods exist for the production of protein pharmaceuticals in cultured animal cells, some big pharmaceutical companies such as Novartis have stopped their crop pharmaceutical production research. Therefore Oregon would be putting their population at risk with little chance of a down stream payoff. Paragraph two. With respect to the FDA safety assessment, there is no mandatory FDA safety assessment prior to field trials. My understanding of the FDA safety requirements for biopharmaceutical crop planting is that the FDA has no meaningful input (the FDA has put out a ‘Guidance for Industry’ document for biotech firms, but its recommended procedures are not required). Planting is overseen by the USDA without regard to the potential risks of the product because the USDA relies instead on confinement requirements, which are not reliable. The suggestion that the federal government change this policy is a great idea, but with the current administration this is unlikely to occur. Paragraph 3. All biopharmaceuticals that can be produced in food crops can be produced in nonfood crops. At a plant biotech meeting at Salk several of these alternatives were discussed, such as aquatic plants grown in greenhouses in the desert. The reason that food crops such as corn or rice are chosen is simply because the less innovative biotech companies find these crops the most convenient. The more innovative nonfood crop paradigms for biopharming from small startup companies should be supported. Last sentence of paragraph three. The statement that the USDA is doing its job with respect to biopharm permits and '"safeguards". This is not true, as very clearly demonstrated by the recent contamination of all US long grain rice by a GE strain that was field tested under USDA ‘supervision’ and never commercially grown. As a result all long grain rice imports to the European Union, Japan and other countries have either been blocked or are only being accepted if testing demonstrates the absence of the illegal GE variety. The result is that rice growers have lost income due to depressed rice prices. This example and the previous contamination of the corn supplies with unapproved GE varieties, as occurred with the Starlink and Bt10, are perfect examples of why it is impossible to contain a GE food crop once it is field grown. The reason that we are not aware of potential contamination from the hundreds of GE biopharm crops that have been field-tested is that we do not have the tools to test for contamination because the companies are not required to provide test kits or assays for biopharmed crops. This is something that Oregon should require! Paragraph four: I am pleased to see that the committee recognizes that it is impossible to contain biopharm crops, but I am at a loss about the statement that they are "not likely to pose significant impacts on human or environmental health" Because of the uncertainty about the nature of the plant product relative to the animal-produced protein there is absolutely no way to make this statement with certainty. It should be pointed out that a recent manuscript and a great deal of previous data clearly demonstrate that very small changes in sugar composition can lead to severe immunological responses and that the amount of (contaminated) material required to elicit these reactions is extremely small. While I fully support Oregon's commitment to biotechnology, the specific technology of biopharming in food crops is very high risk with low chances for reward. Alternative nonfood crop technology exists and should be supported, but the risk of eliminating the State competitiveness in the world food market by contamination such as recently occurred with long grain rice is significant. Conclusions: 1) Oregon should encourage the development of biopharming in non-food crops, but not allow open field-testing of any food crop producing a pharmaceutical or bioindustrial product. 2) I strongly agree that Oregon should develop a strong infrastructure to deal with all aspects of biotechnology, including such areas as nanotechnology and commercial stem cell research. The federal government has failed at this responsibility and will not do the job properly. 3) I also agree that the State should require much more information about any pharmed crop than is currently required by the FDA or USDA, which is clearly inadequate! I would also strongly suggest that the state require that the producer provide the State with a test kit (PCR primers and protocols) such that State authorities can assay for contamination independently of the producing company. 4) Nonfood crop production should indeed be encouraged, for there is no such thing as "safe" outdoor planting. 5) The recommendation that companies be required to post bonds to cover liability in the event that biopharm food crops contaminate food supplies is an implicit admission that such contamination will, indeed, occur. While such bonds might help reimburse conventional food growers for economic losses, they would do nothing to prevent exposure of the public to the potentially hazardous pharmaceutical substance. Bonds would also do nothing to prevent loss of faith in the wholesomeness of the US food supply that is generated by repeated contamination episodes. Therefore, bonds are no substitute for a moratorium on food crop biopharming. However, they should be required if food crop biopharming were to be allowed. It is my understanding that both the federal government and some states are being pushed by big biotech to block the implementation of similar laws. 6 and 7) The fee is another great idea, as is the requirement of open communication during the entire permitting process. At present, there is inadequate communication and insufficient transparency, in part due to the excessive claims of confidential business information being made by biotech companies as pointed out by the committee of the National Academy of Sciences in their 2002 report criticizing USDA regulation of experimental GM crops. I hope that this is of some use. If there are questions, please feel free to contact me.


September 21, 2006

Location unknown Thanks for proposing to further involve state with biopharming. Please allow work to be done in controlled facilities to minimize human and environmental contamination. Washington, DC Dear Oregon Biopharm Ad Hoc Committee: My name is Joseph Mendelson and I’m the Legal Director for the Center for Food Safety in Washington, D.C. The Center for Food Safety (CFS) is a non-profit membership organization dedicated to protecting human health and the environment from the proliferation of harmful food production technologies and by promoting organic and other forms of sustainable agriculture. CFS represents over 40,000 members including many members in the state of Oregon. I have been an attorney working in the field of agricultural and environment law for more than fifteen years. During that time I have predominately focused my legal work on the federal and state regulation and oversight of agricultural biotechnology. This work has been recognized in legal journals, other scholarly publications and throughout the national and international media I have brought numerous cases against the federal government challenging its failure to sufficiently regulate the testing and commercialization of genetically engineered crops. Most recently, I served as counsel in the case of Center for Food Safety, et al v. Veneman, ___ F.Supp.2d ____ ,2006 WL 2348109 (D.HI Aug. 10, 2006), in which a federal court determined that the United States Department of Agriculture actions in overseeing field trials of genetically engineered pharmaceutical producing plants (i.e. biopharm crops) violated Federal environmental laws and was wholly inadequate. My organization has already signed onto the response by Oregon Physicians for Social Responsibility, and I concur with those opinions expressed in that letter. Herein, I’d like to provide additional information that should prove helpful to the state’s deliberations. First, I appreciate Oregon’s leadership in addressing biopharmaceutical crop issues. There are significant questions involved with these crops and it’s to your credit that you are taking action before serious problems arise. It appears clear that you have determined a need for the state to supplement federal actions in order to protect human health, the environment and the agricultural interests of farmers and food processors. One question that may arise is whether the state can assume authority that exceeds the federal government in approving and regulating these crops. Although there are no guarantees that an action won’t be challenged, the short answer is yes. There have already been numerous examples and legal precedents demonstrating such state oversight of genetically engineered (GE) plants and animals. The most obvious examples are actions that states and localities have already taken that go beyond federal authority. For instance, Marin, Trinity and Mendocino counties in California have adopted laws banning the planting of any GE crops. The city of Arcata, CA has voted to do the same. In 2001, Maryland passed legislation banning the raising of any GE fish unless they were in ponds or lakes not connected to any other waterways. In 2003, California enacted a moratorium on growing GE fish in Pacific Ocean waters over which the state has jurisdiction. In 2005, Alaska passed a law requiring the consumer food labeling for all genetically engineered fish. All in all, at least nine states, including Oregon, have either passed legislation or developed state regulations to address the impacts associated with GE fish by limiting or banning their use. See Or. Admin. Rule 635-007-0595 (2004). Moreover, Oregon itself has already acted to set state-based conditions that restrict the field testing of some GE crops. The state has limited the locations where GE bentgrass may be field tested by establishing a Bentgrass Control Area in Jefferson County. See Or. Admin. Code 603-052-1240 (2006). Unfortunately, this restriction has not prevented GE versions of creeping bentgrass from escaping their test plot locations and establishing themselves in the Crooked River National Grassland. See Reichman, et al, Establishment of Transgenic Herbicide-Resistant Creeping Bentgrass (Agrostis stolinerfa L.) In Nonagronomic Habitats, MOLECULAR ECOLOGY (2006). To date, not one of the myriad of state-based laws or regulations addressing oversight of GE crops has been challenged in court or struck down. See CFS, A New View of U.S. Agriculture (2006) (providing a comprehensive list of state laws and regulation addressing agricultural biotechnology). Indeed, the Congressional Research Service (CRS), which provides legal advice to members of the U.S. Congress, was asked to assess the legality of state actions to regulate GE crops. In a 2004 response to the question of the constitutionality of a Vermont bill to place a state-wide moratorium on the planting of all GE crops, CRS replied that the proposed Vermont law would survive any potential constitutional challenge: “There is undoubtedly a growing trend among states to legislatively address GE agribusiness issues. States will likely be able to regulate in this area unless or until Congress addresses the issue in a way that would preempt state efforts.” Memorandum from Stephen R. Vina, Congressional Research Service to Hon. Bernard Sanders (Aug. 25, 2004). Although the opinion applied only to Vermont, legal precedents cited by the CRS would apply to any state. The main legal issue in question is federal preemption of state action. Such preemption can be either express or implied. In express preemption, congressional intent is explicitly stated in statute. In implied preemption, congressional intent is implicitly contained in the statute’s structure or purpose. At least two types of implied preemption have been recognized by courts: field preemption and conflict preemption. Under field preemption, the scheme of federal regulation is so pervasive that it isreasonable to infer that Congress left no room for states to supplement it. In conflict preemption, compliance with both federal and state regulations is a physical impossibility, or state law stands as an obstacle to the accomplishment and execution of the full purpose and objectives of Congress. Regarding express preemption, neither Congress nor any of the three federal agencies (EPA, FDA, and USDA) with primary responsibility for regulating genetic engineering in the United States have directly spoken as to whether states may regulate the liability issues surrounding the dispersal of genetically engineered seeds or traits. On implied preemption, Congress has not passed any comprehensive agricultural biotechnology laws. Federal agencies have only piecemeal addressed the issue through the authority of previously existing laws that deal with plant pests, food safety and pesticide use. As a result, there is no congressionally created scheme of federal regulation pervasive enough for a court to make a reasonable inference that the States were not intended to supplement the existing piecemeal regulation. Regarding damages, Oregon has every right to require a biopharm company to assume financial responsibility for economic harm caused by a contamination incident. State liability legislation seeks to provide a legal remedy for the pollution caused by a patented product and does not interfere with the patent itself. Protecting the resources of the state from such pollution is well within the traditional domain of state police powers. Federal patent law does not have the purpose of extending patent protection to the extent that it shields someone harmed by the patented product from seeking redress. Finally, some may question whether some of your recommendations could violate the “Commerce Clause” of the Constitution, which expressly delegates the authority to regulate interstate commerce from states to Congress. Your proposed restrictions of biopharm crops, in my opinion, could not be challenged successfully on these grounds. First, there is no differential treatment that benefits an in-state company at the expense of an out-of- state company. Any restrictions would apply equally to both. Furthermore, companies may still move freely across the state’s border, as long as proper safety precautions are followed. Finally, the Oregon regulations you are proposing are safety and environmental based-regulations and would not affect any commercial financial transactions that would occur regarding biopharm crops. Indeed, since no biopharm crops have ever been approved, there are no commercial sales. Second, as stated in the CRS analysis, “the (Supreme) Court routinely upholds regulation of threats to crops, livestock and public health.” As noted in Maine v. Taylor (1986), “As long as a state does not needlessly obstruct interstate trade or attempt to ‘place itself in a position of economic isolation,’ it retains broad authority to protect the health and safety of its citizens and the integrity of its natural resources.” There is no attempt by Oregon to totally ban the growing of biopharm crops, but to place restrictions so as to protect health, environmental and agricultural interests of the state. In sum, Oregon should have no fear on proceeding with significant state regulatory actions over and above what is currently provided by the federal government. Thank you for the opportunity to provide input. Beaverton, Oregon Dear Members of the Biopharm Committee: I am writing as a native Oregonian to express my concern that any biopharm experiments be conducted within extremely controlled circumstances. We humans have a duty to protect one another from unintended consequences of our explorations. We also have a duty to protect Oregon farmers from loss of livelihood through contamination of food crops and a duty to protect the natural, wild environment that we all share from all such contamination. If we can't put a moratorium on biopharm testing in Oregon, (the most protective course of action), I am extremely concerned that all biopharm testing be conducted inside tightly controlled indoor facilities. These non-food crops must not be allowed to mingle their genetic information with our food, economic and wild crops. History has shown that GE genes do indeed spread to the environment when field tests are conducted. Havoc has already been wreaked on natural systems. This is negligent and irresponsible on the part of the humans involved. Also, the biotech firms need to be held 100% financially and morally accountable for any and all damage that may occur. They will be much more cautious if they are held responsible for the potential damage that may ensue from their actions. Kindergarteners have to clean up their own messes. Biopharm companies should be at least as responsible. My last request is that NO state funds be wasted on these kinds of activities. I am not against science, but we have hungry children in Oregon, thousands who have no health care. There is no excuse for supporting an industry with such a failed track record. My sources state that none of over 300 trial biopharm crops has yielded a worthy drug. Let the biopharm companies venture their own capital, NOT our strained public resources. With respect and deep commitment to our collective wealth, Portland, Oregon Thank you for receiving "the peoples" comments. Mine are as follows: Please do not use public funds of any kind to experiment with biopharming. Please prohibit ANY outside biopharming until we know more about thispotentially damaging process. Please experiment with non-food crop. Concise, but think it captures what many of us in Oregon feel passion about ... we want to protect our future!


September 22, 2006

Location unknown Based on information I have read about the contamination of our food source in the USA through additives, chemicals, pesticides, food processing and altered genetics ( biopharming ), It seams the HEALTH of our children and the people of this nation have been sold out for corporate profits by the people we have trusted and placed, by vote, in office to protect us from this type of corruption. It saddens me to think we have these types of people in government positions. I oppose any and all type of genetically modified foods, and any type of poisons added to the food to prolong shelf life, especially when it's for corporate gains and not for the best of interest of the public. I strongly believe we are in need of a stronger class of people in government. Ban all biopharming and GM foods. Washington, DC Dear Chairman Rue: The Food Products Association greatly appreciates the opportunity provided by your committee to offer our comments and position with regards to the production of plant-made biopharmaceuticals in the state. Please find attached FPA’s Position Statement on Plant-Made Pharmaceuticals and Industrial Chemicals for your reference. The Food Products Association (FPA) is the largest trade association serving the food and beverage industry in the United States and worldwide. FPA’s laboratory centers, scientists and professional staff provide technical and regulatory assistance to member companies and represent the food industry on scientific and public policy issues involving food safety, food security, nutrition, consumer affairs and international trade. FPA acknowledges that agricultural biotechnology has achieved important improvements in crop production. At the same time, maintaining a safe, wholesome and unadulterated food supply remains the food industry’s top priority In view of the food industry’s commitment to the safety and quality of the food supply, FPA finds there is an unacceptable risk to the integrity of the food supply associated with use of food and feed crops as “factories” for the production of pharmaceuticals or industrial chemicals. At this time, the genetic modification of food and feed crops for this purpose poses too great a risk of contamination to the food supply. Consequently, it is FPA’s position that such plant-made pharmaceuticals (PMP) and industrial compounds that are not approved as human or animal food/feed ingredients, or are not safe or suitable in human food or animal feed, must be controlled through mandatory regulatory oversight to prevent contamination and adulteration of the food supply. FPA advocates a regulatory strategy that prevents the presence of non-food substances such as pharmaceutical agents and industrial chemicals in the food supply. The food industry’s concerns are fueled in part by its experience with adulteration of the food supply by StarlinkTM corn, which also was not approved for human food use. The FPA Position on PMPs as well as plant- made industrial compounds includes the following recommendations: • The U.S. Department of Agriculture (USDA), Food and Drug Administration (FDA) and, as appropriate, the Environmental Protection Agency (EPA) use existing statutory authorities to impose a stringent and mandatory regulatory framework to ensure protection of the U.S. food supply and U.S. food exports from any inadvertent or intentional (i.e sabotage) contamination by plant-made materials that have not been approved for human/animal food and feed use and that would render the food adulterated. • USDA, FDA and EPA impose a stringent regulatory system of mandatory controls for the containment and segregation during the entire process of propagation, cultivation, production, harvesting, distribution and disposal of all food and feed plants designed to produce pharmaceutical and industrial compounds not approved for food and feed use that ensures any adulteration of food and feed via these crops is prevented. • The use of major food crops for production of pharmaceutical active ingredients and industrial compounds that are not approved for human food or animal feed is not appropriate without protective mandatory regulations that are adequate to (1) prevent contamination of the food/feed supply and, (2) detect and mitigate any environmental escape, including but not limited to compulsory systems for inspection, monitoring, oversight, and biological/physical controls. FPA stands ready to assist your committee in anyway possible as you review the effectiveness and adequacy of current requirements for segregation and containment of plants designed for production of pharmaceutical agents and industrial chemicals and all such plant-made materials in the State. FPA will continue its efforts with the federal agencies to ensure the necessary regulations and policies are in place to eliminate the risk of contamination to the food/feed supply when products such as these are commercialized. Once again, FPA and its members, thank you in advance for your consideration of these comments. Please feel free to contact me for further information or should you have any questions. Portland, Oregon RESPONSE TO OREGON BIOPHARMACEUTICAL COMMITTEE POLICY STATEMENT & RECOMMENDATIONS OREGON PHYSICIANS FOR SOCIAL RESPONSIBILITY (PSR) Oregon PSR and the undersigned organizations wish to thank the state of Oregon for appointing the Biopharmaceutical Ad Hoc committee and for being responsive to public input. We also wish to thank the Committee members for all the time and effort they have put into the process. The new laws, rules, policies and procedures to be developed in Oregon may very well have ramifications throughout the country. If not a template, Oregon’s pathway may at least serve as a starting point for other states addressing this issue. This makes it all the more important that these recommendations are responsive to all sectors of the community. Oregon PSR has been working on this issue in depth for the past three years. There has been one guiding principle throughout this period: No one should ingest or be exposed to a drug without their full knowledge and consent. This principle remains intact and serves as the foundation for all the comments below. This response is divided into six sections: 1. Statements and directions we support 2. Inadvertent contamination (adventitious presence) 3. Economic issues 4. Environmental issues 5. Questions for elaboration/clarification 6. Recommendations Statements and directions we support We found several statements that indicate taking steps in a positive direction. We fully support these steps and urge further elaboration and clarification so they can be accomplished in an effective way: 1. The Committee calls for a much higher level of involvement for the state in having access to details of biopharm permit applications and to monitoring the permitting process, including the authority to “modify, restrict or veto” a permit for field trials in Oregon. This is absolutely necessary. First, we believe that the current national biopharm regulations are inadequate to protect public health, the environment and the economic interests of farmers, food processors and retailers. Second, the USDA and its sections that regulate biopharm crops, the Animal and Plant Health Inspection Service (APHIS) and Biotechnology Regulatory Services (BRS), have not even fulfilled the regulatory duties that are in place. These regulatory shortcomings have been extensively documented. The USDA’s own Inspector General’s report , released in December 2005, chronicled a history of failures to adequately regulate all genetically engineered crops, including biopharm, even to the point of not knowing where some of the test crops were located. Oregon PSR’s report on the 2005 Ventria biopharm rice trials in North Carolina, using information from the Union of Concerned Scientists’ FOIA request, revealed the wide discrepancy between what APHIS said they would do to monitor the test crops and what they actually did. And just last month, it was revealed that unapproved genetically engineered rice developed by Bayer CropScience had escaped, apparently from a test growing site to contaminate rice throughout the southeastern United States. This has already led to rice farmers suing Bayer for what could be millions of dollars in lost business to Europe. Also last month, a federal judge ruled that the USDA had violated two federal laws in granting permits for biopharm crops to be grown in Hawaii, acting in an “arbitrary and capricious” manner. It is quite obvious that if Oregon wants to adequately regulate biopharm crops, it will have to take on a more prominent role. 2. The Committee calls for companies wanting permits for growing biopharm crops to assume financial responsibility for its actions. First, it said to consider an application fee if the state needed to implement a permit review system. Second, it requires applicants to post a bond or demonstrate financial responsibility in case of a contamination incident if they plant outdoor food crops. The Department of Agriculture is already stretched thin on its finances. Requiring an application fee makes sense so that biopharm applications do not become a budget issue. Second, biopharm companies often tout their ability to prevent contamination incidents, defined as a biopharm crop inadvertently mixing with food intended for human food or animal feed. We applaud any requirement that ensures they “put their money where their mouth is.” This is a good start, but we strongly urge the state to require corporate financial responsibility for any biopharm planting, food or non-food, indoor or outdoor. The Prodigene contamination incident of 2002 is a good case in point. In Iowa and Nebraska, Prodigene’s biopharm corn contaminated soybeans and corn, leading the USDA to levy a $250,000 fine and levy $3.5 million in damages. However, since Prodigene couldn’t assume these expenses, the U.S. government had to pay the damages up front and accept delayed no-interest payments from Prodigene. This cost U.S. taxpayers over $260,000, mostly in lost interest charges. All too often, companies are allowed to internalize their profits but externalize risks. It makes sense to take every precaution to protect Oregon taxpayers from paying for someone else’s mistakes. 3. The Committee recognizes that public input and transparency is essential to the process of approving and monitoring these crops. It establishes “a public communications plan for biopharmaceuticals and related biotechnologies that is both general to the subject and specific for any applications received.” We applaud this. The potential consequences of biopharm crops, both positive and negative, directly involve the public. Citizens need to be provided the necessary information to participate in the review process, allowing them to contribute their values, knowledge, experience and preferences. This will allow government regulators to make a better-informed decision. Moreover, if biopharm crops are planted, citizens should be kept informed in a timely manner about any significant developments. Inadvertent contamination (adventitious presence) The most disturbing aspects of the Committee’s recommendations are the statements promoting a stance that the inadvertent contamination of drugs in food (adventitious presence) could represent an acceptable level of risk to human health. Indeed, the Committee goes further and even recommends that the FDA develop “safety categories, and thus of tolerances for adventitious presence.” The Committee heard from numerous experts and has stated that absolute containment of biopharm crops is “impossible to attain. This is a consequence of human error, theft, and movement of seeds and pollen via wind, water, or biological agents.” We would certainly agree - no system is 100% risk-free and fool-proof. There are, however, several ways of substantially reducing the likelihood of contamination. The Committee’s reaction to this lack of 100% certainty is very troubling from a public health perspective. Instead of raising the bar of prevention, it lowers the bar of safety. The net effect is to allow and justify contamination of our food by drugs. Another way of putting it is this. The Committee is asking the question, “How much harm is acceptable?” To us, it makes far more sense to ask the question, “How much harm is avoidable?” The answer is nearly all of it. The Committee advocates a case-by-case regulatory approach “because of the enormous diversity in safety and benefits from different biopharm products.” On the surface, this seems reasonable. However, we believe a case-by-case review, if utilized, should only occur after certain parameters have been set to maximize safety. This argument for an open-ended case-by-case approach rests on certain assumptions, which upon closer inspection do not hold up. Assumption #1: There are currently benefits of biopharm crops. If we’re reading the above statement correctly, the Committee is saying there are already benefits. There aren’t. After 15 years and over 300 outdoor plantings, there is not one biopharm drug that has been approved by the FDA. This doesn’t preclude the possibility of one being developed, but the technical problems have proven more difficult than first anticipated. Furthermore, even if a biopharm drug was to be developed, the history of pharmaceutical industry pricing makes it doubtful that such a drug's savings would be passed along to consumers or priced in a way to make it accessible to needy patients. We may very well be jeopardizing public and environmental health and economic livelihoods for a technology that will produce few or no results. Any future benefits are purely speculative. Assumption #2: Some drugs are safe for the population as a whole. The Committee says that “the low level adventitious presence of biopharmaceutical products that will occur in most cases from unintended dispersal is not likely to pose significant impacts on human or environmental health.” Let us be firm on this point: no drug is completely safe, even approved ones, and none, in any amount, should be knowingly allowed in the food supply. The FDA defines “safe” as the benefits of the drug outweighing the risks. It is equally emphatic, stating “No drug is absolutely safe; all drugs have side effects.” In another of its publications, the FDA reiterates its stance using aspirin as an example: “Every prescription and over-the-counter medicine has benefits and risks – even such a common and familiar medicine as aspirin. Aspirin use can result in serious side effects, such as stomach bleeding, bleeding in the brain, kidney failure, and some kinds of strokes. No medicine is completely safe.” Since different people are affected differently by drugs, it would be little consolation if you or a member of your family were harmed by a drug that had been predicted to be safe to the majority of people in the majority of cases. Assumption #3: We will always know when people ingest or are exposed to biopharm drugs. Unfortunately, this is not a realistic assumption. Since the specific locations of the field tests are secret, people could inadvertently get exposed to the plants through pollen or other means. With the extremely lax regulation of the USDA over the past 15 years, it would be stretching credulity to believe that contamination hasn’t occurred and not detected or reported. The USDA doesn’t require testing of the food supply or even surrounding fields of food-grade crops for contamination. Second, it’s unclear whether most companies have even developed tests to detect their biopharm genes. One drug company official, Chris Webster of Pfizer, has already said: “We’ve seen it on the vaccine side where modified live seeds have wandered off and have appeared in other products.” Assumption #4: The safety of an experimental biopharm crop can be determined before FDA clinical trials are even held. A panel of experts may be able to give a qualified opinion that one particular biopharm drug may be more or less hazardous than another if it escaped into the food supply. They may also be able to estimate that certain levels of a drug will be more harmful. But no one can assure the safety about biopharm crops with any degree of certainty - these are untested drugs that have never gone through the FDA’s drug review process. For conventional drug approval, pharmaceutical companies must do pre-clinical (animal) testing and then three phases of human studies typically involving thousands of people to determine safety and effectiveness. But there is no requirement for such testing prior to outdoor field trials of biopharm crops. Even with clinical trials, there are numerous examples of drugs approved by the FDA, such as Vioxx, that have later been found out to have serious side effects and have been taken off the market. Furthermore, many drug companies, some which are involved in agriculture, have suffered heavy fines for a variety of FDA violations over the last decade. This does not inspire confidence in their ability and willingness to minimize risks to, and improve notification of, the public. There are numerous complicating factors that add up to a high level of uncertainty: A gene that is harmless in one organism may turn out to have harmful effects when genetically engineered into another. This was clearly demonstrated when a harmless gene from a bean was genetically engineered into a pea, where it created an immunogenic response. The insertion of one gene into a plant of an entirely different species can also give rise to multiple proteins, many unintended. Moreover, the very act of gene insertion can have significant effects, such as silencing other genes that were active or activating different genes that were silent, which could create a whole host of unknown, unintended consequences. There are still many unknowns in the state of science in determining allergenicity. A joint FAO/WHO committee concluded that “Very limited information exists on the levels of exposure to a food that are minimally necessary to elicit allergenic sensitization in susceptible individuals.” A recent study led by Armin Spok of Austria and including Dr. Hugh Sampson of New York’s Mt. Sinai School of Medicine, went further. They showed that allergenic testing today doesn’t address changes to non-target genes that can occur resulting from one gene being inserted, nor allergic reactions that can result from inhalation, as opposed to ingestion. They make a compelling argument that “. . . current rules and procedures cannot predict or exclude the allergenicity of a given GMO with certainty.” The human genome is far more complex and unknown than originally thought, with many causes of disease and development potentially affected by non-coding, epigenetic (“junk”) DNA and RNA. Two landmark articles in Scientific American, drawing upon the expertise of a dozen leading scientists, concluded that “It will take years, perhaps decades, to construct a detailed theory that explains how DNA, RNA and the epigenetic machinery all fit into an interlocking, self-regulating system.” John Mattick, director of the Institute for Molecular Bioscience at the University of Queensland, asserted that “Indeed, what was damned as junk because it was not understood, may, in fact, turn out to be the very basis of human complexity.” This is the crux of the matter. We’re very supportive of experimental science. What we oppose is the decision to expose the public to these experiments before they’re properly understood. Without the benefit of clinical trials, there is no way that any group of people, no matter how well-intentioned, qualified or educated, could predict with a high level of certainty what could happen when a biopharm drug escapes into the food supply. This is recommending a process to quantify a risk that can’t adequately be quantified. The cart is before the horse. Assumption #5: The Committee believes that establishing tolerances for adventitious presence is a feasible measure necessary to allow scientific advancement of biopharm drugs: “The committee therefore urges the FDA in coordination with USDA to develop . . . designation of safety categories, and thus of tolerances for adventitious presence. Without such clarifications, the legal risks to industry might effectively preclude most forms of biopharm product development – including for products that will provide both high benefits and safety.” In fact, this would be a waste of time, money and resources. The Union of Concerned Scientists, which has led in-depth inquiries into contamination and biopharm crops, concluded this “would require scientifically trained professionals to conduct food safety evaluations and other personnel to enforce requirements once they are set. This expenditure of professional and other resources is not justified considering that none of the substances are intended for food use in the first place.” No one would suggest that special panels be set up to set tolerance levels for conventional drugs in food. The fact that these panels would be set up for experimental drugs, the vast majority of which will never be approved (if any are), is much work for little or no practical benefit. Assumption #6: The Committee’s advocacy of allowing levels of contamination will not affect the marketplace. Even if none of the above factors came into play, this alone is enough to reject the Committee’s stance. In addition to public health and environmental concerns, there are also major financial considerations. How many conventional farmers would stand for allowing drugs to contaminate their food crops? How many food processors would allow for drugs to contaminate their products? How many grocery stores would sell food contaminated by drugs? How many overseas customers would allow the importation of U.S. foods that have been contaminated by drugs? Both the Grocery Manufacturers of America and the National Food Processors Association have expressed formal policy statements opposing the allowance of any level of drugs in food. As the GMA put it, “Plant-made pharmaceuticals aren’t meant to make it to the dinner table.” Former Kraft Foods CEO Betsy Holden cited biopharm contamination as a threat to her company and to the entire food industry. Not only would people refuse to buy products contaminated by biopharm crops, but the food companies would be subject to lawsuits if it was discovered they had sold them. We would expect that the Committee would not advocate the FDA allowing contamination and setting tolerances for conventionally-produced unapproved, experimental drugs on a case-by-case basis. Then why it is recommending that biopharm drugs be placed in a special category that allows them to do just that? Economic issues: We strongly disagree with the Committee’s urging of the state to financially support biopharm efforts in Oregon: “. . . biopharmaceutical production and the related area of bioindustrial/bioenergy production with genetically engineered bioindustrial crops, should be considered as possible areas of investment.” Also: “While it is important to provide safeguards in any technology development, it is also important that laws and rules are not so restrictive that they discourage companies from investing in Oregon . . . The advancement of new technology also requires investment in research and development activities, which is fostered by the environment of a state that welcomes these activities, in addition to providing public funds to support such work.” (underscore ours) First, it’s important to point out that restrictions on biopharm crops have had no effect on other, unrelated biotech research and development in other states. Both California and Missouri have had major public outcries against the outdoor growing of biopharm rice in the past two years, effectively halting field testing in both states. There is no evidence whatsoever that other types of biotech companies have been deterred from investing in other fields of research and manufacturing in these states because of the precautionary approach taken toward biopharm rice. Biopharming is a miniscule subset of the biotech universe and it typically has little or nothing to do with other technological research and production. Everyone would like less expensive, more effective drugs, and we agree that Oregon should provide an open atmosphere for scientific inquiry. But these drugs should only be developed in a way that provides the maximum level of protection for public health, the environment and the financial interests of farmers, food processors and retailers. Biopharm science and safety do not need to be mutually exclusive. Oregon can certainly have both. However, it is one thing for Oregon to be open to corporations who wish to safely test biopharm drug production, but quite another to recommend that Oregon taxpayers’ money be used without their direct consent to subsidize this testing. This is an investment that carries a tiny chance of success. As mentioned above, there have been over 300 biopharm test permits approved over the past 15 years, and not one drug from these tests has ever been approved by the FDA.* Indeed, most have never even made it to clinical trials. Again, this doesn’t mean that no new drugs will ever be developed from biopharming. However, it’s obvious that the vast majority of biopharm ventures will never result in an approved drug, making public investment in this field a highly risky, unwise use of funds that are badly needed for far more urgent uses. Please note: An Iowa state economic development fund gave the Prodigene Corporation $6 million in subsidies for biopharm production, which has gone nowhere. In fact, Prodigene was nearly sued by the Iowa Attorney General’s office for defrauding farmers. CropTech was a private Virginia corporation developing biopharm tobacco crops. In its 10-year existence, it received over $12 million in state and federal subsidies. When it couldn’t stay afloat in Virginia, it sought financing from North and South Carolina, but filed for bankruptcy before it could accept South Carolina’s incentive package. Ventria Bioscience was offered a $30 million subsidy package from federal, state and local sources to set up operations at NW Missouri State University. When the federal and local portions of the subsidy fell through, it asked the state to increase its share from $10 million to $23 million. Missouri state legislators refused to go along with the deal, which eventually collapsed altogether. Most of the larger biotech/drug companies have dropped out of biopharm testing because prospects did not appear profitable. Monsanto’s subsidiary, Integrated Protein Technologies, ceased activities in 2003. Neither Bayer CropScience nor Syngenta has ever conducted field trials. The field is mostly left to small start-up companies utilizing venture capital, which sometimes contract with a larger company. These often have tenuous financial situations. Large Scale Biology conducted the first outdoor field test in 1991. By 2004, it had an operating loss of over $17 million and went bankrupt in 2005. Epicyte Pharmaceutical, a biopharm corn leader, ceased operations in 2004 and sold its assets to Biolex. Just like the dot-com companies of the computer world, biopharm companies are an incredibly risky investment. Unlike the dot-com companies, there has never been a successful product marketed. Not one state subsidizing development of biopharm crops has seen any return on investment from a successful drug. The Committee said that it “recognizes the importance of on-going technological development and advancement which will allow Oregon agriculture, including both production and processing, to continue to be competitive in a global economy.” The entire foundation of marketing Oregon agricultural products, both foreign and domestic, rests on consumer perception of quality, purity and safety. Customers in Asia and Europe have made it quite clear that they want non-genetically engineered foods. It is hard to imagine a more devastating blow to Oregon agriculture and trade than a contamination incident from a biopharm crop. Environmental issues The Committee’s recommendations are largely silent on the potentially harmful and largely unknown effects of biopharm crops on wildlife, plants, soil and water. This may be partly a result of the absence of any representatives from the Oregon Department of Environmental Quality on the Committee or any other representatives from environmental organizations. Nor was there much discussion during the meetings on possible environmental effects. There was one meeting when Drs. Paul Jepson and Carol Mallory-Smith made informative presentations and drove home the main point that it is nearly impossible to completely contain gene flow. Even here, however, the emphasis was on the nature of gene flow itself and impacts on agriculture and commercial activity. There was little discussion in this or any other meeting on purely environmental effects.* The USDA approved a chicken vaccine from tobacco, developed by Dow. However, it was produced using tobacco cells developed in a contained manufacturing plant, not from a whole tobacco plant. The vaccine has not been commercialized. This is a serious consideration. With the outdoor growing of biopharm crops, there is no protection for the environment. Mammals, birds and insects may feed on biopharm crops, which could wreak havoc with their systems. One example of a biopharm crop that has already been field tested is aprotinin, which shortens the life of honeybees. Another example is avidin grown in corn, which kills or impairs numerous species of insects. Finally, “leakage” from biopharm roots may impact microorganisms in the soil and water, further affecting the entire food chain. In the period of 1999-2001, USDA’s APHIS division didn’t conduct any environmental assessments (EA’s) for the 131 biopharm permits granted in that time. The situation hasn’t improved since then. As noted above, the USDA’s own Inspector General released a sharply critical report of APHIS performance in regulating GE crops, including biopharm crops. And in the Hawaii biopharm lawsuit, the federal judge ruled that the USDA had acted in “utter disregard” of the Endangered Species Act by allowing the cultivation of biopharm crops in numerous locations in Hawaii. The judge found that the USDA had failed to conduct even preliminary environmental assessments prior to allowing the growing of the biopharm crops. It is abundantly clear that the USDA/APHIS is not fulfilling its responsibilities to protect the environment. Oregon must step up to fill this void. Questions for elaboration/clarification Some of these recommendations will require a bill to pass in the 2007 legislature. Which ones require a bill and which could be written into rules without a bill? Is the memorandum of understanding part of a bill? If not, when would it be written? Also, what happens if the USDA doesn’t agree with what Oregon wants to do? The recommendations cite “locked greenhouses; use of highly sterile host varieties; large isolation distances from interfertile species; growth out of phenological synchrony with interfertile relatives; use of separate farm equipment; and strict monitoring and reporting” as examples of safeguards reflected in current requirements for a permit for field trials from APHIS. None of these are requirements, except for isolation distances required for corn. For other crops, it is only 50 feet. Regarding planting and harvesting equipment, it is only required that they be dedicated to the field trial for the duration of the test. Before and after that, it can be used in conventional crop fields. It is widely recognized that internal compartments of farm equipment such as combines can’t be effectively cleaned. It is difficult to understand the statement in the Proceedings that says “In some cases, food crops are expected to be the safest (underscore ours) and most economically efficient means of production . . .” By virtually everyone’s account, food crops are the most dangerous means of production because of their higher likelihood of contamination. Moreover, the Committee has emphasized its preference for the use of non-food crops throughout the document. Oregon is authorizing the Directors of Agriculture and Public Health to modify, restrict or veto a permit application. Does this require both people to veto an application, for instance, or does it require just one? What if the two disagree – does one have the final say? There is a strong preference for greenhouse production if food crops are used for biopharming. Many greenhouses are open to free flow of air, insects, etc. What minimum security level of greenhouse would be required? Which branch(es) of the state government would be in charge of the public communication plan? Recommendations for changes to the current document 1. Require that all biopharm plantings be in contained, controlled facilities such as greenhouses that do not allow exposure to outside air flow and insects. Then review each permit application on a case-by-case basis to make the best judgment call on whether a biopharm planting should be allowed to proceed. Moreover, use only non-food crops for any biopharm testing. This is a win-win answer to the biopharm question that accomplishes these goals: Allows scientists to proceed on testing of biopharm crops Provides the maximum liability protection for companies doing biopharm research Substantially reduces any possible harmful exposure to the public from drugs Virtually eliminates any possible harmful environmental effects Provides the maximum protection for Oregon’s agricultural economy, including farmers, food processors and retailers If ever there was a classic example of “An ounce of prevention is worth a pound of cure,” this is it. It should be noted that one of the most well-known chief proponents of biopharm crops, Dr. Charles Arntzen, has changed to only using a non-food plant, tobacco, grown only in greenhouses and that he expects this to be the trend in the future. 2. Require that companies wishing to plant any biopharm crops (not just outdoor food crops) assume all financial responsibility to cover potential damages in case of a contamination incident. 3. Expand the scope of this to genetically engineered industrial crops. The FDA and USDA consider these adulterants and place them in the same category as biopharm crops. The dangers to human health, the environment and the economic interests of food companies and workers are the same. 4. Require that the precise location of any proposed biopharm planting be disclosed to designated state officials. 5. Do not recommend that the FDA establish tolerances for adventitious presence of biopharm drugs in the food supply. 6. Do not recommend that the state use taxpayer funds to subsidize or financially support in any way the development of biopharm crops. 7. Include at least one representative of the Oregon Department of Environmental Quality and at least one designee from a leading environmental organization on any committee writing rules for the proposed changes. END NOTES US Dept. of Agriculture, Office of Inspector General, “Audit Report: Animal and Plant Health Inspection Service Controls Over Issuance of Genetically Engineered Organism Release Permits,” USDA, December 2005. Rick North, Oregon Physicians for Social Responsibility, “Analysis of APHIS’s Regulation of Biopharm/Industrial Crops,” May 12, 2006. “US rice farmers sue Bayer CropScience over GM rice,” Reuters, Aug. 28, 2006. Jan TenBruggencate, , “Ruling a slight setback for ‘biopharm’ growers,” Honolulu Advertiser , Aug. 15, 2006. Justin Gillis, Washington Post, “U.S. Will Subsidize Cleanup of Altered Corn,” March 26, 2003. USDA, www.aphis.usda.gov/brs “The FDA’s Drug Review Process: Ensuring Drugs are Safe and Effective,” FDA Consumer Magazine, July – August 2002. “Aspirin for Reducing Your Risk of Heart Attack and Stroke: KNOW THE FACTS,” FDA Center For Drug Evaluation and Research, www.fda.gov/cder/consumerinfo/dailyaspirin_brochure.htm, accessed 9/3/06). Chris Pfizer, Biologics Meeting II, 2000, p. 77. M. Mitka, “Report criticizes lack of FDA Oversight,” JAMA, 296(8): 920-1, 2006. Vanessa Prescott et al, “Transgenic Expression of Bean Alpha-Amylase Inhibitor in Peas Results in Altered Structure and Immunogenicity,” Journal of Agricultural and Food Chemistry, 53:9023-9030, 2005. Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology, “Report: Evaluation of Allergenicity of Genetically Modified Foods,” Jan. 22-25, 2001. A. Spok et al, “Suggestions for the Assessment of the Allergenic Potential of Genetically Modified Organisms,” International Archives of Allergy and Immunology, 137:167-180, April 11, 2005. W. Wayt Gibbs, “The Unseen Genome: Gems among the Junk,” Scientific American, Nov. – Dec., 2003. Margaret Mellon and Jane Rissler, “A Growing Concern,” Union of Concerned Scientists, December 2004, p. 11. “GMA says stringent FDA and USDA Bio-pharm regs needed to maintain food supply purity,” Grocery Manufacturers of America press release, Feb. 6, 2003. Sandra Guy, “Kraft executive wants tougher rules on planting crops for drugs,” Chicago Sun-Times, April 4, 2003. C. Kauffman, “Investments drain state money,” Des Moines Register, April 4, 2003. D. Ranii, “Biotech company files for bankruptcy: CropTech files for bankruptcy,” Raleigh News and Observer, April 25, 2003. “Ventria cancels move to Northwest Missouri,” Columbia Tribune, Dec. 31, 2005. Bill Freese and Richard Caplan, “Plant-Made Pharmaceuticals: Financial Risk Profile,” Friends of the Earth and U.S. Public Interest Research Group, December 2005, p. 3. E. Burgess et al, “Effects of two proteinase inhibitors on the digestive enzymes and survival of honey bees,” Journal of Insect Physiology, 1996, 42:823-828. National Academy of Sciences, “Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation,” National Academy Press, 2002. D. Saxena et al, “Bt toxin is released in root exudates from 12 transgenic corn hybrids representing three transformation events,” Soil Biology & Biochemistry, 34:1, January 2002. Bill Freese, “Manufacturing Drugs and Chemicals in Crops,” Friends of the Earth, July 2002 Center For Food Safety et al v. Mike Johanns, Secretary, USDA et al, Case 1:03-cv-00621-JMS-BMK, U. S. District Court, Hawaii, Document 247, filed Aug. 10, 2006. Dept. of Agriculture – Animal and Plant Health Inspection Service, “Field Testing of Plants Engineered To Produce Pharmaceutical and Industrial Compounds,” Federal Register, 7 CFR Part 340, 68:46, March 10, 2003, p. 11338. ORGANIZATIONS SIGNING ON TO THIS LETTER NATIONAL: CENTER FOR FOOD SAFETY CONSUMERS UNION (PUBLISHER OF CONSUMER REPORTS) CORNUCOPIA INSTITUTE FRIENDS OF THE EARTH ORGANIC CONSUMERS ASSOCIATION THE CAMPAIGN TO LABEL GENETICALLY ENGINEERED FOOD UNION OF CONCERNED SCIENTISTS STATE: NEW SEASONS MARKET NW RESISTANCE AGAINST GENETIC ENGINEERING OREGON ASSOCIATION OF NATUROPATHIC PHYSICIANS OREGON NURSES ASSOCIATION OREGON SIERRA CLUB OREGON TILTH Location unknown Hello - I'm commenting on the document published via your website informing the public of the policies so far and the results of the BioPharm Ad Hoc Committee's meetings. I am deeply concerned that this matter of a "case to case " basis is based primarily on how much revenue the particular applicant will produce for the state - having this figure outweigh the most obvious dangers of this type of experimentation. As stated in your own document - there is no way to contain the spread of pollen. Another concerning aspect is that the application would be considered only for companies who could afford a "decent clean-up" should the experiment produce negative public results - where are the preventative measures? Another concerning aspect was the committee's commitment to protecting the identity of companies actively genetically modifying crops here in our state. GMO technology has proven nothing beyond devastating and destructive to both native plant life and to those who ingest the product. I urge the committee to reconsider allowing such an irreversible step to our Ecology. It is expensive enough to feed my family organic produce and NON GMO products but how will I know if those expensive products are now infected with GMO pollens and hybrids by the mere wind? Please be responsible to the Land and the People of Oregon and disallow such "Pharming" techniques. The medical field has better ways to cure disease - by removing contaminants from our environment. Salem, Oregon Oregon Department of Agriculture Biopharm Comments c/o ODA Plant Division 635 Capitol Street NE Salem, OR 97301-2532 To: Oregon Department of Agriculture, Oregon Department of Human Services and Members of the Biopharming Ad Hoc Committee The Biotechnology Industry Organization (BIO) and Oregonians for Food & Shelter (OFS) appreciate the opportunity to comment on the draft policy document prepared by the Oregon Biopharming Ad Hoc Committee. BIO is the national trade association for the biotechnology industry, representing more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products, with over 300 biotechnology-derived drugs in clinical development addressing cancer, heart disease, Parkinson’s, Alzheimer’s and other intractable diseases. OFS is a member-funded, state grass roots coalition representing more than 11,000 natural resource based individuals, businesses and trade organizations in Oregon, including BIO. OFS’s mission is “to promote the efficient production of quality food and fiber, while protecting human health, personal property and the environment, through the integrated, responsible use of pest management products, soil nutrients and biotechnology.” This is OFS’s 26th year of service to Oregon’s natural resource base and the businesses and communities it supports. New advances in biotechnology make it possible to turn plants into "factories" that produce therapeutic proteins for use in the manufacture of drugs, medicines and therapies. Plant-made pharmaceuticals (PMPs) are the result of an innovative application of biotechnology to plants to enable them to produce therapeutic proteins that could ultimately be used by the medical community to combat life-threatening illnesses. BIO and OFS and its members are committed to protecting human health and the environment by ensuring the safety of PMPs during all stages of development and production through a close working relationship with state and federal regulatory authorities to assure that applicable requirements are both rigorous and enforceable. BIO and OFS applaud the commitment the State of Oregon has shown to new technologies and research through initiatives such as the Oregon Nanoscience and Microtechnologies Institute. That commitment is also evident in the thoughtful approach the Committee has taken to the issues involved with the cultivation of PMPs. It is BIO’s and OFS’s position, however, that the Committee’s recommendations as a whole are premature at this point. The U.S. Department of Agriculture (USDA) established its Biotechnology Regulatory Services (BRS) division in 2002 to place increased emphasis on USDA’s regulatory responsibilities for biotechnology. Prior to that time, plant products of biotechnology were regulated under the general authority of USDA’s Animal and Plant Health Inspection Service (APHIS). APHIS has a long history of regulating agricultural biotechnology products, overseeing the safe conduct of more than 10,000 field tests of plants produced through biotechnology. Since 2002, BRS has been consistently reviewing and strengthening the requirements for PMP field trial permits, as well as the rigor of the division’s oversight of permit compliance. These modifications to the PMP permitting requirements are based on the experience that BRS personnel have developed over years of dealing with these types of field trials. It is anticipated that PMP permit requirements will continue to be strengthened over the next several planting seasons. Doing so at the federal level promotes needed uniformity and a level regulatory playing field across the entire U.S. This puts no state in a position of advantage or disadvantage. Additionally, BRS announced in 2004 that it was undertaking substantial revisions to its regulations for all plants developed through biotechnology, including PMPs. These regulations will reflect new authority that USDA was granted under the Plant Protection Act of 2000 and, according to public statements made by BRS, will fundamentally alter certain aspects of the current permitting system, including that used for PMP permits. The promulgation of these new regulations is being accompanied by the preparation of a Programmatic Environmental Impact Statement (PEIS), which will examine the potential environmental impacts of this rule-making. The PEIS process includes the opportunity for public comment. Additionally, the rulemaking itself will be subject to public notice and comment. We understand that BRS currently anticipates publication of the draft PEIS by winter of 2006 – prior to the 2007 growing season. In the interests of regulatory economy, the State of Oregon would be best served by directing its resources towards participating in the ongoing federal policy revisions and rulemaking processes, rather than moving ahead prematurely with a policy that would unnecessarily stifle new and valuable technology. Until the State has a better understanding of the types of permit requirements that will be implemented at the federal level, as well as any unique issues that might require review at the state level, adopting policies at the state level may well prove an unnecessary expenditure of time, effort and limited financial resources. Moreover, a number of the specific recommendations do not appear to be designed to address Oregon-specific issues, but are much more broadly based. It would be more appropriate to submit these approaches to BRS for nationwide consideration rather than to seek to impose them at the state level. If, based on its years of experience with these field trials, BRS does not determine that certain specific measures need be taken to protect agriculture and the environment nationwide, there may be little basis to require such measures in a particular state. Additionally, several of the proposed recommendations are likely to disproportionately stifle research and development efforts by small companies and academics. Requiring a researcher to post a bond or demonstrate financial responsibility for potential inadvertent release would create an insurmountable burden, essentially preventing those researchers from operating in the State. It would be particularly onerous and detrimental to future research programs at State universities, as their research budgets have been slashed and are already overtaxed. This requirement is neither science- nor risk-based, and is not based on any evidence of harm to human health or the environment caused by any PMP planting. As the Committee recognized, any adventitious presence from PMP field trials is likely to pose no significant impacts on human or environmental health. The State of Oregon does not require the posting of bonds or other demonstration of financial responsibility for other agricultural activities. Even a suggestion that a financial requirement would be necessary would erroneously portray PMPs as needlessly dangerous to agriculture and human health. Another proposed recommendation would work a similar hardship on small companies and academic researchers. As the Committee has recognized, the creation of an extensive permit review system for PMP field trials would require significant State expenditures, and would likely become a resource burden for the State. However, due to the small size of this industry, and the high percentage of small companies and academic researchers in the field, application fees high enough to pay for services would inevitably be more expensive than most researchers could bear. Given the extensive regulatory oversight administered by BRS, the cost involved with extensive State oversight would be an unnecessary expense, whether paid for by researchers or the State. Another proposed recommendation suggests that the State enter into an agreement or Memorandum of Understanding (MOU) with BRS regarding certain information and authority sharing. While all interested stakeholders agree that increased collaboration among the state and federal governments should be encouraged, several provisions of the proposed MOU will require careful legal scrutiny. With regard to the sharing of confidential business information (CBI), such cooperation will depend on the State Department of Agriculture’s ability to adequately protect the information. This will, in turn, depend on State law, which would be beyond the scope of any MOU. Similarly, the proposed MOU provision that would authorize the State to modify, restrict or veto a permit would appear to conflict with the scope of BRS’s authority as set forth in the federal Plant Protection Act of 2000. Changes made by ODA to their CBI statues in 1999 when promulgating the Pesticide Use Reporting System insured confidentiality of that information. Perhaps this is a template ODA can use to expand CBI protection to include confidential PMP information. BIO and OFS support the careful and balanced approach the Committee has taken with regard to this issue. We highly support the State’s efforts to encourage new technologies, to strengthen its communications with the public regarding the role new technologies play in Oregon, and to increase the State’s interaction with federal authorities regarding PMPs. However, in order to make the most effective use of both State and federal resources, BIO and OFS suggest that the State take no further action on regulatory components of this policy until the completion of the current federal rulemaking. During the course of that rulemaking, the State will have the opportunity to more fully explore all its recommendations, and to receive feedback from not only BRS, but from a multitude of other interested states and other stakeholders. Once that process is complete, the State will be in a position to better understand whether any additional action may be necessary. With no existing PMP problems in Oregon and no PMP planting permits even requested for the near future, the State can afford to take some extra time to deal with this issue using a scientifically based, uniform and federally coordinated approach that protects the public, the environment, Oregon’s research community, the economy and the societal benefits this technology will likely bring. Again, BIO and OFS appreciate the opportunity to present their views on this important issue, and offers any help and technical expertise our organizations can provide in the future. Washington, DC Dear Chairperson Rue: On behalf of the Grocery Manufacturers Association (GMA), I am responding to your request for public comment on the draft policy document for Oregon that includes specific recommendations for the production of biopharmaceuticals in the state. GMA is the world’s largest association of food, beverage and consumer product companies. Led by a board of 46 Chief Executive Officers, GMA applies legal, scientific and political expertise from its more than 140 member companies to vital public policy issues affecting its membership. The association also leads efforts to increase productivity, efficiency and growth in the food, beverage and consumer products industry. With U.S. sales of more than $500 billion, GMA members employ more than 2.5 million workers in all 50 states. Over the past several years, GMA has provided comments and its position on biopharming-related issues to the United States Department of Agriculture and the United States Food and Drug Administration. Please find attached a copy of GMA’s official position paper on plant-made pharmaceuticals and plant-made industrial products for your reference. In particular, we want to emphasize that GMA firmly believes that PMPs and PMIPs should not be produced in food or feed crops due to legitimate concerns about their negative impacts on food safety, on domestic and international markets for food crops, on the integrity of the wider food supply, and on otherwise avoidable regulatory enforcement actions. GMA respectfully requests that its position paper be considered part of our comments on the draft policy paper. If, however, food or feed crops are used to produce biopharmaceuticals, then there must be additional regulatory controls so that biopharming is done in a responsible and controlled manner. We believe the thinking and recommendations in the draft policy document are directionally consistent with this approach, and below we respond specifically to several of the conclusions reached by the committee. 1. An Early Food Safety Evaluation (EFSE) should be required in regulation of the application of biopharming of food crops. The draft policy document states, "The committee concluded that applications in food crops should be reserved for products that have been through at least an initial federal safety assessment, as is currently now recommended by Food and Drug Administration, prior to large scaled field trials and commercial use." This statement is correct, in that the FDA does not require an EFSE, but only recommends this evaluation, and the current FDA EFSE is limited to biotech modifications that are intended to be in the food supply. We are concerned that your language, “should be reserved,” falls short of a requirement to have an early food safety evaluation. However, the sentences that follow seem to suggest a requirement: "The committee therefore urges the FDA in coordination with USDA to develop clear criteria, based on data provided in consultations, for designation of safety categories, and thus of tolerances for adventitious presence. Without such clarifications, the legal risks to industry might effectively preclude most forms of biopharm product development—including for products that will provide both high benefits and safety." Also the following statement found in the Conclusions section regarding formalizing collaboration between BRS and Oregon, suggests the committee is really proposing a requirement: “As part of a state-federal cooperative, information pertaining to the location, crop used, anticipated planting date, intended Plant Made Pharmaceutical, and FDA’s preliminary opinion on product safety for biopharm food crops (as recommended above) be disclosed to designated State officials before a trial permit is granted." There are two important reasons why an EFSE is necessary. First, the results will inform the permitting process that effective and appropriate control and containment measures can be added to the additional permit requirements. Second, the results will inform the food chain of the actions FDA would take if the biopharma crop were to enter the food or feed supply. We believe it is crucial that this committee reach consensus and clearly recommend to the Governor that an EFSE is a requirement to permitting biopharming. However, an EFSE should not be considered in and of itself an acceptance of PMPs and PMIPs into the food chain. 2. GMA supports the proposition that food crops modified to produce biopharmaceuticals are not intended to enter the food or feed supply. GMA would like to reiterate our firm position that PMPs and PMIPs should not be produced in food or feed crops due to legitimate concerns about their negative impacts on food safety. Nevertheless, GMA and its member companies acknowledge that some scientists believe that in certain cases no alternative to food and feed crops would be efficacious and, in those circumstances GMA would not disagree with the committee’s findings that “applications in food crops should also occur only in cases where similar products and efficiencies could not be obtained in alternative non-food host crops in Oregon." Additionally, GMA supports the recommendation to, "encourage the use of non-food crops or [non-] animal feed crops for biopharmaceutical applications intended for outdoor environments." It is imperative that the developers and growers should be required to justify why the food chain - other growers, processors, food manufacturers and consumers - should all take the risk of the entry into the food supply of crops modified to contain plant-made pharmaceuticals. The draft policy document states, “Applications for outdoor growth of biopharmaceuticals using food crops must include a detailed justification for why outdoor planting is considered desirable and safe. GMA recommends that this statement and requirement be modified to read “… is considered desirable, safe and will achieve the intended level of containment from a physical and biological standpoint.” We believe it is imperative to set a very high standard of segregation where open field planting is being considered and the means to achieve this standard should be examined and accepted well in advance of any commercial planting. 3. In formalizing collaboration with USDA’s Biotechnology Regulatory Services (BRS), Oregon should also have access to and follow their standard operating procedures. GMA supports the committee’s conclusion that "all required protocols and tests conducted for bio-containment (such as sterilization techniques) and public health (such as allergenicity tests) should be disclosed to designated state officials before a permit is granted." However, we believe that the committee’s recommendations should also include provisions that allow Oregon officials to have access to the standard operating procedures for, for example, approved equipment cleaning protocols and training of personnel who will be involved at all the stages of planting, growing, harvesting and processing the biopharma products. 4. Mitigation actions and an emergency response plan to address potential contamination should be specific, clearly defined, and required of permit applicants. GMA supports the committee’s recommendation to “require an outline of possible mitigation actions and an emergency response plan to address potential contamination or harm." Currently USDA APHIS Biotechnology Regulatory Services, the Federal permitting body, only requires documented standard operating procedures for prevention (e.g., containment practices, containers, equipment cleaning). However, they do not require the developer to document what it would do if something went wrong. GMA urges the committee to add to its recommendations regarding Oregon mitigation and emergency response a provision that would require developers/growers to notify state officials of problems within a time certain (e.g., Federal regulations at 7 CFR 340.4 (f) (10)). Additionally, state officials should require the developer to provide, as part of its response plan, analytical methods to identify and quantify both rDNA events as well as the expressed plant-made pharmaceutical in the food crop, its products (e.g., grains), and reasonably expected food matrices. 5. GMA believes technology providers, developers, and growers of biopharmaceuticals should be required to have adequate insurance to cover their liability in case inadvertent contamination of the food or feed supply occurs. GMA supports the committee’s conclusion “that upon permit approval for outdoor growth of biopharmaceutical food crops, applicants post a bond or demonstrate financial responsibility, to cover potential damages incurred from contamination or harm as a result of inadvertent release or the adventitious presence of the biopharmaceutical products in the food supply or environment." We believe that developers and growers who get into this business have a specific fundamental responsibility, have legal and financial liability in the case of inadvertent contamination of the food supply and the role of government officials will be to provide additional regulatory control. On behalf of GMA and its members, thank you in advance for your consideration of these comments. Please feel free to contact me for further information or should you have any questions. GMA Position Paper Plant-Made Pharmaceuticals and Plant-Made Industrial Products GMA Position: GMA firmly believes that PMPs and PMIPs should not be produced in food or feed crops due to legitimate concerns about their negative impacts food safety, on domestic and international markets for food crops, on the integrity of the wider food supply, and on otherwise avoidable regulatory enforcement actions. GMA emphasizes that food crops modified to produce PMPs and PMIPs are not intended to enter the food or feed supply. GMA supports the development of PMPs and PMIPs when done in non-food crops or in food crops only if they are amenable to stringent biological and/or physical containment. GMA believes that APHIS should also advocate this approach. GMA believes that APHIS should expand the scope of the permit application to require an early food safety evaluation by FDA CFSAN prior to issuing a permit to produce PMPs or PMIPs in food crops amenable to stringent biological and/or physical containment. GMA recognizes that food crops have been used or are being developed to produce PMPs and/or PMIPs, and believes that, at a minimum, prior to issuing a permit APHIS should require technology providers obtain a mandatory early food safety evaluation by FDA CFSAN. This early food safety evaluation would: not be an acceptance of PMPs or PMIPs in the food or feed supply. guide the USDA to allow a permit for a PMP/PMIP in a food crop only if its presence in the food supply would reasonably be expected not to cause any harm, and to set stringent biological and/or physical containment requirements in the permit in order to prevent its entry into the food supply. guide USDA to deny the development of a PMP or PMIP in a food crop if its presence in the food supply would raise any safety concerns. specify that FDA will apply enforcement discretion in the event the food supply was found to contain a PMP/PMIP food crop enters the food or feed supply. GMA supports the coordinated regulatory framework of USDA, EPA and FDA which assesses the safety of foods using science-based risk assessment and risk management techniques. For PMPs and PMIPs we believe a complete framework is needed, one that formally involves FDA CFSAN and the Association of American Feed Control Officials. GMA wants to emphasize that technology providers, developers and growers, because they are at the beginning of the chain, have a specific fundamental responsibility to ensure that the safety and integrity of the wider food supply is not compromised by the entry of crops modified to contain PMPs and PMIPs. GMA believes technology providers, developers and growers of PMPs/PMIPs should be required to have adequate insurance to cover their liability in case inadvertent contamination of the food or feed supply occurs. Definition: A number of plants can be modified with techniques of modern biotechnology to produce a range of compounds or characteristics. In many cases these compounds provide benefits to the farmers that grow the crops, such as insect resistance or better yields. More recently some plants have been modified to produce in a more cost effective way existing pharmaceuticals or industrial products, so called Plant-Made Pharmaceuticals (PMPs) and Plant-Made Industrial Products (PMIPs). These modifications can be and have been made to both food crops and non-food crops. It is important to note that food crops modified to produce PMPs and PMIPs are not intended to enter the food or feed supply. At Issue: GMA supports the responsible use of biotechnology to develop pharmaceuticals or industrial compounds which can lead to benefits such as more affordable medicines. While food crops modified to produce PMPs and PMIPs are not intended to enter the food supply, recent experience has shown that they can and will. As a result, when a PMP or PMIP food crop enters the food or feed supply the food and feed industries are faced, through no fault of their own, with a situation of adulteration and product recall. Therefore GMA believes APHIS should be advocating and encourage non-food crops, or at a minimum crops amenable to biological and/or physical, for PMP’s and PMIP’s. GMA and its members fully support the recommendation of the National Agricultural Biotechnology Council to focus research and development of PMPs in crops that can not cross with food/feed crops. The USDA has recognized the concerns of GMA and others, and strengthened the permit requirements for field tests, and ultimately commercialization, of PMPs and PMIPs. This included, among other things, significantly increasing the buffer zone around the PMP crops and requiring dedicated equipment. However, these requirements do not address previously approved events, specifically, how to contain what has already been developed or is being commercialized. Of additional concern are certain findings in the recent report of the USDA Office of the Inspector General and the response from APHIS . Currently, according to the OIG report, permit holders for PMP/PMIP crops are not required to report the final disposition of these crops, whether that is devitalization, shipment to another location, or replanting. Disconcertingly, APHIS responded that such reports are “not necessary to ensure confinement measures are met, because this information is already captured in permit conditions and preharvest reports.” GMA believes that to trust but not verify disposition of PMP/PMIP crops is woefully inadequate, particularly in light of the fact that knowing the final disposition of subject food products as part of the effectiveness check of a food recall is expected by USDA FSIS and FDA . GMA recognizes the advantages to technology providers and growers of using food/feed crops to develop PMPs and PMIPs. We also recognize that each participant in the food supply chain - technology providers, developers and growers, processors and manufacturers, and retailers – has a role in ensuring the safety and integrity of the wider food supply. In addition, GMA wants to emphasize technology providers, developers and growers, because they are at the beginning of the chain, have a specific fundamental responsibility to ensure that the safety and integrity of the wider food supply is not compromised by the entry of crops modified to contain PMPs and PMIPs. Further believes that the technology providers must also have contingency plans that include analytical methods to identify and quantify both rDNA events as well as the expressed PMP or PMIP in the food crop, its products (e.g., grains) and, where possible, reasonably expected food matrices. While GMA supports the increasing stewardship efforts claimed by technology providers, developers and growers as described in the Confinement Analysis and Critical Control Points (CACCP) approach, we believe this is only a first step in the right direction. GMA believes PMP/PMIC technology providers, developers and growers have legal and financial liability in case of inadvertent contamination of the food supply, and should be required to have adequate insurance to cover their liability. Unfortunately there is no requirement, or even an informal agreement, for the FDA’s Center for Food Safety and Applied Nutrition to perform a food safety evaluation of a food crop modified to produce a PMP or a PMIP. GMA and its members continue to request that APHIS, in its lead role, require an FDA food safety evaluation of crops modified to produce PMPs or PMIPs, prior to issuance of a permit. We do not believe this evaluation would be a burden to CFSAN. Information on safety and toxicology already exists, within FDA for pharmaceuticals and within EPA for industrial chemicals, which could be combined with reasonable exposure scenarios to evaluate the safety if the PMP/PMIP crop were to enter the food supply. Safety: The safety and efficacy of PMPs as pharmaceuticals will appropriately be evaluated by the FDA’s Center for Drug Evaluation and Research (CDER). The safety of PMIPs will appropriately be evaluated by EPA. Both PMPs and PMIPs developed in food crops also need to be evaluated by CFSAN, and those in feed crops by AAFCO. Eugene, Oregon I am a professor in the Ecology and Evolution (CEEB) section of the Biology Department at the University of Oregon. The opinions stated herein are my own and do not necessarily represent those of the University. I appreciate the hard work the committee has done on the issue of Biopharming in Oregon, and I am pleased that they are recommending strong regulatory oversight. However, I don't think the recommendations were quite careful enough. It is my view that Biopharm products should not be produced outside (in farm fields) in Oregon. Let me briefly elaborate why. First, the potential of leakage of genes into the human food supply is too high, both because of gene flow and because of the high probability of human error. Second there is too much potential for exchange of genes with wild relatives (scientific studies have shown that gene flow is common and likely). This is my biggest fear, as the risk of hybridization with wild relatives is virtually certain. It is necessary to remember that organisms evolve, and that once this particular genie is out, we can never get it back. Finally, the probability of unforeseen ecological consequences is high (for example, the deer and raccoons that eat the corn will be exposed). My recommendation would be to require that all testing and production be done in high security greenhouses that are isolated from external air (so that no pollen flow occurs). I am also concerned that the State needs to think clearly about how it is going to fund its regulatory work on this issue. The public should not be forced to foot the bill...industry should. Portland, Oregon I ask you to prohibit outdoor testing of GM plants in Oregon. Below are a few of the articles that have contributed to my position. At the end are conclusions specific to Oregon. There are lots of red flags and alarm whistles galore going off over GM. I point you to some of them below. European and Asian markets do not want to buy GM tainted produce and products. They are not being irrational. It is the US that is being irrational, in subjecting our population and the world to being guinea pigs. One of Project Censored Top 25 Censored and Under-reported news stories for 2007 is this— I give you the precis from the Project Censored site, which includes a list of references. And I hope the alert engineers at the ODOA will check this information out: Project Censored— Top 25 Censored Stories. #11 DANGERS OF GENETICALLY MODIFIED FOOD CONFIRMED Sources: Independent/UK, May 22, 2005 Title: Revealed: "Health Fears Over Secret Study in GM Food" Author: Geoffrey Lean Organic Consumers Association website, June 2,2005 Title: "Monsanto's GE Corn Experiments on Rats Continue to Generate Global Controversy" Authors: GM Free Cymru Independent/UK, January 8, 2006 Title: GM: New Study Shows Unborn Babies Could Be Harmed" Author: Geoffrey Lean Le Monde and Truthout, February 9, 2006 Title: "New Suspicions About GMOs" Author: Herve Kempf Faculty Evaluator: Michael Ezra Student Researchers: Destiny Stone and Lani Ready Several recent studies confirm fears that genetically modified (GM) foods damage human health. These studies were released as the World Trade Organization (WTO) moved toward upholding the ruling that the European Union has violated international trade rules by stopping importation of GM foods. * Research by the Russian Academy of Sciences released in December 2005 found that more than half of the offspring of rats fed GM soy died within the first three weeks of life, six times as many as those born to mothers fed on non-modified soy. Six times as many offspring fed GM soy were also severely underweight. * In November 2005, a private research institute in Australia, CSIRO Plant Industry, put a halt to further development of a GM pea cultivator when it was found to cause an immune response in laboratory mice.1 * In the summer of 2005, an Italian research team led by a cellular biologist at the University of Urbino published confirmation that absorption of GM soy by mice causes development of misshapen liver cells, as well as other cellular anomalies. * In May of 2005 the review of a highly confidential and controversial Monsanto report on test results of corn modified with Monsanto MON863 was published in The Independent/UK. Dr. Arpad Pusztai (see Censored 2001, Story #7), one of the few genuinely independent scientists specializing in plant genetics and animal feeding studies, was asked by the German authorities in the autumn of 2004 to examine Monsanto's 1,139-page report on the feeding of MON863 to laboratory rats over a ninety-day period. The study found "statistically significant" differences in kidney weights and certain blood parameters in the rats fed the GM corn as compared with the control groups. A number of scientists across Europe who saw the study (and heavily-censored summaries of it) expressed concerns about the health and safety implications if MON863 should ever enter the food chain. There was particular concern in France, where Professor Gilles-Eric Seralini of the University of Caen has been trying (without success) for almost eighteen months to obtain full disclosure of all documents relating to the MON863 study. Dr. Pusztai was forced by the German authorities to sign a "declaration of secrecy" before he was allowed to see the Monsanto rat feeding study, on the grounds that the document is classified as "CBI" or "confidential business interest." While Pusztai is still bound by the declaration of secrecy, Monsanto recently declared that it does not object to the widespread dissemination of the "Pusztai Report."2 Monsanto GM soy and corn are widely consumed by Americans at a time when the United Nations' Food and Agriculture Organization has concluded, "In several cases, GMOs have been put on the market when safety issues are not clear." As GMO research is not encouraged by U.S. or European governments, the vast majority of toxicological studies are conducted by those companies producing and promoting consumption of GMOs. With motive and authenticity of results suspect in corporate testing, independent scientific research into the effects of GM foods is attracting increasing attention. Comment: In May 2006 the WTO upheld a ruling that European countries broke international trade rules by stopping importation of GM foods. The WTO verdict found that the EU has had an effective ban on biotech foods since 1998 and sided with the U.S., Canada, and Argentina in a decision that the moratorium was illegal under WTO rules.3 Notes 1. "GM peas cause immune response–A gap in the approval process?" http://www.GMO-Compass.org, January 3, 2006. 2. Arpad Pusztai, "Mon863-Pusztai Report," http://www.GMWatch.org, September 12, 2004. 3. Bradley S. Clapper, "WTO Faults EU for Blocking Modified Food," Associated Press, May 11, 2006. — So the Europeans and Japanese are not being irrational at all. Here's another story, from a writer for the San Francisco Chronicle who specializes in agricultural subjects. She points out that not a single reason GM promoters gave for using GM have been proven true: http://www.commondreams.org/views06/0921-30.htm Published on Thursday, September 21, 2006 by CommonDreams.org Do the Gene Engineers Know Best? by Deborah Rich We Americans are eating a lot of genetically engineered food, and for no good reason. Since the mid-1990s, when corn and soybean varieties began being injected with genes from bacteria and other unrelated species, we've been paying participants in a food experiment with potentially unprecedented effects on human health, the environment and food security. By 2005, the Agriculture Department says, the vast majority of U.S. soybean acres and 52 percent of corn acres were planted with genetically engineered seed. The bounty of these acres is in our candy, crackers and chicken pot pies, in our pizza and pasta sauce, in our Coca Cola and Campbell's soups. Corn and soybeans are ubiquitous: tens of thousands of processed foods contain soy, and the typical consumer takes in 200 calories of high-fructose corn syrup per day. Alter the genomes of corn and soybeans, and you've altered the diet of most Americans. Corn and soybeans are staples of animal feeds, so we're also modifying the diets of our beef cattle and milk cows, our pigs and chickens. Yet lending our grocery dollars and stomachs to this venture gains us little. The price of modified seed includes a technology fee that effectively siphons off the bulk of any additional revenue farmers might gain from reduced pest damage or decreased management costs. Many hoped that genetically engineered crops would help the environment by cutting pesticide use. We should have known that growing crops engineered to tolerate herbicides could lead to more chemical use. A 2004 analysis funded by the Union of Concerned Scientists found that the introduction of engineered corn, soybeans and cotton caused a 122 million pound increase in pesticide use since 1996. And because resistant crops have encouraged near constant use of one or two classes of herbicides, superweeds that withstand the chemicals have now emerged and will require ever more potent poisons to control. Another hope was that gene tinkering would help end world hunger. But the dream of concocting drought-tolerant, insect-resistant, nutrient-dense supreme species ignores the reality of global markets already awash in food. Hunger and malnutrition result from poverty, not a lack of food in the world. It's unlikely that we're getting health benefits from eating these crops. Scientists are studying their possible effects. Among the findings: abnormal white and red blood cell counts and inflammation of the kidney in rats fed genetically engineered corn, accelerated growth of stomach and intestinal tissues of rats fed engineered potatoes, and immune responses in mice fed altered peas. The findings are controversial, but they should, at the very least, give us pause. Meanwhile, pollen from genetically engineered crops is on the move. In a recent study by the Union of Concerned Scientists, 50 percent of nonengineered corn and soybean varieties tested by one laboratory contained DNA from engineered versions. Chasing down and eliminating this freeflowing DNA from our seed supply, should the need arise, will require Herculean effort. The only clear reason why we're eating so much genetically modified food is that Monsanto, Dupont and Syngenta, which together control over 25 percent of global seed sales, want us to. In the United States, Monsanto dominates many a menu. It owns half of the American corn seed market, and its modified traits are present in roughly 90 percent of soybean acres. Monsanto is tossing salads too. In January 2005, it bought Seminis, supplier of 3,500 varieties of fruit and vegetable seed to 150 countries. Monsanto now controls more than 30 percent of the world's cucumber, hot pepper and bean seed sales, and more than 20 percent of onion, tomato and sweet pepper seed sales, according to the Action Group on Erosion, Technology and Concentration. Now consider that Monsanto and its cohorts are free to undertake the genetic modification of any plant variety they own. The plant varieties they don't modify, they can remove from the market. With one-fourth of the total value of the worldwide commercial seed market already coming from engineered seeds, our choices for unmodified crops and foods are rapidly dwindling. As we relinquish control over our food to the gene engineers, we must ask: Does Monsanto really know best? Deborah Rich grows olive trees near Monterey, Calif., and writes about agriculture for the San Francisco Chronicle and other publications. She wrote this essay for the Land Institute's Prairie Writers Circle, Salina, Kan. ### — Here are only a few snippets of news reports very recently— you can check the full articles out for yourselves. They prove: government reassurances about spread of GM pollen in the wild have been false; GM modified seeds spread far and have a bad effect on wildlife and birds. This from the Christian Science Monitor: When genetically modified plants go wild By Gregory M. Lamb, Staff writer of The Christian Science MonitorThu Aug 31, 4:00 AM ET In rice-growing states, traces of an unapproved genetically modified (GM) rice have been found mixed in with conventional rice meant for human consumption. In Oregon, genetically engineered creeping bentgrass, being tested for possible use on golf courses, has been found miles outside its test beds, making it the first GM plant known to have escaped into the wild. In Hawaii, a federal judge has admonished the US Department of Agriculture (USDA) for displaying "utter disregard" for the state's endangered native plant species. The judge says the USDA failed to conduct research on the environmental effects of fields of experimental corn and sugarcane that had been genetically modified to produce pharmaceuticals. Environmental and food-safety groups have asked for a moratorium on all field tests of experimental drug-producing plants until their safety precautions can be reviewed. — This from Reuters: Published on Monday, September 11, 2006 by Reuters Tainted Biotech Rice Found in Germany - Greenpeace by Jon Smith BRUSSELS - An unauthorised genetically modified (GMO) rice has found its way into the European Union's retail food sector and appeared for sale at branches of discount supermarket Aldi, environment group Greenpeace said on Monday. Rice embryos that have been genetically modified using a 'gene gun'; the blue colour results from a laboratory test that identifies a 'marker' gene. (Photo: CISCO) The biotech rice strain, known as LL Rice 601, was found in Aldi branches in Germany, Greenpeace International said in a report. At present, no biotech rice at all is allowed to be grown, sold or marketed in the 25 countries of the EU. "Tests conducted by an independent accredited laboratory have confirmed the presence of Bayer's Liberty Link rice in U.S. parboiled long grain rice sold in Aldi Nord, a major German supermarket chain," it said in a statement. — This from an Official UK Report: http://www.defra.gov.uk/news/2005/050321b.htm NEWS RELEASE Department for Environment, Food and Rural Affairs Nobel House, 17 Smith Square, London, SW1P 3JR Out of Hours Tel: 020 7270 8960 Out of Hours Fax: 020 7270 8125 21 March 2005 ISSUED ON BEHALF OF THE FSE SCIENTIFIC STEERING COMMITTEE BY DEFRA PRESS OFFICE GM CROP FARM SCALE EVALUATION RESULTS ON WINTER OILSEED RAPE PUBLISHED TODAY A study published today has shown that the abundance of wildlife differs between GM herbicide-tolerant winter oilseed rape and its conventional counterpart. Growing herbicide-tolerant GM winter oilseed rape resulted in the same overall numbers of weeds as conventional winter oilseed rape but there were fewer broad-leaved weeds in the GM crop and more grass weeds. Flowers of broad-leaved weeds provide food for insects, and fewer bees and butterflies were found in the GM crop compared to the conventional crop. Seed numbers of broad-leaved weeds were lower and numbers of grass seeds were higher in the GM crop. Weed seeds are an important food source for other wildlife and seeds from broad-leaved weeds feature strongly in the diet of farmland birds. Some beneficial soil insects were found in greater numbers in the GM crop. Fewer differences between GM and conventional winter oilseed rape were found in the number of other insects, slugs and spiders compared to the other three crops studied in the farm scale evaluations. The researchers stress that the differences they found are not a result of the way in which the crop has been genetically modified. They arose because this GM crop gave farmers taking part in the trial new options for weed control. That is, they used a different herbicide and applied it differently. — CONCLUSION: US Agriculture and food technologists jumped into widespread use of GM plants long before conducting safety studies, making the US population a nation of guinea pigs for the past 15 years or more. As the results come in, and independent labs do tests, it becomes more and more apparent. This technology tears and distorts the fabric of animal and plant life on our planet. How many red flags must be raised, how many whistles go off, before the engineers will stop a run- away train? I therefore ask the engineers at the ODOA to prohibit outdoor testing of GM plants rather than simply laying down guidelines— stop the runaway train here now, don't just work out guidelines to hope to get the train through the obstacle course of flags and warnings. Let's make Oregon a beacon of sound agriculture practice! We will only be richer economically, because the rest of the world will want to deal with Oregon. And you, the ODOA, will be morally richer, having taken off the blinders that certain interests have tried to bind around our eyes. Location unknown PLEASE reconsider the planting of the BioPharm crops outside. There is no way to keep them in one spot and the fact that they could get out and mingle with other crops is just to scary. I don't like the fact that it is being done in the first place, but if you must do it keep it inside in a green house, even there we are at risk of the seeds escaping on the clothing and shoes of the workers. Our food is already so devalued must we continue to make it worse! PLEASE stop now, this is such a beautiful planet, let's keep it that way.

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