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-----Original Message-----
From: Biotech-Mod1
Sent: 29 April 2003 10:51
To: 'biotech-room1@mailserv.fao.org'
Subject: 5: Experimental trials vs. unconfined releases

This message is from Donald MacKenzie, Agriculture and Biotechnology Strategies (AGBIOS). We are a consulting firm specializing in providing public policy, regulatory, and risk assessment expertise for products of biotechnology.

This point addresses the development of biosafety regulatory systems in developing countries and specifically the importance of clearly differentiating experimental trials from unconfined (general) releases into the environment.

While it is certainly the case that regulatory systems from the developed world can rarely, if ever, be directly applied to developing regions, there are some important lessons worth noting. The commercial success of plant biotechnology in Canada and the United States would not have been possible without having systems in place to permit the routine and safe conduct of confined (experimental) field trials of plants of uncertain risk.

In this context, a confined field trial is a small-scale experimental field trial of a genetically modified plant species carried out to collect the data necessary for a complete environmental risk assessment, and is performed under terms and conditions (e.g., reproductive isolation, physical security as necessary, safe transportation, planting, monitoring, harvesting, storage, disposition, and reporting) that mitigate any impact on the surrounding environment.

The necessity of being able to safely evaluate plants of uncertain risk cannot be overemphasized. There is a crucial distinction between general (commercial) environmental releases and confined trials that has not been sufficiently well appreciated in developing countries (or, for that matter, in some developed countries), either by regulators, national biosafety committees, or capacity builders and trainers. At the level of a general release, the focus must be on rigorous risk assessment as the intent is widespread introduction of the modified plant into agriculture, usually with few or no provisions for risk mitigation. Conversely, for confined trials, the risks are not likely to be fully appreciated without data collected during the trial, hence the focus must be on risk management - the terms and conditions that are necessary to permit safe trial conduct.

Much of the current focus on developing country regulatory systems is on Africa, which risks being bypassed by the current "gene revolution" because it lacks the stable and predictable regulatory regimes necessary to create an enabling environment for the application of agricultural biotechnology. In Africa, only South Africa has successfully commercialized plant biotechnology products (insect resistant maize and cotton, and glyphosate herbicide tolerant soya) and has a working system in place for the conduct of experimental field trials of genetically modified plants. In Central and Eastern Africa, Kenya is the only country where a field trial has taken place but its process for the approval of new trials appears stalled. Uganda has reviewed an application for the trial of insect resistant cotton but it was rejected.

The capability to safely perform confined trials is crucially important in developing countries. There must be a system whereby locally developed plant biotechnology products can be assessed in experimental trials, and equally where foreign applications can be evaluated for potential biosafety impacts, prior to their release into local agriculture. The existence of a permissive environment for the conduct of experimental trials is key to continued local research and development (R&D) investment and it is equally important in providing biosafety committees and regulatory officials with experience and expertise. Again, drawing from North American experience, regulators benefited from seven years of experience with confined field trial applications prior to the first unconfined release approvals in 1995.

To date, the activities of national biosafety committees and donor organizations have focused on risk assessment and in building the scientific knowledge capacity to carry out risk assessment. While very important, these activities have failed to address the key limiting factors to conducting confined field trials. With their focus on risk assessment, biosafety committees can become paralyzed into indecision in cases where a complete assessment is not possible because of information gaps, as is often the case when product development is at the trial stage.

For confined field trials, the focus must be on the implementation of effective risk mitigation strategies rather than on exhaustive prior risk assessment. In countries with no, or limited, experience in the design and implementation of audit, inspection, and enforcement systems in other areas, such as food safety or plant and animal health, there is limited risk management capacity. At an operational level, these critical institutional and infrastructure deficiencies in basic inspection services are limiting trial approvals and cannot be overlooked during the design/implementation of a biosafety regulatory framework.

D.J. MacKenzie, Ph.D.
Exec VP/CFO, AGBIOS
106 St. John Street, P.O. Box 475
Merrickville, ON K0G1N0
CANADA
Tel : +1.613.269.7966
Fax : +1.613.269.4367
E-Mail: djmackenzie (at) agbios.com
URL : www.agbios.com
URL : www.essentialbiosafety.info

-----Original Message-----
From: Biotech-Mod1
Sent: 29 April 2003 11:03
To: 'biotech-room1@mailserv.fao.org'
Subject: 6: Re: Regulation of GMOs with homologous or native inserted genes

This is the second message from Donald MacKenzie, Agriculture and Biotechnology Strategies (AGBIOS), Canada.

This point is in response to Dr. Strauss' opening contribution (Message 1, April 28) on the regulation of GMOs with homologous or native inserted genes.

Incorporation of the "categories of risk" argument, as presented by Dr. Strauss, into regulatory systems requires a fundamental re-think of the existing approach to risk assessment of transgenic plants.

Existing regulatory systems attempt to evaluate not only the predictable consequences of inserting genes of known function into plants (or animals) but also the unintended consequences of genetic manipulation. This latter concern is related to the possibility that insertion of a genetic element into the host genome may give rise to unforeseen and/or pleiotropic effects, perhaps due to insertional inactivation or up- or down-regulating of a metabolically important host gene, or some other interaction. [Pleiotropy is the simultaneous effect of a given gene on more than one apparently unrelated trait - see the FAO Biotechnology Glossary...Moderator].

The adoption of a "categories of risk" approach to regulation, wherein certain introduced traits are judged to be less risky than others and, therefore, warranting less stringent oversight, would signal that so-called "pleiotropic effects" are not a serious concern.

The point of this response is not to make the case that "unintentional consequences" pose a significant new risk in plant breeding, as I don't believe that they do, but merely to highlight that this is a principal issue at the heart of unnecessary "regulatory cost" and complexity.

The regulatory preoccupation with "unintentional consequences" has, in large part, been the driving force behind increasingly complex data requirements for the molecular-genetic characterization of transgenic plants. It has resulted in a form of "molecular arms race", whereby developed-country regulators are in competition to develop the most stringent requirements possible, perhaps believing that increasing complexity equates to higher levels of safety. It doesn't, it's just more costly and more complex.

Not only do developers have to provide information on what genes have been introduced into the new plant, but also data on the number of copies of introduced genes and any rearrangements or deletions or truncations that have occurred. In some cases (Belgium, Japan), regulators are requiring the complete nucleotide sequence of the inserted DNA as well as the sequence of at least some of the surrounding host genome, as well as a thorough bioinformatics analysis to uncover any potential novel and/or chimeric open reading frames. While much of this information may be "nice to have", it provides little, if any, insight into environmental or food safety. There is, for example, no correlation between gene copy number and safety, or between evolutionary distance between the host and the introduced gene and safety. Elaborate molecular characterization is not a replacement for direct measurements of changes in the levels of nutrients and antinutrients, endogenous toxicants, or potential allergens in a new food product.

As was already alluded to in Dr. Strauss' contribution (and Dr. Quemada's response - Message 4, April 28), the implementation of elaborate data requirements that are not essential for determining safety plays to the strength of large multinational developers and unfairly prejudices small developers and developing countries. The push for developing "minimum necessary" standards for risk assessment must be led by the developed world. The standard should be, "has the developer effectively demonstrated safety?" and not, "has the developer used every technology available to characterize this product?".

D.J. MacKenzie, Ph.D.
Exec VP/CFO, AGBIOS
106 St. John Street, P.O. Box 475
Merrickville, ON K0G1N0
CANADA
Tel : +1.613.269.7966
Fax : +1.613.269.4367
E-Mail: djmackenzie (at) agbios.com
URL : www.agbios.com
URL : www.essentialbiosafety.info

-----Original Message-----
From: Biotech-Mod1
Sent: 29 April 2003 11:16
To: 'biotech-room1@mailserv.fao.org'
Subject: 7: Non-GM crop biotechnologies- Regulation

As a farmer I find it difficult to understand why non-GM genomics is not being hailed as the best of biotechnology. To be able to identify, mark and fast-track breeding traits such as drought, salt, frost and disease resistance is a breakthrough in our non-GM genomics plant breeding techniques and it is not weighed down by the regulatory process involved with GM crops as mentioned. Any legislation should be promoting biotechnology, but in the form of non-GM genomics, not recombinant DNA. Cell tissue selection, colchicine, protoplast fusion, grafting, plant regeneration, embryo rescue, tissue culture hybridisation, anther culture hybridisation and random mutagenesis have managed to produce consistent improvements in plant breeding to date.

Julie Newman
Network of Concerned Farmers
P.O. Box 6
Newdegate, 6355
West Australia
Ph 08 98711562
newseeds (at) treko.net.au
www.non-gm-farmers.com