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On the Berkeley-British Petroleum Proposition: Things are Often Not what they Appear.
Presented by Ignacio H. Chapela, Associate Professor University of California, Berkeley

I have tried for size the word Prostitution as best describing that for which the Chancellor and his associates would like us to sign. When faced with this concept, I have heard the proponents of this deal simply shrug and say: "But at least we can agree that it IS a lot of money – and even perhaps some science may come out of it!" So leaving prostitution aside, why not glance at the science? What would certainly come out of the BP-Berkeley facilities would be a large number of genetically altered, reproducing, LIVING organisms to be released in the public environment. In Berkeley, in the MidWest and around the world.

Genetically-modified (or "GMO") grasses, trees, algae, bacteria, viruses destined for intentional, large-scale release in the public environment. These organisms do not represent Science. If anything, they may represent our failure as scientists to assume the deep inadequacies of our understanding about living organisms and the ecology of our planet. I do not need to dwell on it: read it in the front pages of your newspapers. Despite a third of a Century and more than $350 billion dollars invested in the trinket, a hurricane remains more predictable, and a wildfire remains more controllable than GMO organisms.

Meanwhile, they have proven to be a disastrous economic proposition, not to speak of their environmental and social consequences. Cognizant of this reality, BP-Berkeley proponents would wish to rename everything in their trade to give it a fresh face of novelty: GMOs should now be called "DNA circuits", pieced together from "Biobricks" through a craft not called transgenesis, but "Synthetic Biology"; decomposition, the process which has defeated many better minds in the past may be more tractable –they suggest - if it can be renamed "depolymerization". And so on…

In the BP-Berkeley spirit I would suggest we rename "science" what used to be called "magic" in my childhood: addressing a question by drawing a cloak of confusion and secrecy over it, only to extract a pre-arranged answer to the pre-arranged question. We hear that the magic of "DNA-circuits" should also produce some science in the physics departments.

BP-Berkeley proponents wish to deny it, but the proposition that more energy can be extracted from a process than what is invested into it does not follow the phoney rules of the stock market or the wild-eyed predictions of venture capitalists. Biofuels may be convenient because they shove the tragic aspects of our insatiable consumption to the invisible corners of the Third World, but they will not change the laws of thermodynamics, nor – I suspect - will they succeed in the medieval quest for perpetual motion machines.

Do we need a solution to the crazed consumerism binge of the short two centuries we have spent burning our fossil-fuel accounts? Certainly. If we do not find it soon, the solution itself may come and get us, and we may not like it. But does the BP-Berkeley proposal address any of the questions necessary to find that solution? I believe not. At least there are very legitimate and reasonable concerns, growing by the day in the last few weeks here and abroad, that the idea of Biofuels embodied in the BP-Berkeley proposal is not only short-sighted, but fatally flawed: For a measure, Indonesia without Biofuels used to be close to 20th in the world as producer of CO2 in the atmosphere. In a few years with biofuels it is now third, only behind the US and China.

Signing the contract with British Petroleum would yoke the university to a flawed and potentially very dangerous route at least for the next decade. Because of the investments and commitments made and because of the roads not taken, most probably much longer. The evidence keeps coming in about the inadequacy and dangerous nature of the proposal, but we cannot afford to even see or acknowledge it, even before signing the contract, for fear of scaring the money away.

If we signed that contract, Can anyone seriously imagine that Berkeley would be in a position to undertake significant research to show the problems with the BP strategy? Can anyone believe that after signing the contract we could be working on alternatives that do not involve patents, immoral profit margins, economies of scale and command-and-control governance? Look at the subserviant motions of this very Senate, and answer these questions truthfully, at least to yourselves (at night, in the bathroom?).

After signing the contract with BP, will anyone ever believe our objectivity and advice as we move into the most difficult part out of the social and environmental decomposition that we live in? Chancellor Berdahl, while signing with one hand the predecessor of the BP-Berkeley agreement, the Novartis-Berkeley deal, was writing with the other hand: "The issue is not that Novartis may direct the research exclusively to topics that may yield profits for the company; it is, rather, that the perception of the objectivity of our faculty may be compromised and with it the confidence that their research is dedicated to the public good. Few would put a great deal of confidence, I suspect, in the objectivity of lung cancer research funded by tobacco companies."

The evidence is in, and we cannot afford to see it? We already missed the opportunity of listening to the best advice of our faculty. In addition to Berdahl's, the following names, and what they could have contributed are but a sampler of the many important campus voices that are clearly not represented here: Clark Kerr – the dangers of the university-industrial complex. Nancy Peluso – probable consequences of the BP deal in Indonesia. Miguel Altieri – ditto for the Amazon basin, plus the many non-patent alternatives to global disaster. Michael Watts – ditto for Asa Claudia Carr – ditto for Africa Gordon Rausser – the difference between first right of refusal and first right of negotiation. Basics of negotiation strategies. Bob Buchanan – the limits of microbial transgenesis Bob Berdahl – the possible limits to privatization Laura Nader – the impossibility of unlimited power through knowledge David Hollinger – the unsustainability of using the university as a political workhorse Tad Patzek Urs Cipolat Gray Brechin Bob Brentano Jennifer Miller Iain Boal Louise Fortmann… the list goes on.

Can we call this a "Berkeley"agreement when these and many other voices are not here? Things are often not what they appear: there are other names. This agreement, which many fear as an unacceptable private-public partnership, is very much a private-private partnership. Attention faculty in English, Music or Rhetoric: do not hold your breath for the financial crumbs to fall from the party table for your programs, because the chickens are all counted, and they carry name-tags around their necks. I mean to say: the reason why you have not heard mention of even the concept of Conflict of Interest is precisely because nobody in the partnership seems to recognize the idea.

To my knowledge the last time Conflict of Interest was considered worth visiting, again involved the Novartis-Berkeley deal. One of the overseers of that Deal, Prof Jasper Rine, stated in his legal declaration on conflict of interest caused by his simultaneous involvement in private and public science-making: "…the possibility of conflict of interest is non-existent, since the science happening in my lab at Berkeley is exactly the same as the science happening in [my outside company]" A curious but clearly faulted definition of the concept, I should point out.

It is not surprising then to see that conflict of interest levels that would have been considered unthinkable even a decade ago would not deserve even a note in the BP-Berkeley designs. The conflicts and mutual-self-serving dealings are many, large and very complex, but once again in eight minutes we are reduced to a mention of a few examples. BP-boosters propose to focus on grasses and other "DNA circuits" controlled by a company in Walnut Creek called Mendel Biotechnology. Mendel is thus a major, little-mentioned partner in this deal. Mendel has an alliance with Monsanto, the world’s monopoly of transgenic seeds, for more than $40 milllion dollars.

This long-term relationship includes a VicePresident of Monsanto on Mendel’s board; in their words, their reciprocal interests are "highly aligned". So it stands to legal reason --by some standard I suppose-- that there would be no conflict of interest between BP, Berkeley, Mendel, Monsanto, and the deployment of their products for profit over more than 200 million acres of transgenic (excuse me, "Synthetic Biology") crops?

In this proposal, Berkeley is nothing but a business partner with these corporations, professors entrepreneurs and students simply cheap labor, paying high fees for the privilege of giving their work to the right corporation. Principals in Mendel's Board of Directors and Scientific Advisory Board are Prof. Brian Staskawicz, of Berkeley, and Prof. Stephen Long of the University of Illinois (the other business partner in this Proposal). Both entrepreneurs' interests inside campus and out are probably so identical that they do not need to worry about conflict of interest.

Whether their students can maintain such clear alignment in their allegiance between finding out what is true and publically desirable and finding out what is profitable might be a different question. Chris Sommerville, CEO of Mendel, has been apparently rushed in to Berkeley through a secretive and highly irregular flash-hire process to be safely on the UC side as a professor for the signing of the agreement. His campus interviews, behind closed doors, apparently happened last Tuesday, although the Chancellor had already announced more than a month ago that he would unilaterally appoint him.

Not surprisingly, there is no outward sign that the Academic Senate even knew about all this. Oh, I nearly forgot: Mr Sommerville's wife is reportedly also getting another professorial position at Berkeley through the same process – I am not sure what she does professionally. Of course, no contract will be official without the signature of the Regents but here again, the Chair of the Regents, Richard Blum, stands in multi-million-dollar conflict of interest over his financial engagement with "development" corporations that are already signed on to begin the digging and concrete-pouring in Strawberry Canyon, as has been well documented by investigative journalist Peter Byrne.

Prof. Dan Kammen's description of the goals here is appropriate, and seems to describe the real environmental interest in the BP-Berkeley proposal: He said that the goal of the BP-Berkeley deal was "to generate an ecosystem of companies". We now have an inkling of the "biodiversity" making up this "innovation environment"; now we know that what is really meant here is a trophic web of favoritism that would have shamed the Soviet system, in an environment of profit-driven conflict of interest.

BP's Benefit

As the smell of depolymerization (British Petroleum-word for decomposition) continues to emerge from the extraordinary proposition, few stop to ask what else would BP get out of all this. Time is short, so we are back to citing samplers from a much larger collection. I will leave a marker here for what I think is the most important benefit to BP apart from the obvious greenwashing and the very large public subsidization of its faulty science, research development, distribution and marketing: the liability haven provided by Berkeley.

If the production of Synthetic Biology "DNA circuits" entails with it very clear risks, Berkeley is providing an unrivalled degree of protection against public scrutiny, through the abuse of the public privilege assigned to us in the Constitution of the State of California to conduct our affairs in privacy, for academic freedom's sake. This privilege can also be used, as if it were a private right to secrecy, to deflect public inquiry and to protect BP, Dow, Monsanto, Mendel, Savia, Amyris and the rest of the "ecosystem of companies" from the evident and imminent liability in Moral, Fiduciary and Legal terms associated with the release of herbicide resistant weeds, algae, all kinds of microbes, crops and the rest of it.

Thanks

It is not all bad. I want to thank the many students and faculty who are awakening to the situation of their university, the public of California and the world who understand what is at stake and will hold us accountable for it, as they are doing here tonight. But I also want to thank British Petroleum, not for the $500,000,000.00 – which, at $600 of after-tax profit per second for last year does not represent much - but for the arrogant and reckless style with which they have come to our Campus. With this they have already helped uncover the depth and breadth of the problems with/for our university that this proposal entails.

These problems were really in need of public attention, and they will get it. I Believe that I stand here for a majority within this campus, throughout the State and in the world who also believe that the time has come to re-take control of our institutions as the only possible way forward from the enormous environmental and social catastrophe that we are already living through.

I Trust that this Academic Senate, the only legitimate body of representation for our faculty, will stand up against this last push to declare us irrelevant in the worst moment of social and environmental need. I know that the people of California will demand a better university for themselves, because without it, their options for a survivable future, let alone a future they might desire, are dim.

Let there be light.
~Ignacio H. Chapela, Associate Professor University of California, Berkeley

Article of Interest by Dr. Chapela:

Dr. Ignacio Chapela on Controversy, Corn and What's Really at Stake in Mexico

In our December 2001 issue, we reported that transgenic corn was found in Oaxaca, Mexico by researchers David Quist and Ignacio Chapela. Dr. Chapela is a microbial ecologist at the University of California at Berkeley and member of the PAN North America Board of Directors. The news is especially troubling because it means that GE corn strains now occupy the center of diversity for the world's maize. It also indicates, as you will read below, that the behavior of the introduced DNA is unpredictable and uncontrolled.

The scientific journal Nature first published the Quist/Chapela study in November 2001 after rigorous peer review. But in April the journal did an about-face, running an editorial and two letters that were extremely critical of the study's conclusions. The controversy was fueled by a barrage of emails to a science oriented listserv that were later traced to a public relations firm tied to Monsanto.

The GPC found that Dr. Chapela had weathered the media storm with a remarkably even temper. He was much more concerned with the long term risks of GE crops and the plight of small farmers in Mexico. However we think it is important to note that Dr. Chapela's petition for tenure is pending at UC Berkeley, and that when the conclusions are uncomfortable, scientific inquiry has been known to have a price. We hope, in this instance, that the price will be paid by Monsanto, not Dr. Chapela.

GPC: The controversy around your study has confused the findings. Is transgenic corn growing in Mexico?
Ignacio Chapela: The reality of contamination of Mexican corn has never been challenged. The group trying to discredit the study said that it was a "no brainer." What they were challenging was our secondary statement, which was based on a separate finding that doesn't have anything to do with the fact of contamination per se. They argued with our technical process -- the inverse PCR method (Polymerase Chain Reaction) -- that we used to analyze where the transgenic DNA was located within the genome of the corn in Mexico. Our experiments revealed that the transgenic DNA is turning up in unpredictable places. That is the finding that is open to interpretation.
Here's a metaphor to explain what the controversy is all about. Let's say you're looking for a planet. You have methods to find out whether there is a planet out there, and other methods to describe the surface of the planet. You take a telescope which is one method. Let's assume the telescope has just been discovered a few years before (which is the case with the method we used to analyze the DNA). You train your telescope, and you take a picture. The picture is really grainy, and you interpret it. You say, "What I see looks like a valley, a river and forests."
What these people who are challenging the study are saying is: "It's not true, it's a grainy picture and what they see as a valley is really a crater, and that forest is really a lake bed. Therefore they're wrong, and the report of the existence of this planet is also wrong." So you have different interpretations of the same photograph, but those interpretations do not disprove the fact that the planet is actually there.

It's not surprising that equally legitimate interpretations exist, given the fact that this was the first attempt to describe where the transgenic DNA is located. But the different interpretations have been exaggerated, to make it look as though there is no legitimacy to the study as a whole, and to deny the reality of the contamination.

GPC: Have others confirmed your findings of contamination?
IC: The Mexican government set out a series of four or five independent studies over a year-long period, and every time they've looked, they have come up with the same results. Contamination is there; it's widespread, much more widespread that the numbers we provided. If you look in the valleys, areas of industrial agriculture, you find more, closer to the roads you find more. No matter how they look at it, they continue to confirm our results.

GPC: Is anyone else following up on the discovery?
IC: The CEC (Commission on Environmental Cooperation), the environmental branch of the North American Free Trade Agreement (NAFTA) is going to look at the question of contamination. The CEC was created to look at environmental problems associated with free trade, in response to concerns that NAFTA would have negative environmental impacts. CEC has looked mostly at chemical pollution problems, and there has been some remedial action that has been somewhat effective, but CEC is open to all kinds of influence.

Several NGOs, driven by Greenpeace and Estudios Rurales y Asesoría and others made a formal request for an examination of contamination that CEC could not overlook. I think it's important to keep their feet to the fire, and make sure that the panel that the CEC puts together is comprised of people who are not open to influence from the industry.

GPC: If the Mexican government banned the commercial cultivation of GE corn in 1998, why is GE corn so widespread?
IC: Mexico has a schizophrenic relationship to corn. On the one hand, it is the most sacred place for corn, but on the other, it is the place that people go to experiment. Biotech companies have experimental fields all over the country.
The other reason is trade. Mexico has had a long term policy to basically get rid of campesinos, to get rid of a whole way of life, based on small scale, family and community agriculture, because it's not competitive in international markets. The policy has been to remove people from the land, to train them to assemble VWs or tennis shoes, work that brings in hard currency.
The government has put in place all kinds of disincentives for local agriculture and incentives for opening the country to imports. In the year 2000, five to six million tons of corn entered Mexico from the U.S., out of which 30% to 40% was transgenic but was not segregated or labeled. That very same year Mexico had exactly the same amount of domestic corn rotting away, unused. It was being imported under the label of grain, under the assumption that grain is different than seed. In the U.S. that differentiation exists, but in the rest of world, you eat what you plant and you plant what you eat.

The corn that comes into Mexico gets distributed through welfare food systems around the country. It is subsidized from beginning to end by U.S. taxpayer dollars. Incredible amounts of money goes into the production of this grain that receives subsidized water, soil, machinery and oil, is subsidized in international markets, and subsidized again in Mexico through distribution. It just floods the country. When you talk to a farmer in Oaxaca, they say, "It costs six pesos to grow seed; I can buy it for four." The farmer is paying out of his or her pocket to plant his or her own seed. Whereas the seed which has traveled many thousands of miles from the U.S. is 20% cheaper than the seed you can produce yourself. This is a recipe for disaster.

For the people I talk to in Oaxaca, this problem is not new. They are welcoming the controversy because it's drawing attention to what they have been saying for decades; "This is connected to the campaign to get us off of the land, and to stop us from growing our own food."

GPC: What is the risk with the introduction of GE corn? What's at stake?
IC: I think the stakes are really high -- they could not be higher. The greatest risk is again for those people who are not here and do not have a voice. What I mean is the consequences are very serious for future generations, for indigenous people, for non-humans, for those that we tend to keep on the margins. What we're risking is their future, which, like it or not, is intricately connected with ours.
Very simply in terms of direct impact, the sustainability of our food supply is at stake; we're playing with the diversity of the genetic heritage which people in places like Oaxaca have maintained for 10,000 years. If we lose it, we open ourselves to serious agricultural failure in the future. It's probably not going to be our generation, but future generations will find themselves without the resources they will need to confront the challenges that come their way. I also fully expect that the transformations that we're doing to the DNA of this planet are going to find their way into the human genome sooner or later. In that sense our descendants are going to be confronted with this. We can expect that what we're doing in corn will come back our way, either directly through genomic transformation or indirectly through the development of antibiotic resistant bacteria, through viral mediated transformation of bacteria, insects or other organisms, or through horizontal gene transfer. To me, those are the most important consequences.

There are also specific consequences that are limited now because they haven't yet been deployed on large tracts of land. Corporations are about to introduce, with exactly the same lack of control, spermicidial corn, plastic producing corn, pharmaceutical producing corn. These crops could have very direct impacts on people who are eating the food and living nearby.

GPC: What do you think can be done about this?
IC: I have a feeling that we should be able to stop it at this point. The risk is too great and the benefit isn't there. There is no added benefit for anybody, not for the farmer, not for the consumer, not even for the companies; they are running in the red all the time. Why are we doing this? At what cost, and what risk? People say "But the genie is out of the bottle; there is nothing that you can do." But there is a whole history of technologies that did not get developed because they were not viable or were too dangerous. More importantly, we must remember that we are not talking about one single "genie." Biotechnology promises to release many thousands of novel organisms in the future that we cannot imagine today. In that sense, there are very many "genies" in very many bottles. These bottles are still closed, and I think they should remain so.

References: "Transgenic DNA introgressed into traditional maize landraces in Oaxaca, Mexico," David Quist & Ignacio H. Chapela, Department of Environmental Science, Policy and Management, University of California, Berkeley, California 94720-3110, USA; Nature, Volume 4141, November 29, 2001, pp. 541-543, http://www.nature.com; Correspondence, Nature, Vol 4171, June 27, 2002, p. 897, http://www.nature.com; "The Fake Persuaders," George Monbiot, The Guardian, May 29, 2002, http://www.alternet.org/story.html?StoryID=13236.
Background articles: "Kernels of Truth", Kara Platoni, East Bay Express, May 29, 2002, http://www.eastbayexpress.com/issues/2002-05-29/feature.html/1/index.html, "Mexican Maze Maize Madness, Part 1 and Part 2," Anna Salleh, ABC Science Online, (Austrailian Broadcasting Company) July 4, 2002, HPERLINK http://www.abc.net.au/science/slab/mexicanmaize/.



Want to read more information? Below are PDF documents you can read or print out.

GE-Free Sonoma County Initiative
GE-Free Sonoma County Overview

Visit the GE-Free Sonoma County website at
www.gefreesonoma.org

Contact GE-Free Sonoma at 707-823-4410
What is a GMO?

A GMO is an organism that has been modified by the insertion of DNA by human intention. It is usually DNA which has been modified or engineered to suit a particular purpose. The DNA can be from a foreign organism, from the same organism or it may be a sequence synthesized in a laboratory. GMOs are "made with techniques that alter the molecular or cell biology of an organism by means that are not possible under natural conditions or processes."
~National Organic Standards Board

Isn't that just like hybridization?

No, genetic engineering is a radical new technology for altering the traits of living organisms by adding genetic material that has been manipulated outside of cells. No version of traditional plant breeding can add genes from oak trees to wheat, much less genes from horses. Only genetic engineering can accomplish such transfers because only genetic engineering transfers genes by artificial means that disregard natural boundaries.
~Union of Concerned Scientists

The Initiative Costs-
Oregon Measure 27
Mandatory Labeling Initiative

In early October, before the media and direct-mail onslaught, polls showed that about two-thirds of Oregon voters favored Measure 27.
The biotech industry, led by Monsanto, used its sizeable resources to tell Oregon voters that the initiative would cost the average family $550/year.
An independent researcher determined the annual cost would be between $.26 and $10 per person.

What's on the Shelf?
60-70% of the foods on grocery store shelves contain genetically engineered ingredients. Genetically engineered corn, soy, canola, and cotton are the most common source of these ingredients...

Crackers, cookies, chips, cereals, salsa, tomato sauces, salad dressings, infant formula, baby food, meat alternatives made with soy, juices, soda, powdered drinks, frozen pizzas, frozen dinners, energy bars, meal mixes, baking mixes, dairy products, animal products, detergents, vitamins.

Statement By Prof. Ignacio Chapela on the effects of Measure M on the availability of drugs and vaccines for people and animals in Sonoma County. 10/16/05
I am writing in connection to the current discussion about the relationship between Sonoma County's Measure M and vaccine production and use.

I am Associate Professor of Microbial Ecology at UC Berkeley, and have been engaged in research and education around environmental aspects of GMO release for the last 10 years, while I have also actively worked on policy aspects of genetic resources for more than 15 years. In the latter field, I was part of an ad-hoc committee of the National Academy of Sciences reviewing the potential impacts of the commercial release of GMOs into the environment, and have served in an advisory role to several national and multilateral agencies in this area. Further, I have taken part in the multiple discussions emerging in California, the Nation and the world on these topics, specifically around the viability and desirability of areas free of open-field transgenic releases into the environment. On occasion, I have been requested by the proponents of Measure M in Sonoma County to provide them with technical advice. From this engagement, I consider myself familiar with the Measure.

It has come to my attention that a technical challenge to Measure M has arisen posing delicate and important questions . The main question is whether the Measure would ban or otherwise restrict the research, development, use or other application of recombinant vaccines. Because this question lies in the diffuse interregnum between medical, veterinary and environmental disciplines, I realize that it can be very confusing and prone to misleading interpretations.

However, after careful analysis and consultation, I am convinced that there is no room for ambiguity: in my understanding Measure M would not affect any existing or foreseen vaccines, with the obvious exception of the open-field production of antigenic proteins by domestic plants or animals, an application which is clearly in need of more careful research and regulation, and which is rapidly losing interest from the scientific community. Below, I will develop my arguments for this position, which I hope you will find useful in your own deliberations.

The overarching principle: "alive and reproducing"?
The principle established by Edward Jenner through his daring experiment of infecting the boy James Phipps with cowpox to protect him from human smallpox in 1796 stands today still as basic to the concept of vaccination, and has two main tenets: (a) a vaccine must induce the patient's immune system to recognize and neutralize a target agent , (b) without the immunizing agent moving to infect other members of the patient's population. Both of these tenets must apply since an intervention which fulfils tenet (a),but not (b) cannot be called a vaccination, but rather an intentional epidemic in the making, while an intervention fulfilling tenet (b) but not (a) is simply ineffective to prevent the development of the target agent.

All modern and foreseeable forms of vaccination conform to these two tenets, explicitly including the non-infectiousness of the immunizing agent (the "vaccine"). Because Sonoma County's Measure M refers exclusively to organisms that can reproduce in the environment ("transmit their DNA" in the language of the Measure), any vaccine conforming to the basic principle of non-infectiousness is clearly excluded from consideration.

Some of the older vaccines (e.g. chickenpox and MMR) and several new approaches to vaccination include the inoculation of a patient with various viral forms which may be considered "live", and might even replicate within the patient to a limited extent. However, in all cases currently available or under development, the immunizing agent does not leave the individual patient to move infect other organisms in the patient's population or other organisms of different species. In other words, these immunizing agents cannot be considered "reproducing" in the environment, even though they might even replicate within an individual. For this reason, Measure M would not apply to any of these vaccines.

Cases where confusion might arise regarding the applicability of Measure M.

Below I briefly review seven different classes of practices which could be considered unclear in the application of Sonoma County's Measure M. As this analysis shows, no major category of vaccine production or delivery available today or in the pipeline would be affected by Measure M, with the obvious exception of the proposal to grow open-field crops that express antigenic proteins or adjuvants.

1- Traditional (non-recombinant) "live" vaccines, such as the polio, rabies, smallpox and MMR vaccines. Several vaccination methods, including the greatly successful polio vaccine, are based on the inoculation of patients with viral particles which, although capable of reproduction, are predictably rendered non-infectious by virtue of dosage, administration route or natural attenuation. Although there might be the suggestion to transgenically modify these traditional vaccines, none of these live virus vaccines would be affected by Measure M because they cannot be said to be reproducing in the environment, which is the standard of definition of the measure. Some difference of interpretation could be found in this respect with those who consider replication of the virus in the individual patient as a form of "reproduction", even though at the environmental (epidemiological) level the virus materials administered in these vaccines are not reproductive since they are not passed on from the individual patient to the host population (human or animal) in general.

2- Several vaccines vectored in the canarypox virus, such as the commercially-available West Nile virus vaccine (Recombitek). Transgenically-modified viruses in the canarypox or other avipox vectors have been developed for immunization using "live" viruses, i.e. viruses which can replicate -at least partially- within the host patient. Avipox viruses are complex and their reproductive viability is apparently dependent on the integrity of their genome and on the compatibility of the animal context in which they attempt to reproduce. The transgenic manipulation of avipox viruses is reported to result in their attenuation, i.e. their incapacitation to reproduce successfully in the host population. The manufacturers of these vaccines have established that although the virus will produce virion particles within the individual patient inoculated with these recombinant vaccines, these virions are abortive and cannot further reproduce, especially not when passed on to other members of the population. For this reason, these viruses cannot be considered "live, reproducing" in the sense of Measure M, which is focused on the transmission of recombinant DNA in the environment. Because these viruses do not reproduce in the host population beyond the individual inoculated with the vaccine agent, they would not be affected by Measure M.

3- Vaccines for various targets, vectored by adenoviruses such as Merck's Ad5 vector. A typical example of this kind of viral vector is the Ad5 construct, which is explicitly designed and tested to be replication-defective. Although proteins are synthesized in the host cells deriving from genetic material introduced by the viral vector, no infective virus particles are passed on to the population of the host. To the extent that these viruses are epidemiologically-inert (i.e., they do not infect other members of the host population beyond the inoculated patient), they would be excluded, by definition, from the application of Measure M, which focuses on the reproduction of transgenic organisms in the environment.

4- Vaccines vectored by RNA-viruses, such as the Venezuelan Equine Encephalitis (VEE) virus. Although not the most favored strategy, RNA-viruses are currently being proposed as possible vectoring agents for recombinant immunization. Here again, the virus is rendered replication-incompetent through the deletion of capsid-encoding and other genetic regions necessary for replication. To the extent that the products of these viruses in the host cells are non-reproductive and non-infectious to other members of the host population (i.e. epidemiologically inert), these vaccination strategies would not be affected by Measure M.

5- DNA vaccines. Recent approaches to immunization include the direct introduction of naked- or adjuvant-associated DNA. Such DNA, often included as a plasmid construct, participates to a limited extent in the synthesis of RNA and proteins in the host which are thought to be responsible for the activation of the immune system. However, this participation is commonly restricted to specific tissues and is not enough to result in any form of reproducing living organisms which can be successfully passed on to other members of the host's population in the environment. Such non-reproducing DNA vaccines would naturally be excluded from the application of Measure M.

6- Immunogenic proteins (antigens and adjuvants) produced in bacterial or mammalian host cells in production plants. A growing and successful approach to vaccine production is the transgenic manipulation of cell cultures of bacteria or other organisms (including human tissue culture) by inserting DNA sequences from the target agent (virus, cancer cell-line, specific tissue) into the genome of such recipient cells. Such transformed cells thereby produce a subset of the viral proteins, which can then be used as the antigens for a successful vaccine. This particular case is clearly outside the scope of Measure M, since the stages of production for this kind of vaccine that require the use of living, reproducing organisms are always practiced in fermentation or tissue-culture plants, not the open, public environment. Undoubtedly, escapes of living reproducing organisms from these production facilities would be undesirable and would be covered by other statutes and regulations already in place.

7- Finally, there is only one kind of suggested vaccine production system which in my view would be clearly affected by Measure M. This is the production of antigenic proteins or DNA for vaccine use in plant hosts, under open-air field conditions . Among these proposed practices are so-called "edible vaccines" which would be composed of food plants transgenically manipulated to express proteins of immunogenic value (as in 6 above). Because the transgenic crops thus produced would be live, reproducing organisms able to transfer their DNA out into the wider population of their conspecifics, this application would fall squarely within the scope of Measure M. I believe that you will agree that the open-field planting of commercial crops which have been transformed to express immunogenic proteins should be the subject of much more research before it would be authorized for widespread use, just as should be the case with pharmaceutical-producing transgenic crops.

In conclusion, it is my firm conviction that on principle and in practice, none of the existing, researched or even foreseeable vaccine applications of transgenic organisms would be affected by Sonoma County's Measure M, given that in all cases the genome containing the transgenic manipulation cannot be "transmitted through the reproduction of the recipient organism" in the environment, as defined by the Measure. The obvious exception, the attempt to produce antigenic proteins in open-field food crops is clearly covered under Measure M, as I believe it should.

I remain available for further comments at the address below.

Sincerely,
Ignacio H. Chapela, PhD
Associate Professor (Microbial Ecology) Dept. of Environmental Science, Policy and Management
334 Hilgard Hall, University of California, Berkeley, CA 94720

 

 

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