My name is Eric Sachs. I am a geneticist and Regulatory Lead,
Scientific Affairs, with 30+ years of experience at Monsanto Company. I
also represent the Global Industry Coalition on behalf of the
biotechnology industry.
This is my first contribution to the rich and important dialogue that I
have followed closely since 21 March. I am personally committed to the
development and safe utilization of modern biotechnology, including
genetic engineering of agricultural crops, to help support the global
goal of improved food security and the conservation and sustainable use
of biological diversity.
I am actively engaged in outreach and communication to the scientific
community and public concerning principles of risk assessment and risk
management, GM crop regulation, stewardship and evidence for the food,
feed and environmental safety and impacts of commercialized GM crops. I
also am actively engaged in supporting research on the economic,
environmental and social impacts of GM crops.
The dialogue and sharing of information and views in this on-line
discussion group has been excellent and I am grateful for the diversity
of perspectives and suggestions made by all of the discussants. My
contribution below is directed to several key matters raised by
discussants. My intent and hope is that these comments complement the
views already expressed, as well as highlight areas for continued
examination and vetting.
My comments focus on:
- Goals of SEC
- Scope Socio-Economic Considerations (SEC) and Triggering by the Risk
Assessment Goals of SEC
- Issues and/or Consequences of SEC Implementation
- Use of GM Technologies and Preservation of Genetic Diversity
- Farmers Rights Includes Choice of Technologies
- Scientific Uncertainty in the Risk Assessment
1. Goals of SEC
A clearer understanding of the goals of SEC under the CPB should be a
priority (Peter Phillips bottom up approach). The language of Article
26 focuses on SEC "arising from the impact of [LMOs] on the conservation
and sustainable use of biodiversity, especially with regard to the value
of biological diversity to indigenous and local communities." If the
principle goal is protection of biological diversity then we should
refer back to Article 15 to ensure that the risk assessment is
sufficiently robust to assess potential risks to biodiversity. I concur
with Jose Falck-Zepeda that more discussion is needed on the
relationship between mandatory risk assessment procedures and the goals
of socio-economic assessment. As others have stated, SEC may be
considered in the decision-making process independently from Article 26
but an assessment of the impacts of SEC is not mandatory, nor is it
applicable in the absence of impacts identified by risk assessment.
2. Scope of SEC and Triggering by the Risk Assessment
The CPB encourages research, information exchange and capacity building
related to SEC but is more limiting when considering the impacts of
LMOs. As a threshold matter, and in contrast to other provisions of the
BSP such as Risk Assessment under Article 15, taking SEC into account is
not a "shall" but a "may." By the language used, Article 26 is a rather
narrowly drawn provision that applies only to SEC "arising from the
impact of [LMOs] on the conservation and sustainable use of biological
diversity, especially with regard to the value of biological diversity
to indigenous and local communities." In other words, if a LMO has no
impact on biological diversity, there is nothing under this provision to
take into account. If some impact is identified as a result of the risk
assessment conducted under Article 15 then the Party could take into
account SEC, and then only those SEC "arising from" that impact. This
same fundamental principle is found in other international agreements
such as the International Plant Protection Convention (IPPC).
Other international obligations that Parties may need to follow include:
The General Agreements on Tariffs and Trade (GATT), The Agreement on the
Application of Sanitary and Phytosanitary Measures (SPS), The Agreement
on Technical Barriers to Trade (TBT), and the IPPC. Under the IPPC a
Party assesses the potential for an imported plant or other article to
present a risk to plant health. If such a risk to plant health is
identified, the Party is then able to consider economic impacts that
might flow from the introduction of that article in determining
appropriate controls to be applied to its introduction. Considerable
attention has been directed to the implementation of a biosafety
regulatory framework that is consistent with WTO obligations such as
GATT, SPS and TBT. See, e.g., Biosafety Regulation Sourcebook, Chapters
7 and 8 (2006) (
http://www.arentfox.com/modelbiosafetyact.pdf).
3. Issues and/or Consequences of SEC
Utilization of new tools and technologies in agriculture often leads to
ethical, moral and social questions related to distribution of costs and
benefits, as some farmers adopt new methods while others do not. While
these are important matters, they should not be the basis for delaying
use of technologies that would provide benefits to other farmers and or
consumers. The Nuffield Council on Bioethics in their discussion paper
from 2003, "The Use of Genetically Modified Crops in Developing
Countries," stated in the face of these concerns that there is an
ethical obligation to pursue modern biotechnologies responsibly to
address challenges that have not been as responsive to traditional
agricultural practices.
"There is an ethical obligation to explore the potential benefits of
biotechnology responsibly to contribute to the reduction of poverty and
improve food security and profitable agriculture in developing countries
given that GM crops have demonstrated the potential to reduce
environmental degradation, and to address specific health, ecological
and agricultural problems which have proven less responsive to the
standard agricultural tools."
Nuffield Council on Bioethics. 2003. The Use of Genetically Modified
Crops in Developing Countries. (Available at:
http://www.nuffieldbioethics.org/gm-crops-developing-countries)
In cases where policy-makers decide to include SEC in decision-making,
it becomes imperative as others have stated to consider implementation
issues and to avoid regulatory frameworks that are unscientific and
unworkable. The inability to make prompt decisions has consequences;
and in fact, delays and uncertainty may ultimately discourage technology
investment and perpetuate the problems of poverty, food security and
environmental degradation that already exist.
4. Use of GM Technologies and Preservation of Genetic Diversity
Preserving genetic diversity as an adaptive capacity resource is
achievable while utilizing additional genetic improvements from
biotechnology. Biological resources are important, particularly for
indigenous and local communities that depend on traditional knowledge.
However, there is nothing about introduced, genetically engineered
traits that is inherently risky to genetic diversity. Improved genes
are added to the genetic pool represented by locally adapted crop
varieties using conventional breeding techniques. Typically, to ensure
productivity farmers will continue to plant adapted varieties with the
same genetic diversity that existed prior to the introduction of LMOs,
except they may choose to plant newer varieties that include improved
traits introduced through biotechnology. It is misleading to state that
utilization of GM crops threatens genetic diversity since any impact on
genetic diversity would be addressed via the risk assessment. In short,
the utilization of LMOs that have been assessed for safety and
authorized for use by regulatory authorities in an agricultural
landscape is no more or less risky than utilization of traditional
varieties.
5. Farmer's Rights Include Choice of Technologies
As stated by Stuart Smyth, choice is essential to current and future
innovations in agriculture. Farmer's rights include access to new
agricultural knowledge and technological advancements that can improve
productivity, the local environment and community livelihood. Of course
it is appropriate to recognize the contributions that local farmers and
indigenous communities have made to conservation and development of
genetic resources. As stated above, these genetic resources are the
foundation for further improvements using biotechnology. The question
is not whether to choose one or the other but to recognize the potential
for utilizing existing genetic resources and improvements using modern
biotechnology in combination.
6. Scientific Uncertainty in the Risk Assessment and Risk Management
Biosafety risk assessment guidelines and procedures are designed to
enable decision-making and to limit uncertainty. If any significant
risks or uncertainties are identified they should be addressed via risk
management. Risk management procedures or conditions of use are
intended to provide a reasonable certainty that unacceptable
consequences do not occur. On the other hand, if policy makers elect to
use SEC to decide whether to utilize new technologies, based on the
inputs to this forum it is unlikely that SEC will provide sufficient
clarity or certainty to improve decision-making. As stated by many
discussants, the outcome of SEC regardless of the methods used is more
likely to highlight irreconcilable differences within the social context
than to improve scientific certainty regarding risk to biodiversity.
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