Agnet Dec. 4/03 -- III
EFSA issues
opinions on new GM maize
Group
protests new pesticide rules at Anchorage, Alaska, agency headquarters
Manitoba
studies biodiesel potential
Scientists
must accept responsibility for anti-intellectual attitudes by improving
communication
Flint
fungicide now registered in Canada for pome fruit and grapes
how to subscribe
EFSA
issues opinions on new GM maize
December 4, 2003
European Food Safety Authority Press Release
NK 603 maize considered as safe as conventional maize
The European Food Safety Authority’s (EFSA) Scientific Panel on
Genetically Modified Organisms (GMO) has published today two opinions on
genetically modified (GM) maize NK603. The Panel has concluded that the
herbicide-tolerant GM maize NK 603 is as safe as conventional maize and
therefore that its placing on the market -- for import for processing and food
or feed use-- is unlikely to have an adverse effect on human or animal health,
or in this context, on the environment.
“These opinions have been requested as the first of a series of risk
assessments of different GM plant varieties,” said Dr. Harry Kuiper, Chair of
the Scientific Panel on Genetically Modified Organisms (GMO). “Our Scientific
Panel was recently asked to review the evidence presented on GM maize NK 603 in
order to evaluate its safety. A comprehensive environmental assessment was not
conducted as the applications for GM maize NK 603 concern only import and
processing, but not cultivation of the maize. The risk assessment process
included examination of: the DNA integrated into NK 603; the nature and safety
of the target proteins produced by the transgenic event and; the possibility
that the genetic modification may have influenced the safety, allergenicity and
nutritional value of NK 603 in comparison with conventional maize.“ Having
considered all of the evidence provided, the Panel concluded that NK 603 maize
is as safe as conventional maize and therefore the placing on the market of NK
603 maize – for import for processing and food or feed use—is unlikely to
have an adverse effect on human or animal health, or in this context, on the
environment. Following EFSA’s scientific risk assessment, the Commission will
draft proposals concerning the possible authorisation of NK 603 maize for
consultation of the Member States in a Regulatory Committee.
Background
These opinions relate to the risk assessment of a new GM maize (NK603 “Roundup
Ready” maize) and of food and feed products derived from it. This maize type
has been genetically modified to provide tolerance to the herbicide glyphosate
(commonly formulated as “Roundup”). The stated purpose of this modification
is to allow farmers to manage weeds more effectively in maize fields during
cultivation.
The risk assessment is based on two questions raised by the Commission related
to applications for the placing of the maize on the market by Monsanto under
Regulation
(EC) No 258/97 on novel food and under Directive 2001/18/EC on the deliberate
release of genetically modified organisms into the environment.
In the first question, the EFSA Panel on Genetically Modified Organisms was
asked to assess the safety of foods and food ingredients derived from NK 603
maize, and in the second question, it was requested to determine whether there
is any scientific reason to believe that the placing on the market of NK 603
maize, for import and processing, is likely to cause any adverse effects on
human health, or in this context,
on the environment. These questions followed two separate scientific assessments
which were initially carried out in the Netherlands and Spain and subsequently
evaluated by all other Member States. The EFSA assessment was requested by the
Commission because of additional questions raised as a result of these Member
State evaluations. EU legislation requires that, in such cases, EFSA should
carry out a further assessment and provide an opinion.
In delivering these opinions the Panel considered the applications and
additional information provided by the applicant and the specific questions and
concerns raised by the Member States. At the request of the Commission, the
Panel has provided two separate opinions. However, as both dossiers cover to a
large extent the same issues, a single risk assessment has been provided for
both opinions. NK603 maize has been developed for resistance to “Roundup”
herbicide by introducing a glyphosate tolerant gene. The risk assessment process
was conducted using the 2003 EU scientific guidance for the risk assessment of
genetically modified plants and derived food and feed1.
The opinions are on the EFSA web site at: http://www.efsa.eu.int/p_gmo_en.html
For media enquiries, please contact: Andy Stimpson:
Tel: +32 2 337 2221
Andrew.Stimpson@efsa.eu.int
Or EFSA Communications Director, Anne-Laure Gassin
Tel : +32 2 337 2248
Anne-Laure.Gassin@efsa.eu.int
For more background information about the European Food Safety Authority, go to:
http://www.efsa.eu.int/_
Regulatory framework/Approval process
Applications for the placing on the market of genetically modified organisms (GMOs)that
are currently transmitted to the European Food Safety Authority (EFSA) for
request of an opinion have been submitted within the framework of Directive
2001/18/EC on the deliberate release into the environment of genetically
modified organisms and/or Regulation (EC) 258/97 on Novel Foods and Novel Food
Ingredients. Under this approval process, applications are first assessed at
national level by a lead Competent Authority followed by a “Community
period” during which Member States can comment and raise objections to the
applications.
Consultation of the European Food Safety Authority is required if objections
based on
environmental or human health considerations are not withdrawn by all Member
States at the end of this period. The European Food Safety Authority is required
to provide an opinion within 90 days.
Further information regarding the EU regulatory framework for GMO authorisation,
is provided on the website of the Health and Consumer Protection
Directorate-General of the European Commission, including the European
Commission press releases of:
· 1 July 2003 on “Questions and Answers on the regulation of GMOs in the EU”,
http://www.europa.eu.int/comm/dgs/health_consumer/library/press/press298_ en.pdf;
· 7 November 2003 on the “State of play on GMO authorisations under EU
law”,
http://www.europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&doc=ME
MO/03/221|0|RAPID&lg=EN&display=).
Panel on genetically modified organisms
With the establishment of EFSA, the Scientific Panel on GMOs has been created to
deal with all GMO issues, whereas before, GMO questions were dealt among other
subjects by the Scientific Committees on Food and Plants of the European
Commission.
The mandate of the Scientific Panel on GMOs is to deliver opinions on scientific
questions relating to genetically modified micro-organisms, plants and animals.
These questions relate to the deliberate release of GMOs into the environment
and to genetically modified food and feed including the derived products. Thus,
questions may range from environmental issues to human and animal health.
The GMO Panel is composed of 21 experts. The experts have expertise in very
different and complementary areas such as biochemistry, food and environmental
microbiology, molecular biology, toxicology, allergenicity, biotechnology, food
safety sciences, environmental biology and agricultural sciences. Moreover, the
Panel seeks additional expertise from colleagues from other panels and external
experts on specific issues (e.g. feed matters, natural toxins, nutrition,
entomology, etc.), on a case by case basis.
In addition to the formal legal questions addressed to the GMO Panel, projects
of selftasking are also undertaken. For instance a working group has been
established to deliver a scientific opinion on the use of antibiotic resistance
marker genes in GMOs.
Other self-tasking projects such as post-market environmental monitoring of GM
crops are being considered for further action (see the Minutes of the 3rd
Plenary Meeting of the GMO Panel held on 2nd October 2003,
http://www.efsa.eu.int/pdf/minutes_gmo_03_adopted_en.pdf
Risk assessment of applications for placing on the market of GMOs
The EC Guidance document of the Joint Working Group on Novel Foods and GMOs1 is
used by the GMO panel as a basis for the assessment of applications introduced
within the framework of Directive 2001/18/EC and Regulation (EC) 258/97, and
prescribes the different elements to be considered in the risk assessment
process of genetically modified plants and derived food and feed.
The following elements are to be considered in the safety assessment process of
these
applications:
- the molecular characterisation of the GMO, taking into account the
characteristics of the donor and recipient organisms,
- the potential environmental impact following a deliberate release,
- the compositional, nutritional, safety and agronomic characteristics,
- the potential toxicity and allergenicity of gene products and metabolites,
- the nutritional assessment of the GM food and feed.
The DNA that is inserted into the plant genome has to be fully characterised and
any
newly produced protein(s) must be clearly identified. A homology analysis of the
expressed proteins to known toxins or allergens has to be performed to ascertain
the absence of any toxin or allergen.
1 Guidance document for the risk assessment of genetically modified plants and
derived food and feed,
prepared by the Joint Working Group on Novel Foods and GMOs, 6-7 March 2003.
http://www.europa.eu.int/comm/food/fs/sc/ssc/out327_en.pdf
If the GMO is intended to be released into the environment, the characteristics
of the GMO and its effect and stability in the environment have to be assessed,
combined with ecological characteristics of the environment in which the
introduction will take place. This includes consideration of the impact of the
release of the GMO on wild plants and on non-modified crops, as well as on
different target and non-target organisms (soil organisms, insects …)
interacting directly or indirectly with the GMO.
Analysis of the composition of the GM crop and derived food and feed is crucial
when comparing the product with its non-GM counterparts and includes the
assessment of key macro- and micro-nutrients, toxicants, anti-nutritional
compounds, and other constituents (including moisture and total ash). In
addition to the compositional analysis, agronomic and phenotypic parameters of
the crop are compared with those of the conventional counterpart to assure that
there are no meaningful changes in the metabolism or physiology of the plant.
The evaluation of possible toxicity of the GMO will be determined by the outcome
of the assessment of the biological significance of any differences identified
between the GM product and its conventional counterpart. In principle, the
toxicological assessment must consider the presence of proteins expressed as
result of the genetic modification, the potential presence of other novel
constituents and/or possible changes in the level of natural constituents beyond
normal variation. The allergenicity assessment deals with the risks to
genetically predisposed (i.e.
atopic) individuals when exposed to foods derived from GM plants with regard to
sensitisation or to elicitation of an allergic reaction. The potential
allergenicity of a protein is not a completely predictable parameter and will
depend upon the genetic diversity and variability of specific IgE response in
atopic humans. Given this lack of complete predictability, the allergenicity
assessment is based on a cumulative body of evidence which minimises any
uncertainty with regard to the protein in question. The nutritional evaluation
of GM foods includes the analysis of the nutrient composition, the evaluation of
the biological efficacy of nutrient components and the assessment of dietary
intake and nutritional impact.
With regard to the nutritional assessment of GM feeds, a full range of
physiologicalnutritional
studies should be carried out on a case-by-case basis with representative target
animals in cases where composition of the GM plant differs significantly from
the non-GM counterpart.
Request for an opinion on GM maize NK603
A request for placing on the market foods and food ingredients derived from
herbicide-tolerant GM maize NK603 was submitted to the Dutch authorities by
Monsanto under the Novel Food Regulation (EC) No 258/97. A notification for
import and processing of the same GM maize was also introduced in Spain under
part C of Directive 2001/18/EC.
NK603 Roundup Ready maize has been genetically modified to provide tolerance to
the herbicide glyphosate, commonly formulated as “Roundup.” The summary of
the notification can be downloaded from the JRC-website at:
http://gmoinfo.jrc.it/csnifs/C-ES-00-01.pdf. The proposed uses of this maize are
the same as for any other maize. The primary use of maize is for animal feed.
Maize is also processed for use in food and industrial products, such as ethyl
alcohol by fermentation, maize meal by dry milling, and highly refined starch by
the wet milling process. The majority of the maize used for food and industrial
uses is processed by wet milling to produce starch and sweetener products for
use in foodstuffs. Both lead Member States, the Netherlands and Spain, forwarded
to the Commission their initial assessment report of the product concerned,
stating that at the current scientific and technical “state of the art”,
there was no scientific evidence which indicated any risk associated with NK 603
for human and animal health, or in this context, on the environment. Food and
food ingredients derived from maize NK603 are as safe as foods and food
ingredients produced from “conventional” maize and may be used in the same
manner.
Within both regulatory frameworks, several Member States supported the
conclusion of the rapporteur Member States. However, some Member States opposed
the same conclusion, raising scientific concerns with regard to the risk
assessment and/or claiming lack of relevant data. When there is disagreement
between Member States regarding such a risk assessment, EFSA is required to
provide a scientific opinion whether there is any scientific reason to believe
that the placing on the market of the NK603, for import for processing and food
or feed use, is likely to cause any adverse effects on human health, or in this
context, on the environment.
In its evaluation the Panel considered the applications and additional
information provided by the applicant and focussed in particular on the issues
that were raised by Member States during their initial assessment of the
applications introduced under Regulation (EC) 258/97 and Directive 2001/18/EC.
The risk assessment was conducted using the EC Guidance document of the Joint
Working Group on Novel Foods and GMOs. The different issues of the safety
assessment are considered and detailed in the opinions of the GMO panel on GM
maize NK603 for Regulation (EC) 258/97 and for Directive 2001/18/EC. A
comprehensive environmental assessment was not conducted as the applications for
GM maize NK 603 concern only import for processing and food or feed use, but not
cultivation of the maize.
The opinions can be found on the EFSA website at:
http://www.efsa.eu.int/p_gmo_en.html.
Group
protests new pesticide rules at Anchorage, Alaska, agency headquarters
December 3, 2003
Knight-Ridder Tribune
Paula Dobbyn, Anchorage Daily News, Alaska
Demonstrators, according to this story, shivered outside the Department of
Environmental Conservation headquarters in Anchorage on Tuesday while protesting
the state's new pesticide regulations which took effect Sunday that allow aerial
spraying of chemicals that kill brush, insects and other pests.
River Bean, an organic farmer from Palmer, was quoted as shouting into a
microphone that, "Toxic chemicals have one purpose, and that's to kill
living organisms. Aren't we living organisms? Haven't we learned by now about
food chain contamination?"
The DEC's environmental health chief, Kristin Ryan, was cited as saying the
regulations aren't really new they've just been strengthened, and that aerial
spraying of pesticides has been legal in Alaska for 30 years, during which time
the state has issued three permits, adding, "These are really safer
regulations than what we've had in the past."
The new regulations establish a minimum 35-foot pesticide-free zone around
lakes, rivers and streams. DEC officials also can order a wider buffer beyond 35
feet depending on the topography and other local conditions, Ryan said. Around
public drinking water sources, sprayers must leave a minimum 200-foot buffer.
The old rules required no mandatory buffers, she said.
Manitoba
studies biodiesel potential
December 4, 2003
Western Producer Volume 81, No. 49
Ian Bell
http://www.producer.com/articles/20031204/news/20031204news13.html
The Manitoba government is, according to this story, setting up an advisory
council to investigate biodiesel potential.
There is small-scale production of biodiesel in the province, said Manitoba
energy minister Tim Sale.
The advisory council is expected to look into whether there's potential to
produce that fuel on a larger scale.
Scientists
must accept responsibility for anti-intellectual attitudes by improving
communication
December 2003
CSA Newsletter
Margaret A. Davidson
Via AgBioView at www.agbioworld.org
In a tour de force performance Sunday evening, Nov. 2, at the Adam’s Mark
Hotel in Denver, CO, Margaret A. Davidson delivered the E.T. and Vam York
Distinguished Lectureship to more than 400 Annual Meetings attendees. Introduced
by ASA President Bob Hoeft as a challenging and provocative speaker, Davidson
immediately confronted her audience with the schism between scientists and
"regular people." She challenged scientists to explore the role of
science in society and their responsibility for science communication in light
of current challenges.
Davidson urged her listeners to focus on the transition from research to
resource management. She used the example of nonpoint source pollution to
illustrate how science dollars could be better used to protect resources through
communication at the local level about the effects of lawn chemicals and even
dogs on water quality rather than for more research in areas such as modeling.
Pointing out the counterproductive paradigm in which scientists view themselves
as seeking truth and the media as not communicating truth, Davidson called upon
scientists to accept responsibility for anti-intellectual attitudes by improving
scientific communication. She urged scientists to reward their great
communicators--people like Carl Sagan and Jacques Cousteau--rather than
ridiculing or vilifying them.
Davidson said it was time to reward these kinds of efforts within career paths
and within the Societies. She urged attendees to create ties with their
journalism departments and the Society of Environmental Journalists. She
suggested building a bank of ideas and cultivating media attention, but
emphasized that the first step is to figure out your message: "If you
can’t tell me what the essence of your work is in 30 seconds, you don’t know
what it is."
In the context of a society that is anti-intellectual and anti-tax and a climate
of declining enrollment and membership, Davidson urged her audience to reach out
to other organizations and disciplines. Davidson invoked the metaphor of
ecology, where systems that fail to adapt, fail. "Why do we think our
institutions are different?" Driving home her point that scientists must
accept their role in politics, Davidson concluded her presentation with a stark
projection from the General Accounting Office. At current rates of federal
expenditures and taxation, after debt interest, defense spending, and 25% of
current social service spending, within 10 years there will be no money left for
"everything we do…To defend science is essential."
Flint
fungicide now registered in Canada for pome fruit and grapes
December 4, 2003
Bayer CropScience – Press Release
Campbellville, ON - Flint fungicide, a product that's performed well for US
fruit and vegetable growers for the past two years, is now registered for use on
pome fruit and grapes in Canada. Manufactured by Bayer CropScience, Flint is
registered to control apple scab and powdery mildew, as well as a number of
secondary diseases. A member of the strobilurin family, Flint is registered for
control of a broad range of fungal diseases. In apples, Flint controls apple
scab, powdery mildew, black rot, sooty blotch and fly speck. And in grapes,
Flint controls powdery mildew and black rot.
"After a challenging scab year like 2003, growers now have a reliable
source of protection with Flint," says Greig Zamecnik, horticulture
products portfolio manager with Bayer CropScience. "And Flint offers a
great alternative for growers, with more fungal diseases on the label than any
other product in its class."
Flint works by forming a powerful barrier against disease with its
"locked-in" activity to protect the leaf surface, penetrate leaf
tissue and redistribute throughout the plant. And as with all crop protection
products, Flint must be used as part of an integrated pest management program,
including rotating Flint with fungicides that have different modes of action.
Bayer CropScience is one of the world's top crop production companies with
approximately 22,000 employees and sales of roughly EUR 6.5 billion. Bayer
CropScience focuses on researching, developing and marketing innovative
solutions that meet the needs of today's growers - healthy crops, increased
yields, improved crop and food quality - while constantly striving to meet the
needs of the environment.
Agnet is produced by the Food Safety Network at
the University of Guelph and is sponsored by the Ontario Ministry of Agriculture
and Food, Plants Program at the University of Guelph, Agricultural Adaptation
Council (CanAdapt Program), AGCare, Canadian Council of Grocery Distributors,
ConAgra Foods, Inc., Pioneer Hi-Bred Limited (Canada), Ag-West Biotech, Inc.,
Monsanto Canada, Meat and Livestock Australia, National Pork Board, Pew
Initiative on Food and Biotechnology, Syngenta Seeds, Inc., Council for
Biotechnology Information, Canadian Animal Health Institute, Croplife Canada,
Syngenta Seeds Canada, Inc., Canadian Food Information Council, Saskatchewan
Agriculture, Food and Rural Revitalization, JIFSAN, National Cattlemen's Beef
Association, National Food Processors Association, Ontario Agri-Food
Technologies, Institute of Environmental Science and Research, Ltd., BC Ministry
of Agriculture, Food and Fisheries, Feedlot Health Management Services, Syngenta
Crop Protection, Ontario Corn Producers' Association, DuPont Canada, Inc.,
Office of Consumer Affairs, Burger King, Sobeys Ontario, McCain Produce Inc.,
Canadian Institute for Food Inspection and Regulation, Canadian Wheat Board,
National Meat Association, Seminis Vegetable Seeds, Ontario Soybean Growers,
Bunge, Ltd., UC Davis Biotechnology Program, Consumer Federation of America
Foundation, Optibrand, University of Idaho Department of Microbiology, Molecular
Biology and Biochemistry, Tactix Government Consulting, Inc., Plant Bioscience
Ltd., CanAmera Foods, Hospitality Institute of Technology and Management, Inc.,
Hartono and Company, Agri Business Group, Inc., and Global Public Affairs.
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