Home Page Link AgBioWorld Home Page
About AgBioWorld Donations Ag-Biotech News Declaration Supporting Agricultural Biotechnology Ag-biotech Info Experts on Agricultural Biotechnology Contact Links Subscribe to AgBioView Home Page

AgBioView Archives

A daily collection of news and commentaries on
ag-biotech.


Subscribe AgBioView Subscribe

Search AgBioWorld Search

AgBioView Archives

Subscribe

 


SEARCH:     

Date:

April 9, 2004

Subject:

Alert! - Send Your Input to USDA/APHIS; Death By Regulation; Food Phobias - Behind the Fuss; Sweden OKs GM Potato; Explaining Biotech to the Public; Adventitious Presence

 

Today in AgBioView from www.agbioworld.org - April 10, 2004:

* Send Your Input on the USDA/APHIS Environmental Impact Statement
* Death By Regulation
* Food Phobias: Behind the Fuss Over GM Crops
* Sweden Approves GM Potato Crops
* Explaining Biotech to the Public and Students
* Cost vs. Benefit of Bt Cotton in India?
* Adventitious Presence

--

IMPORTANT ALERT TO AGBIOVIEW READERS.....!

Your Input for the 'USDA/APHIS Environmental Impact Statement: Introduction of Genetically Engineered Organisms'

** Send your Comments - On Proposed Revisions to USDA Regulations! **

Dear Friends:

The purpose of this e-mail is to request your assistance in providing comments to USDA APHIS on proposed rules notifying the public of their intent to prepare an 'Environmental Impact Statement for the introduction of genetically engineered organisms into the environment.'

The initial comment cutoff date was March 23, but the agency has extended the public comments until April 13, 2004. APHIS is being targeted by a letter writing and e-mail campaign launched by "Save Organic Food" a companion project of "The Campaign to Label Genetically Engineered Food.”

It is important that APHIS hear from the scientific community! Numbers of letters count, so it is very important that we mobilize supporters of biotechnology to respond! To that end, I am requesting that you submit your comments to APHIS before the April 13, 2004 deadline.

** Comments can be emailed to APHIS at

** Email messages should include the name and address of the sender in the message and the subject line should be "Docket No. 03-031-2"

Comments also can be provided via the APHIS web site at: http://www.aphis.usda.gov/ppd/rad/cominst.html

Please read the comments prepared by Drs. Steven Strauss, Scott Merkle and Wayne Parrott and co-signed by over 60 scientists who work on crop transformations in an academic setting at http://www.cropsoil.uga.edu/~parrottlab/APHIS

To assist in this effort, you will also find below comments prepared by Susan Harlander (BIOrational Consultants, Inc) and me.

These comments are provided as a guide. Please customize your comments or feel free to use portions of the attached texts.

Thanks in advance for your assistance! Please take a few minutes right now to send your comments!!

**********
Comments on proposed revisions to USDA regulations - 7 CFR Part 340

'Environmental Impact Statement: Introduction of Genetically Engineered Organisms'

These comments are submitted by Dr. Susan Harlander, BIOrational Consultants, Inc., in response to USDA's notice of intent to prepare an environmental impact statement in connection with potential changes to the regulations regarding genetically engineered (GE) organisms:

I commend APHIS for its continuing efforts to update its regulations. It is my personal belief that the existing tiered reviews where oversight restrictions are commensurate with potential risk and degree of familiarity has served us very well for the first generation of GE crops.
Any revisions to these regulations must be based on sound scientific risk assessment principles that protect health and the environment without undue burdens to research, development and commercial introduction of GE crops. In reviewing its current regulations, APHIS should recognize and acknowledge that the risks present from plants that have been GE are not fundamentally different from those present with plants derived through traditional breeding.

Comments on Guiding Principles

Listed below is a set of guiding principles that are relevant and should be considered by APHIS as part of the EIS process that will be used in developing amendments to the current system:

1. The assessment of environmental risk or safety of a GE plant should be based on the properties of the plant, not the process by which it was produced. It is appropriate to consider the nature of the host plant, the nature of and familiarity with the introduced gene(s) and trait, including factors that influence factors such as persistence in the environment, impact on non-target organisms, and other relevant plant-specific environmental safety considerations.

2. Regulation must be proportional to the risk involved and risks should be considered in perspective and in comparison with documented, ongoing and widespread risks that are inherent to agriculture.

3. There is a diversity of GE plants that are under development that could pose different kinds of risks; therefore, it is appropriate to implement a tiered system of regulation with discrete categories based upon potential risk.

4. There is a need to provide for early safety assessment so that GE plants meeting a defined safety standard may be present at low levels (adventitious presence) in seed and commodities.

5. It is appropriate to require reporting of adverse or unexpected effects that could impact human or animal health, or the environment.
Monitoring is appropriate when necessary to address science-based questions associated with identifiable risks, not as a routine risk assessment or management tool.

Responses to Specific Questions:

>1. Do regulatory requirements for these organisms need to be
>established?
What environmental considerations should influence this change in regulatory scope?

The focus of the regulations should remain on plant pest or noxious weed potential, and clearly indicate that GE plants are not a priori considered to be plants pests or noxious weeds. APHIS regulations and guidelines should continue to be based on the plant pest and weediness assessments that are current elements of the petitions.

>2. What environmental factors should be considered in further
>delineating
such requirements? What criteria should be used to establish the risk-based categories? Should certain low-risk categories be considered for exemption from permitting requirements? If so, what criteria should apply?

It is appropriate for APHIS to develop a system for field-testing GE plants where the level of review and oversight corresponds with the potential risk and degree of familiarity with the product and the introduced protein/phenotype. Such a system may be based upon, for example, a series of decision trees designed to place products into corresponding categories of low, medium or high risk. The criteria to be used to determine potential environmental risk and the corresponding level of review/oversight should include the nature of the host plant, the nature of the introduced gene, and the scale of the proposed trial including isolation and containment procedures to be implemented. For low risk crops/traits, the regulations should provide for an expedited process similar to the current notification process or exemptions.

>3. What environmental factors should be considered in distinguishing
between these kinds of decisions?

In keeping with the principle that regulatory oversight should be proportionate with assessed environmental risk, a system that has flexibility in making commercialization decisions is laudable. However, in the proposal put forth by APHIS there is not sufficient information to evaluate how such an approach would work. It is important to understand what would constitute "minor unresolved risks" and what kinds of traits or crop/trait combinations may require conditional approval. APHIS should define the endpoint it intends to reach when making a decision that would allow for commercial-scale planting. This will be needed to determine if environmental concerns are adequately addressed and whether there is any need to place any use restriction on the GE plant. Given the extensive data that is collected prior to commercialization it is likely that most decisions would not result in the imposition of restrictions.

>4. Are there changes that should be considered relative to
>environmental
review of, and permit conditions for, genetically engineered plants that produce pharmaceutical and industrial compounds? Should the review process, permit conditions, and other requirements for non-food crops used for production of pharmaceutical and industrial compounds differ from those for food crops? How should results of a food safety evaluation affect the review, permit conditions, and other requirements for these types of plants? How should the lack of a completed food safety review affect the requirements for these types of plants?

Novel PMP/PMIP traits should be regulated for the foreseeable future, but at different levels of stringency, until their environmental, food and feed safety are better understood. Regulations should be highly differentiated for different classes of PMP/PMIP crops based on the level of risk from inadvertent consumption or contact by humans and animals.
For example, common, rapidly digested, and highly specific antibodies might be treated with far less stringency than broad-spectrum stable toxins, and the latter should be treated much more stringently than common, rapidly degraded, non-toxic proteins used in industrial
processing.

Data from laboratory and computer screens for digestibility and allergenicity should help to assign them to broad classes prior to significant environmental release. If warranted due to the toxicological properties of the product in question, USDA should coordinate with EPA and FDA to establish acceptable, legal levels of low level presence for different classes of compounds based on such early assessments that can be revised as toxicological data accumulate. Additional allowances toward relaxed regulation of PMP/PMIP could be made when various biological or physical containment procedures and employed (i.e., use of a non-food/non-feed crop, use of a crop species that outcrosses at a very low level, use of a male-sterile parent, etc.)

>5. Is the regulation of nonviable material appropriate and, if so, in
what cases should we regulate?

It would be appropriate to regulate non-viable plant material but only in the rare instance where the material is deemed to pose a noxious weed risk. When used for specific commercial purposes non-viable material would still be subject to the regulatory authority ofother relevant regulatory authorities (i.e., FDA ). Harvested material (both viable and
non-viable) that is not used for commercial purposes would be devitalized/disposed, as outlined in existing USDA guidance documents.
For cases where non-viable material needs to be treated in a specific manner to address an assessed risk, condition could be added to a field trial permit, and give APHIS authority over how the non-viable material is to be handled.

>6. What should be the characteristics of this mechanism? To what
>extent
should this mechanism be employed for commercial production of plants not intended for food or feed? What environmental considerations should influence the development of this mechanism?

It is important that APHIS provide regulatory oversight of PMP/PMIP products and that APHIS adopt appropriate conditions that enable continued development and commercial production of these products. These products should be produced with containment measures and oversight that are appropriately aimed at relevant and important processes associated with growing, production and processing activities. The extent of regulatory oversight should be determined on a case-by-case basis and allow for reasonable and justifiable modifications of confinement standards and practices when supported by scientific data and or experience. APHIS should have the flexibility to modify and potentially relax confinement requirements once a product has been assessed and found to have acceptable food, health and environmental safety.

>7. Should APHIS establish a separate component within a revised
regulatory system to address adventitious presence? Should the low-level occurrence be exempt from APHIS regulation? If so, what are the conditions under which the low level occurrence should be allowed? What environmental considerations would apply to establishment of such allowance?

Currently, USDA regulations recognize that 100% genetic containment of field tests is impossible to obtain, and the US has no provisions, other than full regulatory approval, to address the issue of adventitious presence. It is appropriate to establish a set of criteria for assessing the potential risk of presence of low levels of GE material that have not completed the required regulatory process for full commercial use. USDA in conjunction with EPA and FDA could categorize traits/proteins as allowable in food/feed based on prior FDA review and/or establishment of an EPA tolerance or exemption from tolerance.

In addition, USDA could establish processes to review potential environmental risk for adventitious presence of GE plants. GE plants that successfully complete this review would be allowed at low levels in commercial seed or grain. This approach is consistent with the science-based tiered system discussed above, where the level of review and oversight is commensurate with the potential risk and degree of familiarity with the product and the introduced protein/phenotype. GE plant material that has not completed the required regulatory process would continue to be handled under conditions designed to limit its possible presence in commercial material.

The presence of transgenes in organic grain and/or produce continues to be a point of contention. It would be appropriate for USDA to quantify "detectable residues" by setting a 5% tolerance threshold for the presence of excluded methods. The 5% figure is consistent with the threshold for the National Organic Program's Organic Label requirements.

>8. Should APHIS provide for expedited review or exemption from review
>of
certain low risk genetically engineered commodities intended for importation that have received all necessary regulatory approvals in their country of origin and are not intended for propagation in the United States? What environmental considerations should be applied to determination of any such allowances?

Risk-based criteria could be established to delineate those imported crops/traits where exemptions would be appropriate. In general those plants that are currently imported and do not pose a significant environmental risk should be considered to pose low risk when they are genetically engineered.

>9. Should the regulation of other similar genetically engineered plants
be consistent with the regulation of genetically engineered Arabidopsis spp.? Should the exemption from interstate movement restrictions apply only to those products that meet specific risk-based criteria? What should these criteria be? What species and/or traits should be considered for this exemption? What environmental factors should be considered?

The existing exemptions for organisms like Arabidopsis, E. coli, Saccharomyces cerevisiae, and Bacillus subtilis should remain in place and be extended to include those plant/trait combinations that are eligible for movement under notification, as well as to any Agrobacterium strain that does not have wild-type T-DNA. When the plant or trait is less familiar or high risk, the exemption from interstate movement restrictions may not apply.

The experience of the past decade with plants and traits for which USDA has a high level of familiarity demonstrates that shipment can occur without significant risk of release and environmental impact. This long history of movement notification establish that plants could be moved between the states in a safe manner according to a specified set of performance standards and that continued government oversight through an official application approval process is no longer warranted.

>10. What are other areas where APHIS might consider relieving
>regulatory
requirements based on the low level of risk?

Certain products should be considered to be low risk and eligible for a simplified review. For example, in cases where the crop, protein and trait are very similar to a product already deregulated by APHIS, there is strong scientific rationale to support a "low level risk" simplified review.

>11. What environmental considerations should be evaluated if APHIS
>were
to move from prescriptive container requirements for shipment of genetically engineered organisms to performance-based container requirements, supplemented with guidance on ways to meet the performance standards?

See answer under number 9 above. Anything that is safe enough to permit free interstate shipment is also safe enough to be exempt from any particular container requirements.

**********************************************

Comments provided by C. S. Prakash

From: Prakash
Subject: Docket No. 03-031-2


1. The potential revisions in the way APHIS regulates biotech crops is a welcome move. While APHIS's existing system has been effective and protective, the Plant Protection Act gives APHIS a stronger statutory footing for its science-based oversight. The authority provided under the PPA gives APHIS flexibility to anticipate and keep pace with the evolving array of biotech solutions that scientists are discovering and companies are developing. The new authority will also ensure transparency, thus increasing public understanding of how biotechnology is tested and regulated.

2. The current risk-assessment approach has worked well. The system under which APHIS has regulated biotechnology since 1987 is effective and protective, as evidenced by the fact that more than 10,000 trials have been field tested and more than 60 biotech products have entered into commerce without adverse effect on human health or the environment.

This approach allows for the assessment of risk on a case-by-case basis for a particular trait in a particular crop of interest. This approach is equally applicable for the new products under development including in-plant pharmaceuticals, new types of agronomic traits and forest trees.

The environmental considerations under which biotech products are currently evaluated are the same environmental considerations that should be utilized to assess risk for new biotech products, for example - outcrossing to wild relatives, effect on other flora or fauna, fitness to survive outside of a highly managed agricultural environment, etc.

This process is fully capable of identifying products that may pose higher risk due to their potential impact on human health or the environment and is therefore the appropriate process for APHIS to use in evaluating the potential risk of new and evolving products of biotechnology.

3. Little would be served by categorizing products according to risk. Rather, APHIS should assess each product and develop a regulatory regimen appropriate for each product. Placing a product in a "higher risk" category would needlessly stigmatize the product, which in theory would pose no unreasonable risk given that it would be subject to a more rigorous regulatory regimen. Furthermore, not every product that might be categorized as "higher risk" would pose the same types of concern. For example, an unfamiliar protein might cause concern even though it is expressed in a plant that does not outcross. Another more familiar protein could cause a concern because it DOES pose an 'outcrossing' risk. Clearly, little would be gained by similarly categorizing two products that would likely have different regulatory requirements.

4. However, if a tiered risk system is to become part of the new regulations, individual products should be assigned a particular level of risk on a case by case basis using sound scientific evaluation. It is essential that regulations be based on the risk assessment of a particular trait in a particular species.

Assessing how a particular trait performs in a particular crop is the appropriate way to assess the degree of risk for products of biotechnology. A trait that poses low risk in one crop could potentially pose a higher risk in another crop. Likewise a transformed crop may or may not pose a risk, depending on which trait is expressed in the crop. APHIS has been employing this trait-by-speciesd approach successfully since 1987 and should continue to do so. As APHIS updates its regulations, it should refrain from creating criteria for categories of products, traits and/or species to evaluate risk.

We agree that some product types present a low risk to the environment and some new products may be perceived to have additional risk associated with them due to the degree of experience by APHIS with the product, trait or
species. As APHIS updates its regulations, it should not move toward
broadly defining or categorizing the risk associated with new traits, species or products. Rather, APHIS should continue to address risk on a
trait-by-species basis. It is through this process that APHIS can
identify the risk posed by a specific product, trait or species and develop an appropriate regulatory regimen for each product.

At first glance, it seems to make sense that products having demonstrated low risk could be classified as "low risk" and treated as such through an expedited or reduced oversight based on specific criteria resulting from experience with the plant or product. There are, however, many products in the pipeline that may be equally low in risk. If they can demonstrate ?- through product performance standards based on biology of the organism, trait and management practices - that they are also of low risk, then they should be assessed under the same principles as previously commercialized products.

5. Familiarity can be established through science. Science should be the basis for making scientific decisions regarding safety and risk. The National Academy of Sciences defines familiarity as having enough data for regulators to make a determination of safety. Many new products that will enter into the regulatory system may be new to APHIS but have substantial underlying scientific familiarity through product performance standards based on biology of the organism, trait and management practices. Additional information about the trait is learned through scientific research, laboratory work, greenhouse experimentation and field trials. APHIS should allow applicants to use all of this information to demonstrate familiarity.

*********
Reminder to AgBioView Readers:

Please write your comments in the body of the message. The message 'subject' line should read "Docket No. 03-031-2." In your message, include your name and address. DO NOT SEND ATTACHMENTS.

Send your message to

Please Remember - submit your comments to APHIS before the April 13, 2004 deadline!

**********************************************

Death By Regulation

- Dean Kleckner, Truth About Trade and Technology http://www.truthabouttrade.org/article.asp?id=1622

"I started out with nothing," a wag once said,"and I’ve still got most of it left."

That grim joke crossed my mind last week when I read the news that biotech crops won’t be taking root in Britain after all.

You may recall that just three weeks ago I was celebrating the British government's long overdue decision to let farmers in the United Kingdom grow a particular kind of biotech enhanced corn. The move suggested that Britain was ready to abandon the politics of fear and follow Spain in becoming the second European country to permit the large-scale growth of genetically enhanced crops.

But now everybody’s had a chance to read the fine print--and it turns out the British are imposing so many onerous regulations on the newly approved corn that its maker, Bayer CropScience, has decided not to release it at all. What initially looked like a victory for individual farmers and sound science has been turned into a Kafka-like defeat.

British environmental minister Elliot Morley defended the government’s charades this way: "We always said it would be for the market to decide the viability of growing and selling GM once government assessed safety and risk."

If only! The British government did in fact assess safety and risk--over the course of 15 years of field trials and four years of large-scale evaluations. It determined that this strain of biotech corn is safe and risk-free. But now regulators have imposed so many strangling restrictions that the corn won’t ever make it to market. Bayer says the corn is now "economically non-viable."

This turn of events brings to mind something Ronald Reagan once said: "The nine most terrifying words in the English language are, 'I’m from the government and I’m here to help.'"

With help like this, who needs hindrances?

Call it death by regulation. Under Britain’s harsh rules, farmers would have been required to plant the crops exactly as scientists did, as if they were running experiments rather than running businesses. What's more, Bayer would have been held liable for any unintentional crossbreeding between biotech plants and non-biotech plants in neighboring fields. That sounds like a trial lawyer’s dream come true.

"New regulations should enable GM crops to be grown in the UK--not disable future attempts to grow them," said a Bayer spokesman in the Financial Times.

By caving into a fear-mongering lobby of anti-biotech activists, the British government is telling its farmers that they must step aside while the rest of the world moves forward. Europe is a continent of old cultures and aging demographics--and its views on science and technology unfortunately belong in another century.

There is simply no evidence anywhere that biotech crops are anything but safe and risk-free. Up-and-coming nations like China and India know this and are determined to take advantage of all science can offer them. It may not be long before their agricultural know-how passes Europe’s. Here in the United States, we’ve embraced biotechnology so completely that nearly half of all corn acres and 90 percent of all soybean acres will grow genetically-enhanced plants this summer, according to figures recently released by the U.S. Department of Agriculture.

A huge irony is that Britain's Food Standards examined organic corn meal products last year and found high concentrations of fumonisin, a cancer-causing residue left behind when fungus infects ears of corn. Every brand of organic corn meal that was tested for fumonisin failed--the government had to yank all of them from the food chain. Biotech crops, of course, are much less susceptible to this kind of contamination.

Biotech crops deserve a chance to succeed in Britain and the rest of Europe--and consumers there deserve a chance to decide whether they want to utilize these products. But, before they can be accepted or rejected in the marketplace, the bureaucrats need to step out of the way and let them make it to market.

**********************************************

Food Phobias: Behind the Fuss Over GM Crops

- Phillip Killicoat, Policy, (Australia) Autumn 2004

http://www.cis.org.au/policy/autumn04/autumn04-3.htm

'The biggest problem consumers have with agricultural biotechnology is not genetic modification, but misinformation argues Phillip Killicoat'

Ignorance is a key weapon in the arsenal of lobbyists against genetic
modification (GM). In a 1998 survey gauging public sentiment towards GM food, (1) respondents were asked the question: 'Do you currently consume any foods that contain DNA?'. Two thirds confidently answered 'No'. Yet ever since humans moved away from hunter-gatherer subsistence, genetic modification has been a fact of life in food production.

The first conscious effort at genetic modification in agriculture is attributed to the 18th century Austrian monk, Gregory Mendel, who systematically cross-bred sweet peas. Since then, hybridisation and controlled cross-cultivation have led to consistent improvements in the yield and nutritional content of crops. When Francis Crick and James Watson discovered DNA in 1953, we gained the capacity to cross-cultivate with a greater degree of precision. Rather than the mate-and-wait
methods of conventional plant cultivation, genetic modification allows plant breeders to develop crop varieties more suitable for diverse growing locations.

Genetically modified crops can be divided into three broad groups depending on which 'generation' they belong to. First-generation GM technology involves altering some aspect of production, leaving the end product identical to a conventional variety. Second-generation plants possess improved nutritional content, such as protein-enriched 'golden rice'. Third-generation plants are currently being developed to provide specific health benefits by way of providing ingestible vaccines for common infectious diseases. However, the potential for GM crops to save lives in developing nations is not limited to overcoming hunger. Plant varieties have recently been developed that can detect landmines by changing colour when their roots come in contact with explosives.2

While the potential for GM crops in the developing world is significant, the issues associated with first-generation crops are of greatest concern to Australian farmers. The most common first-generation traits are herbicide tolerance and insect resistance, although drought- and salt-tolerant crop varieties are also being developed and trialled. In 2001, 130 million acres of GM crops (principally soy, cotton, canola, and
corn) were grown in 13 different countries. More than five million farmers now grow GM crops in North America, Argentina, China, South Africa and elsewhere.3 Where farmers have not been encumbered by stifling bureaucratic regulations or outright moratoria, they have enthusiastically adopted GM technology, reaping the benefits that come from agronomically--and economically--superior varieties of crops.

If genetic modification of crops is just another step in the process of more efficient and sustainable food production, why does the prospect of GM crop production in Australia elicit such rabid reactions from certain quarters? Critics such as Greenpeace and the Network of Concerned Farmers have received a tremendous amount of media coverage with claims that Australia's environment and exports will be ruined if we adopt GM crops.4 How valid are these assertions?

The environment. Anti-GM lobbyists argue that direct genetic modification of crops is unnatural and will deal a devastating blow to delicate ecosystems. They often cite a study from Iowa State University, which concluded that Monarch butterflies experienced an increased incidence of poison-induced death when they ate the leaves of insect-resistant corn. This study has since been discredited because it conveniently ignored the fact that Monarch butterflies are not normally interested in eating corn leaves, and that the quantities of leaf matter the butterflies were force-fed was far in excess of what they would normally consume.

Holding Agriculture To Ransom -- Again

Genetically modified crops are not the first agricultural development to be held to ransom by a coalition of green-left lobbyists and a group of farmers not prepared to adapt to changing practices. Australian farm history is replete with examples of extortionary conduct to prevent adoption of an innovative new technology.

* In the 1950s, dairy co-operates warned Australians that consumption of margarine would cause cancer because of 'unnatural' hydrogenation. The influential National Party leader of the day, 'Black Jack' McEwan, came up with a novel way of dealing with this new product to appease dairy
farmers: instead of an outright ban, legislation was passed that margarine be coloured pink so that people would not confuse it with butter. That margarine was considered a healthier and more convenient
alternative to butter was apparently less important than protecting dairy farmers from competition.

* The pasteurisation of milk is even more confounding. From the time Louis Pasteur found a way to kill the harmful bacteria that breed in untreated milk, it took nearly a hundred years for pasteurised milk to be sold without some form of stifling regulation or punitive tax. For many
years governments agreed with small-scale dairy operators that pasteurisation was an 'unnatural' process, and gave too much power to the downstream processors. It therefore had to be restricted. Today it is unthinkable to sell milk that has not been pasteurised.

* The commotion over GM crops also bears an uncanny resemblance to the impassioned town-hall debates during the interwar years when tractors were replacing the use of horses in broadacre agriculture. Concern about the environment and monopolistic tractor manufacturers, not to mention the loss of business for local saddlers, were cited as reasons for sticking with horses and leaving expensive tractors to renegade Americans.

The creation of uncontrollable 'superweeds' is another misplaced concern. The likelihood of herbicide-tolerance being transferred to wild weeds is effectively nil because the tolerance characteristic requires the genetic
insertion of novel genes which could not occur through natural breeding processes. In the unlikely event that the tolerance characteristic were somehow transferred, say by way of mutation, then the offending weed could be eradicated by applying a type of herbicide other than that to which the weed had supposedly become tolerant. In any case, integrated weed management techniques can satisfactorily handle any problems associated with weeds or volunteer plants in subsequent crops.

The various 'environmental' arguments used against the adoption of GM appear more concerned with preventing agricultural progress than with
preserving ecological systems. Yet by using less herbicide and pesticide, the environment is likely to experience a windfall benefit from the adoption of GM crop varieties. If green activists were true to their objective of environmental sustainability, they would be lobbying for GM agriculture, not against it.

Concentration of supply
GM technology is also opposed because it is being developed and sold by multinational companies (MNCs). As any good socialist knows, MNCs monopolise supply and reap obscene profits and so their products should
be boycotted or banned. But what sort of a philosophy is it that will deny farmers an opportunity to improve their practices simply because a company extracts some profit from the transaction? Of course companies want to make profits. But so do farmers. Unless you are a government or a thief, you only make a profit if you provide a product or service that someone wants.

In 1997, Canadian canola grower Percy Schmeiser became a poster boy for the socialist cause when he took on the agrichemical giant Monsanto
after the company alleged that he had been illegally cultivating Roundup-Ready canola, a Monsanto innovation. Schmeiser denied the claim and in turn filed a counter-suit against the agricultural group for 'contamination' of his crops via pollen flight from bees and drifts from vehicles transporting GM seeds. Unfortunately for Schmeiser, the Canadian Federal Court found that he obtained his seed by less fanciful means ('borrowing' and breeding samples from other farms) and had knowingly used Roundup-Ready canola, thus violating Monsanto's plant breeders' rights (PBR).

Schmeiser toured country town halls in Europe and Australia presenting
himself as the victim of a multinational corporation and proselytising that GM technology will spell the end of agriculture. Yet the irony is
that he actually found the GM technology useful--so useful that he was trying to produce as much of the herbicide tolerant seed as he could without being caught and without paying for the use of the technology. Moreover, were it not for the existence of the profit motive and defined and enforceable property rights, the herbicide-tolerant GM technology he found so practical would never have been created in the first place.

Most farmers know better than Schmeiser. They understand that the theft of PBR amounts to little more than modern-day cattle-rustling. As stewards of their private property, Australian farmers have a strong incentive to ensure their land's ongoing sustainability. The profit motive ensures this. Many serious farmers are quietly looking forward to the opportunity to take up first-generation GM crop varieties. Adopting herbicide tolerant and insect resistant strains means that farmers will
be able to reduce chemical application by up to 70%, and more confidently practise minimum-till cultivation. As a result, farmers can increase their gross profit margin through lower net input costs and higher yield volumes. By reducing tilling and spraying applications,
valuable management time can be freed up for the farmer to undertake other activities. The health benefits for farmers and their families
in reducing their exposure to potentially harmful chemicals is also an important consideration for primary producers.

Market access
A concern often raised in the rural press is the fear that Australia will lose its 'clean, green' image and hence lose agricultural export markets in Europe if we adopt GM crops. The EU parliament has determined that, until further notice, it will only permit imports if they are certified GM-free. EU legislators argue that the precautionary principle must apply to this 'new' technology. Since they cannot be 100% certain that nothing will ever go wrong with the technology at any point in the future, the argument goes that GM agricultural products represent an unreasonable risk to the people of Europe and must therefore be prohibited.

The real motivation for the GM moratorium, however, is to restrict further import competition for European farmers. It is an inconvenient
fact that a French farmer who has a 50 hectare block with mixed crops and some assorted livestock is unable to match the prices of an Australian farmer with a 1000 hectare property specialising in two crops for cash export. Fortunately for uncompetitive European farmers, agricultural bureaucrats are able to cajole billions of dollars worth of subsidies out of Brussels.

GM crops would give large-scale New World farmers yet another advantage
by making their output even more price competitive. The European farm lobby has attempted to neutralise this threat by having GM crops banned
and, as a back-up plan, recommending the imposition of draconian
labelling, traceability and identity preservation requirements. These extra burdens on producers from the New World who use GM technology ought to keep EU farmers in business for a little while longer. Interestingly, genetically modified ingredients used in traditional EU exports--in yeast for beer, in the distilling process for wine, and in the maturation of dairy products--do not have to meet similar segregation and labelling requirements.

To label or not to label?
The weight of evidence suggests that producers and the environment are likely beneficiaries from GM adoption. But how will consumers fare?
Since GM crops ultimately mean more efficient farming, consumers will benefit from cheaper food products. GM crops will also be healthier
than their conventionally-bred counterparts. The nutritional content of first-generation GM crops is identical to conventional varieties, with the added advantage that they have been exposed to significantly less herbicide and/or pesticide. It is curious that anti-GM lobbyists claim that consuming GM foods will cause cancer, infertility or blindness when scientific evidence indicates that such outcomes are more likely when
consuming non-GM crops that have a less predictable genetic make-up and have been exposed to greater quantities of herbicides and pesticides.

GM foods are subjected to much more rigorous testing and trialling than their conventionally-bred counterparts, and are likely to be safer for
consumers. North and South Americans have been consuming
first-generation GM food products for 15 years and there has been no recorded incidence of ill-health associated with consumption of GM foods.5 Australians have been eating meat from livestock that have been fed imported GM soybean for roughly the same period, similarly without incident.

Given the scientific evidence that appropriately tested GM food products have no deleterious health effects, it is highly questionable whether government should enforce compulsory labelling requirements for
first-generation GM foods. The problem with segregation and compulsory
labelling is that it not only imposes costs on GM-adopting farmers and downstream processors but also places an onus on non-adopting farmers to prove that their produce does not contain GM. Enforcing compulsory labelling for any one section of the farming community therefore imposes a tax on all farmers and, in turn, all consumers.

The most appropriate response from government to calls for the compulsory labelling of first-generation GM crops is to do nothing. If producers perceive that there is a demand for GM-free products they will label their goods as such and voluntarily build alternative supply
chains. Consumers can then express their preference by buying products voluntarily labelled GM-free. If demand for GM-free is as strong as some would have us believe then GM-free products will be rewarded with strong sales. There are numerous examples of companies voluntarily responding to consumer demand for information about the manner of food production, a recent case being 'dolphin-safe' tuna labelling.
Voluntary labelling works because it allows the concerned section of society to express their preferences without imposing burdens on all producers and consumers.

The biggest potential beneficiaries from the brouhaha over GM labelling may in fact be organic growers. Irrespective of whether their products
are actually better for consumers, organic farmers have already differentiated their products according to a perceived consumer demand
for more 'natural' methods of food production. Organic growers' vocal opposition to GM might therefore be seen as nothing but implicit
advertising: GM is bad, and organic is good, so buy organic.

Australia appears to be inching towards adoption of genetically-modified
(GM) crops. Genetically-modified Bt Cotton has been grown in Australia since 1999, and in July 2003 herbicide-tolerant LibertyLink canola from Bayer was approved for commercial production by the Office of the Gene Technology Regulator (OGTR). However, GM canola has since been subjected
to state-imposed moratoria and will not be commercially adopted for at least the next two growing seasons. It would appear that State
governments have succumbed to anti-GM lobbyists who wish to turn back the clock on agricultural innovation.

The question for this farming generation is whether and/or for how long
Australian governments will yield to the protests and scaremongering
of opponents to agricultural biotechnology. It would be a tragedy if the opportunity to adopt GM crops and maintain world's best practice in agriculture is hijacked by a short-sighted coalition of naysayers. Genetically modified crops may not be an instant panacea for farming viability and world hunger but like the invention and adoption of the tractor, GM technology is a step in the right direction.

Endnotes
1 Per Pinstrup-Anderson, Keynote Address, Australian Association of Agricultural and Resource Economics Society Conference (Adelaide: 2001). 2 ABC Sci-Tech NewsOnline, 'GM Plant Detects Landmines' (26 January 2004), http://www.abc.net.au/science/news/scitech/SciTechRepublish_1031573.htm
3 Clive James, 'Global Status of Commercialized Transgenic Crops: 2002,'
(Ithaca: International Service for the Acquisition of Agri-biotech Applications, 2003). 4 http://www.abc.net.au/worldtoday/content/2003/s910338.htm
5 Leighton Jones, 'Science, Medicine and the Future: Genetically Modified Foods,' British Medical Journal 318:2 (1999), pp.581-584.

--
Phillip Killicoat is an Economics graduate majoring in agriculture from the University of Adelaide and is the 2004 South Australian Rhodes Scholar.

**********************************************

Sweden Approves GM Potato Crops

- Paul Brown, The Guardian (UK), April 9, 2004 http://www.guardian.co.uk/gmdebate/Story/0,2763,1188926,00.html

Sweden has approved the growing of the first genetically modified potato - not for human consumption but for production of starch for paper. The move is likely to prove controversial in the EU, which has still to ratify the Swedish decision, because waste products from the process will be used as animal fodder and may enter the human food chain.

Debate rages over the safety of GM potatoes after Dr Arped Pusztai experimented with them in 1998. He said afterwards he would never eat them. Dr Pusztai, who was working at the Rowett Institute in Aberdeen, found that rats fed on GM potatoes developed immune system defects and stunted growth after a human equivalent period of 10 years.

His results were challenged by the pro-GM scientific community, the Rowett Institute suspended him and the Royal Society attacked him. The row damaged the credibility of those involved and cost Dr Pusztai his career but the question of whether GM potatoes were safe was never resolved, because there were no plans to grow them as food.

Pete Riley from Friends of the Earth, said: "There are a lot of questions still not answered to our satisfaction about GM potatoes and there will have to be stringent rules about keeping them away from the human food chain."

There is no evidence animals fed GM crops suffer any harm or pass on any antibiotic resistance or other traits further up the food chain but there is considerable public resistance. Gabriella Cahlin, a spokeswoman for the Swedish Board of Agriculture, insisted: "It's not a food potato."

The new potato contains high amounts of a starch that can be used in paper production, she said, although she conceded that by-products from the starch extraction would be used for animal fodder and fertiliser. This may hold up its EU approval - something the Swedes concede could take up to six years, depending on opposition.

The EU has approved about a dozen genetically engineered crops, including types of corn, rapeseed and soy beans but this is the first attempt to introduce a potato. It has already been cultivated in trials by Plant Science Sweden, and is the first GM crop in the country.

**********************************************

Explaining Biotechnology to the Public and Students

http://ucbiotech.org/ and Click on "Resources"

"Public understanding of biotechnology is a necessary factor in the public's making wise decisions about the use of this powerful technology. The university (UC Berkeley) has an important role in providing information in this area since it can be a credible source of information trusted by the public. However, effective public communication about biotechnology requires that individuals be empowered to assume active roles in educating clientele, such as practitioners, government legislators and policy-makers, the press, industry and consumers."

---
From Prakash: This site has many useful presentations including powerpoint slides, streaming video and lecture notes from Dr. Peggy Lemaux and colleagues including topics such as '"Isolating DNA from Veggies", and "The What and How of Plant Biotechnology" - a 4-page brochure. Recent presentations by Lemaux include "Food and Environmental Safety and the New Crops" and the "The Changing Landscape for Crops and Foods".

There is also information on the "Educational Exhibit" - an Educational display to describe "the way foods have changed in the past and at present using the new genetic tools. Composed of visually striking modules, such as "How Much DNA Do You Eat?", "Classical Genetics", "The New Genetics", "The Changing Face of Corn" and "Controversy". For more information, please contact balonso@nature.berkeley.edu "

**********************************************

Cost vs. Benefit of Bt Cotton in India?

- From: P.Venkatesan

Dear AC Nielsen: I have seen the message about Bt Cotton survey statement in the AgBioView. Can you please give me the actual Cost Benefit ratio (CB Ratio with reference to the total cost and receipt) For Bt Cotton and Conventional Cotton, from your survey.

---
Response From: Sunil Kumar, Communications Manager, Monsanto India Ltd

With regards to the cost factor, typically in agriculture, a farmer is willing to share 1/3 of the incremental benefit that he derives from any agricultural product. Trials with Bt cotton have shown an incremental benefit of approximately Rs. 5000 ($111) per acre (from reduction in pesticide and increased yields). This has been considered while pricing the seed. The Indian farmer will pay Rs. 1600 for the Bt cotton technology package which will cover 1.2 acres and includes the cost of the seed, the biotech trait and seed for the refuge area.

The details, as per the ACNielsen - ORG Marg survey, sought by you are as follows;

All India Average Bollgard (Bt) Non Bollgard

Cost of cultivation (Rs. Per acre) 10858 9479
Gross Returns (Rs. Per acre) 18007 13503
Net Returns (Rs. Per acre) 7149 4024
Cost Benefit Ratio 1.66 1.42

(From Prakash: 1US$ = Rs. 45)

**********************************************

Adventitious Presence

- Biotechnology Industry Organization, www.bio.org

'Standards need to be developed for adventitious presence of biotech products'

The term "adventitious presence" refers to the unintentional and incidental commingling of trace amounts of one type of seed, grain or food product with another. Adventitious presence is an unavoidable reality of plant biology, seed production and the distribution of commodity crops. There are a number of factors that contribute to commingling of approved biotech products in nonbiotech products: Pollen flow; volunteerism; mixing during harvesting, transport, storage and processing; human error; and accidents can all play a role in adventitious presence.

While adventitious presence can be minimized, as a practical matter it cannot be eliminated entirely and is not unique to crops enhanced through biotechnology. As a result, allowances for adventitious presence have been recognized in laws, regulations and standards that establish allowances for these materials. In the United States, for example, 5 percent of corn seed is allowed to be off-types for labeling purposes. No. 1 grade corn may contain no more than 2 percent foreign material; for No. 5 grade corn, it is 7 percent. Even USDA's organic standards allow up to 5 percent nonorganic substances.

Adventitious presence of biotech products does not compromise food safety. Nevertheless, the large-scale planting of biotech crops has raised the issue of adventitious presence and its impact on international trade. Currently, there are no international standards for allowable trace amounts of biotech products in non-biotech products. Instead, some countries piecemeal have started to set standards for adventitious presence. In most cases, the biotech product thresholds being discussed are unrealistically low (usually from 1 to a fraction of a percent) compared with existing allowances. Such low thresholds are driven more by the increasing sensitivity of sampling and detecting technologies and, in some cases, protectionist trade policies than by safety.

Sound, science-based regulations are needed to recognize trace amounts of approved biotech material. The lack of clear international standards has disrupted the flow of trade in seed, agricultural commodities and food. Adventitious presence has been the subject of discussion in the Codex Alimentarius, the international food standard-setting body. Internationally recognized standards will be especially important in establishing the criteria for "biotech free" foods under a voluntary labeling regime. (For more information on labeling, click here.)

The biotechnology industry remains committed to working within Codex and other international venues to establish realistic standards for trace amounts of biotech products. In the meantime, BIO believes that the U.S. government should adopt a science-based policy on adventitious presence that could become an international model. Without such a policy, the United States could find it increasingly difficult to persuade other countries to adopt similar measures, and U.S. farmers could be vulnerable to arbitrary restrictions on U.S. exports. In August 2002 the Office of Science and Technology Policy proposed new federal actions to establish a science-based policy for adventitious presence.

More resources at http://www.bio.org/foodag/adventitious.asp


####